Unassociated Document
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): September 23,
2010
NeoStem,
Inc.
(Exact
Name of Registrant as Specified in Charter)
Delaware
(State
or Other Jurisdiction of Incorporation)
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0-10909
(Commission
File
Number)
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22-2343568
(IRS
Employer Identification No.)
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420 Lexington Avenue, Suite
450, New York, New York 10170
(Address
of Principal Executive Offices)(Zip Code)
(212)
584-4180
Registrant's
Telephone Number
Check
the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2.
below):
x
|
Written communications pursuant
to Rule 425 under the Securities Act (17 CFR
230.425)
|
o
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
o
|
Pre-commencement communications pursuant
to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
o
|
Pre-commencement communications pursuant
to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
1.01.
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Entry
into a Material Definitive
Agreement.
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Agreement and Plan of
Merger
The Board
of Directors of NeoStem, Inc., a Delaware corporation (“NeoStem” or the
“Parent”) and
the Board of Managers of Progenitor Cell Therapy, LLC, a Delaware limited
liability company (“PCT”), have
unanimously approved the merger (the “Merger”) of NBS
Acquisition Company LLC, a newly formed wholly-owned subsidiary of NeoStem
(“Subco”), with
and into PCT pursuant to an Agreement and Plan of Merger, dated September 23,
2010 (as such agreement may be amended from time to time, the “Merger Agreement”),
among NeoStem, PCT and Subco. PCT, in its capacity as the limited
liability company surviving the Merger, is hereinafter sometimes referred to as
the “Surviving
Company.”
Pursuant
to the terms of the Merger Agreement, all of the membership interests of PCT
outstanding immediately prior to the effective time of the Merger (the “Effective Time”) will
be converted into the right to receive, in the aggregate, 11,200,000 shares of
the common stock, par value $0.001 per share, of NeoStem (the “NeoStem Common
Stock”) and warrants to purchase an aggregate of no less that 1,000,000
and a maximum of 3,000,000 shares of NeoStem Common Stock, based on the
following:
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(i)
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common
stock purchase warrants to purchase one million (1,000,000) shares of
NeoStem Common Stock exercisable over a seven year period at an exercise
price of $7.00 per share (the “$7.00
Warrants”), and which will vest only if a specified business
milestone (described below) is accomplished within three (3) years of the
closing date of the Merger (the “Closing Date”);
and
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(ii)
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if
the volume weighted average of the closing prices of sales of NeoStem
Common Stock on the NYSE-Amex for the three (3) trading days ending on the
trading day that is two (2) days prior to the Closing Date (the “Parent Per Share
Value”) is less than $2.50, common stock purchase warrants to
purchase one million (1,000,000) shares of NeoStem Common Stock
exercisable over a seven year term at an exercise price of $3.00 per share
(the “$3.00
Warrants”); and
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(iii)
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if
the Parent Per Share Value is less than $1.70, common stock purchase
warrants to purchase one million (1,000,000) shares of NeoStem Common
Stock exercisable over a seven year period at an exercise price of $5.00
per share (the “$5.00 Warrants”
and, collectively with the $7.00 Warrants and the $3.00 Warrants, the
“Warrants”).
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The $7.00
Warrants will not vest and will not become exercisable unless the Surviving
Company secures, prior to the third annual anniversary of the Closing Date, one
or more material binding commercial manufacturing contracts with one or more
third parties, each on an arm’s length basis, which commercial manufacturing
contracts result in aggregate revenues to the Surviving Company in excess of $5
million per year over
a period of at least three (3) years and in the reasonable judgment of the
Parent’s Board of Directors, the manufacturing contracts will be profitable each
year during the term of such contracts in accordance with generally accepted
accounting principles as in effect in the United States (“GAAP”).
The
shares of NeoStem Common Stock issuable in the Merger are subject to adjustment,
provided that in no event will NeoStem be required to issue more than 11,200,000
shares of NeoStem Common Stock, except pursuant to exercise of any
Warrants. The shares of NeoStem Common Stock issuable in the Merger
(not including any NeoStem Common Stock issuable in the future upon exercise of
any Warrants) are sometimes referred to herein as the “Stock
Consideration.” The Merger Agreement provides that to the
extent that PCT’s adjusted working capital (calculated in the manner described
in the Merger Agreement) on the Closing Date is less than the Target Working
Capital (as defined below) by more than Two Hundred Fifty Thousand Dollars
($250,000) (the “Collar”), the Stock
Consideration will be decreased by the amount by which such adjusted working
capital is less than the Target Working Capital minus the Collar. Any
such decrease will reduce the Stock Consideration on a dollar for dollar basis,
with each share of Stock Consideration valued at the Parent Per Share
Value. The “Target Working Capital” is $105,593, exclusive of at
least $353,860 of restricted cash (which restricted cash must also be available
to the Surviving Company at the closing of the Merger (the “Closing”)), but
inclusive of $392,192 of deferred
financing costs.
The Stock
Consideration will also be reduced (and not increased) by an amount equal to the
product of 250,000 shares of NeoStem Common Stock multiplied by any Net Lost
Agreements. "Net Lost Agreements"
is defined in the Merger Agreement to mean a number (not less than zero) equal
to (i) the number of material service agreements of PCT which are terminated
prior to the Closing Date, or as to which PCT receives a notice of termination
prior to the Closing Date minus (ii) the number of comparable new material
service agreements entered into and as to which services are provided by PCT to
the counterparty between the date of the Merger Agreement and the Closing
Date.
The
consummation of the Merger is subject to various conditions, including the
approval by NeoStem’s stockholders and PCT's Members; the affirmation by NeoStem
that it has $3 million available to it to repay certain indebtedness owed by PCT
to an affiliate of PCT's CEO; if requested by NeoStem, the receipt by NeoStem of
an updated valuation analysis; the absence of any legal proceeding preventing
the consummation of the Merger and other legal and regulatory
requirements.
The
Merger Agreement provides that the Stock Consideration will be placed in escrow
(the “Escrow
Account”) pursuant to an escrow agreement to be executed at the Closing,
for the purpose of paying any damages payable to NeoStem in accordance with the
indemnification provisions contained in the Merger Agreement. The
Escrow Account will continue from the Closing until the date (the “Termination Date”) which is two
(2) years and one day after the Closing Date (the “Escrow Period”). Up
to 25% of the shares of NeoStem Common Stock issuable to certain members of PCT
who hold in the aggregate 38.4% of the membership interests in PCT may be
released from the Escrow Account and distributed to those members on the 15th
day of the month that is at least one month after the Closing Date and at any
time thereafter, for the payment of income taxes by such
members. After the date that is one (1) year after the Closing Date,
a number of shares of NeoStem Common Stock will be released from the Escrow
Account such that 5,600,000 shares of NeoStem Common Stock (50% of the Stock
Consideration), plus any shares then being held with respect to pending
indemnification claims by NeoStem, will remain in the Escrow
Account. As soon as practical after the Termination Date, all shares
of NeoStem Common Stock then remaining in escrow will be released and
distributed to the former members of PCT; provided that NeoStem Common Stock
representing 120% of the maximum amount of any claim made pursuant to the
indemnification provisions of the Merger Agreement during the Escrow Period will
be withheld and remain in the Escrow Account pending resolution of such
claim. In addition, a number of shares of NeoStem Common Stock in the
Escrow Account which is necessary to satisfy any unsatisfied claims specified in
any indemnification claim previously delivered by NeoStem prior to the
Termination Date with respect to facts and circumstances existing prior to the
expiration of the Escrow Period, shall remain in the Escrow Account until such
claims have been resolved.
Pursuant
to a voting agreement (the “Voting Agreement”)
dated the same date as the Merger Agreement, holders of a sufficient number of
membership interests of PCT to approve the Merger Agreement and the Merger have
irrevocably agreed to vote in favor of the Merger Agreement and the Merger at
any meeting of the Members of PCT called to approve the Merger Agreement and
Merger (the "PCT Meeting")
and agreed to certain transfer restrictions with respect to their membership
interests prior to the Effective Time. Stockholders of NeoStem owning
greater than 50% of NeoStem Common Stock on the date of the Merger Agreement
have agreed to vote their shares in favor of the issuance of the NeoStem Common
Stock and Warrants in the Merger at a special meeting of stockholders which will
be held for such purpose.
By
approval of the Merger at the PCT Meeting, each member of PCT will be deemed to
have irrevocably constituted and appointed Andrew Pecora, currently the Chairman
and CEO of PCT, as the “PCT Representative” under the Merger
Agreement. The PCT Representative will act on behalf of all of the
members of PCT in executing various closing documents and in reviewing and, if
he deems it appropriate, disputing, any indemnification claims made against the
Escrow Account after the Closing.
The
Merger Agreement provides that as soon as reasonably practical after the
Closing, Andrew Pecora will be invited to join the Board of Directors of
NeoStem, and NeoStem will use its reasonable best efforts to cause Mr. Pecora to
be appointed to the Board of Directors and nominated for election as a director
at its annual meeting of shareholders when his initial term ends, provided
however, that in order to comply with the listing standards for the NYSE-Amex,
simultaneously with such appointment, and as a condition precedent, NeoStem also
must find and appoint to NeoStem’s Board of Directors, one (1) individual who
meets all conditions of independence imposed by the Securities and Exchange
Commission (the “SEC”) and the
NYSE-Amex, so that at all times a majority of the members of NeoStem’s Board of
Directors are independent. If such an independent person is not found
by NeoStem, and has not agreed to be so designated and appointed, NeoStem and
PCT will work together in good faith to find and designate another person
acceptable to NeoStem, through the Nominating Committee of its Board of
Directors, as an independent director. NeoStem has agreed that it
will not delay the appointment of Mr. Pecora by reason of such need to designate
another independent director for more than three (3) months after the Closing
Date.
Officers of
PCT
Andrew L.
Pecora, MD, FACP
Chairman,
Chief Executive Officer and Chief Medical Officer of PCT
Currently,
Dr. Pecora, age 53, is Chairman, Chief Executive Officer and Chief Medical
Officer of PCT, and is a member of the Board of Managers. He has held
these positions with PCT since 1999. Upon consummation of the Merger,
Dr. Pecora will serve as PCT’s Chief Medical Officer.
Dr.
Pecora has served as the Chairman and Director of the Cancer Center at
Hackensack University Medical Center (HUMC) since 2001, and Managing Partner of
the Northern New Jersey Cancer Center, which is a private physicians practice
group affiliated with HUMC, since 1996. He has also been a Professor
of Medicine at the University of Medicine and Dentistry of New Jersey since
2004. Additionally, Dr. Pecora is a scientific advisor for numerous
state, national, and international organizations. He is a Diplomate
of the American Board of Internal Medicine, subspecialty of hematology and
subspecialty of oncology, a member of the National Blue Cross and Blue Shield
Quality Centers for Transplant Experts Panel, a fellow of the Academy of
Medicine of New Jersey, a fellow of the American College of Physicians, and a
member of the American Society of Bone Marrow Transplantation, American Society
of Clinical Oncology and American Society of Hematology. Dr. Pecora
co-founded and serves as Chairman of Amorcyte, Inc., a biotechnology company
developing cell therapies for cardiovascular disease. He serves on
the board of Cancer Genetics and is chairman of the board of Tetralogics, Inc.,
a company developing small molecules to treat cancer. He has served on the Board
of Directors of the American Society of Bone Marrow Transplant and Cytotherapy
and was a member of Accreditation Committee of the Foundation for Accreditation
of Hematopoietic Cell Therapy. He has been a member of several
National Heart, Lung and Blood Institute/National Cancer Institute state of the
science meetings in transplantation and stem cell
therapies. Dr. Pecora is actively involved as principal
investigator and coinvestigator in many national research studies. He has been
invited to present his work at various scientific meetings and continues to
contribute to the published literature. Dr. Pecora received his
medical degree from the University of Medicine and Dentistry of New Jersey,
graduating with honors. He went on to complete his medical education in internal
medicine at New York Hospital and in hematology and oncology at Memorial
Sloan-Kettering Cancer Center, both in New York City. He is board certified in
internal medicine, hematology, and oncology.
Robert A.
Preti, PhD
President
and Chief Scientific Officer of PCT
Currently,
Dr. Preti, age 53, is President and Chief Scientific Officer for PCT, and is a
member of PCT’s Board of Managers. He has held these positions with
PCT since March 1999. Upon consummation of the Merger, Dr. Preti will
serve as PCT’s President.
Dr. Preti
was Scientific Director of Hackensack University Medical Center’s stem cell
laboratory from 1996-1999. Prior to that, he served as director at
the Clinical Services Division of the New York Blood Center from 1989 to
1996. He is one of the country’s leading authorities on cell
engineering and the principal investigator for a number of clinical trials
relating to stem cell transplantation. He was a founding member and
Treasurer of the International Society for Hematotherapy and Graft Engineering
and served for 10 years on its Executive Committee and Board of
Directors. He is now representing Cellular Therapy as a Director of
the American Association of Blood Banks. Dr. Preti has authored
numerous papers in the field and has been invited to speak at national and
international meetings relating to the manufacturing, regulatory and quality
aspects of cell therapy and regenerative medicine. In addition to
having served as an inspector for the Foundation for Accreditation of Cellular
Therapy, Dr. Preti also serves on professional and state committees charged with
the development of regulations for cellular therapy. Dr. Preti
received his Doctor of Philosophy degree from New York University, graduating
with distinction. During his tenure at NYU, Dr. Preti studied and
received his degrees in Cellular Biology, with a specialty in hematology,
studying erythropoiesis under the mentorship of Albert S. Gordon,
PhD. Immediately following his graduate work, Dr. Preti joined Marrow
Tech, Inc. (which later became Advanced Tissue Sciences) where he served as
Group Leader in the development Marrow Tech’s proprietary three-dimensional,
matrix-based hematopoietic culture system for ex vivo expansion of bone
marrow stem cells.
Daryl
LeSueur
Vice
President, Manufacturing Operations of PCT
Mr.
LeSueur, age 48, has served as PCT’s Vice President, Manufacturing Operations
since June 2007. As head of Manufacturing Operations, Mr. LeSueur is
responsible for managing and supervising the day-to-day conduct of the
manufacturing and packaging functions and the operational aspects of PCT’s
operating facilities. Mr. LeSueur will continue to serve as Vice
President, Manufacturing Operations upon completion of the Merger.
Prior to
joining PCT, Mr. LeSueur served as Vice President, Operations, Pomona, East
Hanover, Northvale, Cincinnati, New York and New Jersey for Barr Laboratories at
varying times during the period from 2004 to 2009. Mr. LeSueur brings
over 25 years of experience in manufacturing operations in a regulated
industry. His experience includes proven leadership and success in
developing and implementating operational initiatives to reduce production
costs, increase profitability and operational efficiencies. Prior to
joining Barr, Mr. LeSueur served as Vice President of Pharmaceutical Production
at Novartis Pharmaceutical Corporation, from 1997 to 2004. At
Novartis, he was responsible for managing all North American production
operations, specializing in solid dosage, raw material and transdermal systems
and oversaw a $70 million budget. Prior to Novartis, Mr LeSueur was
Associate Director of Pharmaceutical Production with Sandoz Pharmaceutical
Company.
Mr.
LeSueur has a BS in Chemistry from the State University of New York at
Plattsburgh and has completed the Leadership Program, Finance Program, and
Management Program at Harvard Business School.
George S.
Goldberger
Chief
Business and Financial Officer, Treasurer and Secretary of PCT
Mr.
Goldberger, age 63, is PCT’s Chief Business and Financial Officer. He
has held these positions since March 1999. He will serve as PCT’s
Vice President, Business Development upon consummation of the
Merger.
Before
joining PCT, Mr. Goldberger served as President and Chief Executive Officer of
Goldberger & Associates Inc., an international management consulting firm
with offices in New York, Budapest, Bucharest and Kiev, assisting multinational
companies in developing their business in Eastern Europe with a focus on
providing a variety of health care services. Through Goldberger &
Associates, Mr. Goldberger assisted National Medical Care (now part of Fresenius
Medical Care) in establishing and developing dialysis center operations in
Europe. Prior to that, Mr. Goldberger was in charge of mergers and
acquisitions at Figgie International Inc. (now Scott Technologies Inc.), a
diversified conglomerate. Before working at Figgie, Mr. Goldberger
was Assistant to J. Peter Grace, then Chairman and Chief Executive Officer of W.
R. Grace & Co., with corporate development and financial management
responsibilities in the United States and the Far East. While at
Grace, Mr. Goldberger served as project director on the Reagan Administration’s
President’s Private Sector Survey on Cost Control, also known as the Grace
Commission, and subsequently as president of Citizens Against Government Waste,
a nonprofit foundation established to eliminate waste, mismanagement, and
inefficiency in the federal government. He continues as the
foundation’s chairman of the board. Mr. Goldberger began his career
as a management consultant with Booz, Allen & Hamilton.
Mr.
Goldberger holds an MBA in Finance from the Wharton School of the University of
Pennsylvania and a BS in Systems Engineering from the Polytechnic Institute of
New York University.
Interests of Certain PCT
Officers in the Merger
Dr.
Pecora, Dr. Preti and Mr. Goldberger beneficially own 17.2%, 17.0% and 2.5%,
respectively, of the outstanding membership interests in PCT (or, on a fully
diluted basis, 17.5%, 17.0%, and 2.5%, respectively).
Employment
Agreements
All or
substantially all employees of PCT, including the executive officers, will
remain in the employ of PCT after the Merger at comparable salaries as prior to
the Merger. As a condition to the execution of the Merger Agreement,
NeoStem and PCT entered into employment agreements that become effective upon
consummation of the Merger (the “Commencement Date”)
with each of Robert Preti, Andrew Pecora, George Goldberger and Daryl
LeSueur. The following is a description of these
agreements:
Preti
Employment Agreement
Upon
consummation of the Merger, Robert Preti will serve as President of PCT and as
Chairman of the to be formed Quality Assurance and Ethics
Committee. The four year employment agreement dated as of September
23, 2010 between Dr. Preti, PCT and NeoStem (the “Preti Employment
Agreement”) provides for, among other things, (i) an initial annual base
salary of $330,000, which will be increased to $350,000 upon the first annual
anniversary of the Commencement Date, (ii) an option to purchase 400,000 shares
of NeoStem Common Stock under the Parent’s 2009 Equity Compensation Plan (“2009 Equity Plan”) at
an exercise price per share equal to closing price of NeoStem Common Stock on
the Commencement Date (the "Commencement Price")
which will vest in four equal annual installments beginning on the first annual
anniversary of the Commencement Date, and (iii) eligibility for cash bonuses as
determined by the compensation committee of the Parent’s Board of
Directors. The Preti Employment Agreement further provides that upon
Termination without Cause (as defined) or Resignation for Good Reason (as
defined), Dr. Preti will be entitled to certain post-termination benefits in
consideration of executing a release and compliance with certain non-competition
restrictive covenants, including (i) continuation of his base salary for up to
twelve (12) months in accordance with customary payroll practices, (ii)
reimbursement of COBRA healthcare premiums for up to twelve (12) months, and
(iii) the accelerated vesting for all unvested option shares that would have
vested during the twelve (12) months following termination of employment had Dr.
Preti remained in the employ of PCT. The Preti Employment Agreement
also gives PCT the option, in its sole discretion, to continue Dr. Preti’s base
salary for an additional twelve (12) months (for a total of twenty-four (24)
months) in consideration for a twelve month extension of the non-competition
restrictive covenants to which Dr. Preti is subject. The Company
intends to secure a key man life insurance policy with respect to Dr.
Preti.
Pecora
Employment Agreement
In addition to serving on the Board of
Directors of NeoStem, Andrew Pecora will serve as Chief Medical Officer of PCT
in a part-time capacity upon consummation of the Merger. The four
year employment agreement dated as of September 23, 2010 between Dr. Pecora, PCT
and NeoStem (the “Pecora Employment
Agreement”) provides for, among other things, (i) an annual base salary
of $180,000 and (ii) an option to purchase 400,000 shares of NeoStem Common
Stock under the Parent’s 2009 Equity Plan at the Commencement Price which will
vest in four equal annual installments beginning on the first annual anniversary
of the Commencement Date. The Pecora Employment Agreement further
provides that upon Termination without Cause (as defined) or Resignation for
Good Reason (as defined) Dr. Pecora will be entitled to continuation of his base
salary for three (3) months in accordance with customary payroll practices in
consideration for executing a release and compliance with certain
non-competition restrictive covenants.
Goldberger
Employment Agreement
Upon
consummation of the Merger, George Goldberger will serve as Vice President –
Business Development of PCT. The three year employment agreement
dated as of September 23, 2010 between Mr. Goldberger, PCT and NeoStem (the
“Goldberger Employment
Agreement”) provides for, among other things, (i) an annual base salary
of $200,000, (ii) an option to purchase 200,000 shares of NeoStem Common Stock
under the Parent’s 2009 Equity Plan at the Commencement Price which will vest in
three equal annual installments beginning on the first annual anniversary of the
Commencement Date and (iii) eligibility for an annual cash bonus of up to 30% of
his base salary. The Goldberger Employment Agreement further provides
that upon Termination without Cause (as defined) or Resignation for Good Reason
(as defined), in consideration for executing a release and compliance with
certain non-competition restrictive covenants, Mr. Goldberger will be entitled
to (i) continuation of his base salary for three (3) months in accordance with
customary payroll practices and (ii) the accelerated vesting for all unvested
option shares that would have vested during the twelve (12) months following
termination of employment had Mr. Goldberger remained in the employ of
PCT.
LeSueur
Employment Agreement
Upon
consummation of the Merger, Daryl LeSueur will serve as Vice President –
Manufacturing Operations of PCT. The three year employment agreement
dated as of September 23, 2010 between Mr. LeSueur, PCT and NeoStem (the “LeSueur Employment
Agreement”) provides for, among other things, (i) an annual base salary
of $250,000 and (ii) an option to purchase 200,000 shares of NeoStem Common
Stock under the Parent’s 2009 Equity Plan at the Commencement Price which will
vest in three equal annual installments beginning on the first annual
anniversary of the Commencement Date. The LeSueur Employment Agreement further
provides that upon Termination without Cause (as defined) or Resignation for
Good Reason (as defined), Mr. LeSueur will be entitled to continuation of his
base salary for one (1) month in accordance with customary payroll practices in
consideration of executing a release and compliance with certain non-competition
restrictive covenants. The LeSueur Employment Agreement also gives
PCT the option, in its sole discretion, to continue Mr. LeSueur’s base salary
for up to twenty-four (24) months in consideration for Mr. LeSueur being subject
to certain additional non-competition restrictive covenants for a period of up
to twenty-four (24) months.
Registration
Statement
In
connection with the Merger, NeoStem intends to file with the SEC a registration
statement on Form S-4 (including any amendments, supplements and exhibits
thereto, the “S-4”) to register the
NeoStem Common Stock (including the NeoStem Common Stock underlying the
Warrants) issuable in the Merger. The S-4 will contain a
prospectus/joint proxy statement pertaining to (a) the special meeting of
stockholders of NeoStem at which NeoStem’s stockholders will be asked to approve
the NeoStem Common Stock and Warrants issuable in the Merger and (b) the special
meeting of Members of PCT at which PCT's Members will be asked to approve the
Merger Agreement and Merger. It is expected that at the special
meeting, NeoStem’s stockholders will also be asked to vote upon a proposal to
increase the number of authorized shares under NeoStem’s 2009 Equity
Compensation Plan.
The
foregoing description of the Merger Agreement is not complete and is qualified
in its entirety by reference to the Merger Agreement, which is filed as Exhibit
2.1 hereto and incorporated herein by reference. On September 23,
2010, NeoStem issued a press release announcing the execution of the Merger
Agreement, a copy of which is filed as Exhibit 99.1 hereto and incorporated
herein by reference.
Business of
PCT
PCT is
engaged in a wide range of services in the stem cell therapy market for the
treatment of human disease, including but not limited to contract manufacturing,
product and process development, consulting, product characterization and
comparability, and storage, distribution, manufacturing and transport of cell
therapy products.
The
Field of Cell Therapy
All
living complex organisms start as a single cell that replicates, differentiates
(matures) and perpetuates in an adult through its lifetime. Cell
therapy is aimed at tapping into the power of cells to prevent and treat
disease, regenerate damaged or aged tissue and provide cosmetic
applications. The most common type of cell therapy has been the
replacement of mature, functioning cells such as through blood and platelet
transfusions. Since the 1970s, bone marrow and then blood and
umbilical cord-derived stem cells have been used to restore bone marrow and
blood and immune system cells damaged by chemotherapy and radiation used to
treat many cancers. These types of cell therapies have been approved
for use worldwide and are typically reimbursed by insurance.
Over the
past number of years, cell therapies have been in clinical development to treat
an array of human diseases. The use of autologous (self-derived)
cells to create vaccines directed against tumor cells in the body has been
demonstrated to be effective and safe in clinical trials. The
Dendreon Corporation’s Provenge therapy for prostate cancer received Food and
Drug Administration (“FDA”) approval in
early 2010. Companies are evaluating the effectiveness of cell therapy as a form
of replacement or regeneration of cells to treat diseases of the brain and
spinal cord, while others are developing cell therapies for cardiovascular
disease, including for the treatment of acute myocardial infarction (heart
attack) and chronic ischemia. Cell therapies are also being evaluated
for safety and effectiveness to treat autoimmune diseases such as diabetes,
inflammatory bowel disease and bone diseases. Finally, the
development of cell therapies to supplement or replace damaged or aged tissue
and organs is also under development by certain companies. While no
assurances can be given regarding future medical developments, management of PCT
believes that the field of cell therapy is a subset of biotechnology that holds
promise to better the human experience and minimize or ameliorate the pain and
suffering from many common diseases and from the process of aging.
Background
Founded
in 1997 by Dr. Pecora and Dr. Preti. as a New Jersey limited liability company,
PCT has become an internationally recognized cell therapy services and
development company. The intent was to create a business for “as
needed” development and manufacturing services for the emerging cell therapy
industry and to prepare for eventual commercialization. With its cell
therapy manufacturing facilities and team of professionals, PCT offers a
platform that can facilitate the preclinical and clinical development and
commercialization of cellular therapies for clients throughout the world. PCT
offers current Good Manufacturing Practices (cGMP)-compliant cell
transportation, manufacturing, storage, and distribution services and supporting
clinical trial design, process development, logistics, regulatory and quality
systems development services. In addition, through its network of
contacts throughout the cell therapy industry, PCT has historically targeted and
identified early stage development opportunities in the cell therapy field and
developed cell therapies to be spun off into independent entities using PCT’s
core capabilities for development.
PCT began
operations by acquiring the stem cell laboratory of Hackensack University
Medical Center (HUMC) on March 1, 1999, and as a part of the acquisition
arrangement, HUMC has agreed to use PCT as its exclusive provider of stem cell
services for its cancer patients. PCT benefited from HUMC’s national
reputation as a leading stem cell transplant center in the United States. Dr.
Preti, PCT’s current President and Chief Scientific Officer, was the Scientific
Director of HUMC’s stem cell laboratory at the time of the
acquisition.
In August
2002, PCT acquired a cell therapy manufacturing facility from the Dendreon
Corporation in Mountain View, California, thus establishing a second facility
and the capability of offering nationwide processing and distribution for
manufactured cell therapy products. Dendreon is a biotechnology company that
develops targeted therapies for cancer.
On
October 6, 2004, PCT converted from a New Jersey entity into a Delaware entity
by merging with and into a newly formed Delaware limited liability company
carrying the same name. The Delaware company is the surviving entity
of the merger.
In 2007,
PCT acquired an office condominium facility in Allendale, New Jersey that has
been developed into a cell therapy manufacturing facility. The
facility has been qualified to be accredited by the Foundation for Accreditation
of Cellular Therapy (FACT) and complies with cGMP guidelines promulgated by the
FDA.
PCT
Business
PCT
serves the developing cell therapy industry that includes biotechnology,
pharmaceutical and medical products companies, health care providers, and
academic investigators from licensed cell therapy manufacturing facilities in
Allendale, New Jersey and Mountain View, California. PCT supports the
research of leading academic investigators designed to expedite the broad
clinical application of cell therapy. PCT’s core strategy is to provide a global
network of cell therapy manufacturing and storage facilities and an integrated
and regulatory compliant distribution capacity for the evolving cell therapy
industry to meet international commercial demands.
cGMP
Cell Therapy
|
Manufacturing
Experience
|
HSC
|
Animal
cell processing
|
HPC
|
CD
34 selected cells
|
MISC
|
Keratinocytes
|
Gene
Tx
|
Fibroblasts
|
DC
|
DLI
|
APC
|
Cytokine
cell induction
|
T
Cell (Activated)
|
Ex-vivo
expansion
|
B
Cell
|
Cellular
cultures
|
NK
|
CD
34 selection
|
Macrophages
|
Adherent
neural stem cells
|
NSC
|
Porcine
islets
|
Cell
Matrix implants
|
Activated
T-cells
|
Artificial
Skin Membranes
|
|
PCT has
accumulated experience in the service and business of cell therapy manufacturing
for clinical use. PCT has served over 100 clients and is experienced
with more than 20 different cell based therapeutics, including neuronal and skin
based cells for brain and spinal cord repair, myoblast, mesenchymal cells and
bone marrow derived cells for heart disease, Tumor, T, B, NK and dendritic cells
and monocytes for cancer treatment, cord blood, peripheral blood, bone marrow
CD34+ selected cells for transplantation and islet cells for diabetes. PCT has
performed over 30,000 cell therapy procedures in its cell therapy manufacturing
facilities, processed and stored over 18,000 cell therapy products (including
approximately 7,000 umbilical cord blood, 10,000 blood and marrow derived stem
cells and 1,000 dendritic cells) and arranged the logistics and transportation
for over 14,000 cell therapy products for clinical use by over 5,000 patients
nationwide.
PCT’s
Contract Manufacturing Experience
|
Hematopoietic
replacement
|
Cancer,
genetic diseases
|
HSC,
HPC, MSC, Gene Tx
|
Immune
modulation
|
Cancer,
autoimmunity, infectious diseases
|
DC,
APC, T cell, B cell, NK, HSC, MSC, Macrophages, Gene Tx
|
Tissue
repair and regeneration
|
Cardiovascular,
spinal, neuronal, corneal, orthopedic
|
HSC,
MSC, NSC, Cell matrix implants
|
Wound
healing
|
Ulcers,
burns
|
Artificial
skin, membranes, MSC
|
The
management team of PCT has over 100 years of collective experience in the
business and science of cell therapy. Team members are recognized
experts in cell therapy product development and characterization, manufacturing,
delivery, and clinical development and use. PCT’s personnel have experience with
the design, validation, and operation of cGMP cell therapy manufacturing
facilities, participated in regulatory filings in the United States and Europe,
and have contributed over 100 peer reviewed cell therapy
publications. The team has extensive experience in biologics
development, sales, marketing, medical practice, hospital administration,
insurance contracting, and regulatory compliance. Collectively, the
management team has experience in all aspects of cell therapy product and
clinical development and use (other than with the use of embryonic stem cells),
covering cancer, autoimmunity, infectious diseases, cardiovascular diseases, and
spinal, brain, corneal, orthopedic, hormonal and skin regenerative
therapies.
Affiliated
Companies
Amorcyte,
Inc.
PCT’s
strategy has historically included the periodic formation of companies intended
to develop specific therapeutic products. From its vantage point in
the industry, PCT sought to identify, incubate, and spin off cell therapy-based
development companies that could become clients of PCT. To date, PCT
has spun off Amorcyte, Inc. (“Amorcyte”). Amorcyte
completed its Phase I clinical trial for a cell based product in the
cardiovascular area, relying on PCT’s management, scientific know how, and
preclinical and clinical manufacturing resources. Amorcyte was
initially formed as a wholly owned subsidiary of PCT and was spun off to its
members during 2005. It is a therapeutics company pursuing cell-based
therapies for cardiovascular diseases. Amorcyte’s primary product,
based on certain patents licensed from Baxter Healthcare Corporation and
intellectual property granted to Amorcyte, is an autologous stem cell product in
clinical trials for the treatment of damaged heart muscle following acute
myocardial infarction (AMI).
Amorcyte
is a Delaware corporation, originally formed in June 2004 as a subsidiary of
PCT. In July 2005, Amorcyte was spun off so that each member of PCT acquired a
direct ownership interest in Amorcyte pro rata to such member’s then existing
ownership interest in PCT. Certain members of management hold a small
percentage of preferred stock in Amorcyte and the remainder of the outstanding
preferred stock was issued to outside investors who provided equity financing to
Amorcyte beginning in 2006. Amorcyte plans to develop bone marrow derived stem
cell therapies to treat a variety of cardiovascular diseases using certain
technology licensed from Baxter Healthcare Corporation. PCT has
entered into (i) a Cell Processing Agreement with Amorcyte dated as of May 31,
2005, pursuant to which PCT is the exclusive provider of cell processing
services to Amorcyte in exchange for a payment to Amorcyte of $200,000 (an
“evergreen” arrangement), and (ii) a Line of Credit and Security Agreement with
Amorcyte dated as of May 19, 2005, pursuant to which PCT has agreed to make up
to $500,000 available to Amorcyte. While members of PCT are also
stockholders of Amorcyte from the spin-off, and PCT provides Amorcyte with
management services through a management agreement, Amorcyte is an
independent company and its value and revenue is not included in those of
PCT.
PCT has
benefited from its relationship with Amorcyte as its exclusive, evergreen
provider of cell processing services. For the six months ended June
30, 2010 and the year ended December 31, 2009, PCT recognized revenue under the
Cell Processing Agreement with Amorcyte of $93,000 and $428,000
respectively.
During
June 2010, PCT made an investment in Amorcyte in the purchase of Series A
Redeemable Preferred Stock totaling $50,000.
DomaniCell,
LLC
PCT
formed DomaniCell, LLC (“DomaniCell”) as a
Delaware limited liability company in May 2005. DomaniCell is a wholly owned
subsidiary of PCT which assists hospitals with providing umbilical cord blood
unit collection and long-term storage services to patients for potential future
therapeutic use. DomaniCell provides the front-end interface and
support services to hospitals and in turn employs PCT’s cell therapy
manufacturing facilities network for the processing and long-term storage of
umbilical cord blood units.
Market
Review and Analysis of the Core Business
PCT
believes that an increasing portion of healthcare spending in the United States
will be directed to cell and tissue based therapies in the coming years, driven
by aging baby boomers accustomed to seeing continual medical advancement within
their lifetime. An excerpt from “2020: A New Vision - A Future for
Regenerative Medicine” from the U.S. Department of Health and Human Services,
dated January, 2005, highlights the potential
of cell therapy, given present demand:
|
·
|
250,000
patients receive heart valves, at a cost of $27 billion annually;
and
|
|
·
|
950,000
people die of heart disease or stroke, at a cost of $351 billion
annually.
|
According
to the same report, “Regenerative medicine is the vanguard of 21st century
healthcare. We are on the cusp of a worldwide explosion of activity in this
rapidly growing field of biomedicine that will revolutionize health care
treatment. Regenerative medicine (cell therapies) will lead to the
creation of fully biological or bio-hybrid tissues and organs that can replace
or regenerate tissues and organs damaged by disease, injury, or congenital
anomaly.” Regenerative medicine offers the promise to address many of
these conditions by replacing or repairing malfunctioning
tissues. The same report also indicated that a large fraction of the
costs cited above are attributable to tissue loss or organ failure, with
approximately eight million surgical procedures being performed annually in the
United States to treat these disorders. If approved and effective,
cell therapies may have the effect of cutting health care cost as they may
facilitate functional restoration of damaged tissues and not just abatement or
moderation of symptoms.
Aside
from early tissue-based therapies approved in the 1990s, e.g., therapies
developed by Genzyme and Organogenesis, the regenerative medicine industry is
yet to mature to the point of having a number of approved therapies available on
the market. However, there are a number of companies in late-stage clinical
trials and one company, PCT’s former client Dendreon, has received approval from
the FDA for the use of a cellular product as a cancer therapy. In
addition, the growing interest in storing one’s own stem cells has the potential
to further fuel the cell therapy field.
The scope
of the evolving field of regenerative medicine entails:
|
·
|
Cell Therapy, which is
the use of cells (adult or embryonic, donor or patient, stem or
differentiated) for the treatment of many debilitating injuries and
diseases. Near term, therapeutic applications include heart disease,
diabetes, Parkinson’s and Alzheimer’s diseases, vision impairments,
orthopedic diseases and spinal cord injuries. This sector also includes
the development of growth factors and serums and natural reagents that
promote and guide cell development.
|
|
·
|
Tissue Engineering,
which is the combination of cells with biomaterials (also called
“scaffolds”) to generate partially or fully functional tissues and organs.
Some natural materials, like collagen, can be used as biomaterial, but
advances in materials science have resulted in a variety of synthetic
polymers with attributes that would make them uniquely attractive for
certain applications. Near term, therapeutic applications include heart
patch, bone re-growth, wound repair, replacement bladders, inter-vertebral
disc and spinal cord repair.
|
|
·
|
Tools & Devices,
i.e., creating cell lines that embody genetic defects or disease
characteristics that are used for the discovery and development of new
drugs. This sector also includes companies developing devices that are
designed and optimized for regenerative medicine techniques, such as
specialized catheters for the delivery of cells, tools for the extraction
of stem cells, cell-based diagnostic tools,
etc.
|
|
·
|
Aesthetic Medicine,
which includes developing cell therapies, tissues and biomaterials
for cosmetic applications. This sector comprises hair follicle cells for
hair regeneration, and collagen-secreting human dermal fibroblasts for
facial wrinkles and other skin
disorders.
|
PCT
believes, based on clients it has served, that PCT’s manufacturing service and
developmental offerings are strategically aligned to participate in all aspects
of the evolving cell therapy (regenerative medicine) industry as defined
above. Since its formation, PCT’s goal has been to position itself as
the recognized leader of cell therapy manufacturing and development services for
this emerging industry.
PCT’s
Client Services
PCT
provides services to clients who are pursuing the development and
commercialization of cell therapies for a broad array of human diseases,
disorders and injuries, including:
|
·
|
Pre-clinical
and clinical process and product development including outsourcing of cell
therapy manufacturing for clinical trials by therapeutic
companies;
|
|
·
|
Processing
or manufacture of cell-based products for cell therapy or tissue
engineering companies or academic
programs;
|
|
·
|
Development
and manufacture of stem cell lines for diagnostic purposes for
pharmaceutical companies;
|
|
·
|
Development
and validation studies on behalf of tool and device
companies;
|
|
·
|
Processing
and transporting hematopoietic stem cells, immune system cells and
umbilical cord blood cells used for blood and marrow stem cell
transplantation by academic clinical stem cell transplantation programs;
and
|
|
·
|
Consulting
in the areas of FDA guideline compliance, technology evaluations, clinical
trials design, process optimization and product development, product
characterization, assay development, and facility or system design for
therapeutics, device, or investment companies or academic
programs.
|
PCT’s
Client Base
PCT’s
client portfolio focuses on meeting the existing needs of the cell
therapy/regenerative medicine market. Clients include:
|
·
|
Academic
and Other Hospitals and Clinics – These clients may be conducting
cell therapy research and/or treating patients with cell and tissue
therapies. This includes the processing for stem cell transplant
programs. For over 20 years, blood and marrow stem cell
transplants have been used following radiation and/or chemotherapy for
certain cancers – particularly leukemia, lymphoma and
myeloma. While the number of patients diagnosed with one of
these cancers in the United States has not grown significantly from year
to year, growth in bone marrow transplants has grown at a faster rate, due
in part to the establishment of the National Marrow Donor
Program. This program facilitates cell type matching, which was
previously a significant limiting factor in the use of blood and bone
marrow transplants.
|
|
·
|
Private
Sector Customer Base - There are currently about 350 cell and
tissue/regenerative medicine therapeutic product companies globally and
over 500 companies in the sector when including technology, device, and
service companies. PCT believes that a significant percentage
of the therapeutic companies outside the United States are viable customer
prospects for PCT and, in fact, already represent one of PCT’s fastest
growing customer bases. Currently, these companies retain PCT
for their expansion into the United States market. If PCT is
able to develop operations outside the United States within geographic
proximity of such clients, the percentage of these companies that retain
PCT in connection with their local markets should
increase. Additionally, there is a steady stream of new
entrants into the cell therapy and regenerative medicine market both in
the United States and globally.
|
|
·
|
Strategic
Relationships – These are relationships into which PCT has entered
with product and service providers complimentary to PCT’s service
offerings and intended to bolster both PCT’s revenue as well as its market
position. The relationships currently take the form of
subsidiary or affiliated companies as well as independent companies with
which PCT has a co-marketing and/or co-development
relationship.
|
|
·
|
Investors
– Investors use PCT to evaluate the technologies, development
capabilities, and development capacities of companies in which they are
invested or potentially investing.
|
Management
believes that PCT's long-term client base will look very similar to its current
client base but is expected to also include pharmaceutical companies requiring
manufacturing of stem cell lines for use in drug discovery.
For each
type of client, the cell therapy sector presents unique challenges, which
provide PCT with opportunities to position its expertise and services as
potential solutions. For example, in pharmaceutical drug development,
after FDA approval, typically, a large quantity (batch) of drug is manufactured,
a sample is tested for potency and identity, and then the batch is released by
the manufacturer for packaging in multiple doses, distribution and
sales. Typically, a dose of a drug can be stored for prolonged
periods before it is dispensed to the patient. In contrast, the cells
used for cell therapy usually originate from the patient for whom the cell
treatment is intended. The biologic shelf life is measured in hours
to days as opposed to months to years as is the case with pharmaceutical drugs.
PCT believes it has more relevant experience manufacturing and delivering
cell-based therapies than most traditional pharmaceutical drug developers. PCT’s
facilities and personnel can create value for corporate clients that are
developing a cell-based therapy by decreasing development time, optimizing the
manufacturing process and saving capital otherwise needed to build and staff
cGMP facilities for current and future clinical trials. PCT’s offering generally
decreases the time and cost of commercializing these technologies, bringing
value to PCT’s client base.
PCT’s
Operations
Facilities
PCT
presently operates two cell therapy manufacturing facilities, in Allendale, New
Jersey and in Mountain View, California. In 2007, PCT acquired the
30,067 square foot facility in Allendale, New Jersey which has been developed
into a cell manufacturing facility. Longer-term plans could include
the acquisition and development of a number of such buildings throughout the
country and outside of the United States, to be developed into replicable and
scalable manufacturing facilities, strategically located to best serve clients
needs. Inherent in the nature of cell therapy today is the biologic
shelf life of the cell therapy product itself. This limits the
transit times between the time the cell product is extracted from a patient
until it arrives at a PCT facility and the time that a processed product leaves
the PCT facility and arrives for re-infusion in the
patient. Therefore, it is preferable for cell therapy manufacturing
facilities to be located in major population centers and within close proximity
of major airport hubs.
PCT's
Allendale facility is a 30,000 square foot facility of which 22,000 square feet
have been developed. This facility is comprised of ISO Class 7, Class
10,000, ISO Class 8, Class 100,000 manufacturing suites, in addition to quality
control, research and development laboratories and support
facilities. It has been designed to meet the accreditation
requirements of the Foundation for the Accreditation of Cellular Therapy (FACT)
and to comply with the FDA’s requirements, including applicable cGMP
regulations, and to meet the standards of the American Association of Blood
Banks (AABB). The facility is also in compliance with a range of
state and federal regulatory and licensing requirements.
PCT’s
Mountain View facility is also a licensed cell therapy manufacturing facility,
encompassing 25,024 square feet within a single building, of which 17,425 square
feet is developed. The developed space is presently used for
manufacturing client products. Mountain View is equipped with ISO Class 7 and
Class 10,000 manufacturing suites, quality control, research and development
laboratories and support facilities. PCT plans to further develop space for cell
therapy manufacturing within the facility on an as needed basis. The
Mountain View facility is subject to a lease agreement.
Because
of the specialized nature of these cell processing facilities and the time
required to conceptualize, design, build, and obtain certification and operating
authority, it takes approximately nine months to go from concept to operations
once space has been qualified.
PCT’s
Facilities
Space
in Square Feet
|
|
Present
|
Manufacturing
Facilities
|
Developed
|
Undeveloped
|
Total
|
|
|
|
|
Mountain
View, California
|
17,425
|
7,599
|
25,024
|
Allendale,
New Jersey
|
22,000
|
8,067
|
30,067
|
Total
|
39,425
|
15,666
|
55,091
|
Transportation
Network
PCT
believes that today’s commercially available transportation systems are not set
up for shipment of biological or other perishable goods and will not be able to
meet the demands of the emerging cell therapy market. To succeed, the
large-scale commercialization of cell therapy products will need to overcome the
present weaknesses of the major air carriers, including the lack of a true
point-to-point chain of control, non-controlled X-ray and inspection, no
guarantee of package orientation, handling or storage conditions and in many
cases no standard, documented and tracked operating procedures.
A
successful transportation network for cell therapy will require a completely
secure point-to-point chain of control and custody; cGMP standard operating
procedures in all phases of transit; a highly specialized and trained air and
ground courier network; quality assurance at each transfer point; and real-time
package tracking.
PCT
strives to maintain high standards in transportation and handling of client cell
products. Shipments of products are tracked as PCT and its clients
develop confidence in the abilities of PCT’s transportation
partners. PCT is laying the groundwork for such a network as part of
its business development process.
While
reliable ground carriers with experience in the transport of blood products
already exist in major metropolitan areas of the country, air carriers meeting
such needs are limited. PCT evaluated the major domestic express
carriers, including Federal Express and UPS, and concluded that even their
highest-level services are inadequate to meet the sector’s
needs. However, PCT identified and validated AirNet Systems, Inc., a
specialty air carrier with a fleet of over 100 aircraft serving over 100 cities
nationwide, as a transportation partner. AirNet has built its business on check
delivery and other services to banks, and it now specializes in shipping medical
products, including whole blood and blood products, tissue for transplantation,
and diagnostic specimens. AirNet also handles cryopreserved specimens
and biologics. PCT currently use the services of AirNet for its
transportation needs and has a co-marketing agreement with AirNet centered on
combining their logistical expertise and transportation infrastructure with
PCT’s point-to-point logistics and handling protocols to provide a
non-integrated but complimentary and comprehensive transportation network for
the shipment of cell therapy products.
Current Good Manufacturing
Practices (cGMP) Standards
FDA
current Good Manufacturing Practices (cGMP) requirements, set forth in Title 21,
Parts 210 and 211, of the Code of Federal Regulations (21 CFR Parts 210 and 211)
are federal regulations that govern the manufacture, processing, packaging and
holding of drug and cell therapy products. The objective of
compliance with cGMP standards is to protect the public health and safety by
ensuring that:
|
·
|
Products
have the identity, strength, quality and purity that they purport or are
represented to possess;
|
|
·
|
Products
meet their specifications; and
|
|
·
|
Products
are free of objectionable microorganisms and
contamination.
|
A central
focus of the cGMP requirements is to design and build quality into the
manufacturing processes and the facilities in which products are produced. This
is done by implementing quality systems and processes, such as:
|
·
|
Identifying
critical points that need to be controlled, monitored and
tested.
|
|
·
|
Preparing
a set of written instructions or procedures, including product
specifications, to ensure consistency and reproducibility of results and
product characteristics.
|
|
·
|
Designing
systems and procedures to prevent contamination and ensure product
integrity.
|
|
·
|
Documentation
of product testing results and
procedures.
|
|
·
|
Validating
the process and test methods to ensure reliability of results and
consistency in processing.
|
|
·
|
Protecting
the product from introduction of contamination or objectionable
microorganisms by manufacturing in a clean room environment, which
includes control of particulates and microorganisms while ensuring
adequate space and proper facility
controls.
|
PCT’s
processing typically occurs in class 10,000, Controlled Environment Rooms (CER)
in a class 100 Biologic Safety Cabinet (BSC). Environmental monitoring, done
weekly, includes air sampling, contact plates for surface monitoring, and Met
One particle counts. PCT’s cleaning and sanitizing program involves daily,
weekly, monthly, and quarterly cleaning protocols for the equipment and the
rooms with bactericidal and sporicidal agents to control introduction of
microorganisms and insect and pest control procedures. PCT has ongoing equipment
validation, calibration and preventive maintenance programs to ensure
reproducibility and consistency of results.
PCT
employs an inspection and testing program for incoming materials, and for
in-process and final products, as required. PCT employs scientifically sound
procedures approved by a quality assurance function, and performs product
sterility testing and release assays reviewed by the quality assurance
department. PCT has labeling controls to prevent product mix-ups,
employs a materials management program to ensure that only approved materials
are used in manufacturing and to provide forward and backward traceability; a
supplier approval program to ensure that the raw materials used are made under
acceptable conditions and to provide a high degree of confidence in their
efficacy. A separate quality unit is charged with the responsibility
for review and approval of anything that affects the identity, strength,
quality, and purity of the cell therapy product.
Sales & Marketing
Strategy
PCT
targeted what it believes to be the most promising companies for aggressive
sales and business development efforts. Among early stage
regenerative medicine companies, PCT's strategy is to aggressively market the
advantages of outsourcing cell and tissue manufacturing for clinical trials,
testing and processing. Among later stage companies, the strategy is
to explore opportunities for collaboration without compromising the ability to
remain independent. PCT believes that the expertise of its founders
and senior management team, combined with PCT’s practical experience, provides a
competitive advantage over potential competitors in marketing to our customer
prospects in the private sector.
PCT’s
Potential to Develop Cell Therapy Products
PCT
believes that it is qualified and experienced to reduce the risk of development
of cell therapy products because:
|
·
|
PCT
has the expertise to cost efficiently and rapidly analyze the potential
for product development through
commercialization.
|
|
·
|
PCT
has the structure in place to develop new cell therapy products and to
enable the commencement of Phase I clinical trials for such
products.
|
|
·
|
PCT
has the personnel and facilities in place to offer cost effective
development and manufacturing
services.
|
|
·
|
PCT
has the technical, scientific, clinical, and business expertise to make
timely go/no go development decisions for potential cell therapy
products.
|
|
·
|
PCT
has the fiscal discipline and low incremental capital investment to cut
project development early if chances for success are low thus preserving
resources for future product
development.
|
PCT’s
initial effort to incubate a cell therapy product development company resulted
in the development, spin-off, and subsequent infusion of capital from outside
investors into Amorcyte. Experience with Amorcyte has provided the management
team with guidelines for key factors for future development of cell therapy
products. PCT’s new product development opportunities include
therapies for cancer, diabetes, cardiovascular disease, neurological disorders,
and skin repair.
In
summary, historically the key elements of PCT’s business strategy were
to:
|
·
|
Establish
a nationwide and then international infrastructure, capacity and expertise
to meet clients needs;
|
|
·
|
Maximize
penetration of startup companies in the
sector;
|
|
·
|
Optimize
use of PCT's physical plants;
|
|
·
|
Evaluate
international opportunities and enter markets as
necessary;
|
|
·
|
Develop
information systems, logistics and create proprietary intellectual
property (e.g., process patents);
|
|
·
|
Collaborate
closely with the FDA (and other regulatory authorities as appropriate);
and
|
|
·
|
Invest
in research to diversify PCT's portfolio of
services.
|
In light
of the above, PCT's business development has focused on all stages of
regenerative medicine, cell and tissue therapeutic product companies, academic
stem cell and other cell therapy clinical trials, device companies serving the
regenerative medicine sector, investors and pharmaceutical companies with an
interest in a cell or tissue therapeutic or research product, and any other
client with needs in the manufacturing and development of a cell or tissue-based
product. Serving such clients PCT aimed to:
|
·
|
Be
the global leader in services for the development, regulatory approval and
commercialization of cell and tissue therapies around the
world;
|
|
·
|
Be
the leader in the development and manufacture of cells and tissues as
therapeutic agents in cGTP/cGMP (current Good Manufacturing Practices and
current Good Tissue Practices) compliant
facilities;
|
|
·
|
Continue
to expand PCT's facilities, capacity, expertise, and experience to meet
the demand for quality and value-driven services for companies in the
regenerative medicine sector; and
|
|
·
|
Leverage
PCT’s domain experience to create product-based companies which would
exclusively use PCT’s services for manufacturing, delivery and
commercialization.
|
Competition
With its
core business, PCT has identified a small number of direct competitors with
substantially greater resources than PCT and a number of potential competitors,
classified as follows:
|
o
|
Medical
and Research Centers - Medical and research centers with interest
or expertise in regenerative medicine and the handling and manipulating of
cell products offer competitive services. This group includes
the major blood and bone marrow transplant centers around the country, the
American Red Cross and major medical research
institutions. Such research institutions include the Johns
Hopkins Medical Center in Baltimore, Maryland, Baylor College of Medicine
in Houston, Texas, the National Institutes of Heath-funded, multi-center
Production Assistance for Cellular Therapies Network, and the Fred
Hutchinson Cancer Research Center in Seattle,
Washington.
|
|
o
|
Other
For-Profit Corporations – Other for profit
corporations who are our direct competitors include: the Lonza Group Ltd,
with the acquisition of the bioservices division of Cambrex Corporation
with cell therapy manufacturing facilities in the United States and
continental Europe; Cognate Bioservices, owned by Toucan Capital and which
services its own internal sister-portfolio companies, as well as offering
its services to external customers, with facilities in Maryland and
California; Euffets, part of the Fresenius Medical Care group, with a
facility in Germany and which has an existing network of apheresis
centers; Angel Biotechnology in the United Kingdom, currently
restructuring to focus exclusively in cell therapies; Cell Therapies Pty
Ltd in Melbourne, Australia. In addition, there are other
providers of support services with a peripheral offering or interest in
cell or tissue therapy development or
manufacturing.
|
|
o
|
Divisions
of Biotechnology Companies -- The development and
manufacturing divisions of selected major biotechnology companies (e.g.,
Genzyme and Cell Genesys) which provide services using their existing
spare infrastructure to offset costs also present competition to
PCT. Moreover, they may be able to offer such unused capacity
as a loss leader and at lower rates than those offered by
PCT.
|
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o
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Early
Stage Companies. Some early stage companies, which constitute a
portion of our target market, have their own development and manufacturing
facilities. These companies are competitive not only in that
they may leverage their capacity by making it available to others but also
in that, their decision to “build” precludes them – at least for the
interim – from deciding to “buy” from
PCT.
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However,
the decision by therapeutic companies to develop and / or manufacture their own
product remains PCT’s most significant competition in the early stages of this
sector, other than specialized contract manufacturing organizations
(CMOs). This competition is analogous to the evolution of earlier
therapeutic biotechnology sectors and is expected to decrease as the sector
matures. In terms of capability, efficiency and price, PCT’s
management believes that PCT is positioned and perceived in the marketplace to
be positioned as the leading company among its direct
competitors. The Lonza Group Ltd., based in Basel, Switzerland, is
PCT’s primary corporate competitor.
The
leading bone marrow transplant centers are experienced in handling stem cells
and other blood products. However, PCT believes generally that many
of these centers do not operate profitably and may not be capable of doing so
unless and until they gain independence from the institutions in which they
currently operate. PCT is not aware of any transplant center that is
planning to attain such independence. Similarly, while the larger
not-for-profit research institutions are well financed, such institutions may be
hampered by geographical limitations and political
considerations. Finally, it is not within the mission of the
organizations owning these facilities to provide large-scale manufacturing for
the private sector.
Certain
divisions of biotechnology companies are well financed and have existing
capacity with related experience. However, most of these
biotechnology product companies may not be in the manufacturing service business
for the long-term despite short-term forays into the service business to offset
infrastructure costs for extra capacity. In addition, because many of
the larger public companies have much larger and more pressing business issues
(e.g., patent expirations and pipeline management), PCT believes that they will
not commit significant capital or management resources to regenerative medicines
in the near term. Finally, in PCT’s view, the cell and tissue
manufacturing and delivery system could represent a new and challenging
distribution model for these companies. PCT believes that a number of
pharmaceutical and biotechnology product companies, having seen the merits of
outsourced manufacturing in their traditional business, will perceive the
benefits of PCT’s business model as they prepare to commercialize regenerative
medicines themselves.
The
smaller biotech companies, which are a significant part of PCT’s target market,
may also decide to expand their laboratory facilities and offer their services
to others. However, we expect that it is unlikely, given the
relatively limited resources of such companies and the risk that such a change
in strategy would detract from their core research and development
efforts. It is likely that these companies, like their larger and
more established peers, will very quickly be confronted with a “build versus
buy” decision, and the case for outsourcing cell manufacturing will appeal to
these companies.
Business
of DomaniCell
Overview
DomaniCell
is a wholly owned subsidiary of PCT, which assists hospitals with providing
umbilical cord blood unit collection, and long-term storage services to patients
for potential future therapeutic use. DomaniCell provides the
front-end interface and support services to hospitals and in turn employs PCT’s
cell therapy manufacturing facilities network for the processing and long-term
storage of umbilical cord blood units. PCT intends to leverage its
position in the market place as an industry leader in cell therapy
manufacturing, storage, and distribution for clinical use to expand the
umbilical cord blood collection and storage business of DomaniCell.
Background and
Market
Stem
cells are the building blocks of the immune system and scientific evidence
indicates that they may be effective in treating a variety of life-threatening
diseases including leukemia, cancers, and many blood and immune
disorders. Research indicates that billions of dollars are currently
being spent on research that is solely focused on cellular therapy to treat the
diseases of age. Medical science has shown that the body will respond
best to such treatments arising from its own cells. Only your own cells are a
perfect genetic match to your body – thus minimizing the toxicity associated
with allogeneic (someone else’s cells) cellular therapy and improving the
chances of success.
As these
therapies advance, a limiting factor as to their use may eventually be the
availability of each individual’s healthy cells. Umbilical cord blood
has been shown to be a plenteous and rich source of stem cells. Each
day, our stem cells get older and have been shown to become less effective with
age. Our stem cells have something called “telomeres” that get
shorter and shorter every day until there are no more telomeres left on the
cells and then the cells die. Studies have shown that the decline in
telomere length is even faster in people with disease than in people without
disease. For example, people with diseases like diabetes will show a
rapid decline in the quality of their stem cells. There may even be
evidence that stem cells of people affected by cardiovascular disease are less
healthy and decreased in quantity than in people without this
disease.
PCT
believes that just as people plan for their own financial future, they can plan
towards their health future by storing their own stem cells for their own
use. The banking of cord blood is marketed and sold to expecting
parents as “biological insurance.” PCT’s own research showed that
while this practice is gaining in acceptance, the market is still in its infancy
with cord blood banking occurring for only 3.5% of total births in the United
States. Patients regardless of age can choose stem cell and immune
system cell collection and storage as personal insurance that their stem cells
will be available for their own use if needed in the future. Based on
current science, the preferable time for collection is when one is healthy and
unlikely to have stem cells already programmed for disease or before the immune
system is damaged by disease or toxins (drugs including chemotherapy or
radiation).
However,
there remains scepticism in the marketplace with recently published articles
pointing out how certain doctors believe it is a waste of money to store the
cord blood privately, since it gives a false sense of security to the parent at
a substantial cost at times. An important advantage of the national,
public cord blood collection system is that it costs nothing for patients to
donate their cord blood. Additionally, major medical organizations,
including the American Academy of Pediatrics (AAP), the American Medical
Association (AMA), the American College of Obstetricians and Gynaecologists
(ACOG), and the American Society of Blood and Marrow Transplantation (ASBMT) do
not recommend private storage, except in very limited
instances. Further, PCT believes that the medical community is
currently supportive of public cord blood donation and of the national cord
blood registry that is administered by the National Marrow Donor
Program.
DomaniCell’s
Approach
Management
of PCT believes that central to increasing market share for umbilical cord blood
collection and storage is compliance with cGMP and documented experience in the
clinical distribution and usage of cells as therapies. These are both
advantages that PCT can offer DomaniCell. PCT intends to leverage PCT’s position
in the market place for cell therapy manufacturing, storage, and distribution
for clinical use to expand the umbilical cord blood collection and storage
business of DomaniCell.
