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Certain identified information has been excluded from this exhibit because it
both (i) is not material and (ii) would be competitively harmful if publicly
disclosed. Omissions are designated as [**] FIBROCELL SCIENCE, INC. AND CASTLE
CREEK PHARMACEUTICALS, LLC CO-DEVELOPMENT AND LICENSE AGREEMENT April 12, 2019
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TABLE OF CONTENTS Page 1. DEFINITIONS
........................................................................................................................1
2. LICENSE GRANTS
..............................................................................................................13
2.1 License Grant to CCP
..........................................................................................13
2.2 Sublicense Rights.
................................................................................................13
2.3 Assignment of Assigned Contracts.
....................................................................14 2.4
Access to Fibrocell Know-How
...........................................................................14
2.5 No Implied Rights or Licenses
............................................................................15
2.6 Retained Rights
....................................................................................................15
3. GOVERNANCE
....................................................................................................................15
3.1 General
..................................................................................................................15
3.2 Joint Development
Committee............................................................................15
3.3 Dissolution of the JDC
.........................................................................................17
4. DEVELOPMENT PROGRAM
................................................................................................17
4.1 Project
...................................................................................................................17
4.2 Development Plan and Development Budget.
...................................................18 4.3 Technical
Cooperation.........................................................................................19
4.4 Compliance with Applicable Laws
.....................................................................19 4.5
Subcontracting Permitted.
..................................................................................19
5. REGULATORY MATTERS
...................................................................................................20
5.1 Pharmacovigilance Agreement
...........................................................................20
5.2 Preparation of Regulatory Filings.
.....................................................................20 5.3
Notice of Communication with Regulatory Authorities.
..................................21 5.4 Regulatory Compliance
.......................................................................................22
5.5 Regulatory Documentation
.................................................................................22
5.6 BLA Transfer
.......................................................................................................22
5.7 Product Recall
......................................................................................................22
5.8 Cooperation
..........................................................................................................22
5.9 Priority Review Voucher
.....................................................................................23
5.10 Rights of Reference to Regulatory Materials
....................................................23 6. COMMERCIALIZATION
......................................................................................................23
6.1 Responsibility for
Commercialization................................................................23
6.2 Packaging; CCP Trademarks
.............................................................................23
7. MANUFACTURE AND SUPPLY OF PRODUCT
......................................................................23
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TABLE OF CONTENTS PAGE 7.1 Commercial Manufacturing
...............................................................................23
8. DILIGENCE
.........................................................................................................................23
8.1 By
Fibrocell...........................................................................................................23
8.2 By CCP
..................................................................................................................23
9. PAYMENT OBLIGATIONS
...................................................................................................24
9.1 Upfront Payment
..................................................................................................24
9.2 Development Cost Sharing
..................................................................................24
9.3 Profit Sharing
.......................................................................................................25
9.4 Method and Timing of Payments
.......................................................................25 9.5
Milestone Payments.
............................................................................................25
9.6 Disputed
Payments...............................................................................................26
9.7 Currency of Payment
...........................................................................................26
9.8 Accounting.
...........................................................................................................26
9.9 Withholding Tax
..................................................................................................27
10. RECORD KEEPING, RECORD RETENTION AND AUDITS
....................................................27 10.1 Record Keeping
....................................................................................................27
10.2 Record Retention
.................................................................................................28
10.3 Audit Request
.......................................................................................................28
10.4 Survival
.................................................................................................................28
11. INVENTIONS, KNOW-HOW AND PATENTS
.........................................................................28 11.1
Existing Intellectual Property
.............................................................................28
11.2 Ownership of Inventions.
....................................................................................28
11.3 Patent Prosecution and
Maintenance.................................................................29
11.4 Third Party
Licenses............................................................................................31
11.5 Infringement by Third Parties.
...........................................................................31
11.6 Infringement Outside the
Field...........................................................................33
11.7 Further Actions
....................................................................................................33
11.8 Intrexon Patents
...................................................................................................33
11.9 Change of Control
................................................................................................33
12. TRADEMARKS
....................................................................................................................33
12.1 Product Trademark
.............................................................................................33
12.2 Trademark Prosecution and Maintenance
........................................................33 13. REPRESENTATIONS,
WARRANTIES AND COVENANTS
......................................................34 13.1 The Parties’
Representations and Warranties
..................................................34 13.2 Additional
Representations and Warranties of Fibrocell ................................35
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TABLE OF CONTENTS PAGE 13.3 Covenants of the Parties
......................................................................................37
13.4 Covenants of Fibrocell
.........................................................................................38
13.5 Covenant of
CCP..................................................................................................39
14. MUTUAL INDEMNIFICATION AND INSURANCE
..................................................................39 14.1
Fibrocell’s Right to Indemnification
..................................................................39 14.2 CCP’s
Right to Indemnification
.........................................................................39 14.3
Process for Indemnification
................................................................................40
14.4 Insurance
..............................................................................................................41
15. LIMITATION OF LIABILITY AND EXCLUSION OF DAMAGES; DISCLAIMER OF WARRANTY
..................................................................................41
16. CONFIDENTIALITY
.............................................................................................................41
16.1 Confidentiality; Exceptions
.................................................................................41
16.2 Degree of Care; Permitted Use
...........................................................................42
16.3 Permitted Disclosures
..........................................................................................42
16.4 Irreparable Injury
...............................................................................................43
16.5 Return of Confidential Information
...................................................................43 16.6
Survival of Obligations
........................................................................................43
17. PUBLICITY
.........................................................................................................................43
17.1 Public Disclosure
..................................................................................................43
17.2 Use of Marks
.........................................................................................................44
18. TERM AND TERMINATION
.................................................................................................44
18.1 Term
......................................................................................................................44
18.2 Termination by
CCP............................................................................................44
18.3 Termination for Material Breach
.......................................................................45 18.4
Termination upon Insolvency
.............................................................................45
18.5 Termination by CCP pursuant to Section 18.2 or Fibrocell pursuant to
Section 18.3 or 18.4.
.........................................................................................45
18.6 Termination by CCP Pursuant to Section 18.3 or 18.4
....................................47 18.7 General Surviving Obligations
...........................................................................48
18.8 Accrued Rights, Surviving
Obligations..............................................................49 18.9
Rights in Bankruptcy
...........................................................................................49
19. MISCELLANEOUS
...............................................................................................................49
19.1 Agency
...................................................................................................................49
19.2 Assignment; Change of Control.
........................................................................49 19.3
Further Actions
....................................................................................................50
19.4 Force Majeure
......................................................................................................50
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TABLE OF CONTENTS PAGE 19.5 Notices
...................................................................................................................50
19.6 Amendment
..........................................................................................................51
19.7 Waiver
...................................................................................................................51
19.8 Counterparts
........................................................................................................51
19.9 Construction
.........................................................................................................51
19.10 Governing Law
.....................................................................................................51
19.11 Severability
...........................................................................................................51