GOVERNMENT
REGULATION
The
health care industry is one of the most highly regulated industries in the
United States. The federal government, individual state and local
governments, as well as private accreditation organizations, oversee and monitor
the activities of individuals and businesses engaged in the development,
manufacture and delivery of health care products and
services. Federal laws and regulations seek to protect the health,
safety, and welfare of the citizens of the United States, as well as to prevent
fraud and abuse associated with the purchase of health care products and
services with federal monies. The relevant state and local laws and
regulations similarly seek to protect the health, safety, and welfare of the
states’ citizens and prevent fraud and abuse. Accreditation
organizations help to establish and support industry standards and monitor new
developments. The following is a general description of the current
material laws and regulations.
FDA
Regulation of Cell Therapy Facilities
Manufacturing
facilities that produce cellular therapies are subject to extensive regulation
by the FDA. In particular, FDA regulations set forth requirements
pertaining to establishments that manufacture human cells, tissues, and cellular
and tissue-based products (“HCT/Ps”). Title
21, Code of Federal Regulations, Part 1271 (21 CFR Part 1271) provides for a
unified registration and listing system, donor-suitability, current good tissue
practices, and other requirements that are intended to prevent the introduction,
transmission, and spread of communicable diseases by HCT/Ps. More specifically,
key elements of Part 1271 include:
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Registration
and listing requirements for establishments that manufacture
HCT/Ps;
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Requirements
for determining donor eligibility, including donor screening and
testing;
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Current
good tissue practice requirements, which include requirements pertaining
to the manufacturer’s quality program, personnel, procedures,
manufacturing facilities, environmental controls, equipment, supplies and
reagents, recovery, processing and process controls, labeling, storage,
record-keeping, tracking, complaint files, receipt, pre-distribution
shipment, distribution, and donor eligibility determinations, donor
screening, and donor testing;
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Adverse
reaction reporting;
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Labeling
of HCT/Ps; and
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FDA
inspection, retention, recall, destruction, and cessation of manufacturing
operations.
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Additional
FDA laws and regulations apply to cellular therapies comprised of HCT/Ps that
are regulated as a drug, biological product, or medical device. (See 21 CFR
1271.10(a)). These laws and regulations include requirements for
current Good Manufacturing Practices (“cGMP”). In
summary, FDA’s cGMP requirements embody a set of principles that govern a
facility’s laboratory and manufacturing operations. These
requirements are designed to ensure that a facility’s processes – and products
resulting from those processes – meet defined safety requirements and have the
identity, strength, quality and purity characteristics that they are represented
to have.
PCT
currently collects, processes, stores and manufactures HCT/Ps, as well as
manufactures cellular therapy products that are regulated as biological
products. DomaniCell also collects, processes, and stores
HCT/Ps. Therefore, both PCT and DomaniCell must comply with Part 1271
and with the cGMP guidelines that apply to biological products. PCT’s
management believes that other requirements pertaining to biological products,
such as requirements pertaining to premarket approval, do not currently apply to
PCT because PCT does not intend to market and sell cellular therapy
products. However, these additional requirements may apply to
companies that PCT incubates and spins off, such as Amorcyte, if these companies
pursue marketing of cellular therapy products. Additionally, if
either PCT or DomaniCell changes its business operations in the future, the FDA
requirements that apply to PCT or DomaniCell may also change.
Compliance
with FDA requirements can be time consuming, costly and can result in delays in
product approval or product sales. Further, failure to comply with
applicable FDA requirements can result in regulatory inspections and associated
observations, warning letters, other requirements of remedial action, and, in
the case of failures that are more serious, suspension of manufacturing
operations, seizure, injunctions, product recalls, fines, and other
penalties. PCT believes that its facilities are in material
compliance with applicable existing FDA requirements, and intends to continue to
comply with new requirements that may apply in the future.
Additionally,
FDA, other regulatory agencies, or the United States Congress may be
considering, and may enact laws or regulations regarding the use and marketing
of stem cells, cell therapy products, or products derived from human cells or
tissue. These laws and regulations can affect PCT directly or the
business of some of PCT’s clients and therefore the amount of business PCT
receives from these clients.
State
Regulation of Cell Therapy
Certain
state and local governments regulate cell-processing facilities by requiring
them to obtain other specific licenses. As required under applicable
state law, PCT’s New Jersey and California facilities are licensed,
respectively, as a blood bank in New Jersey and as a drug manufacturing facility
in California. PCT also maintains licenses with respect to states
that require licensure of out-of-state facilities that process cell, tissue
and/or blood samples of residents of such states (e.g., New York and
Maryland). PCT has the relevant state licenses needed for processing
and is AABB (American Association of Blood Banks) accredited for this
purpose. PCT’s management believes that it is in material compliance
with currently applicable federal, state, and local laboratory licensure
requirements, and intends to continue to comply with new licensing requirements
that may become applicable in the future.
Certain
states may also have enacted laws and regulations, or may be considering laws
and regulations, regarding the use and marketing of stem cells or cell therapy
products, such as those derived from human embryos. While these laws and
regulations should not directly affect PCT’s business, they could affect the
business of some of PCT’s clients and therefore the amount of business PCT
receives from these clients.
Federal
Regulation of Clinical Laboratories
The
Clinical Laboratory Improvement Act Amendments of 1988 (“CLIA”) extends
federal oversight to clinical laboratories that examine or conduct testing on
materials derived from the human body for the purpose of providing information
for the diagnosis, prevention, or treatment of disease or for the assessment of
the health of human beings. CLIA requirements therefore include those
laboratories that handle biological matter. CLIA requires that these
laboratories be certified by the government, satisfy governmental quality and
personnel standards, undergo proficiency testing, be subject to biennial
inspections, and remit fees. The sanctions for failure to comply with
CLIA include suspension, revocation, or limitation of a laboratory’s CLIA
certificate necessary to conduct business, fines, or criminal
penalties. Additionally, CLIA certification may sometimes be needed
when an entity, such as PCT or DomaniCell, desire to obtain accreditation,
certification, or license from non-government entities for cord blood
collection, storage, and processing. Currently CLIA certification is not
required for our facilities in New Jersey and in California. However,
to the extent that any of the activities of PCT or DomaniCell (for example, with
regard to processing or testing blood and blood products) require CLIA
certification, PCT intends to obtain and maintain such certification and/or
licensure.
Health
Insurance Portability and Accountability Act – Protection of Patient Health
Information
The
Administrative Simplification provisions of the Health Insurance Portability and
Accountability Act of 1996 (“HIPAA”) require
health care plans, health care providers and health care clearinghouses,
collectively defined under HIPAA as “Covered Entities,” to comply with standards
for the use and disclosure of health information within such organizations and
with third parties. These include standards for:
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Common
health care transactions, such as claims information, plan eligibility,
payment information and the use of electronic
signatures;
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Unique
identifiers for providers, employers, health plans and individuals;
and
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Security
and privacy of health information.
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Although
the obligations of HIPAA only apply directly to Covered Entities, any Covered
Entity that uses third parties (referred to in HIPAA as “Business Associates”)
to perform functions on its behalf involving the creation or use of certain
patient health information is required to have a contract with the Business
Associate that limits the use and disclosure of such information by the Business
Associate.
While
PCT’s management believes that the current business operations of PCT or
DomaniCell would not cause either of them to be considered a Covered Entity,
there is a risk that due to conflicting interpretations of the regulations,
DomaniCell may be a Covered Entity. If DomaniCell is a Covered
Entity, there is a risk of liability that DomaniCell may not be complying fully
with all HIPAA requirements. PCT has signed Business Associate
Agreements where requested by PCT’s customers who are Covered Entities, which
would require compliance with certain privacy and security requirements relating
to individually identifiable health information created or used in connection
with such relationships. PCT is in substantial compliance with such Business
Associate Agreements. However, given its complexity and the
possibility that the regulations may change and may be subject to changing and
even conflicting interpretation, PCT’s ability to comply fully with all of the
HIPAA requirements and requirements of its Business Associate Agreements is
uncertain.
Stem
Cell Therapeutic and Research Act of 2005
The Stem
Cell Therapeutic and Research Act of 2005 established a national donor bank of
cord blood and created a national network for matching cord blood to
patients. The National Marrow Donor Program (NMDP) carries out this
legislation, which entails acting as the nation’s Cord Blood Coordinating Center
and actively recruiting parents for cord blood donations. The NMDP
also administers the National Cord Blood Inventory (NCBI), which has a goal of
collecting 150,000 cord blood units that could be used to treat patients all
over the United States. Importantly, the legislation also authorized
federal funding to support the legislation’s goals for collecting cord blood
units.
The
existence and proliferation of this public cord blood bank may adversely affect
PCT and/or the business of DomaniCell, because parents may opt to donate their
newborn’s cord blood to the public registry and to use the public registry if
stem cells from cord blood are needed for treatment purposes. In this
regard, an important advantage of the national, public cord blood collection
system is that it costs nothing for patients to donate their cord
blood. Additionally, major medical organizations, including the
American Academy of Pediatrics (AAP), the American Medical Association (AMA),
the American College of Obstetricians and Gynaecologists (ACOG), and the
American Society of Blood and Marrow Transplantation (ASBMT) do not recommend
private storage, except in very limited instances. Further, this
national, public cord blood registry is widely accepted by the medical
community, and therefore physicians and others in the health care community may
be less willing to use or recommend a private cord blood facility.
Other
Applicable Laws
In
addition to those described above, other federal and state laws and regulations
that could directly or indirectly affect PCT’s ability to operate the business
and/or financial performance of PCT and DomaniCell include:
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State
and local licensure, registration and regulation of laboratories, the
processing and storage of human cells and tissue, and the development and
manufacture of pharmaceuticals and
biologics;
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Other
laws and regulations administered by the United States Food and Drug
Administration, including the Federal Food Drug and Cosmetic Act and
related laws and regulations and the Public Health Service Act and related
laws and regulations;
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Laws
and regulations administered by the United States Department of Health and
Human Services, including the Office for Human Research
Protections;
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State
laws and regulations governing human subject
research;
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Federal
and state coverage and reimbursement laws and regulations, including laws
and regulations administered by the Centers for Medicare & Medicaid
Services and state Medicaid
agencies;
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The
federal Medicare and Medicaid Anti-Kickback Law and similar state laws and
regulations;
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The
federal physician self-referral prohibition commonly known as the Stark
Law, and state equivalents of the Stark
Law;
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Occupational
Safety and Health (“OSHA”)
requirements;
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State
and local laws and regulations dealing with the handling and disposal of
medical waste; and
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The
Intermediate Sanctions rules of the IRS providing for potential financial
sanctions with respect to “Excess Benefit Transactions” with HUMC or other
tax-exempt organizations.
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Enactment
of Comprehensive Health Care Reform
In late
March 2010, the Federal government enacted a comprehensive health care reform
package which consists of the Patient Protection and Affordable Care Act, as
amended by the Health Care and Education Reconciliation Act of 2010 ("Health
Reform"). Among other provisions, the Health Reform imposes
individual and employer health insurance requirements, provides certain
insurance subsidies (e.g., premiums and cost sharing), mandates extensive
insurance market reforms, creates new health insurance access points (e.g.,
State-based health insurance exchanges), expands the Medicaid program, promotes
research on comparative clinical effectiveness of different technologies and
procedures, and makes a number of changes to how products and services will be
reimbursed by the Medicare program.
There are
a number of provisions in the Health Reform that may directly impact our
customers and, therefore, indirectly affect us. For example, the
Health Reform expands the number of individuals that will be covered by either
private or public health insurance, which may, in turn, increase the pool of
potential purchasers for our customers’ products to the extent they are
reimbursable by private or public health insurance. The Health Reform
also requires health insurance issuers in the individual and small group markets
to cover certain “essential health benefits,” which include prescription drugs
and which may increase coverage for our customers’ products. In
addition, the Health Reform reduces income and raises costs for our customers
through, for instance, the imposition of drug price discounts for Medicare Part
D enrollees in the “donut hole” and the imposition of an annual fee on
prescription drug and biologic manufacturers. Such provisions may
cause our customers to seek to restrain costs in other areas, including the
services which we provide.
The
Health Reform also authorizes the FDA to approve biosimilar products (sometimes
referred to as “generic” biologic products). The new law established a period of
12 years of data exclusivity for the original, reference products in order to
preserve incentives for future innovation. The statute also sets
forth approval standards for biosimilars, which require a demonstration of
biosimilarity via analytical and clinical studies, as well as similarities in
the products’ conditions for use, route of administration, and other factors.
With the introduction of a pathway for the approval of biosimilars in the United
States, demand for our services may increase.
The
effective dates of the various provisions within the Health Reform are staggered
over the next several years, with some changes occurring
immediately. Much of the interpretation of the Health Reform will be
subject to administrative rulemaking, the development of agency guidance, and
court interpretation. Therefore, the consequences of the Health
Reform on PCT’s services are unknown and speculative at this point.
OTHER
RELATIONSHIPS BETWEEN THE PARTIES
On
January 9, 2009, PCT entered into a Cell Processing and Storage Customer
Agreement (the “PCT
Agreement”) with NeoStem. Under the PCT Agreement, PCT will
provide to NeoStem autologous adult stem cell processing and storage services
utilizing cGMP standards. Such services will be provided at both
PCT’s California and New Jersey facilities. NeoStem agrees to use PCT
for processing and storage services for commercial purposes on an exclusive
basis commencing with such time as PCT completes certain preliminary services
and is ready and able to start the processing and storage services as required
by the agreement. PCT agreed to provide to NeoStem stem cell
processing and long term storage services for NeoStem’s business on an exclusive
basis. Prior to commencing these services, PCT agreed to provide
certain preliminary services consisting of technology transfer and protocol
review and revision to ensure that the processing and storage services are cGMP
compliant. The agreement sets forth agreed upon fees for the delivery
of the services as well as providing for a one-time payment of $35,000 for the
preliminary services which has been paid. The agreement is for a four
year term, subject to earlier termination on 365 days notice as set forth in the
agreement. Pursuant to the PCT Agreement, in April 2009, NeoStem’s
cryopreservation operations were transferred from NeoStem’s California facility
to PCT’s California facility.
As of
December 31, 2009, NeoStem, NeoStem (China), Inc., ("NeoStem China") its
subsidiary, and PCT entered into an Agreement whereby NeoStem and NeoStem China
engaged PCT to perform the services necessary to construct in Beijing, China a
facility consisting of a clean room for adult stem cell clinical trial
processing and other stem cell collections which will have the processing
capacity on an annual basis sufficient for at least 10,000 samples, research and
development laboratory space, collection and stem cell storage area and offices,
together with the furnishings and equipment and the installation of quality
control systems consisting of materials management, equipment maintenance and
calibration, environmental monitoring and compliance and adult stem cell
processing and preservation which comply with cGMP standards and regulatory
standards that would be applicable in the United States under GTP standards, as
well as all regulatory requirement applicable to the program under the laws of
the People's Republic of China. The aggregate cost of the program,
including the phase 1 equipment purchases, is expected to be approximately $3
million.
RISK
FACTORS
You are
urged to read all relevant documents filed with the SEC concerning the Merger,
including, without limitation, the S-4 and the prospectus/joint proxy statement
contained therein, when such documents are available, because they will contain
important information about NeoStem and the proposed Merger, including risk
factors relating thereto. Set forth below are certain risk factors
relating to the proposed Merger of which you should be aware.
Risks Related
to PCT and PCT’s Business
PCT’s
business is highly speculative and subject to a high degree of
risk. The risks and uncertainties described below are not the only
ones that could affect PCT. Additional risks and uncertainties of
which PCT is aware, or currently believes are immaterial, may become important
factors affecting PCT’s business. If any of the following risks
occur, PCT’s business, financial condition or operating results could be
materially harmed, or differ materially from those expressed in any
forward-looking statements.
Cell
therapy is still a developing field and a significant global market for the
services of PCT and DomaniCell is yet to emerge.
Cell
therapy is still a developing area of research, with few cell therapy products
approved for clinical use. At the PCT level, the current market and
current contracts principally consist of providing manufacturing of cell and
tissue-based therapeutic products in clinical trial and processing of stem cell
products for transplantation programs. PCT’s subsidiary, DomaniCell,
provides services related to the collection and storage of umbilical cord blood
units. There is no significant global market for stem cell processing
or their collection and storage, nor is there any guarantee that such markets
will develop in the near future. Major medical institutions do not
recommend private storage and PCT believes that the medical community is
supportive of the public cord blood collective system. Patients can
donate their cord blood to the system without charge. The market for
cell and tissue-based therapies is early-stage, substantially research oriented,
and financially speculative. Very few companies have been successful
in their efforts to develop and commercialize a stem cell
product. Stem cell products in general may be susceptible to various
risks, including undesirable and unintended side effects, unintended immune
system responses, inadequate therapeutic efficacy, or other characteristics that
may prevent or limit their approval or commercial use. The demand for
stem cell processing and the number of people who may use cell or tissue-based
therapies is difficult to forecast. As there are no real experts who
can forecast this market with accuracy, there is limited data from which the
future use of our services may be forecasted. The success of PCT and
its subsidiary, DomaniCell is dependent on the establishment of a large global
market for their products and services and their ability to capture a share of
this market.
PCT
has had a history of losses and may continue to incur such losses for the near
future. PCT faces liquidity issues.
Since PCT
began operations in 1999, cumulative expenses have exceeded our cumulative
revenues, resulting in losses, accumulating to a deficit of $11,815,365 million through June 30,
2010.
PCT has
not generated any significant amount of revenue nor been profitable in any
quarter since inception. Operations have been funded through the sale
of equity, loans from affiliates and a mortgage on PCT’s
property. PCT has limited working capital for development and growth;
as of June 30, 2010, PCT had negative working capital of $6,143,954. PCT cannot
provide any assurance that PCT will generate a profit from its operations in the
near future to fund its growth.
As of
June 30, 2010 and December 31, 2009, respectively, PCT had unrestricted cash
balances of $775,848 and $1,127,138. See Notes to 4 and 6 of the
Notes to the Consolidated Financial Statements of PCT filed as an exhibit to
this Current Report on Form 8-K for outstanding loan obligations, commitments
and contingencies.
A
significant portion of PCT's current revenues are derived from a small number of
customers.
Revenues
recognized over the past two fiscal years and the six months ended June 30, 2010
received to date are concentrated with three customers. These three
customers make up 20%, 13% and 15% of revenue (a total of 48% for all three) for
the six months ended June 30, 2010 and 18%, 15% and 12% of revenue (a total of
45% for all three) for the year ended December 31, 2009. One of these
is a related party. The loss of one or more of our customers or
material changes to the contracts with or payment terms of these customers may
result in significant business downturn through reduced revenues, reduced cash
flows, delays in revenues or cash flows and such delays or reductions could have
a material impact on the future revenue growth and profitability of
PCT. See Note 11 to the PCT Consolidated Financial Statements filed
as an exhibit to this Current Report on Form 8-K.
PCT
and its subsidiaries will require additional funding, and there is no certainty
that either will be able to obtain such financing. If PCT's capital requirements
are not met, the business of PCT and its subsidiaries may be adversely
affected.
PCT and
its subsidiaries will require additional financing to fund ongoing operations,
as current sales and revenue growth are insufficient to meet its operating costs
and perhaps its maturing obligations. Its inability to obtain necessary capital
or financing to fund these needs could adversely affect its business, results of
operations and financial condition. Additional financing may not be
available when needed or may not be available on acceptable terms. If
adequate funds are not available, PCT and its subsidiaries will most likely be
required to delay, scale back or eliminate one or more of its business
strategies, which may affect its overall business results of operations and
financial condition.
PCT
may be subject to significant product liability claims and
litigation.
The
business of PCT exposes it to potential product liability risks inherent in the
testing, processing and marketing of cell therapy products. Such liability
claims may be expensive to defend and result in large judgments against
PCT. PCT presently has product liability insurance limited to $2
million per incident and $2 million in annual aggregate, and also maintains
errors and omissions, directors and officers, workers’ compensation and other
insurance appropriate to the activities of PCT and those of
DomaniCell. If PCT or DomaniCell were to be subject to a claim in
excess of this coverage or to a claim not covered by PCT’s insurance and the
claim succeeded, PCT would be required to pay the claim from its own limited
resources, which could have a material adverse effect on the financial
condition, results of operations and business of PCT. Additionally,
liability or alleged liability could harm the business of PCT by diverting the
attention and resources of management and damaging the reputation of PCT and
that of its subsidiaries.
PCT
and its subsidiaries may fail to compete effectively, particularly against
larger, more established biotechnology and life science companies, which may
adversely affect their ability to develop and market its services and
products.
The
biotechnology and life science industries are highly
competitive. They include multinational biotechnology and life
science, pharmaceutical and chemical companies, academic and scientific
institutions, governmental agencies, and public and private research
organizations. Many of these companies or entities have significantly
greater financial and technical resources and production and marketing
capabilities than PCT. The biotechnology and life science industries
are characterized by extensive research and development, and rapid technological
progress. Competitors may successfully develop services or products
superior or less expensive than cell therapy services or products, rendering our
services less valuable or marketable.
PCT
has limited manufacturing capabilities.
PCT’s
management believes that it can provide services and produce materials for
clinical trials and for human use at its existing facilities, which it believes
are compliant with FDA requirements for current Good Manufacturing Practices
(“cGMP”) and
current Good Tissue Practices (“cGTP”). PCT’s
management also believes that PCT has sufficient capacity to meet expected near
term demand. However, PCT may need to, depending on demand, expand
its manufacturing capabilities for cell therapy services and products in the
future. In 2007, PCT acquired an additional facility in Allendale,
New Jersey, which is a cGMP compliant facility. The demand for PCT’s
services and products could, at times, exceed existing manufacturing
capacity. If PCT does not meet rising demand for products and
services on a timely basis or is not able to maintain cGMP compliance standards
then PCT’s clients and potential clients may elect to obtain the
products and services from competitors, which could materially and adversely
affect PCT’s revenues.
Current
cell therapy products have a limited biologic shelf life as a result of which
there are constraints on transit times between the time stem cells are extracted
from a patient and the time that a processed product leaves PCT’s facility and
arrives for re-infusion in the patient. Thus, PCT’s current business
model has to assume that, in order to effectively provide many of PCT’s services
in a market, PCT needs to have a suitable facility that can provide timely
service in such market. This could add significantly to PCT’s capital
requirements and be a limiting factor on the growth and profitability of
PCT.
Current
cell therapy products have a limited shelf life, in certain instances limited to
less than 12 hours. Thus, there are constraints on transit times
between the time the cell product is extracted from a patient and the product
arrives at one of PCT’s facilities for processing, as well as constraints on the
time that a processed product leaves PCT’s facility and arrives for re-infusion
in the patient. Therefore, cell therapy facilities need to be located
in major population centers in which patients of the cell therapy products are
likely to be located and within close proximity of major airports from which
they can be timely delivered. Building new facilities requires
significant commitments of time and capital, which PCT may not have available in
a timely manner. Even if such new facilities are established, there
may be challenges to ensuring that they are compliant with cGMP, other FDA
requirements, and/or applicable state or local regulatory
requirements. PCT cannot be certain that it would be able to recoup
the costs of establishing a facility and attaining regulatory compliances in a
given market. Thus, the limited biologic shelf life of cell therapy
products is a hindrance on the rate at which PCT can expand its cell processing
and manufacturing services into new geographic markets and requires significant
capital risk by PCT, which PCT may or may not be able to recover.
Technologies
for the treatment of cancer and other diseases and processes used by PCT are
subject to rapid change, and the development of treatment strategies that are
more effective than PCT’s products and services could render the services of PCT
and its subsidiaries obsolete. Given their exclusive focus on the
field of cell therapy, such obsolescence could jeopardize the success or
long-term survival of PCT and/or its subsidiaries.
The
activities of PCT and DomaniCell involve treatment modalities and protocols
influenced by advancements in technology. Various methods for
treating cancer and other diseases, of which cell therapy is but only one,
currently are, and in the future may be expected to be, the subject of extensive
research and development. There is no assurance that cell therapies
will achieve the degree of success envisioned by PCT in the treatment of cancer
and other diseases. Nor is there any assurance that new technological
improvements and techniques will not render processes currently used by PCT and
DomaniCell obsolete. In addition, the successful development and
acceptance of any one or more alternative forms of treatment could render the
need for our services obsolete. PCT is exclusively focused on cell
therapy, and if this field is substantially unsuccessful, this could jeopardize
the long-term survival of PCT and/or its subsidiaries.
There
is a scarcity of experienced professionals in the field of cell therapy and PCT
may not be able to retain key officers or employees or hire new key officers or
employees needed to implement its business strategy and develop its products and
businesses. For example, DomaniCell does not have any management at
the current time and is being managed by PCT with assistance from outside
consultants. If PCT is unable to retain or hire key officers or employees, it
may be unable to continue to grow its business or to implement its business
strategy, and its business may be materially and adversely
affected.
Given the
specialized nature of cell therapy and the fact that it is a young field, there
is an inherent scarcity of experienced personnel in the field. PCT
and DomaniCell are substantially dependent on the skills and efforts of current
senior management of PCT for their management and operations, as well as for the
implementation of their business strategy. As a result of the
difficulty in locating qualified new management, the loss or incapacity of
existing members of management or unavailability of qualified management or as
replacements for management of PCT who resign or are terminated could adversely
affect the operations of PCT or DomaniCell, as the case may be. The
future success of both PCT and DomaniCell also depends upon their ability to
attract and retain additional qualified personnel to support their anticipated
growth. There can be no assurance that PCT will be successful in
attracting or retaining personnel required by PCT to continue and grow its
operations. The loss of a key employee, the failure of a key employee
to perform in his or her current position or PCT’s or DomaniCell’s inability to
attract and retain skilled employees, as needed, could result in the inability
of PCT and DomaniCell to continue to grow their business or to implement their
business strategy, or may have a material adverse effect on PCT’s business,
financial condition and operating results.
PCT,
DomaniCell, and their customers conduct business in a heavily regulated
industry. If one or more of these companies fail to comply with
applicable current and future laws and government regulations, PCT’s business
and financial results could be adversely affected.
The
healthcare industry is one of the most highly regulated industries in the United
States. The federal government, individual state and local
governments and private accreditation organizations all oversee and monitor the
activities of individuals and businesses engaged in the delivery of health care
products and services. Current laws, rules and regulations that could
directly or indirectly affect the ability of PCT, DomaniCell and their customers
to operate each of their businesses could include, without limitation, the
following:
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State
and local licensure, registration and regulation of laboratories, the
collection, processing and storage of human cells and tissue and cord
blood, and the development and manufacture of pharmaceuticals and
biologics;
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The
federal Clinical Laboratory Improvement Act and amendments of
1988;
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Laws
and regulations administered by the FDA, including the Federal Food Drug
and Cosmetic Act and related laws and
regulations;
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The
Public Health Service Act and related laws and
regulations;
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Laws
and regulations administered by the United States Department of Health and
Human Services, including the Office for Human Research
Protections;
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State
laws and regulations governing human subject
research;
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Occupational
Safety and Health requirements;
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State
and local laws and regulations dealing with the handling and disposal of
medical waste;
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The
federal Medicare and Medicaid Anti-Kickback Law and similar state laws and
regulations;
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Federal
and state coverage and reimbursement laws and regulations, including laws
and regulations administered by the Centers for Medicare & Medicaid
Services;
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The
federal Health Insurance Portability and Accountability Act of 1996
(“HIPAA”), including the amendments included in the American Recovery and
Reinvestment Act of 2009, commonly known as the HITECH Act, and
regulations promulgated thereunder;
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The
federal physician self-referral prohibition, commonly known as the Stark
Law, and state equivalents of the Stark
Law;
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State
funding decisions on stem cell research and the development of cellular
therapies; and
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The
Intermediate Sanctions rules of the IRS providing for potential financial
sanctions with respect to “Excess Benefit Transactions” with HUMC or other
tax-exempt organizations.
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In
addition, as PCT expands into other parts of the world, it will need to comply
with the applicable laws and regulations in such foreign
jurisdictions. PCT has not yet thoroughly explored the requirements
or feasibility of such compliance. It is possible that it may not be
permitted to expand its business into one or more foreign
jurisdictions.
Although
PCT intends to conduct its business in compliance with applicable laws and
regulations and believes that PCT and DomaniCell are in material compliance with
applicable governmental healthcare laws and regulations, the laws and
regulations affecting these relationships are complex, and many aspects of such
relationships have not been the subject of judicial or regulatory
interpretation. Furthermore, the cell therapy industry is the topic
of significant government interest, and thus the laws and regulations applicable
to PCT and its business are subject to frequent change and/or
reinterpretation. There also can be no assurance that the laws and
regulations applicable to PCT and DomaniCell will not be amended or interpreted
in a manner that adversely affects their business, financial condition, or
operating results. For example, the federal government could issue
tighter restrictions on private cord blood banking that prevents DomaniCell from
collecting cord blood for private banking. While PCT is not aware of
any such developments or that any court or federal or state government is
reviewing PCT’s operations, it is possible that such a review could result in a
determination that would have a material adverse effect on the business,
financial condition and operating results of PCT.
It
is uncertain to what extent the government, private health insurers and
third-party payors will approve coverage or provide reimbursement for the
therapies and products to which the services of PCT and DomaniCell
relate. Availability for such reimbursement may be further limited by
an increasing uninsured population and reductions in Medicare and Medicaid
funding in the United States.
To the
extent that the health care provider customers of PCT and DomaniCell cannot
obtain coverage or reimbursement for therapies and products related to which PCT
and DomaniCell provide services, they may elect not to provide such therapies
and products to their patients and, thus, may not need our
services. Further, as cost containment pressures are increasing in
the health care industry, government and private payors adopt strategies
designed to limit the amount of reimbursement paid to health care
providers. Such cost containment measures may include:
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Reducing
reimbursement rates;
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Challenging
the prices charged for medical products and
services;
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Limiting
services covered;
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Decreasing
utilization of services;
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Negotiating
prospective or discounted contract
pricing;
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Adopting
capitation strategies; and
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Seeking
competitive bids.
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Similarly,
the trend toward managed health care and bundled pricing for health care
services in the United States, which may accelerate under the Health Reform,
could significantly influence the purchase of healthcare services and products,
resulting in lower prices and reduced demand for cancer therapies.
PCT
currently receives a small portion of its revenues from services rendered to
patients enrolled in federal health care programs, such as Medicare, and
DomaniCell may also directly or indirectly receive revenues from federal health
care programs. Federal health care programs are subject to changes in
coverage and reimbursement rules and procedures, including retroactive rate
adjustments. These contingencies could materially decrease the range
of services covered by such programs or the reimbursement rates paid directly or
indirectly for our products and services. To the extent that any
health care reform favors the reimbursement of other cancer therapies over stem
cell therapies, such reform could affect the ability of PCT to sell its
services, which may have a material adverse effect on its revenues.
The
limitation on reimbursement available from private and government payors may
reduce the demand for, or the price of, the services of PCT, which would have a
material adverse effect on their revenues. Additional legislation or
regulation relating to the health care industry or third-party coverage and
reimbursement may be enacted in the future which could adversely affect the
revenues generated from the sale of the products and services of
PCT.
Furthermore,
there has been a trend in recent years towards reductions in overall funding for
Medicare and Medicaid. There has also been an increase in the number
of people who do not have any form of health care coverage in recent years and
who are not eligible for or enrolled in Medicare, Medicaid or other governmental
programs. The extent to which the reforms brought about under Health
Reform may be successful in reducing the number of such uninsured is unclear,
and the reduced funding of governmental programs and increase in uninsured
populations could have a negative impact on the demand for the services of PCT
to the extent they relate to products and services which are reimbursed by
government and private payors.
Health
care companies have been the subjects of federal and state investigations, and
PCT or DomaniCell, could become subject to investigations in the
future.
Both
federal and state government agencies have heightened civil and criminal
enforcement efforts. There are numerous ongoing investigations of
health care companies, as well as their executives and managers. In
addition, amendments to the Federal False Claims Act, including under Health
Reform, have made it easier for private parties to bring “qui tam”
(whistleblower) lawsuits against companies under which the whistleblower may be
entitled to receive a percentage of any money paid to the
government. The Federal False Claims Act provides, in part, that an
action can be brought against any person or entity that has knowingly presented,
or caused to be presented, a false or fraudulent request for payment from the
federal government, or who has made a false statement or used a false record to
get a claim approved. The government has taken the position that
claims presented in violation of the federal anti-kickback law, Stark Law or
other healthcare–related laws, including laws enforced by the FDA, may be
considered a violation of the Federal False Claims Act. Penalties
include substantial fines for each false claim, plus three times the amount of
damages that the federal government sustained because of the act of that person
or entity and/or exclusion from the Medicare program. In addition, a
majority of states have adopted similar state whistleblower and false claims
provisions.
PCT’s
management is not aware of any government investigations involving any of the
facilities or management of PCT or DomaniCell. While management
believes that PCT and DomaniCell are in material compliance with applicable
governmental healthcare laws and regulations, any future investigations of PCT,
DomaniCell or their executives or managers could result in significant
liabilities or penalties, as well as damage to the reputation of both
companies.
Failure
to comply with applicable licensure, registration, certification, and
accreditation standards may result in loss of licensure, certification or
accreditation or other government enforcement actions.
FDA laws
and regulations provide for registration and listing requirements for
establishments that manufacture human cells, tissues, and cellular and
tissue-based products (“HCT/Ps”), and
additional FDA requirements may apply to HCT/Ps, or products comprised of
HCT/Ps, that are regulated as a drug, biological product, or medical
device. This includes the cellular therapy products that PCT may
manufacture for itself or on behalf of its customers. In addition,
certain state and local governments regulate stem cell laboratories by requiring
them to be licensed or to register with the state or
locality. Currently, PCT is licensed as a blood bank with respect to
its activities in New Jersey, as a tissue bank with respect to its activities in
New York and as a drug manufacturer with respect to its facility in California.
PCT’s management
believes that PCT and DomaniCell are in material compliance with current
federal, state, and local stem cell laboratory licensure
requirements. However, the licensing requirements in the states where
it is currently licensed may change, and PCT and/or DomaniCell may become
subject to the additional licensing, registration and/or compliance requirements
of other states, local governments and/or the federal government as it expands
its network and as new regulations are implemented. If PCT and/or
DomaniCell fails to comply with the various licensure requirements,
certification and accreditation standards to which it is subject, PCT and/or
DomaniCell may be subject to a loss of licensure, certification, or
accreditation that could adversely affect them.
Additionally,
certain non-government entities have promulgated standards for certification,
accreditation, and licensing of cord blood businesses that may apply to PCT
and/or DomaniCell’s operations. These organizations include, but may
not be limited to, AABB (formerly the American Association of Blood Banks), the
Foundation for the Accreditation of Cellular Therapy (FACT), and the American
Association of Tissue Banks (AATB). While currently these standards
are voluntary, in some cases compliance with them may be necessary for a cord
blood business to be accepted and competitive in the
marketplace. Compliance with these standards and obtaining the
applicable accreditation, certification, or license can be costly and
time-consuming. These accreditation, certification, or license
requirements may also change and new standards may be developed. If
PCT fails to comply with applicable standards, or fail to obtain or maintain
applicable accreditations, certifications, or licenses, PCT and/or DomaniCell
may be adversely affected.
Unintended
consequences of recently adopted health reform legislation in the U.S. may
adversely affect PCT’s business.
The
healthcare industry is undergoing fundamental changes resulting from political,
economic and regulatory influences. In the U.S., comprehensive
programs are under consideration that seek to, among other things, increase
access to healthcare for the uninsured and control the escalation of healthcare
expenditures within the economy. On March 23, 2010, health reform
legislation was approved by Congress and has been signed into
law. While PCT does not believe this legislation will have a direct
impact on its business, the legislation has only recently been enacted and
requires the adoption of implementing regulations, which may have unintended
consequences or indirectly impact PCT's business. For instance, the
scope and implications of the recent amendments pursuant to the Fraud
Enforcement and Recovery Act of 2009 (“FERA”), have yet to
be fully determined or adjudicated and as a result it is difficult to predict
how future enforcement initiatives may impact PCT's business. Also,
in some instances PCT’s clients may be health insurers that will be subject to
limitations on their administrative expenses and new federal review of
“unreasonable” rate increases which could impact the prices they pay for PCT's
services. If the legislation causes such unintended consequences or
indirect impact, it could have a material adverse effect on our business,
financial condition and results of operations.
Recent
legislation regarding the establishment and funding of public cord blood
collection and storage may adversely affect the business of
DomaniCell.
The Stem
Cell Therapeutic and Research Act of 2005 established requirements for a
national donor bank of cord blood and for a national network for matching cord
blood to patients. The federal government has entered into contracts
with the National Marrow Donor Program (NMDP) to carry out the provisions of
this legislation. Under these contracts, the NMDP acts as the
nation’s Cord Blood Coordinating Center and actively recruits parents for cord
blood donations. The NMDP also administers the National Cord Blood
Inventory (NCBI), which has a goal of collecting 150,000 cord blood units that
may be used for patients throughout the United States. The
legislation also authorized federal funding to support its goals and
requirements.
Parents
may opt to donate their newborn’s cord blood to the public registry and to use
the public registry if stem cells from cord blood are needed for treatment
purposes. In this regard, an important advantage of the national,
public cord blood collection system is that it costs nothing for patients to
donate their cord blood. This national, public cord blood registry
has also been widely accepted and supported by the medical community, so
physicians and others in the health care community may be less willing to use or
recommend a private cord blood facility when public collection is
available. Additionally, major medical organizations, including the
American Academy of Pediatrics (AAP), the American Medical Association (AMA),
the American College of Obstetricians and Gynaecologists (ACOG), and the
American Society of Blood and Marrow Transplantation (ASBMT) do not recommend
private storage, except in very limited instances. Further, PCT
believes that the medical community is currently supportive of public cord blood
donation and the national cord blood registry that is administered by the
National Marrow Donor Program. For these reasons, a significant
amount of patients may choose to use to donate their cord blood to the national,
public cord registry instead of privately banking cord blood. The
medical community could also issue stronger recommendations and opinions that
favor the use of the national registry. Therefore, the existence and
proliferation of the national registry may adversely affect the business of PCT
and/or DomaniCell.
DomaniCell
is an early-stage company and faces substantial risks and challenges, which
could negatively affect the overall value of PCT.
DomaniCell
was formed in 2005 and, as any company with a short history of operations, it is
subject to all of the risks that similar entities are subject to,
including:
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The
ability to attract and retain competent and experienced management and
operating personnel;
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The
ability to secure appropriate debt and equity capital to finance desired
growth;
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The
ability to develop and protect intellectual property through patents,
trademarks and other protective methods and
licenses;
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The
maintenance and development of good relations with referral
sources;
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The
efficient management of its everyday business operations;
and
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The
ability to implement its growth
strategy.
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PCT is
yet to hire permanent management for DomaniCell and intends to continue to
manage and fund the operations of DomaniCell until it has its own management and
generates enough revenues to sustain its own operations. There can be no
assurance that DomaniCell will be able to grow its business or achieve
profitability in the near future and may, in fact, continue to generate losses,
which would negatively affect the overall value of PCT.
If
PCT’s processing and storage facilities are damaged or destroyed, the business,
programs, and prospects of DomaniCell could be negatively affected and could
adversely affect the value of PCT as a whole.
PCT
processes and stores the umbilical cord blood of customers of DomaniCell at
PCT’s facility in Allendale, New Jersey, and may do so at PCT’s Mountain View,
California facility in the future. If these facilities or the
equipment in these facilities was to be significantly damaged or destroyed, PCT
could suffer a loss of some or all of the stored cord blood
units. Depending on the extent of loss, such an event could reduce
the ability of DomaniCell to provide cord blood stem cells when requested, could
expose DomaniCell to significant liability from its cord blood banking
customers, and could affect its ability to continue to provide umbilical cord
blood preservation services. While PCT believes that it has insured
against losses from damage to or destruction of its facilities consistent with
typical industry practices, if PCT has underestimated its insurance needs, PCT
may not have sufficient insurance to cover losses beyond the limits on its
policies. Such events could have a material adverse effect on the
value of PCT as a whole.
Competitors
of DomaniCell, may have greater resources or capabilities or better technologies
than DomaniCell, or may succeed in developing better service than DomaniCell,
and DomaniCell may not be successful in competing with them.
The
private umbilical cord banking business is a relatively new, highly competitive,
and an evolving field. DomaniCell competes with companies such as ViaCell, Inc.,
a subsidiary of the Perkin-Elmer Corporation, CBR Systems, Cryo-Cell
International, Inc., CorCell, Inc., a subsidiary of Cord Blood America Inc., and
LifeBank USA, a division of Celgene Cellular Therapeutics, a wholly owned
subsidiary of Celgene Corporation. Any of these companies may choose
to invest more in sales, marketing, and research and product development than
DomaniCell.
DomaniCell
will also have to compete with the national, public program, which has the
support of the medical community and which receives federal
funding. In this regard, DomaniCell also competes with public cord
blood banks such as the New York Blood Center (National Cord Blood Program),
University of Colorado Cord Blood Bank, Milan Cord Blood Bank, Dusseldorf Cord
Blood Bank, and other public cord blood banks around the world. Public cord
blood banks provide families with the option of donating their cord blood for
public use at no cost. The Stem Cell Therapeutic Act provides
financing for a national system of public cord blood banks in the United States
to encourage cord blood donations from an ethnically diverse
population. In addition, many states are evaluating the feasibility
of establishing cord blood repositories for transplantation
purposes. An increase in the number and diversity of publicly
available cord blood units from public banks would increase the probability of
finding suitably matched cells for a family member, which may result in a
decrease in the demand for private cord blood banking. If the science
of human leukocyte antigens, or HLA, typing advances, then unrelated cord blood
transplantation may become safer and more efficacious, similarly reducing the
clinical advantage of related cord blood transplantation. Such events could
negatively affect our forecasts regarding the business and revenues of
DomaniCell and of PCT.
Commercially
available transportation systems are not set up for shipment of biological or
other perishable goods and will not be able to meet the demands of the emerging
cell therapy market. To succeed, the large-scale commercialization of cell
therapy products will need to overcome the present weaknesses of the major air
carriers.
PCT has
determined that the weaknesses in existing transportation carriers include the
lack of a true point-to-point chain of control, non-controlled X-ray and
inspection, no guarantee of package orientation, handling or storage conditions
and in many cases no standard, documented and tracked operating
procedures. While reliable ground carriers with experience in the
transport of blood products already exist in major metropolitan areas of the
country, air carriers meeting such needs are limited. PCT evaluated the major
domestic express carriers, and concluded that even their highest-level services
are inadequate to meet the sector’s needs. However, PCT identified
and validated only one specialty air carrier as a transportation partner, which
specializes in shipping medical products, including whole blood and blood
products, tissue for transplantation, and diagnostic specimens There
are presently no alternative sources for the safe transportation of cell therapy
products. If this carrier should cease its medical shipping
operations or otherwise be unable to properly meet PCT's transportation needs.
The lack of access to safe and effective transportation options could adversely
affect PCT's business.
PCT is
required to comply with good manufacturing practice requirements an its failure
to do so may subject it to fines and other penalties that will delay or prevent
PCT or its affiliates and related parties from marketing and selling their
products and services.
FDA
current Good Manufacturing Practices (cGMP) requirements, set forth in Title 21,
Parts 210 and 211, of the Code of Federal Regulations (21 CFR Parts 210 and 211)
are federal regulations that govern the manufacture, processing, packaging and
holding of drug and cell therapy products. PCT must comply with cGMP,
requirements demanded by customers and enforced by the FDA through its
facilities inspection program. These requirements include quality
control, quality assurance and the maintenance of records and
documentation. PCT may be unable to comply with these cGMP
requirements and with other FDA, state and foreign regulatory
requirements. These requirements may change over time and PCT or
third party manufacturers may be unable to comply with the revised
requirements. A failure to comply with these requirements may result
in fines and civil penalties, suspension of production, suspension or delay in
product approval, product seizure or recall, or withdrawal of product
approval. If the safety of any quantities supplied by third-parties
is compromised due to their failure to adhere to applicable laws or for other
reasons, PCT may not be able to obtain regulatory approval for or successfully
commercialize product candidates that it may develop.
PCT
has a limited marketing staff and budget.
The
degree of market acceptance of PCT’s services depends upon a number of factors,
including the strength of its sales and marketing support. If PCT’s
marketing is not effective, its ability to generate revenues could be
significantly impaired. Due to capital constraints, PCT’s marketing
and sales activities are somewhat limited and thus PCT may not be able to make
its services known to a sufficient number of potential customers and
partners. Limitations in PCT’s marketing and sales activities, and
the failure to attract enough customers, will affect PCT’s ability to operate
profitably.
The demand for PCT’s services depends
in part on its customers’ research and development and marketing efforts. PCT’s
business, financial condition and results of operations may be harmed if its
customers spend less on, or are less successful in, these
activities.
Many of
PCT's customers are engaged in research, development, production and
marketing. The amount of customer spending on research, development,
production and marketing has a large impact on PCT's revenues
and profitability, particularly the amount customers choose to spend
on outsourcing. Customers determine the amounts that they will spend
based upon, among other things, available resources and their need to develop
new products, which, in turn, is dependent upon a number of factors, including
their competitors’ research, development and production initiatives, and the
anticipated reimbursement scenarios for specific products and therapeutic
areas. In addition, consolidation in the industries in which PCT’s
customers operate may have an impact on such spending as customers integrate
acquired operations, including research and development departments and their
budgets. PCT’s customers finance their research and development
spending from private and public sources. A reduction in spending by
PCT’s customers could have a material adverse effect on its business, financial
condition and results of operations. If PCT’s customers are not
successful in attaining or retaining product sales due to market conditions,
reimbursement issues or other factors, PCT’s results of operations
may be materially impacted
The
nature and duration of PCT contracts can yield varying revenues and
profits.
PCT's
contracts with customers may be subject to repeated renegotiation and amendments
which change the objectives of PCT's work and the milestones which determine
when revenues are received by PCT. Due to the fact that PCT's
customers are engaged in businesses that are in many instances experimental, the
objectives of such customer relationships with PCT are subject to change as
customer research and development and business models
develop. Additionally, most of these customers are subject to
regulatory controls and approval processes over their businesses and
products. If such customers fail to comply with such processes or do
not receive necessary approvals, PCT may be required to alter or halt the
activities for which such customers have contracted with PCT. Each of
these factors may have an adverse affect on PCT's revenues.
The
mortgage on PCT's Allendale facility contains various covenants that limit its
ability to take certain actions and PCT's failure to comply with any of the
covenants could have a material adverse effect on PCT's business.
The
mortgage on PCT's Allendale facility a contains debt coverage and total debt to
tangible net worth financial covenants which limit its ability to incur
additional debt and make capital expenditures. The mortgage note is
secured by substantially all of the assets of PCT, including a first mortgage on
the Allendale facility. In connection with the mortgage PCT assigned an amount
approximately equal to 18 months debt service to be held in escrow.
Risks Relating to the
Merger
A
condition to consummation of the Merger is that NeoStem or PCT obtains certain
consents or approvals from third parties. In addition, the
stockholders of NeoStem must approve the issuance of the securities to be issued
in the Merger and the Members of PCT must approve the Merger Agreement and
Merger. There can be no assurance that NeoStem or PCT will be able to
obtain all such relevant consents and approvals on a timely basis or at
all. NeoStem has incurred, and expects to continue to
incur, significant costs and expenses in connection with the proposed
Merger. Any failure to obtain, or delay in obtaining, the necessary
consents or approvals would prevent NeoStem from being able to consummate, or
delay the consummation of, the transactions contemplated by the Merger
Agreement, which could materially adversely affect the business, financial
condition and results of operations of NeoStem. There is no guarantee
that such approvals will be obtained or that such conditions will be
satisfied.
Failure
to satisfy closing conditions and complete the Merger could cause NeoStem’s
stock price to decline and could harm NeoStem’s business and operating
results.
The
Merger Agreement contains conditions which NeoStem must meet in order to
consummate the Merger, including that NeoStem affirm to PCT that it has $3
million available to repay certain indebtedness owed by PCT to an affiliate of
PCT’s CEO. No assurance can be given that the condition will be
satisfied. In addition, the Merger Agreement may be terminated by
either NeoStem or PCT under certain circumstances. If the Merger is
not completed for any reason, NeoStem may be subject to a number of risks,
including the following:
|
·
|
the
market price of NeoStem Common Stock may decline to the extent that the
relevant current market price previously reflected a market assumption
that the Merger will be completed;
|
|
·
|
many
costs related to the Merger, such as legal, accounting and financial
printing fees, must be paid regardless of whether the Merger is completed;
and
|
|
·
|
there
may be substantial disruption to the business of NeoStem and distraction
of its workforce and management
team.
|
The
announcement of the Merger may adversely affect NeoStem and PCT.
In
response to the announcement of the Merger, customers or suppliers of NeoStem
and/or PCT may delay, defer or cancel purchase or other
decisions. Any delay, deferral or cancellation in purchase or other
decisions by customers or suppliers could harm the business of the relevant
company, regardless of whether the Merger is completed. Similarly,
current and prospective NeoStem and/or PCT employees may experience uncertainty
about their future roles with NeoStem or PCT until the Merger is
completed. As a result, the ability of NeoStem and/or PCT to attract
and retain key management, sales, marketing and technical personnel could
suffer. Any such disruption of purchases and/or orders, as well as
any uncertainty regarding professional roles, could harm the business, financial
condition and operating results of the constituent entities, and such setbacks
could carry over into the combined entity.
Any
acquisition exposes a company to additional risks.
Acquisitions
may entail numerous risks for NeoStem, including:
|
·
|
difficulties
in assimilating acquired operations, technologies or products, including
the loss of key employees from acquired
businesses;
|
|
·
|
diversion
of management’s attention from NeoStem’s core
business;
|
|
·
|
risks
of entering markets in which NeoStem has limited or no prior
experience;
|
|
·
|
competing
claims for capital resources; and
|
|
·
|
NeoStem’s
management team has limited experience in purchasing and integrating new
businesses.
|
NeoStem’s
failure to successfully complete the integration of PCT could have a material
adverse effect on NeoStem’s business, financial condition and operating
results.
Failure
of the Merger to achieve potential benefits could harm the business and
operating results of the combined company.
NeoStem
and PCT expect that the combination of their businesses will result in potential
benefits for the combined company. Achieving these potential benefits
will depend on a number of factors, some of which include:
|
·
|
retention
of key management, marketing and technical personnel after the
Merger;
|
|
·
|
the
ability of the combined company to increase its customer base and to
increase the sales of products and services;
and
|
|
·
|
competitive
conditions in the industry surrounding the collection, processing, and
storage of stem cells.
|
The
failure to achieve anticipated benefits could harm the business, financial
condition and operating results of the combined company.
NeoStem
will need additional financing to continue operations successfully.
The
historic NeoStem business will require additional capital to fund NeoStem’s
current operating plan for NeoStem’s business, including the development of
NeoStem’s VSEL technology. The PCT business also will require
financing. Cash requirements may vary materially from those now
planned because of expenses relating to marketing, advertising, sales,
distribution, research and development and regulatory affairs, as well as the
costs of maintaining, expanding and protecting NeoStem’s intellectual property
portfolio, including potential litigation costs and
liabilities. Additional financing may not be available when needed or
may not be available on terms acceptable to us. The combined
company's inability to obtain necessary capital or financing to fund these needs
could adversely affect the combined company's business, results of operations
and financial condition.
NeoStem’s
outstanding warrants may negatively affect NeoStem’s ability to raise additional
capital.
As part
of the Merger, NeoStem will be issuing warrants to purchase up to an additional
3,000,000 shares of NeoStem Common Stock. NeoStem already had, at
June 30, 2010, approximately 29.9 million stock options and warrants
outstanding. Holders of NeoStem’s outstanding warrants are given the
opportunity to profit from a rise in the market price of NeoStem Common
Stock. So long as these warrants are outstanding, the terms on which
NeoStem could obtain additional capital may be adversely
affected. The holders of these warrants might be expected to exercise
them at a time when NeoStem would, in all likelihood, be able to obtain any
needed capital by a new offering of securities on terms more favorable than
those provided by these warrants.
NeoStem
and PCT cannot accurately predict the future growth rate or the size of the
market for the combined company’s products and technology. The
expansion of this market depends on a number of factors, such as:
|
·
|
the
cost, performance and reliability of the combined company’s
products/technologies, and the products/technologies offered by
competitors;
|
|
·
|
customers’
perceptions regarding the benefits of the combined company’s products and
technologies;
|
|
·
|
public
perceptions regarding the use of the combined company’s products and
technologies;
|
|
·
|
customers’
satisfaction with the products and technologies;
and
|
|
·
|
marketing
efforts and publicity regarding the products and
technologies.
|
If
the combined company is unable to manage growth in its business, its prospects
may be limited and its future results of operations may be adversely
affected.
The
combined company intends to expand its sales and marketing programs, its
manufacturing capacity, and its provision of innovative therapies as needed to
meet future demand. Any significant expansion may strain the combined
company’s managerial, financial and other resources. If the combined
company is unable to manage its growth, its business, operating results and
financial condition could be adversely affected. The combined company
will need to continually improve its operations, financial and other internal
systems to manage its growth effectively, and any failure to do so may lead to
inefficiencies and redundancies, and result in reduced growth prospects and
diminished operational results.
As a
result of the Merger, the equity holders of PCT will own approximately 16.5% of
the NeoStem Common Stock outstanding immediately after the Merger (exclusive of
the warrants to be issued to the PCT equity holders). This represents
dilution of the ownership interests and voting power of the current NeoStem
stockholders.
The
shares of NeoStem Common Stock issued to PCT and distributed to PCT's equity
holders will be freely tradable in the public market once released from escrow
(approximately 10% one month after Closing, 40% one year after Closing and 50%
two years after Closing). The market price of NeoStem Common Stock
could fall in response to sales of a large number of shares of NeoStem Common
Stock in the market after the release of the shares or in response to the
perception that sales of a large number of shares could occur. In
addition, these sales could create the perception by the public of difficulties
or problems with NeoStem’s products and services. As a result, these
sales also might make it more difficult for NeoStem to sell equity or
equity-related securities in the future at a time and price that its board of
directors deems appropriate.
Safe Harbor for
Forward-Looking Statements
This
Current Report on Form 8-K contains “forward-looking” statements within the
meaning of the Private Securities Litigation Reform Act of
1995. These statements are typically preceded by words such as
“believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or
similar expressions. These forward-looking statements are subject to
risks and uncertainties that may cause actual future experience and results to
differ materially from those discussed in these forward-looking
statements. Important factors that might cause such a difference
include, but are not limited to, costs related to the Merger; failure of
NeoStem's stockholders to approve the issuance of NeoStem securities in the
Merger; NeoStem's or PCT’s inability to satisfy the conditions of the Merger;
NeoStem's inability to maintain its American Stock Exchange listing; the
inability to integrate NeoStem’s and PCT’s businesses successfully; the need for
outside financing to meet capital requirements; and other events and factors
disclosed previously and from time to time in NeoStem’s filings with the SEC,
including NeoStem’s Annual Report on Form 10-K for the year ended December 31,
2009, as amended (the “10-K”), Quarterly Reports on Form 10-Q filed after such
10-K and, when filed with the SEC, the S-4. NeoStem does not
undertake any obligation to release publicly any revisions to such
forward-looking statements to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
This
Current Report on Form 8-K may be deemed to be solicitation material in respect
of the proposed Merger. The directors and executive officers of each
of NeoStem and PCT may be deemed to be participants in the solicitation of
proxies from the holders of NeoStem Common Stock in respect of the proposed
transaction. Information about the directors and executive officers
of NeoStem is set forth in the NeoStem Form 10-K. Investors may
obtain additional information regarding NeoStem and its directors and executive
officers, and PCT and its Board of Managers and executive officers, in
connection with the proposed Merger by reading the S-4 and the prospectus/joint
proxy statement contained therein, when it becomes available.
Item
9.01.
|
Financial
Statements and Exhibits.
|
The
following financial statements and exhibits are filed with this Current Report
on Form 8-K.
(a)
|
Financial
Statements of Businesses Acquired:
|
Progenitor
Cell Therapy, LLC and Subsidiaries Consolidated Financial Statements for the
Years Ended December 31, 2009, 2008 and 2007 and the Six Months Ended June 30,
2010 and 2009 (Unaudited)
(b)
|
Pro
Forma Financial Information:
|
Unaudited
Pro Forma Condensed Combined Financial Statements
Exhibit
2.1 – Agreement and Plan of Merger, dated as of September 23, 2010, by and
among NeoStem, PCT and Subco.*
Exhibit
23.1 – Consent of EisnerAmper LLP.
Exhibit
99.1 – Press release, dated September 23, 2010.
________________
* The
schedules to this agreement have been omitted from this filing pursuant to Item
601(b)(2) of Regulation S-K. NeoStem will furnish copies of any
schedules to the SEC upon request.
SIGNATURE
Pursuant to the requirements of the
Securities Exchange Act of 1934, NeoStem has duly caused this Report to be
signed on its behalf by the undersigned hereunto duly authorized.
|
NEOSTEM,
INC.
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
|
Name: Catherine
M. Vaczy
|
|
|
|
Title: Vice
President and General Counsel
|
|
Date:
September 23, 2010
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
CONSOLIDATED
FINANCIAL STATEMENTS
FOR
THE YEARS ENDED DECEMBER 31, 2009, 2008, AND 2007
AND
SIX MONTHS ENDED JUNE 30, 2010 AND 2009 (UNAUDITED)
|
|
Page
|
|
|
|
Report
of Independent Registered Accounting Firm
|
|
1
|
|
|
|
Consolidated
Balance Sheets
|
|
2
|
|
|
|
Consolidated
Statements of Operations
|
|
3
|
|
|
|
Consolidated
Statements of Members’ Equity
|
|
4
|
|
|
|
Consolidated
Statements of Cash Flow
|
|
5
|
|
|
|
Notes
to the Consolidated Financial Statements
|
|
6 –
17
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors of
Progenitor
Cell Therapy, LLC and Subsidiaries
Allendale,
New Jersey
We have
audited the accompanying consolidated balance sheet of Progenitor Cell Therapy,
LLC and Subsidiaries as of December 31, 2009, 2008 and 2007 and the related
consolidated statements of income, changes in stockholders’ equity,
comprehensive income (loss) and cash flows for each of the three years in the
period ended December 31, 2009. These consolidated financial
statements are the responsibility of the Company's management. Our responsibility is
to express an opinion on these consolidated financial statements and financial
statement schedule based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included
consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express
no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of Progenitor Cell
Therapy, LLC and Subsidiaries as of December 31, 2009, 2008 and 2007 and the
consolidated results of their operations and their cash flows for each of the
three years in the period ended December 31, 2009, in conformity with accounting
principles generally accepted in the United States of America.
EisnerAmper
LLP
Hackensack,
New Jersey
September
17, 2010
PROGENITOR
CELL THERAPY, LLC
CONSOLIDATED
BALANCE SHEETS
|
|
June 30,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
775,848 |
|
|
$ |
1,127,138 |
|
|
$ |
1,582,026 |
|
|
$ |
1,214,035 |
|
Accounts
receivable, less allowance for doubtful accounts of $67,255, $67,255,
$67,255 and $67,255, at June 30, 2010 and December 31, 2009,
2008 and 2007, respectively
|
|
|
768,882 |
|
|
|
1,534,447 |
|
|
|
1,051,436 |
|
|
|
814,374 |
|
Prepaid
expenses and other current assets
|
|
|
488,099 |
|
|
|
446,824 |
|
|
|
235,248 |
|
|
|
213,045 |
|
Deferred
project costs
|
|
|
3,315,945 |
|
|
|
2,116,118 |
|
|
|
450,329 |
|
|
|
953,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Current Assets
|
|
|
5,348,774 |
|
|
|
5,224,527 |
|
|
|
3,319,039 |
|
|
|
3,194,888 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net of accumulated depreciation
|
|
|
9,728,815 |
|
|
|
7,519,638 |
|
|
|
6,686,212 |
|
|
|
7,317,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
cash and cash equivalents
|
|
|
353,860 |
|
|
|
353,860 |
|
|
|
353,860 |
|
|
|
353,860 |
|
Other
assets
|
|
|
196,090 |
|
|
|
146,090 |
|
|
|
99,646 |
|
|
|
200,449 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
15,627,539 |
|
|
$ |
13,244,115 |
|
|
$ |
10,458,757 |
|
|
$ |
11,067,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND MEMBERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
maturities of long term debt
|
|
$ |
106,165 |
|
|
$ |
103,521 |
|
|
$ |
98,413 |
|
|
$ |
1,093,128 |
|
Borrowings
under line of credit - related party
|
|
|
3,400,000 |
|
|
|
1,080,000 |
|
|
|
500,000 |
|
|
|
- |
|
Accounts
payable
|
|
|
1,590,295 |
|
|
|
1,032,974 |
|
|
|
559,106 |
|
|
|
480,562 |
|
Accrued
expenses and other current liabilities
|
|
|
336,941 |
|
|
|
672,497 |
|
|
|
309,456 |
|
|
|
302,859 |
|
Due
to Amorcyte, Inc.
|
|
|
500,000 |
|
|
|
500,000 |
|
|
|
500,000 |
|
|
|
500,000 |
|
Deferred
revenues
|
|
|
5,559,327 |
|
|
|
4,295,965 |
|
|
|
1,606,923 |
|
|
|
3,118,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Current Liabilities
|
|
|
11,492,728 |
|
|
|
7,684,957 |
|
|
|
3,573,898 |
|
|
|
5,494,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
debt, net of current maturities
|
|
|
2,763,222 |
|
|
|
2,817,172 |
|
|
|
2,920,704 |
|
|
|
3,011,747 |
|
Deferred
lease liability
|
|
|
107,393 |
|
|
|
108,642 |
|
|
|
96,838 |
|
|
|
49,628 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Liabilities
|
|
|
14,363,343 |
|
|
|
10,610,771 |
|
|
|
6,591,440 |
|
|
|
8,556,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Members'
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Members'
contributions and other, net
|
|
|
13,079,561 |
|
|
|
12,678,399 |
|
|
|
12,104,722 |
|
|
|
9,961,784 |
|
Accumulated
deficit
|
|
|
(11,815,365 |
) |
|
|
(10,045,055 |
) |
|
|
(8,237,405 |
) |
|
|
(7,456,365 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Members' Equity
|
|
|
1,264,196 |
|
|
|
2,633,344 |
|
|
|
3,867,317 |
|
|
|
2,505,419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
15,627,539 |
|
|
$ |
13,244,115 |
|
|
$ |
10,458,757 |
|
|
$ |
11,061,776 |
|
See
accompanying notes to consolidated financial statements.
PROGENITOR
CELL THERAPY, LLC
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR THE
SIX MONTHS ENDED JUNE 30, 2010 AND JUNE 30, 2009 (UNAUDITED)
AND THE
YEARS ENDED DECEMBER 31, 2009, 2008 AND 2007
|
|
Six Months Ended June 30,
|
|
|
Year Ended December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical
services
|
|
$ |
4,271,316 |
|
|
$ |
4,372,862 |
|
|
$ |
8,238,159 |
|
|
$ |
9,741,581 |
|
|
$ |
6,990,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical
services
|
|
|
2,762,598 |
|
|
|
2,474,681 |
|
|
|
5,479,897 |
|
|
|
6,618,197 |
|
|
|
4,978,891 |
|
Selling,
general and administrative expenses
|
|
|
2,944,514 |
|
|
|
2,147,255 |
|
|
|
4,369,808 |
|
|
|
3,688,919 |
|
|
|
5,050,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
5,707,112 |
|
|
|
4,621,936 |
|
|
|
9,849,705 |
|
|
|
10,307,116 |
|
|
|
10,029,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(1,435,796 |
) |
|
|
(249,074 |
) |
|
|
(1,611,546 |
) |
|
|
(565,535 |
) |
|
|
(3,039,094 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,335 |
|
|
|
3,048 |
|
|
|
5,502 |
|
|
|
16,487 |
|
|
|
142,987 |
|
Interest
expense
|
|
|
(335,849 |
) |
|
|
(76,694 |
) |
|
|
(280,220 |
) |
|
|
(247,663 |
) |
|
|
(56,426 |
) |
Other
income (expense)
|
|
|
- |
|
|
|
(460 |
) |
|
|
(460 |
) |
|
|
15,671 |
|
|
|
(2,690 |
) |
Gain
on asset disposal
|
|
|
- |
|
|
|
- |
|
|
|
79,074 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,770,310 |
) |
|
$ |
(323,180 |
) |
|
$ |
(1,807,650 |
) |
|
$ |
(781,040 |
) |
|
$ |
(2,955,223 |
) |
See
accompanying notes to consolidated financial statements.
PROGENITOR
CELL THERAPY, LLC
CONSOLIDATED
STATEMENT OF MEMBERS' EQUITY
FOR THE
YEARS ENDED DECEMBER 31, 2009, 2008 AND 2007
AND SIX
MONTHS ENDED JUNE 30, 2010 (UNAUDITED)
|
|
Number of
|
|
|
Contributions
|
|
|
Accumulated
|
|
|
|
|
|
|
Units
|
|
|
and other, net
|
|
|
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at January 1, 2007
|
|
|
6,820,843 |
|
|
$ |
10,211,968 |
|
|
$ |
(4,501,142 |
) |
|
$ |
5,710,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributions
to Members
|
|
|
- |
|
|
|
(257,424 |
) |
|
|
- |
|
|
|
(257,424 |
) |
Stock-based
compensation
|
|
|
- |
|
|
|
7,240 |
|
|
|
- |
|
|
|
7,240 |
|
Net
loss for the year ended December 31, 2007
|
|
|
- |
|
|
|
- |
|
|
|
(2,955,223 |
) |
|
|
(2,955,223 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2007
|
|
|
6,820,843 |
|
|
|
9,961,784 |
|
|
|
(7,456,365 |
) |
|
|
2,505,419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributions
from members
|
|
|
322,458 |
|
|
|
2,125,000 |
|
|
|
- |
|
|
|
2,125,000 |
|
Stock-based
Compensation
|
|
|
- |
|
|
|
17,938 |
|
|
|
- |
|
|
|
17,938 |
|
Net
loss for the year ended December 31, 2008
|
|
|
- |
|
|
|
- |
|
|
|
(781,040 |
) |
|
|
(781,040 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2008
|
|
|
7,143,301 |
|
|
|
12,104,722 |
|
|
|
(8,237,405 |
) |
|
|
3,867,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributions
from members
|
|
|
42,719 |
|
|
|
229,444 |
|
|
|
- |
|
|
|
229,444 |
|
Stock-based
Compensation
|
|
|
- |
|
|
|
17,938 |
|
|
|
- |
|
|
|
17,938 |
|
Beneficial
conversion feature of issued warrant
|
|
|
- |
|
|
|
326,295 |
|
|
|
- |
|
|
|
326,295 |
|
Net
loss for the year ended December 31, 2009
|
|
|
- |
|
|
|
- |
|
|
|
(1,807,650 |
) |
|
|
(1,807,650 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2009
|
|
|
7,186,020 |
|
|
|
12,678,399 |
|
|
|
(10,045,055 |
) |
|
|
2,633,344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
Compensation (unaudited)
|
|
|
- |
|
|
|
8,970 |
|
|
|
- |
|
|
|
8,970 |
|
Beneficial
conversion feature of issued warrant (unaudited)
|
|
|
- |
|
|
|
392,192 |
|
|
|
- |
|
|
|
392,192 |
|
Net
loss for the six months ended June 30, 2010 (unaudited)
|
|
|
- |
|
|
|
- |
|
|
|
(1,770,310 |
) |
|
|
(1,770,310 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at June 30, 2010 (unaudited)
|
|
|
7,186,020 |
|
|
$ |
13,079,561 |
|
|
$ |
(11,815,365 |
) |
|
$ |
1,264,196 |
|
See
accompanying notes to consolidated financial statements.
PROGENITOR
CELL THERAPY, LLC
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR THE
YEARS ENDED DECEMBER 31, 2009, 2008 AND 2007 AND
THE SIX
MONTHS ENDED JUNE 30, 2010 AND 2009 (UNAUDITED)
|
|
Six
Months Ended June 30,
|
|
|
Year
Ended December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows from Operating Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,770,310 |
) |
|
$ |
(323,180 |
) |
|
$ |
(1,807,650 |
) |
|
$ |
(781,040 |
) |
|
$ |
(2,955,223 |
) |
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
475,016 |
|
|
|
430,124 |
|
|
|
848,979 |
|
|
|
882,832 |
|
|
|
730,989 |
|
Provision
for doubtful accounts
|
|
|
- |
|
|
|
125,000 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Non-cash
compensation for services
|
|
|
8,970 |
|
|
|
8,969 |
|
|
|
17,938 |
|
|
|
17,938 |
|
|
|
7,240 |
|
Amortization
of deferred financing costs
|
|
|
206,081 |
|
|
|
- |
|
|
|
120,214 |
|
|
|
- |
|
|
|
- |
|
Deferred
lease liability
|
|
|
(1,249 |
) |
|
|
13,054 |
|
|
|
11,805 |
|
|
|
47,210 |
|
|
|
42,528 |
|
Net
gain from sale of fixed assets
|
|
|
- |
|
|
|
- |
|
|
|
(79,074 |
) |
|
|
- |
|
|
|
- |
|
(Increase)
decrease in:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
765,565 |
|
|
|
56,072 |
|
|
|
(483,011 |
) |
|
|
(237,062 |
) |
|
|
80,105 |
|
Prepaid
expenses and other current assets
|
|
|
144,837 |
|
|
|
131,462 |
|
|
|
(5,495 |
) |
|
|
(22,203 |
) |
|
|
94,297 |
|
Deferred
project costs
|
|
|
(1,199,827 |
) |
|
|
(782,032 |
) |
|
|
(1,665,789 |
) |
|
|
503,105 |
|
|
|
(533,088 |
) |
Increase
(decrease) in:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
557,321 |
|
|
|
44,382 |
|
|
|
473,867 |
|
|
|
78,544 |
|
|
|
(288,692 |
) |
Accrued
expenses and other current liabilities
|
|
|
(335,556 |
) |
|
|
39,426 |
|
|
|
363,041 |
|
|
|
6,597 |
|
|
|
(207,437 |
) |
Deferred
revenue
|
|
|
1,263,362 |
|
|
|
669,957 |
|
|
|
2,689,042 |
|
|
|
(1,511,510 |
) |
|
|
1,113,482 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Provided by (Used in) Operating Activities
|
|
|
114,210 |
|
|
|
413,234 |
|
|
|
483,867 |
|
|
|
(1,015,589 |
) |
|
|
(1,915,799 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments
for purchases of property and equipment
|
|
|
(2,684,194 |
) |
|
|
(298,126 |
) |
|
|
(1,753,331 |
) |
|
|
(251,068 |
) |
|
|
(5,457,998 |
) |
Restricted
cash and cash equivalents
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
120,775 |
|
Proceeds
from sale of equipment
|
|
|
- |
|
|
|
- |
|
|
|
150,000 |
|
|
|
- |
|
|
|
- |
|
Change
in other assets
|
|
|
(50,000 |
) |
|
|
(13,207 |
) |
|
|
(46,444 |
) |
|
|
100,803 |
|
|
|
(69,991 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Used in Investing Activities
|
|
|
(2,734,194 |
) |
|
|
(311,333 |
) |
|
|
(1,649,775 |
) |
|
|
(150,265 |
) |
|
|
(5,407,214 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from notes payable
|
|
|
2,320,000 |
|
|
|
- |
|
|
|
1,080,000 |
|
|
|
1,500,000 |
|
|
|
4,120,000 |
|
Principal
payments of notes payable
|
|
|
(51,306 |
) |
|
|
(540,859 |
) |
|
|
(598,424 |
) |
|
|
(2,085,758 |
) |
|
|
(15,128 |
) |
Principal
payments on capital lease obligations
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5,397 |
) |
|
|
(8,968 |
) |
Distributions
to members
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(257,424 |
) |
Contributions
from members
|
|
|
- |
|
|
|
229,444 |
|
|
|
229,444 |
|
|
|
2,125,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Provided by (Used in) Financing Activities
|
|
|
2,268,694 |
|
|
|
(311,415 |
) |
|
|
711,020 |
|
|
|
1,533,845 |
|
|
|
3,838,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
change in cash and cash equivalents
|
|
|
(351,290 |
) |
|
|
(209,514 |
) |
|
|
(454,888 |
) |
|
|
367,991 |
|
|
|
(3,484,533 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents - beginning of period
|
|
|
1,127,138 |
|
|
|
1,582,026 |
|
|
|
1,582,026 |
|
|
|
1,214,035 |
|
|
|
4,698,568 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents - ending of period
|
|
$ |
775,848 |
|
|
$ |
1,372,512 |
|
|
$ |
1,127,138 |
|
|
$ |
1,582,026 |
|
|
$ |
1,214,035 |
|
Supplementary
Disclosures of Cash Flow Information
Cash
paid during the period for interest
|
|
$ |
129,768 |
|
|
$ |
76,694 |
|
|
$ |
160,006 |
|
|
$ |
246,849 |
|
|
$ |
52,000 |
|
Beneficial
conversion feature of warrant issuance
|
|
$ |
392,192 |
|
|
$ |
- |
|
|
$ |
326,295 |
|
|
$ |
- |
|
|
$ |
- |
|
See
accompanying notes to consolidated financial statements.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 - NATURE OF OPERATIONS AND
LIQUIDITY
Nature of
Operations
Progenitor
Cell Therapy, LLC (“PCT” or the “Company”) was originally organized as a New
Jersey limited liability company. The Company was formed on
December 16, 1997 and began operations on February 27, 1999 pursuant
to an operating agreement (the “Operating Agreement”) entered into by the
members (the “Members”). Effective August 31, 2004, PCT was
merged into Progenitor Cell Therapy, LLC, a Delaware limited liability
company. Members are not personally liable for any debts or losses of
PCT in excess of the Members’ capital contributions. PCT is engaged
in a wide range of services in the stem cell therapy market for the treatment of
human disease. Substantially all of the Company’s operations are in
New Jersey and California.
DomaniCell,
LLC (“DomaniCell”) is a Delaware limited liability company and is wholly owned
by its sole member, PCT. DomaniCell was formed on May 10, 2005
and began its operations thereafter. DomaniCell is engaged in the
collection and storage of stem cells derived from umbilical cord blood units for
the treatment of human disease.
PCT
Allendale, LLC (“Allendale”) is a New Jersey limited liability company and is
wholly owned by its sole member, PCT. Allendale was formed on August
22, 2007 and is the owner of the Company’s building in Allendale, New
Jersey.
Liquidity
The
Company has experienced net losses in the past and has limited capital resources
to fund its operations. An affiliated company of our CEO has provided
short term financing as needed. The Company believes there is
adequate liquidity at June 30, 2010 combined with projected operating results to
fund future operations; however, the Company operates in a competitive industry
and should projected future operations be negatively impacted for any reason,
future operations would need to be scaled back or discontinued.
NOTE
2 - SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Basis of
Presentation
The
accompanying interim consolidated financial statements of the Company as of June
30, 2010 and for the six months ended June 30, 2010 and 2009 are unaudited, but
in the opinion of management, reflect all adjustments, consisting of normal,
recurring adjustments, necessary for a fair presentation of the results for the
interim period. Accordingly, they do not include all information and notes
required by generally accepted accounting principles for complete financial
statements. The results of operations for interim periods are not
necessarily indicative of results to be obtained for a full fiscal
year.
Principles of
Consolidation
The
consolidated financial statements of the Company include the accounts of PCT,
DomaniCell, Allendale; all intercompany balances and transactions have been
eliminated in consolidation.
Revenue
Recognition
The
Company enters into contracts with corporations, hospitals, private physicians,
physicians’ practices and medical centers for the processing of human cells in
patient specimens. The cell processing involves multiple related
sequential procedures. The Company recognizes revenue from cell
processing of patient specimens as a multiple element arrangement in accordance
with Codification Topic 605: “Revenue Recognition.” In accordance with Topic
605, the Company recognizes revenue when there is persuasive evidence of an
arrangement, title and risk of loss have passed, product is shipped or the
services have been rendered, the sales price is fixed or determinable and
collection of the related receivable is reasonably assured.
Thus,
revenue resulting from the processing of a patient’s specimen is recognized upon
completion of the processing. If revenue is deferred because such
processing is not complete, the associated costs, if material, are also deferred
and are classified as deferred costs on the accompanying Consolidated Balance
Sheets. Milestone contract billings in excess of revenue recognized
are included in deferred revenue on the balance sheet.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES (continued)
Revenue Recognition
(continued)
The
Company also provides a cell storage service, for which a separate defined fee
is charged. Revenue for cell storage services is deferred and
recognized ratably over the storage period. In certain instances, the
Company will charge a customer a single fee, which will include cell processing
and storage. In these situations, the fair value fee of the storage
is separated from the total fee, and is deferred and recognized pro rata over
the cell storage period.
The
Company has adopted the requirements of ASC Codification Topic 605: “Revenue
Recognition,” for recognizing revenue on reimbursed program
costs. This pronouncement allows the Company to record its
contractual expense reimbursements as a component of its revenue on a gross
basis, since it is the primary obligor of the reimbursable costs, has discretion
over the supplier choice and bears the underlying credit risk. The
Company will reflect the expense reimbursements received as revenue and the
related expenses as a contra revenue account.
Interest
income is recognized as earned.
Accounts Receivable and
Allowance for Doubtful Accounts
The
Company extends credit to certain customers, primarily with terms up to 30
days. Bad debts are provided on the allowance method based on
management’s evaluation of outstanding accounts receivable based on the length
of time the receivables are outstanding, the current business environment and
historical experience. Accounts are written off when they are deemed
uncollectible. The Company does not require collateral from its
customers.
Property and
Equipment
Laboratory
and office equipment, computers, building and improvements, and furniture and
fixtures are stated at cost and are depreciated on a straight-line basis over
their estimated useful lives. Leasehold improvements are stated at
cost and are amortized on a straight-line basis over the life of the lease or of
the improvement, whichever is shorter.
Expenditures
for maintenance and repairs that do not materially extend the useful lives of
the assets are charged to expense as incurred. The cost and
accumulated depreciation of assets retired or sold are removed from the
respective accounts and any gain or loss is recognized in
operations.
Cash and Cash
Equivalents
The
Company considers all highly liquid investments that have maturities of three
months or less, when acquired, to be cash equivalents.
Restricted Cash and Cash
Equivalents
Restricted
cash and cash equivalents of $353,860 at June 30, 2010, and December 31, 2009,
2008 and 2007 is related to amounts held in escrow as required under the
mortgage agreement which is described in Note 4.
Deferred
Rent
The
Company recognizes rental expense for leases with scheduled rent increases on a
straight-line basis over the life of the lease. The Company records a
deferred rent liability to account for the difference between the actual
payments and the straight-line expense, which will reverse in future years when
the actual payments will exceed the straight-line expense.
Income
Taxes
PCT,
Allendale and DomaniCell are organized as limited liability companies, which are
treated as partnerships for income tax purposes. Accordingly, there
is no provision for income taxes in the accompanying financial
statements. Individual owners have the responsibility to include
their share of taxable income or to deduct their share of the Company’s losses
in their own income tax return.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES (continued)
Income Taxes
(continued)
On July
1, 2007, the Financial Accounting Standards Board (“FASB”) issued ASC 740-10,
“Income Taxes” (“ASC 740-10”). ASC 740-10 provides recognition
criteria and a related measurement model for uncertain tax positions taken or
expected to be taken in income tax returns. ASC 740-10 requires that
a position taken or expected to be taken in a tax return be recognized in the
financial statements when it is more likely than not that the position would be
sustained upon examination by tax authorities. Tax positions that
meet the more likely than not threshold are then measured using a probability
weighted approach recognizing the largest amount of tax benefit that is greater
than 50% likely of being realized upon ultimate settlement. It also
provides guidance on derecognition, measurement, and classification of amounts
relating to uncertain tax positions, accounting for and disclosure of interest
and penalties, accounting in interim periods, disclosures and transition
relating to the adoption of the new accounting standard. The Company
adopted Topic 7401-0 on January 1, 2009. The adoption of Topic 740-10
did not have a material impact on the Company’s financial position and results
of operation.
Estimates
The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the amounts reported in the financial
statements and accompanying notes. Significant estimates include
useful lives of fixed assets, estimates used to test asset impairments, deferred
project costs, collectibility of accounts receivable and valuation of the
Company’s equity-based instruments. Actual results could differ from
those estimates.
Equity-Based
Compensation
The
Company follows ASC Codification Topic 718: “Compensation – Stock Compensation,”
which requires that compensation cost relating to share based payment awards
made to employees and directors be recognized in the financial
statements. The cost for awards issued is measured at the grant date
based on the calculated fair value of the award. The value of the
portion of the award that is ultimately expected to vest is recognized over the
requisite service periods (generally the vesting period of the equity award) in
the accompanying Consolidated Statements of Operations.
Advertising
The
Company expenses advertising costs as they are incurred. Advertising
expenses for the six months ended June 30, 2010 and 2009 and the years ended
December 31, 2009, 2008 and 2007 were approximately $63,000, $68,000, $86,000,
$152,000 and $284,000, respectively.
Fair Value
Measurement
The
Company’s financial instruments include cash and cash equivalents, accounts
receivable from customers, accounts payable, and accruals which are short-term
in nature. The Company believes the carrying amounts of these financial
instruments reasonably approximates their fair value. We believe the
carrying value of our notes payable approximates their fair value given the
interest rates charged and other terms of the instruments.
The
Company adopted ASC 820 Fair
Value Measurements (“ASC 820”) in January 2009. ASC 820
defines fair value, establishes a common framework for measuring fair value
under U.S. GAAP, and expands disclosures about fair value measurements for
assets and liabilities. ASC 820 does not require additional assets or
liabilities to be accounted for at fair value beyond that already required under
other U.S. GAAP accounting standards.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES (continued)
New Accounting
Pronouncements
In April
2010, the FASB
issued ACS Topic 605,
Milestone Method of Revenue Recognition. FASB Topic 605 provides guidance
on defining a milestone and determining when it may be appropriate to apply the
milestone method of revenue recognition for research or development
transactions. Consideration that is contingent on achievement of a milestone in
its entirety may be recognized as revenue in the period in which the milestone
is achieved only if the milestone is judged to meet certain criteria to be
considered substantive. Milestones should be considered substantive in their
entirety and may not be bifurcated. An arrangement may contain both substantive
and nonsubstantive milestones, and each milestone should be evaluated
individually to determine if it is substantive. FASB Topic 605 is
effective on a prospective basis for milestones achieved in fiscal years, and
interim periods within those years, beginning on or after June 15, 2010. The
adoption of FASB Topic 605 is not expected to have a material impact on the
Company’s financial position and results of operations.
In June
2009, the FASB issued FASB ASC Topic 105, Generally Accepted Accounting
Principles, which establishes the FASB Accounting Standards Codification
as the sole source of authoritative generally accepted accounting
principles. Pursuant to the provisions of FASB ASC 105, the Company
has updated references to GAAP in its financial statements issued for the period
ended December 31, 2009. The adoption of FASB ASC Topic did not
impact the Company’s financial position or results of
operations.
NOTE
3 - PROPERTY AND
EQUIPMENT
Property and equipment consists
of the following at:
|
|
Estimated
Useful Lives
|
|
June 30,
2010
|
|
|
December
31, 2009
|
|
|
December
31, 2008
|
|
|
December
31, 2007
|
|
Computer
equipment
|
|
3
years
|
|
$ |
325,110 |
|
|
$ |
292,661 |
|
|
$ |
259,034 |
|
|
$ |
244,559 |
|
Laboratory
and office equipment*
|
|
7
years
|
|
|
3,209,289 |
|
|
|
2,938,007 |
|
|
|
2,667,467 |
|
|
|
2,497,311 |
|
Furniture
and fixtures
|
|
12
years
|
|
|
181,789 |
|
|
|
179,311 |
|
|
|
174,279 |
|
|
|
173,007 |
|
Leasehold
improvements
|
|
Life
of lease
|
|
|
2,647,055 |
|
|
|
2,632,526 |
|
|
|
2,450,180 |
|
|
|
2,429,230 |
|
Building
and improvements
|
|
25
years
|
|
|
7,862,673 |
|
|
|
5,503,038 |
|
|
|
4,332,585 |
|
|
|
4,298,280 |
|
|
|
|
|
|
14,225,916 |
|
|
|
11,545,543 |
|
|
|
9,883,545 |
|
|
|
9,642,387 |
|
Less,
Accumulated depreciation
and
amortization
|
|
|
|
|
(4,497,101 |
) |
|
|
(4,025,905 |
) |
|
|
(3,197,333 |
) |
|
|
(2,324,411 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
9,728,815 |
|
|
$ |
7,519,638 |
|
|
$ |
6,686,212 |
|
|
$ |
7,317,976 |
|
Depreciation
and amortization expense for the six months ended June 30, 2010 and 2009, and
the years ended December 31, 2009, 2008 and 2007 was approximately
$475,000, $430,000, $849,000, $883,000, and $731,000,
respectively.
*Net of
approximately $823,000 as of June 30, 2010, December 31, 2009 and 2008, and
$813,000 as of December 31, 2007, with respect of grant received (see Note 10 – Grant
Agreement).
NOTE
4 - LONG-TERM
DEBT
Mortgage
On
October 31, 2007, the Company entered into a note to borrow $3,120,000 (the
“Note”) in connection with its $3,818,500 purchase of condominium units of an
existing building in Allendale, New Jersey (the “Property”) that the Company
intends to use as a laboratory and stem cell processing
facility.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
4 - LONG-TERM DEBT
(continued)
Mortgage
(continued)
The Note
is payable in 239 consecutive monthly payments of principal and interest, based
on a 20 year amortization schedule; and one final payment of all outstanding
principal plus accrued interest then due. The current monthly
installment is $20,766, which includes interest at an initial rate of 5.00%; the
interest rate and monthly installments payments are subject to adjustment on
October 1, 2017. On that date, upon prior written notice, the lender
shall have the option to declare the entire outstanding principal balance,
together with all outstanding interest, due and payable in full. The
Note is secured by substantially all of the assets of the Company, including a
first mortgage on the Property and assignment of an amount approximately equal
to eighteen months debt service held in escrow (see Note 2 – Restricted Cash and
Cash Equivalents). The Note matures on October 1, 2027 if not called by the
lender on October 1, 2017. The Note is subject to certain debt service coverage
and total debt to tangible net worth financial covenant ratios. The Company was
not in compliance with such covenants through June 30, 2010, and has obtained a
covenant waiver letter from the lender for all periods through June 30,
2010. The outstanding balance was approximately $2,869,000
at June 30, 2010 and $2,921,000, $3,019,000 and $3,105,000 at December 31, 2009,
2008 and 2007, respectively.
Northern New Jersey Cancer
Associates
On March
14, 2008 the Company arranged for a $2,000,000 line of credit with Northern New
Jersey Cancer Associates (“NNJCA”). The Company’s Chief Executive
Officer is also Co-Managing Partner of NNJCA. The term of the
agreement is one year and interest on amounts drawn down from the line of credit
will accrue at the prime rate plus 2% and will be payable
monthly. NNJCA may elect to receive payment of the outstanding
balance in cash or in membership interest of PCT. For calculating the
membership interest that NNJCA will receive if it so chooses, the Company will
be valued at the valuation offered to investors with the Company’s next round of
equity financing. A one-time origination fee of $20,000 was paid in
April 2008 for the line-of-credit.
On March
26, 2008, the Company borrowed $1,500,000 against the NNJCA line of credit and
used $1,000,000 of the proceeds to repay in full the StemCells, Inc. loan
borrowed in December 2007. The balance remaining at December 31, 2008
was $500,000. As of April 14, 2009, the entire amount of the loan was
re-paid.
On
September 14, 2009, the Company entered into a line of credit and security
agreement with NNJCA for $3,000,000. The credit line has an interest
rate of 5.5% accruing on the first $2,000,000 and 6% thereafter. The
advance and accrued interest is due and payable on June 30, 2010. The
Note is secured by substantially all of the assets of the Company. In
conjunction with this credit line warrant to purchase shares were issued by the
company to NNJCA. The holder is entitled to purchase, at its option,
up to 73,052 Shares of Limited Liability Company Interests at an exercise price
of $6.16 per Share. The warrant is for seven years and expires
September 14, 2016. The warrant is accounted for under the
Black-Scholes pricing model. This resulted in deferred financing cost
of approximately $326,000, which will be amortized to interest expense over the
tem of the loan. During 2009, approximately $120,000 was amortized;
in the six months ended June 30, 2010, approximately $206,000 was
amortized.
On June 30, 2010, the above agreement
with NNJCA was amended. The revised credit line is $3,400,000; the
entire amount with accrued interest is due and payable on June 30,
2011. The remaining $400,000 of availability under the credit line,
which was drawn on June 30, 2010, is subject to an interest rate of
6%. The amended agreement entitled the holder to purchase at its
option, up to 85,000 units of Limited Liability Company interest at an exercise
price of $4.00 per Unit. The warrant is accounted for under the
Black-Scholes pricing model. This resulted in deferred financing cost
of approximately $392,000, which will be amortized to interest expense over the
term of the loan.
Interest
expense related to the NNJCA loan for the six months ended June 30, 2010 and
2009, and the year ended December 31, 2009 and 2008 was approximately $57,400,
$8,000, $12,500, and $76,900, respectively.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
4 - LONG-TERM DEBT
(continued)
Other
Loans
On
December 3, 2007, the Company borrowed $1,000,000 from StemCells, Inc, one of
its customers. The note carries an interest rate of 5.00% and was due
in full by the maturity date of July 30, 2008. The Company repaid the
entire amount of the loan on April 7, 2008.
Future
maturities of long-term debt, including the borrowings under the NNJCA facility,
at June 30, 2010 are:
12 Months Ended
June 30,
|
|
June 30, 2010
|
|
2011
|
|
$ |
3,506,165 |
|
2012
|
|
|
111,295 |
|
2013
|
|
|
117,449 |
|
2014
|
|
|
123,543 |
|
2015
|
|
|
129,954 |
|
Thereafter
|
|
|
2,280,981 |
|
|
|
|
6,269,387 |
|
Less:
current maturities
|
|
|
3,506,165 |
|
Long-term
portion
|
|
$ |
2,763,222 |
|
NOTE
5 - MEMBERS’ EQUITY
In
October, 1998, the founding Members entered into a Formation Agreement and
contributed a total of $82,564. Pursuant to the Operating Agreement
(see Note 1), as amended
on August 4, 1999, each Member is required to make an initial capital
contribution in exchange for a percentage ownership interest in the Company
(“Membership Interest”) and to make future contributions as determined by the
Members. New Members may be admitted to the Company, subject to
approval of the Company’s Board of Managers, upon execution of the Operating
Agreement and payment of a contribution determined by the Board of
Managers. Membership interests entitle each Member to the Member’s
share of the Company’s net profits, net losses and the right to receive
distributions of the Company’s assets in the event of liquidation and to vote,
as defined. There are 10,000,000 units authorized, and 7,186,020,
7,186,020, 7,143,301, and 6,820,843 are issued and outstanding at June 30, 2010
and December 31, 2009, 2008 and 2007, respectively.
On April
30, 2009, with the receipt of $229,444, the Company closed out Private Placement
#4 (the “Offering”). In connection with the offering, the Company
sold a total of 365,177 units for gross proceeds of $2,354,444 from 2008 to
2009. The Company received $2,125,000 during the fourth quarter of
2008.
NOTE
6 - COMMITMENTS AND
CONTINGENCIES
Operating
Leases
On
April 1, 1999, the Company entered into an operating lease with Hackensack
University Medical Center (“HUMC”), a member – see Note 7, for stem cell
laboratory and office space at HUMC (the “HUMC Lease”). The HUMC
Lease has a term of 10 years with an option, by the Company, for renewal for an
additional five-year period. The HUMC Lease provides for an
escalation of base rent on the fifth anniversary date and for additional charges
for operating expenses and real estate taxes (the “Additional
Charges”). Upon expiration of the 10 year term, the Company began
renewing the lease on a month-to-month basis. Rent expense for the
six months ended June 30, 2010 and 2009, and the years ended December 31, 2009,
2008 and 2007 was approximately $107,000, $110,000, $110,000,
$110,000 and $50,000, respectively.
In
October 2004, PCT entered into a two-year lease for laboratory space in the
Jurist Institute in Hackensack, New Jersey (the “Jurist Lease”). The
lease provides for monthly base rent which includes a provision for certain
utilities. The lease has been extended several times, most recently
through December 2010 at a monthly base rent of $3,174.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
6 - COMMITMENTS AND
CONTINGENCIES (continued)
Operating Leases
(continued)
In
September 2005, PCT entered into a one-year lease directly with Vanni
Business Park, LLC, the landlord for the Mountain View, California laboratory
space (the “Vanni Lease”), leasing the entire building. A portion of
this space was previously occupied by PCT under the “Jurist Lease”, which is
described above. This new lease commenced July 1, 2006, with a
monthly base rent of $26,275. In July 2006, PCT entered into an
agreement to amend this lease and extended the term through June 30, 2012,
for an initial monthly base rent of $33,782, with yearly escalations
thereafter.
In
February 2006, PCT entered into a five-year lease agreement for its new
office headquarters location in Hackensack, New Jersey (the “Court Plaza
Lease”). The Court Plaza Lease term commenced April 1, 2006 with
a base rent of $77,500 per annum, subject to a real estate tax and operating
expense escalation adjustment to be determined annually. The lease
included two months of free rent that is being expensed ratably over the life of
the lease.
In June
2010, PCT sublet the above mentioned headquarters office space in Hackensack,
New Jersey to Springstead & Maurice, LLC for the remaining term of the Court
Plaza lease. The sublease is for approximately $3,500 per
month.
For the
six months ended June 30, 2010 and 2009, and the years ended December 31, 2009,
2008 and 2007, rent expense under all operating leases was approximately
$479,000, $454,000, $715,000, $728,000 and $696,000, respectively. As
of June 30, 2010 and December 31, 2009, 2008 and 2007 the total rent expense
recognized in excess of scheduled rent payments, referred to as “deferred lease
liability”, totaled approximately $107,000, $109,000, $97,000 and $49,000,
respectively.
Future
minimum rental payments under the operating leases noted above are
approximately:
12
months Ended
June
30,
|
|
Amount
|
|
2011
|
|
$ |
604,000 |
|
2012
|
|
|
278,000 |
|
|
|
$ |
882,000 |
|
Capital
Leases
The
Company leases certain equipment under various non-cancelable capital lease
agreements (the “Capital Leases”). The Capital Leases are for periods
ranging from two to four years, after which the Company: (i) either has the
option or is required to purchase the equipment at defined monthly amounts,
(ii) may extend the lease upon agreed-upon terms at defined monthly
amounts, or (iii) is required to return the equipment as per the respective
lease agreement. Leased equipment included as a component of fixed
assets at June 30, 2010 and December 31, 2009, 2008 and 2007 was $88,000 at all
dates. Related accumulated depreciation was $88,000,
$88,000, $87,000 and $82,000 for the same dates. The capital leases
were paid in full in 2009.
Funding Obligation -
Amorcyte
On
May 19, 2006, the Company entered into a line of credit agreement with
Amorcyte Inc. (“Amorcyte”), an entity which was spun out of the Compaony in
2006, whereby PCT agreed to loan Amorcyte up to $500,000 at an annual interest
rate of 5%. The line of credit agreement was a condition to Amorcyte
closing the Series A Preferred Stock Financing rounds completed during 2006, and
therefore could be required to be funded by the Company at the discretion of
Amorcyte. The Company did not loan any amount to Amorcyte under this
agreement through June 30, 2010; however, the maximum obligation of $500,000 was
recorded as a liability.
The line
of credit agreement expires on the earlier of (i) the date on which the
Company declares the outstanding principal and accrued interest due and payable
based on an event of default as defined within the agreement, or (ii) the
date of closing of the first debt or equity financing of Amorcyte following the
initial borrowing of the principal. These events have not occurred to
date.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
6 - COMMITMENTS AND CONTINGENCIES
(continued)
Litigation
The
Company may be subject to legal proceedings, claims and litigation arising in
the ordinary course of business, including one case of alleged breach of
employment contract with a former employee. In 2007, the Company paid
approximately $70,000 of severance pay plus interest in connection with this
case; this amount was recorded as an accrued expense in the Company's 2006
financial statements and was paid during 2007. In February 2009, the
parties have reached a settlement to resolve all claims under which the former
employee paid the Company $54,000 to purchase 0.23% of PCT's fully diluted
equity.
NOTE
7 - RELATED PARTY
TRANSACTIONS
Hackensack University
Medical Center – Services Agreements
In
connection with the Company’s LLC agreement, HUMC is entitled to a seat on the
Company’s Board of Managers as long as it remains a member. On
February 27, 1999, the Company and HUMC, a Member, entered into two
services agreements
|
(i)
|
A
Stem Cell Services Agreement, under which HUMC agreed to use the Company
as the sole provider of stem cell services as long as HUMC remains a
Member. During the term of the Stem Cell Services Agreement,
the Company will provide such
services, and related supply and testing expenses, at its cost, which will
be paid monthly by HUMC. In the event HUMC is able to obtain
stem cell services below the Company’s cost, the Company will have the
right to meet the lower price. Either party may terminate the
Stem Cell Services Agreement upon written notice of breach by the other
party that is not cured within 30 days. For the six months
ended June 30, 2010 and 2009, and the years ended December 31, 2009, 2008
and 2007, revenue recognized under the Stem Cell Services Agreement
amounted to approximately $1,078,000, $1,009,000, $2,003,000,
$2,220,000 and $1,970,000, respectively. At June 30,
2010 and December 31, 2009, 2008 and 2007
approximately $129,000, $94,000, $156,000 and $267,000
respectively, related to the Stem Cell Services Agreement were recorded as
accounts receivable.
|
|
|
(ii)
|
A
Support Services Agreement, under which HUMC will be the exclusive
provider of support services, as defined, for the Company’s stem cell
laboratory at HUMC as long as HUMC remains a Member. During the
term of the Support Services Agreement, HUMC will provide services to the
Company at its cost, payable monthly. Either party may
terminate the Support Services Agreement without cause upon 90 days’
written notice or upon written notice of breach by the other party that is
not cured within 30 days. For the six months ended June 30,
2010 and 2009, and the years ended December 31, 2009, 2008 and 2007,
expense recognized under the Support Services Agreement amounted to
approximately $18,500, $39,000, $76,900, $93,500 and $48,100,
respectively. At June 30, 2010 and
December 31, 2009, 2008 and 2007, approximately $13,600,
$17,400, $6,900 and $8,800, respectively, related to the Support Services
Agreement were recorded as accounts
payable.
|
Nexell of California,
Inc.
On
August 4, 1999, the Company and Nexell, a Member, entered into a Supply
Agreement (the “Nexell Supply Agreement”) under which the Company will purchase,
exclusively from Nexell, all supplies, as defined, required by the Company for
use in its stem cell processing and storage business, subject to certain
exceptions, as defined. The Nexell Supply Agreement will continue as
long as Nexell remains a Member and may be extended upon mutual written
agreement of the parties. Either party may terminate the Nexell
Supply Agreement upon written notice of breach by the other party that is not
cured within ten days. During 2002, the parties agreed that Nexell’s
obligations under this agreement will be fulfilled by Baxter International,
Inc., which assumed the obligations of Nexell. For the six months
ended June 30, 2010 and 2009, and the years ended December 31, 2009, 2008 and
2007, expense recognized under the Nexell Supply Agreement amounted to
approximately $106,400, $64,000, $153,000, $5,100
and $12,200, respectively. At June 30, 2010 and December 31, 2009,
2008 and 2007, approximately $25,000, $33,100, $300 and $700,
respectively, related to the Nexell Supply Agreement were recorded as accounts
payable.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
7 - RELATED PARTY
TRANSACTIONS (continued)
Amorcyte,
Inc.
On
May 31, 2005, the Company entered into a Cell Processing Agreement with
Amorcyte (the “Amorcyte Agreement”) whereby Amorcyte engaged PCT to be its
exclusive provider of cell processing procedures and related services at rates
specified within the agreement that include a monthly fee during the clinical
trial period for oversight services. The term of the Amorcyte
Agreement extends beyond the initial clinical period (defined within the
agreement as of one year from initiation of clinical trials), after which time
the service rates can be renegotiated.
In the
event of commercialization of any product of Amorcyte, PCT and Amorcyte shall
mutually agree upon charges for services related to such
commercialization. In the event that the parties are unable to agree
on such charges, then Amorcyte shall pay to PCT an amount equal to 125% of PCT’s
direct and indirect costs in connection with the services
provided. Also pursuant to the Amorcyte Agreement, PCT paid $200,000
to Amorcyte in 2006 as consideration for exclusivity granted to PCT under the
Amorcyte Agreement. This amount is being amortized over the minimum
estimated benefit period of the exclusivity, which is the completion of
Amorcyte’s Phase I clinical trials. For the six months ended June 30,
2010 and 2009, and the years ended December 31, 2009, 2008 and 2007, $0, $0, $0,
$50,000 and $95,000, respectively, of the consideration was recorded as
expense. The intangible asset was fully amortized as of December 31,
2008.
For the
six months ended June 30, 2010 and 2009, and the years ended December 31, 2009,
2008 and 2007, revenue recognized under the Amorcyte Agreement amounted
to $93,000, $253,000, $428,000, $327,000 and $415,000,
respectively. At June 30, 2010 and December 31, 2009, 2008 and 2007,
approximately $115, $300, $500 and $47200, respectively, due from
Amorcyte were recorded as accounts receivable.
During
June 2010, PCT made an investment in Amorcyte in the purchase of Series A
Redeemable Preferred Stock totaling $50,000, which is included in other assets
on the accompanying consolidated balance sheet.
Becton, Dickinson and
Company
On
August 25, 2006, the Company and Becton, Dickinson and Company (“BD”), a
Member, entered into a one year Consulting and Product Development Services
Agreement (the “BD Agreement”), whereby the Company will provide consulting and
product development services and advice to BD for fees not to exceed $480,000,
plus reimbursement for approved out-of-pocket expenses. On February
20, 2008, the parties entered into a subsequent agreement whereby PCT agrees to
provide a laboratory investigational study service to BD. For the six
months ended June 30, 2010 and 2009, and the years ended December 31, 2009, 2008
and 2007, revenue recognized under the BD Agreement, amounted to $0,
$35,000 $35,000, $25,000 and $230,000, respectively. Amounts recorded as revenue
for reimbursement for approved out-of-pocket expenses under the BD Agreement for
the six months ended June 30, 2010 and 2009, and the years ended December 31,
2009, 2008 and 2007, totaled approximately $0, $0, $0, $0 and
$141,000. At June 30, 2010 and December 31, 2009, 2008 and 2007,
approximately $0, $0, $2,500 and $29,500, respectively, due from BD were
recorded as accounts receivable.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
7 - RELATED PARTY
TRANSACTIONS (continued)
StemCells,
Inc.
On March
2, 2006, the Company entered into a Cell Processing Agreement with StemCells
Inc. whereby Stem Cells engaged PCT to be its exclusive provider of cell
processing procedures and related services at rates specified within the
agreement that include a monthly fee during the clinical trial period for
oversight services. For the six months ended June 30, 2010 and 2009,
and the years ended December 31, 2009, 2008 and 2007, revenue recognized from
Stem Cells amounted to approximately $723,000, $761,000, $1,724,000,
$1,460,000 and $1,303,000, respectively. As further explained in
Note 4, the Company
borrowed $1,000,000 from StemCells, Inc. on December 3, 2007 and repaid the
entire amount of the loan on April 7, 2008.
All of the Company’s related parties,
with the exception of StemCells, Inc., are also unit holders.
NOTE
8 - OPTIONS TO ACQUIRE
MEMBER’S UNITS (“STOCK OPTIONS”)
In August
2007 the Company entered into agreements with five individuals to serve on the
Wellness Advisory Board (the “WAB”) of Domani, all of whom are non-employees of
the Company. The WAB members agree to serve as advisors on the development of
Domani’s stem cell banking program and related business
activities. The term of the WAB Agreement is three years and can be
terminated by either party by written notice at any time and for any
reason. The Company paid four of the WAB members an initiation fee of
$10,000 upon execution of the WAB Agreement; one member received an option to
acquire 961 member units of PCT (“Shares”) at an exercise price of $10.41 per
share in lieu of the $10,000 cash payment. These 961 share options vested
immediately.
As
consideration of their service on the WAB, the Company has issued options to
purchase 3,756 member units of PCT to each of the five members of the WAB at an
exercise price of $10.41 per share. Options vest in tranches of 313 shares, with
the first tranche vesting on the last day of the fiscal quarter following the
fiscal quarter in which the options were granted and an additional tranche
vesting on the last day of each subsequent consecutive fiscal
quarter. Options are fully vested three years after the date of grant
and are exercisable within ten years after the date of grant. The
weighted average fair value of the options on the date of grant was $2.87, which
was calculated using the Black-Scholes option pricing model with the following
assumptions:
Risk-free
interest rate
|
|
|
4.61 |
% |
Expected
life
|
|
6.00
years
|
|
Expected
volatility
|
|
|
82.47 |
% |
Expected
dividends
|
|
None
|
|
The
Company had no historical data to use in determining its expected life
assumption and therefore used the simplified method for determining expected
life that is described in SEC Staff Accounting Bulletin No. 107. The
simplified method is used when companies have difficulty making an estimate of
the expected term and under this method the expected term would equal the
vesting term plus the contractual term divided by two. Additionally,
the Company had no historical data to determine expected volatility and
therefore estimated its volatility assumptions based on the volatility of
comparable companies. The Company did not calculate the forfeiture
rate for the stock options since there were only five grants issued to WAB
members and no forfeiture is forecasted.
Stock
based compensation recognized in the financial statements during for the six
months ended June 30, 2010 and 2009 and the years ended December 31, 2009, 2008
and 2007 amounted to approximately $9,000, $9,000, $18,000, $18,000
and $7,200, respectively. At June 30, 2010 total unrecognized stock
based compensation amounted to approximately $4,500. The intrinsic
value of stock options outstanding at December 31, 2009 is minimal.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
8 - OPTIONS TO ACQUIRE MEMBER’S
UNITS (“STOCK OPTIONS”) (continued)
A summary
of changes in the stock options outstanding for the three years ended December
31, 2009 and the six months ended June 30, June 30, 2010 is as
follows:
|
|
Number of
options
|
|
|
Weighted Average
Exercise
Price
|
|
Outstanding
at December 31, 2006
|
|
|
48,930 |
|
|
$ |
6.37 |
|
Granted
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Forfeited
|
|
|
- |
|
|
|
- |
|
Outstanding
at December 31, 2007
|
|
|
48,930 |
|
|
$ |
6.37 |
|
Granted
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Forfeited
|
|
|
- |
|
|
|
- |
|
Outstanding
at December 31, 2008
|
|
|
48,930 |
|
|
$ |
6.37 |
|
Granted
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Forfeited
|
|
|
- |
|
|
|
- |
|
Outstanding
at December 31, 2009
|
|
|
48,930 |
|
|
$ |
6.37 |
|
Granted
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Forfeited
|
|
|
- |
|
|
|
- |
|
Outstanding
at June 30, 2010
|
|
|
48,930 |
|
|
$ |
6.37 |
|
Summarized
information about stock options outstanding as of June 30, 2010 is as
follows:
|
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
Exercise Price
|
|
|
Number of
Options
|
|
|
Weighted
Average
Remaining Life
(in Years)
|
|
|
Number of Options
|
|
$ |
1.00 |
|
|
|
20,660 |
|
|
No
expiry date
|
|
|
|
20,660 |
|
$ |
10.00 |
|
|
|
8,529 |
|
|
3.16
|
|
|
|
8,529 |
|
$ |
10.41 |
|
|
|
19,741 |
|
|
7.62
|
|
|
|
8,786 |
|
Total
|
|
|
|
48,930 |
|
|
|
|
|
|
37,975 |
|
NOTE
9 - PHANTOM EQUITY
PLAN
On
April 13, 2000 the Company adopted a Phantom Equity Plan (the “Plan”),
under which a committee of the Board of Managers (the “Committee”) may grant to
officers, full-time employees and independent contractors of the Company (the
“Grantee”) a right to receive in cash, or property of equal value, the
difference in the (a) fair value of the award on the date of grant and
(b) the fair value of the award on the date the award is exercised by the
Grantee (the “Award”). The fair value of an Award shall be equal to
the product of: (a) either the total value of the Company’s equity as most
recently determined by the Committee prior to the date of grant or payout, or an
amount determined by a triggering event, as defined, and (b) the percentage
interest represented by the Award. Awards vest on a straight-line
basis over five years, unless specified otherwise by the Committee, and may only
be exercised in the last two months of a fiscal year. Upon the
occurrence of a triggering event, all Awards will become immediately
vested. Upon termination of service by a Grantee, the Company, at the
discretion of the Committee, may choose to pay out the fair value of the
terminated Grantee’s vested balance. Cash payments made under the
Plan are subject to limitation clauses, whereby the amount payable at any time
will be limited to defined thresholds. The Plan may be terminated at
any time by the Committee, in which case the terms of all outstanding Awards
will continue until exercised or forfeited. As of December 31,
2009, 2008 and 2007 and June 30, 2010 there are no outstanding awards under this
plan.
PROGENITOR
CELL THERAPY, LLC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE
10 - GRANT AGREEMENT
On
August 26, 2005, the Company entered into a $900,000 grant agreement (the
“Grant”) with the New Jersey Economic Development Authority (the "EDA"), a
department of the State of New Jersey, to design and develop a software system
dealing with cell product testing and storage (the
“Project”). $810,000 of the Grant was advanced to the Company in
2005, and the remaining final disbursement of $90,000 was received by the
Company in April 2007. All costs for the Project in excess of
$900,000 are the sole responsibility of the Company. For financial
reporting purposes, the Grant proceeds reduced the amount capitalized as
internally developed software.
All Grant
funds advanced to PCT are included in current liabilities until actual Project
costs are incurred. Project costs are capitalized as assets when
incurred and are offset by the amount remaining in the Grant
liability. Through December 31, 2009, costs of approximately $
823,000, were incurred with respect to the Project, and at June 30, 2010
and December 31, 2009 was $77,000 of unexpended Grant funds are
included in deferred revenue.
NOTE
11 - CONCENTRATION
OF CREDIT RISK
Financial
instruments that potentially subject the Company to concentrations of credit
risk consist of cash and cash equivalents. At June 30, 2010, the
Company held its cash and cash equivalents principally in two financial
institutions, respectively. The Company cash balances may exceed
federally insured limits at times during the year.
Major
Customers
The
Company enters into contracts for the processing and storing of human
cells. In 2010 and 2009, the Company’s revenue is mainly derived from
agreements with Hackensack University Medical Center (“HUMC”), StemCells, Inc.,
and Sangamo Biosciences, Inc. These three customers make up 20%, 13%
and 15% of revenue (total of 48% for all three customers) for the six
months ended June 30, 2010, and 19%, 15% and 13% of revenue (total of 47% for
all three customers) for the six months ended June 30, 2009,
respectively. These three customers make up 18%, 15% and 12% of
revenue (total of 45% for all three customers) for the year ended December 31,
2009. In 2008, the Company’s revenue is mainly derived from HUMC,
StemCells, Inc., and Microislet, Inc. These three customers make up
23%, 12% and 11% of revenue (total of 46% for all three customers) for the year
ended December 31, 2008. In 2007, the Company’s revenue is mainly
derived from agreements with HUMC and Dendreon Corporation. These two
customers make up 28% and 23% (total of 51% for both customers) for the year
ended December 31, 2007. The only major customer that is also
currently a related party is HUMC.
Four
customers, one of which is a related party, made up 24%, 16%, 11% and
11% of total accounts receivable (a total of 62%) at June 30,
2010. The significant customer base may change from year to year as
projects are completed and new contracts are entered into.
Major
customers are considered to be those who accounted for more than 10% of total
sales.
NOTE
12 - SUBSEQUENT EVENTS
In August
2010, the members of the Company agreed in principle to be acquired by a
publicly traded international biopharmaceutical company. However,
there can be no assurances that the transaction will be successfully
consummated.
Unaudited
Pro Forma Condensed Combined Balance Sheets
June
30, 2010
(
in $000's)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NeoStem
|
|
|
Progenitor
Cell Therapy
|
|
|
|
Proforma
Adjustments
|
|
|
|
Pro
Forma
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
10,958.8 |
|
|
$ |
775.8 |
|
|
|
$ |
- |
|
|
|
$ |
11,734.6 |
|
Short
term investments
|
|
|
294.0 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
294.0 |
|
Restricted
Cash
|
|
|
4,096.2 |
|
|
|
353.9 |
|
|
|
|
- |
|
|
|
|
4,450.1 |
|
Accounts
receivable trade, less allowances for doubtful accounts
|
|
|
6,013.8 |
|
|
|
768.9 |
|
|
|
|
- |
|
|
|
|
6,782.7 |
|
Inventories
|
|
|
16,381.6 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
16,381.6 |
|
Deferred
project costs
|
|
|
- |
|
|
|
3,316.0 |
|
|
|
|
2,223.7 |
|
(d)
|
|
|
5,539.7 |
|
Prepaid
expenses and other current assets
|
|
|
1,015.4 |
|
|
|
488.1 |
|
|
|
|
(392.2 |
) |
(k)
|
|
|
1,111.3 |
|
Total
current assets
|
|
|
38,759.8 |
|
|
|
5,702.7 |
|
|
|
|
1,831.5 |
|
|
|
|
46,294.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net
|
|
|
30,192.1 |
|
|
|
9,728.9 |
|
(e)
|
|
|
- |
|
|
|
|
39,921.0 |
|
Prepaid
land use rights, net
|
|
|
4,659.0 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
4,659.0 |
|
Goodwill
|
|
|
34,425.7 |
|
|
|
- |
|
|
|
|
12,139.0 |
|
(b)
|
|
|
46,564.7 |
|
Intangible
assets, net
|
|
|
15,493.1 |
|
|
|
- |
|
|
|
|
11,000.0 |
|
(c)
|
|
|
26,493.1 |
|
Other
assets
|
|
|
317.8 |
|
|
|
196.1 |
|
(e)
|
|
|
- |
|
|
|
|
513.9 |
|
|
|
$ |
123,847.5 |
|
|
$ |
15,627.7 |
|
|
|
$ |
24,970.5 |
|
|
|
$ |
164,445.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes
payable and credit line
|
|
$ |
10,902.3 |
|
|
$ |
3,400.0 |
|
(e)
|
|
$ |
- |
|
|
|
$ |
14,302.3 |
|
Due
to Amorcyte, Inc.
|
|
|
- |
|
|
|
500.0 |
|
(e)
|
|
|
- |
|
|
|
|
500.0 |
|
Accounts
payable
|
|
|
9,350.1 |
|
|
|
1,590.3 |
|
|
|
|
- |
|
|
|
|
10,940.4 |
|
Accrued
liabilities
|
|
|
4,993.1 |
|
|
|
337.0 |
|
|
|
|
- |
|
|
|
|
5,330.1 |
|
Current
maturities of long-term debt
|
|
|
|
|
|
|
106.2 |
|
(e)
|
|
|
- |
|
|
|
|
106.2 |
|
Unearned
revenues
|
|
|
1,432.5 |
|
|
|
5,559.3 |
|
(e)
|
|
|
- |
|
|
|
|
6,991.8 |
|
Total
current liabilities
|
|
|
26,678.0 |
|
|
|
11,492.8 |
|
|
|
|
- |
|
|
|
|
38,170.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long
term debt
|
|
|
- |
|
|
|
2,763.2 |
|
(e)
|
|
|
- |
|
|
|
|
2,763.2 |
|
Deferred
tax liability
|
|
|
4,319.5 |
|
|
|
- |
|
|
|
|
5,289.5 |
|
(f)
|
|
|
9,609.0 |
|
Unearned
revenues
|
|
|
203.7 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
203.7 |
|
Deferred
lease liability
|
|
|
- |
|
|
|
107.4 |
|
(e)
|
|
|
- |
|
|
|
|
107.4 |
|
Amount
due related party
|
|
|
7,855.2 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
7,855.2 |
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
B convertible redeemable preferred stock
|
|
|
0.1 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
0.1 |
|
Common
stock
|
|
|
56.7 |
|
|
|
- |
|
|
|
|
11.2 |
|
(a)
|
|
|
67.9 |
|
Members'
contributions
|
|
|
- |
|
|
|
13,079.7 |
|
|
|
|
(13,079.7 |
) |
(l)
|
|
|
- |
|
Additional
paid-in capital
|
|
|
129,485.7 |
|
|
|
- |
|
|
|
|
20,934.1 |
|
(a)
|
|
|
150,419.8 |
|
Accumulated
deficit
|
|
|
(81,839.6 |
) |
|
|
(11,815.4 |
) |
|
|
|
11,815.4 |
|
(l)
|
|
|
(81,839.6 |
) |
Accumulated
other comprehensive loss
|
|
|
99.8 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
99.8 |
|
Total
shareholders' equity
|
|
|
47,802.7 |
|
|
|
1,264.3 |
|
|
|
|
19,681.0 |
|
|
|
|
68,748.0 |
|
Non-controlling
interests
|
|
|
36,988.4 |
|
|
|
- |
|
|
|
|
- |
|
|
|
|
36,988.4 |
|
Total
equity
|
|
|
84,791.1 |
|
|
|
1,264.3 |
|
|
|
|
19,681.0 |
|
|
|
|
105,736.4 |
|
|
|
$ |
123,847.5 |
|
|
$ |
15,627.7 |
|
|
|
$ |
24,970.5 |
|
|
|
$ |
164,445.7 |
|
Unaudited
Pro Forma Condensed Combined Statements of Operations
|
|
For
the Six Months Ended June 30, 2010
|
|
(in
$000's)
|
|
|
|
NeoStem
|
|
|
Progenitor
Cell Therapy
|
|
|
Proforma
Adjustments
|
|
|
|
Pro
Forma
|
|
Revenues
|
|
$ |
35,240.7 |
|
|
$ |
4,271.3 |
|
|
$ |
(822.8 |
) |
(h),
(i)
|
|
$ |
38,689.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of revenue
|
|
|
23,763.4 |
|
|
|
2,762.6 |
|
|
|
525.0 |
|
(g)
|
|
|
26,743.1 |
|
|
|
|
|
|
|
|
|
|
|
|
(21.7 |
) |
(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(286.2 |
) |
(h)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
3,433.5 |
|
|
|
- |
|
|
|
(1.4 |
) |
(i)
|
|
|
3,432.1 |
|
Selling,
general and administrative
|
|
|
14,155.0 |
|
|
|
2,944.5 |
|
|
|
75.0 |
|
(g)
|
|
|
17,400.5 |
|
|
|
|
|
|
|
|
|
|
|
|
226.0 |
|
(j)
|
|
|
|
|
Operating
loss
|
|
|
(6,111.2 |
) |
|
|
(1,435.8 |
) |
|
|
(1,339.5 |
) |
|
|
|
(8,886.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
(14.5 |
) |
|
|
1.3 |
|
|
|
- |
|
|
|
|
(13.2 |
) |
Interest
expense
|
|
|
(14.7 |
) |
|
|
(335.8 |
) |
|
|
206.1 |
|
(k)
|
|
|
(144.4 |
) |
|
|
|
(29.2 |
) |
|
|
(334.5 |
) |
|
|
206.1 |
|
|
|
|
(157.6 |
) |
Loss
from operations before provision for
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
income
taxes and non-controlling interests
|
|
|
(6,140.4 |
) |
|
|
(1,770.3 |
) |
|
|
(1,133.4 |
) |
|
|
|
(9,044.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision
for income taxes
|
|
|
905.2 |
|
|
|
- |
|
|
|
(240.0 |
) |
(g)
|
|
|
665.2 |
|
Net
loss
|
|
|
(7,045.6 |
) |
|
|
(1,770.3 |
) |
|
|
(893.4 |
) |
|
|
|
(9,709.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less
- Net income attributable to
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
non-controlling
interests
|
|
|
2,940.2 |
|
|
|
- |
|
|
|
- |
|
|
|
|
2,940.2 |
|
Net
loss attributable to controlling interests
|
|
|
(9,985.8 |
) |
|
|
(1,770.3 |
) |
|
|
(893.4 |
) |
|
|
|
(12,649.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
dividends
|
|
|
153.5 |
|
|
|
- |
|
|
|
- |
|
|
|
|
153.5 |
|
Net
loss attributable to common shareholders
|
|
$ |
(10,139.3 |
) |
|
$ |
(1,770.3 |
) |
|
$ |
(893.4 |
) |
|
|
$ |
(12,803.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding
|
|
|
44,419,734 |
|
|
|
|
|
|
|
|
|
|
|
|
55,619,734 |
(m) |
Net
loss attributable to common shareholders
|
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
(0.23 |
) |
Unaudited
Pro Forma Condensed Combined Statements of Operations
|
|
For
the Twelve Months Ended December 31, 2009
|
|
(in
$000's)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NeoStem
|
|
|
Progenitor
Cell Therapy
|
|
|
Proforma
Adjustments
|
|
|
|
Pro
Forma
|
|
Revenues
|
|
$ |
11,565.1 |
|
|
$ |
8,238.2 |
|
|
$ |
(270.0 |
) |
(i)
|
|
$ |
19,533.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of revenues
|
|
|
9,504.2 |
|
|
|
5,479.9 |
|
|
|
1,050.0 |
|
(g)
|
|
|
15,902.9 |
|
|
|
|
|
|
|
|
|
|
|
|
(131.2 |
) |
(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,318.8 |
|
|
|
- |
|
|
|
(8.1 |
) |
(i)
|
|
|
4,310.7 |
|
Selling,
general and administrative
|
|
|
23,431.2 |
|
|
|
4,369.8 |
|
|
|
150.0 |
|
(g)
|
|
|
28,272.3 |
|
|
|
|
|
|
|
|
|
|
|
|
(130.7 |
) |
(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
452.0 |
|
(j)
|
|
|
|
|
Operating
loss
|
|
|
(25,689.1 |
) |
|
|
(1,611.5 |
) |
|
|
(1,652.0 |
) |
|
|
|
(28,952.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
(1.4 |
) |
|
|
84.1 |
|
|
|
- |
|
|
|
|
82.7 |
|
Interest
expense
|
|
|
(37.8 |
) |
|
|
(280.2 |
) |
|
|
120.2 |
|
(j)
|
|
|
(197.8 |
) |
|
|
|
(39.2 |
) |
|
|
(196.1 |
) |
|
|
120.2 |
|
|
|
|
(115.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations before provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and
non-controlling interests
|
|
|
(25,728.3 |
) |
|
|
(1,807.6 |
) |
|
|
(1,531.8 |
) |
|
|
|
(29,067.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision
for income taxes
|
|
|
64.2 |
|
|
|
- |
|
|
|
(480.0 |
) |
(g)
|
|
|
(415.8 |
) |
Net
loss
|
|
|
(25,792.5 |
) |
|
|
(1,807.6 |
) |
|
|
(1,051.8 |
) |
|
|
|
(28,651.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less
- Net income attributable to non-controlling
interests
|
|
|
300.5 |
|
|
|
- |
|
|
|
- |
|
|
|
|
300.5 |
|
Net
loss attributable to controlling interests
|
|
|
(26,093.0 |
) |
|
|
(1,807.6 |
) |
|
|
(1,051.8 |
) |
|
|
|
(28,952.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
dividends
|
|
|
5,612.0 |
|
|
|
- |
|
|
|
- |
|
|
|
|
5,612.0 |
|
Net
loss attributable to common shareholders
|
|
$ |
(31,705.0 |
) |
|
$ |
(1,807.6 |
) |
|
$ |
(1,051.8 |
) |
|
|
$ |
(34,564.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding
|
|
|
13,019,518 |
|
|
|
|
|
|
|
|
|
|
|
|
24,219,518 |
(m) |
Net
loss attributable to common shareholders
|
|
$ |
(2.44 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
(1.43 |
) |
Notes
to the NeoStem Unaudited Proforma Condensed Combined Financial
Statements
On
September 16, 2010, the Board of Directors of NeoStem, Inc., a Delaware
corporation (“NeoStem”) and on
September 22, 2010 the Board of Managers of Progenitor Cell Therapy, LLC, a
Delaware limited liability company (“PCT”), unanimously
approved the merger (the “Merger”) of NBS
Acquisition Sub Co., LLC, a newly formed wholly-owned subsidiary of NeoStem
(“Subco”), with
and into PCT pursuant to an Agreement and Plan of Merger, dated
September 23, 2010 (as such agreement may be amended from time to time, the
“Agreement and Plan of
Merger”), among NeoStem, PCT and Subco.