19.12 Compliance with Applicable
Law.......................................................................52
19.13 Entire Agreement of the Parties
.........................................................................52
19.14 Performance by Affiliates.
...................................................................................52
19.15 Non-Solicitation
....................................................................................................52
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CO-DEVELOPMENT AND LICENSE AGREEMENT THIS CO-DEVELOPMENT AND LICENSE AGREEMENT
(the “Agreement”) is made and entered into as of April 12, 2019 (the “Effective
Date”) by and between FIBROCELL SCIENCE, INC., a Delaware corporation with a
principal place of business at 405 Eagleview Blvd., Exton, Pennsylvania 19341
(“Fibrocell”), and CASTLE CREEK PHARMACEUTICALS, LLC, a Delaware limited
liability company with a principal place of business at 6 Century Drive,
Parsippany, New Jersey 07054 (“CCP”). Fibrocell and CCP are sometimes referred
to herein individually as a “Party” and collectively as the “Parties”. Except as
otherwise provided in Section 19.14, references to “Fibrocell” and “CCP” will
not include their respective Affiliates. RECITALS WHEREAS, Fibrocell is a
biotechnology company engaged in the research, development, and
commercialization of pharmaceutical biologics for the amelioration, treatment
and/or prevention of human diseases and conditions, including Recessive
Dystrophic Epidermolysis Bullosa (“RDEB”); WHEREAS, CCP is a pharmaceutical
company engaged in the research, development and commercialization of
pharmaceutical compounds for the amelioration, treatment and/or prevention of
human diseases and conditions; WHEREAS, Fibrocell has developed and is
conducting clinical trials of its product known as FCX-007, which consists of an
autologous dermal fibroblast genetically modified to express functional Type VII
collagen (the “Product”); WHEREAS, CCP and Fibrocell desire to collaborate in
certain activities to develop the Product for the treatment of RDEB; and
WHEREAS, CCP desires to obtain, and Fibrocell is willing to grant to CCP, a
license under Fibrocell’s proprietary technology to Exploit the Product, on the
terms and conditions provided in this Agreement. AGREEMENT NOW, THEREFORE, in
consideration of the foregoing and the covenants and promises contained in this
Agreement and intending to be legally bound, the Parties agree as follows: 1.
DEFINITIONS. As used herein, the following terms will have the following
meanings: 1.1 “Acquired Party” has the meaning set forth in Section 11.9. 1.2
“Acquiror” has the meaning set forth in Section 11.9. 1.3 “Acquiror Affiliate”
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1.4 “Affiliate” means a corporation, partnership, trust or other entity that
directly, or indirectly through one or more intermediates, controls, is
controlled by or is under common control with a specified Party. For such
purposes, “control,” “controlled by” and “under common control with” will mean
the possession of the power to direct or cause the direction of the management
and policies of an entity, whether through the ownership of voting equity,
voting member or partnership interests, control of a majority of the board of
directors or other similar body, by contract or otherwise. In the case of a
corporation, the direct or indirect ownership of more than fifty percent (50%)
of its outstanding voting shares or the ability otherwise to elect a majority of
the board of directors or other managing authority of the entity will in any
event be presumptively deemed to confer control, it being understood that the
direct or indirect ownership of a lesser percentage of such shares will not
necessarily preclude the existence of control. 1.5 “Agreement” has the meaning
set forth in preamble hereto. 1.6 “Applicable Law” means all applicable laws,
rules, and regulations, including any rules, regulations, guidelines or other
requirements of the Regulatory Authorities or other governmental authorities,
that may be in effect from time to time in the Territory, including Health Care
Laws. 1.7 “Assigned Contracts” means those contracts mutually agreed upon by the
Parties. 1.8 “Assignment Date” has the meaning set forth in Section 2.3(b). 1.9
“Balancing Statement” has the meaning set forth in Section 9.4. 1.10 “Biosimilar
Application” means an application or submission filed with a Regulatory
Authority for marketing authorization of a Biosimilar Product. 1.11 “Biosimilar
Product” means, with respect to the Product following Regulatory Approval in the
applicable country, a biological product (a) that is “biosimilar” to or
“interchangeable” with the Product, as the term “biosimilar” is defined in 42
U.S.C. § 262(i)(2) or 262(i)(3), as applicable, (b) for which Regulatory
Approval is obtained in the Territory by referencing any regulatory materials of
the Product, (c) that is approved for use in the Territory pursuant to a
Regulatory Approval process governing approval of interchangeable or biosimilar
biologics as described in 42 U.S.C. §§ 262, or any other similar provision that
comes into force, or is the subject of a notice with respect to the Product
under 42 U.S.C. § 262(l)(2), and (d) is sold in the Territory by any Third Party
that is not a Sublicensee of CCP or its Affiliates under this Agreement and did
not purchase the Product in a chain of distribution that included any of CCP or
its Affiliates or Sublicensees. 1.12 “BPCIA” means Biologics Price Competition
and Innovation Act of 2009, as amended. 1.13 “BLA” means a Biologics License
Application for the Product under Section 351 of the Public Health Service Act,
as may be amended, supplemented, or replaced, or any foreign equivalent thereto.
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1.14 “Breaching Party” has the meaning set forth in Section 18.3. 1.15 “CCP” has
the meaning set forth in the preamble hereto. 1.16 “Change of Control” means,
with respect to a Party, (a) the consummation of a merger or consolidation of
such Party in which the shareholders of such Party that directly or indirectly
control such Party immediately prior to such merger or consolidation do not
continue to hold immediately following the closing of such merger or
consolidation at least fifty percent (50%) of the combined voting power of the
then outstanding securities of the surviving or resulting entity; (b) the
consummation of a sale or transfer of all or substantially all of the assets of
such Party to one or more Third Parties, or other similar transaction or series
of related transactions; or (c) any transaction or series of transactions in
which any person or entity or group of persons or entities acquires beneficial
ownership of securities of a Party representing more than fifty percent (50%) of
the combined voting power of the then outstanding securities of such Party;
provided, however, that, notwithstanding subsections (a), (b) or (c) above, a
sale of a Party’s securities in an underwritten public offering of such Party’s
securities to multiple non-affiliated investors will not constitute a Change of
Control. 1.17 “Clinical Trials” means Phase I Clinical Trials, Phase II Clinical
Trials, Phase III Clinical Trials, Phase IV Clinical Trials (if applicable),
and/or variations of such trials (e.g., Phase II/III) as those terms are defined
by the FDA. 1.18 “CMC Data” means any and all Information contained in, as well
as data supporting, the Chemistry, Manufacturing and Control sections (or
sections corresponding thereto) of a BLA or other equivalent regulatory filing
relating to the Product. 1.19 “Commencement” or “Commence” means, when used with
respect to Clinical Trials (or the local equivalent), the date of enrollment of
the first patient or subject in such Clinical Trials (or the local equivalent).