Pursuant
to the terms of the Agreement and Plan of Merger, all of the membership
interests of PCT outstanding immediately prior to the effective time of the
Merger (the “Effective
Time”) will be converted into the right to receive, in the aggregate,
11,200,000 shares of the common stock, par value $0.001 per share, of NeoStem
(the “NeoStem Common
Stock” or the “Parent Common Stock”)
and, subject to the satisfaction of certain conditions, warrants to purchase up
to an aggregate of 3,000,000 shares of NeoStem Common Stock, as
follows:
(i)
|
common
stock purchase warrants to purchase one million (1,000,000) shares of
Parent Common Stock exercisable over a seven year period at an exercise
price of $7.00 per share (the “$7.00
Warrants”), and which will vest only if a specified business
milestone is accomplished within three (3) years of the closing date of
the Merger; and
|
(ii)
|
common
stock purchase warrants to purchase one million (1,000,000) shares of
Parent Common Stock exercisable over a seven year term at an exercise
price of $3.00 per share (the “$3.00
Warrants”), if the volume weighted average of the closing prices of
sales of Parent Common Stock on the NYSE-Amex for the three (3)
trading days ending on the trading day that is two (2) days prior to the
closing date of the Merger (the “Parent Per Share
Value”) is less than $2.50;
and
|
(iii)
|
common
stock purchase warrants to purchase one million (1,000,000) shares of
Parent Common Stock exercisable over a seven year period at an exercise
price of $5.00 per share (the “$5.00 Warrants”
and, collectively with the $7.00 Warrants and the $3.00 Warrants, the
“Warrants”), if
the Parent Per Share Value is less than
$1.70.
|
The
shares of Parent Common Stock issuable in the Merger are subject to adjustment,
provided that in no event will NeoStem be required to issue more than 11,200,000
shares of NeoStem Common Stock.
Pursuant
to a consent and voting agreement dated the same date as the Agreement and Plan
of Merger, holders of a sufficient number of membership interests of PCT to
approve the Agreement and Plan of Merger and the Merger have irrevocably
consented to the Agreement and Plan of Merger and the Merger and agreed to
certain transfer restrictions with respect to their membership interests prior
to the Effective Time. Stockholders of NeoStem owning greater than
50% of NeoStem Common Stock on the date of the Agreement and Plan of Merger have
agreed to vote their shares in favor of the issuance of the NeoStem Common Stock
and Warrants in the Merger at a special meeting of stockholders which will be
held for such purpose.
The
statements contained in this section may be deemed to be forward-looking
statements within the meaning of Section 21E of the Securities Exchange Act
of 1934, as amended, and Section 27A of the Securities Act of 1933, as
amended. Such statements are intended to be covered by the safe harbor to
“forward-looking statements” provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are typically identified by the
words “believe,” “expect, “anticipate,” “intend,” “estimate” and similar
expressions. These forward-looking statements are based largely on management’s
expectations and are subject to a number of uncertainties. Actual results could
differ materially from these forward-looking statements. NeoStem, Inc. does not
undertake any obligation to update publicly or revise any forward-looking
statements.
Basis
of Presentation
The
unaudited pro forma condensed combined financial statements set forth above have
been prepared by NeoStem and give effect to the following
transactions:
1)
|
The
acquisition of the membership interests of PCT for aggregate consideration
of approximately $20.9 million,
and;
|
2)
|
The
issuance of 11.2 million shares of common stock and 3 million common stock
purchase warrants.
|
The
unaudited condensed combined proforma results of operations for the six months
ended June 30, 2010 and the year ended December 31, 2009 are presented to give
effect to the acquisition of PCT as if it had occurred on January 1,
2009. The unaudited condensed combined proforma balance sheet is
presented to give effect to the acquisition of PCT as if it had occurred on June
30, 2010. This proforma information is based on, derived from, and should be
read in conjunction with, the historical consolidated financial statements of
NeoStem for the year ended December 31, 2009, included in our Annual
Report on Form 10-K filed on March 31, 2010 and for the quarter ended
June 30, 2010 included in our Quarterly Report on Form 10-Q filed on August 16,
2010 and the historical financial statements of PCT for the year ended
December 31, 2009, and as of and for the unaudited six months ended June
30, 2010, which are included elsewhere in this document. We have not adjusted
the historical financial statements of either entity for any costs recognized
during the year that may be considered to be nonrecurring.
All
unaudited interim financial statements incorporated by reference or furnished
herein reflect all adjustments which are, in the opinion of management,
necessary to present a fair statement of the results for the interim periods
presented. All such adjustments are of a normal and recurring
nature.
The
unaudited proforma condensed combined financial statements were prepared using
the assumptions described below and in the related notes.
The
unaudited proforma condensed combined financial statements are provided for
illustrative purposes only. They do not purport to represent what NeoStem’s
consolidated results of operations and financial position would have been had
the transaction actually occurred as of the dates indicated, and they do not
purport to project NeoStem’ future consolidated results of operations or
financial position.
The
actual adjustments to our consolidated financial statements upon the closing of
the acquisition of PCT will depend on a number of factors, including additional
information that becomes available. Therefore, the actual adjustments
will differ from the unaudited pro forma adjustments, and the differences may be
material.
The
acquisition of PCT will be accounted for under the acquisition method of
accounting. For the purposes of determining the unaudited pro forma adjustments,
the assets and liabilities of PCT have been measured based on various
preliminary estimates using assumptions that NeoStem management believes are
reasonable utilizing information currently available.
The
process for estimating the fair values of in-process research and development,
identifiable intangible assets, and certain tangible assets requires the use of
significant estimates and assumptions, including estimating future cash flows,
developing appropriate discount rates, and estimating the costs, timing and
probability of success to complete in-process projects. Transaction costs are
not included as a component of consideration transferred. The excess of the
purchase price (consideration transferred) over the estimated amounts of
identifiable assets and liabilities of PCT as of the effective date of the
acquisition will be allocated to goodwill. The purchase price allocation is
subject to finalization of NeoStem’s analysis of the fair value of the assets
and liabilities of PCT as of the effective date of the acquisition. Accordingly,
the purchase price allocation in the unaudited pro forma condensed combined
financial statements presented above is preliminary and will be adjusted upon
completion of the final valuation. Such adjustments could be material. The final
valuation is expected to be completed as soon as practicable but no later than
one year after the consummation of the acquisition.
For
purposes of measuring the estimated fair value of the assets acquired and
liabilities assumed as reflected in the unaudited pro forma condensed combined
financial statements, fair value is the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market
participants at the measurement date (an exit price). Market participants are
assumed to be buyers and sellers in the principal (most advantageous) market for
the asset or liability. Additionally, fair value measurements for an asset
assume the highest and best use of that asset by market participants. As a
result, NeoStem may be required to value assets at fair value measures that do
not reflect NeoStem’s intended use of those assets. Use of different estimates
and judgments could yield different results.
In
connection with the Merger, four PCT executives have entered into employment
agreements with PCT that will become effective on the closing date of the
Merger. These employment agreements are specific to each executive and specify
the employment term (3 to 4 years), salary levels and in certain circumstances
performance bonuses. Each employment agreement contains non-compete provisions
and each individual will be granted a NeoStem stock option vesting over term of
the agreement. A total of 1,200,000 stock options will be granted to these
individuals.
When
these transactions are completed, NeoStem will account for these transactions in
accordance with Accounting Standards Codification 805-10 (“ASC 805-10”). ASC
805-10 provides revised guidance for recognizing and measuring identifiable
assets and goodwill acquired, liabilities assumed, and any noncontrolling
interest in the acquiree. ASC 805-10 also requires that assets acquired and
liabilities assumed in a business combination that arise from contingencies be
recognized at fair value if fair value can be reasonably estimated. If the fair
value of an asset or liability cannot be determined, the asset or liability that
arises from a contingency, the asset or liability would be recognized in
accordance with Accounting Standards Codification 30-1 (“ASC 30-1”) and if the
fair value is not determinable no asset or liability would be recognized. At the
present time, we are not in possession of all of the information to apply ASC
805-10 or ASC 30-1 to these unaudited proforma condensed combined financial
statements and will not be in possession of such information until the Effective
Date. Therefore, for the purposes of preparing these unaudited proforma
condensed combined financial statements we have established an estimated fair
value of the equities being offered in this transaction as of September 10,
2010. The preliminary purchase price allocation is
based on management’s estimate of acquired tangible and intangible assets and
will be adjusted based on the final valuation to be completed within one year
from the acquisition date. The excess of the total purchase price over the fair
value of the net assets acquired, including the estimated fair value of the
identifiable intangible assets, has been allocated to goodwill. We expect that the fair value of current
assets and remaining machinery and equipment will approximate the book value of
these assets and that the excess of purchase price over net deficit will be
assigned to Goodwill and intangible assets including, customer lists, in process
research and development, specialized manufacturing knowledge and any
non-compete agreements. The useful lives of these intangible assets are expected
to range between 5 years and 10 years based on the useful lives of the various
assets.
Calculation
of Estimated Consideration Transferred and Preliminary Allocation of
Consideration Transferred to Net Assets Acquired
The fair
value of equity securities issued as consideration transferred will be measured
using the market price of NeoStem common stock on the closing date. As of
September 10, 2010 the estimated fair value of the various equities being issued
is as follows:
Calculation
of Estimated Consideration Transferred (in $000's)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
of Shares
|
|
Fair
Value Per Share at September 10, 2010
|
|
Fair
Value at September 10, 2010
|
|
Common
Stock
|
|
|
11,200,000 |
|
|
$ |
1.73 |
|
|
$ |
19,376.0 |
|
Common
Stock Purchase Warrants
|
|
|
3,000,000 |
|
|
|
|
|
|
|
1,569.3 |
|
|
|
|
|
|
|
|
|
|
|
$ |
20,945.3 |
|
Based on
the terms and conditions of each of the warrants to be issued, we have
determined that all warrants are to be accounted for as an equity instrument and
included in the purchase price based on the probability that each warrant will
be issued or vested.
Assuming
a $0.50 change in NeoStem’s closing common stock price, the estimated
consideration transferred would increase or decrease by approximately $5.6
million which would have a corresponding offset to estimated
goodwill.
Preliminary
Allocation of Consideration Transferred to Net Assets
Acquired
|
|
(in
$000's)
|
|
|
|
Identifiable
intangible assets
|
|
$ |
11,000.0 |
|
Property,
plant and equipment
|
|
|
9,728.9 |
|
Deferred
costs
|
|
|
5,539.7 |
|
Other
non-current assets
|
|
|
196.1 |
|
Current
assets, excluding deferred costs
|
|
|
1,994.5 |
|
Current
liabilities
|
|
|
(11,492.8 |
) |
Deferred
income taxes
|
|
|
(5,289.5 |
) |
Long-term
debt, net of current maturities
|
|
|
(2,763.2 |
) |
Deferred
lease liability
|
|
|
(107.4 |
) |
Goodwill
|
|
|
12,139.0 |
|
Estimated
purchase price to be allocated
|
|
$ |
20,945.3 |
|
Proforma
Adjustments for the Unaudited Proforma Condensed Combined Financial Statements
(Dollar amounts in $000’s):
(a)
|
This
entry records the acquisition of the membership interests of PCT for
aggregate consideration of approximately $20,945.3, through the issuance
of 11,200,000 shares of NeoStem common stock and 3,000,000 common stock
purchase warrants.
|
(b)
|
This
entry records the estimated goodwill that will be recorded in connection
with the Merger.
|
(c)
|
This
entry records the intangible assets management expects to acquire in the
Merger. The preliminary purchase price allocation is based on management’s
estimate of acquired tangible and intangible assets and will be adjusted
based on the final valuation to be completed within one year from the
acquisition date. The excess of the total purchase price over the fair
value of the net assets acquired, including the estimated fair value of
the identifiable intangible assets, has been allocated to goodwill. Below
is a preliminary summary of the significant intangible assets that NeoStem
expects to acquire in the
Merger:
|
Preliminary
Summary of Intangible Assets (in $000's)
|
|
|
|
|
|
|
|
|
|
Estimated
Value
|
|
|
Useful
Life
|
|
|
Estimated
Annual Amortization
|
|
Customer
list and other related intangibles
|
|
$ |
1,500.0 |
|
|
|
10 |
|
|
$ |
150.0 |
|
In
process R&D
|
|
|
500.0 |
|
|
|
* |
|
|
|
- |
|
Non-compete
agreements
|
|
|
1,500.0 |
|
|
|
5 |
|
|
|
300.0 |
|
Knowledge
related to manufacturing clinical and patient specific
therapeutics
|
|
|
7,500.0 |
|
|
|
10 |
|
|
|
750.0 |
|
|
|
$ |
11,000.0 |
|
|
|
|
|
|
$ |
1,200.0 |
|
*
This amount will be capitalized and accounted for as an indefinite-life
intangible asset, subject to impairment testing. NeoStem will evaluate this
intangible asset at least annually to determine if any impairment has
occurred.
(d)
|
This
entry records the capitalization of estimated gross profit associated with
PCT projects in process at June 30, 2010 based on the total estimated
gross profit to be earned and the estimated percentage of completion for
each project at June 30, 2010.
|
(e)
|
For
the purposes of these proforma combined financial statements it is assumed
that the carrying value of this asset or liability approximates its fair
value.
|
(f)
|
This
entry records the estimated tax liability to be paid in the future due to
the non-deductibility of the identifiable intangible assets and increase
in deferred project costs expected to be acquired in the
Merger.
|
(g)
|
This
entry reflects the impact of amortizing the estimated value of the
intangible assets that will be acquired in the Merger and realization of
the related deferred tax liability. The amortization is based on the
estimated useful lives of these intangibles ranging between 5 and 10
years.
|
(h)
|
On
December 31, 2009, NeoStem and PCT entered into a construction management
agreement for the construction of NeoStem’s stem cell laboratory in
Beijing, China. This transaction has been reflected on NeoStem’s balance
sheet at June 30, 2010 in property, plant and equipment, and PCT reflected
this transaction in revenue and cost of revenue in its statement of
operations for the six months ended June 30, 2010. This entry eliminates
the intercompany revenue and intercompany profit that exists on these
transactions.
|
(i)
|
On
January 9, 2009, NeoStem and PCT entered into an agreement which calls for
PCT to provide stem cell cryopreservation services and stem cell storage
services, and on March 6, 2009, NeoStem and PCT entered into a consulting
agreement in connection with the design of a stem cell laboratory in
Beijing, China. This entry eliminates the intercompany sales and
intercompany profit that exists on these transactions for the year ended
December 31, 2009 and the six months ended June 30,
2010.
|
(j)
|
In
connection with the Merger, four PCT executives have entered into
employment agreements with PCT that will become effective on the closing
date of the Merger. These employment agreements are specific to each
executive and specify the employment term (3 to 4 years), salary levels
and in certain circumstances performance bonuses. Each employment
agreement contains non-compete provisions and each individual will be
granted NeoStem stock options vesting over term of the agreement. A total
of 1,200,000 stock options will be granted to these individuals. This
entry records the stock option compensation associated with these
collective grants.
|
(k)
|
On
September 14, 2009, PCT entered into a line of credit for $3.0
million. The credit line has an interest rate of 5.5% accruing
on the first $2.0 million and 6% thereafter. The advance and
accrued interest was due and payable on June 30, 2010. In
conjunction with the original credit line, a warrant to purchase shares
were issued by PCT to the lender. The holder is entitled to
purchase, at its option, up to 73,052 Shares of Limited Liability Company
Interests (PCT’s ownership interests are expressed as shares of ownership
with a maximum of 10,000,000 ownership shares authorized to be issued) at
an exercise price of $6.16 per Share. NeoStem has agreed to payoff this
credit line shortly after the Closing Date. The warrant is for seven years
and expires September 14, 2016. The warrant was accounted for
as deferred financing costs and valued using the Black-Scholes pricing
model. This resulted in deferred financing cost of
approximately $326 thousand which was amortized as interest expense over
the term of the loan ($120.2 thousand in 2009 and $206.1 thousand in
2010). On June 30, 2010, PCT increased the maximum amount of
the line of credit from $3.0 million to $3.4 million and the line of
credit now has a revised maturity date of June 30, 2011. In connection
with the revision of the credit line PCT issued a warrant for 85,000
Shares of Limited Liability Company Interests that had a fair value of
$392.2 thousand and has been reflected on PCT’s balance sheet as deferred
financing costs categorized within prepaids and other current assets. This
entry reverses the expense charges associated with the warrant issued in
June 2009, that were recognized in 2009 and 2010, since the charges will
not continue after the close of the Merger. In addition, this entry also
eliminates the value of the warrant issued in June 2010 for the extension
of the credit line. In accordance with the terms of the Merger Agreement
these warrants will be cancelled and not replaced with equity instruments
issued by NeoStem.
|
(l)
|
This
entry eliminates the equity accounts of
PCT.
|
(m)
|
At
the conclusion of this transaction, an additional 11,200,000 common shares
will have been issued and for the purposes of calculating the unaudited
proforma earnings/(loss) per share it has been assumed that these shares
were outstanding as of January 1,
2009.
|
Unassociated Document
AGREEMENT
AND PLAN OF MERGER
THIS
AGREEMENT AND PLAN OF MERGER, dated as of September 23, 2010, is by and among
NEOSTEM, INC., a
Delaware corporation (the “Parent” or “NeoStem”), NBS ACQUISITION COMPANY LLC, a
Delaware limited liability company (“Subco”) and PROGENITOR CELL THERAPY, LLC,
a Delaware limited liability company (“PCT”).
RECITALS
WHEREAS, PCT and its
subsidiaries are engaged in a wide range of services in the stem cell therapy
market for the treatment of human disease, including but not limited to contract
manufacturing, product and process development, consulting, product
characterization and comparability, and storage, distribution, manufacturing and
transport of Cell Therapy Products (as heretofore practiced by PCT, the “PCT
Business”);
WHEREAS, NeoStem desires to
acquire the PCT Business through the merger of Subco with and into PCT, with PCT
as the surviving entity (the “Merger”). Each
of the parties has determined that the Merger is consistent with and in
furtherance of its respective long-term business strategies and desires to
combine their respective businesses and for the Members to have a continuing
equity interest in the combined NeoStem/PCT businesses through the ownership of
NeoStem securities;
WHEREAS, pursuant to the terms
and subject to the conditions set forth in this Agreement, as consideration in
the Merger, NeoStem shall issue to the Members (inclusive of Members holding any
membership interests issued upon exercise of any PCT Options or PCT Warrants
prior to the Closing) the following:
1. 11,200,000
shares of Parent Common Stock; and
2. Subject
to certain conditions, certain Warrants to purchase an aggregate of up to
3,000,000 shares of Parent Common Stock on terms described herein;
and
WHEREAS, the respective Boards
of Directors or Managers of NeoStem, Subco and PCT have determined that the
Merger, in the manner contemplated herein, is advisable and in the best
interests of their respective equity holders and, by resolutions duly adopted,
have approved and adopted this Agreement;
NOW, THEREFORE, in
consideration of the mutual covenants and undertakings contained herein, and
subject to and on the terms and conditions set forth herein, the parties hereto
hereby agree as follows:
ARTICLE
I
Definitions;
Interpretations
Section
1.1 Definitions. As
used in this Agreement, the following terms shall have the respective meanings
set forth below:
“Affiliate” means,
with respect to any Person, any other Person who directly or indirectly, through
one or more intermediaries, controls, is controlled by, or is under common
control with, such Person. The term “control” means the
possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of a Person, whether through the
ownership of voting securities, by contract or otherwise, and the terms
“controlled” and “controlling” have meanings correlative thereto.
“Affiliated Members”
means Andrew Pecora, Robert Preti, Hackensack University Medical Center,
BioScience 2002 LLC, George Goldberger, Marc Beer and Dempsey
Gable.
“Agreement” means this
Agreement and Plan of Merger.
“Balance Sheet Date”
means June 30, 2010.
“Benefit Arrangement”
means each (i) employee benefit plan, as defined in Section 3(3) of ERISA, (ii)
employment contract and (iii) bonus, deferred compensation, incentive
compensation, performance compensation, stock purchase, stock option, stock
appreciation, restricted stock, phantom stock, savings, profit sharing,
severance, termination pay (other than statutory or common law requirements for
reasonable notice), health or other medical, salary continuation, cafeteria,
dependent care, vacation, sick leave, overtime, holiday pay, fringe benefit,
reimbursement, life insurance, disability or other (whether insured or
self-insured) insurance, supplementary unemployment, pension retirement,
supplementary retirement, welfare or other plan, program, policy or arrangement,
whether written or unwritten, formal or informal, to which any employee or
consultant of the PCT Business participates in or is covered under, or is
otherwise a party.
“Business Day” means a
day, other than a Saturday or Sunday, on which commercial banks in New York City
are open for the general transaction of business.
“Cell Therapy Product”
means each of (i) human cells, tissues, and cellular- and tissue- based products
as defined under 21 C.F.R. § 1271, specifically, articles, containing or
consisting of human cells or tissues that are intended for implantation,
transplantation, infusion, or transfer into a human recipient, including but not
limited to hematopoietic stem/progenitor cells derived from peripheral and cord
blood; (ii) human cellular- and tissue-based products PCT produces that are more
than minimally manipulated for non-homologous use combined with at least one
other article that raises new clinical safety concerns and/or has systemic
effect on the metabolic activity of living cells for its primary function and
are applicable to the prevention, treatment, or cure of a disease or condition
of human beings; (iii) somatic cell-based products that are procured from a
donor and intended for manipulation and/or administration as it is defined by
the America Association of Blood Banks; and (iv) any definition proscribed by
applicable state, local, or other Non-governmental Regulatory Body.
“Charter Members”
means Andrew L. Pecora; Robert A. Preti; Hackensack University Medical Center;
BioScience 2002 LLC; George S. Goldberger; Harry D. Harper; Andrew A. Jennis;
Mark S. Pascal; Richard J. Rosenbluth; and Stanley E. Waintraub.
“Code” means the
Internal Revenue Code of 1986, as amended.
“Contract” means any
contract, agreement, indenture, note, bond, mortgage, loan, instrument, lease,
license, commitment or other arrangement, understanding, undertaking, commitment
or obligation, whether written or oral.
“Environmental Laws”
means any federal, state or local law, statute, ordinance, rule, regulation,
license, permit, authorization, approval, consent, court order, judgment,
decree, injunction, code requirement or agreement with any Governmental
Authority (x) relating to pollution (or the cleanup thereof or the filing of
information with respect thereto), human health or the protection of air,
surface water, ground water, drinking water supply, land (including land surface
or subsurface), plant and animal life or damages for injury or loss of natural
resources, or (y) concerning exposure to, or the use, storage, recycling,
treatment, generation, transportation, processing, handling, labeling,
production or disposal of Regulated Substances, in each case as amended and as
now or hereafter in effect. The term “Environmental Laws” includes,
without limitation, any common law or equitable doctrine (including, without
limitation, injunctive relief and tort doctrines such as negligence, nuisance,
trespass and strict liability) that may impose liability or obligations for
injuries or damages due to or threatened as a result of the presence of,
exposure to, or ingestion of, any Regulated Substance.
“ERISA” means the
Employee Retirement Income Security Act of 1974, as amended.
“ERISA Affiliate”
means, the PCT Group and any other Person that, together with PCT, would be
treated as a single employer under Section 414 of the Code.
“Escrow Account” means
the escrow account established with the Escrow Agent in accordance with the
Escrow Agreement to hold the Stock Consideration for up to two (2) years after
Closing, as further described in Section 8.4.
“Escrow Agent” means
Continental Stock Transfer, or any successor thereto acting as escrow agent
under the Escrow Agreement.
“Excluded Liabilities”
means the following liabilities or obligations of the PCT Group (whether or not
relating to the PCT Business, and whether known or unknown, absolute, accrued,
contingent or otherwise, or whether due or to become due, arising out of events
or transactions or facts occurring on or prior to, the Closing
Date):
(i) all
liabilities and obligations of any kind existing as of the Closing Date owed or
owing by PCT or its Subsidiaries to any Member or any Affiliate of a
Member;
(ii) all
liabilities and obligations of any kind existing as of the Closing Date of a
nature properly characterized under GAAP as a long-term liability, including all
Indebtedness properly characterized under GAAP as a long-term liability, other
than the Real Estate Mortgage Loan and the NNJCA Obligation in the amount of up
to $3 million;
(iii) all
liabilities and obligations, whether absolute, accrued, contingent or otherwise,
for Taxes, including, without limitation, any such liability or obligation for
any income, sales, use or similar Taxes resulting from the transactions
contemplated by this Agreement with respect to any period, other than currently
due sales taxes for the second quarter reflected on the June 30, 2010 balance
sheet or related to sales after June 30, 2010;
(iv) all
damages, losses, liabilities, actions, claims, costs and expenses (including,
without limitation, closure costs, fines, penalties, expenses of investigation
and remediation and ongoing monitoring and reasonable attorneys’ fees) directly
or indirectly based upon, arising out of, resulting from or relating to (a) any
violation of any Environmental Law by the PCT Group or any Person or entity
acting on behalf of the PCT Group or any Person from or through which the PCT
Group acquired title on or prior to the Closing Date (including, without
limitation, any failure to obtain or comply with any permit, license or other
operating authorization under provisions of any Environmental Law), (b) any
violation of any rule, regulation or promulgation of the FDA by the PCT Group or
any Person or entity acting on behalf of the PCT Group or any Person from or
through which PCT Group acquired title on or prior to the Closing Date, (c) any
act, omission, event, condition or circumstance occurring or existing, in
connection with the PCT Business or otherwise, as of or prior to the
consummation of the Closing relating to (X) removal, remediation, containment,
cleanup or abatement of the presence of any Regulated Substance, whether on-site
or off-site, or (Y) any claim by any third party, including without limitation,
tort suits for personal or bodily injury, property damage or injunctive relief
or (d) any failure to comply with any escheat law;
(v) all
liabilities and obligations arising out of any lawsuit, action, proceeding,
inquiry, claim, order or investigation by or before any Governmental Authority
arising out of events, transactions, facts, circumstances, acts or omissions
which occurred prior to or on the Closing Date, including, without limitation,
personal injury or property damage, product liability or strict
liability;
(vi) all
liabilities or obligations of the PCT Group, related to the PCT Business or
otherwise, not disclosed in the GAAP Financial Statements (or not arising in the
Ordinary Course of PCT's Business after the Balance Sheet Date), of any kind or
nature, whether known or unknown, absolute, accrued, contingent or otherwise, or
whether due or to become due, arising out of events, transactions, facts, acts
or omissions which occurred prior to or on the Closing Date; and
(vii) all
liabilities that PCT, any Subsidiary of PCT and any Member may have with respect
to PCT Expenses in excess of $200,000.
“FDA” means the United
States Food and Drug Administration or any successor agency performing similar
functions.
“FDA Package” means
the FDA and state regulatory filings, approvals, correspondence and audit
reports previously sent by PCT to Parent and its counsel.
“GAAP” means generally
accepted accounting principles as in effect in the United States on the date of
this Agreement.
“Governmental
Authority” means any national, federal, state, provincial, county,
municipal or local government, foreign or domestic, or the government of any
political subdivision of any of the foregoing, or any entity, authority, agency,
ministry or other similar body exercising executive, legislative, judicial,
regulatory or administrative authority or functions of or pertaining to
government, including any authority or other quasi-governmental entity
established to perform any of such functions.
“Indebtedness” means
at a particular time, without duplication, (i) any obligations under any
indebtedness for borrowed money (including, without limitation, all principal,
interest, premiums, penalties, fees, expenses, indemnities and breakage costs),
(ii) any indebtedness evidenced by any note, bond, debenture or other debt
security, (iii) any commitment by which a Person assures a creditor against
loss (including contingent reimbursement obligations with respect to letters of
credit), (iv) any indebtedness pursuant to a guarantee, (v) any
obligations under capitalized leases or with respect to which a Person is
liable, contingently or otherwise, as obligor, guarantor or otherwise, or with
respect to which obligations a Person assures a creditor against loss, and
(vi) any indebtedness secured by a Lien on a Person’s assets.
“Intellectual
Property” any and all worldwide rights in, arising from or associated
with the following, whether protected, created or arising under the Laws of the
United States or any other jurisdiction or under any international
convention: (i) all patents and applications therefor, including
continuations, divisionals, continuations-in-part, or reissues of patent
applications and patents issuing thereon, and all similar rights arising under
the Laws of any jurisdiction (collectively, “Patents”), (ii) all
trademarks, service marks, trade names, service names, brand names, corporate
names, trade dress rights, logos, rights to use Internet domain names, and other
general intangibles of a like nature, together with the goodwill associated with
any of the foregoing, and all applications, registrations and renewals thereof
(collectively, “Marks”), (iii)
copyrights and registrations and applications therefor, works of authorship and
mask work rights (collectively, “Copyrights”), (iv)
discoveries, concepts, ideas, research and development, know-how, formulae,
inventions, compositions, technical data, procedures, designs, drawings,
specifications, databases, and other proprietary and confidential information,
including, without limitation, lists and databases of attendees, speakers,
exhibitors and sponsors, customer lists, supplier lists, pricing and cost
information, and business and marketing plans and proposals, in each case
excluding any rights in respect of any of the foregoing that comprise or are
protected by Copyrights or Patents (collectively, “Trade Secrets”), (v)
all Software and Technology and (vi) all rights to any of the foregoing pursuant
to any Intellectual Property License.
“Intellectual Property
License” means (i) any grant to a third Person of any right to use any of
the PCT Group Intellectual Property, and (ii) any grant to the PCT Group of a
right to use a third-person’s Intellectual Property.
“Knowledge” means the
actual knowledge, after due inquiry, of each of the managers and executive
officers of PCT, including but not limited to the following individuals (the
“Knowledge
Group”): Andrew Pecora, Robert Preti, Daryl LaSueur, George Goldberger,
Marc Beer, and Dempsey Gable; except when Knowledge refers to the knowledge of
NeoStem, the Knowledge Group means Robin Smith, Larry May and Catherine
Vaczy.
“Law” means any
foreign, federal, state or local law (including common law), statute, code,
ordinance, rule, regulation or other requirement.
“Legal Proceeding”
means any judicial, administrative or arbitral actions, suits, investigations,
proceedings or claims by or before a Governmental Authority.
“Lien” or “Liens” means any
mortgage, pledge, security interest, right of first refusal, option,
encumbrance, lien or charge of any kind (including any conditional sale or other
title retention agreement or lease in the nature thereof), any sale of
receivables with recourse against PCT or any of its Subsidiaries, any filing or
agreement to file a financing statement as debtor under the Uniform Commercial
Code or any similar statute (other than to reflect ownership by a third party of
property leased to PCT or any of its Subsidiaries under a lease which is not in
the nature of a conditional sale or title retention agreement), any
subordination arrangement in favor of another Person, or voting trusts, proxies
or restrictions (other than restrictions imposed by federal or state securities
laws) of any kind.
“Material Adverse
Effect” means, with respect to any Person, any change, occurrence or
development that individually or in the aggregate has or would reasonably be
expected to have a material adverse effect on the business, results of
operations, assets, liabilities, operations, or financial condition of such
party and its subsidiaries taken as a whole, but does not include any event,
circumstance, change or effect that individually or in the aggregate results
from (a) any event, condition or circumstance affecting the industry in which
the Person is engaged, provided such Person is not disproportionately adversely
impacted thereby, (b) the announcement or pendency of the transactions
contemplated by this Agreement, (c) with respect to PCT, any action taken by PCT
at NeoStem’s request or pursuant to this Agreement, (d) acts of war or
terrorism, and (e) general economic, political or financial market
conditions.
“Member” means an
equity holder of PCT.
“NNJCA Obligation”
means the working capital loan due to Northern New Jersey Cancer Associates
(“NNJCA”) from
PCT with a current principal balance of $3,400,000 and which shall have been
reduced to a total claim (whether for principal, interest or otherwise) of
$3,000,000 immediately prior to Closing.
“Order” means any
order, injunction, judgment, decree, ruling, writ, assessment or arbitration
award of a Governmental Authority.
“Ordinary Course of PCT’s
Business” means the ordinary and usual course of day-to-day operations of
the PCT Business through the date hereof consistent with past
practice.
“Parent Common Stock”
shall mean shares of common stock, par value $0.001 per share, of NeoStem,
Inc.
“Parent Per Share
Value” shall mean, with respect to Parent Common Stock, the volume
weighted average of the closing prices of sales of Parent Common Stock on the
NYSE-Amex for the three trading days ending on the trading day that is two days
prior to the Closing Date.
“PCT Documents” means
this Agreement and each other agreement, document, instrument or certificate to
be executed by PCT or any of the Subsidiaries or Members in connection with the
consummation of the transactions contemplated hereby.
“PCT Expenses” means
all costs and expenses incurred by PCT or any Subsidiary in connection with the
negotiation, preparation and execution of this Agreement and the consummation of
the transactions contemplated hereby or obtaining any requisite consents or
approvals of the Agreement or the transactions contemplated hereby, including
any brokerage, investment bankers or similar fees and any attorneys’ or
accounting fees.
“PCT Group” means PCT,
each of its Subsidiaries and any other entity that is controlled by PCT or any
of its Subsidiaries or under common control (but not Amorcyte,
Inc.). Unless the context expressly indicates to the contrary, each
reference herein to the PCT Group constitutes a reference to PCT and each other
Person that is part of the PCT Group both conjunctively and disjunctively. Any
reference herein to a “Person in the PCT
Group” shall be broadly interpreted, and refers to PCT, each of its
Subsidiaries and any other entity that is a Person in the PCT
Group.
“PCT Group Intellectual
Property” means all rights, including but not limited to, rights of
ownership and rights under license from any Person, of the PCT Group with
respect to any Intellectual Property. Notwithstanding the foregoing, PCT Group
Intellectual Property does not include patents owned by Amorcyte, Inc. or one
patent owned by Robert Preti, each as described on Schedule 4.15(a).
“PCT Options and PCT
Warrants” shall mean (a) all options to acquire equity of PCT issued to
former or current employees or consultants of PCT and (b) all other options,
warrants or rights or agreements to acquire or commitments to issue the equity
of PCT.
“PCT Product” means
any product or service offering of the PCT Group or product or service marketed,
sold, licensed or distributed by the PCT Group.
“PCT Representative”
shall mean Andrew Pecora.
“Permits” means any
approvals, authorizations, consents, licenses, permits or certificates of a
Governmental Authority and any non-governmental regulatory body licenses,
certifications or accreditations, such as those from the American Association of
Blood Banks (AABB) and the Foundation for the Accreditation of Cellular Therapy
(FACT).
“Person” means an
individual, partnership, corporation, limited liability company, joint stock
company, unincorporated organization or association, trust or joint venture, or
a governmental agency or political subdivision thereof.
“Purchaser Documents”
means this Agreement and each other agreement, document, instrument or
certificate to be executed by the Parent or Subco in connection with the
consummation of the transactions contemplated hereby.
“Real Estate Mortgage
Loan” means the mortgage loan secured by PCT’s real estate in Allendale,
New Jersey with a principal balance of approximately $2.9 million as of July 31,
2010 due to TD Bank.
“Regulated Substances”
means pollutants, contaminants, hazardous or toxic substances, compounds or
related materials or chemicals, hazardous materials, hazardous waste, flammable
explosives, radon, radioactive materials, asbestos, urea formaldehyde foam
insulation, polychlorinated biphenyls, petroleum and petroleum products
(including, but not limited to, waste petroleum and petroleum products) as
regulated under applicable Environmental Laws.
“Software” means any
and all (i) computer programs, including any and all software implementations of
algorithms, models and methodologies, whether in source code or object code,
(ii) databases and compilations, including any and all data and collections of
data, whether machine readable or otherwise, (iii) descriptions, flow-charts and
other work product used to design, plan, organize and develop any of the
foregoing, screens, user interfaces, report formats, firmware, development
tools, templates, menus, buttons and icons, and (iv) all documentation including
user manuals and other training documentation related to any of the
foregoing.
“Subsidiary” means any
entity (a) the accounts of which are required as of the date hereof or as of the
Closing Date to be consolidated with those of PCT in PCT’s consolidated
financial statements pursuant to GAAP; or (b) of which securities or other
ownership interests representing more than 50% of the equity or more than 50% of
the ordinary voting power or, in the case of a partnership, more than 50% of the
general partnership interests or more than 50% of the profits or losses are, as
of the date hereof or as of the Closing Date, owned, controlled or held by PCT
or one or more Subsidiaries of PCT, and shall include, but not be limited to PCT
Allendale LLC, DomaniCell LLC and Athelos Corporation.
“Tax,” “tax,” “Taxes” or “taxes” means (i) all
federal, state, local or foreign taxes, charges, fees, imposts, levies or other
assessments, including, without limitation, all net income, alternative minimum
or add-on minimum tax, gross income, gross receipts, capital, paid-up capital,
sales, use, ad valorem, value added, transfer, franchise, profits, inventory,
capital stock, license, withholding, payroll, employment, social security,
unemployment, excise, severance, stamp, occupation, property and estimated
taxes, environmental, windfall profits, customs duties, fees, or other like
assessments and charges of any kind whatsoever, (ii) all interest, penalties,
fines, additions to tax or additional amounts imposed by any Taxing Authority in
connection with any item described in clause (i) and (iii) any transferee
liability in respect of any items described in clauses (i) and/or (ii) payable
by reason of Contract, assumption, transferee liability, operation of Law,
Treasury Regulation Section 1.1502-6(a) (or any predecessor or successor thereof
of any analogous or similar provision under Law) or otherwise, in each case
whether or not disputed.
“Taxing Authority”
means the Internal Revenue Service and any other Governmental Authority
responsible for the administration of any Tax.
“Tax Return” or “tax return” means any
return, report or statement filed or required to be filed with respect to any
Tax (including any attachments thereto, and any amendment thereof) including any
information return, claim for refund, amended return or declaration of estimated
Tax, and including, where permitted or required, combined, consolidated or
unitary returns for any group of entities that includes any Person within the
PCT Group or any Affiliate of any Person within the PCT Group.
“Technology” means,
collectively, (i) all designs, formulae, algorithms, procedures, methods,
techniques, ideas, know-how, research and development, technical data, programs,
subroutines, tools, materials, specifications, processes, inventions (whether
patentable or unpatentable and whether or not reduced to practice), apparatus,
creations, improvements, works of authorship and other similar materials, (ii)
all recordings, graphs, drawings, reports, analyses, and other writings, and
other tangible embodiments of any of the foregoing, in any form whether or not
specifically listed herein, and (iii) all related technology that is used in,
incorporated in, embodied in, displayed by or relate to any of the foregoing or
is otherwise owned or used by the PCT Group (except that it is understood that
the PCT Group does not own customer-owned Technology used by it in the PCT
Business).
“Transaction
Documents” means Purchaser Documents and PCT Documents.
“Warrants” means
collectively any of the following common stock purchase warrants of Parent which
may be issued to the Members at the Closing: the $3.00 Warrants, the
$5.00 Warrants and the $7.00 Warrants.
Section
1.2 Other
Definitions. The following table identifies the sections in
this Agreement where certain other definitions are set forth:
Defined Term
|
|
Section
|
$3.00
Warrants
|
|
Section
3.1(b)
|
$3.00
Warrant Condition
|
|
Section
3.1(d)
|
$5.00
Warrants
|
|
Section
3.1(b)
|
$5.00
Warrant Condition
|
|
Section
3.1(e)
|
$7.00
Warrants
|
|
Section
3.1(b)
|
$7.00
Warrant Condition
|
|
Section
3.1(c)
|
Adjusted
Stock Consideration
|
|
Section
3.3(b)
|
Adjusted
Closing Working Capital
|
|
Section
3.3(c)
|
Adjusted
Closing Working Capital Statement
|
|
Section
3.3(c)
|
Balance
Sheet
|
|
Section
4.9(a)
|
Bankruptcy/Equity
Exception
|
|
Section
4.2
|
Business
Consultant
|
|
Section
4.18(b)
|
Business
Employees
|
|
Section
4.18(a)
|
Business
Property
|
|
Section
4.7(b)
|
Certificate
of Merger
|
|
Section
2.2
|
Closing
|
|
Section
2.2
|
Closing
Balance Sheet
|
|
Section
3.3(c)
|
Closing
Date
|
|
Section
2.2
|
Collar
|
|
Section
3.3(b)
|
Company
Benefit Plan
|
|
Section
4.17
|
Company
Disclosure Letter
|
|
Article
IV - First Paragraph
|
Company
Employees
|
|
Section
4.17
|
Competitive
Business
|
|
Section
6.6(a)
|
Confidential
Information
|
|
Section
6.6(b)
|
Control
|
|
Section
1.1, Definition of “Affiliate”
|
Copyrights
|
|
Section
1.1, Definition of “Intellectual Property”
|
Damages
|
|
Section
8.2(a)
|
DLLCA
|
|
Section
2.1
|
Effective
Time
|
|
Section
2.2
|
EisnerAmper
|
|
Section
4.9(a)
|
Employee
Claims
|
|
Section
3.6(a)
|
Escrow
Agreement
|
|
Section
3.2
|
Escrow
Period
|
|
Section
8.4(a)
|
Exchange
Act
|
|
Section
4.27
|
Exchange
|
|
Section
7.1(f)
|
Fair
Market Value
|
|
Section
8.4(b)
|
Final
Submission
|
|
Section
2.5(b)(iii)
|
FINRA
|
|
Section
4.28
|
GAAP
Financial Statements
|
|
Section
4.9(a)
|
Indemnified
Party
|
|
Section
8.2(c)
|
Indemnifying
Party
|
|
Section
8.2(c)
|
Key
Employees
|
|
Section
7.2(i)
|
Leased
Property
|
|
Section
4.7(a)
|
Lock-Up
Member
|
|
Section
4.11(c)
|
Marks
|
|
Section
1.1, Definition of “Intellectual Property”
|
Merger
|
|
Second
Recital
|
Material
Contracts
|
|
Section
4.16(a)
|
Multiemployer
Plan
|
|
Section
4.17(b)
|
NBS
Acquisition Proposal
|
|
Section
6.5(b)
|
NeoStem
|
|
Opening
Paragraph
|
NeoStem
Meeting
|
|
Section
4.27
|
Net
Lost Agreements
|
|
Section
3.3(h)
|
NNJCA
|
|
Section
1.1; Definition of NNJCA Obligation
|
Off-The-Shelf
Software
|
|
Section
4.15(f)
|
Owned
Property
|
|
Section
4.7(a)
|
Parent
|
|
Opening
Paragraph
|
Parent
Indemnified Parties
|
|
Section
8.2(a)
|
Parent
Notice
|
|
Section
8.4(b)
|
Patents
|
|
Section
1.1, Definition of “Intellectual Property”
|
PCT
|
|
Opening
Paragraph
|
PCT
Acquisition Proposal
|
|
Section
6.5(a)
|
PCT
Business
|
|
First
Recital
|
PCT
Claims
|
|
Section
6.10(a)
|
PCT
Indemnified Parties
|
|
Section
8.2(b)
|
PCT
LLC Agreement
|
|
Section
4.11(b)
|
PCT
Meeting
|
|
Section
4.27
|
PCT
Permits
|
|
Section
4.20(b)
|
Percentage
Certification
|
|
Section
3.4(b)
|
Person
In the PCT Group
|
|
Section
1.1; Definition of “PCT Group”
|
Prospectus/Joint
Proxy Statement
|
|
Section
4.27
|
Real
Property
|
|
Section
4.7
|
Registration
Statement
|
|
Section
4.27
|
Related
Persons
|
|
Section
4.22(a)
|
SEC
|
|
Section
4.2
|
Securities
Act
|
|
Section
4.09(e)
|
Service
Provider
|
|
Section
4.18(e)
|
Stock
Consideration
|
|
Section
3.1(b)
|
Subco
|
|
Opening
Paragraph
|
Supplemental
Financial Information
|
|
Section
6.3(e)
|
Survival
Period
|
|
Section
8.1(a)
|
Surviving
Company
|
|
Section
2.1
|
Target
Working Capital
|
|
Section
3.3(b)
|
Termination
Date
|
|
Section
8.4(a)
|
Threshold
|
|
Section
8.2(d)
|
Trade
Secrets
|
|
Section
1.1, Definition of “Intellectual Property”
|
Valuation
Report
|
|
Section
6.2(b)
|
Voting
Agreement
|
|
Section
4.11(c)
|
Section
1.3 Interpretation. Unless
otherwise indicated to the contrary herein by the context or use thereof: (i)
the words, “herein,” “hereto,” “hereof” and words of similar import refer to
this Agreement as a whole and not to any particular Section or paragraph hereof;
(ii) words importing the masculine gender shall also include the feminine and
neutral genders, and vice versa; and (iii) words importing the singular shall
also include the plural, and vice versa.
ARTICLE
II
The
Merger
Section
2.1 The Merger. Upon
the terms and subject to the conditions hereof, and in accordance with the
provisions of the Delaware Limited Liability Company Act (the “DLLCA”), Subco shall
be merged with and into PCT at the Effective Time. As a result of the
Merger, the separate existence of Subco shall cease and PCT shall continue its
existence under the laws of the State of Delaware as a wholly-owned Subsidiary
of NeoStem. PCT, in its capacity as the limited liability company
surviving the Merger, is hereinafter sometimes referred to as the “Surviving
Company.”
Section
2.2 Effective
Time. The parties shall cause the Merger to be consummated by
filing with the Secretary of State of the State of Delaware a certificate of
merger (the “Certificate of
Merger”) in such form as is required by Section 18-209 of DLLCA and
executed in accordance with the DLLCA. The Merger shall become
effective (the “Effective Time”) when
the Certificate of Merger has been filed with the Delaware Secretary of State,
which filing shall occur on the Closing Date, or at such later time as shall be
agreed upon by NeoStem and PCT and specified in the Certificate of
Merger. Prior to the filing referred to in this Section 2.2, a
closing (the “Closing”) shall be
held at the offices of Lowenstein Sandler PC, 65 Livingston Avenue, Roseland,
New Jersey 07068 or such other place as the parties may agree, as soon as
practicable (but in any event within five Business Days) following the date upon
which all conditions set forth in Article VII hereof have been satisfied or
waived, or at such other date as NeoStem and PCT may agree, provided that the
conditions set forth in Article VII have been satisfied or waived at or prior to
such date. The date on which the Closing takes place is referred to
herein as the “Closing
Date.” For all tax purposes, the Closing shall be effective at the end of
the day on the Closing Date.
Section
2.3 Effects of the
Merger. From and after the Effective Time, the Merger shall
have the effects set forth in Section 18-209(g) of the DLLCA.
Section
2.4 Certificate of Formation and
Operating Agreement. At the Effective Time, (i) the
certificate of formation of the Surviving Company as in effect immediately prior
to the Effective Time shall be amended as of the Effective Time so as to contain
the provisions, and only the provisions, contained immediately prior thereto in
the certificate of formation of PCT (with any modifications reasonably requested
by Parent), and (ii) the limited liability company agreement of Subco in effect
immediately prior to the Effective Time shall be the limited liability company
agreement of the Surviving Company; in each case until amended in accordance
with applicable law. All obligations of the Members of PCT under the
Operating Agreement, including obligations to PCT with respect to
confidentiality and competition, to the extent applicable to any Member, shall
remain in full force and effect for the time periods set forth in the Operating
Agreement for the continued benefit of the Surviving Company, and no release
from those obligations is intended by reason of the Merger.
Section
2.5 Managers and Officers of the
Surviving Company. From and after the Effective Time,
individuals designated by NeoStem prior to the Effective Time shall be the
officers and managers of the Surviving Company, in each case until their
respective successors are duly elected and qualified. On or prior to
the Closing Date, PCT shall deliver to NeoStem a written resignation, in form
and substance satisfactory to NeoStem, from each manager and officer of PCT,
effective as of the Effective Time.
ARTICLE
III
Conversion
and Distribution of Securities
Section
3.1 Conversion of Capital
Stock. At the Effective Time, by virtue of the Merger and
without any action on the part of NeoStem, Subco or PCT or their respective
stockholders or members, as the case may be:
(a) Each
membership interest of Subco issued and outstanding immediately prior to the
Effective Time shall be converted into a membership interest of the Surviving
Company. Such membership interests shall thereafter constitute all of
the issued and outstanding equity of the Surviving Company, so that NeoStem
shall own all of the membership interests in, and equity of, the Surviving
Company.
(b) Subject
to the other provisions of this Article III, all of the membership interests of
PCT issued and outstanding immediately prior to the Effective Time (inclusive of
any PCT Membership Interest issued upon exercise of any PCT Options or Warrants)
shall be cancelled and converted into the right to receive in the aggregate the
following securities of NeoStem:
(i) 11,200,000
shares of Parent Common Stock, adjusted as set forth in Section 3.3 (the “Stock
Consideration”), and
(ii) Subject
to satisfaction of certain conditions described below, (x) common stock purchase
warrants to purchase one million (1,000,000) shares of Parent Common Stock over
a seven year period at an exercise price of $3.00 per share (the “$3.00 Warrants”), (y)
common stock purchase warrants to purchase one million (1,000,000) shares of
Parent Common Stock over a seven year period at an exercise price of $7.00 per
share (the “$7.00
Warrants”), and which vest only if the $7.00 Warrant Condition is
satisfied within three (3) years of the Closing Date, and (z) common stock
purchase warrants to purchase one million (1,000,000) shares of Parent Common
Stock over a seven year period at an exercise price of $5.00 per share (the
“$5.00
Warrants”).
(c) Exercise
of the $7.00 Warrants shall be subject to a performance condition such that the
$7.00 Warrants will not vest and will not become exercisable unless the
Surviving Company secures, prior to the third annual anniversary of the Closing
Date, one or more material binding commercial manufacturing contracts with one
or more third parties, each on an arm’s length basis, which commercial
manufacturing contracts result in aggregate revenues to the Surviving Company in
excess of $5 million per year over a period of at least
3 years and in the reasonable judgment of Parent’s Board of Directors the
manufacturing contracts will be profitable each year during the term of such
contracts in accordance with GAAP (the “$7.00 Warrant
Condition”).
(d) Issuance
of the $3.00 Warrants will not be required nor occur, and all references to the
$3.00 Warrants shall be deemed to be eliminated from this Agreement, if the
Parent Per Share Value is $2.50 or greater (the “$3.00 Warrant
Condition”).
(e) Issuance
of the $5.00 Warrants will not be required nor occur, and all references to the
$5.00 Warrants shall be deemed eliminated from this Agreement, if the Parent Per
Share Value is $1.70 or greater (the “$5.00 Warrant
Condition”).
(f) Transfer
of any shares issued upon exercise of the Warrants will be restricted until the
date one year after the Closing Date pursuant to the terms of the
Warrants. The $7.00 Warrants will vest only if and after the $7.00
Warrant Condition is satisfied. The Warrants otherwise shall be on
customary terms for Parent common stock purchase warrants as set forth in Exhibit C.
(g) PCT
covenants that, prior to the Closing Date, it will cause all PCT Options and PCT
Warrants to have been cancelled or exercised, without liability to PCT or
Parent, so that no amounts will be due to holders of PCT Options and PCT
Warrants unless they exercise such instruments prior to Closing and receive
their portion of the Stock Considerations and Warrants as a Member of
PCT.
Section
3.2 Payments by the
Parent. Upon the terms and subject to the conditions of this
Agreement and on the basis of the representations, warranties and agreements
contained herein, at the Closing, the Parent shall cause its transfer agent to
issue the Stock Consideration in the name of the Escrow Agent, as agent for the
Members, and to deliver the Stock Consideration to the Escrow Agent, to be held
and disbursed by the Escrow Agent pursuant to the terms and conditions of an
escrow agreement in the form and substance of the escrow agreement annexed
hereto as Exhibit B,
subject to such modifications thereof as the Escrow Agent shall reasonably
request prior to the Closing and as shall be accepted by the Parent and PCT
(such acceptance not to be unreasonably denied) (as so modified, the “Escrow
Agreement”). The stock certificates representing such shares
of Parent Common Stock shall bear restrictive legends as set forth in the Escrow
Agreement. Parent also shall issue the Warrants in the name of the
Members. The Escrow Agreement shall prohibit transfers of interests
in the Escrow Account or any of the Stock Consideration, directly or indirectly,
until released from the Escrow Account.
Section
3.3 Adjustment to Total
Consideration.
(a) At
Closing, PCT shall provide the Parent with an estimated balance sheet of PCT’s
Business as of the close of business on the Closing Date (the “Estimated Closing Balance
Sheet”) and a statement of the estimated Adjusted Closing Working Capital
(as defined in Section 3.3(c) below), derived from the Estimated Closing
Balance Sheet (the “Estimated Adjusted Closing
Working Capital”). The Estimated Closing Balance Sheet shall
reflect all payments required to be made by PCT on or as of the Closing Date
(including, without limitation, the PCT Expenses).
(b) If
the Estimated Adjusted Closing Working Capital is less than the Target Working
Capital (as defined below) by more than Two Hundred Fifty Thousand Dollars
($250,000) (the “Collar”) , the Stock
Consideration payable at Closing will be decreased by the amount by which the
Estimated Adjusted Closing Working Capital is less than the Target Working
Capital minus the Collar. The decrease will reduce the Stock
Consideration on a dollar for dollar basis, with each Share of Stock
Consideration valued at the Parent Per Share Value. The “Target
Working Capital” shall be $105,593, exclusive of at least $353,860 of restricted
cash securing the Mortgage (which restricted cash must also be available to the
Surviving Company at Closing) and inclusive of $392,192 of deferred financing
costs. The term “Adjusted Stock
Consideration”, as used in Section 3.3, shall mean the Stock
Consideration as decreased (if at all) by this Section 3.3.
(c) The
Adjusted Stock Consideration shall be further adjusted as provided herein after
the Closing to reflect the difference, if any, between the Adjusted Closing
Working Capital determined pursuant to this Section 3.3(c) and the Estimated
Adjusted Closing Working Capital. “Adjusted Closing Working
Capital” means the Current Assets of PCT’s Business (including cash, cash
equivalents, prepaid expenses and other current assets, and accounts receivable
but, for these purposes, not including the $353,860 of restricted cash or
deferred project costs) less the sum of the Current Liabilities of the Business
(but not included, for these purposes, the following line items: current
maturity of long-term debt, borrowings under line of credit-related party, due
to Amorcyte, Inc. and deferred revenues). Except as otherwise
specified in the definition, each of the elements of Adjusted Closing Working
Capital shall be determined as of the close of business on the Closing Date and
in accordance with GAAP applied consistently with the GAAP Financial Statements
(except that no fair value adjustment required by acquisition accounting shall
be made to any of PCT’s assets or liabilities and for the purposes of this
calculation the above referred to deferred financing costs at Closing shall
remain at $392,192 irrespective of the amortization of deferred financing costs
or cancellation of the warrants) and reflect all payments required to be made by
PCT on or as of the Closing Date (including, without limitation, the PCT
Expenses). Within sixty (60) calendar days following the Closing Date, the
Parent shall deliver to the PCT Representative a balance sheet of PCT’s Business
as of the open of business on the Closing Date (the “Closing Balance
Sheet”) and a statement setting forth the Adjusted Closing Working
Capital derived from the Closing Balance Sheet (the “Adjusted Closing Working
Capital Statement”). To the extent the Parent fails to deliver
the Closing Balance Sheet to the PCT Representative within such sixty (60) day
period, then the Estimated Closing Balance Sheet shall be final, conclusive and
binding on upon all parties.
(d) The
Closing Balance Sheet and the Adjusted Closing Working Capital Statement (and
the computation of the Adjusted Closing Working Capital indicated thereon)
delivered by the Parent to the PCT Representative shall be conclusive and
binding upon the parties unless the PCT Representative, within thirty (30)
calendar days after receipt by the PCT Representative of the Closing Balance
Sheet and the Adjusted Closing Working Capital Statement, notifies the Parent in
writing that the PCT Representative disputes any of the amounts set forth
therein, specifying the nature of the dispute and the basis
therefor. The parties shall in good faith attempt to resolve any
dispute, in which event the Closing Balance Sheet and the Adjusted Closing
Working Capital Statement (and the computation of Adjusted Closing Working
Capital indicated thereon), as amended to the extent necessary to reflect the
resolution of the dispute, shall be conclusive and binding on the
parties. If the parties do not reach agreement in resolving any and
all such disputes within twenty (20) calendar days after notice is given by the
PCT Representative to the Parent pursuant to the second preceding sentence, the
parties shall, within twenty (20) days thereafter, jointly select and engage an
independent accounting firm (other than the Parent’s or the PCT Representative’s
accounting firm) (the “Firm”) to resolve any
remaining disputes regarding the Closing Balance Sheet and the Adjusted Closing
Working Capital Statement. Promptly, but no later than twenty (20)
calendar days after acceptance of its appointment as the Firm, the Firm shall
determine (it being understood that in making such determination, the Firm shall
be functioning as an expert and not as an arbitrator), based solely on written
submissions by the Parent and the PCT Representative, each containing a
computation of Adjusted Closing Working Capital (the final submission made by
the Parent and the PCT Representative to the Firm being referred to herein as
such Party’s “Final
Submission”), and not by independent review, only those issues in dispute
and shall render a written report as to the resolution of the disputes and the
resulting computation of the Adjusted Closing Working Capital. Such
written report shall be conclusive and binding on the parties. All
proceedings conducted by the Firm shall take place in New York, New
York. In resolving any disputed item, the Firm (x) shall be bound by
the provisions of this Section 3.3(d) and (y) may not assign a value to any item
greater than the greatest value for such item claimed by either Party or less
than the smallest value for such item claimed by either Party. The
fees, costs and expenses of the Firm shall be borne solely by the Party whose
calculation of Adjusted Closing Working Capital, as reflected in such Party’s
Final Submission, is furthest in amount, whether positive or negative, from the
amount of Adjusted Closing Working Capital as determined by the
Firm.
(e) Upon
final determination of the Adjusted Closing Working Capital as provided in
Section 3.3(d), if the Adjusted Closing Working Capital is less than the
Estimated Adjusted Closing Working Capital, the Adjusted Stock Consideration
shall be further decreased by the lesser of (i) the excess of the
Estimated Adjusted Closing Working Capital over the Adjusted Closing Working
Capital or (ii) the excess of (x) the Target Working Capital minus the collar
over (y) the Adjusted Closing Working Capital. Parent shall direct
the Escrow Agent to return to Parent, within five (5) Business Days of such
determination, Shares of Parent Stock representing such amount with each Share
of stock valued at the Parent Per Share Value as of the payment
date.
(f)
Upon
final determination of the Adjusted Closing Working Capital as provided in
Section 3.3(d), if the Adjusted Closing Working Capital is greater than the
Estimated Adjusted Closing Working Capital, the Adjusted Stock Consideration
shall be increased by the lesser of (x) the excess of the Adjusted Closing
Working Capital over the Estimated Adjusted Closing Working Capital and (y) the
dollar amount of the adjustment to the Adjusted Stock Consideration made
pursuant to paragraph (b) above (and in any case limited so that the Stock
Consideration may never exceed 11.2 million shares). Parent shall,
within five (5) Business Days of such determination, return to the Escrow Agent
Shares of Parent Stock representing such amount with each Share of stock valued
at the Parent Per Share Value as of the payment date.
(g) PCT
undertakes and covenants to make all payments required in the Ordinary Course of
PCT’s Business through the Closing Date, including the payment of all accounts
payable, the payment of $400,000 to NNJCA and other obligations, when
due. It is understood that payment in the Ordinary Course of PCT’s
Business would not require payment prior to the Closing Date of (i) accounts
payable which are less than 60 days past due as of the Closing Date, and (ii)
accounts payable which are currently in dispute and listed on Schedule 3.3(g); provided,
however, that all expenses of PCT (including those that might be less than 60
days past due at Closing) have been accounted for in the Working Capital
Adjustment. The Surviving Company will obtain the benefit of all cash
and accounts receivable of PCT (including without limitation, approximately
$353,860 held in escrow with TD Bank and all amounts in PCT’s operating
accounts), and will be responsible for all PCT accounts payable incurred in the
Ordinary Course of PCT’s Business subject to Article VIII.
(h) Schedule 3.3(h) lists all
material service agreements to which PCT is currently a party. The
Stock Consideration shall be reduced (and not increased) by an amount equal to
the product of 250,000 shares of Parent Common Stock multiplied by the Net Lost
Agreements. "Net Lost Agreements"
means a number (not less than zero) equal to (i) the number of material service
agreements listed on Schedule
3.3(h) which are terminated prior to the Closing Date, or as to which PCT
receives a notice of termination prior to the Closing Date minus (ii) the number
of comparable new material service agreements entered into and as to which
services are provided by PCT to the counterparty between the date hereof and the
Closing Date.
Section
3.4 Distributions; Exchange Ratio;
Fractional Shares; Adjustments.
(a) Pursuant
to the Voting Agreement, dated as of the date hereof, the Lock-Up Members have
irrevocably agreed to vote in favor of the Merger, the Merger Agreement and the
Escrow Agreement and agreed to certain transfer restrictions with respect to
their membership interests in the Company prior to the Effective
Time.
(b) Each
Member shall receive, for its membership interest in PCT, a percentage of the
Adjusted Stock Consideration and Warrants equal to its membership percentage
interest. At the Closing, PCT shall deliver to the Parent and the
Escrow Agent a certification from Andrew Pecora and Robert Preti with respect to
each Member’s membership percentage interests, which certification shall be
conclusive and binding on the Members (the “Percentage
Certification”).
(c) No
certificates for fractional shares of Parent Common Stock or Warrants to
purchase fractional shares of Parent Common Stock shall be issued. In
lieu of any fractional shares or Warrants to purchase a fractional share to
which the Members would otherwise be entitled as a result of the distributions
provided for herein or in the Escrow Agreement based on the Percentage
Certification, all stock issuances of Parent Common Stock or Warrant amounts
shall be rounded up or down to the nearest whole share, so that no more than the
whole number of shares represented by the Adjusted Stock Consideration and no
more than 1,000,000 Warrants of each class shall ever be issued.
(d) In
the event that, subsequent to the date hereof and prior to the Effective Time,
NeoStem shall declare a stock dividend or other distribution payable in shares
of Parent Common Stock or securities convertible into shares of Parent Common
Stock or effect a stock split, reclassification, combination or other change
with respect to shares of Parent Common Stock, the Adjusted Stock Consideration
and Warrants shall be proportionately adjusted to reflect such dividend,
distribution, stock split, reclassification, combination or other
change.
Section
3.5 Delivery of Certificates to Escrow
Agent. Promptly following the Effective Time, NeoStem shall
deposit with the Escrow Agent, for distribution in accordance with the Escrow
Agreement, certificates representing 11,200,000 shares of the Parent Common
Stock in the name of the Escrow Agent for eventual distribution to the Members
consistent with the Escrow Agreement. So long as any shares of Parent
Common Stock are held in escrow, the Escrow Agreement shall provide that the
shares of Parent Common Stock be voted on any matter presented to the
shareholders of NeoStem by the Escrow Agent as directed by the Board of
Directors of NeoStem.
Section
3.6 Document Deliveries at the
Closing.
(a) Document Deliveries by PCT and the
Members. Upon the terms and subject to the conditions of this
Agreement and on the basis of the representations, warranties and agreements
contained herein, PCT, the other Persons in the PCT Group and/or the Members, as
the case may be, shall execute and deliver, or cause to be executed and
delivered, as the case may be, the following documents at or prior to the
Closing:
(i) The
Certificate of Merger.
(ii) PCT
shall cause its counsel, Epstein Becker, to deliver to Parent and Subco an
opinion of counsel, in the form and substance of the opinion letter annexed
hereto as Exhibit D,
which shall be dated as of the Closing Date.
(iii) PCT
shall execute and deliver to Parent and Subco a certificate of amendment to
PCT’s certificate of formation, if requested by Parent.
(iv) PCT
shall execute and deliver to Parent and Subco a certificate, in form reasonably
satisfactory to the Parent, stating that each of the conditions set forth in
Section 7.2(a), (b) and (c) has been satisfied.
(v) PCT
shall deliver to Parent and Subco evidence of the termination, without any
liability to PCT, Parent or the Surviving Company, of (x) the employment
agreements with key Employees (other than those consented to by Parent on or at
after the date hereof, and (y) those other employment agreements set forth on
Schedule 4.16(a), and
(z) all options, warrants and other rights to acquire equity of PCT, effective
on or prior to the Closing Date, in form and substance reasonably satisfactory
to the Parent.
(vi) PCT
shall deliver releases, in
form and substance satisfactory to the
Parent, duly executed by each of the Key Employees, other officers and Affiliated
Members of PCT, which
unconditionally and irrevocably release, waive and forever discharge the
Parent, Subco, PCT, PCT’s Subsidiaries and each of their past and present members, directors,
officers, employees, agents, predecessors, successors, assigns, Subsidiaries and
Affiliates, from any and all claims, demands, damages, judgments, causes of
action and liabilities of any nature whatsoever, whether or
not known, suspected or claimed, arising directly or indirectly from any act,
omission, event or transaction occurring (or any circumstances existing) with
respect to PCT or any of its Subsidiaries on or prior to the Closing
(collectively, “Employee Claims”), including
without limitation any and all Employee Claims arising out
of or relating to any contract, agreement
or other arrangement (whether written or verbal) with PCT or any of its
Subsidiaries entered into or established prior to the Closing, including any equity purchase agreements,
employment agreements or compensation
arrangements.
(vii) PCT
shall deliver (x) all Permits relating to, or necessary to the conduct of, the
PCT Business by the Surviving Company and proof reasonably satisfactory to
Parent of their continuing validity and (y) proof reasonably satisfactory to
Parent that no modification or assignment of any Material Contract is required
by virtue of the Merger (or an appropriate executed assignment or
modification).
(viii) PCT
shall execute and shall cause the PCT Representative to execute the Escrow
Agreement and deliver it to Parent and the Escrow Agent.
(ix) PCT
shall deliver to Parent forms of letters of transmittal to be sent to the
Members as soon as practical after the Closing. The letters of
transmittal will provide that each Member, as a condition to receipt of its pro
rata portion of the Warrants and the Adjusted Stock Consideration, shall execute
and deliver to the Parent a letter of transmittal (a) providing the Parent and
its transfer agent with its address, tax identification number and other
information reasonably requested, (b) releasing PCT and the Parent from all
claims other than claims pursuant to this Agreement, and (c) acknowledging that
their shares of Parent Common Stock are subject to the Escrow Agreement and the
appointment of the PCT Representative. If any Member has not
delivered an acceptable letter of transmittal to the Parent within two (2) years
after the Closing Date (i.e. upon the date when all shares of Parent Common
Stock would be released by the Escrow Agent unless held for then pending
disputes), the Escrow Agent may be directed by the Parent and the PCT
Representative to return such shares to Parent for cancellation.
(x) PCT
shall deliver to Parent an affidavit of non-foreign status of PCT dated as of
the Closing Date that complies with section 1445 of the Code.
(b) Document Deliveries by
Parent. Upon the terms and subject to the conditions of this
Agreement and on the basis of the representations, warranties and agreements
contained herein, Parent and Subco shall execute and deliver the following
documents at or prior to the Closing:
(i) Parent
and Subco shall execute and deliver to PCT a certificate, in form reasonably
satisfactory to PCT, stating that each of the conditions set forth in Section
7.3(a) has been satisfied.
(ii) Parent
shall execute and deliver the Escrow Agreement to PCT and the Escrow
Agent.
Section
3.7 Allocation of the Consideration.
Following the Closing, the Parent shall determine the final tax
allocation of the Adjusted Stock Consideration and Warrants and shall provide
the PCT Representative with such tax allocation. The PCT
Representative shall have the opportunity to review and evaluate such
allocation. Unless the PCT Representative reasonably objects to such
allocation, the Parent and the PCT Representative agree that such tax allocation
will be binding on all parties for federal income tax purposes in connection
with the Merger and will be consistently reflected by each party on its
respective income Tax Returns. The Parent and PCT agree to prepare
and timely file all applicable Internal Revenue Service forms, including Form
8594 (Asset Acquisition Statement), and other governmental forms, to cooperate
with each other in the preparation of such forms and to furnish each other with
a copy of such forms prepared in draft, within a reasonable period prior to the
filing due date thereof. In the event the PCT Representative
reasonably objects to such allocation, the Parent shall engage a third party
accounting firm, which is reasonably acceptable to the PCT Representative to
provide advice on the tax allocation. Such allocation will then be
binding on all parties.
Section
3.8 Insurance. Prior
to Closing, PCT
shall cause the Parent to be named as an additional insured on all insurance
policies existing as of the date of this Agreement (true and complete copies of
which have been previously provided to the Parent) and/or purchase such new or
amended insurance coverages as are acceptable to Parent in its reasonable
discretion after discussions with its insurance agents.
ARTICLE
IV
Representations
and Warranties of PCT
Except as
set forth in the correspondingly numbered section of the disclosure schedule
delivered by PCT to the Parent and Subco prior to the execution of this
Agreement (the “Company Disclosure
Letter”), PCT represents and warrants to the Parent and Subco as follows
(after review by each member of the Knowledge Group):
Section
4.1 Organization, Good Standing and
Qualification. PCT and each of its Subsidiaries is a limited liability
company or corporation duly organized, validly existing and in good standing
under the laws of its respective state of formation, with full power and
authority to own or lease its property and assets and to carry on the PCT
Business as presently conducted, and is duly qualified to do business as a
foreign limited liability company or corporation and is in good standing in each
jurisdiction where the failure to be so qualified would have a Material Adverse
Effect. Schedule
4.1 lists each jurisdiction in which PCT and each Subsidiary is so
qualified. The only Subsidiaries of PCT are PCT Allendale, DomaniCell
and Athelos Corporation.
Section
4.2 Authorization. PCT
has full power and authority to execute and deliver this
Agreement. PCT has full power and authority to execute and deliver
each other PCT Document to be executed by it, and to consummate the transactions
contemplated by the PCT Documents. The execution, delivery and
performance by PCT of this Agreement and the execution, delivery and performance
by PCT of the other PCT Documents to be executed by PCT have been duly
authorized by all necessary action on behalf of PCT. This Agreement has been,
and each other PCT Document will be at or prior to the Closing, duly executed
and delivered by PCT and, if applicable, the appropriate Subsidiaries or
Members, and (assuming the due authorization, execution and delivery by the
other parties hereto and thereto) this Agreement constitutes, and each other PCT
Document when so executed and delivered will constitute, the legal, valid and
binding obligation of PCT and, if applicable, its Subsidiaries and Members,
enforceable against PCT and, if applicable, its Subsidiary and Members in
accordance with its terms, subject to applicable bankruptcy, insolvency,
reorganization, moratorium and similar laws affecting creditors’ rights and
remedies generally, and subject, as to enforceability, to general principles of
equity, including principles of commercial reasonableness, good faith and fair
dealing (regardless of whether enforcement is sought in a proceeding at law or
in equity) (the “Bankruptcy/Equity
Exception”). The Members executing the Voting Agreement own
over 51% of the Membership Interests of PCT, have the authority to grant all
consents of Members required with respect to this Agreement and will grant such
consents at the PCT Special Meeting pursuant to the Voting
Agreement.
Section
4.3 Non-contravention. Neither
the execution or delivery by PCT and, if applicable, the Subsidiaries or any
Members, of this Agreement nor the other PCT Documents referred to herein nor
the performance by PCT or, if applicable, the Subsidiaries or any Members of
their obligations hereunder and thereunder will (i) contravene any provision
contained in the certificate of formation, PCT LLC Agreement or other
organizational documents of PCT or any Subsidiary, (ii) violate or result in a
breach (with or without the lapse of time, the giving of notice or both) of or
constitute a default under (A) any Material Contract or (B) any judgment, order,
decree, law, rule or regulation or other restriction of any Governmental
Authority, in each case to which any entity within the PCT Group or any of the
Members is a party or by which any entity within the PCT Group or any of the
Members is bound or to which any of the assets or properties of any entity
within the PCT Group are subject, (iii) result in the creation or imposition of
any lien, claim, charge, encumbrance, equity, restriction or right on any of the
assets or properties of any entity within the PCT Group, or (iv) result in the
acceleration of, or permit any Person to accelerate or declare due and payable
prior to its stated maturity, any Liability of any Person in the PCT Group
(except where the result of such acceleration would not cause a Material Adverse
Effect).
Section
4.4 No
Consents. Except as set forth in Schedule 4.4, no notice to,
filing with, or authorization, registration, consent or approval of, any
Governmental Authority or other Person is necessary for the execution, delivery
or performance of this Agreement or any other PCT Document or the consummation
of the transactions contemplated hereby or thereby by PCT or, to the extent
applicable, the Members, except for the Proxy Statement/Prospectus to be filed
with the SEC on Form S-4.
Section
4.5 PCT Assets. PCT
has good title to, or leasehold interest in, all properties and assets (real,
personal or mixed, tangible or intangible) which are used or held for use in the
conduct of the PCT Business. No third party (including any Affiliate
of PCT other than the Subsidiaries) owns or has any interest by lease, license
or otherwise in any of assets.
Section
4.6 Personal
Property. PCT has delivered to the Parent true, correct and
complete copies of the all leases of personal property used in the PCT Business,
together with all amendments, modifications or supplements
thereto. Each of such leases is in full force and effect and none of
the Persons in the PCT Group has received or given any notice of any default or
event that with notice or lapse of time, or both, would constitute a default by
any of the Persons in the PCT Group under any of such leases and, to the
Knowledge of PCT, no other party is in default thereof. All material
items of personal property used in the PCT Business are in good operating
condition and fit for operation in the Ordinary Course of PCT’s Business
(subject to normal wear and tear) with no defects that could reasonably be
expected to interfere with the conduct of the normal operation of such items and
are suitable for the purposes for which they are currently being
used.
Section
4.7 Real Property.
(a) Schedule 4.7 sets forth a
true, correct and complete list of all real property and interests in real
property owned in fee by the PCT Group (an “Owned Property”) or
leased by the PCT Group (a “Leased Property”) and
used, held for use or intended to be used primarily in the operation or conduct
of the PCT Business, and identifies the landlord of any Leased Property and any
material reciprocal easement or operating agreements of PCT relating and/or
beneficial thereto.
(b) The
applicable Person in the PCT Group has good and marketable fee title to all
Owned Property or a valid leasehold interest in all Leased Property (an Owned
Property or Leased Property being sometimes referred to herein, individually, as
a “Business
Property”), in each case free and clear of all Liens, except (i) the Real
Estate Mortgage Loan, (ii) easements, covenants, rights of way and other similar
restrictions of record, (iii) any conditions that may be shown by a current,
accurate American Land Title Association survey or physical inspection of any
Business Property made prior to Closing and (iv) zoning, building and other
similar restrictions. None of the items set forth in clauses (ii),
(iii) or (iv) above, individually or in the aggregate, could reasonably be
expected materially to impair the continued use and operation of the property to
which they relate in the conduct of the Business as presently
conducted.
(c) There
(i) is adequate access between each Business Property and public roads, and
there are no pending or, to PCT’s Knowledge, threatened Legal Proceedings that
could have the effect of impairing or restricting such access, (ii) are
sufficient parking spaces on each Business Property to comply with all
applicable provisions of any agreements to which such Business Property is
subject, local zoning requirements and all other Applicable Laws, (iii) are no
material defects in the roof, foundation, sprinkler mains, structural,
mechanical and HVAC systems and masonry walls in any of the improvements upon
each Business Property, no significant repairs thereof are required, and all
periodic maintenance has been done and is being done consistent with
commercially reasonable maintenance standards for real property of similar size
and age in the vicinity of such Business Property.
(d) PCT
has made available to Parent true, legible and complete copies of all title
insurance policies, title reports, surveys, certificates of occupancy,
appraisals, permits, Liens, title documents, leases and other documents relating
to or otherwise affecting each Business Property which are in the possession of
PCT. The copies of the leases to all Leased Properties provided by
PCT are correct and complete in all material respects, and no oral
understandings exist with respect to any Leased Property not reflected in the
written materials supplied by PCT. The leases to all Leased
Properties, including all renewals, extensions, modifications or supplements to
any of the foregoing or substitutions for any of the foregoing, are valid and in
full force and effect, without default (or event which with notice or passage of
time or both would constitute a default) on the part of PCT or to its Knowledge
any other party to such leases. PCT is in peaceful and undisturbed
possession of the respective Business Property, and has no Knowledge of any
contractual or legal restrictions that preclude or restrict in any material way
the ability to use any Business Property for the purposes for which it is
currently being used. No Person other than PCT has any right to the
use, occupancy or enjoyment of any Business Property or any portion
thereof. To PCT’s Knowledge, there are no material defects and there
are no adverse physical conditions affecting any Business Property or any of the
facilities, buildings, structures, erections, improvements, fixtures, fixed
assets and personality of a permanent nature annexed, affixed or attached to,
located on or forming part of any Business Property that materially interfere
with the use of such Business Property for the purposes for which it is
currently being used. To PCT's Knowledge, there is no material
violation of any Applicable Law (including any building, planning or zoning Law)
relating to any Business Property materially affecting the current use or
operation of the Business. All Business Property is in material
compliance with all applicable deed restrictions and covenants and all
applicable building, zoning, subdivision, health, safety and other laws,
including the Americans with Disabilities Act and the Occupational Safety and
Health Act, and no Person in the PCT Group has received notification of any
alleged violation.
(e) All
brokerage commissions and other similar compensation and fees payable in
connection with any Business Property have been paid in full by PCT and no
additional brokerage commissions or other similar compensation and fees are or
will be due in the future thereunder. Since January 1, 2009, PCT has
not exercised or given any notice of exercise of any option or right pertaining
to the purchase, expansion, renewal, extension, termination or relocation of any
Leased Properties. All leases for Leased Properties will continue to
be legal, binding, and enforceable and in full force and effect immediately
following the Closing Date in accordance with the terms in effect immediately
prior to the Closing Date.
(f) Neither
the whole nor any portion of any Business Property is subject to any
governmental decree or order to be sold nor have any Legal Proceedings for the
condemnation, expropriation or other taking of all or any portion of any
Business Property been instituted or, to PCT's Knowledge, threatened by any
Governmental Entity, with our without payment therefor.
(g) Each
Business Property is occupied under a valid and current certificate of occupancy
or similar permit and, to PCT’s Knowledge, there are no facts that would prevent
such Business Property from continuing to be occupied and used by the PCT Group
after the Closing in the same manner as occupied and used by the PCT Group
immediately prior to the Closing.
(h) To
PCT’s Knowledge, no improvements on any Owned Property and none of the current
uses and conditions thereof violate in any material respect any Liens,
applicable deed restriction or other applicable covenant, restriction, contract,
existing site plan approval, zoning or subdivision regulation or urban
redevelopment plan as modified by any duly issued variances.
(i) All
buildings, improvements and facilities located on each Business Property are
supplied with utilities and other services necessary for the operation thereof
(including, but not limited to, gas, electricity, water, sanitary sewer and
storm sewer) and all of such services are in all material respects adequate for
the current use or operation of the Business.
(j) All
real estate Taxes for which any Person in the PCT Group is responsible with
respect to any Business Property (and which are not otherwise incorporated into
payments made under any lease), have been paid in full, as and when
due.
(k) The
sole asset of PCT Allendale is the Owned Property in Allendale, New
Jersey.
Section
4.8 Absence of Questionable
Payments. No Person in the PCT Group nor any Affiliate,
director, officer, manager, member, partner, employee, agent, representative or
other Person acting on behalf of the PCT Group has: (i) used any funds for
contributions, payments, gifts or entertainment, or made any expenditures
relating to political activities of foreign, federal, state or local government
officials or others in violation of any Law (including the Foreign Corrupt
Practices Act of 1977, as amended), or (ii) accepted or received any unlawful
contributions, payments, gifts or expenditures.
Section
4.9 Financial Statements; Books and
Records; Accounts Receivable; Funded Indebtedness.
(a) Attached
as Schedule 4.9(a) is
(i) a true and complete copy of PCT’s unaudited consolidated balance sheet as of
June 30, 2010 (the “Balance Sheet Date”)
and June 30, 2009 and the related unaudited consolidated statements of
operations, changes in member’s deficit and cash flows for the six month periods
then ended and (ii) a true and complete copy of PCT’s audited balance sheet as
of December 31, 2009 and December 31, 2008 and the related audited statements of
operations, changes in member’s deficit and cash flows for each of the years
ended December 31, 2007, December 31, 2008 and December 31, 2009, prepared in
accordance with GAAP, together with the report of EisnerAmper LLP ("EisnerAmper"), which
has served as PCT’s auditors since the audit of its 2007 financial statements
(such statements, including the related notes and schedules thereto, are
referred to herein as the “GAAP Financial
Statements”). The GAAP Financial Statements have been
prepared from, are in accordance with, and accurately reflect, the books and
records of PCT, comply in all material respects with applicable accounting
requirements in the case of the GAAP Financial Statements; fairly present in all
material respects the financial position and the results of operations and cash
flows (and changes in financial position, if any) of PCT as of the times and for
the periods referred to therein (subject, in the case of unaudited statements,
to normally recurring year end adjustments that are not material either
individually or in the aggregate and the absence of footnotes). The
GAAP Financial Statements have been prepared in accordance with GAAP applied on
a consistent basis during the periods involved (except as set forth in the notes
thereto). The GAAP Financial Statements are in form appropriate for
filing with the Securities and Exchange Commission.
(b) All
books, records and accounts of the PCT Group are accurate and complete in all
material respects and are maintained in all material respects in accordance with
good business practice and all applicable Laws.
(c) Schedule 4.9(c) sets forth a
true and complete listing of all of the PCT Group’s Accounts Receivable as of
last day of the most recently completed calendar month and an aging schedule
reflecting the aggregate amount of all such Accounts Receivable outstanding (i)
30 days or less, (ii) more than 30 days but not more than 60 days, (iii) more
than 60 days but not more than 90 days, and (iv) more than 90
days. All of the PCT Group’s Accounts Receivable have arisen in the
ordinary and regular course of business, represent bona fide transactions with
third parties and to PCT’s Knowledge are not subject to any counterclaims or
offsets (except for those for which adequate reserves have been established in
accordance with GAAP in preparing the GAAP Financial Statements) and have been
billed in the Ordinary Course of PCT’s Business. PCT is not
guaranteeing collection of the Accounts Receivable.
(d) Neither
PCT nor any of its Subsidiaries has any funded Indebtedness other than
Indebtedness being satisfied in full at Closing (or shortly thereafter with
respect to up to $3 million due to NNJCA) and the Real Estate Mortgage
Loan. The Merger will not cause the Real Estate Mortgage Loan to be
taxable or violate any rules or regulations of the New Jersey Economic
Development Authority.
(e) EisnerAmper
who has certified PCT’s GAAP Financial Statements and related schedules is an
independent registered public accounting firm with respect to PCT as required by
the Securities Act of 1933 (the "Securities Act") and
the Rules and Regulations and the Public Company Accounting Oversight Board
(United States).
(f) There
are no relationships or services, or any other factors that may affect the
objectivity and independence of EisnerAmper, PCT’s auditors, under applicable
auditing standards. EisnerAmper has not performed any non-audit services for any
Person in the PCT Group since the Balance Sheet Date.
Section
4.10 Internal Control over Financial
Reporting. PCT maintains a system of internal control over
financial reporting that is reasonably designed to ensure (i) that PCT maintains
records that in reasonable detail accurately and fairly reflect its transactions
and dispositions of assets, (ii) that transactions are recorded as necessary to
permit preparation of financial statements in conformity with GAAP, (iii) that
receipts and expenditures are executed only in accordance with authorizations of
management and the Board of Managers and (iv) the prevention or timely detection
of the unauthorized acquisition, use or disposition of PCT’s assets that would
have a material effect on PCT’s consolidated financial
statements. PCT maintains disclosure controls and procedures which
are designed to ensure that all material information concerning the PCT Group is
made known on a timely basis to the individuals responsible for the preparation
of its financial statements. Neither PCT nor EisnerAmper has
identified any material weaknesses or significant deficiencies in the design or
operation of PCT’s internal control over financial reporting or its disclosure
controls and procedures.
Section
4.11 Capitalization;
Votes.
(a) The
authorized and outstanding equity interests of PCT are set forth in Schedule
4.11(a). No other capital stock or other equity interests of
PCT is authorized, issued or outstanding. All equity interests
outstanding are duly authorized, validly issued, fully paid and
non-assessable. None of the holders of outstanding equity interests
of PCT have rescission or pre-emptive rights. Except as set forth on Schedule
4.11(a), none of the equity interests issued by PCT were issued in violation of
any registration requirements under federal or state securities
laws. Except as set forth on Schedule 4.11(a), there are no
options, warrants, or other rights, agreements, arrangements, or commitments to
which PCT or any member or other equity holder of PCT is a party or by which any
such party is bound obligating PCT or the member or equity holder of PCT to
grant, issue, or sell any capital stock or any other equity interest in
PCT. All such options, warrants and other rights may be cancelled
effective as of the Closing Date by PCT without cost to PCT or
Parent.
(b) Except
for the Limited Liability Company Agreement of PCT dated as of October 7, 2004
(the “PCT LLC
Agreement”), there are no voting trusts or other agreements or
understandings to which any of the Members or other equity holders of PCT or PCT
is a party with respect to the voting of the equity interests of
PCT.
(c) This
Agreement and the Merger have been unanimously approved by PCT’s Board of
Managers, who have recommended that it be approved by the
Members. Members of PCT representing a majority of the outstanding
Membership Interests of PCT, and a majority of the Membership Interests held by
the Charter Members (collectively, the “Lock-Up Members”)
have agreed to enter into, and will enter into promptly after execution and
delivery of this Merger Agreement, the Voting Agreement annexed hereto as Exhibit A, under which such
Members irrevocably agree to vote in favor of the Merger and the other
transactions contemplated hereby (the “Voting
Agreement”). Such Member votes or consents will be sufficient
without any other votes or consents to approve this Agreement, this Merger and
all the transactions contemplated hereby under the PCT LLC Agreement, the DLLCA
and all applicable law, and no other approvals or Member votes or consents are
required to consummate the Merger. To PCT's Knowledge, the provisions
of the Voting Agreement are legal, valid and binding obligations of the Lock-Up
Members subject to the Bankruptcy/Equity Exception.
(d) No
Member will have dissenters or appraisal rights with respect to the Merger or
the other transactions contemplated by this Agreement.
Section
4.12 No Undisclosed
Liabilities. The PCT Group does not have any debt, loss,
damage, adverse claim, liability or obligation (whether direct or indirect,
known or unknown, asserted or unasserted, absolute or contingent, accrued or
unaccrued, liquidated or unliquidated, or due or to become due, and whether in
contract, tort, strict liability or otherwise) which are not accurately
reflected or provided for in the balance sheet dated as of the Balance Sheet
Date included within the GAAP Financial Statements (whether or not they are
required to be disclosed under GAAP), other than (a) those incurred in the
Ordinary Course of PCT’s Business since the Balance Sheet Date and (b) those
material obligations arising subsequent to the date hereof pursuant to the
express terms of executory Contracts, which executory Contracts (to the extent
such Contracts are Material Contracts) are identified in Schedule
4.16(a). No Person in the PCT Group has effected any
securitization transactions or “off-balance sheet arrangements” (as defined in
Item 303(c) of Regulations S-K of the SEC) since January 1,
2007.
Section
4.13 Absence of Certain
Developments. Except as set forth in Schedule 4.13; since December
31, 2009: (a) each Person in the PCT Group has conducted its businesses only in
the Ordinary Course of PCT’s Business; (b) there has not been any event, change,
occurrence, development, circumstance or state of facts that has had or could
reasonably be expected to have a Material Adverse Effect; (c) the PCT Group has
not suffered any damage, destruction or casualty loss which individually or in
the aggregate materially and adversely affects the business, financial condition
or results of operations of PCT; (d) no Person in the PCT Group has incurred or
discharged any material obligation or liability except in the Ordinary Course of
PCT's Business; and (e) PCT has not entered into any material transaction or
made any material expenditures or commitments other than in the Ordinary Course
of PCT’s Business.
Section
4.14 Taxes
(a) All
Tax Returns required to be filed by or on behalf of PCT and each of its
Subsidiaries have been duly and timely filed with the appropriate Taxing
Authority in all jurisdictions in which such Tax Returns are required to be
filed (after giving effect to any valid extensions of time in which to make such
filings), and all such Tax Returns are true, complete and correct in all
material respects. All Taxes payable by or on behalf of PCT and each
of its Subsidiaries (whether or not shown on any Tax Return) have been fully and
timely paid. With respect to any period for which Tax Returns have
not yet been filed or for which Taxes are not yet due or owing, PCT has made due
and sufficient accruals for such Taxes in the GAAP Financial Statements and in
its books and records. All required estimated Tax payments sufficient
to avoid any underpayment penalties or interest have been made by or on behalf
of PCT and each of its Subsidiaries. PCT and each of its Subsidiaries
has complied in all material respects with all applicable Laws relating to the
payment and withholding of Taxes in connection with amounts paid or owing to any
employee, independent contractor, creditor, equity owner or other third party
and has duly and timely withheld and paid over to the appropriate Taxing
Authority all amounts required to be so withheld and paid under all applicable
Laws.
(b) PCT
has delivered to the Parent complete copies of (i) all federal, state, local and
foreign income or franchise Tax Returns of PCT and each of its Subsidiaries
relating to the taxable periods since January 1, 2005 and (ii) any audit report
issued within the last three years relating to any Taxes due from or with
respect to PCT and each of its Subsidiaries. Schedule 4.14 lists each such
audit. To PCT’s Knowledge, there are no audits or investigations of
PCT or any of its Subsidiaries by any Taxing Authority in progress, nor has PCT
or any of its Subsidiaries received any notice from any Taxing Authority that it
intends to conduct such an audit or investigation. No claim has been
made by a Taxing Authority in a jurisdiction where PCT and its Subsidiaries do
not file Tax Returns to the effect that PCT or any of its Subsidiaries are or
may be subject to taxation by that jurisdiction. There are no Liens
on any of the assets of PCT or any of its Subsidiaries arising as a result of
any failure (or alleged failure) to pay any Tax. PCT and each of its
Subsidiaries has disclosed on their federal income Tax Returns all positions
taken therein that could give rise to substantial understatement of federal
income Tax within the meaning of Section 6662 of the Code, and neither PCT nor
any of its Subsidiaries has participated in a “reportable transaction” within
the meaning of Treasury Regulation Section 1.6011-4(b).
(c) Neither
PCT nor any of its Subsidiaries (i) requested any extension of time within which
to file any Tax Return, which Tax Return has since not been filed, (ii) granted
any extension for the assessment or collection of Taxes, which Taxes have not
since been paid, or (iii) granted to any Person any power of attorney that is
currently in force with respect to any Tax matter (other than to the tax matters
partner under the PCT LLC Agreement). Neither PCT nor any of PCT’s
Subsidiaries is a foreign person within the meaning of Sections 7701(a)(1) and
7701(a)(5) of the Code. Neither PCT nor any of its Subsidiaries has
ever been a member of any consolidated, combined, affiliated or unitary group of
corporations for any Tax purposes. Neither PCT nor any of its
Subsidiaries is a party to any Tax allocation or Tax sharing agreement nor has
any liability for the Taxes of any Person under Treasury Regulation Section
1.1502-6(a) (or any predecessor or successor thereof of any analogous or similar
provision under Law), as a transferee or successor, by contract, or
otherwise.
(d) Neither
PCT nor any of its Subsidiaries has made any payments, is obligated to make any
payments, or is a party to any agreement that obligates it to make any payments
that are not deductible under Section 280G of the Code. Neither PCT
nor any of its Subsidiaries has been a United States real property holding
corporation within the meaning of Section 897(c)(2) of the Code during the
applicable period specified in Section 897(c)(1)(a)(ii) of the
Code.
(e) PCT
and all of its Subsidiaries have been, since inception, treated as partnerships
or as disregarded entities for federal, state, and local income tax
purposes.
Section
4.15 Intellectual
Property.
(a) Schedule 4.15(a) sets forth an
accurate and complete list of the PCT Group Intellectual Property as
follows: (i) all Patents, Marks and Copyrights owned by the PCT Group
that have been issued or registered in any jurisdiction, or for which an
application to issue or register the rights in such Intellectual Property has
been filed in any jurisdiction, (ii) all Marks owned by the PCT Group that are
material to the Business but that are not registered or subject to an
application to register and (iii) all Software that is owned exclusively by the
PCT Group that is material to the operation of the PCT Business as presently
conducted and presently proposed to be conducted by the PCT
Group. Schedule
4.15(a) lists the jurisdictions in which each such item of Intellectual
Property has been issued or registered or in which any such application for such
issuance and registration has been filed, and the name of the owner of each such
registration or application. Schedule 4.15(a) also lists
any Patents owned by Amorcyte and Robert Preti or otherwise owned by an
Affiliate of PCT which is totally unrelated to the PCT Business.
(b) PCT
owns or possesses adequate rights to use all Intellectual Property necessary to
carry on the PCT Business. The PCT Group has taken all steps
necessary to perfect its ownership of and interest in the PCT Group Intellectual
Property.
(c) The
PCT Group’s products and services, and the conduct of the
PCT Business as presently conducted do not infringe, violate or
constitute an unauthorized use or misappropriation of any Intellectual Property
Right or other similar right, or any contractual right, of any
Person.
(d) Each
item of the PCT Group Intellectual Property that has been issued and registered
in any jurisdiction by PCT is valid and subsisting, all necessary registration,
maintenance and renewal fees currently due in connection with such registered
PCT Group Intellectual Property have been paid and all necessary documents and
certificates in connection with such registered PCT Group Intellectual Property
owned by the PCT Group have been filed with the relevant patent, copyright,
trademark or other authorities in the United States or foreign jurisdictions, as
the case may be, for the purposes of maintaining such registered PCT Group
Intellectual Property.
(e) Except
as set for in Schedule 4.15(e), no other Person has
any rights to any material PCT Group Intellectual Property owned by the PCT
Group.
(f) Except
with respect to licenses of generally available, commercial, off-the-shelf
Software licensed pursuant to standardized end-user or enterprise licenses for
Software in object code format available for a license fee of no more than
$5,000 (collectively, “Off-The-Shelf
Software”), and except pursuant to the Intellectual Property Licenses
listed in Schedule
4.15(f) or as reflected in the GAAP Financial Statements, the PCT Group
is not under any liability whatsoever to make any payments or provide any other
consideration, to any Person with respect to the PCT Group’s use of any
Intellectual Property in connection with the conduct of the PCT Business as
presently conducted.
(g) Schedule 4.15(g) sets forth a
complete and accurate list of all Contracts to which the Persons in the PCT
Group are a party (other than licenses to the PCT Group of
Off-The-Shelf-Software) that (i) grant any Intellectual Property Licenses to or
from the PCT Group, (ii) contain a covenant not to compete or otherwise limit
the PCT Group’s ability to use or exploit fully any of the PCT Group
Intellectual Property, or (iii) contain an agreement by any of the Persons in
the PCT Group to indemnify any other Person against any claim of infringement
of, violation, misappropriation or unauthorized use of any intellectual property
rights of any third Person. PCT has delivered to the Parent true,
correct and complete copies of each Contract set forth on Schedule 4.15(g), together
with all amendments, modifications or supplements thereto. All
Intellectual Property Licenses are valid, binding and enforceable agreements,
subject to the Bankruptcy/Equity Exception.
(h) The
PCT Group has taken all commercially reasonable steps to protect the secrecy and
confidentiality of all Trade Secrets of any Person in the PCT
Group.
(i) The
PCT Group is not, or has not been at any time during the five (5) years prior to
the date hereof, the subject of any pending or, to the Knowledge of PCT,
threatened Legal Proceedings which involve a claim of infringement,
misappropriation, unauthorized use or violation of any intellectual property
rights of any Person, or challenging the PCT Group’s ownership, use, validity or
enforceability of any Intellectual Property. None of the Persons in
the PCT Group has received notice of any such threatened claim and to the
Knowledge of PCT, there are no facts or circumstances that would form the basis
for any such claim. To PCT’s Knowledge, all of the PCT Group’s rights
in and to PCT Group Intellectual Property are valid and enforceable in all
material respects.
(j) To
the Knowledge of PCT, no Person is infringing, violating, misusing or
misappropriating any PCT Group Intellectual Property, and no claims of such
infringements, violations, misuse or misappropriations have been made against
any Person by any of the Persons in the PCT Group.
(k) No
present or former employee of the PCT Group has any right, title, or interest,
directly or indirectly, in whole or in part, in any PCT Group Intellectual
Property owned or used by any of the Persons in the PCT Group. To the
Knowledge of PCT, no employee, consultant or independent contractor of any of
the Persons in the PCT Group is, as a result of or in the course of such
employee’s, consultant’s or independent contractor’s engagement by any of the
Persons in the PCT Group, in default or breach of any material term of any
employment agreement, non-disclosure agreement, assignment of invention
agreement or similar agreement. Each employee of and consultant to
the PCT Group is bound by a non-disclosure and assignment of inventions
agreement, copies of which have been made available to the Parent.
(l) Each
Person in the PCT Group has at all times complied in all material respects with
all applicable Laws, as well as their own rules, policies, and procedures,
relating to privacy, data protection, and the collection and use of personal
information collected, used, or held for use by the PCT Group in the conduct of
the PCT Business. No claims have been asserted or, to PCT’s
Knowledge, threatened against any Person in the PCT Group alleging a violation
of any Person’s privacy or personal information or data rights and the
consummation of the transactions contemplated hereby will not breach or
otherwise cause any violation of any Law or rule, policy, or procedure related
to privacy, data protection, or the collection and use of personal information
collected, used, or held for use by the PCT Group in the conduct of the PCT
Business. Each Person in the PCT Group takes reasonable measures to
ensure that such information is protected against unauthorized access, use,
modification, or other misuse.
Section
4.16 Material
Contracts.
(a) Schedule 4.16(a) sets forth
all of the following Contracts to which any of the Persons in the PCT Group is a
party or by which any of them or their respective assets or properties are bound
(collectively, the “Material
Contracts”):
(i) Contracts
with any current or former officer, director, partner, member, manager,
stockholder or Affiliate of any Person in the PCT Group;
(ii) Contracts
for the sale of any of the assets of any of the Persons in the PCT Group other
than in the Ordinary Course of PCT’s Business;
(iii) Contracts
for joint ventures, strategic alliances, partnerships, licensing arrangements or
sharing of profits or proprietary information;
(iv) Contracts
containing covenants of any Person in the PCT Group not to compete in any line
of business or with any Person in any geographical area or not to solicit or
hire any individual with respect to employment or covenants of any other Person
not to compete with any of the Persons in the PCT Group in any line of business
or in any geographical area or not to solicit or hire any Person with respect to
employment;
(v) Contracts
relating to the acquisition (by merger, purchase of stock or assets or
otherwise) by any Person in the PCT Group of any operating business or material
assets or the capital stock or other equity interests of any other
Person;
(vi) Contracts
relating to the incurrence, assumption or guarantee of any Indebtedness or
imposing a Lien on any assets of the PCT Group, including indentures,
guarantees, loan or credit agreements, purchase money obligations incurred in
connection with the acquisition of property, pledge agreements and security
agreements;
(vii) Contracts
entered into outside of the Ordinary Course of PCT’s Business providing for the
license of the PCT Group Products or the provision of services by any Person in
the PCT Group;
(viii) Contracts
providing for severance, retention, change in control or other similar
payments;
(ix) Contracts
for the employment of any individual on a full-time, part-time or consulting or
other basis;
(x) outstanding
agreements of guaranty or surety, direct or indirect, by any of the Persons in
the PCT Group;
(xi) Contracts
providing for indemnification by any of the Persons in the PCT Group arising out
of or in connection with any PCT Product or service provided by any of the
Persons in the PCT Group;
(xii) Contracts
(or group of related contracts) which involve the expenditure or receipt of more
than $50,000 annually or which require performance by any party more than one
year from the date hereof;
(xiii) Contracts
for the lease of Business Property, including, without limitation, the Real
Property Leases;
(xiv) Contracts
pursuant to which any Person in the PCT Group provides services to any third
party related to the conduct of the PCT Business, including all customer or
client Contracts;
(xv) Contracts
and agreements related to obtaining materials and services used in the
manufacture of Cell Therapy Products and other material supplier
Contracts;
(xvi) Contracts
with any Person that require PCT to deal exclusively with such Person or that
require PCT to transact a minimum amount of business with such Person (or
provide for negative consequences if PCT fails to do either of the foregoing) or
that give any Person "most favored nations" treatment;
(xvii) powers
of attorney given by any Person within the PCT Group;
(xviii) confidentiality
agreements, assignments of invention and non-compete or non-solicitation
agreements signed by employees of or consultants to any Person in the PCT
Group;
(xix) Contracts
involving licenses of any Intellectual Property; and
(xx) Contracts
that are otherwise material to any of the Persons in the PCT Group.
(b) Each
of the Material Contracts is in full force and effect and is the legal, valid
and binding obligation of the Person in the PCT Group signatory thereto,
enforceable against them in accordance with its terms, subject to the
Bankruptcy/Equity Exception. None of the Persons in the PCT Group is
in material default under any Material Contract, nor, to the Knowledge of PCT,
is any other party to any Material Contract in material default thereunder, and
no event has occurred that with the lapse of time or the giving of notice or
both would constitute a material default thereunder. No party to any
of the Material Contracts has exercised any termination rights with respect
thereto, and, to PCT’s Knowledge, no party has given notice of any significant
dispute with respect to any Material Contract. PCT has delivered to
the Parent true, correct and complete copies of all of the Material Contracts,
together with all amendments, modifications or supplements
thereto. If consent is required for the transfer of any Material
Contract, PCT has no Knowledge that any counterparty will not or can not provide
such a consent.
Section
4.17 Employee Benefits
Plans.
(a) Schedule 4.17(a) sets forth a
correct and complete list of (i) all employee welfare benefit plans (as defined
in Section 3(1) of ERISA, (ii) all
employee pension benefit plans (as defined in Section 3(2) of ERISA) and
(iii) all other employee benefit plans, programs, policies, agreements or
arrangements, including any deferred compensation plan, incentive plan, bonus
plan or arrangement, stock option plan, stock purchase plan, stock award plan or
other equity-based plan, change in control agreement, retention, severance pay
plan, dependent care plan, sick leave, disability, death benefit, group
insurance, hospitalization, dental, life, any fund, trust or arrangement
providing health benefits including a multiemployer welfare arrangement, a
multiple employer welfare fund or arrangement, cafeteria plan, employee
assistance program, scholarship program, employment contract, retention
incentive agreement, termination agreement, severance agreement, noncompetition
agreement, consulting agreement, confidentiality agreement, vacation policy,
employee loan, or other similar plan, agreement or arrangement, whether written
or oral, funded or unfunded, or actual or contingent that (A) is maintained
or contributed to by PCT or any of its Subsidiaries for the benefit of any
current or former employees, consultants or managers of PCT or any of its
Subsidiaries, or their beneficiaries (collectively, “Company Employees”),
(B) has been approved by PCT or any of its Subsidiaries but is not yet
effective for the benefit of Company Employees, or (C) was previously
maintained by PCT or any of its Subsidiaries for the benefit of the Company
Employees and with respect to which PCT or any of its Subsidiaries has any
liability (each a “Company Benefit
Plan”). PCT has delivered to Parent a correct and complete
copy (where applicable) of (1) each Company Benefit Plan (or, where a
Company Benefit Plan has not been reduced to writing, a summary of all material
terms of such Company Benefit Plan), (2) each current trust or funding
arrangement relating to each Company Benefit Plan, (3) the three most
recently filed annual reports on Internal Revenue Service (“IRS”) Form 5500 or
any other annual report required by applicable Law with respect to each Company
Benefit Plan, (4) the most recently received IRS determination letter for
each Company Benefit Plan, (5) the most recently prepared actuarial report
and financial statement in connection with each Company Benefit Plan,
(6) the most recent summary plan description, any summaries of material
modification, any employee handbooks and any material written communications (or
a description of any material oral communications) by PCT or any of its
Subsidiaries to any Company Employee concerning the extent of the benefits
provided under any Plan, (7) for the last three years, all material
correspondence with the IRS, United States Department of Labor (“DOL”) and any
other Governmental Authority regarding an audit or examination any Company
Benefit Plan, (8) all contracts with third-party administrators, actuaries,
investment managers, consultants and other independent contractors that relate
to any Company Benefit Plan and (9) any other documents in respect of any
Company Benefit Plan reasonably requested by Parent. Neither PCT nor
any of its Subsidiaries has any plan or commitment to establish any new Company
Benefit Plan or to modify any Company Benefit Plan, except to the extent
required by Law.
(c) (i)
Each Company Benefit Plan has been maintained and operated in all material
respects in compliance with its terms and applicable Law, including ERISA, the
Code, Section 4980B of the Code and Sections 601 through 608, inclusive, of
ERISA, which provisions are hereinafter referred to collectively as “COBRA”, and
any other applicable Laws, including the Americans with Disabilities Act of
1990, the Family and Medical Leave Act of 1993 and the Health Insurance
Portability and Accountability Act of 1996, (ii) with respect to each Company
Benefit Plan, all
reports, returns, notices and other documentation that are required to have been
filed with or furnished to the IRS, the DOL or any other Governmental Authority,
or to the participants or beneficiaries of such Company Benefit Plan have been
filed or furnished on a timely basis, and (iii) each Company Benefit Plan that
is intended to be qualified within the meaning of Section 401(a) of the Code is
so qualified and has received a favorable determination letter from the IRS to
the effect that the Company Benefit Plan satisfies the requirements of Section
401(a) of the Code taking into account all changes in qualification requirements
under Section 401(a) for which the applicable “remedial amendment period” under
Section 401(b) of the Code has expired, and there are no facts or circumstances
that could cause the loss of such qualification or the imposition of any
liability, penalty or tax under ERISA, the Code or any other applicable
Laws.
(d) With
respect to any Company Benefit Plan, (i) no actions, claims or proceedings
(other than routine claims for benefits in the ordinary course) are pending or,
to PCT’s Knowledge, threatened, (ii) no facts or circumstances exist that
would reasonably be expected to give rise to any such actions, claims or
proceedings, and (iii) no administrative investigation, audit or other
administrative proceeding by the U.S. DOL, the IRS or other Governmental
Authority, including any voluntary compliance submission through the IRS’s
Employee Plans Compliance Resolution System or the DOL’s Voluntary Fiduciary
Correction Program or Delinquent Filer Voluntary Correction Program, is pending,
in progress or, to PCT’s Knowledge, threatened.
(e) Neither
PCT nor any of its Subsidiaries, nor to the best of their Knowledge any other
persons who participate in the Operation of any Company Benefit Plan or related
trust or funding vehicle, has engaged in any transaction with respect to any
Company Benefit Plan or breached any fiduciary responsibilities or obligations
under Title I of ERISA that would subject them to a tax, penalty or liability
for prohibited transactions or breach of any obligations under ERISA or the Code
or would result in any claim being made under, by or on behalf of any such
Company Benefit Plan by any party with standing to make such claim.
(f) Except
as set forth on Schedule
4.17(f), neither the execution and delivery of this Agreement nor the
consummation of the transactions contemplated hereby will (either alone or in
combination with another event) (i) result in any payment or benefit becoming
due, or increase the amount of any compensation due, to any Company Employee,
(ii) increase any benefits otherwise payable under any Company Benefit Plan, or
(iii) result in the acceleration of the time of payment or vesting of any such
compensation or benefits; and except as set forth on Schedule 4.17(f), no such
payment or benefit will be characterized as an “excess parachute payment,” as
such term is defined in Section 280G of the Code. Except as set
forth on Schedule
4.17(f), neither PCT nor any of its Subsidiaries is a party to any
contract, arrangement or plan pursuant to which it is bound to compensate any
Person for any excise or other additional taxes under Section 409A or 4999 of
the Code or any similar provision of state, local or foreign law.
(g) Each
Company Benefit Plan (other than an employment agreement or any similar
agreement that cannot be terminated without the consent of the other party) may
be amended or terminated at any time without incurring liability to PCT or any
of its Subsidiaries thereunder, other than in respect of accrued and vested
obligations and medical or welfare claims incurred prior to such amendment or
termination.
(h) All
contributions (including all employer contributions and employee salary
reduction contributions) or premium payments required to have been made under
the terms of any Plan, and in accordance with applicable Law (including pursuant
to 29 C.F.R. Section 2510.3-102), as of the date hereof have been timely made or
reflected on the PCT Group’s financial statements in accordance with
GAAP.
(i) Except
for the continuation coverage requirements under COBRA or as otherwise disclosed
on Schedule 4.17(i),
neither PCT nor its Subsidiaries have any obligations or potential liability for
health, life or similar welfare benefits to Company Employees or their
respective dependents following termination of employment.
(j) Each
Plan subject to the provisions of Section 401(k) or 401(m) of the Code, or both,
has been tested for and has satisfied the requirements of Section 401(k)(3),
Section 401(m)(2) and Section 416 of the Code, as applicable, for each plan year
ending prior to Effective Time.
(k) No
Company Benefit Plan is maintained in a jurisdiction outside of the United
States or for employees outside of the United States.
(l) Schedule 4.17(l) identifies
each Company Benefit Plan that is a “nonqualified deferred compensation plan”
(within the meaning of Section 409A of the Code and Treasury regulations
issued thereunder (“Section
409A”)), and each Company Benefit Plan so identified has been operated
and administered in compliance with Section 409A. Without
limitation of the foregoing, no “service provider” (within the meaning of
Section 409A) of PCT or any of its Subsidiaries has any equity-based right or
incentive (such as a stock option, stock appreciation right, phantom stock,
restricted stock or restricted stock unit) that is either subject to
Section 409A or in violation of Section 409A. Neither PCT nor any of its
Subsidiaries has any commitment to compensate or reimburse any individual for
penalty taxes imposed under Section 409A.
Section
4.18 Labor.
(a) PCT
has delivered to Parent an accurate and complete list of the names of all of the
employees engaged in the PCT Business (“Business Employees”),
together with each such Business Employee’s annual rate of salary or hourly wage
rate, two most recent annual bonuses, including, without limitation, profit
distributions, job title, work location, accrued unused vacation pay or days,
most recent promotion or pay raise, and hire date. To the Knowledge
of PCT, no Business Employee has any plans to terminate employment with any
Person in the PCT Group.
(b) Schedule 4.18(b) contains an
accurate and complete list of the names of each consultant or independent
contractor who currently provides, or who has within the prior twelve month
period provided, services to the PCT Business (each, a “Business
Consultant”).
(c) All
Business Employees are actively at work (or on vacation) and no Business
Employee is currently on a leave of absence, layoff, suspension, sick leave,
workers compensation, short or long term disability, family leave, military
leave, or otherwise not actively performing his or her work during all normally
scheduled business hours (other than vacation).
(d) PCT
has delivered to the Parent a copy of each employment, consulting or independent
contractor agreement, confidentiality/assignment of inventions agreement and/or
non-competition agreement entered into with a Business Employee or Business
Consultant and all personnel policies, manuals, employee handbooks and similar
materials pertaining to the Business. All current employees are
subject to confidentiality and assignment of inventions agreements with
PCT.
(e) With
respect to current and former employees, consultants and service providers of
the Business (each a “Service
Provider”):
(i) the
PCT Group is and has been in compliance in all material respects with all
applicable Laws respecting employment and employment practices, terms and
conditions of employment and wages and hours, including any Laws respecting
minimum wage and overtime payments, employment discrimination, workers’
compensation, family and medical leave, immigration, and occupational safety and
health requirements, affirmative action requirements and has not and is not
engaged in any unfair labor practice;
(ii) there
is not now, nor within the past six years has there been, any actions, suits,
claims, labor disputes or grievances pending, or, to PCT’s Knowledge, threatened
or reasonably anticipated relating to any labor, safety or discrimination
matters involving any Service Provider, including charges of unfair labor
practices or discrimination complaints;
(iii) no
collective bargaining agreement is binding and in force against the PCT Group or
currently being negotiated by any Person in the PCT Group, and to the Knowledge
of PCT, no union organization campaign is in progress with respect to any of the
Service Providers, and no question concerning representation exists respecting
such Service Providers; and
(iv) the
PCT Group does not have any liability for any payment to any trust or other fund
governed by or maintained by or on behalf of any Governmental Authority with
respect to unemployment compensation benefits, social security or other benefits
or obligations for Service Providers (other than routine payments to be made in
the normal course of business and consistent with past practice).
(f) No
“mass layoff,” “plant closing” or similar event as defined by the Worker
Adjustment and Retraining Notification Act with respect to any Person in the PCT
Group has occurred or will occur as a result of the consummation of the
Merger.
(g) The
PCT Group does not have any contracts to render services to any Government
Authority.
Section
4.19 Litigation. There
is no Legal Proceeding pending or, to the Knowledge of PCT, threatened against
any of the Persons in the PCT Group (or to the Knowledge of PCT, pending or
threatened against any employees of any of the Persons in the PCT Group with
respect to their business activities on behalf of the PCT Group), or to which
any of the Persons in the PCT Group is otherwise a party, before any
Governmental Authority; nor to the Knowledge of PCT is there any reasonable
basis for any such Legal Proceeding. None of the Persons in the PCT
Group is subject to any Order. There are no Legal Proceedings pending
or, to the Knowledge of PCT, threatened that are reasonably likely to prohibit
or restrain the ability of PCT, its Subsidiaries or the Members to perform their
obligations under this Agreement or consummate the transactions contemplated
hereby.
Section
4.20 Compliance with Laws; Orders;
Permits.
(a) Each
of the Persons in the PCT Group is in compliance in all material respects with
all Laws of each Governmental Authority applicable to its business, operations
or assets, including without limitation all FDA rules and regulations,
comparable state laws, regulations governing current Good Manufacturing Practice
(cGMP) and current Good Tissue Practice (cGTP), the Health Insurance Portability
and Accountability Act of 1996 (HIPAA), the federal Clinical Laboratory
Improvement Act of 1988, as amended (CLIA), Occupational Safety and Health
requirements, the Stark Law and state equivalents, escheat laws, abandoned
property laws, laws relating to employment and compensation and marketing laws
and other laws relating to privacy and internet communications. Since
January 1, 2005, none of the Persons in the PCT Group has received any notice of
or been charged with the violation of any material Law by any Governmental
Authority. To the Knowledge of PCT, none of the Persons in the PCT
Group is or since January 1, 2005, has been, under investigation with respect to
the violation of any Law and to the Knowledge of PCT, there are no facts or
circumstances which could reasonably form the basis for any such violation other
than violations which would have an immaterial effect upon the PCT
Business. Except as set forth in Schedule 4.20(a), none of the PCT Permits will be impaired
or in any way affected by the Merger.