1.20 “Commercialization” means all activities undertaken relating to the
manufacture for commercial use, marketing, and/or sale of the Product, including
advertising, education, planning, marketing, promotion, distribution, market and
product support, and will include post-Commercial Launch research, development,
and medical activities such as Phase IV Clinical Trials but will exclude other
Development activities. “Commercialize” will have a corresponding meaning. 1.21
“Commercial Launch” means the first arm’s length commercial sale of the Product
by CCP or its Affiliate or Sublicensee to a Third Party (including any final
sale to a distributor or wholesaler under any non-conditional sale arrangement)
in a country where Regulatory Approval of the Product has been obtained;
provided, however, that in no event will any sale or distribution of the Product
for Pre-Launch Activities or use in a Clinical Trial be deemed a Commercial
Launch. 1.22 “Commercially Reasonable Efforts” means (a) with respect to the
efforts to be expended by a Party with respect to an agreed objective, except as
otherwise 3 US-DOCS\106669270.9

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[ex105castlecreekfibrocel009.jpg]
provided in clause (b), such reasonable, diligent, and good faith efforts as
such Party would normally use to accomplish a similar objective under similar
circumstances taking into account the responsible allocation of such Party’s
resources under the circumstances, but no less than the level of efforts and
resources (including the promptness with which such efforts and resources would
be applied) commonly used in the pharmaceutical industry with respect to a
product of similar commercial potential at a similar stage in its development or
product life by a party of the same or similar size as the Party, and with the
same or similar resources as the Party, to achieve that applicable objective,
and (b)(i) with respect to CCP’s obligations relating to the Commercialization
of the Product under this Agreement, the efforts and resources normally used by
a company in the biopharmaceutical industry of similar size and resources as CCP
for a product that is of similar market potential at a similar stage in its
product life, taking into account all relevant factors, including the
responsible allocation of such company’s resources under the circumstances, the
potential profitability of the Product, the costs and risks of Developing,
Manufacturing, and Commercializing the Product, scientific, safety, efficacy and
regulatory concerns, product profile, the competitiveness of the marketplace,
regulatory exclusivity, the likelihood of regulatory approval given the
regulatory structure involved, performance of other products that are of similar
market potential and the likely timing of other products’ entry into the market,
the patent protection and other proprietary position of the Product, relevant
Third Party intellectual property necessary to Develop and Commercialize the
Product, and other relevant factors commonly considered in similar
circumstances, but not taking into account a competitive product in CCP’s
portfolio, and (ii) with respect to Fibrocell’s obligations relating to the
Development or Manufacturing of the Product under this Agreement, means efforts
that are not less than those discovery, research, Development or Manufacturing
efforts normally used by a company in the biopharmaceutical industry of similar
size and resources as Fibrocell (including for purposes of such calculation, the
financial resources afforded to Fibrocell as a result of CCP’s payments
hereunder). For the avoidance of doubt, where a Party has an obligation to use
Commercially Reasonable Efforts, the efforts of such Party and its Affiliates
and Sublicensees will be considered in determining whether such Party has
satisfied such obligation. 1.23 “Confidential Disclosure Agreement” has the
meaning set forth in Section 16.1. 1.24 “Confidential Information” has the
meaning set forth in Section 16.1. 1.25 “Control” means, with respect to any
item of Information, Patent, Patent Application, know-how or other intellectual
property right, the right to grant a license or sublicense with respect thereto
as provided for in this Agreement, without violating the terms of any agreement
or other arrangement with, or any legal rights of any Third Party. 1.26 “Cost
Overruns” has the meaning set forth in Section 9.2. 1.27 “Damages” has the
meaning set forth in Section 14.1. 1.28 “Debarred or Excluded” has the meaning
set forth in Section 13.1(g). 1.29 “Develop” or “Development” means all
activities relating to obtaining Regulatory Approval of the Product and all
manufacturing activities undertaken prior to 4 US-DOCS\106669270.9

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[ex105castlecreekfibrocel010.jpg]
Commercialization (including those activities reasonably required for the scale
up of Manufacturing processes or equipment in preparation for commercial supply
of Product). This includes, for example, (a) preclinical testing, toxicology,
formulation, clinical studies, including Clinical Trials, and regulatory
affairs, and (b) manufacturing process development for bulk and finished forms
of the Product, as applicable, production of clinical supply of Product, and
manufacturing and quality assurance technical support activities. 1.30
“Development Budget” has the meaning set forth in Section 4.2(a). 1.31
“Development Costs” means the costs and expenses incurred by a Party or for its
account after the Effective Date that are consistent with the approved
Development Plan and are specifically attributable to the Development of the
Product, and, in the case of Fibrocell, including the Intrexon Obligations, but
excluding any royalties, milestones, sublicense income, reimbursements or other
payments due to Intrexon under the Intrexon Agreement. 1.32 “Development Plan”
has the meaning set forth in Section 4.2(a). 1.33 “Dollar” means a U.S. dollar,
and “$” will be interpreted accordingly. 1.34 “Effective Date” has the meaning
set forth in the preamble hereto. 1.35 “Excess Initial Development Costs” has
the meaning set forth in Section 9.2. 1.36 “Executives” has the meaning set
forth in Section 3.2(d). 1.37 “Exploit” or “Exploitation” means the making,
having made, using, having used, selling, having sold, offering for sale and/or
otherwise disposing of, the Product, including all discovery, research,
Development (including the conduct of Clinical Trials), registration,
modification, enhancement, improvement, manufacturing, labeling, storage,
formulation, exportation, importation, optimization, transportation,
distribution, promotion, marketing and Commercialization activities related
thereto. 1.38 “FDA” means the United States Food and Drug Administration, or any
successor thereto, having the administrative authority to regulate the marketing
of human pharmaceutical products or biological therapeutic products in the
United States. 1.39 “FDCA” has the meaning set forth in Section 1.51. 1.40
“Fibrocell” has the meaning set forth in the preamble hereto. 1.41 “Fibrocell
Know-How” means all Information (a) listed in Exhibit 1.41 or (b) that is (i)
Controlled by Fibrocell or its Affiliates as of the Effective Date or at any
time during the term of this Agreement and (ii) used with, incorporated or
included in, or otherwise necessary for the Exploitation of, the Product in the
Field in the Territory. Fibrocell Know-How includes the Intrexon Confidential
Information, Intrexon Know-How, Intrexon Materials (as those terms are defined
in the Intrexon Agreement) and any other Information licensed or disclosed to
Fibrocell under the Intrexon Agreement. Fibrocell Know-How includes Fibrocell’s
5 US-DOCS\106669270.9

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[ex105castlecreekfibrocel011.jpg]
or its Affiliates’ interest in unpublished Inventions and unpublished Joint
Inventions. Fibrocell Know-How does not include Fibrocell Patent Rights. 1.42
“Fibrocell Patent Rights” means (a) the Patents listed in Exhibit 1.42, (b) any
Patents that issue from the Patent Applications listed in Exhibit 1.42, (c) any
Patents and/or Patent Applications that claim priority to a Patent or Patent
Application listed in Exhibit 1.42, including any continuation, continued
prosecution application, divisional, reissue or re- examination, (d) any other
Patent and/or Patent Application that is Controlled by Fibrocell or its
Affiliates as of the Effective Date or at any time during the term of this
Agreement and that claims the Product or any other product, method, apparatus,
material, manufacturing process or other technology that is necessary to Exploit
the Product in the Field in the Territory, and (e) any foreign equivalents of
the Patents and/or Patent Applications referenced in Section 1.42(a), (b), (c)
or (d). Fibrocell Patent Rights include the Patents and Patent Applications
licensed to Fibrocell under the Intrexon Agreement. Fibrocell Patent Rights
includes Fibrocell’s interest in Joint Patent Rights. Fibrocell Patent Rights do
not include Fibrocell Know-How. 1.43 “Field” means the amelioration, treatment
and/or prevention of any and all diseases and conditions. 1.44 “Force Majeure
Event” has the meaning set forth in Section 19.4. 1.45 “Fully Burdened
Manufacturing Costs” has the meaning set forth in Exhibit 1.45. 1.46 “GAAP”
means United States generally accepted accounting principles consistently
applied. 1.47 “General Disclosure” has the meaning set forth in Section 17.1.