(b) Schedule 4.20(b) is a true and
complete listing of all Permits which are required for the operation of the PCT
Business as presently conducted (“PCT
Permits”). The Persons in the PCT Group currently have all
Permits which are required for the operation of their respective businesses as
presently conducted. Each issued Permit currently is in full force
and effect. None of the Persons in the PCT Group is in default or
violation, and no event has occurred which, with notice or the lapse of time or
both, would constitute a default or violation, in any material respect of any
term, condition or provision of any PCT Permit, and to the Knowledge of PCT,
there are no facts or circumstances which form the basis for any such default or
violation. No Person in the PCT Group has received notification of
any revocation or modification of any Permit. PCT has completed all
necessary registration of its establishments and facilities with all
Governmental Authorities that are necessary for PCT to conduct its business in
the manner and to the extent now conducted. Each PCT Permit is
current and up to date. Except as set forth in Schedule 4.20(a), none of the
PCT Permits will be impaired or in any way affected by Merger or the
consummation of any other transaction contemplated by this
Agreement.
(c) The
drug or biological substances manufactured by PCT on behalf of PCT’s clients and
used in studies, tests, preclinical studies and clinical trials have been and,
if still pending, are being manufactured, under current Good Manufacturing
Practices. PCT has not received any notices or correspondence from
the FDA or any foreign, state or local governmental body exercising comparable
authority requiring the termination, suspension or material modification of any
studies, tests, preclinical studies or clinical trials conducted by or on behalf
of PCT’s clients and to which PCT was involved as either a contract manufacturer
and/or product and/or process consultant. No filing or submission to
the FDA or any other regulatory body, that was or is intended to be the basis
for any approval of PCT’s client’s products or product candidates, contains any
material omission or material false information by PCT.
(d) The
consulting services and/or process development services that PCT provides its
clients or customers for the purpose of clinical trials for Investigational New
Drug Applications, New Drug Applications, and/or Biologic License Application
are conducted in accordance with good clinical practices and are in compliance
with all applicable Laws and state and federal regulatory requirements. PCT has
not received any notices or other correspondence from the FDA or any other
governmental agency requiring the termination, suspension or modification of any
clinical trials.
(e) To
PCT’s Knowledge, no Person in the PCT Group, nor any manager, director, agent,
employee or any other person acting for or on behalf of a Person in the PCT
Group, has directly or indirectly made any unlawful contribution, gift, bribe,
payoff, influence payment, kickback, or any other fraudulent payment in any
form, whether in money, property, or services to any person, including but not
limited to any staff member at any hospital or any government officer (a) to
obtain favorable treatment in securing business for PCT, (b) to pay for
favorable treatment for business secured, (c) to obtain special concessions or
for special concessions already obtained, for or in respect of any Person in the
PCT Group, or (d) in violation of any applicable anti-corruption
law.
(f) No
Person in the PCT Group nor, to PCT’s Knowledge, any manager, director, agent,
employee or any other person acting for or on behalf of PCT, has established or
maintained any fund or assets in which PCT has proprietary rights that have not
been recorded in the books and records of PCT. Each transaction is properly and
accurately recorded in all material respects on the books and records of PCT,
and each document upon which entries such books and records are based is
complete and accurate in all material respects. PCT maintains a system of
internal accounting controls reasonably designed to insure that there are no
off-the-books accounts and its assets are used only in accordance with its
corporate management directives.
(g) The
FDA Package contains true and complete copies of all filings made by PCT with
the FDA and any state or third party regulatory authority (including but not
limited to state regulatory authorities in New Jersey, New York, California and
Maryland), all Permits obtained by PCT from the FDA and any state or third party
regulatory authority and all approvals and disapprovals, audit reports and
correspondence from or with the FDA or such state regulatory authorities,
including but not limited to an audit report received by PCT from New York
regulatory authorities for its Hackensack facility and follow up correspondence,
a PCT created chart of documents requested by the FDA during its inspection of
its Mountain View, California facility, and PCT created daily summaries of FDA
inspections of PCT and its clients. PCT also represented to the
Parent and its counsel that the FDA did not find any 483 observations and did
not provide PCT with a 483, Establishment Inspection Report or audit report at
the close of its inspection in 2010. To the Knowledge of PCT and to
the knowledge of any manager, officer, agent, or employee of PCT, all
information contained in such filings made by PCT to any Governmental Authority
is true and accurate.
(h) Neither
PCT nor, to the Knowledge of PCT, any manager, officer, agent, employee, Member
or Affiliate of PCT, is currently subject to any U.S. sanctions administered by
the Office of Foreign Assets Control of the U.S. Treasury
Department.
(i) Subsequent
to the FDA inspection of the PCT Mountain View facility in 2010, PCT was
informed by the FDA inspectors that there were no regulatory or compliance
issues found at this facility.
Section
4.21 Insurance. The PCT
Group has insurance policies in full force and effect for such amounts as are
sufficient for all requirements of Law and all agreements to which each of the
Persons in the PCT Group is a party or by which such Persons are bound and which
provide commercially reasonable levels of insurance. No event has
occurred, including, without limitation, the failure by any of the Persons in
the PCT Group to give any notice or information or any of the Persons in the PCT
Group giving any inaccurate or erroneous notice or information, which limits or
impairs the rights of any Person in the PCT Group under any such insurance
policies.
Section
4.22 Related Party
Transactions. (a) No employee, officer, director, shareholder,
partner, manager or Member of any of the Persons in the PCT Group, any member of
his or her immediate family or any of their respective Affiliates (“Related Persons”) (i)
owes any amount to the PCT Group and none of the Persons in the PCT Group owe
any amount to, or have any of the Persons in the PCT Group committed to make any
loan or extend or guarantee credit to or for the benefit of, any Related Person,
(ii) is involved in any business arrangement or other relationship (other than
customary employment relationships) with any of the Persons in the PCT Group
(whether written or oral), (iii) owns any property or right, tangible or
intangible, that is used by any of the Persons in the PCT Group (other than
rights arising out of employment arrangements), (iv) to the Knowledge of PCT,
has any claim or cause of action against any of the Persons in the PCT Group or
(v) is obligated to make any payment to any other Person in the PCT Group or
Related Person in connection with the transactions contemplated by this
Agreement.
(b) There
are no transactions, arrangements or other relationships between and/or among
PCT, any of its Affiliates and any unconsolidated entity, including, but not
limited to, any structured finance, special purpose or limited purpose entity
that could reasonably be expected to materially affect PCT’s liquidity or the
availability of or requirements for its capital resources. There are
no transactions, arrangements or other relationships between and/or among PCT,
any of Person in the PCT Group and any Members or their Affiliates that are not
on terms at least as favorable to PCT as would be obtained in an arm's length,
commercially reasonable transaction with an unrelated third party.
(c) No
Person in the PCT Group has, since January 1, 2002, extended or maintained
credit, arranged for the extension of credit, or renewed an extension of credit,
in the form of a personal loan to or for any director or executive officer (or
equivalent thereof) of PCT.
(d) All
agreements, payment obligations, and other business relationships between PCT or
any other Person in the PCT Group or their Affiliates, on the one hand, and
Amorcyte Inc., on the other hand, are commercially reasonable and on terms no
less favorable to PCT than would be available in an arm’s length transaction
with an unrelated third party. PCT provides Amorcyte with a $500,000
line of credit on terms no less favorable to PCT than would be available in an
arm’s length transaction in an unrelated bank financing, and no borrowings are
outstanding under that line of credit.
Section
4.23 Suppliers and
Customers. Schedule 4.23 sets forth a
list identifying (i) each supplier to the PCT Group during PCT’s current fiscal
year (through July 31, 2010) and each of the two preceding fiscal years, showing
the approximate total purchases by the PCT Group from each such supplier during
each such period and (ii) each customer of the PCT Group during PCT’s current
fiscal year (through July 31, 2010) and each of the two preceding fiscal years,
showing the approximately revenue generated from each such customer during each
such period. Notwithstanding the foregoing, suppliers who have
charged the PCT Group less than $50,000 per year and customers who have
generated less than $50,000 per year in revenue for PCT need not be included on
such list. Since December 31, 2009, no supplier or customer listed on
Schedule 4.23 has
terminated its relationship with any of the Persons in the PCT Group or
materially increased, decreased or changed the pricing, the volume of business
or other terms of its business with any of the Persons in the PCT Group and, to
the Knowledge of PCT, no supplier or customer listed on Schedule 4.23 has notified any
of the Persons in the PCT Group that it intends to terminate or materially
increase, decrease or change the pricing, the volume of business or other terms
of its business with the PCT Group.
Section
4.24 Financial
Advisors. Except as set forth in Schedule 4.24, no Person has
acted, directly or indirectly, as a broker, finder or financial advisor for the
PCT Group or the Members in connection with the transactions contemplated by
this Agreement and no Person is or will be entitled to any fee or commission or
like payment in respect thereof.
Section
4.25 Environmental
Matters. Each Person in the PCT Group is in compliance with
all Environmental Laws and the requirements of all Permits issued under such
Environmental Laws with respect to PCT in all material
respects. There are no pending or, to the Knowledge of PCT,
threatened Environmental Legal Proceedings against any Person in the PCT
Group.
Section
4.26 Construction
Projects. Schedule 4.26 contains a true
and complete list of all construction projects undertaken, pending or completed
by PCT since January 1, 2007 together with any construction projects which PCT
reasonably expects to undertake within the current fiscal year. PCT
has complied with all obligations imposed upon it in connection with any such
construction projects, and no claims are pending or, to PCT’s Knowledge,
threatened against any member of the PCT Group with respect to such construction
projects.
Section
4.27 Registration Statement;
Prospectus/Joint Proxy Statement. None of the information
supplied or to be supplied by PCT for inclusion in the Form 8-K under the
Securities Exchange Act of 1934 (the "Exchange Act") or the
registration statement under the Securities Act registering the Parent Common
Stock or other Parent securities as to be issued pursuant to this Agreement
(such registration statement, as amended by any amendments thereto, being
referred to herein as the “Registration
Statement”) or the Prospectus/Joint Proxy Statement to be sent to the
stockholders of Parent and the Members of PCT in connection with the special
meeting of stockholders of Parent at which such stockholders will be asked to
approve the issuance of Parent Common Stock pursuant to this Agreement (the
“NeoStem
Meeting”) and the special meeting of the Members of PCT at which the
Members will be asked to approve the Merger and this Agreement (the “PCT Meeting”) (such
Prospectus/Joint Proxy Statement, as amended or supplemented by any amendments
or supplements thereto, being referred to herein as the “Prospectus/Joint Proxy
Statement”), including all amendments and supplements to the Registration
Statement and Prospectus/Joint Proxy Statement, shall, in the case of the
Registration Statement, at the time the Registration Statement becomes effective
and, in the case of the Prospectus/Joint Proxy Statement, on the date or dates
the Prospectus/Joint Proxy Statement is first mailed to NeoStem stockholders and
the Members of PCT and on the date or dates of the NeoStem Meeting and the PCT
Meeting, contain any untrue statement of a material fact or omit to state a
material fact required to be stated therein or necessary in order to make the
statements therein, in the light of the circumstances under which they were
made, not misleading. PCT will supply NeoStem with all business, financial,
accounting, legal, management and other information about PCT, the PCT Group,
any Person in the PCT Group, the Members and the PCT Business as is required to
be disclosed in a Form S-4 under SEC rules.
Section
4.28 FINRA. None of the
Members are a registered representative under the Financial Industry Regulatory
Authority (“FINRA”), a member of
FINRA or associated or affiliated with any member of the FINRA, or a
broker-dealer registered with the SEC under the Exchange Act or engaged in a
business that would require it to be so registered, nor is it an affiliate of
such a broker-dealer or any person engaged in a business that would require it
to be registered as a broker-dealer.
Section
4.29 Full
Disclosure. No representation or warranty, exhibit or schedule
furnished by or on behalf of the Company or any of its Subsidiaries in this
Agreement, the Company Disclosure Letter or any other Transaction Document
contains or will contain any untrue statement of a material fact, or omits or
will omit to state a material fact necessary to make the statements contained
herein or therein not misleading. Neither the Company nor its
Subsidiaries has any Knowledge of any facts pertaining to the Company, its
Subsidiaries, the PCT Business or its assets that has or could reasonably be
expected to have a Material Adverse Effect and that have not been disclosed in
this Agreement, the schedules and exhibits hereto and the Transaction
Documents.
ARTICLE
V
Representations
and Warranties of the Parent and Subco
The
Parent and Subco jointly and severally represent and warrant to PCT as
follows:
Section
5.1 Organization and Good
Standing. The Parent is a corporation, validly existing and in
good standing under the laws of the State of Delaware and has all requisite
power and authority to own, lease and operate its properties and to carry on its
business. Subco is a limited liability company validly existing and
in good standing under the laws of the State of Delaware.
Section
5.2 Authorization. Each
of the Parent and Subco has full power and authority to execute and deliver this
Agreement and each other Purchaser Document, to the extent applicable, and to
consummate the transactions contemplated hereby and thereby. The
execution, delivery and performance by each of the Parent and Subco of this
Agreement and each other Purchaser Document, to the extent applicable, have been
duly authorized by all necessary action on behalf of each of the Parent and
Subco. This Agreement has been, and each other Purchaser Document
will be at or prior to the Closing, duly executed and delivered by the Parent
and/or Subco, to the extent applicable, and (assuming the due authorization,
execution and delivery by the other parties hereto and thereto) this Agreement
constitutes, and each other Purchaser Document when so executed and delivered
will constitute, the legal, valid and binding obligation of the Parent and/or
Subco, to the extent applicable, enforceable against the Parent or Subco, to the
extent applicable, in accordance with its respective terms, subject to
applicable bankruptcy, insolvency, reorganization, moratorium and similar laws
affecting creditors’ rights and remedies generally, and subject, as to
enforceability, to general principles of equity, including principles of
commercial reasonableness, good faith and fair dealing (regardless of whether
enforcement is sought in a proceeding at law or in equity).
Section
5.3 Conflicts; Consents of Third
Parties.
(a) Neither
the execution or delivery by the Parent or Subco of this Agreement or any of the
other Purchaser Documents, nor the performance by the Parent or Subco of its
obligations hereunder and thereunder will (i) contravene any provision contained
in the organizational documents of the Parent or Subco or (ii) violate or result
in a breach (with or without the lapse of time, the giving of notice or both) of
or constitute a default under any judgment, order, decree, law, rule or
regulation or other restriction of any Governmental Authority, in each case to
which the Parent or Subco is a party or by which the Parent or Subco is bound or
to which any of its assets or properties are subject or (iii) violate or result
in a breach (with or without the lapse of time, the giving of notice, or both)
of or constitute a default under any material contract to which the Parent or
Subco is a party where the breach or default would have a Material Adverse
Effect on Parent.
(b) No
notice to, filing with, or authorization, registration, consent or approval of,
any Governmental Authority or other Person is necessary for the execution,
delivery or performance of this Agreement or any other Purchaser Document or the
consummation of the transactions contemplated hereby or thereby by the Parent
and Subco other than (i) the Joint Proxy Statement/Prospectus and Form S-4 of
which it is a part and (ii) the additional listing application with the New York
Stock Exchange-Amex.
Section
5.4 Litigation. There
are no Legal Proceedings pending or, to the Knowledge of the Parent, threatened
that are reasonably likely to prohibit or restrain the ability of the Parent to
perform its obligations under this Agreement or consummate the transactions
contemplated hereby.
Section
5.5 Financial
Advisors. Except as set forth in Schedule 5.5, no Person has
acted, directly or indirectly, as a broker, finder or financial advisor for the
Parent in connection with the transactions contemplated by this Agreement who is
or will be entitled to any fee or commission or like payment in respect thereof
other than those paid by Parent.
Section
5.6 Compliance with Laws; Orders;
Permits.
Except as
disclosed in the Parent’s filings with the SEC since December 31,
2009:
(a) The
Parent is in compliance in all material respects with all laws of each
Governmental Authority applicable to its business, operations or assets,
including, without limitation all FDA rules and regulations, comparable state
laws, regulations governing current Good Tissue Practice (cGTP), the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), the federal
Clinical Laboratory Improvement Act of 1988, as amended (CLIA), Occupational
Safety and Health requirements, the Stark Law and state equivalents, escheat
laws, abandoned property laws, laws relating to employment and compensation and
marketing laws and other laws relating to privacy and internet
communications. Since January 1, 2006, the Parent has not received
any notice of or been charged with the violation of any material Law by any
Governmental Authority. To the Knowledge of the Parent, none of its
Affiliates is or since January 1, 2006, has been, under investigation with
respect to the violation of any Law and to the Knowledge of the Parent, there
are no facts or circumstances which could reasonably form the basis for any such
violation other than violations which would not have a Material Adverse Effect
upon the Parent’s business.
(b) To
the Knowledge of Parent, neither it nor any manager, director, agent, employee
or any other person acting for or on behalf of Parent, has directly or
indirectly made any unlawful contribution, gift, bribe, payoff, influence
payment, kickback, or any other fraudulent payment in any form, whether in
money, property, or services to any person, including but not limited to any
staff member at any hospital or any government officer (a) to obtain favorable
treatment in securing business for Parent, (b) to pay for favorable treatment
for business secured, (c) to obtain special concessions or for special
concessions already obtained, for or in respect of Parent or any Affiliate of
Parent, or (d) in violation of any applicable anti-corruption law.
Section
5.7 Registration Statement;
Prospectus/Joint Proxy Statement. None of the information
supplied or to be supplied by Parent for inclusion in the Registration Statement
under the Securities Act registering the NeoStem Common Stock to be issued
pursuant to this Agreement or the Prospectus/Joint Proxy Statement to be sent to
the stockholders of Parent and the Members of PCT in connection with the NeoStem
Meting and the PCT Meeting, including all amendments and supplements to the
Registration Statement and Prospectus/Joint Proxy Statement, shall, in the case
of the Registration Statement, at the time the Registration Statement becomes
effective and, in the case of the Prospectus/Joint Proxy Statement, on the date
or dates the Prospectus/Joint Proxy Statement is first mailed to NeoStem
stockholders and the Members and on the date or dates of the NeoStem Meeting and
the PCT Meeting, contain any untrue statement of a material fact or omit to
state a material fact required to be stated therein or necessary in order to
make the statements therein, in the light of the circumstances under which they
were made, not misleading; provided, however, that Parent
is not responsible for any information supplied by the PCT Group.
ARTICLE
VI
Covenants
and Agreements
Section
6.1 Meetings of Stockholders and
Members.
(a) NeoStem
Meeting. Parent shall take all action in accordance with the
federal securities law, the DLLCA, the applicable rules of the Exchange on which
the Parent Common Stock is listed or quoted, NeoStem’s certificate of
incorporation, as amended, and NeoStem’s by-laws, as amended, necessary to
convene the NeoStem Meeting on the earliest practical date as reasonably
determined by NeoStem in light of the circumstances, and to obtain the consent
and approval of NeoStem’s stockholders with respect to the issuance of the Stock
Consideration and the Warrants pursuant to this Agreement, including (in the
absence of conditions that would justify the termination of this Agreement)
recommending such approval to NeoStem’s stockholders.
(b) PCT Meeting. PCT
shall take all action in accordance with the federal securities laws, the DLLCA,
the Voting Agreement, and the PCT LLC Agreement, necessary to give notice to the
PCT Members and convene the PCT Meeting to be held on the earliest practical
date as reasonably determined by NeoStem in light of the circumstances, and to
obtain the consent and approval of PCT's Members with respect to the Agreement
and the transactions contemplated hereby, including recommending such approval
to the Members.
(c) PCT
will provide Parent and its transfer agent with (a) a representation that the
information provided by PCT and contained in the Prospectus/Joint Proxy
Statement and any other disclosure documents is true and accurate in all
material respects and that there is no fact or matter which has not been
disclosed in such disclosure documents which renders such information untrue or
misleading and (b) appropriate other certifications, accountant comfort letters
and consents, and opinions of counsel with respect to the Securities Act
registration of the issuance of the Stock Consideration and Warrants and
compliance with the PCT LLC Agreement (or other organizational documents of any
Person in the PCT Group) and Law with respect to this transaction.
(d) Parent
and Subco will provide PCT with a representation that the information provided
by Parent and Subco and contained in the Prospectus/Joint Proxy Statement and
any other disclosure documents is true and accurate in all material respects and
that there is no fact or matter which has not been disclosed in such disclosure
documents which renders such information untrue or misleading.
Section
6.2 Preparation of the Prospectus/Joint
Proxy Statement and the Registration Statement.
(a) Parent
and PCT shall, as soon as is reasonably practicable, cooperate to prepare the
Prospectus/Joint Proxy Statement to be included in the Registration
Statement. Once Parent and PCT consent to the filing of the
Prospectus/Joint Proxy Statement with the SEC (which consent shall not be
unreasonably withheld), Parent shall file the Registration Statement with the
SEC. Consistent with the timing for the NeoStem Meeting and the PCT
Meeting as determined by NeoStem in accordance with Section 6.1, NeoStem shall
use reasonable efforts to have the Registration Statement declared effective by
the SEC as promptly as practicable thereafter and to maintain the effectiveness
of the Registration Statement through the Effective Time. If, at any
time prior to the Effective Time, Parent or PCT shall obtain knowledge of any
information contained in or omitted from the Registration Statement that would
require an amendment or supplement to the Registration Statement or the
Prospectus/Joint Proxy Statement, the party obtaining such knowledge will
promptly so advise the other parties in writing and each of Parent and PCT will
promptly take such action as shall be required to amend or supplement the
Registration Statement and/or the Prospectus/Joint Proxy
Statement. PCT shall promptly furnish to Parent all financial and
other information concerning it as may be required for the Prospectus/Joint
Proxy Statement and any supplements or amendments thereto. Parent and
PCT shall cooperate in the preparation of the Prospectus/Joint Proxy Statement
in a timely fashion and shall use all reasonable efforts to clear the
Prospectus/Joint Proxy Statement and the Registration Statement with the staff
of the SEC. Promptly after the Registration Statement is declared
effective by the SEC, each of Parent and PCT shall use all reasonable efforts to
mail at the earliest practicable date to its stockholders or Members, as the
case may be, the Prospectus/Joint Proxy Statement, which shall include all
information required under applicable Law to be furnished to PCT’s Members and
NeoStem’s stockholders in connection with this Agreement and the transactions
contemplated hereby and shall include the recommendation of PCT’s managers in
favor of the transactions contemplated hereby.
(b) Notwithstanding
anything contained in this Agreement to the contrary, NeoStem shall not be
obligated to take any action under Section 6.2 unless and until the following
conditions shall have been met: (i) NeoStem shall have received the audited
financial statements of PCT and any other financial information of PCT or its
Subsidiaries required for inclusion in the Registration Statement as determined
by NeoStem, (ii) NeoStem shall have received all information it needs to prepare
pro forma financial statements required to be included in the Registration
Statement, under SEC rules, (iii) NeoStem shall have received such auditor
comfort letters and consents from its, and PCT’s auditors, and legal opinions
from PCT’s counsel as it deems necessary or desirable and (iv) NeoStem shall
have received from an investment banking firm reasonably acceptable to it a
valuation analysis of PCT which shows a valuation satisfactory to the Board of
Directors of NeoStem (the “Valuation Report”),
each in form and substance reasonably satisfactory to NeoStem.
Section
6.3 Financial Statements for NeoStem
Current Report on Form 8-K.
(a) Attached
as Schedule 4.9(a), PCT
has provided to NeoStem (i) audited consolidated balance sheets of PCT and its
Subsidiaries as of December 31, 2009 and 2008, (ii) audited consolidated
statements of income, cash flows and changes in shareholders’ equity of each of
PCT and its Subsidiaries for the years ended December 31, 2009, 2008 and 2007,
(iii) an unqualified report with respect to such audited financial statements by
EisnerAmper and a consent by EisnerAmper to have such audited financial
statements incorporated by reference into NeoStem’s Securities Act filings,
which report and consent shall be in form and substance reasonably satisfactory
to NeoStem, and (iv) unaudited consolidated statements of income, cash flows and
changes in shareholders’ equity of PCT and its Subsidiaries for the six months
ended June 30, 2010 and 2009 and an unaudited balance sheet as of June 30,
2010. PCT has also provided to NeoStem all other financial
statements, business descriptions, risk factors, compensation data, ownership
data and other information of PCT required for any SEC filing to be filed by
NeoStem or which needs to be incorporated in any existing NeoStem registration
statement or other SEC filings to make the information therein complete,
including, without limitation, pro forma financial statements that give effect
to the transaction contemplated by this Agreement and a full description of the
business of the PCT Group. Such financial statements have been
prepared in accordance with generally accepted accounting principles, so that
such financial statements meet the requirements for filing by NeoStem with the
SEC as required by the SEC’s Current Report on Form 8-K and for incorporation
into any Form S-3 or other registration statement on file or to be filed by
NeoStem, all so that NeoStem’s currently effective Form S-3 may immediately be
used by NeoStem in a capital raising transaction.
(b) PCT
will provide Parent with a representation that the information provided by it
for inclusion and/or incorporation into the Registration Statement and/or Form
8-K is true and accurate in all material respects and that there is no material
fact or matter which has not been disclosed in the disclosure document which
renders such information untrue or misleading in any material
respect. Parent and Subco will provide PCT with a representation that
the information provided by Parent and Subco for incorporation into the
Registration Statement is true and accurate in all material respects and that
there is no material fact or matter which has not been disclosed in the
disclosure document which renders such information untrue or misleading in any
material respect.
(c) Upon
execution of this Agreement, PCT shall cause EisnerAmper to deliver to NeoStem
an executed consent, in form and substance reasonably satisfactory to NeoStem
and suitable for filing by NeoStem with the SEC, which consent shall authorize
NeoStem to file with the SEC the reports delivered pursuant to Section
6.3(a).
(d) Upon
NeoStem’s request, contemporaneous with the delivery of the consolidated
financial statements described in Section 6.3(a), PCT shall cause EisnerAmper to
make available to NeoStem and its representatives the work papers generated in
connection with such accounting firm’s audit of the audited consolidated
financial statements delivered pursuant to Section 6.3(a).
(e) Prior
to the Closing, PCT shall cooperate with NeoStem in providing to NeoStem such
consolidated financial statements, financial data and accountants’ reports as
NeoStem shall reasonably request with respect to any filing that NeoStem shall
make or be required to make under the Securities Act or the Exchange
Act. Not in limitation of the foregoing, PCT shall deliver to Parent,
without charge, the following financial information (the “Supplemental Financial Information”): (i)
promptly after each fiscal quarter ending after the date hereof, the unaudited
consolidated balance sheet of PCT as of the end of such quarter and the
unaudited consolidated statements of income, stockholders’ equity and cash flows
of PCT for such quarter and for the portion of the fiscal year then prepared in
accordance with GAAP, and (ii) promptly upon the reasonable request by Parent,
such additional financial information as may be required in connection with any
filing by Parent pursuant to the requirements of federal or state securities
laws. Such Supplemental Financial Information shall present fairly,
in all material respects, the consolidated financial position of PCT and its
Subsidiaries as of the last day of the periods covered and the consolidated
results of operations, cash flows and changes in stockholders’ equity of PCT and
its Subsidiaries for the periods covered, subject in the case of unaudited
financials, to normal year-end adjustments.
Section
6.4 Access and
Information.
(a) Prior
to the Closing, and except for disclosures which would cause PCT or any of its
Subsidiaries to waive the attorney-client privilege or otherwise violate
applicable Law or any material confidentiality agreement, NeoStem shall be
entitled to make or cause to be made such investigation of PCT and its
Subsidiaries, and the financial and legal condition thereof, as NeoStem deems
necessary or advisable, and PCT and its Subsidiaries shall cooperate with any
such investigation. In furtherance of the foregoing, but not in
limitation thereof, PCT shall (a) permit NeoStem and its agents and
representatives or cause them to be permitted to have full and complete access
to the premises, operating systems, computer systems (hardware and software) and
books and records of PCT and its Subsidiaries upon reasonable notice during
regular business hours, (b) furnish or cause to be furnished to NeoStem such
financial and operating data, projections, forecasts, business plans, strategic
plans and other data relating to PCT and its Subsidiaries and their businesses
as NeoStem shall request from time to time and (c) cause its accountants to
furnish to NeoStem and its accountants access to all work papers relating to any
of the periods covered by financial statements provided by PCT to NeoStem
hereunder.
(b) Prior
to the Closing, NeoStem shall not use any information provided to it in
confidence by PCT for any purposes unrelated to this Agreement. PCT
shall not use any information provided to it in confidence by NeoStem for any
purposes unrelated to this Agreement. Except with respect to publicly
available documents, in the event that this Agreement is terminated, (a) NeoStem
will return to PCT all documents obtained by it from PCT and its Subsidiaries in
confidence and any copies thereof in the possession of NeoStem or its agents and
representatives or, at the option of NeoStem, NeoStem shall cause all of such
documents and all of such copies to be destroyed and shall certify the
destruction thereof to PCT and (b) PCT will return to NeoStem all documents
obtained by it from NeoStem and its Subsidiaries in confidence and any copies
thereof in the possession of PCT or its agents and representatives or, at the
option of PCT, PCT shall cause all of such documents and all of such copies to
be destroyed and shall certify the destruction thereof to NeoStem.
(c) No
investigation of PCT, its Subsidiaries or the PCT Business by the Parent
heretofore shall modify or otherwise affect any representations and warranties
of PCT, which shall survive any such investigation, or the conditions to the
obligation of the Parent and Subco to consummate the transactions contemplated
hereby.
Section
6.5 No Solicitation. (a) PCT shall not, nor
shall it authorize or permit any of its Affiliates or any Member, officer,
director, employee, investment banker, attorney or other adviser or
representative of PCT or any of its Affiliates to (a) solicit, initiate, or
encourage the submission of, any PCT Acquisition Proposal (as hereinafter
defined), (b) enter into any agreement or understanding with respect to any PCT
Acquisition Proposal or (c) participate in any discussions or negotiations
regarding, or furnish to any person any information for the purpose of
facilitating the making of, or take any other action to facilitate any inquiries
or the making of, any proposal that constitutes, or may reasonable be expect to
lead to, any PCT Acquisition Proposal. Without limiting the
foregoing, it is understood that any violation, of which PCT or any of its
Affiliates had knowledge at the time of such violation, of the restrictions set
forth in the immediately preceding sentence by any Member, officer, director,
employee, investment banker, attorney or other adviser or representative of PCT
or any of its Affiliates, whether or not such Person is purporting to act on
behalf of PCT or any of its Affiliates or otherwise, shall be deemed to be a
breach of this Section 6.5 by PCT and its Affiliates. PCT shall
notify Parent in accordance with the notice provisions of this Agreement in
writing and orally within 24 hours after receipt of any PCT Acquisition Proposal
or receipt of any inquiries with respect to any PCT Acquisition Proposal, such
notice to include the identity of the Person making such proposal, offer,
inquiry or contact, and the terms of such PCT Acquisition Proposal; provided,
however, that PCT shall remain liable for payment of liquidated damages
hereunder and under Article IX notwithstanding providing such
notice. PCT immediately shall cease and cause to be terminated in all
respects all existing discussions or negotiations with any parties conducted
heretofore with respect to a PCT Acquisition Proposal. PCT shall not
release any third party from, or waive any provision of, any confidentiality or
standstill agreement to which it is a party. “PCT Acquisition
Proposal” means any proposal for a merger or other business combination
involving PCT or any of its Affiliates or any proposal or offer to acquire in
any manner, directly or indirectly, an equity interest in PCT or any of its
Affiliates, any voting securities of PCT or any of its Affiliates or a
substantial portion of the assets of PCT but a PCT Acquisition Proposal shall
not include (i) the sales of PCT Products in the Ordinary Course of PCT’s
Business consistent with past practice or (ii) any sale of a minority interest
in Athelos. PCT acknowledges that damages for any breach of the
obligations in this paragraph will be difficult to measure. PCT
agrees that, as liquidated damages for any breach of this paragraph, PCT shall
pay to Parent and Subco an amount in cash equal to the sum of (a) all expenses
incurred by Parent or Subco in any way in connection with investigating,
negotiating, drafting or otherwise pursuing this transaction, including a
reasonable sum for the time spent by its in-house personnel, plus (b) $2
million; provided, however, that if (i) the breach results in consummation of a
transaction in which all of the equity or substantially all of the assets of
Parent is also sold to an unrelated third party in a transaction approved by the
Board of Directors and stockholders of the Parent, or (ii) the Parent waives the
breach and consummates the Merger, then no such liquidated damages shall be
due.
(b) NeoStem
shall not, nor shall it authorize or permit any of its Affiliates or any
officer, director, employee, investment banker, attorney or other adviser or
representative of NeoStem or any of its Affiliates to (a) solicit, initiate, or
encourage the submission of, any NBS Acquisition Proposal (as hereinafter
defined), (b) enter into any agreement or understanding with respect to any NBS
Acquisition Proposal or (c) participate in any discussions or negotiations
regarding, or furnish to any person any information for the purpose of
facilitating the making of, or take any other action to facilitate any inquiries
or the making of, any proposal that constitutes, or may reasonable be expect to
lead to, any NBS Acquisition Proposal. Without limiting the
foregoing, it is understood that any violation, of which NeoStem or any of its
Affiliates had knowledge at the time of such violation, of the restrictions set
forth in the immediately preceding sentence by any officer, director, employee,
investment banker, attorney, employee or other adviser or representative of
NeoStem or any of its Affiliates, whether or not such Person is purporting to
act on behalf of NeoStem or any of its Affiliates or otherwise, shall be deemed
to be a breach of this Section 6.5 by NeoStem. NeoStem shall notify
PCT in accordance with the notice provisions of this Agreement in writing and
orally within 24 hours after receipt of any NBS Acquisition Proposal or receipt
of any inquiries with respect to any NBS Acquisition Proposal, such notice to
include the identity of the Person making such proposal, offer, inquiry or
contact, and the terms of such NBS Acquisition Proposal. NeoStem
immediately shall cease and cause to be terminated in all respects all existing
discussions or negotiations with any parties conducted heretofore with respect
to an NBS Acquisition Proposal. NeoStem shall not release any third
party from, or waive any provision of, any confidentiality or standstill
agreement to which it is a party. “NBS Acquisition Proposal”
means any proposal for a merger or other change of control business transaction
involving NeoStem or any proposal or offer to acquire in any manner, directly or
indirectly, a controlling equity interest in NeoStem or a substantial portion of
the assets of NeoStem (other than sales of NeoStem’s Products in the Ordinary
Course of NeoStem’s Business consistent with past practice or capital raising
transactions not involving a change of control of NeoStem) which results in
NeoStem terminating this Agreement. NeoStem acknowledges that damages
for any breach of the obligations in this paragraph will be difficult to
measure. NeoStem agrees that, as liquidated damages for any breach of
this paragraph which results in NeoStem terminating this Agreement, NeoStem
shall pay to PCT an amount in cash equal to the sum of (a) all expenses incurred
by PCT in any way in connection with investigating, negotiating,
drafting or otherwise pursuing this transaction, including a reasonable sum for
the time spent by its in-house personnel, plus (b) $2 million; provided,
however, that if (i) the breach results in consummation of a transaction in
which all of the equity or substantially all of the assets of PCT is also sold
to an unrelated third party in a transaction approved by the Board of Managers
and Members of PCT, or (ii) PCT waives the breach and consummates the Merger,
then no such liquidated damages shall be due.
(c) The
provisions of this Section 6.5 shall not adversely affect any party’s right or
ability to have the provisions of this Agreement specifically enforced pursuant
to Section 10.3
Section
6.6 Non-Competition and Confidentiality
Agreement.
(a) For
a period of four (4) years after the Closing Date, the Key Employees will not
(i) directly or indirectly, anywhere in the world, including but not limited to
the United States or the People’s Republic of China, engage in any manner
(including, without limitation, by owning any interest in, managing,
controlling, participating in (whether as an officer, director, employee,
partner, agent, representative, consultant or otherwise), rendering services to,
organizing, planning to organize, providing funding) in a business that is
competitive in any respect with NeoStem’s business or the PCT Business as
conducted as of the Closing Date (a “Competitive
Business”); (ii) directly or indirectly solicit business from any Person
who is, or within the immediately preceding twelve (12) months has been, a
customer or client of the PCT Group or (iii) directly or indirectly employ,
engage, contract for or solicit the services in any capacity of any Person who
is, or within the immediately preceding twelve (12) months has been, employed by
or providing services to the PCT Group in the operation of the PCT Business on
the date hereof.
(b) For
a period of two (2) years after the Closing Date, the Lock-Up Members and the
Key Employees agree that they will not, directly or indirectly, use for its or
his own benefit or divulge or convey to any third party, any Confidential
Information (as hereinafter defined) relating to the PCT Business, unless the
Confidential Information indisputably becomes of public knowledge or enters the
public domain (other than through such party’s direct or indirect act or
omission), or the disclosure of which is required by Law and reasonable written
notice has been provided to the Parent sufficient to enable the Parent to
contest the disclosure. For purposes of this Agreement, “Confidential
Information” consists of all information, knowledge or data relating to
the PCT Business including, without limitation, contacts in PCT’s databases,
customer and supplier lists, formulae, trade know-how, processes, secrets and
trade secrets, consultant contracts, pricing information, marketing plans,
product development plans, business acquisition plans and all other information
relating to the operation of the PCT Business not in the public domain or
otherwise publicly available. The term “Confidential Information”
does not include information that (a) is or becomes generally available to the
public other than as a result of (i) a wrongful disclosure by the person subject
to this limitation or its Affiliates, or its employees, officers, directors,
shareholders, principals, agents, advisors, contractors, subcontractors, or
representatives, or by any person in such capacity at any of its Affiliates
(collectively, “Agents”), or
(ii) a wrongful disclosure, to PCT’s Knowledge, by any other person under a duty
to keep such information confidential; (b) was actually known or becomes known
by the receiving party prior to or after disclosure hereunder as evidenced by
the receiving party’s tangible records; or (c) is developed or discovered by the
receiving party independently and solely without the use of any Confidential
information described hereunder.
(c) The
Key Employees and Lock-Up Members acknowledge that the restrictions contained in
this Section 6.6 are reasonable and necessary to protect the legitimate
interests of the Parent and that any breach by the Lock-Up Members or the Key
Employees of any provision hereof will result in irreparable injury to the
Parent. The Key Employees and Lock-Up Members acknowledge that, in
addition to all remedies available at law, the Parent shall be entitled to seek
equitable relief, including injunctive relief, and an equitable accounting of
all earnings, profits or other benefits arising from such breach and shall be
entitled to receive such other damages, direct or consequential, as may be
appropriate. The Parent shall not be required to post any bond or
other security in connection with any proceeding to enforce the provisions of
this Section 6.6. Without limiting the generality of Section 10.4, the
provisions of this Section 6.6 shall inure to the benefit of any subsequent
transferee of the PCT Business or any substantial portion thereof, whether or
not this Agreement is assigned to such transferee. The provisions of
this Section 6.6 shall survive the Closing. The covenants contained
herein are in addition to any other covenants which are signed or may be signed
by any Member or Key Employee as an employee or otherwise.
Section
6.7 Commercially Reasonable Efforts;
Further Assurances. Subject to the terms and conditions herein
provided, each of the parties hereto shall use commercially reasonable efforts
to take, or cause to be taken, all actions, and to do, or cause to be done, all
things reasonably necessary, proper or advisable under applicable Law to
consummate and make effective the transactions contemplated by this
Agreement. Each of the parties hereto will use their respective
commercially reasonable efforts to obtain the consents of all Governmental
Authorities and third parties necessary to the consummation of the transactions
contemplated by this Agreement. Without limiting the generality of
the foregoing, the parties will, as promptly as practicable, apply for and
diligently prosecute all applications for, and will use their commercially
reasonable efforts promptly to: (a) effect all necessary registrations and
filings, (b) defend any lawsuits or other legal proceedings, whether judicial or
administrative, whether brought derivatively or on behalf of third parties
(including Governmental Authorities or officials), challenging this Agreement or
the consummation of the transactions contemplated hereby and (c) furnish to each
other such information and assistance and to consult with respect to the terms
of any registration, filing, application or undertaking as reasonably may be
requested in connection with the foregoing. The provisions of this
Section 6.7 shall survive the Closing.
Section
6.8 Employment
Matters. All employment agreements and Benefit Arrangements to
which any Person in the PCT Group is a party, shall be disclosed on Schedule 4.16(a) and if so
disclosed continue in full force and effect after the Closing, unless the Parent
in its sole discretion on an individual contract by contract, or plan by plan,
basis requests for it to be terminated, in which case PCT will cause it to be
terminated without liability to PCT or Parent. If termination is
waived by Parent, each such employment agreement and Benefit Arrangement shall
remain in full force and effect after the Merger.
Section
6.9 Board of Directors of
NeoStem. As soon as reasonably practical after the Closing,
Andrew Pecora shall be invited to join the Board of Directors of Parent, and
Parent shall use its reasonable best efforts to cause Mr. Pecora to be appointed
to the Board of Directors and nominated for election as a director at its annual
meeting of shareholders when his initial term ends, provided however, that in
order to comply with the listing standards for the NYSE-Amex, simultaneously
with such appointment, and as a condition precedent, Parent also must find and
appoint to NeoStem’s Board of Directors, one (1) individual who meets all
conditions of independence imposed by the SEC and the NYSE-Amex, so that at all
times a majority of the members of NeoStem’s Board of Directors are
independent. If such an independent person is not found by Parent,
and has not agreed to be so designated and appointed, Parent and PCT shall work
together in good faith to find and designate another person acceptable to the
Parent, through the Nominating Committee of its Board of Directors, as an
independent director. Parent agrees that it will not delay the
appointment of Mr. Pecora by reason of such need to designate another
independent director for more than three (3) months after the Closing
Date..
Section
6.10 Waiver and Release of
Claims.
(a) Effective
as of the Closing, subject to the limitations set forth in Section 6.10(b), each
of the Lock-Up Members agrees that, on behalf of himself or itself and his
or its successors, assigns, representatives, administrators, executors and
agents, and any other person or entity claiming by, through, or under any of the
foregoing, he/it does hereby unconditionally and irrevocably release, waive and
forever discharge the Parent, Subco, PCT, PCT’s Subsidiaries and each
of their past and present members, directors, officers, employees, agents,
predecessors, successors, assigns, Subsidiaries and Affiliates, from any and all
claims, demands, damages, judgments, causes of action and liabilities of any
nature whatsoever, whether or not known, suspected or claimed, arising directly
or indirectly from any act, omission, event or transaction occurring (or any
circumstances existing) with respect to PCT or any of its Subsidiaries on or
prior to the Closing (collectively, “PCT Claims”), including
without limitation any and all PCT Claims arising out of or relating to: (i)
such individual’s capacity as a current or former shareholder, member, officer
or director, manager, employee or agent of PCT or any of its predecessors,
Subsidiaries or Affiliates (or his capacity as a current or former trustee,
director, officer, manager, employee or agent of any other entity in which
capacity he is or was serving at the request of PCT or any of its Subsidiaries);
or (ii) any contract, agreement or other arrangement (whether written or verbal)
with PCT or any of its Subsidiaries entered into or established prior to the
Closing, including any shareholders agreements, equity purchase agreements,
employment agreements or previous noncompetition agreements. PCT shall
procure similar releases from all Key Employees and other employees designated
by Parent at or prior to the Closing.
(b) Notwithstanding
the foregoing Section 6.10(a), no Lock-Up Member releases or discharges, and
each Lock-Up Member expressly does not release or discharge any PCT Claims
which arise out of or are in connection with any conduct on the part of PCT or
its Subsidiaries which arise under or are based upon the terms of this Agreement
or any other agreement executed or delivered in connection
herewith. For the avoidance of doubt, the release and discharge
provided by the Lock-Up Members in Section 6.10(a) shall be for the sole benefit
of the parties set forth therein and their respective successors, assigns and
legal representatives and is not intended, nor shall be construed, to give any
Person, other than such parties and their respective successors, assigns and
legal representatives, any legal or equitable right, remedy or claim
hereunder.
Section
6.11 Permits. To
the extent required by applicable Law, each Person in the PCT Group shall
cooperate with Parent and use best efforts to assure that PCT retains all
Permits required by it to operate the PCT Business, whether by way of renewal of
Permits held by Persons in the PCT Group or through obtaining new
Permits.
Section
6.12 PCT’s Affirmative
Covenants. Prior to the Closing, except as otherwise expressly
provided herein, PCT shall (and PCT shall cause each its Subsidiaries
to):
(a) conduct
its business only in the Ordinary Course of PCT’s Business;
(b) use
commercially reasonable efforts to keep in full force and effect its corporate
existence and all material rights, franchises, PCT Intellectual Property Rights
and goodwill relating or pertaining to its businesses;
(c) endeavor
to retain its employees and preserve its present relationships with customers,
suppliers, contractors, distributors and employees, and continue to compensate
its employees consistent with past practices;
(d) use
commercially reasonable efforts to maintain the PCT Intellectual Property Rights
so as not to affect adversely the validity or enforcement thereof; maintain its
other assets in customary repair, order and condition and maintain insurance
reasonably comparable to that in effect on the date of this
Agreement;
(e) maintain
its books, accounts and records in accordance with generally accepted accounting
principles;
(f) use
commercially reasonable efforts to obtain all authorizations, consents, waivers,
approvals or other actions and to make all filings and applications necessary or
desirable to consummate the transactions contemplated hereby, and to cause the
other conditions to NeoStem’s obligation to close to be satisfied;
and
(g) promptly
notify NeoStem in writing if, prior to the consummation of the Closing, to its
knowledge (a) any of the representations and warranties contained in Article IV
cease to be accurate and complete in all material respects or (b) PCT fails to
comply with or satisfy any material covenant, condition or agreement to be
complied with or satisfied by it hereunder; provided, however, that the delivery
of any notice pursuant to this Section 6.12 shall not limit or otherwise affect
the remedies available hereunder to NeoStem.
Section
6.13 NeoStem’s Affirmative
Covenants. Prior to the Closing, except as otherwise expressly
provided herein, Parent and Subco shall:
(a) conduct
its business only in the ordinary and regular course of business consistent with
past practices (it being understood that financing efforts are consistent with
past practice);
(b) use
commercially reasonable efforts to obtain all authorizations, consents, waivers,
approvals or other actions and to make all filings and applications necessary or
desirable to consummate the transactions contemplated hereby and to cause the
other conditions to PCT’s obligation to close to be satisfied; and
(c) promptly
notify PCT in writing if, prior to the consummation of the Closing, to its
knowledge (i) any of the representations and warranties contained in Article V
cease to be accurate and complete in all material respects or (ii) Parent fails
to comply with or satisfy any material covenant, condition or agreement to be
complied with or satisfied by it hereunder; provided, however, that the delivery
of any notice pursuant to this Section 6.13 shall not limit or otherwise affect
the remedies available hereunder to PCT.
Section
6.14 PCT’s Negative
Covenants. Prior to the Closing, without the prior written
consent of NeoStem or as otherwise expressly provided herein, PCT will not, and
PCT will cause its Subsidiaries not to:
(a) take
any action or omit to take any action which would result in PCT’s or any of its
Subsidiaries’ (i) incurring any trade accounts payable outside of the Ordinary
Course of Business or making any commitment to purchase quantities of any item
of inventory in excess of quantities normally purchased in the Ordinary Course
of PCT’s Business; (ii) increasing any of its indebtedness for borrowed money;
(iii) guaranteeing the obligations of any entity other than PCT’s Subsidiaries,
(iv) merging or consolidating with, purchasing substantially all of the assets
of, or otherwise acquiring any business or any proprietorship, firm,
association, limited liability company, corporation or other business
organization; (v) increasing the rate or type of compensation payable to any
officer, manager, employee or consultant of PCT or any of its Subsidiaries
(other than regularly scheduled increases in base salary consistent with prior
practice); (vi) entering into or amending any collective bargaining agreement or
other agreement related to employment (except as required by law), or creating
or modifying any pension or profit-sharing plan, bonus, deferred compensation,
death benefit, or retirement plan, or any other employee benefit plan, or
increasing the level of benefits under any such plan, or extending the
exercisability of any outstanding stock option or increasing or decreasing any
severance or termination pay benefit or any other fringe benefit; (vii) making
any representation to anyone indicating any intention of NeoStem to retain,
institute, or provide any employee benefit plans; (viii) declaring or paying any
dividend or making any distribution with respect to, or purchasing or redeeming,
membership interests of PCT; (ix) selling or disposing of any assets otherwise
than in the Ordinary Course of PCT’s Business; (x) making any capital
expenditures other than in the Ordinary Course of PCT’s Business consistent with
past practices and in no event in excess of $50,000 in the aggregate; (xi) after
the Registration Statement and/or Joint Proxy Statement is filed, issuing any
Shares or membership interests of any kind of PCT or its Subsidiaries, except
for PCT membership interests issuable upon exercise of a PCT Option or PCT
Warrant outstanding on the date hereof; (xii) issuing or granting any
subscriptions, options, rights, warrants, convertible securities or other
agreements or commitments to issue, or contracts or any other agreements
obligating PCT or its Subsidiaries to issue, any equity , or securities
convertible into any equity; (xiii) modifying, amending or terminating any
material PCT Contract other than in the Ordinary Course of PCT’s Business that
is consistent with past practices; or (xiv) entering into any other transaction
outside of the Ordinary Course of PCT’s Business;
(b) change
any method or principle of accounting in a manner that is inconsistent with past
practice, except to the extent required by generally accepted accounting
principles as advised by PCT’s regular independent accountants;
(c) take
any action that would likely result in the representations and warranties set
forth in Article IV becoming false or inaccurate in any material respect (or, as
to representations and warranties, which, by their terms, are qualified as to
materiality, becoming false or inaccurate in any respect);
(d) incur
any Indebtedness, or increase the outstanding amount of any existing
Indebtedness; provided however that the
principal amount of borrowings under the Real Estate Mortgage Loan may be
increased by up to $1 million so long as (i) all proceeds of such increase are
held by PCT for use in the Ordinary Course of PCT’s Business or used only to pay
(x) the $400,000 due to NNJCA and (y) up to $600,000 in accounts payable due in
the Ordinary Course of PCT’s Business, (ii) NeoStem consents to such
borrowings and (iii) prior to any advance, TD Bank as lender and the NJEDA have
consented to the Real Estate Mortgage Loan remaining in place as contemplated by
Section 7.2(c);
(e) incur
or create any encumbrances, liens, pledges or security interests on
assets;
(f) except
as contemplated herein, take any action or omit to take any action which would
materially interfere with NeoStem’s rights to compel performance of each of the
obligations of PCT under this Agreement;
(g) take
or omit to be taken any action, or permit any of its Affiliates to take or to
omit to take any action, which would reasonably be expected to result in a
Material Adverse Effect;
(h) grant
or otherwise issue any option, warrant or other securities exercisable for or
convertible into equity of PCT; or
(i) agree
or commit to take any action precluded by this Section 6.14.
Section
6.15 NeoStem’s Negative
Covenants. Prior to the Closing, without the prior written
consent of PCT or as otherwise expressly provided herein, NeoStem will
not:
(a) take
any action that would likely result in the representations and warranties set
forth in Article V becoming false or inaccurate in any material respect (or, as
to representations and warranties, which, by their terms, are qualified as to
materiality, becoming false or inaccurate in any respect);
(b) except
as contemplated herein, take any action or omit to take any action which would
materially interfere with PCT’s rights to compel performance of each of the
obligations of NeoStem under this Agreement; or
(c) agree
or commit to take any action precluded by this Section 6.15.
ARTICLE
VII
Conditions
to Closing
Section
7.1 Mutual
Conditions. The obligation of the Parent, Subco, and PCT to
consummate the transactions contemplated hereby is subject to the satisfaction
as of the Closing of the following conditions unless waived (to the extent that
such conditions can be waived) in writing by the Parent, Subco and
PCT:
(a) Laws. There
shall not be any Law in effect that would prevent the consummation of the
transactions contemplated by the Transaction Documents.
(b) Absence of
Litigation. There shall not be (i) any Order of any nature
issued by a Governmental Authority with competent jurisdiction directing that
the transactions provided for in the Transaction Documents or any material
aspect of them not be consummated as provided herein or therein, or (ii) any
Legal Proceeding pending wherein an unfavorable Order would prevent the
performance of any of the Transaction Documents or the consummation of any
material aspect of the transactions contemplated hereby or thereby, declare
unlawful any material aspect of the transactions contemplated by the Transaction
Documents or cause any material aspect of the transactions contemplated by the
Transaction Documents to be rescinded.
(c) Government
Approvals. All authorizations, consents, Orders or approvals
of, or declarations or filings with or expiration of waiting periods imposed by,
applicable Law necessary for the consummation of the transactions contemplated
hereby shall have been obtained or made or shall have occurred.
(d) Escrow
Agreement. The Escrow Agent, Parent and PCT shall have
executed the Escrow Agreement.
(e) Member
Approval. The requisite percentage of Members of PCT and the
stockholders of Parent shall have approved this Agreement and the Merger and
issuance of securities by Parent hereunder.
(f) Registration
Statement. The SEC shall have declared the Registration
Statement effective under the Securities Act, and no stop order or similar
restraining order suspending the effectiveness of the Registration Statement
shall be in effect and no proceedings for such purpose shall be pending before
or threatened by the SEC or any state securities administrator. The
shares of Parent Common Stock required to be issued pursuant to this Agreement
shall have been approved for listing on the NYSE-Amex or such other stock
exchange (the "Exchange") on which
the Parent Common Stock is listed or quoted, subject to official notice of
issuance.
Section
7.2 Conditions to the Obligations of the
Parent and Subco. The obligations of the Parent and Subco to
consummate the transactions contemplated by this Agreement shall be subject to
the fulfillment prior to or at Closing of each of the following
conditions:
(a) Representations and
Warranties; Performance of Covenants. Except for those representations
and warranties which are made as of a particular date, the representations and
warranties of PCT contained in this Agreement shall be true and correct in all
material respects (except with respect to those representations and warranties
which are qualified as to materiality, which shall be true and correct in all
respects) on the Closing Date. The representations and warranties of
PCT contained in this Agreement which are made as of a particular date shall be
true and correct in all material respects (except with respect to those
representations and warranties which are qualified as to materiality, which
shall be true and correct in all respects) as of such date. PCT, its
Subsidiaries and the Lock-Up Members shall have performed in all material
respects the agreements, covenants and obligations to be performed by them prior
to the consummation of the Closing.
(b) No Material
Events. Since the date hereof, there shall have been (i) no material
damage, destruction or loss to the PCT Business, regardless of insurance
coverage, and (ii) no other Material Adverse Effect.
(c) Consents. All
authorizations, consents, waivers, approvals or other actions legally required
in connection with the execution, delivery and performance by PCT of this
Agreement and the other PCT Documents and the consummation by PCT of the
transactions contemplated hereby and thereby shall have been obtained and shall
be in full force and effect; without limiting the foregoing, PCT shall have
obtained any authorizations, consents, waivers, approvals or other actions
required to prevent a breach or default by any Person in the PCT Group under any
Contract to which any Person in the PCT Group is a party or required for the
continuation of any agreement or Permit to which any Person in the PCT Group is
a party and which relates to the PCT Business, including without limitation all
authorizations, consents, waivers, approvals, licenses, PCT Permits or other
actions necessary to permit the Surviving Company to operate the PCT Business in
compliance with all applicable Laws immediately after the
Closing. Not in limitation of the foregoing, PCT shall deliver (i) a
consent from the lender and the New Jersey Economic Development Authority with
respect to the Real Estate Mortgage Loan on PCT’s Allendale, New Jersey real
estate permitting such loan to remain in full force and effect on the same
terms, (ii) a consent from Hackensack University Medical Center (“HUMC”) with
respect to all agreements between PTC and HUMC, (iii) landlord consents and
estoppel certificates from the landlords of each Leased Property, (iv) a consent
from Stem Cell Inc., (v) if requested by Parent and not previously delivered, a
consent to this Agreement from Nexell/Baxter/BioScience 2002, (vi) a consent
from ADP and (vii) a consent to each other agreement where consent is indicated
to be required on Schedule
4.16.
(d) NNJCA. PCT
shall deliver (i) a pay-off letter from NNJCA, and (ii) proof of simultaneous
payment by PCT or other third parties of the greater of (x) $400,000 or (y) a
sum such that the balance due to NNJCA is $3 million.
(e) Secretary’s
Certificate. PCT shall have delivered to the Parent a
certificate of the Secretary or Assistant Secretary of PCT, in form and
substance satisfactory to the Parent, certifying (i) resolutions of the managers
and Members of PCT approving this Agreement, the other PCT Documents and the
transactions contemplated hereby and thereby and (ii) the PCT LLC agreement and
other governing documents of PCT, as amended, and setting forth (I) such good
standing certificates as the Parent shall reasonably request, (II) a certified
copy of PCT’s certificate of formation, as amended, and (III) an incumbency
certificate with respect to all officers of PCT and its Subsidiaries executing
this Agreement, the other PCT Documents and/or any instrument or document
contemplated hereby or thereby.
(f) Valuation
Report. If requested by Parent, the Parent and Subco shall
have received from its investment banking firm an update to the Valuation Report
satisfactory to the Parent.
(g) Legal
Opinion. The Parent and Subco shall have received an opinion
or opinions from counsel to PCT in form and substance satisfactory to the Parent
and its counsel, including opinions with respect to the matters set forth in
Exhibit D.
(h) Comfort
Letter. The Parent and Subco shall have received a letter from
PCT’s independent auditors permitting Parent to include the GAAP Financial
Statements and its opinion with respect to such statements in Parent’s filings
with the SEC, as well as providing comfort as needed with respect to the Form
S-4 and any subsequent securities offerings by Parent.
(i) Employment
Agreements. The following persons shall have terminated all
existing employment agreements, except they shall not have terminated the new
employment agreements with PCT on terms acceptable to Parent and Subco being
entered into promptly following the execution of this Agreement (but conditional
on closing the Merger): Andrew Pecora, George Goldberger, Robert
Preti and Daryl LaSueur (the “Key
Employees”).
(j) Options and
Warrants. The Parent and Subco shall have received proof
reasonably satisfactory to them that all rights to acquire equity of any member
of the PCT Group or benefits similar to benefits of an equity holder, have been
exercised or terminated without liability to PCT or Parent.
(k) Non-Compete
Agreements. Each Key Employee shall have executed a
non-compete and non-solicitation agreement in form and substance satisfactory to
Parent.
(l) Non-Disclosure
Agreements. Each Key Employee, and each other employee
designated by Subco, shall have executed a non-disclosure and confidentiality
agreement and an assignment of inventions in form satisfactory to Parent and
Subco.
(m) Notices to Customers and
Suppliers. PCT shall have provided Parent with evidence of
delivery by them of a notice to suppliers and customers of the transactions
contemplated by this Agreement (as may be required under any agreements with
such suppliers or customers or as NeoStem otherwise deems
desirable). Such form of notice shall be delivered to Parent at least
15 days prior to the scheduled date of the NeoStem Meeting and have been
approved in advance by Parent, which consent shall not be unreasonably
withheld.
(n) Due
Diligence. The result of any and all due diligence, including,
but not limited to, legal due diligence, financial due diligence and business
due diligence, shall be satisfactory to NeoStem, in its sole discretion;
provided, however, that NeoStem’s right to terminate this Agreement pursuant to
this paragraph shall terminate upon mailing the Prospectus/Joint Proxy Statement
to the Members and NeoStem’s stockholders.
(o) Other Documents. PCT
and the Members shall have executed and delivered to the Parent the documents
set forth in Section 3.6(a) and such other documents or instruments as the
Parent reasonably requests to effect the transactions contemplated by this
Agreement and the other PCT Documents.