1.48 “Good Clinical Practices” or “GCP” means the then current standards,
practices and procedures set forth in the guidelines entitled in “Good Clinical
Practice: Consolidated Guideline,” including related regulatory requirements
imposed by the FDA and (as applicable) any equivalent or similar standards in
jurisdictions outside the Territory. 1.49 “Good Laboratory Practices” or “GLP”
means the then current regulations set forth in 21 C.F.R. Part 58 and the
requirements expressed or implied thereunder imposed by the FDA and (as
applicable) any equivalent or similar standards in jurisdictions outside the
Territory. 1.50 “Good Manufacturing Practices” or “GMP” means the then current
regulations set forth in 21 C.F.R. Parts 210–211, 820 and 21 C.F.R. Subchapter C
(Drugs), Quality System Regulations and the requirements thereunder imposed by
the FDA, and, as applicable, any similar or equivalent regulations and
requirements in jurisdictions outside the Territory. 1.51 “Health Care Laws”
means, as applicable: (a) the U.S. Anti-Kickback Statute (42 U.S.C. Section
1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.),
Sections 1320a-7, 1320a-7a, and 1320a-7b of Title 42 of the United States Code 6
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[ex105castlecreekfibrocel012.jpg]
and the regulations promulgated pursuant to such statutes and any comparable
self-referral or fraud and abuse laws promulgated by any state; (b) the U.S.
Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section
1320d et seq.), as amended by the Health Information Technology for Economic and
Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations
promulgated thereunder (“HIPAA”) and any law or regulation the purpose of which
is to protect the privacy of individually-identifiable patient information; (c)
Medicare (Title XVIII of the Social Security Act); (d) Medicaid (Title XIX of
the Social Security Act); (e) Patient Protection and Affordable Care Act of
2010, as amended by the Health Care and Education Affordability Reconciliation
Act of 2010; (f) the Federal Food, Drug and Cosmetic Act (the “FDCA”), the
Public Health Service Act (the “PHSA”) and FDA regulations promulgated
thereunder; (g) the Sunshine/Open Payments Law (42 U.S.C. § 1320a-7h); and (h)
any other requirements of law applicable to a Party’s (i) design, development,
testing, studying, manufacturing, processing, storing, importing or exporting,
licensing, labeling or packaging, advertising, distributing, selling, pricing,
or marketing of biologics, (ii) remuneration (including ownership) to or by
physicians or other health care providers (including kickbacks) or the
disclosure or reporting of the same, (iii) patient or program charges,
record-keeping, claims processing, documentation requirements, medical
necessity, referrals, (iv) hiring of employees (excluding general employment
laws and practices), (v) acquisition of services or supplies from those who have
been excluded from government health care programs, (vi) quality, safety,
privacy, security, licensure, accreditation activities or (vii) any other aspect
of providing health care products or services, including the collection and
reporting requirements and the processing of any applicable rebate, chargeback
or adjustment. 1.52 “HIPAA” has the meaning set forth in Section 1.51. 1.53
“IND” means an Investigational New Drug application for the Product, which must
be approved by the FDA (or foreign equivalent) before shipment of the Product
intended for administration to humans. 1.54 “Indemnified Party” has the meaning
set forth in Section 14.3(a). 1.55 “Indemnifying Party” has the meaning set
forth in Section 14.3(a). 1.56 “Information” means ideas, inventions,
discoveries, concepts, formulas, practices, procedures, processes, methods,
knowledge, know-how, trade secrets, technology, designs, drawings, computer
programs, skill, experience, documents, apparatus, results, clinical and
regulatory strategies, test data, including pharmacological, toxicological and
clinical data, analytical and quality control data, manufacturing data and
descriptions, Patent and legal data, market data, financial data or
descriptions, devices, assays, chemical formulations, specifications,
compositions of matter, product samples and other samples, physical, chemical
and biological materials and compounds, and the like, in written, electronic or
other form, now known or hereafter developed, whether or not patentable. 1.57
“Initial BLA Approval” has the meaning set forth in Section 9.2. 1.58 “Initial
Cost Cap” has the meaning set forth in Section 9.2. 7 US-DOCS\106669270.9

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[ex105castlecreekfibrocel013.jpg]
1.59 “Initial Development Costs” has the meaning set forth in Section 9.2. 1.60
“Initial Indication” means the amelioration, treatment and/or prevention of
RDEB. 1.61 “Initial Public Disclosure” has the meaning set forth in Section
17.1. 1.62 “Intrexon” means Intrexon Corporation. 1.63 “Intrexon Agreement”
means that certain Exclusive Channel Collaboration Agreement by and between
Fibrocell and Intrexon, effective as of October 5, 2012, as amended by that
certain First Amendment to Exclusive Channel Collaboration Agreement, dated June
28, 2013, that certain Second Amendment to Exclusive Channel Collaboration
Agreement, dated January 10, 2014, and that certain letter agreement dated
September 29, 2015, and as further amended from time to time. 1.64 “Intrexon
Obligations” means amounts due to Intrexon pursuant to and in accordance with
Section 4.7 of the Intrexon Agreement in consideration for the research and
development support services performed by Intrexon for Fibrocell thereunder, to
the extent such amounts due are (a) approved by CCP in advance and in writing,
(b) directly and exclusively related to the Development of the Product in the
Field and in the Territory, and (c) incurred in connection with such services
performed after the Effective Date. 1.65 “Intrexon Rights” has the meaning set
forth in Section 13.4(b). 1.66 “Inventions” has the meaning set forth in Section
11.2(a). 1.67 “Joint Development Committee” or “JDC” has the meaning set forth
in Section 3.1. 1.68 “Joint Inventions” has the meaning set forth in Section
11.2(a). 1.69 “Joint Patent Rights” has the meaning set forth in Section
11.3(a)(iii). 1.70 “KOL” means key opinion leader. 1.71 “Manufacture” or
“Manufacturing” means the activities to be performed by Fibrocell or CCP in
connection with the manufacture, testing (including quality control, quality
assurance and lot release testing), bulk packaging and/or storage of the
Product, as applicable. 1.72 “Manufacturing and Supply Agreement” has the
meaning set forth in Section 7.1. 1.73 “Milestone Payments” has the meaning set
forth in Section 9.5(a). 8 US-DOCS\106669270.9

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1.74 “Net Sales” means the gross amount received by CCP, its Affiliates or
Sublicensees from Third Parties for sales of the Product in the Territory, less
(solely to the extent related to the Product): (a) sales returns and allowances,
including trade, quantity and cash discounts and any other adjustments,
including those granted on account of price adjustments, billing errors,
rejected goods, damaged goods, returns, rebates, recalls, replacements,
uncollectible amounts due, chargeback rebates, fees, reimbursements or similar
payments granted or given to wholesalers or other distributors, buying groups,
healthcare insurance carriers or other institutions, managed health care
organizations, pharmacy benefit managers (or equivalents thereof), national,
state/provincial, local, and other governments, their agencies and purchasers
and reimbursers, or to trade customers (managed care and similar types of
rebates and chargebacks) or inventory writeoffs, (b) accrued allowances for
normal and customary trade, quantity and cash discounts, (c) all of the
following actually invoiced to the Third Party: freight, transportation,
insurance, handling, packing and distribution charges, (d) inventory management
fees or similar fees for bona fide services provided by wholesalers,
distributors, warehousing chains and other Third Parties related to the
distribution of the Product, (e) the actual loss experienced in respect of bad
debts written off, (f) customs or excise taxes including import duties and other
duties relating to sales, or other governmental charges (including any tax such