Section
7.3 Conditions to the Obligations of PCT
and the Members. The obligation of PCT to consummate the
transactions contemplated by this Agreement shall be subject to the fulfillment
at or prior to the Closing of each of the following conditions:
(a) Representations and
Warranties; Performance of Covenants. Except for those
representations and warranties which are made as of a particular date, the
representations and warranties of the Parent and Subco contained in this
Agreement shall be true and correct in all material respects (except with
respect to those representations and warranties which are qualified as to
materiality, which shall be true and correct in all respects) on the Closing
Date. The representations and warranties of the Parent and Subco
contained in this Agreement which are made as of a particular date shall be true
and correct in all material respects (except with respect to those
representations and warranties which are qualified as to materiality, which
shall be true and correct in all respects) as of such date. The
Parent and Subco shall have performed in all material respects the agreements,
covenants and obligations to be performed by them prior to the consummation of
the Closing.
(b) Consents. All
authorizations, consents, waivers, approvals or other actions legally required
in connection with the execution, delivery and performance by Parent and Subco
of this Agreement and the other Purchaser Documents and the consummation by
Parent and Subco of the transactions contemplated hereby and thereby shall have
been obtained and shall be in full force and effect.
(c) Secretary’s
Certificates. Prior to or at the Closing, the Parent shall
have delivered an executed certificate of the Secretary or Assistant Secretary
of the Parent, in form and substance satisfactory to PCT, certifying resolutions
of the governing body of the Parent and Subco approving this Agreement and
setting forth an incumbency certificate with respect to all officers of the
Parent and Subco executing this Agreement and any other Purchaser Document
and/or any instrument or document contemplated hereby or thereby.
(d) Employment
Agreements. The new employment agreements with PCT being
executed on or about this date by the following individuals, on terms acceptable
to Parent and Subco, shall not have been terminated by Parent other than for
Cause (as defined therein): Andrew Pecora, George Goldberger and
Robert Preti.
(e) Officer’s
Certificate. The Parent shall have delivered to PCT a
certificate from its CEO or CFO affirming the availability of funds to be able
to make the $3 million payment due to NNJCA within seven (7) days of the Closing
and that it will in fact make such payment.
(f) Other
Documents. The Parent or Subco, as applicable, shall have
executed and delivered to PCT the documents set forth in Section 3.6(b) and such
other documents or instruments as PCT reasonably requests to effect the
transactions contemplated by this Agreement or any other Purchaser
Document.
ARTICLE
VIII
Survival
of Representations and Warranties; Survival of Covenants;
Indemnification
Section
8.1 Survival of Representations,
Warranties and Covenants.
(a) Except
as set forth in the immediately succeeding sentences, the representations and
warranties provided for in this Agreement shall survive the Closing until the
date in 2012 that is two years after the Closing Date. The survival
period of each representation or warranty as provided in this Section 8.1 is
hereinafter referred to as the “Survival
Period.” Any claim in the nature of fraud, willful breach or
intentional misconduct or intentional misrepresentation or similar claim may be
made notwithstanding the end of the Survival Period so long as the statute of
limitations has not expired.
(b) The
covenants contained in this Agreement shall survive the Closing until they are
otherwise terminated by their respective terms.
(c) Any
representation, warranty, covenant or other agreement in respect of which
indemnity may be sought under this Article VIII, and the indemnity with respect
thereto, shall survive the time at which it would otherwise terminate pursuant
to this Section 8.1 if written notice of the claim giving rise to
such right or potential right of indemnity shall have been given to the PCT
Representative or the party against whom such indemnity may be sought prior to
such time and, in any such case, such representation, warranty, covenant or
other agreement shall survive until any claim for indemnity related to such
inaccuracy or breach or potential inaccuracy or breach is settled or resolved,
provided in each case that the claim is asserted in good faith.
(d) The
representations, warranties and covenants contained in this Agreement or in any
certificate or other writing delivered in connection with this Agreement shall
survive for the periods set forth in this Section 8.1 and shall in no event be
affected by any investigation, inquiry or examination made for or on behalf of
any party, or the knowledge of any party’s representatives or the acceptance by
any party of any certificate or opinion hereunder.
Section
8.2 Indemnification.
(a) The
Members (to the extent of their collective interest in the Escrow Account) shall
jointly and severally indemnify and hold harmless the Parent, Subco, their
Affiliates, and their officers, directors, employees, agents and
representatives, and any Person claiming by or through any of them (the “Parent Indemnified
Parties”), against and in respect of any and all claims, costs, expenses,
damages, liabilities, losses or deficiencies (including, without limitation,
counsel’s fees and other costs and expenses incident to any suit, action or
proceeding) (the “Damages”) arising out
of, resulting from or incurred in connection with (i) any inaccuracy in any
representation or the breach of any warranty made by PCT in this Agreement
(ignoring, for purposes of determining the existence of any such
misrepresentation or breach or the amount of Damages with respect thereto, any
“materiality”, “Material Adverse Effect” or similar qualifier set forth in such
representation or warranty), (ii) the breach by PCT of any covenant or agreement
to be performed by it hereunder, (iii) any Taxes relating to the PCT Business
with respect to any time prior to the Closing Date, (iv) any Excluded Liability,
(v) any liability arising from the operation of the PCT Business or services
provided by any Person in the PCT Group with respect to any time prior to the
Closing Date outside of the Ordinary Course of PCT’s Business, (vi) any claim by
any Person relating to any equity interest, or option, warrant or other right
exercisable, convertible or exchangeable into or for any equity interest of PCT,
(vii) any product liability claim by any Person relating to the PCT Business
with respect to any time prior to the Closing Date (to the extent not covered by
insurance), and (viii) any claim by any Person relating to the construction
projects with respect to any time prior to the Closing Date. The
Parent Indemnified Parties shall not be entitled to recover Damages from PCT or
its Members or any member(s) of the Knowledge Group for any claim for
indemnification pursuant to Section 8.2(a) first made after the expiration of
the Survival Period nor from any other source other than the Escrow Account,
except for claims in the nature of fraud, willful breach or intentional
misconduct or intentional misrepresentation.
(b) The
Parent shall indemnify and hold harmless the Members (the “PCT Indemnified
Parties”), against and in respect of any and all Damages arising out of,
resulting from or incurred in connection with (i) any inaccuracy in any
representation or the breach of any warranty made by the Parent and Subco in
this Agreement, or (ii) the breach by the Parent or Subco of any covenant or
agreement to be performed by such party hereunder. PCT Indemnified
Parties shall not be entitled to recover Damages from the Parent for any claim
for indemnification pursuant to Section 8.2(b) first made after the expiration
of the Survival Period.
(c) Any
Person providing indemnification pursuant to the provisions of this Section 8.2
is hereinafter referred to as an “Indemnifying Party”
and any Person entitled to be indemnified pursuant to the provisions of this
Section 8.2 is hereinafter referred to as an “Indemnified
Party.”
(d) Notwithstanding
anything to the contrary contained in this Agreement, the Parent may not seek
indemnification with respect to any claim for Damages until the aggregate amount
of all Damages for which the Parent is seeking indemnification under Section 8.2
equals or exceeds $100,000 (the "Threshold"),
whereupon the Parent shall be entitled to seek indemnification with respect to
all Damages exceeding the Threshold. Notwithstanding anything to the
contrary contained in this Agreement, the Members may not seek indemnification
with respect to any claim for Damages until the aggregate amount of all Damages
for which the Members are seeking indemnification under Section 8.2 equals or
exceeds the Threshold whereupon the Members, through the PCT Representative,
shall be entitled to seek indemnification with respect to all such Damages
exceeding the Threshold.
(e) The
liability of the Members or any member(s) of the Knowledge Group to the Parent
for all Damages for which indemnification is provided hereunder shall not exceed
the Escrow Account, except for any claims of fraud, willful breach, intentional
misconduct or intentional misrepresentation. The liability of the
Parent to the Members for all Damages for which indemnification is provided
hereunder shall not exceed $100,000, except for any claims of fraud, willful
breach, intentional misconduct or intentional misrepresentation. Any
claim for fraud, willful breach, intentional misconduct or intentional
misrepresentation, may be asserted jointly or severally against any of the
Members. Notwithstanding any provision herein to the contrary, no
limitation on a party’s liability provided for herein shall apply in the event
of the fraudulent conduct, willful breach, intentional misconduct, or
intentional misrepresentation of such party.
(f) If
and to the extent any provision of Section 8.2(a) is unenforceable for any
reason, the Members (to the extent of the Escrow Account other than in the case
of fraud) shall make the maximum contribution to the payment and satisfaction of
any Damages for which indemnification is provided for in Section 8.2(a) which is
permissible under applicable Laws, such amount not to exceed the amount
otherwise available under this Agreement if such provision were
enforceable. If and to the extent any provision of Section 8.2(b) is
unenforceable for any reason, the Parent hereby jointly and severally agree to
make the maximum contribution to the payment and satisfaction of any Damages for
which indemnification is provided for in Section 8.2(b) which is permissible
under applicable Laws, such amount not to exceed the amount otherwise available
under this Agreement if such provision were enforceable.
(g) For
the purposes of determining the amount of any Damages related to a breach of any
representation or warranty, the representations and warranties set forth in this
Agreement shall be considered without regard to any “material,” “Material
Adverse Effect”, or similar qualifications set forth therein.
Section
8.3 Procedures for Third Party
Claims. In the case of any claim for indemnification arising
from a claim of a third party, an Indemnified Party shall give prompt written
notice, following such Indemnified Party’s receipt of such claim or demand, to
the Indemnifying Party of any claim or demand of which such Indemnified Party
has knowledge and as to which it may request indemnification hereunder; provided, however,
that failure to give such notice will not affect such Indemnified Party’s rights
furnished hereunder unless, and then solely to the extent that, the rights of
the parties from whom indemnity is sought are materially prejudiced as a result
of such failure. The Indemnifying Party shall have the right to
defend and to direct the defense against any such claim or demand, in its name
or in the name of the Indemnified Party, as the case may be, at the expense of
the Indemnifying Party, and with counsel selected by the Indemnifying Party
provided that the Indemnifying Party shall have provided the Indemnified Party
with the prior written assumption, in form and substance reasonably acceptable
to the Indemnified Party, by the Indemnifying Party of any and all liability
with respect to the matter in controversy, unless (i) such claim or demand seeks
an order, injunction or other equitable relief against the Indemnified Party, or
(ii) the Indemnified Party shall have reasonably concluded that (x) there is a
conflict of interest between the Indemnified Party and the Indemnifying Party in
the conduct of the defense of such claim or demand or (y) the Indemnified Party
has one or more defenses not available to the Indemnifying
Party. Notwithstanding anything in this Agreement to the contrary,
the Indemnified Party shall, at the expense of the Indemnifying Party, cooperate
with the Indemnifying Party, and keep the Indemnifying Party fully informed, in
the defense of such claim or demand. The Indemnified Party shall have
the right to participate in the defense of any claim or demand with counsel
employed at its own expense; provided, however, that, in the case of any claim
or demand described in clause (i) or (ii) of the second preceding sentence or as
to which the Indemnifying Party shall not in fact have employed counsel to
assume the defense of such claim or demand, the reasonable fees and
disbursements of such counsel shall be at the expense of the Indemnifying
Party. The Indemnifying Party shall have no indemnification
obligations with respect to any such claim or demand which shall be settled by
the Indemnified Party without the prior written consent of the Indemnifying
Party, which consent shall not be unreasonably withheld or delayed. The
Indemnifying Party shall not settle any such claim without the prior written
consent of the Indemnified Party, unless such claim solely involves a claim for
monetary Damages and such settlement is accompanied by a document releasing the
Indemnified Party from all liability with respect to the matter in
controversy.
Section
8.4 Escrow
Account. Upon approval of this Agreement the Members shall be
deemed to have consented to the right of Parent or any Parent Indemnified Party
to collect from the Escrow Account the amount of any Damages payable to the
Parent or any of the Parent Indemnified Parties in accordance with this Article
VIII as and when the Parent or any of the Parent Indemnified Parties incurs or
suffers such Damages.
(a) Escrow Period; Release of
Escrow Account. The Escrow Account shall commence on the date
hereof and terminate on the date (the “Termination Date”) which is two
(2) years and one day after the Closing Date (the “Escrow Period”). PCT
has represented that the only Members who will have a material taxable gain as a
result of this transaction are Andrew Pecora, Robert Preti and George Goldberger
(the “Taxable
Members”). Pecora, Preti and Goldberger have membership
interests of approximately 17.9%, 17.9%, and 2.6%, respectively, or an aggregate
of 38.4% (the “Taxable
Percentage”). The Escrow Account will be divided into two
sub-accounts, the “Taxable Account”
representing a number of shares (rounded down to the nearest whole share) equal
to the Taxable Percentage times the Adjusted Stock Consideration, and the “Balance Account”
equal to a number of shares equal to the Adjusted Stock Consideration less the
number of shares in the Taxable Account.
(i) An
aggregate of up to 25% of the shares of Parent Common Stock in the Taxable
Account may be released from the Escrow Account and distributed to the Taxable
Members of PCT in accordance with their proportional interests on the 15th day
of the month that is at least one month after the Closing Date and at any time
thereafter. By way of example, if the Closing Date were October 1,
2010, then November 15, 2010, would be the commencement date for releases under
this paragraph. Prior to each release of shares from the Taxable
Member’s proportionate interest in the Taxable Account, a Taxable Member must
certify that (x) the Fair Market Value of the amount being withdrawn, plus the
Fair Market Value of all prior withdrawals (at the time of withdrawal) by such
Taxable Member through and including the date of such certification, is less
than the Taxable Member’s actual federal and state tax liability arising from
his taxable gain with respect to the Merger, (y) the number of shares of Parent
Common Stock being withdrawn, plus the number of shares previously withdrawn by
such Taxable Member through and including the date of the certification, is not
more than 25% of the number of shares represented by such Taxable Member’s
proportionate interest in the Taxable Account on the Closing Date and (z) there
are no impediments under federal or state securities laws, Parent's insider
trading policies, or otherwise, that would restrict a current sale of the shares
being withdrawn.
(ii) After
the date one (1) year after the Closing Date, a number of shares of Parent
Common Stock shall be released from the Escrow Account such that 5,600,000
shares of Parent Common Stock (50% of the Stock Consideration), plus any shares
then being held with respect to pending claims by NeoStem, will remain in the
Escrow Account. Shares subject to pending claims will be released to
the party entitled to such shares when the pending claim is finally resolved and
5,600,000 shares will remain in the Escrow Account until the Termination Date
(or later so that if any claims are pending at such Termination Date, as
provided in paragraph (iii) below). To effectuate the foregoing,
Parent and the PCT Representative will take into account all shares previously
released to the Taxable Members fro the Taxable Account, so that the percentage
of shares being released to Members other than the Taxable Members from the
Balance Account shall be equal to the sum of the percentage of shares being
released to the Taxable Members pursuant to this paragraph (ii) and the
percentage of shares previously released to the Taxable Members pursuant to
paragraph (i), and so that all the Members of PCT have the same
percentage interest in the remaining Escrow Account after the release pursuant
to this paragraph (ii) as they had when the Escrow Account was initially funded
at Closing.
(iii) As
soon as practical after the Termination Date, all shares of Parent
Common Stock then remaining in the Escrow Account shall be released and
distributed to the Members; provided that Parent Common Stock representing 120%
of the maximum amount of any claim made pursuant to Article VIII during the
Escrow Period shall be withheld and remain in the Escrow Account pending
resolution of such claim; provided, further, that the Parent Common Stock in the
Escrow Account which is necessary to satisfy any unsatisfied claims specified in
any Parent Notice theretofore delivered to the Escrow Agent prior to the
termination of the Escrow Period with respect to facts and circumstances
existing prior to the expiration of the Escrow Period, shall remain in the
Escrow Account until such claims have been resolved. Parent shall
direct the Escrow Agent to promptly distribute to PCT’s former Members any
portion of the Escrow Account at the Termination Date for which there is no
claim pending or unsatisfied pursuant to this Article VIII. All
shares of Parent Common Stock in the Escrow Account shall have been registered
on the Form S-4.
(b) Claims Upon Escrow
Account. Subject to the provisions of this Section 8.4, the
Parent or Subco may make claims upon the Escrow Account by delivering to the
Escrow Agent at any time on or before the last day of the Escrow Period a notice
signed by a representative of Parent or Subco (a “Parent Notice”) specifying
in reasonable detail the individual items of Damages for which indemnification
is being sought. Seven (7) calendar days after receipt by the Escrow
Agent of a Parent Notice, the Escrow Agent shall deliver to Parent, the number
of Shares held in the Escrow Account having a Fair Market Value equal to such
Damages. Parent shall, concurrent with the sending of any Parent
Notice to the Escrow Agent, provide a copy of such Parent Notice to the PCT
Representative. For purposes of this Agreement and the Escrow
Agreement, the “Fair Market Value” of one share
of Parent Common Stock shall equal the average per share closing price on the
NYSE-Amex of Parent Common Stock for the last three (3) trading days prior to
the date of such Parent Notice. Any payments made to an Indemnified
Person pursuant to this Article VIII or the Escrow Agreement shall be treated as
an adjustment to the total consideration being paid hereunder for Tax
purposes.
(c) Objections to
Claims.
(i) If
the PCT Representative shall deliver a written objection to a Parent Notice to
Parent and the Escrow Agent within the seven (7) calendar day period after
Parent or Subco’s delivery thereof, then Parent and the PCT Representative shall
use their good faith efforts to resolve such dispute. If Parent and
the PCT Representative resolve such dispute, the parties shall deliver a written
notice to the Escrow Agent directing the delivery of the applicable portion of
the Escrow Account based upon such resolution. In the event that no
objection is made by the PCT Representative as provided herein, the PCT
Representative, PCT and the Members shall have irrevocably waived any right to
object to such Parent Notice.
(ii) If
timely notice of such an objection is given and Parent and the PCT
Representative are unable to resolve the applicable dispute within thirty (30)
days after the PCT Representative objects to such Parent Notice, either Parent
or the PCT Representative may, by written notice to the other and the Escrow
Agent, demand arbitration of such dispute. Any such arbitration shall
be conducted by JAMS/Endispute, Inc. or such other alternative dispute service
(“Arbitration Service”) as shall be reasonably acceptable to Parent and the PCT
Representative. The Arbitration Service shall select one (1)
arbitrator reasonably acceptable to both Parent and the PCT Representative who
shall be expert in the area in dispute. The decision by the
arbitrator shall be binding and conclusive and, notwithstanding any other
provisions of this Section 8.4, the Escrow Agent shall be entitled to act in
accordance with such decisions and make delivery of the Escrow Account in
accordance therewith. The arbitration shall be held in New York, New
York. The costs of any such arbitration shall be borne one-half by
the Parent and one-half by the Members (out of the Escrow Account to the extent
available after all claims have been satisfied and shares
released). Judgment upon any award rendered by the arbitrator may be
entered in any court of competent jurisdiction.
Section
8.5 PCT
Representative.
(a) By
approval of the Merger at the PCT Meeting, each Member shall be deemed to
irrevocably constitute and appoint the PCT Representative as such Member’s
attorney-in-fact and agent in connection with the transactions contemplated by
this Agreement and the Escrow Agreement. This power is irrevocable
and coupled with an interest, and shall not be affected by the death,
incapacity, illness or other inability to act of any Member. Each
Member hereby irrevocably grants the PCT Representative full power and authority
on behalf of such Member, including, but not limited, to:
(i) execute
and deliver, and to accept delivery of, such documents as may be deemed by the
PCT Representative, in its sole discretion, to be appropriate to consummate the
transactions contemplated by this Agreement or the Escrow
Agreement;
(ii) certify
as to the accuracy of the representations and warranties of the Company and of
such Member under, or pursuant to the terms of, this Agreement and to deliver
such documents, instruments, certificates or agreements contemplated by this
Agreement on behalf of such Member;
(iii) (A)
dispute or refrain from disputing any claim made by the Parent and Subco under
this Agreement; (B) negotiate and compromise any dispute that may arise under,
and to exercise or refrain from exercising any remedies available under, this
Agreement and (C) execute any settlement agreement, release or other document
with respect to such dispute or remedy;
(iv) waive
any closing condition contained in Article VII and give or agree to any and all
consents, waivers, amendments or modifications deemed by the PCT Representative,
in its sole discretion, to be necessary or appropriate under this Agreement or
the Escrow Agreement, and, in each case, to execute and deliver any documents
that may be necessary or appropriate in connection therewith.
(v) enforce
any claim against the Parent and Subco arising under this
Agreement;
(vi) engage
attorneys, accountants and agents at the expense of the Members;
(vii) exercise
all rights of, and take all actions that may be taken by, the Members or any of
them hereunder or under the Escrow Agreement; and
(viii) give
such instructions and to take such action or refrain from taking such action as
the PCT Representative deems, in his sole discretion, necessary or appropriate
to carry out the provisions of, and to consummate the transactions contemplated
by, this Agreement.
(b) Notwithstanding
any other provision herein to the contrary, the Parent shall be able to rely
conclusively on the instructions and decisions of the PCT Representative as to
any matter requiring action or decision by PCT or the Members under this
Agreement or the Escrow Agreement, notwithstanding any dispute or disagreement
among the Members, without any liability to, or obligation to inquire of, any
Member, and notwithstanding any Knowledge on the part of the Parent and Subco of
any such dispute or disagreement. PCT and the Members shall not have
any cause of action against the Parent or any of its Affiliates for any action
taken by the Parent in reliance upon the instructions or decisions of the PCT
Representative. All actions, decisions and instructions of the PCT
Representative shall be conclusive and binding upon PCT and the Members and, in
the absence of fraud or intentional misconduct, neither PCT nor the Members
shall have any right to object, dissent, protest or otherwise contest the same
or have any cause of action against the PCT Representative for any action taken,
decision made or instruction given by the PCT Representative under this
Agreement, the Escrow Agreement or any other agreement contemplated
hereby.
(c) By
approval of the Merger at the PCT Meeting, each Member shall be deemed to agree
that:
(i)
notice to the PCT Representative, delivered in the manner provided herein, shall
be deemed to be notice to each Member for the purposes of this
Agreement;
(ii) the
authority of the PCT Representative, as described in this Agreement and the
Escrow Agreement, shall be effective until the rights and obligations of the PCT
Representative under this Agreement shall terminate by virtue of the termination
of any and all rights and obligations of such Member to the Parent and Subco
under this Agreement;
(iii) if
the PCT Representative is removed, resigns or otherwise ceases to function in
his capacity as such for any reason whatsoever, and no successor is appointed by
a majority-in-interest of the Members based on their Proportional Percentage
within thirty (30) days of such removal, resignation or otherwise, then the
Parent and Subco shall have the right to appoint a PCT Representative to serve
as described in this Agreement (who shall be a Member) and, under such
circumstances, the Parent and Subco and the Company shall be entitled to rely on
and all actions taken by such PCT Representative; and
(iv) the
PCT Representative shall not be liable to any Member for Losses with respect to
any action taken or any omission by the PCT Representative pursuant to this
Section 8.5 or the Escrow Agreement, except to the extent such Losses are caused
by the PCT Representative’s gross negligence or willful misconduct.
(d) Each
Member shall be deemed to have agreed that, notwithstanding the foregoing, at
the request of the Parent and Subco, he/she/it shall take all actions necessary
or appropriate to consummate the transactions contemplated by this Agreement
(including, without limitation, delivery of Shares and/or the letter of
transmittal contemplated by this Agreement and acceptance of the purchase price
in escrow at Closing) individually on his/her/its own behalf. Each
Member shall deliver to the PCT Representative, the Parent and its Transfer
Agent a letter of transmittal duly endorsed (signature guaranteed by a
commercial bank), to be held by the PCT Representative and delivered by the PCT
Representative to the Parent and Subco at the Closing if the Closing shall occur
or immediately after such Closing.
(e) Any
claim, action, suit or other proceeding, whether at law or in equity, to enforce
any right, benefit or remedy granted to Members under this Agreement shall be
asserted, brought, prosecuted, or maintained only by the PCT Representative on
behalf of the Members. Any claim, action, suit or other proceedings,
either at law or in equity, to enforce any right, benefit or remedy granted
under this Agreement, including, without limitation, any right of
indemnification provided in this Agreement, may be asserted, brought, prosecuted
or maintained by the Parent or Subco against the Member by service of process on
the PCT Representative and without the necessity of serving process on, or
otherwise joining or naming any other Member as a defendant in such action, suit
or other proceeding. With respect to any matter contemplated by this
Section, a Member shall be bound by any determination in favor of or against the
PCT Representative or the terms of any settlement or release to which the PCT
Representative shall become a party.
(f) Each
Member shall indemnify the PCT Representative against any Losses that the PCT
Representative may suffer or incur in connection with any action taken or any
omission by the PCT Representative, except to the extent such Losses were caused
by the PCT Representative’s gross negligence or willful misconduct.
ARTICLE
IX
Termination
Section
9.1 Termination. This
Agreement may be terminated and the Merger may be abandoned at any time prior to
the Effective Time (notwithstanding any approval of this Agreement by Parent’s
stockholders and/or PCT’s Members):
(a) by
mutual written consent of PCT and Parent;
(b) by
either PCT or Parent if there shall be any law or regulation that, as supported
by the written opinion of outside legal counsel, makes consummation of the
Merger illegal or otherwise prohibited, or if any judgment, injunction, order or
decree of a court or other competent Governmental Authority enjoining PCT or
Parent from consummating the Merger shall have been entered and such judgment,
injunction, order or decree shall have become final and non-appealable, provided
that the party seeking to terminate this Agreement shall have used reasonable
commercial efforts to remove or lift such injunction, order, decree or
ruling;
(c) by
Parent if the requisite vote (under all applicable Laws) of PCT’s Members to
approve the Merger and the transactions contemplated hereby shall not have been
obtained;
(d) by
Parent if the investment banking firm engaged to provide the Valuation Report,
acting in good faith and in accordance with recognized professional standards
consistent with prior practices, declines to provide Parent with an updated
Valuation Report as of the Closing Date if requested, in form and substance
reasonably satisfactory to Parent, or if in the reasonable judgment of the Board
of Directors of the Parent, the valuation of PCT is inconsistent or unfair to
Parent in relation to the consideration to be paid by Parent in the
Merger;
(e) by
either PCT or Parent if any representation or warranty made in this Agreement
(including without limitation the Company Disclosure Letter) for the benefit of
the other party is untrue in any material respect (other than representations
and warranties which are qualified as to materiality, which representations and
warranties will give rise to a right to terminate if untrue in any respect);
provided that, in each case, (i) the party seeking to terminate this Agreement
is not then in material breach of any material representation or warranty
contained in this Agreement, and (ii) such untrue representation or warranty
cannot be or has not been cured within 30 days after receipt of written notice
of such breach;
(f) by
either PCT or Parent if the other party shall have defaulted in the performance
of any material covenant or agreement set forth in this Agreement; provided
that, in each case, (i) the party seeking to terminate this Agreement has
complied with its covenants and agreements under this Agreement in all material
respects and (ii) such failure to comply cannot be or has not been cured within
30 days after receipt of written notice of such default;
(g) by
Parent if any authorization, consent, waiver or approval required for the
consummation of the transactions contemplated hereby shall impose any material
condition or requirement, which condition or requirement, in the reasonable
judgment of the Parent’s Board of Directors (or a committee thereof), would be
reasonably likely to have a Material Adverse Effect after the Effective Time
giving effect to consummation of the transactions contemplated by this
Agreement;
(h) by
Parent, in the event that the conditions to its obligations set forth in Article
VII have not been satisfied or waived by the date set for the Closing, provided
that Parent is not then in material breach of any material representation,
warranty, covenant or other agreement contained in this Agreement;
or
(i) by
PCT, in the event that the conditions to its obligations set forth in Article
VII have not been satisfied or waived by the date set for the Closing, provided
that PCT is not then in material breach of any material representation,
warranty, covenant or other agreement contained in this Agreement.
Section
9.2 Effect of
Termination. In the event of the termination of this Agreement
pursuant to Section 9.1, this Agreement, except for any provisions relating to
the confidentiality obligations of the parties hereto to each other, the
provisions of this Section 9.2, the provisions of Section 6.5 with respect to
the payment of liquidated damages and the first sentence of Section 10.2, shall
become void and have no effect, without any liability on the part of any party
or its directors, officers, stockholders or members. Notwithstanding
the foregoing, nothing in this Section 9.2 shall relieve any party to this
Agreement of liability for a breach of any material representation or covenant
expressly set forth herein.
Section
9.3 Termination Fee.
(a) In
the event this Agreement is terminated by the Parent or PCT pursuant to Section
9.1(j), PCT shall within two business days of such termination of this Agreement
pay to Parent in immediately available funds an amount in cash equal to the
liquidated damages due pursuant to Section 6.5(a).
(b) In
the event this Agreement is terminated by the Parent pursuant to Section 9.1(k),
then the Parent shall within two business days of such termination of this
Agreement pay to PCT in immediately available funds an amount in cash equal to
the liquidated damages due pursuant to Section 6.5(b).
ARTICLE
X
Miscellaneous
Section
10.1 Notices. All
notices and other communications hereunder will be in writing and will be deemed
received (a) on the date of delivery if delivered personally or by telecopy or
facsimile, (b) on the first Business Day following the date of dispatch if
delivered by a recognized next-day courier service, or (c) on the fifth Business
Day following the date of mailing if delivered by registered or certified mail,
return receipt requested, postage prepaid. All notices hereunder must
be delivered as set forth below, or pursuant to instructions as may be
designated in writing by the party to receive such notice:
If
to the Parent:
|
NeoStem,
Inc.
|
|
420
Lexington Avenue, Suite 450
|
|
New
York, NY 10107
|
|
Telephone:
212-584-4171
|
|
Facsimile:
646-514-7787
|
|
Attention:
|
Catherine
Vaczy, Esq.
|
|
|
Vice
President - General
Counsel
|
With
a copy to:
|
Lowenstein
Sandler PC
|
|
65
Livingston Avenue
|
|
Roseland,
NJ 07068
|
|
Telephone:
973-597-2564
|
|
Facsimile: 973-597-2565
|
|
Attention:
Alan Wovsaniker, Esq.
|
|
|
If
to PCT, the Affiliated
|
Hackensack
University Medical Center
|
Members
or the
|
20
Prospect Street
|
PCT
Representative:
|
Suite
400
|
|
Hackensack,
NJ 07601
|
|
Telephone: 201-996-5814
|
|
Facsimile: 201-996-9246
|
|
Attention: Dr.
Andrew Pecora
|
|
|
With
a copy to:
|
Epstein
Becker & Green, P.C.
|
|
1227
25th Street, N.W.
|
|
Suite
700
|
|
Washington,
D.C. 20037
|
|
Telephone: 202-861-0900
|
|
Facsimile: 202-296-2882
|
|
Attention: Robert
D. Reif, Esq.
|
|
|
If
to the Escrow
|
|
Agent:
|
Continental
Stock Transfer
|
|
As
provided in the Escrow
Agreement
|
Section
10.2 Expenses. Unless
the transactions provided for in this Agreement are consummated, each party
hereto shall pay its own expenses incident to this Agreement and the
transactions contemplated hereby. If the PCT Expenses exceed the
amount projected for such expenses in the Estimated Closing Balance Sheet, the
Stock Consideration shall be reduced on a dollar for dollar basis by the excess
in accordance with Section 3.3 of this Agreement.
Section
10.3 Governing Law; Consent to
Jurisdiction; Injunctive Relief.
(a) This
Agreement will be governed in all respects, including but not limited to, as to
validity, interpretation and effect, by the internal laws of the State of New
York, without giving effect to its principles or rules of conflict of laws (to
the extent such principles or rules are not mandatorily applicable by statute
and would require or permit the application of the laws of another
jurisdiction).
(b) Notwithstanding
anything to the contrary set forth herein or elsewhere, the parties agree that
irreparable damage would occur in the event that any of the provisions of this
Agreement were not performed in accordance with their specific terms or were
otherwise breached. It is accordingly agreed that the parties will be
entitled to an injunction or injunctions to prevent breaches of this Agreement
and to enforce specifically the terms and provisions of this Agreement in any
court of the United States of America sitting in New York City, this being in
addition to any other remedy to which they are entitled at law or in
equity. Each of the parties hereto hereby irrevocably and
unconditionally submits, for itself and its property, to the exclusive
jurisdiction of any New York state court or federal court of the United States
of America sitting in New York City, and any appellate court from any thereof,
in any action or proceeding arising out of or relating to this Agreement or the
transactions contemplated hereby or for recognition or enforcement of any
judgment relating thereto, and each of the parties hereto hereby irrevocably and
unconditionally agrees that all claims in respect of any such action or
proceeding may be heard and determined in such New York state court or, to the
extent permitted by Law, in such federal court. Each of the parties
hereto agrees that a final judgment in any such action or proceeding will be
conclusive and may be enforced in other jurisdictions by suit on the judgment or
in any other manner provided by Law.
(c) Each
party to this Agreement irrevocably consents to service of process in the manner
provided for notices in Section 10.1. Nothing in this Agreement will
affect the right of any party to this Agreement to serve process in any other
manner permitted by Law.
Section
10.4 Assignment; Successors and Assigns;
No Third Party Rights. Except as otherwise provided herein,
this Agreement may not be assigned, and any attempted assignment shall be null
and void. The Parent may assign all of its rights under this
Agreement to any Affiliate of the Parent or any third party that acquires all or
substantially all of the assets of the Parent, or more than 50% of the
outstanding stock of the Parent, whether by sale, consolidation, merger or
otherwise; provided that the assignee assumes all of the obligations of the
Parent hereunder. This Agreement shall be binding upon and inure to
the benefit of the parties hereto and their respective successors, assigns and
legal representatives. This Agreement shall be for the sole benefit
of the parties to this Agreement and their respective successors, assigns and
legal representatives and is not intended, nor shall be construed, to give any
Person, other than the parties hereto and their respective successors, assigns
and legal representatives, any legal or equitable right, remedy or claim
hereunder; provided, however, that Article
VIII shall also be for the benefit of the Parent Indemnified Parties and PCT
Indemnified Parties.
Section
10.5 Counterparts;
Facsimile. This Agreement may be executed in one or more
counterparts, by facsimile or otherwise. Each such counterpart shall be deemed
an original agreement, but all of which together shall constitute one and the
same instrument.
Section
10.6 Headings. The
headings in this Agreement are for reference purposes only, and shall not in any
way affect the meaning or interpretation of this Agreement.
Section
10.7 Entire
Agreement. This Agreement, including the Schedules and
Exhibits attached thereto, constitutes the entire agreement among the parties
with respect to the matters covered hereby and supersedes all previous written,
oral or implied understandings among them with respect to such
matters.
Section
10.8 Amendment and
Modification. This Agreement may only be amended or modified
in a writing signed by the party against whom enforcement of such amendment or
modification is sought.
Section
10.9 Public
Announcement. Except for the current report on Form 8-K that
the Parent will file with the SEC within four business days following the date
of this Agreement and except as may otherwise be required by Law or requirements
of any national securities exchange on which the Parent Common Stock is quoted
or listed, prior to the Closing, neither the Parent, PCT nor the Members shall
issue any press release or otherwise make any public disclosures regarding this
Agreement or the transactions contemplated hereby or any dealings between or
among the parties in connection with the subject matter hereof without the prior
written approval of the other party. In the event that any such press
release or other public disclosure shall be required by Law or applicable
Exchange requirements, PCT shall consult in good faith with the Parent with
respect to the form and substance of such release or other disclosure prior to
the public dissemination thereof if time permits and if such consultation is
permitted by Law.
Section
10.10 Waiver. Any of the
terms or conditions of this Agreement may be waived at any time by the party or
parties entitled to the benefit thereof, but only by a writing signed by the
party or parties waiving such terms or conditions.
Section
10.11 Severability. The invalidity
of any portion hereof shall not affect the validity, force or effect of the
remaining portions hereof. If it is ever held that any restriction
hereunder is too broad to permit enforcement of such restriction to its fullest
extent, such restriction shall be enforced to the maximum extent permitted by
Law.
Section
10.12 Joint Negotiation and
Drafting. The parties hereto have participated jointly in the
negotiation and drafting of this Agreement and the agreements ancillary hereto
and, in the event that an ambiguity or question of intent or interpretation
arises, this Agreement and the agreements ancillary hereto shall be construed as
jointly drafted by the parties hereto or thereto and no presumption or burden of
proof shall arise favoring or disfavoring any party by virtue of the authorship
of any provision of this Agreement or of any of the agreements ancillary
hereto.
Section
10.13 Risk of
Loss. Prior to the consummation of the Closing, the risk of
loss with respect to the PCT Business shall remain with PCT. In the
event of any material casualty prior to the consummation of the Closing, in
addition to any other rights the Parent may have hereunder, the Parent shall
have the right to terminate this Agreement upon giving written notice of its
election to terminate to PCT.
Section
10.14 Schedules. All
references herein to Schedules refer to the disclosure schedules delivered by
PCT to the Parent contemporaneous with the execution of this
Agreement.
Section
10.15 Waiver of Trial by Jury. EACH
PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY THAT MAY ARISE UNDER THIS
AGREEMENT OR ANY AGREEMENT EXECUTED PURSUANT TO THIS AGREEMENT IS LIKELY TO
INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE IT HEREBY IRREVOCABLY
AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT
OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS
AGREEMENT OR ANY AGREEMENT EXECUTED PURSUANT TO THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY. EACH PARTY CERTIFIES AND
ACKNOWLEDGES THAT (i) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER
PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT,
IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER, (ii) IT
UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVER, (iii) IT MAKES
SUCH WAIVER VOLUNTARILY, AND (iv) IT HAS BEEN INDUCED TO ENTER INTO THIS
AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS
SECTION 10.15.
[Balance
of this page intentionally blank]
IN WITNESS WHEREOF, the
parties hereto have caused this Agreement to be duly executed as of the date
first above written.
|
NEOSTEM,
INC.
|
|
|
|
By:
|
/s/
Robin Smith |
|
|
Name:
Robin Smith
|
|
|
Title: CEO
|
|
PROGENITOR
CELL THERAPY, LLC
|
|
|
|
By:
|
/s/
Andrew Pecora |
|
|
Name:
Andrew Pecora
|
|
|
Title: Chairman &
CEO
|
|
NBS
ACQUISITION COMPANY LLC
|
|
|
|
By:
|
/s/
Robin Smith |
|
|
Name:
Robin Smith
|
|
|
Title: CEO
|
|
|
|
|
/s/
Andrew Pecora |
|
Andrew
Pecora, as PCT
Representative
|
The
undersigned hereby consent and agree to all the covenants set forth in Section
6.6 and the releases contained in Section 6.10 effective upon the Closing of the
Merger.
|
/s/ Andrew
Pecora
|
|
Andrew
Pecora
|
|
|
|
/s/ Robert
Preti
|
|
Robert
Preti
|
|
|
|
/s/ George
Goldberger
|
|
George
Goldberger
|
|
|
|
/s/ Daryl
LeSueur
|
|
Daryl
LeSueur
|
The
undersigned hereby consent and agree to the covenants set forth in Section
6.6(b) and the releases contained in Section 6.10 effective upon the Closing of
the Merger.
|
HACKENSACK
UNIVERSITY MEDICAL CENTER
|
|
|
|
By:
|
/s/
Robert Garrett |
|
|
Name:
Robert Garrett
|
|
|
Title: President and CEO
|
|
|
|
/s/ Harry D.
Harper
|
|
Harry
D. Harper
|
|
|
|
/s/ Andrew A.
Jennis
|
|
Andrew
A. Jennis
|
|
|
|
/s/ Mark S.
Pascal
|
|
Mark
S. Pascal
|
|
|
|
/s/ Richard J.
Rosenbluth
|
|
Richard
J. Rosenbluth
|
|
|
|
|
|
Stanley
E. Waintraub
|
|
|
|
/s/ Marc Beer
|
|
Marc
Beer
|
|
|
|
/s/ Dempsey
Gable
|
|
Dempsey
Gable
|
TABLE OF
CONTENTS
|
|
PAGE
|
|
|
|
ARTICLE
I DEFINITIONS; INTERPRETATIONS
|
|
1
|
|
|
|
Section 1.1 Definitions
|
|
1
|
Section
1.2 Other
Definitions
|
|
9
|
Section
1.3 Interpretation
|
|
11
|
|
|
|
ARTICLE
II THE MERGER
|
|
11
|
|
|
|
Section 2.1 The
Merger
|
|
11
|
Section
2.2 Effective
Time
|
|
11
|
Section
2.3 Effects
of the Merger
|
|
11
|
Section
2.4 Certificate
of Formation and Operating Agreement
|
|
11
|
Section
2.5 Managers
and Officers of the Surviving Company
|
|
12
|
|
|
|
ARTICLE
III CONVERSION AND DISTRIBUTION OF
SECURITIES
|
|
12
|
|
|
|
Section
3.1 Conversion
of Capital Stock
|
|
12
|
Section
3.2 Payments
by the Parent
|
|
13
|
Section
3.3 Adjustment
to Total Consideration
|
|
13
|
Section
3.4 Distributions;
Exchange Ratio; Fractional Shares;
Adjustments
|
|
16
|
Section
3.5 Delivery
of Certificates to Escrow Agent
|
|
17
|
Section
3.6 Document
Deliveries at the Closing
|
|
17
|
Section
3.7 Allocation
of the Consideration
|
|
18
|
Section 3.8 Insurance
|
|
19
|
|
|
|
ARTICLE
IV REPRESENTATIONS AND WARRANTIES OF
PCT
|
|
19
|
|
|
|
Section
4.1 Organization,
Good Standing and Qualification
|
|
19
|
Section
4.2 Authorization
|
|
19
|
Section
4.3 Non-contravention
|
|
20
|
Section 4.4 No
Consents
|
|
20
|
Section 4.5 PCT
Assets
|
|
20
|
Section
4.6 Personal
Property
|
|
20
|
Section
4.7 Real
Property
|
|
20
|
Section
4.8 Absence
of Questionable Payments
|
|
22
|
Section
4.9 Financial
Statements; Books and Records; Accounts Receivable; Funded
Indebtedness
|
|
23
|
Section
4.10 Internal
Control over Financial Reporting
|
|
24
|
Section
4.11 Capitalization;
Votes
|
|
24
|
Section
4.12 No
Undisclosed Liabilities
|
|
25
|
Section
4.13 Absence
of Certain Developments
|
|
25
|
Section 4.14 Taxes
|
|
25
|
Section
4.15 Intellectual
Property
|
|
27
|
Section
4.16 Material
Contracts
|
|
28
|
Section
4.17 Employee
Benefits Plans
|
|
31
|
Section 4.18 Labor
|
|
33
|
Section 4.19 Litigation
|
|
34
|
Section
4.20 Compliance
with Laws; Orders; Permits
|
|
35
|
Section 4.21 Insurance
|
|
37
|
Section
4.22 Related
Party Transactions
|
|
37
|
Section
4.23 Suppliers
and Customers
|
|
38
|
Section
4.24 Financial
Advisors
|
|
38
|
Section
4.25 Environmental
Matters
|
|
38
|
Section
4.26 Construction
Projects
|
|
38
|
Section
4.27 Registration
Statement; Prospectus/Joint Proxy Statement
|
|
38
|
Section 4.28 FINRA
|
|
39
|
Section
4.29 Full
Disclosure
|
|
39
|
|
|
|
ARTICLE
V REPRESENTATIONS AND WARRANTIES OF THE PARENT AND
SUBCO
|
|
39
|
|
|
|
Section
5.1 Organization
and Good Standing
|
|
39
|
Section
5.2 Authorization
|
|
39
|
Section
5.3 Conflicts;
Consents of Third Parties
|
|
40
|
Section 5.4 Litigation
|
|
40
|
Section
5.5 Financial
Advisors
|
|
40
|
Section
5.6 Compliance
with Laws; Orders; Permits
|
|
40
|
Section
5.7 Registration
Statement; Prospectus/Joint Proxy Statement
|
|
41
|
|
|
|
ARTICLE
VI COVENANTS AND AGREEMENTS
|
|
41
|
|
|
|
Section
6.1 Meetings of
Stockholders and Members
|
|
41
|
Section
6.2 Preparation
of the Prospectus/Joint Proxy Statement and the Registration
Statement
|
|
42
|
Section
6.3 Financial
Statements for NeoStem Current Report on Form
8-K
|
|
43
|
Section
6.4 Access and
Information
|
|
44
|
Section
6.5 No
Solicitation
|
|
45
|
Section
6.6 Non-Competition and
Confidentiality Agreement
|
|
47
|
Section
6.7 Commercially
Reasonable Efforts; Further Assurances
|
|
48
|
Section
6.8 Employment
Matters
|
|
48
|
Section
6.9 Board of
Directors of NeoStem
|
|
48
|
Section
6.10 Waiver and
Release of Claims
|
|
49
|
Section 6.11 Permits
|
|
49
|
Section
6.12 PCT’s
Affirmative Covenants
|
|
49
|
Section
6.13 NeoStem’s
Affirmative Covenants
|
|
50
|
Section
6.14 PCT’s
Negative Covenants
|
|
50
|
Section
6.15 NeoStem’s
Negative Covenants
|
|
52
|
|
|
|
ARTICLE
VII CONDITIONS TO CLOSING
|
|
52
|
|
|
|
Section
7.1 Mutual
Conditions
|
|
52
|
Section
7.2 Conditions to
the Obligations of the Parent and Subco
|
|
53
|
Section
7.3 Conditions to
the Obligations of PCT and the Members
|
|
55
|
ARTICLE
VIII SURVIVAL OF REPRESENTATIONS AND WARRANTIES; SURVIVAL OF
COVENANTS; INDEMNIFICATION
|
|
56
|
|
|
|
Section
8.1 Survival of
Representations, Warranties and Covenants
|
|
56
|
Section
8.2 Indemnification
|
|
57
|
Section
8.3 Procedures
for Third Party Claims
|
|
59
|
Section
8.4 Escrow
Account
|
|
59
|
Section
8.5 PCT
Representative
|
|
61
|
|
|
|
ARTICLE
IX TERMINATION
|
|
63
|
|
|
|
Section 9.1 Termination
|
|
64
|
Section
9.2 Effect of
Termination
|
|
65
|
Section
9.3 Termination
Fee
|
|
65
|
|
|
|
ARTICLE
X MISCELLANEOUS
|
|
65
|
|
|
|
Section 10.1 Notices
|
|
65
|
Section 10.2 Expenses
|
|
66
|
Section
10.3 Governing
Law; Consent to Jurisdiction; Injunctive
Relief
|
|
66
|
Section
10.4 Assignment;
Successors and Assigns; No Third Party
Rights
|
|
67
|
Section
10.5 Counterparts;
Facsimile
|
|
67
|
Section 10.6 Headings
|
|
67
|
Section
10.7 Entire
Agreement
|
|
67
|
Section
10.8 Amendment
and Modification
|
|
67
|
Section
10.9 Public
Announcement
|
|
68
|
Section 10.10 Waiver
|
|
68
|
Section 10.11 Severability
|
|
68
|
Section
10.12 Joint
Negotiation and Drafting
|
|
68
|
Section 10.13 Risk
of Loss
|
|
68
|
Section 10.14 Schedules
|
|
68
|
Section
10.15 Waiver of
Trial by Jury
|
|
69
|
LIST OF
EXHIBITS
Exhibit
A
|
Voting
Agreement
|
Exhibit
B
|
Form
of Escrow Agreement
|
Exhibit
C
|
Form
of Warrants
|
Exhibit
D
|
Form
of Counsel Opinion
|
Exhibit
A
VOTING
AGREEMENT
VOTING
AGREEMENT dated September 23, 2010 (the “Voting Agreement”) by
and between NEOSTEM, INC., a Delaware corporation (the "Parent”), PROGENITOR
CELL THERAPY, LLC, a Delaware limited liability company (the “Company”), and the
individuals or entities listed on Schedule A annexed
hereto (collectively, the “Voting Members” and
each individually, a “Voting
Member”).
RECITALS
WHEREAS,
immediately prior to the execution of this Voting Agreement, the Company, Parent
and NBS Acquisition Company, (“Subco”), a Delaware
limited liability company and a wholly owned subsidiary of Parent, have entered
into an Agreement and Plan of Merger dated of even date herewith (as amended
from time to time, the “Merger Agreement”)
pursuant to which Subco will be merged with and into the Company, with the
Company continuing as the surviving company and as a direct wholly owned
subsidiary of Parent (the “Merger”);
WHEREAS,
the Voting Members are the record and beneficial owners of certain membership
interests of the Company (the “Shares”),
representing interests as members of the Company in the amounts and percentages
set forth opposite each Voting Member's name on Schedule A hereto;
and
WHEREAS,
as an inducement and a condition to entering into the Merger Agreement, Parent
desires that each of the Voting Members agree, and each of the Voting Members is
willing to agree, to enter into this Voting Agreement.
NOW,
THEREFORE, in consideration of the foregoing and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parent, the Company and each of the Voting Members, intending to be legally
bound, hereby agree as follows:
1. Certain
Definitions. In addition to the terms defined elsewhere
herein, capitalized terms used and not defined herein have the respective
meanings ascribed to them in the Merger Agreement. For purposes of
this Voting Agreement:
|
(a)
|
“Beneficially Own” or
“Beneficial
Ownership” with respect to any securities means having “beneficial
ownership” of such securities as determined pursuant to Rule 13d-3 under
the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
including pursuant to any agreement, arrangement or understanding, whether
or not in writing. Without duplicative counting of the same
securities by the same holder, securities Beneficially Owned by a Person
shall include securities Beneficially Owned by all other Persons with whom
such Person would constitute a “group” within the meaning of Section
13(d)(3) of the Exchange Act.
|
|
(b)
|
“Person” means any
individual, corporation, partnership, limited liability company, joint
venture, association, joint stock company, trust (including any
beneficiary thereof), unincorporated organization or government or any
agency or political subdivision
thereof.
|
2. Disclosure. Each
of the Voting Members hereby agrees to permit the Company and Parent to publish
and disclose in the Prospectus/Proxy Statement, and any press release or other
disclosure document which Parent and the Company reasonably determine to be
necessary or desirable in connection with the Merger and any transactions
related thereto, each Voting Member's identity and ownership of the Shares and
the nature of each Voting Member's commitments, arrangements and understandings
under this Voting Agreement.
3. Voting of Membership
Interests.
(a) Each
of the Voting Members irrevocably agrees to vote in favor of the Merger and the
terms of the Merger Agreement.
(b) Each
of the Voting Members consents to the provisions in the Merger Agreement which
provide for the creation of the Escrow Account and the terms of the Escrow
Agreement annexed to the Merger Agreement.
(c) Each
of the Voting Members hereby agrees that, during the period commencing on the
date hereof and continuing until the first to occur of (x) the Effective Time of
the Merger or (y) the taking by the Board of Managers of the Company of any
action permitted under the Merger Agreement properly to terminate the Merger
Agreement in accordance with its terms (the “Termination Date”),
at any meeting of the holders of the Shares, however called, or in connection
with any written consent of the holders of the Shares, he shall vote (or cause
to be voted) the Shares held of record or Beneficially Owned by the Voting
Member, whether now owned or hereafter acquired: (i) in favor of approval of the
Merger, adoption of the Merger Agreement and any actions required in furtherance
thereof and hereof, (ii) against any action or agreement that would result in a
breach in any respect of any covenant, representation or warranty, or any other
obligation or agreement, of the Company under the Merger Agreement or any Voting
Member under this Voting Agreement and (iii) except as otherwise agreed to in
writing in advance by Parent, against the following actions (other than the
Merger and the transactions contemplated by this Voting Agreement and the Merger
Agreement): (A) any extraordinary corporate transaction, such as a merger,
consolidation or other business combination involving the Company, (B) a sale,
lease or transfer of a material amount of assets of the Company, or a
reorganization, recapitalization, dissolution or liquidation of the Company;
(C)(1) any change in a majority of the individuals who constitute the Company's
board of managers; (2) any change in the present capitalization of the Company
or any amendment of the Company's Certificate of Formation or LLC Agreement; (3)
any material change in the Company's limited liability company structure or
business; or (4) any other action which, in the case of each of the matters
referred to in clauses (C)(1), (2) or (3), is intended, or could reasonably be
expected, to impede, interfere with, delay, postpone, or materially and
adversely affect the Merger and the transactions contemplated by this Voting
Agreement and the Merger Agreement.
(d) To
the extent that any Voting Member holds any options, warrants or other rights to
acquire securities of the Company, the Voting Member consents to the treatment
of such securities under the Merger Agreement and agrees to exercise and/or
cancel any options or warrants as provided in the Merger Agreement within 10
days of the date hereof.
(e) Each
of the Voting Members agrees that upon the vote of the Voting Members at the
meeting of Members in accordance with Section 3(a), notwithstanding anything
else in any agreement to the contrary, (i) no further consent of or notice to
the Voting Members shall be required in connection with the Company’s execution
of the Merger Agreement or consummation of the transactions contemplated
thereby, including, without limitation, the Merger and (ii) neither the
Company’s execution of the Merger Agreement or consummation of the transactions
contemplated thereby, including, without limitation, the Merger, shall trigger,
or give any legal rights except as contemplated by the Merger
Agreement.
4. Covenants, Representations and
Warranties of the Company and each Voting Member. The Company
represents and warrants to Parent, and each Voting Member represents and
warrants to Parent severally with respect to the securities held by it, that to
the best of its knowledge, (a) the Board of Managers of the Company has
unanimously approved the Merger Agreement, the Merger and the other transactions
contemplated thereby and related thereto, (b) the signatories to this Voting
Agreement, as listed on Schedule A,
constitute (i) the holders of more than 51% of the Shares of the Company and
(ii) the holders of more than 51% of the Shares of the Company owned by the
Charter Members (as defined in the PCT LLC Agreement), and (c) that the
percentages set forth in the preceding clauses (i) and (ii) reflect more than
the requisite votes needed for the approval by the Company and its Members of
the Merger Agreement, the Merger and the other transactions contemplated by the
Merger Agreement so that, if and upon the vote at a meeting of Members by the
signatories to this Voting Agreement consistent with this Voting Agreement, the
Merger Agreement, the Merger, the other transactions contemplated by the Merger
Agreement and all matter related thereto will receive all requisite approvals
under the PCT LLC Agreement, Delaware law and otherwise. Each of the
Voting Members hereby severally represents and warrants (with respect to such
Voting Member only and not with respect to each other Voting Member) to, and
agrees with, Parent as follows:
|
(a)
|
Ownership of
Securities. Such Voting Member is the sole record and
Beneficial Owner of the number of shares set forth opposite such Voting
Member's name on Schedule A
hereto. On the date hereof, the Shares set forth opposite the
Voting Member's name on Schedule A
hereto constitute all of the Shares or other securities of the Company
owned of record or Beneficially Owned by such Voting Member or with
respect to which such Voting Member has voting power by proxy, voting
agreement, voting trust or other similar instrument. Such
Voting Member has sole voting power and sole power to issue instructions
with respect to the matters set forth in Section 3 hereof, sole power of
disposition, sole power of conversion, sole power to demand and waive
appraisal rights and sole power to agree to all of the matters set forth
in this Voting Agreement, in each case with respect to all of the Shares
set forth opposite such Voting Member's name on Schedule A
hereto, with no limitations, qualifications or restrictions on such
rights, subject to applicable securities laws, and the terms of this
Voting Agreement.
|
|
(b)
|
Authorization. Such
Voting Member has the legal capacity, power and authority to enter into
and perform all of such Voting Member's obligations under this Voting
Agreement. The execution, delivery and performance of this
Voting Agreement by such Voting Member will not violate any other
agreement to which such Voting Member is a party including, without
limitation, any voting agreement, membership agreement, voting trust,
trust or similar agreement. This Voting Agreement has been duly
and validly executed and delivered by such Voting Member and constitutes a
valid and binding agreement enforceable against such Voting Member in
accordance with its terms. There is no beneficiary or holder of
a voting trust certificate or other interest of any trust of which such
Voting Member is a trustee whose consent is required for the execution and
delivery of this Voting Agreement or the consummation by such Voting
Member of the transactions contemplated hereby. If such Voting
Member is married and such Voting Member's Shares constitute community
property, this Voting Agreement has been duly authorized, executed and
delivered by, and constitutes a valid and binding agreement of, such
Voting Member's spouse, enforceable against such person in accordance with
its terms.
|
|
(c)
|
No
Conflicts. (i) Except as may be required
under Section 13 of the Exchange Act, no filing with, and no permit,
authorization, consent or approval of, any state or federal public body or
authority is necessary for the execution of this Voting Agreement by such
Voting Member and the consummation by such Voting Member of the
transactions contemplated hereby and (ii) none of the execution and
delivery of this Voting Agreement by such Voting Member, the consummation
by such Voting Member of the transactions contemplated hereby or
compliance by such Voting Member with any of the provisions hereof shall
(A) conflict with or result in any breach of the organizational documents
of such Voting Member (if applicable), (B) result in a violation or breach
of, or constitute (with or without notice or lapse of time or both) a
default (or give rise to any third party right of termination,
cancellation, material modification or acceleration) under any of the
terms, conditions or provisions of any note, bond, mortgage, indenture,
license, contract, commitment, arrangement, understanding, agreement or
other instrument or obligation of any kind to which such Voting Member is
a party or by which such Voting Member or any of its properties or assets
may be bound, or (C) violate any order, writ injunction, decree, judgment,
order, statute, rule or regulation applicable to such Voting Member or any
of its properties or assets.
|
|
(d)
|
No
Encumbrances. Such Voting Member's Shares at all times
during the term hereof will be Beneficially Owned by such Voting Member,
free and clear of all liens, claims, security interests, proxies, voting
trusts or agreements, understandings or arrangements or any other
encumbrances whatsoever.
|
|
(e)
|
No
Solicitation. Such Voting Member agrees not to take any
action inconsistent with or in violation of the Merger
Agreement.
|
|
(f)
|
Restriction on Transfer;
Proxies and Non-Interference. At any time during the
period (the "Lock-Up
Period") from the date hereof until the Termination Date, such
Voting Member shall not, directly or indirectly, (i) except for a
Permitted Transfer (as defined below) and except as contemplated by the
Merger Agreement, offer for sale, sell, transfer, tender, pledge,
encumber, assign or otherwise dispose of, or enter into any contract,
option or other arrangement or understanding with respect to or consent to
the offer for sale, sale, transfer, tender, pledge, encumbrance,
assignment or other disposition of, any or all of any such Voting Member's
Shares, or any interest therein, whether such Shares are held by such
Voting Member as of the date hereof or are acquired by such Voting Member
from and after the date hereof (the "Lock-Up
Shares"), (ii) except as contemplated by this Voting Agreement,
grant any proxies or powers of attorney, deposit any Shares into a voting
trust or enter into a Voting Agreement with respect to the Lock-Up Shares,
or (iii) take any action that would make any representation or warranty of
such Voting Member contained herein untrue or incorrect or have the effect
of preventing or disabling such Voting Member from performing such Voting
Member's obligations under this Voting
Agreement.
|
|
(g)
|
Reliance by
Parent. Such Voting Member understands and acknowledges
that Parent is entering into the Merger Agreement in reliance upon such
Voting Member's execution and delivery of this Voting
Agreement.
|
|
(h)
|
Permitted
Transfer. Notwithstanding the foregoing or any other
provision of this Agreement to the contrary, any Voting Member may sell or
transfer any Shares to any Voting Member or any other Person who executes
and delivers to Parent an agreement, in form and substance acceptable to
Parent, to be bound by the terms of this Agreement to the same extent as
the transferring Voting Member (any such transfer, a “Permitted
Transfer”).
|
|
(i)
|
Diligence. Each
of the Voting Members acknowledges that it has been afforded a reasonable
opportunity to review information and ask questions regarding Parent, the
Merger Agreement and the Merger.
|
|
(j)
|
Non-Disclosure. Each
of the Voting Members agrees not to make any public disclosure with
respect to the Merger Agreement or this Voting Agreement without the
consent of the Parent and the
Company.
|
5. Stop Transfer.
|
(a)
|
Each
of the Voting Members agrees and covenants to Parent that such Voting
Member shall not request that the Company register the transfer
(book-entry or otherwise) of any certificate or uncertificated interest
representing any of such Voting Member's Shares, unless such transfer is
made in compliance with this Voting
Agreement.
|
|
(b)
|
Without
limiting the covenants set forth in paragraph (a) above, in the event of a
stock dividend or distribution, or any change in Shares by reason of any
stock dividend, split-up, recapitalization, combination, exchange of
shares or the like, other than pursuant to the Merger, the term “Shares”
shall be deemed to refer to and include any and all shares into which or
for which any or all of the Shares may be changed or exchanged, including,
without limitation, shares of NeoStem Common Stock issued in respect
thereof in connection with the Merger Agreement or otherwise, and
appropriate adjustments shall be made to the terms and provisions of this
Voting Agreement.
|
6. Further
Assurances. From time to time until the expiration of the
Lock-Up Period, at Parent's request and without further consideration, each
Voting Member shall execute and deliver such additional documents and take all
such further lawful action as may be necessary or desirable to consummate and
make effective, in the most expeditious manner practicable, the transactions
contemplated by this Voting Agreement, including executing a proxy to be used at
the Special Meeting to vote in favor of the Merger.