as a value added or similar tax, other than any taxes based on income) relating
to the sale of the Product, (g) any payment in respect to sales to any
governmental authority in respect of any government subsidized program,
including Medicare and Medicaid rebates, (h) the annual fee on prescription drug
manufacturers imposed by the United States Patient Protection and Affordable
Care Act, and (i) any item substantially similar in character and/or substance
to the above, all as determined in accordance with GAAP on a basis consistent
with CCP’s annual audited financial statements, and any other deductions not
otherwise itemized above but which are hereinafter consistently applied across
CCP’s products as a result of a change in Applicable Law or GAAP. In addition,
Net Sales by CCP hereunder are subject to the following: (1) Any transfer, sale
or other disposal of the Product by CCP to an Affiliate of CCP will not be
included in Net Sales if that Affiliate is not an end-user of the Product; in
such case, Net Sales will be calculated as above on the value charged or
invoiced on the first arm’s length sale to a Third Party; 9 US-DOCS\106669270.9

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(2) Use of the Product in Clinical Trials or pre-clinical trials or other
research or development activities (including pursuant to an Expanded Access
Program) or disposal of the Product for non-profit purposes of a commercially
reasonable program (including, pursuant to patient assistance, indigent care,
compassionate use, free goods and similar programs) will not give rise to any
deemed sale for purposes of this definition, unless the Product is sold or
disposed of for a profit; (3) In the event that the Product is Commercialized in
combination with one or more products which are themselves not the Product under
this Agreement for a single price, the Net Sales for the Product will be
calculated by multiplying the sales price of such combination sale by the
fraction A/(A+B) where A is the fair market value of the Product and B is the
fair market value of the other product(s) in the combination sale. If the fair
market value for any product sold in combination with the Product cannot be
reasonably determined, the price attributed to such product will be based on the
relative cost of goods for such product, as determined in accordance with GAAP.
In addition, in the event that the Product is sold with any other product(s) or
if any giveaways, discounts, rebates or charge-backs (whether as part of a
customer loyalty, bundling or “loss leader” program, or otherwise) are provided
for the Product to promote or sell other products or otherwise, the Net Sales
for the Product will be no less than the fair market value of the Product on a
stand-alone basis (excluding any such discounts, rebates or charge-backs); and
(4) Notwithstanding anything to contrary contained herein, the following will
not be considered Net Sales for purposes of this Agreement: sales of (x) a
Biosimilar Product by any Sublicensee that has received a royalty-free license
from CCP in settlement of any dispute or pursuant to any judgment (provided that
any amounts received in settlement of an infringement claim will be treated in
accordance with Section 11.5(a)), (y) the Product or a Biosimilar Product by a
compulsory Sublicensee pursuant to a royalty-free license or sublicense granted
to a Third Party through the order, decree or grant of a governmental authority
having competent jurisdiction, authorizing such Third Party to Manufacture, use,
sell, offer for sale, import or export the Product in the Territory, or (z) the
Product as to which CCP does not receive any consideration tied to sales of the
Product. If CCP appoints a distributor to sell an authorized Biosimilar Product
of the Product, then only the consideration actually paid to CCP by such
distributor will be included in the calculation of Net Sales. 1.75
“Non-Breaching Party” has the meaning set forth in Section 18.3. 1.76
“Non-Publishing Party” has the meaning set forth in Section 17.1. 1.77 “Party”
or “Parties” has the meaning set forth in the preamble hereto. 1.78 “Patent”
means (a) letters patent (or other equivalent legal instrument), including
utility and design patents, and including any extension, substitution,
registration, confirmation, reissue, re-examination or renewal thereof and (b)
all foreign or international equivalents of any of the foregoing in any country
in the Territory. 1.79 “Patent Application” means (a) an application for letters
patent, including a reissue application, a re-examination application, a
continuation application, a 10 US-DOCS\106669270.9

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continued prosecution application, a continuation-in-part application, a
divisional application or any equivalent thereof that is pending at any time
during the term of this Agreement before a government Patent agency and (b) all
foreign or international equivalents of any of the foregoing in any country in
the Territory. 1.80 “Pharmacovigilance Agreement” has the meaning set forth in
Section 5.1. 1.81 “Phase I Clinical Trial” means any clinical study conducted on
sufficient numbers of human subjects to establish the safety of the Product over
a range of doses, as more fully defined in 21 C.F.R. § 312.21(a), or its
successor regulation. 1.82 “Phase II Clinical Trial” means any clinical study
conducted on sufficient numbers of human subjects for an indication, to
establish the safety and efficacy of the Product for such indication in a target
patient population over a dosage range, as more fully defined in 21 C.F.R. §
312.21(b), or its successor regulation. 1.83 “Phase III Clinical Trial” means
any clinical study intended as a pivotal study for purposes of seeking
Regulatory Approval that is conducted on sufficient numbers of human subjects to
establish that the Product is safe and efficacious for its intended use, to
define warnings, precautions, and adverse reactions that are associated with the
Product in the dosage range to be prescribed, and to support Regulatory Approval
of the Product or label expansion of such pharmaceutical product, as more fully
defined in 21 C.F.R. § 312.21(c), or its successor regulation. 1.84 “Phase IV
Clinical Trial” means clinical study of the Product on human subjects commenced
after receipt of Regulatory Approval of the Product for the purpose of
satisfying a condition imposed by a Regulatory Authority to obtain Regulatory
Approval, or to support the marketing of such pharmaceutical product, and not
for the purpose of obtaining initial Regulatory Approval of the Product. 1.85
“PHSA” has the meaning set forth in Section 1.51. 1.86 “Pre-Launch Activities”
means all Commercialization activities undertaken with respect to the Product in
the Territory prior to Commercial Launch and in preparation for the launch of
the Product in the Territory. Pre-Launch Activities will include advertising,
education, product-related public relations, health care economic studies,
governmental affairs activities for reimbursement and formulary acceptance,
sales force training, and other activities as determined by CCP in its sole
discretion that are to be conducted in the Territory prior to the Commercial
Launch of the Product. 1.87 “Product” has the meaning set forth in the recitals
hereto. 1.88 “Product Gross Profit” means Net Sales less Fully Burdened
Manufacturing Costs and any amounts paid for Third Party licenses pursuant to
Section 11.4. Notwithstanding the foregoing, Product Gross Profit shall never be
less than zero dollars ($0). 1.89 “Product Patents” has the meaning set forth in
Section 11.3(a)(i). 11 US-DOCS\106669270.9

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1.90 “Rare Pediatric Disease Priority Review Voucher” means a priority review
voucher issued by the FDA or otherwise under the authority of the United States
Department of Health and Human Services to Fibrocell (or its Affiliate(s)) as
the sponsor of a rare pediatric disease product application related to the
Product, that entitles the holder of such voucher to priority review of a single
human drug application submitted under Section 505(b)(1) or 505(b)(2) of the
FDCA or Section 351(a) of the United States Public Health Service Act, as
further defined in the FDCA, or any successor or similar voucher under any
successor statute. 1.91 “RDEB” has the meaning set forth in the recitals hereto.