7. Voting Member
Capacity. If any Voting Member is or becomes during the term
hereof a manager or an officer of the Company, such Voting Member makes no
agreement or understanding herein in his capacity as such manager or
officer. Each of the Voting Members signs solely in his or her
capacity as the record and Beneficial Owner of the Voting Member's
Shares.
8. Termination. Except
as otherwise provided herein, the covenants and agreements contained herein with
respect to the Shares shall terminate upon the Termination Date.
9. Miscellaneous.
|
(a)
|
Entire
Agreement. This Voting Agreement constitutes the entire
agreement among the parties with respect to the subject matter hereof and
supersedes all other prior agreements and understandings, both written and
oral, between the parties with respect to the subject matter
hereof.
|
|
(b)
|
Certain
Events. Each of the Voting Members agrees that this
Voting Agreement and the obligations hereunder shall attach to each such
Voting Member's Shares and shall be binding upon any Person to which legal
or Beneficial Ownership of such Shares shall pass, whether by operation of
law or otherwise, including without limitation, each Voting Member's
heirs, guardians, administrators or successors. Notwithstanding
any such transfer of Shares, the transferor shall remain liable for the
performance of all obligations under this Voting
Agreement.
|
|
(c)
|
Assignment. This
Voting Agreement shall not be assigned by operation of law or otherwise
without the prior written consent of Parent in the case of an assignment
by any Voting Member and each Voting Member in the case of any assignment
by Parent; provided that Parent may assign, in its sole discretion, its
rights and obligations hereunder to any direct or indirect wholly owned
subsidiary of Parent, but no such assignment shall relieve Parent of its
obligations hereunder if such assignee does not perform such
obligations.
|
|
(d)
|
Amendment and
Modification. This Voting Agreement may not be amended,
changed, supplemented, waived or otherwise modified or terminated, except
upon the execution and delivery of a written agreement executed by the
parties hereto affected by such
amendment.
|
|
(e)
|
Notices. Any
notice or other communication required or which may be given hereunder
shall be in writing and delivered (i) personally, (ii) via telecopy, (iii)
via overnight courier (providing proof of delivery) or (iv) via registered
or certified mail (return receipt requested). Such notice shall be deemed
to be given, dated and received (i) when so delivered personally, via
telecopy upon confirmation, or via overnight courier upon actual delivery
or (ii) two days after the date of mailing, if mailed by registered or
certified mail. Any notice pursuant to this section shall be delivered as
follows:
|
If to the
Voting Member, to the address set forth for the Voting Member on Schedule A to
this Voting Agreement.
If to
Parent:
NeoStem,
Inc.
420
Lexington Avenue
Suite
450
New York,
New York 10170
Attn: Catherine Vaczy, Esq.
Facsimile:
(646) 514-7787
with
copies to:
Lowenstein
Sandler, PC
65
Livingston Avenue
Roseland,
NJ 07078
Attention: Alan
Wovsaniker, Esq.
Fax: 973-597-2565
|
(f)
|
Severability. Whenever
possible, each provision or portion of any provision of this Voting
Agreement will be interpreted in such a manner as to be effective and
valid under applicable law but if any provision or portion of any
provision of this Voting Agreement is held to be invalid, illegal or
unenforceable in any respect under any applicable law or rule in any
jurisdiction, such invalidity, illegality or unenforceability will not
affect any other provision or portion of any provision of this Voting
Agreement in such jurisdiction, and this Voting Agreement will be
reformed, construed and enforced in such jurisdiction as if such invalid,
illegal or unenforceable provision or portion of any provision had never
been contained herein.
|
|
(g)
|
Specific
Performance. Each of the parties hereto agrees,
recognizes and acknowledges that a breach by it of any covenants or
agreements contained in this Voting Agreement will cause the other parties
to sustain damages for which they would not have an adequate remedy at law
for money damages, and therefore each of the parties hereto agrees that in
the event of any such breach any aggrieved party shall be entitled to the
remedy of specific performance of such covenants and agreements (without
any requirement to post bond or other security and without having to prove
actual damages) and injunctive and other equitable relief in addition to
any other remedy to which it may be entitled, at law or in
equity.
|
|
(h)
|
Remedies
Cumulative. All rights, powers and remedies provided
under this Voting Agreement or otherwise available in respect hereof at
law or in equity shall be cumulative and not alternative, and the exercise
of any such rights, powers or remedies by any party shall not preclude the
simultaneous or later exercise of any other such right, power or remedy by
such party.
|
|
(i)
|
No
Waiver. The failure of any party hereto to exercise any
right, power or remedy provided under this Voting Agreement or otherwise
available in respect hereof at law or in equity, or to insist upon
compliance by any other party hereto with its obligations hereunder, and
any custom or practice of the parties at variance with the terms hereof,
will not constitute a waiver by such party of its right to exercise any
such or other right, power or remedy or to demand such
compliance.
|
|
(j)
|
No Third Party
Beneficiaries. This Voting Agreement is not intended to
confer upon any person other than the parties hereto any rights or
remedies hereunder.
|
|
(k)
|
Governing
Law. This Voting Agreement will be governed and
construed in accordance with the laws of the State of Delaware, without
giving effect to the principles of conflict of laws
thereof.
|
|
(l)
|
Submission to
Jurisdiction. Each party to this Voting Agreement
irrevocably consents and agrees that any legal action or proceeding with
respect to this Agreement and any action for enforcement of any judgment
in respect thereof will be brought in the state or federal courts located
within the jurisdiction of the United States District Court for the
Southern District of New York, and, by execution and delivery of this
Voting Agreement, each party to this Voting Agreement hereby irrevocably
submits to and accepts for itself and in respect of its property,
generally and unconditionally, the exclusive jurisdiction of the aforesaid
courts and appellate courts from any appeal thereof. Each party
to this Voting Agreement further irrevocably consents to the service of
process out of any of the aforementioned courts in any such action or
proceeding by the mailing of copies thereof in the manner set forth in
Section 10(e). Each party to this Voting Agreement hereby
irrevocably waives any objection which it may now or hereafter have to the
laying of venue of any of the aforesaid actions or proceedings arising out
of or in connection with this Voting Agreement brought in the courts
referred to above and hereby further irrevocably waives and agrees not to
plead or claim in any such court that any such action or proceeding
brought in any such court has been brought in an inconvenient
forum.
|
|
(m)
|
WAIVER
OF JURY TRIAL. EACH PARTY HERETO HEREBY WAIVES ANY RIGHT TO A TRIAL BY
JURY IN CONNECTION WITH ANY ACTION, SUIT OR PROCEEDING IN CONNECTION WITH
THIS VOTING AGREEMENT.
|
|
(n)
|
Description
Headings. The description headings used herein are for
convenience of reference only and are not intended to be part of or to
affect the meaning or interpretation of this Voting
Agreement.
|
|
(o)
|
Counterparts. This
Voting Agreement may be executed in counterparts, each of which will be
considered one and the same Voting Agreement and will become effective
when such counterparts have been signed by each of the parties and
delivered to the other parties, it being understood that all parties need
not sign the same counterpart.
|
|
(p)
|
No
Survival. No representations, warranties and covenants
of the Voting Member in this Agreement shall survive the
Merger.
|
IN
WITNESS WHEREOF, Parent, the Company and each of the Voting Members have caused
this Voting Agreement to be duly executed as of the day and year first above
written.
|
NEOSTEM,
INC.
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
PROGENITOR
CELL THERAPY, LLC
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
|
|
Andrew
L. Pecora
|
|
|
|
|
|
|
Robert
A. Preti
|
|
|
|
|
HACKENSACK
UNIVERSITY MEDICAL CENTER
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
|
|
George
S. Goldberger
|
|
|
|
|
|
|
Harry
D.
Harper
|
Signature
page to Voting Agreement
|
|
|
Andrew
A. Jennis
|
|
|
|
|
|
Mark
S. Pascal
|
|
|
|
|
|
Richard
J. Rosenbluth
|
|
|
|
|
|
Stanley
E. Waintraub
|
|
|
|
|
|
Marc
Beer
|
|
|
|
|
|
Dempsey
Gable
|
Signature
page to Voting Agreement
Schedule
A
Names
|
|
Shares
|
|
|
Options
|
|
|
Percentage Interest
(Fully Diluted)
|
|
|
Address
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew
L. Pecora
|
|
|
1,234,871.6 |
|
|
|
20,660.4 |
|
|
|
17.40 |
% |
|
424
Hidden Valley Court Wyckoff, NJ 07481
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert
A. Preti
|
|
|
1,219,697.0 |
|
|
|
|
|
|
|
16.90 |
% |
|
80
Nursery Road Ridgefield, CT 06877
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hackensack University Medical
Center
|
|
|
1,222,634.2 |
|
|
|
|
|
|
|
16.95 |
% |
|
Attn:
Mr. William J. Murray 920 Cherokee Lane
Franklin
Lakes, NJ 07417
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George S. Goldberger
|
|
|
177,054.5 |
|
|
|
|
|
|
|
2.45 |
% |
|
200 Central Park South
Apt 12Q
New York, NY 10019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Harry D. Harper
|
|
|
142,431.2 |
|
|
|
|
|
|
|
1.97 |
% |
|
2 Algonquin Trail
Saddle River, NJ
07458-2502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andrew A. Jennis
|
|
|
142,431.2 |
|
|
|
|
|
|
|
1.97 |
% |
|
205 Zachary Court
Wyckoff, NJ 07481
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark
S. Pascal
|
|
|
142,431.2 |
|
|
|
|
|
|
|
1.97 |
% |
|
1349
Mercedes Street
Teaneck,
NJ 07666
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Richard J. Rosenbluth
|
|
|
121,382.3 |
|
|
|
|
|
|
|
1.68 |
% |
|
73 Dana Place
Englewood, NJ 07631
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stanley E. Waintraub
|
|
|
142,431.2 |
|
|
|
|
|
|
|
1.97 |
% |
|
480 Winthrop Road
Teaneck, NJ 07666-2911
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marc Beer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dempsey Gable
|
|
|
21,049.0 |
|
|
|
|
|
|
|
0.29 |
% |
|
180 Central Park South
Mail Box 81
New York, NY
10019
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Exhibit
B
ESCROW
AGREEMENT
THIS
ESCROW AGREEMENT (“Agreement”) is made and entered into as of _______, 2010, by
and among: NeoStem Inc.,
a Delaware corporation (“Parent”); Progenitor Cell Therapy,
LLC, a Delaware limited liability
company (the “Company”), Andrew
Pecora, as representative (the “PCT Representative”), of the Members of
the Company identified from time to time on Schedule 1 hereto; and Continental Stock Transfer &
Trust Company, a New York corporation (the “Escrow Agent”).
RECITALS
WHEREAS,
Parent, NBS Acquisition Company, LLC, a Delaware limited liability company and a
wholly-owned subsidiary of Parent (“Subco”), the Company and the PCT
Representative have entered into an Agreement and Plan of Merger and
Reorganization dated as of September 23, 2010 (the “Merger Agreement”), pursuant
to which, among other things, (i) Subco is merging with and into the Company,
and (ii) certain stock issuances are to be made by Parent to the Members (as
defined below). A copy of the Merger Agreement is attached hereto as
Exhibit
A;
WHEREAS,
the Merger Agreement contemplates the establishment of an escrow account to
secure certain rights of the Parent Indemnified Persons (as defined in the
Merger Agreement) to indemnification, compensation and reimbursement as provided
in the Merger Agreement; and
WHEREAS,
pursuant to Section 8.5 of the Merger Agreement, Andrew Pecora has been
irrevocably appointed by the Members to serve as the PCT Representative in
connection with all matters under this Agreement and the resolution of all
indemnification claims under the Merger Agreement.
AGREEMENT
The
parties, intending to be legally bound, agree as follows:
Section
1. Defined
Terms.
1.1 Capitalized
terms used and not defined in this Agreement shall have the meanings given to
them in the Merger Agreement.
1.2 As
used in this Agreement, the term “Members” refers to the Persons who were
members, or equity holders, of the Company immediately prior to the Effective
Time or to which the rights under this Agreement have been assigned as set forth
herein. “Escrowed Shares” refers to the Stock Consideration under the
Merger Agreement, as it may be reduced pursuant to the terms of the Merger
Agreement (the “Adjusted Stock Consideration”).
Section
2. Escrow and
Indemnification.
2.1 Shares and Stock Powers Placed in
Escrow. At or following the Effective Time, in accordance with
the Merger Agreement, (a) Parent shall issue certificates for the Escrowed
Shares registered in the name of the Escrow Agent evidencing the shares of
Parent Common Stock to be held in escrow under this Agreement (initially
11,200,000 shares of Parent Common Stock unless reduced pursuant to Section 3.3
of the Merger Agreement prior to being placed in escrow), and shall cause such
certificates to be delivered to the Escrow Agent, and (b) the PCT Representative
shall deliver to the Escrow Agent an “assignment separate from certificate”
(“Stock Power”) endorsed by him in blank. Such endorsement by the PCT
Representative shall have been guaranteed by a national bank or an NYSE-Amex
member firm.
2.2 Escrow Account. The
Escrowed Shares being held in escrow pursuant to this Agreement, together with
any distributions on the Escrowed Shares, shall collectively constitute an
escrow fund securing the indemnification rights of Parent and the other Parent
Indemnified Persons under the Merger Agreement. The Escrow Agent
agrees to accept delivery of the Escrowed Shares and to hold the Escrowed Shares
in a separate escrow account (such account, the “Escrow Account”), subject to
the terms and conditions of this Agreement and the Merger
Agreement.
2.3 Voting of Escrow
Shares. The Escrow Agent, as record owner of the Escrowed
Shares, shall exercise all voting rights with respect to such Escrowed Shares in
accordance with Section 3.5 of the Merger Agreement, upon receipt of written
instructions from the Parent. The Escrow Agent is not obligated to
distribute to the Members or to the PCT Representative any proxy materials or
other documents relating to the Escrowed Shares received by the Escrow Agent
from Parent.
2.4 Reports. Upon the
request of either Parent or the PCT Representative, the Escrow Agent shall
provide a statement to the requesting party that describes any deposit,
distribution or investment activity or deductions with respect to shares held in
the Escrow Account in addition to quarterly account statements from the Escrow
Agent.
2.5 Dividends,
Etc. Parent and the PCT Representative, on behalf of each of
the Members, agree that any shares of Parent Common Stock or other property
(including ordinary cash dividends) distributable or issuable (whether by way of
dividend, stock split or otherwise) in respect of or in exchange for any
Escrowed Shares (including pursuant to or as a part of a merger, consolidation,
acquisition of property or stock, reorganization or liquidation involving
Parent) shall not be distributed or issued to the beneficial owners of such
Escrowed Shares, but rather shall be distributed or issued to and held by the
Escrow Agent in the Escrow Account. Any securities or other property
received by the Escrow Agent in respect of any Escrowed Shares held in escrow as
a result of any stock split or combination of shares of Parent Common Stock,
payment of a stock dividend or other stock distribution in or on shares of
Parent Common Stock, or change of Parent Common Stock into any other securities
pursuant to or as a part of a merger, consolidation, acquisition of property or
stock, reorganization or liquidation involving Parent, or otherwise, shall be
held by the Escrow Agent as part of the Escrow Account.
2.6 Transferability. Except
as expressly provided for herein or by operation of law, the interests of the
Members in the Escrow Account shall not be assignable or
transferable.
2.7 Trust Fund. The
Escrow Account shall be held as trust funds and shall not be subject to any
lien, attachment, trustee process or any other judicial process of any creditor
of Escrow Agent, any Member or Parent, respectively, or of any party
hereto. The Escrow Agent shall hold and safeguard the Escrow Account
until the Termination Date (as defined in Section 6) or earlier distribution in
accordance with this Agreement.
Section
3. Release of Escrow
Shares.
3.1 General. (X) Within
ten (10) calendar Days after receiving either (a) written instructions from the
Parent (a “Parent Notice”) which have not been objected to by the PCT
Representative within seven (7) calendar days after the later of the PCT
Representative’s receipt of the Parent Notice or the Escrow Agent’s receipt of
such Parent Notice, (b) joint written instructions from Parent and the PCT
Representative (“Joint Instructions”), (c) a decision and/or award from the
Arbitrator (an “Arbitration Award”) or (d) an order issued by a court of
competent jurisdiction (a “Court Order”) relating to the release of any Escrowed
Shares from the Escrow Account or (Y) in accordance with Section 3.4 hereof, the
Escrow Agent shall release or cause to be released any such Escrowed Shares and
any other amounts from the Escrow Account, in the amounts, to the Persons and in
the manner set forth in such Parent Notice, Joint Instructions, Arbitration
Award, Court Order or as provided in Section 3.4. If a Parent Notice
is sent under Section 8.4 of the Merger Agreement and such Parent Notice is not
disputed as provided in Section 8.4 within 7 calendar days, the Escrow Agent
shall make the distribution requested by the Parent Notice without action by the
PCT Representative.
3.2 Potential Tax
Liability. Upon receipt of (i) a certification from a Taxable
Member pursuant to Section 8.4(a)(i) of the Merger Agreement, and
(ii) joint instructions from the Parent and the PCT Representative, the Escrow
Agent shall release shares to a Taxable Member in accordance with the
certification of the Taxable Member and such joint instructions.
3.3 Pro Rata
Distributions. For purposes of this Agreement, (i) all
distributions (except distributions to the Taxable Members as such pursuant to
Section 3.2 above and Section 8.4(i) of the Merger Agreement) to the Members
shall be pro rata distributions made based on the percentages set forth on
Schedule 1, as may be amended from time to time pursuant to Section 9.8 of this
Agreement, except as follows:
(1) the
Escrow Agent will maintain sub-accounts, referred to as the Taxable Account and
the Balance Account, as provided in Section 8.4 of the Merger Agreement, until
the first anniversary of the date hereof. The distributions at the
end of the first year pursuant to Section 8.4(a)(ii) shall be made to the
Taxable Members from the Taxable Account and to the Members other than the
Taxable Members from the Balance Account. The Parent and the PCT
Representative shall provide the Escrow Agent with joint instructions with
respect to the amounts to be distributed to each Member after the first
anniversary of the Closing Date.
(2) no
fractional shares shall be issued, and all amounts released from escrow and
distributed to the Members shall be rounded up or down pursuant to Section
3.4(c) of the Merger Agreement.
The
Company and the PCT Representative represent and warrant that Schedule 1 (the
“Percentage Certifications”) accurately reflects each Member’s percentage
membership interest in the Company immediately prior to the consummation of the
Merger.
3.4 Release of the Escrowed
Shares. Within 10 Business Days following the two year
anniversary of the Closing Date, if there are no Claims against the Escrow
Account that have not been finally resolved and paid, the Escrow Agent shall
deliver to the Members pro rata in accordance with the Percentage Certification
the balance of shares of Parent Common Stock and other property held in the
Escrow Account at such time. If, on the Termination Date there are
claims against the Escrow Account that have not been finally resolved, then,
within 10 Business Days of the Termination Date, the Escrow Agent shall deliver
to the Members the excess, if any, by which the value of the amounts held in the
Escrow Account exceed an amount equal to 120% of the amount of any claims
against the Escrow Account that have not been finally resolved and paid at such
time. The Parent and the PCT Representative shall provide the Escrow
Agent with joint instructions with respect to the amounts to be distributed to
each Member after the second anniversary of the Closing Date (and thereafter if
shares remain in the Escrow Account after the second anniversary with respect to
unresolved claims at such date). Thereafter, final distributions of
the Escrow Account shall be made in accordance with Section 3.1(X)(a), (b), (c)
or (d), as applicable.
3.5 Distributions. Whenever
a distribution of a number of shares of Parent Common Stock is to be made
pursuant to the terms of this Agreement, the Escrow Agent shall requisition the
appropriate number of shares from Parent’s stock transfer agent, delivering to
the transfer agent the appropriate stock certificates accompanied by the
respective Stock Powers, together with the specific instructions, as
appropriate. Within 5 Business Days prior to the date the Escrow
Agent is required to make a distribution of shares of Parent Common Stock or
other property (including ordinary cash dividends) to the Members pursuant to
the terms of this Agreement, the Escrow Agent shall provide the PCT
Representative and the Parent with a notice specifying that a distribution will
be made and requesting that the PCT Representative update the then current
Schedule 1 to this Agreement. The Escrow Agent shall make the
corresponding distributions to the Persons listed on such updated Schedule 1 in
accordance with the terms hereof, to their respective addresses as set forth
therein. Notwithstanding anything to the contrary set forth herein,
the Escrow Agent shall not be obligated to make any distribution under this
Agreement to the Members unless it has received from the PCT Representatives an
updated Schedule 1 to this Agreement as provided herein. Any
distributions to Parent pursuant to the terms of this Agreement shall be made to
the address set forth in Schedule 2 hereto.
3.6 Disputes. All
disputes, claims, or controversies arising out of or relating to Section 3 of
this Agreement that are not resolved by mutual agreement between Parent and the
PCT Representative shall be resolved solely and exclusively as set
forth in Section 8.4 of the Merger Agreement by the PCT Representative and the
Parent.
Section
4. Fees and
Expenses.
The
Escrow Agent shall be entitled to receive, from time to time, fees in accordance
with Schedule 3. In accordance with Schedule 3, the Escrow Agent will
also be entitled to reimbursement for reasonable and documented out-of-pocket
expenses incurred by the Escrow Agent in the performance of its duties hereunder
and the execution and delivery of this Agreement. All such fees and
expenses shall be paid by Parent.
Section
5. Limitation of
Escrow Agent’s Liability.
5.1 The
Escrow Agent undertakes to perform such duties as are specifically set forth in
this Agreement only and shall have no duty under any other agreement or
document, and no implied covenants or obligations shall be read into this
Agreement against the Escrow Agent. The Escrow Agent shall incur no
liability with respect to any action taken by it or for any inaction on its part
in reliance upon any notice, direction, instruction, consent, statement or other
document believed by it in good faith to be genuine and duly authorized, nor for
any other action or inaction except for its own negligence or willful
misconduct. In all questions arising under this Agreement, the Escrow
Agent may rely on the advice of counsel, and for anything done, omitted or
suffered in good faith by the Escrow Agent based upon such advice the Escrow
Agent shall not be liable to anyone. In no event shall the Escrow
Agent be liable for incidental, punitive or consequential damages.
5.2 Parent
and the PCT Representative, acting on behalf of the Members hereby agree to
indemnify the Escrow Agent and its officers, directors, employees and agents
for, and hold it and them harmless against, any loss, liability or expense
incurred without negligence or willful misconduct on the part of Escrow Agent,
arising out of or in connection with the Escrow Agent’s carrying out its duties
hereunder. This right of indemnification shall survive the
termination of this Agreement and the resignation of the Escrow
Agent.
Section
6. Termination.
This
Agreement shall terminate upon the release by the Escrow Agent of the final
amounts held in the Escrow Account in accordance with Section 3 (the date of
such release being referred to as the “Termination Date”).
Section
7. Successor Escrow
Agent.
In the
event the Escrow Agent becomes unavailable or unwilling to continue as escrow
agent under this Agreement, the Escrow Agent may resign and be discharged from
its duties and obligations hereunder by giving its written resignation to the
parties to this Agreement. Such resignation shall take effect not
less than 30 days after it is given to all the other parties
hereto. In such event, Parent may appoint a successor Escrow Agent
(acceptable to the PCT Representative, acting reasonably). If Parent
fails to appoint a successor Escrow Agent within 15 days after receiving the
Escrow Agent’s written resignation, the Escrow Agent shall have the right to
apply to a court of competent jurisdiction for the appointment of a successor
Escrow Agent. The successor Escrow Agent shall execute and deliver to
the Escrow Agent an instrument accepting such appointment, and the successor
Escrow Agent shall, without further acts, be vested with all the estates,
property rights, powers and duties of the predecessor Escrow Agent as if
originally named as Escrow Agent herein. The Escrow Agent shall act
in accordance with written instructions from Parent and the PCT
Representative as to the transfer of the Escrow Accounts to a
successor Escrow Agent.
Section
8. PCT
Representative.
8.1 Unless
and until Parent and the Escrow Agent shall have received written notice of the
appointment of a successor PCT Representative, Parent and the Escrow Agent shall
be entitled to rely on, and shall be fully protected in relying on, the power
and authority of the PCT Representative to act on behalf of the
Members.
Section
9. Miscellaneous.
9.1 Attorneys’ Fees. In
any action at law or suit in equity to enforce or interpret this Agreement or
the rights of any of the parties hereunder, the prevailing party in such action
or suit shall be entitled to receive a reasonable sum for its attorneys’ fees
and all other reasonable costs and expenses incurred in such action or
suit.
9.2 Notices. Any notice
or other communication required or permitted to be delivered to any party under
this Agreement shall be in writing and shall be deemed properly delivered, given
and received when delivered (by hand, by registered mail, by courier or express
delivery service or by facsimile) to the address or facsimile telephone number
set forth beneath the name of such party below (or to such other address or
facsimile telephone number as such party shall have specified in a written
notice given to the other parties hereto):
if to Parent:
NeoStem,
Inc.
Suite
450
420
Lexington Avenue
New York,
NY 10170
Attention: Catherine
Vaczy, Esq.
Facsimile: _________________
with a
copy, which shall not constitute notice, to:
Lowenstein
Sandler, PC
65
Livingston Avenue
Roseland,
NJ 07068
Attention: Alan
Wovsaniker
Facsimile: ______________
if
to the PCT Representative :
Andrew
Pecora
_______________________________
_______________________________
_______________________________
_______________________________
Facsimile: ______________
with a
copy, which shall not constitute notice, to:
Epstein
Becker
_______________________________
_______________________________
_______________________________
_______________________________
Attention: Robert
Reif, Esq.
Facsimile: ______________
if
to the Escrow Agent:
Continental
Stock Transfer & Trust Company
17
Battery Place
New York,
NY 10004
Attention: ____________
Facsimile: ______________
Notwithstanding
the foregoing, notices addressed to the Escrow Agent shall be effective only
upon receipt. If any notice or other document is required to be
delivered to the Escrow Agent and any other Person, the Escrow Agent may assume
without inquiry that notice or other document was received by such other Person
on the date on which it was received by the Escrow Agent.
9.3 Headings. The
bold-faced headings contained in this Agreement are for convenience of reference
only, shall not be deemed to be a part of this Agreement and shall not be
referred to in connection with the construction or interpretation of this
Agreement.
9.4 Counterparts and Exchanges by
Facsimile or Other Electronic Transmission. This Agreement may
be executed in several counterparts, each of which shall constitute an original
and all of which, when taken together, shall constitute one
agreement. The exchange of a fully executed Agreement (in
counterparts or otherwise) by facsimile or other means of electronic
transmission shall be sufficient to bind the parties to the terms and conditions
of this Agreement.
9.5 Applicable Law;
Jurisdiction. This Agreement shall be governed by, and
construed in accordance with, the laws of the State of New York, regardless of
the laws that might otherwise govern under applicable principles of conflicts of
laws thereof. Subject to Section 3.5 of this Agreement, in any action
between the parties arising out of or relating to this Agreement or any of the
transactions contemplated by this Agreement: (a) each of the parties irrevocably
and unconditionally consents and submits to the non-exclusive jurisdiction and
venue of the state and federal courts located in the State of New York; (b) if
any such action is commenced in a state court, then, subject to applicable law,
no party shall object to the removal of such action to any federal court located
in the State of New York; and (c) each of the parties irrevocably waives the
right to trial by jury.
9.6 Successors and
Assigns. This Agreement shall be binding upon and shall inure
to the benefit of each of the parties hereto and each of their respective
permitted successors and assigns, if any. No director indirect
interest in the Escrow Account or the shares of Parent Common Stock held in the
Escrow Account may be sold, assigned, transferred or pledged except by operation
of law.
9.7 Waiver. No failure
on the part of any Person to exercise any power, right, privilege or remedy
under this Agreement, and no delay on the part of any Person in exercising any
power, right, privilege or remedy under this Agreement, shall operate as a
waiver of such power, right, privilege or remedy; and no single or partial
exercise of any such power, right, privilege or remedy shall preclude any other
or further exercise thereof or of any other power, right, privilege or
remedy. No Person shall be deemed to have waived any claim arising
out of this Agreement, or any power, right, privilege or remedy under this
Agreement, unless the waiver of such claim, power, right, privilege or remedy is
expressly set forth in a written instrument duly executed and delivered on
behalf of such Person; and any such waiver shall not be applicable or have any
effect except in the specific instance in which it is given.
9.8 Amendment. This
Agreement may not be amended, modified, altered or supplemented other than by
means of a written instrument duly executed and delivered on behalf of Parent,
the PCT Representative and the Escrow Agent; provided, however, that any
amendment executed and delivered by the PCT Representative shall be
deemed to have been approved by and duly executed and delivered by all of the
Members.
9.9 Severability. Any
term or provision of this Agreement that is invalid or unenforceable in any
situation in any jurisdiction shall not affect the validity or enforceability of
the remaining terms and provisions hereof or the validity or enforceability of
the offending term or provision in any other situation or in any other
jurisdiction. If the final judgment of a court of competent
jurisdiction declares that any term or provision hereof is invalid or
unenforceable, the parties hereto agree that the court making such determination
shall have the power to limit the term or provision, to delete specific words or
phrases, or to replace any invalid or unenforceable term or provision with a
term or provision that is valid and enforceable and that comes closest to
expressing the intention of the invalid or unenforceable term or provision, and
this Agreement shall be enforceable as so modified. In the event such
court does not exercise the power granted to it in the prior sentence, the
parties hereto agree to replace such invalid or unenforceable term or provision
with a valid and enforceable term or provision that will achieve, to the extent
possible, the economic, business and other purposes of such invalid or
unenforceable term.
9.10 Parties in
Interest. Except as expressly provided herein, none of the
provisions of this Agreement, express or implied, is intended to provide any
rights or remedies to any Person other than the parties hereto and their
respective successors and assigns, if any.
9.11 Entire
Agreement. This Agreement and the Merger Agreement set forth
the entire understanding of the parties hereto relating to the subject matter
hereof and supersede all prior agreements and understandings among or between
any of the parties relating to the subject matter hereof.
9.12 Waiver of Jury
Trial. Each of the parties hereto hereby irrevocably waives
any and all right to trial by jury in any action arising out of or related to
this Agreement or the transactions contemplated hereby.
9.13 [Tax Reporting
Information. Parent agrees to provide the Escrow Agent with a
certified tax identification number for Parent and the PCT Representative agrees
to provide the Escrow Agent with tax identification numbers for each of the
Members by furnishing appropriate forms W-9 (or Forms W-8, in the case of
non-U.S. persons) and any other forms and documents that the Escrow Agent may
reasonably request (collectively, “Tax Reporting Documentation”) to the Escrow
Agent within 30 days after the date hereof. The parties hereto
understand that, if such Tax Reporting Documentation is not so furnished to the
Escrow Agent, the Escrow Agent shall be required by the Code to withhold a
portion of any interest or other income earned on the investment of monies held
by the Escrow Agent pursuant to this Agreement, and to immediately remit such
withholding to the Internal Revenue Service and shall not make any distributions
to any Member who has not supplied such Tax Reporting
Documentation.]
9.14 Cooperation. The
PCT Representative on behalf of the Members and Parent agree to cooperate fully
with each other and the Escrow Agent and to execute and deliver such further
documents, certificates, agreements, stock powers and instruments and to take
such other actions as may be reasonably requested by Parent, the PCT
Representative or the Escrow Agent to evidence or reflect the
transactions contemplated by this Agreement and to carry out the intent and
purposes of this Agreement.
9.15 Construction.
(a) For
purposes of this Agreement, whenever the context requires: the singular number
shall include the plural, and vice versa; the masculine gender shall include the
feminine and neutral genders; the feminine gender shall include the masculine
and neutral genders; and the neutral gender shall include masculine and feminine
genders.
(b) The
parties hereto agree that any rule of construction to the effect that
ambiguities are to be resolved against the drafting party shall not be applied
in the construction or interpretation of this Agreement.
(c) As
used in this Agreement, the words “include” and “including,” and variations
thereof, shall not be deemed to be terms of limitation, but rather shall be
deemed to be followed by the words “without limitation.”
(d) Except
as otherwise indicated, all references in this Agreement to “Sections”,
“Schedules” and “Exhibits” are intended to refer to Sections of this Agreement,
Schedules to this Agreement and Exhibits to this Agreement.
[Remainder
of page intentionally left blank]
IN WITNESS WHEREOF, the
parties have duly caused this Agreement to be executed as of the day and year
first above written.
NEOSTEM, INC., a
Delaware corporation
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By:
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Name:
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Title:
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PROGENITOR
CELL THERAPY, INC.
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By:
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Name:
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Title:
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Andrew
Pecora, as PCT Representative
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CONTINENTAL
STOCK TRANSFER &
TRUST COMPANY, a New
York corporation
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By:
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Name:
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Title:
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[Escrow
Agreement Signature Page]
SCHEDULE
1
MEMBERS
Percentage
Certification Attached.
SCHEDULE
2
ESCROWED
SHARES
Number
of Escrowed Shares:
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11,200,000
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Address
for distributions to Parent:
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NeoStem
Inc.
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Suite
450
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420
Lexington Avenue
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New
York, New York 10170
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Attention: Catherine
Vaczy, Esq.
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SCHEDULE
3
ESCROW
AGENT’S FEES AND EXPENSES
Monthly
Fee for holding securities and/or cash:
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$________
per month
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Additional
out of pocket expenses including postage and stationary:
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Additional
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EXHIBIT
A
MERGER
AGREEMENT
Exhibit C
NEITHER
THIS SECURITY NOR ANY INTEREST OR PARTICIPATION HEREIN MAY BE SOLD, ASSIGNED,
TRANSFERRED, ENCUMBERED, OR OTHERWISE DISPOSED OF, EXCEPT PURSUANT TO AN
EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR AN OPINION OF
COUNSEL REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT
REQUIRED.
Warrant
No. [ ]
WARRANT
TO PURCHASE SHARES OF COMMON STOCK
OF
NEOSTEM,
INC.
THIS
CERTIFIES that, for value received, [__________]. is entitled to purchase from
NEOSTEM, INC., a Delaware corporation (the “Corporation”), subject to the
terms and conditions hereof, [__________] shares (the “Warrant Shares”) of common
stock, $.001 par value (the “Common
Stock”). This warrant, together with all warrants hereafter
issued in exchange or substitution for this warrant, is referred to as the
“Warrant” and the
holder of this Warrant is referred to as the “Holder.” The
number of Warrant Shares is subject to adjustment as hereinafter
provided. This Warrant shall vest in full and become exercisable on
[[________] [__], 2010] [upon achievement of the $7.00 Warrant Condition set
forth in Section 8 below] (the “Vesting Date”) and,
notwithstanding anything to the contrary contained herein, shall expire at 5:00
p.m. (Eastern Time) on [______], 2017 (the “Termination Date”). Capitalized
terms used and not otherwise defined herein shall have the meanings set forth in
that certain Agreement and Plan of Merger, dated September [_], 2010 by and
among the Corporation, NBS Acquisition Company LLC, a wholly-owned subsidiary of
the Corporation, and Progenitor Cell Therapy, LLC (as such agreement may be
amended from time to time, the “Merger
Agreement”).
1. Exercise of
Warrants. The Holder may, at any time on or after the Vesting
Date and prior to the Termination Date, exercise this Warrant in whole or in
part at an exercise price per share equal to $[3.00][5.00][7.00] per
share, subject to adjustment as provided herein (the “Exercise Price”), by the
surrender of this Warrant (properly endorsed), together with delivery of the
Warrant Exercise Form annexed hereto duly completed and executed, at the
principal office of the Corporation, or at such other agency or office of the
Corporation in the United States of America as the Corporation may designate by
notice in writing to the Holder at the address of such Holder appearing on the
books of the Corporation, and by payment to the Corporation of the Exercise
Price in lawful money of the United States by certified check or wire transfer
for each share of Common Stock being purchased. Upon any partial
exercise of this Warrant, there shall be executed and issued to the Holder a new
Warrant in respect of the shares of Common Stock as to which this Warrant shall
not have been exercised. In the event of the exercise of the rights
represented by this Warrant, a certificate or certificates for the Warrant
Shares so purchased, as applicable, registered in the name of the Holder, shall
be delivered to the Holder hereof as soon as practicable after the rights
represented by this Warrant shall have been so exercised.
2. Reservation of Warrant
Shares. The Corporation agrees that, prior to the expiration
of this Warrant, it will at all times have authorized and in reserve, and will
keep available, solely for issuance or delivery upon the exercise of this
Warrant, the number of Warrant Shares as from time to time shall be issuable by
the Corporation upon the exercise of this Warrant.
3. No Stockholder Rights; No
Rights to Net Cash Settled. This Warrant shall not entitle the
holder hereof to any voting rights or other rights as a stockholder of the
Corporation. In no event may this Warrant be net cash
settled.
4. Transferability of Warrant
and Underlying Shares. Prior to the Termination Date and
subject to compliance with applicable Federal and State securities and other
laws, this Warrant and all rights hereunder are transferable, in whole or in
part, at the office or agency of the Corporation by the Holder in person or by
duly authorized attorney, upon surrender of this Warrant together with the
Assignment Form annexed hereto properly endorsed for transfer. The
Corporation shall be entitled to require, as a condition of any such transfer,
that the Holder and the transferee execute or provide such documents and make
such representations and warranties as the Corporation may deem appropriate to
evidence compliance with applicable law or otherwise. None of the
Warrant Shares, if issued, may be transferred by the Holder until after the date
that is one year after the date of issuance of this Warrant.
5. Certain
Adjustments. With respect to any rights that Holder has to
exercise this Warrant and convert into shares of Common Stock, Holder shall be
entitled to the following adjustments:
(a) Merger or
Consolidation. If at any time there shall be a merger or a
consolidation of the Corporation with or into another entity when the
Corporation is not the surviving corporation, then, as part of such merger or
consolidation, lawful provision shall be made so that the holder hereof shall
thereafter be entitled to receive upon exercise of this Warrant, during the
period specified herein and upon payment of the aggregate Exercise Price then in
effect, the number of shares of stock or other securities or property (including
cash) of the successor corporation resulting from such merger or consolidation,
to which the holder hereof as the holder of the stock deliverable upon exercise
of this Warrant would have been entitled in such merger or consolidation if this
Warrant had been exercised immediately before such transaction. In
any such case, appropriate adjustment shall be made in the application of the
provisions of this Warrant with respect to the rights and interests of the
holder hereof as the holder of this Warrant after the merger or
consolidation.
(b) Reclassification,
Recapitalization, etc. If the Corporation at any time shall,
by subdivision, combination or reclassification of securities, recapitalization,
automatic conversion, or other similar event affecting the number or character
of outstanding shares of Common Stock, or otherwise, change any of the
securities as to which purchase rights under this Warrant exist into the same or
a different number of securities of any other class or classes, this Warrant
shall thereafter represent the right to acquire such number and kind of
securities as would have been issuable as the result of such change with respect
to the securities that were subject to the purchase rights under this Warrant
immediately prior to such subdivision, combination, reclassification or other
change.
(c) Split or Combination of
Common Stock and Stock Dividend. In case the Corporation shall
at any time subdivide, redivide, recapitalize, split (forward) or change its
outstanding shares of Common Stock into a greater number of shares or declare a
dividend upon its Common Stock payable solely in shares of Common Stock, the
Exercise Price shall be proportionately reduced and the number of Warrant Shares
proportionately increased. Conversely, in case of a reverse stock
split or the outstanding shares of Common Stock of the Corporation shall be
combined into a smaller number of shares, the Exercise Price shall be
proportionately increased and the number of Warrant Shares proportionately
reduced.
6. Compliance with Securities
Laws; Legend
and Stop Transfer Orders. Unless the Warrant Shares are
subject to an effective registration statement under the Securities Act, upon
exercise of any part of the Warrant, (i) the Corporation shall be entitled to
require that the Holder make such representations and warranties as may be
reasonably required by the Corporation to assure that the issuance of Warrant
Shares is exempt from the registration requirements of applicable securities
laws and (ii) the Corporation shall instruct its transfer agent to enter stop
transfer orders with respect to such Warrant Shares, and all certificates or
instruments representing the Warrant Shares shall bear on the face thereof
substantially the following legend:
THE
SECURITIES EVIDENCED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE U.S.
SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY OTHER
APPLICABLE SECURITIES LAWS AND HAVE BEEN ISSUED IN RELIANCE UPON AN EXEMPTION
FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND SUCH OTHER
SECURITIES LAWS. NEITHER THIS SECURITY NOR ANY INTEREST OR
PARTICIPATION HEREIN MAY BE SOLD, ASSIGNED, TRANSFERRED, ENCUMBERED, OR
OTHERWISE DISPOSED OF, EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OR AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE
CORPORATION THAT SUCH REGISTRATION IS NOT REQUIRED.
7. Redemption of
Warrant. This Warrant is subject to redemption by the
Corporation as provided in this Section
7.
(a) This
Warrant may be redeemed, at the option of the Corporation, in whole and not in
part, at a redemption price of $.0001 per Warrant (the “Redemption Price”),
provided the average closing price of the Common Stock as quoted by Bloomberg,
LP., or the Principal Trading Market (as defined below) on which the Common
Stock is included for quotation or trading, shall equal or exceed
$[5.00][7.00][9.00]1 per share (taking into account all
adjustments) for twenty (20) out of thirty (30) consecutive trading
days. [Notwithstanding the foregoing, the Corporation may not redeem
this Warrant (a) unless it waives (if then applicable) the last sentence of
Section 4 of the Warrant, (b) unless the issuance of the Warrant Shares is
registered or there is an effective resale registration statement available to
the Holders with respect to the Warrant Shares and (c) unless the $7.00 Warrant
Condition has been achieved or the Corporation waives the $7.00 Warrant
Condition concurrently with its provision of the Redemption Notice (as defined
below).]2
(b) If
the conditions set forth in Section 7(a) are met,
and the Corporation desires to exercise its right to redeem this Warrant, it
shall mail a notice (the “Redemption Notice”)
to the registered holder of this Warrant by first class mail, postage prepaid,
at least fourteen (14) business days prior to the date fixed by the Corporation
for redemption of the Warrants (the “Redemption
Date”).
(c) The
Redemption Notice shall specify (i) the Redemption Price, (ii) the Redemption
Date, (iii) the place where the Warrant certificates shall be delivered and the
redemption price paid, and (iv) that the right to exercise this Warrant shall
terminate at 5:00 p.m. (New York time) on the business day immediately
preceding the Redemption Date. No failure to mail such notice nor any defect
therein or in the mailing thereof shall affect the validity of the proceedings
for such redemption except as to a holder (a) to whom notice was not mailed, or
(b) whose notice was defective. An affidavit of the Secretary or an
Assistant Secretary of the Corporation that the Redemption Notice has been
mailed shall, in the absence of fraud, be prima facie evidence of the
facts stated therein.
(d) Any
right to exercise a Warrant shall terminate at 5:00 p.m. (New York time) on
the business day immediately preceding the Redemption Date. On and after the
Redemption Date, the holder of this Warrant shall have no further rights except
to receive, upon surrender of this Warrant, the Redemption Price.
(e) From
and after the Redemption Date, the Corporation shall, at the place specified in
the Redemption Notice, upon presentation and surrender to the Corporation by or
on behalf of the holder thereof the warrant certificates evidencing this Warrant
being redeemed, deliver, or cause to be delivered to or upon the written order
of such holder, a sum in cash equal to the Redemption Price of this Warrant.
From and after the Redemption Date, this Warrant shall expire and become void
and all rights hereunder and under the warrant certificates, except the right to
receive payment of the Redemption Price, shall cease.
1 The
redemption price for the $3.00 Warrants is $5.00. The redemption
price for the $5.00 Warrants is $7.00. The redemption price for the $7.00
Warrants is $9.00.
2 Such
clause (c) will be included only in the $7.00 Warrant.
8. [$7.00 Warrant
Condition. The $7.00 Warrants will not vest and will not become
exercisable unless the Surviving Company secures, prior to the third annual
anniversary of the Closing Date, one or more material binding commercial
manufacturing contracts with one or more third parties, each on an arm’s length
basis, which commercial manufacturing contracts result in aggregate revenues to
the Surviving Company in excess of $5 million per year over a period of at least
3 years and in the reasonable judgment of the Corporation’s Board of Directors
the manufacturing contracts will be profitable each year during the term of such
contracts in accordance with GAAP (the “$7.00 Warrant
Condition”). The $7.00 Warrant Condition will be deemed to have
been achieved, and the $7.00 Warrants will vest, upon certification by the
Corporation's Board of Directors that all the elements of the $7.00 Warrant
Condition have been met, which certification shall be provided as soon as
practicable following the presentation by the PCT Representative to the
Corporation's Board of Directors of all appropriate supporting documents and
materials necessary to determine whether each of the elements of the $7.00
Warrant Condition has been met.]
9. Miscellaneous. This
Warrant shall be governed by and construed in accordance with the laws of the
State of New York. All the covenants and provisions of this Warrant
by or for the benefit of the Corporation shall bind and inure to the benefit of
its successors and assigns hereunder. Nothing in this Warrant shall
be construed to give to any person or corporation other than the Corporation and
the holder of this Warrant any legal or equitable right, remedy, or claim under
this Warrant. This Warrant shall be for the sole and exclusive
benefit of the Corporation and the Holder. The section headings
herein are for convenience only and are not part of this Warrant and shall not
affect the interpretation hereof. Upon receipt of evidence
satisfactory to the Corporation of the loss, theft, destruction, or mutilation
of this Warrant, and of indemnity reasonably satisfactory to the Corporation, if
lost, stolen, or destroyed, and upon surrender and cancellation of this Warrant,
if mutilated, the Corporation shall execute and deliver to the Holder a new
Warrant of like date, tenor, and denomination.
[10. Piggyback Registration
Rights. The parties shall provide in a separate mutually
acceptable agreement that the Corporation will use reasonable commercial efforts
to provide them with piggyback registration rights (standard for an acquisition
transaction) commencing after the later of the date one year after the issuance
date of the Warrants and the date on which the Form S-4 pursuant to which this
Warrant is being registered, as amended, is no longer available with respect to
the Warrant Shares.]
[11. The
parties may vary the form of this Warrant so that the Warrants may be issued in
book-entry/uncertificated form.]
IN
WITNESS WHEREOF, the Corporation has caused this Warrant to be executed by its
duly authorized officer, this ______ day of ____________ 2010.
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NEOSTEM,
INC.
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Robin
L. Smith
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Chairman
& Chief Executive
Officer
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WARRANT
EXERCISE FORM
To
Be Executed by the Holder in Order to Exercise Warrant
To: NeoStem,
Inc. Dated: ________________
__, 20__
420
Lexington Avenue
Suite
450
New York,
New York 10170
Attn: Chairman
and CEO
The
undersigned, pursuant to the provisions set forth in the attached Warrant
No. ______, hereby irrevocably elects to purchase ____________ shares of
the Common Stock of NeoStem, Inc. covered by such Warrant.
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The
undersigned herewith makes payment of the full purchase price for such
shares at the price per share provided for in such
Warrant. Such payment takes the form of $__________ in lawful
money of the United States.
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The
undersigned hereby requests that certificates for the Warrant Shares purchased
hereby be issued in the name of:
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(please
print or type name and address)
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(please
insert social security or other identifying number)
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and
be delivered as follows:
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(please
print or type name and address)
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(please
insert social security or other identifying number)
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and if
such number of shares of Common Stock shall not be all the shares evidenced by
this Warrant Certificate, that a new Warrant for the balance of such shares be
registered in the name of, and delivered to, Holder.
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Signature
of Holder
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SIGNATURE
GUARANTEE:
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ASSIGNMENT
FORM
(To
assign the foregoing warrant, execute
this
form. Do not use this form to exercise the warrant.)
FOR VALUE
RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby
assigned to
______________________________________________________________________________ whose
address is
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Dated: ________
__, 200_
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Holder’s
Signature:
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Holder’s
Address:
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Signature
Guaranteed: _______________________________________________
NOTE: The
signature to this Assignment Form must correspond with the name as it appears on
the face of the Warrant, without alteration or enlargement or any change
whatsoever, and must be guaranteed by a bank or trust
corporation. Officers of corporations and those acting in a fiduciary
or other representative capacity should file proper evidence of authority to
assign the foregoing Warrant.
Exhibit D
FORM OF
OPINION FROM PCT COUNSEL
All
capitalized terms used but not defined herein shall have the meanings ascribed
to them in the Merger Agreement.
The
opinion of counsel to the Progenitor Cell Therapy LLC (the "Company") shall be
to the effect that:
1.
The Company and each of its subsidiaries is a limited liability company, duly
organized, validly existing and in good standing under the laws of the State of
Delaware [or conform for any corporations and/or New Jersey
entities].
2.
The Company has the requisite power and authority to own its assets and
conduct its business as presently conducted and to execute, deliver and perform
its obligations under the Merger Agreement and the Escrow Agreement, and to
consummate the transactions contemplated thereby.
3.
The Company’s managers and members have taken all action necessary for the
authorization, execution and delivery of the Merger Agreement and the Escrow
Agreement by the Company and the performance by the Company of its obligations
under the Merger Agreement and the Escrow Agreement.
4.
The Merger Agreement and the Escrow Agreement have been duly authorized,
executed and delivered by the Company and such agreements constitute valid and
binding obligations of the Company enforceable against it in accordance with
their terms.
5.
The execution and delivery of the Merger Agreement and Escrow Agreement
and the Company's performance of its obligations thereunder do not and will not
(i) contravene any provision contained in the Certificate of Formation, the PCT
LLC Agreement or other organizational documents of the Company or any
Subsidiary, (ii) violate the provisions of any law, rule or regulation
applicable to the Company or any Subsidiary; (iii) violate or result in a breach
(with or without the lapse of time, the giving of notice or both) of or
constitute a default under any Material Contract known to us, (iv) violate any
judgment, decree, order or award of any government entity naming the Company or
any Subsidiary known to us, (v) to our knowledge result in the creation or
imposition of any lien, claim, charge, encumbrance, equity, restriction or right
on any of the assets or properties of any entity within the PCT Group, or (vi)
result in the acceleration of, or permit any Person to accelerate or declare due
and payable prior to its stated maturity, any Liability known to us of any
Person in the PCT Group (except where the result of such acceleration would not
cause a Material Adverse Effect).
6.
The authorized equity interests of the Company consist of
[ ] membership interests, of which
[ ] are
outstanding. All of the equity interests which are issued and
outstanding on the date hereof have been duly authorized and validly issued, are
fully paid and non-assessable and were not issued in violation of any preemptive
or similar rights. None of the equity interests issued by the Company
since ______, 2007 were issued in violation of any registration requirements
under federal securities laws. Immediately prior to the Effective
Time, the Company validly cancelled in accordance with their terms and without
liability to the Company all outstanding options, warrants, or other rights,
agreements, or commitments known to us or listed in the schedules to the Merger
Agreement to which the Company or any member or other equity holder of the
Company is a party or by which any such party is bound obligating the Company or
the member or equity holder of the Company to grant, issue, or sell any capital
stock or any other equity interest in the Company.
7.
None of the Members have any dissenters or appraisal rights with respect
to the Merger or the other transactions contemplated by the Merger
Agreement.
8.
Except for the filing of the Certificate of Merger with the Secretary of
State of the State of Delaware, no consent, approval or authorization of or
designation, declaration, filing with any Governmental Authority or other action
on the part of the Company is required in connection with the consummation of
the transactions contemplated by the Merger Agreement and the Escrow
Agreement.
9. Upon the filing by
the surviving corporation of the Certificate of Merger with the Secretary of
State of the State of Delaware, the Merger will be effective under the
DLLCA.
10. To our knowledge, there
are no civil, criminal or administrative actions, suits or proceedings which are
pending or have been threatened in writing against the Company or any Subsidiary
which (a) seek either damages in excess of $25,000 or equitable relief or (b) in
any manner challenge or seek to prevent, enjoin, alter or delay the transactions
contemplated by the Agreement.
Unassociated Document
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the
incorporation by reference in the Registration Statements on Form S-8
(Registration No. 333-107438, Registration No. 333-144265, Registration No.
333-159282 and Registration No. 333-162733) and in the Registration Statements
on Form S-3 (Registration No. 333-145988 and Registration No. 333-166169) of
NeoStem, Inc. of our report dated September 17, 2010 with respect to the
consolidated financial statements of Progenitor Cell Therapy, LLC and
Subsidiaries as of and for the years ended December 31, 2009, 2008 and 2007,
which appears in NeoStem, Inc.'s Current Report on Form 8-K dated
September 23, 2010.
/s/
EisnerAmper LLP
Unassociated Document
NeoStem,
Inc.
Robin
Smith, CEO
Phone: +1
(212) 584-4174
E-mail:
rsmith@neostem.com
http://www.neostem.com
NeoStem
and Progenitor Cell Therapy Announce Entry Into Merger
Agreement
Companies
to form an Integrated Global Cell Therapy Company
New York,
New York and Allendale, New Jersey, September 23, 2010 – NeoStem, Inc. (NYSE
Amex: NBS) an international biopharmaceutical company with operations in the
U.S. and China and Progenitor Cell Therapy, LLC a privately held cell therapy
company that serves the cell therapy industry from licensed, state-of-the art
cell therapy manufacturing facilities in New Jersey and California today jointly
announced the signing of a definitive merger agreement whereby NeoStem will
acquire Progenitor Cell Therapy. The definitive merger agreement provides for
the issuance of an aggregate of 11,200,000 shares of NeoStem common stock and
warrants to purchase an aggregate of no less than 1,000,000 and a maximum of
3,000,000 additional shares of NeoStem common stock in exchange for all of
Progenitor Cell Therapy membership interests.
Holders
of greater than 50% of NeoStem’s common stock and greater than 50% of PCT’s
membership interests have agreed to vote in favor of the merger. The closing of
the merger is subject to various conditions, including the approval by NeoStem’s
stockholders of the issuance of NeoStem’s securities in the merger.
PCT’s
revenue generating business would be accretive to NeoStem’s growing adult stem
cell operations and PCT’s management would add to NeoStem the over 100 years
collective experience of the PCT management team in the business and science of
cell therapy and its development. Since its inception in 1999, PCT has served
over 100 clients from around the world and is experienced with more than 20
different cell based therapeutics. PCT has performed over 30,000 cell therapy
procedures in its cell therapy manufacturing facilities and processed and stored
over 18,000 cell therapy products (including approximately 7,000 umbilical cord
blood units, 10,000 blood and marrow derived stem cells and 1,000 dendritic
cells) and arranged the logistics and transportation for over 14,000 cell
therapy products for clinical use by over 5,000 patients.
Dr. Robin
Smith, CEO of NeoStem said “We are excited to have reached this agreement with
PCT and believe this combination is beneficial to the stakeholders of both
companies. The acquisition is a significant step in NeoStem’s efforts to develop
a “one-stop-shop” global network of cell therapy core competencies by adding
cell therapy manufacturing and storage facilities as well as integrated
regulatory compliant distribution capacity for the evolving cell therapy
industry. PCT’s global reach and reputation will accelerate the combined
companies’ reach into this exciting market”.
Dr.
Andrew Pecora, PCT’s CEO, who will be invited to join the NeoStem Board of
Directors upon the closing of the merger, said “We are pleased after over a
decade of hard work by our PCT team to bring liquidity to our loyal investors by
combining with NeoStem into a platform for growth of a wide range of adult stem
cell capabilities. Having played an instrumental role in manufacturing Provenge,
Dendreon Corporation’s autologous cellular immunotherapy through its clinical
trials to FDA approval, we are especially excited about bringing to NeoStem our
competencies in the cell therapy development market to contribute to moving
forward NeoStem’s VSEL ™ Technology and other future cell therapy products.
Furthermore, with NeoStem’s autologous adult stem cell collection capabilities
and PCT’s umbilical cord blood collection and long term storage services, the
combined company will be the first of its kind providing families with current
Good Manufacturing Practices (cGMP) autologous stem cell collection and storage
services”.
LifeTech
Capital, an investment banking firm focused on the life science industry,
advised NeoStem by providing valuation analyses of the transaction.
LifeTech Capital is a division of Aurora Capital.
The
Company along with PCT will be appearing at the NASDAQ MarketSite in New York
City and will be able to answer questions about the transaction.
When: September
23, 2010, 1:00 p.m. EDT
Where: NASDAQ
MarketSite, 4 Times Square, New York City (43rd and
Broadway)
RSVP
required: 917.680.6011; Bradley.smith@muncmedia.com
About
NeoStem, Inc.
NeoStem,
Inc. is engaged in the development of stem cell-based therapies, pursuit of
anti-aging initiatives and building of a network of adult stem cell collection
centers in the U.S. and China that are focused on enabling people to donate and
store their own (autologous) stem cells for their personal use in times of
future medical need. The Company also has licensed various stem cell
technologies, including a worldwide exclusive license to VSELTM
technology which uses very small embryonic-like stem cells, shown to have
several physical characteristics that are generally found in embryonic stem
cells, and is pursuing the licensing of other technologies for therapeutic use.
NeoStem’s majority-controlled Chinese pharmaceutical operation, Suzhou Erye,
manufactures and distributes generic antibiotics in China. For more information,
please visit: www.neostem.com.
About
PCT
PCT
serves the developing cell therapy industry that includes biotechnology,
pharmaceutical and medical products companies, health care providers, and
academic investigators from licensed, state-of-the-art cell therapy
manufacturing facilities in Allendale, New Jersey and Mountain View, California.
PCT supports the research of leading academic investigators designed to expedite
the broad clinical application of cell therapy. PCT’s core strategy is to
provide a global network of cell therapy manufacturing and storage facilities
and an integrated and regulatory compliant distribution capacity for the
evolving cell therapy industry to meet international commercial demands. For
more information, please visit: www.progenitorcelltherapy.com.
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking statements
reflect management's current expectations, as of the date of this press release,
and involve certain risks and uncertainties. Forward looking statements include
statements herein with respect to the proposed merger with Progenitor Cell
Therapy, LLC, about which no assurances can be given. The Company's actual
results could differ materially from those anticipated in these forward- looking
statements as a result of various factors. Factors that could cause future
results to materially differ from the recent results or those projected in
forward-looking statements include the "Risk Factors" described in the Company's
most recent Annual Report on Form 10-K and other periodic reports filed with the
Securities and Exchange Commission since the filing of such 10-K. The Company's
further development is highly dependent on future medical and research
developments and market acceptance, which is outside its control.
###