1.92 “Regulatory Approval” means, with respect to the Product, approval by the
FDA of a BLA or other applicable filing and satisfaction of related applicable
FDA registration and notification requirements with respect to the Product. 1.93
“Regulatory Authority” means any applicable supra-national, federal, national,
regional, state, provincial or local regulatory agencies, departments, bureaus,
commissions, councils or other government entities, including the FDA,
regulating or otherwise exercising authority with respect to the Exploitation of
the Product in the Territory. 1.94 “Regulatory Plan” has the meaning set forth
in Section 5.2. 1.95 “Representing Party” has the meaning set forth in Section
13.1. 1.96 “Sublicense” means any agreement entered into by CCP and any person
or entity, including Affiliates of CCP, granting such person or entity rights
under any Fibrocell Patent Rights or Fibrocell Know-How, as the case may be,
including grants of covenants not to sue and options to obtain licenses and/or
sublicenses. 1.97 “Sublicensee” means any person or entity, including Affiliates
of CCP, to which CCP grants a Sublicense under this Agreement. 1.98 “Territory”
means the United States of America and its territories, commonwealths and
protectorates (including Puerto Rico and Guam). 1.99 “Third Party” means any
person or entity other than CCP, Fibrocell, or an Affiliate of either of them.
1.100 “Trademark” means any word, name, symbol, color, designation or device or
any combination thereof, whether registered or unregistered, including any
trademark, trade dress, service mark, service name, brand mark, trade name,
brand name, logo or business symbol. 1.101 “Valid Claim” means, for a country, a
claim of an unexpired issued Patent or a pending Patent Application filed and
kept pending in good faith, where either or both (a) such Patent or Patent
Application is included in either the Patents or Patent Applications licensed to
CCP under this Agreement, or (b) such claim directed to an Invention made solely
or jointly by Fibrocell (whether or not assigned to CCP pursuant to Article 11)
that in the absence of ownership thereof or a license thereto, would be
infringed by the Exploitation of the Product 12 US-DOCS\106669270.9

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and that has not been (i) cancelled with prejudice, (ii) withdrawn from
consideration without the ability to submit or refile, (iii) finally determined
to be unallowable by the applicable governmental authority (and from which no
appeal is or can be taken), (iv) finally determined to be invalid or
unenforceable by a court of competent jurisdiction, (v) disclaimed, or (vi)
abandoned. For purposes hereof, a claim in a Patent Application that has not
been granted before the later to occur of (A) the date that is seven (7) years
after its earliest effective priority date in a given country, or (B) the date
of Commercial Launch in such country, will not be considered to be a Valid Claim
unless and until it is granted. 2. LICENSE GRANTS 2.1 License Grant to CCP. On
the terms and subject to the conditions of this Agreement, including the payment
obligations under Article 9, Fibrocell, on behalf of itself and its Affiliates,
hereby grants to CCP, effective upon the Effective Date, an exclusive (even as
to Fibrocell and its Affiliates) license with the right to grant sublicenses in
accordance with Section 2.2, under the Fibrocell Know-How and Fibrocell Patent
Rights, to Exploit the Product in the Field in or for the Territory, provided
that the foregoing license is subject to Fibrocell’s rights to Develop the
Product as set forth in Article 4 and Manufacture the Product as set forth in
Article 7. 2.2 Sublicense Rights. (a) CCP will have the right to grant written
Sublicenses, through multiple tiers, under the rights granted to it under
Section 2.1 to any of its Affiliates and Third Parties. CCP’s right to grant
such Sublicenses will be subject to the following: (a) each Sublicensee will
agree to be bound by all of the applicable terms and conditions of this
Agreement; (b) the terms of each Sublicense granted by CCP will provide that the
Sublicensee will be subject to the terms and conditions of this Agreement; (c)
CCP’s grant of any Sublicense will not relieve CCP from any of its obligations
under this Agreement; (d) CCP will notify Fibrocell of the identity of any
Sublicensee promptly after entering into any Sublicense and provide Fibrocell
with a copy of the Sublicense, provided that CCP may redact such copy at its
discretion to remove information that is not relevant to this Agreement; and (e)
the Sublicense must be in writing. (b) Unless a Sublicense provides that it will
terminate upon termination of this Agreement, if this Agreement terminates for
any reason other than termination by CCP pursuant to Section 18.2(a), then at
the option of any Sublicensee not in material breach of the applicable
Sublicense such Sublicensee will, from the effective date of such termination,
become a direct licensee of Fibrocell under, and subject to the terms and
conditions of, this Agreement, subject to modifications to the Sublicense with
respect to territory, field and exclusivity consistent with the scope of this
Agreement and so as to accommodate all such Sublicensees; provided, however,
that such Sublicensee promptly cures all material breaches by CCP of this
Agreement; and provided further that Fibrocell (i) will not have under any such
direct license any obligations that are greater than or inconsistent with the
obligations of Fibrocell under this Agreement or any fewer rights than it has
under this Agreement, and (ii) Fibrocell will have no liability for any
obligations arising prior to effective date of such direct 13
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license or for any obligations of CCP whenever arising and Fibrocell will be
released from any and all liability relating to such obligations. 2.3 Assignment
of Assigned Contracts. (a) Promptly following the Effective Date, the Parties
will discuss and agree on which contracts that Fibrocell is a party to will be
deemed Assigned Contracts. Fibrocell agrees to assign, and hereby assigns (to
the extent permitted by the terms of such Assigned Contract), (i) as promptly as
reasonably possible following the date of determination, all Assigned Contracts
identified pursuant to the first sentence of this section, and (ii) from time to
time after the Effective Date, all other Assigned Contracts as mutually agreed
by the Parties. (b) In the event that (i) the assignment of the Assigned
Contracts or any claim, right or benefit arising thereunder or resulting
therefrom, without the consent of any Third Party, would constitute a breach or
other contravention thereof, be ineffective with respect to any party thereto,
or in any way adversely affect the claims, rights or benefits of CCP thereunder,
and (ii) Fibrocell shall not have received the consent or approval of such Third
Party prior to the proposed date of such assignment pursuant to Section 2.3(a)
(such date, the “Assignment Date”), at the request of and for the benefit of CCP
as to a particular Assigned Contract, Fibrocell and CCP shall use good faith
efforts to obtain the consent or approval of any such Third Party to the
assignment of such Assigned Contract or any claims, rights or benefits arising
thereunder for the assignment thereof to CCP. Until such consent or approval is
obtained, at the request of and for the benefit of CCP as to a particular
Assigned Contract, Fibrocell will cooperate with CCP to enter into a mutually
agreeable arrangement under which (A) CCP would obtain, to the maximum extent
possible, the claims, rights and benefits under each such Assigned Contract (to
the extent such claims, rights or benefits constitute Assigned Contract), (B)
CCP would (i) assume, to the extent possible, all obligations of Fibrocell with
respect to each such Assigned Contract arising on or after the Assignment Date
and indemnify CCP in connection therewith and (ii) promptly pay to Fibrocell any
amounts accruing under such Assigned Contract on or after the Assignment Date
that are required to be paid by Fibrocell, and actually paid to a Third Party.
At the request of and for the benefit of CCP as to a particular Assigned
Contract, Fibrocell shall continue to use reasonable commercial efforts to
obtain all such required consents and approvals, it being understood that upon
receipt of all required consents and approvals for the assignment of an Assigned
Contract (or any claim, right or benefit arising thereunder or resulting
therefrom) to CCP, the assignment of such Assigned Contract shall be deemed to
be effective as of the Assignment Date. Fibrocell will promptly pay to CCP, when
received, all monies received under any Assigned Contract, or any claim, right
or benefit arising thereunder, not assigned or transferred to the CCP on the
Assignment Date. 2.4 Access to Fibrocell Know-How. Promptly after the Effective
Date, Fibrocell will, at its sole expense, make available to CCP copies of the
Fibrocell Know-How set forth on Exhibit 1.41. On a quarterly basis during the
term of this Agreement, Fibrocell will, at its sole expense, make available to
CCP any new material Fibrocell Know-How generated by or on behalf of Fibrocell
of which Fibrocell is aware. For the sake of clarity, the transfer of Fibrocell
Know-How contemplated by this Section 2.4 is intended to be documentary only,
and is not intended to include any services by, or on behalf of Fibrocell. 14
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2.5 No Implied Rights or Licenses. Neither Party grants to the other Party any
rights or licenses in or to any Patent or other intellectual property right,
whether by implication, estoppel or otherwise, except to the extent expressly
provided for under this Agreement. 2.6 Retained Rights. Except as set forth
herein, Fibrocell retains for itself, its Affiliates and future licenses any and
all rights under the Fibrocell Know-How and Fibrocell Patent Rights to Exploit
products and services other than the Product in the Field and in the Territory.
3. GOVERNANCE 3.1 General. Promptly after the Effective Date, the Parties will
establish a joint development committee (the “Joint Development Committee” or
“JDC”) in accordance with Section 3.2(a) to oversee the Parties’ Development
activities under this Agreement, including the financial and budgetary aspects
thereof. The JDC may establish subcommittees, by unanimous agreement, to monitor
and direct the Parties’ Development activities under this Agreement, including,
by way of example, a CMC subcommittee, a clinical supply subcommittee, a
regulatory subcommittee, or a finance subcommittee. The JDC will have the
responsibilities and authority allocated to it in this Article 3 and elsewhere
in this Agreement, and will make decisions consistent with the goal of
implementing the Development Plan and conducting other activities under this
Agreement in a manner consistent with the optimization of Product Development
and Commercialization. The representatives of each Party on the JDC and any
subcommittee will be responsible for ensuring that their decisions and actions
are consistent with the views of, and have been approved by, the Party that
appointed them. 3.2 Joint Development Committee. (a) Composition. Each Party
will appoint two (2) of its senior employees to serve on the JDC or any
subcommittee thereof, it being understood that each Party shall always have an
equal number of representatives appointed to the JDC, or any subcommittee. CCP’s
initial JDC representatives will be Timothy M. Cunniff and Ronald Ritz.
Fibrocell’s initial JDC representatives will be Sean Buckley and Anna Malyala.
The chairperson of the JDC and each subcommittee will alternate annually between
the Parties. The initial JDC chairperson will be appointed by CCP. Each Party
may replace its JDC representatives (including the chairperson appointee) by
written notice to the other Party. (b) Responsibilities. The JDC will oversee
and monitor the direction and course of the Development activities to be
conducted hereunder. Without limiting the generality of the foregoing, the JDC
will: (i) review, provide comment on, and approve Development Plans and related
Development Budget, adjustments and updates thereto proposed by a Party,
including through such Party’s representatives on the JDC, from time to time as
it deems appropriate; (ii) review the Development activities and obligations of
the Parties and the subcommittees under this Agreement; (iii) resolve any
Development-related disputes or disagreements submitted to it by the Parties’
representatives thereto or by the subcommittees, as further described in Section
3.2(d); (iv) review all material data arising in the course of Development
activities conducted pursuant to this Agreement by either Party; (v) review and
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discuss the preparation of regulatory filings for the Product, including new IND
filings, applications for Regulatory Approval, and supportive filings with
Regulatory Authorities; (vi) discuss the Development of label expansions, new
dosage forms, formulations, or other new developments; (vii) appoint
subcommittees as it deems appropriate for carrying out its responsibilities
hereunder; (viii) perform such other Development-related oversight and
monitoring functions as appropriate to further the purposes of this Agreement as
determined by the Parties, including the periodic evaluation of performance
against goals; and (ix) designate policies and procedures for the Parties’
reporting and calculation of Product Gross Profit and other financial terms set
forth in this Agreement, and approve all variances from the applicable
Development Budget in accordance with Section 9.2. (c) Meetings and Voting. The
JDC will meet at least once per calendar quarter at times mutually agreed upon
by the Parties until Commercial Launch of the Product for the Initial
Indication, after which time the frequency of such meetings may be as otherwise
agreed by the Parties. At least two (2) such meetings per calendar year must be
held in person, and all other such meetings may be held by teleconference or
videoconference. The location of the meetings of the JDC to be held in person
will alternate between sites designated by each Party, with each meeting held at
a location within the Territory mutually agreed by the Parties. Each Party will
bear all the expenses of its representatives on the JDC. The JDC chairperson
will issue an agenda reasonably in advance of each meeting for review and
comment by the other Party’s JDC representatives. The other Party’s JDC
representatives shall have five (5) days to review and comment on the agenda.
The JDC chairperson shall incorporate all reasonable comments of the Party’s
representatives to the JDC in the agenda, and that agenda (i.e., with the
reasonable comments of the other Party’s JDC representatives) shall be the
agenda for the relevant meeting of the JDC. The JDC chairperson will appoint one
(1) member of the JDC from the other Party to keep accurate minutes of each
meeting and that person will use all reasonable efforts to circulate draft
minutes of each JDC meeting to all JDC representatives for comment and review
within five (5) business days after the relevant meeting. The JDC
representatives will have ten (10) business days from the date of circulation of
such draft minutes to provide comments. The JDC representative preparing the
minutes will incorporate timely received comments and, after receiving approval
from the JDC chairperson, distribute finalized minutes to all JDC
representatives within twenty (20) business days after the relevant meeting. A
meeting of the JDC will be effective only if it has been duly called in writing
upon at least twenty (20) business days prior notice, an agenda for the meeting
is circulated at least ten (10) business days prior to the meeting, and at least
the JDC chairperson (or his or her designee) and at least one representative
from each Party are present or participating in such meeting. The JDC and each
subcommittee will take action only by unanimous consent. If any subcommittee is
unable to decide a matter unanimously after five (5) business days of due
consideration, then such disagreement will be submitted to the JDC. Each of CCP
and Fibrocell will have one (1) collective vote on the JDC regardless of how
many representatives such Party has in attendance at such meeting, and any
matter voted on will require the unanimous vote of both Parties. If a
disagreement among members of the JDC remains unresolved for more than ten (10)
days after the JDC first addresses such matter (or such longer period as the
Parties may mutually agree upon), such disagreement will be resolved in
accordance with Section 3.2(d). (d) Dispute Resolution. If the JDC is unable to
resolve any dispute, controversy, or claim arising under this Agreement,
including matters escalated to the JDC by 16 US-DOCS\106669270.9

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any subcommittee, within ten (10) days after it first addresses such matter (or
such longer period as the Parties may mutually agree upon), then the dispute
will be referred to senior executive officers of each Party having authority to
make decisions in such matters (“Executives”) of each Party, and, in the event
the Executives of each Party are unable to resolve the dispute within ten (10)
days after receiving notice of the dispute (or such longer period as the Parties
may mutually agree upon), then the matter will be finally decided by CCP. For
clarity, matters relating to a Party’s alleged breach of its obligations under
this Agreement will not be finally decided by CCP but may be submitted for
resolution by either Party, after the applicable discussion periods set forth
above have expired, to a court of competent jurisdiction as set forth in Section
19.10. Notwithstanding the foregoing, neither the JDC nor CCP shall use its
final decision making authority to (i) dissolve any subcommittee of the JDC once
established except as set forth in Section 3.3, (ii) allocate to a Party any
authority intended to be delegated to the JDC, (iii) resolve any dispute as to
what level of efforts constitutes Commercially Reasonable Efforts, (iv) alter or
amend the Development Budget in a manner that would increase the Development
Costs above the Development Cost Cap or that would reduce the Initial
Development Costs to an amount less than what is set forth in the initial
Development Budget; (v) require any Party to take any action that would, or fail
to take any action where the failure to take such action would, to the knowledge
of CCP, (A) violate Applicable Laws or any agreement with any Third Party, or
(B) infringe the intellectual property rights of any Third Party; (vi) frustrate
the purpose of this Agreement or any provision hereof; or (vii) amend the
Development Plan to include the Development of any indication or use for the
Product other than the Initial Indication. The JDC will have no power to alter,
amend, modify or waive compliance with this Agreement or Applicable Law, to
interpret, alter, increase, expand, or waive a Party’s rights or obligations
under this Agreement, including to expand Development of the Product under the
Development Plan into any indication(s) other than the Initial Indication, or,
subject to Section 9.2(a), to increase the scope of any Party’s responsibilities
under this Agreement or cause any Party to spend amounts in furtherance of the
Development Plan in excess of those amounts budgeted in the initial Development
Plan. 3.3 Dissolution of the JDC. The JDC and any subcommittees will exist until
such time as CCP decides to dissolve the JDC; provided, that the JDC and any
subcommittee may not be dissolved until the Commercial Launch in the Territory,
and provided further, that upon such dissolution, CCP will establish a
replacement governance structure that is materially consistent with the
governance structure provided under this Article 3 that will provide Fibrocell
with substantially the same representation, consultation and other rights with
respect to the matters that were otherwise subject to the monitoring and
oversight of the JDC. Each subcommittee will exist until such time as the JDC
decides to dissolve such subcommittee. In the event that any subcommittee is
dissolved, the JDC will take on all of the responsibilities of such
subcommittee. 4. DEVELOPMENT PROGRAM 4.1 Project. During the period of time in
which the Product is being Developed, the Parties will cooperate with each other
to provide reasonable support in the conduct of all activities that are
reasonably necessary or useful for the Development of the Product in the
Territory consistent with the Development Plan. Notwithstanding the foregoing,
Fibrocell will, subject to the authority of the JDC, be solely responsible for
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the Product for the Initial Indication through Initial BLA Approval, and CCP
will be solely responsible for Development of the Product for the Initial
Indication thereafter. Each Party will be responsible for conducting the
activities assigned to it in the Development Plan under the direction and
supervision of the JDC, provided, that neither Party will be assigned
obligations under the Development Plan without such Party’s prior written
approval, which will not be unreasonably withheld, delayed or conditioned, it
being understood that each Party has approved and consented to the Development
Plan and Development Budget attached hereto as Exhibits 4.2(a)(i) and
4.2(a)(ii), and a Party will act reasonably when considering amendments to the
initial Development Plan and Development Budget. Each Party will be responsible
for selection and supervision of its personnel assigned to tasks related to
Development activities. The JDC will be responsible for making, and have
authority to make, all decisions, and undertake any actions necessary as a
result of such decisions, regarding Development (including additional
preclinical and clinical Development and testing) and preparing and filing BLAs
and any other applications for Regulatory Approval, all in a manner consistent
with this Agreement; provided that the JDC will not take any action for the
purpose of delaying milestone payments to be made under Article 9. Subject to
JDC oversight as set forth in Section 3.2, each Party will carry out its
obligations under the development program in accordance with the Development
Plan. 4.2 Development Plan and Development Budget. (a) The Development of the
Product will be governed by a Development plan (“Development Plan”), and the
costs and expenses relating to the Development of the Product will be governed
by a Development budget (“Development Budget”), the initial agreed versions of
which are attached as Exhibits 4.2(a)(i) and 4.2(a)(ii), respectively. Updates
thereto made pursuant to Section 4.2(b) will be prepared by the JDC; provided,
that either Party may propose updates to the Development Plan to be made by the
JDC. Each Development Plan may include, as mutually agreed by the Parties: (1) a
description of all Clinical Trials to be conducted by Fibrocell and, if
applicable, CCP to support Regulatory Approval in the Territory, and related
timelines; (2) other material activities necessary for Development of the
Product in the Territory; (3) the proposed overall program of Development for
the Product in the Territory, including all preclinical studies, toxicology,
pharmacology studies, formulation, process development, clinical studies, and
Regulatory Plans and other elements of obtaining Regulatory Approval in the
Territory; (4) at an appropriate stage of Development, a publication strategy;
(5) the roles and responsibilities of each Party and the JDC, and, if
applicable, each subcommittee of the JDC; and (6) plans related to clinical
Manufacturing of the Product and to Manufacturing scale-up to enable commercial
scale manufacturing prior to Commercial Launch. The Development Plan and the
Development Budget will be updated at least once per calendar year in accordance
with Section 4.2(b) and will cover the following three (3) calendar year period.
(b) The JDC will, on an annual basis, prepare and approve updates to the
Development Plan and Development Budget by September 30 of each calendar year
for the following three (3) calendar year period, which updates shall be subject
to the unanimous consent of the JDC through Initial BLA Approval. From time to
time in between such annual updates, the JDC may amend the Development Budget or
Development Plan, consistent with the principles set forth in Section 4.1. 18
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(c) The costs of the Development activities set out in each Development Plan as
set forth in the applicable approved Development Budget will be allocated
between the Parties as set out in Article 9, provided that CCP will be solely
responsible for the first twenty million Dollars ($20,000,000) of such costs.
The Parties agree that the total amount of the Fibrocell costs set forth in the
initial Development Budget attached hereto as Exhibit 4.2(a)(ii) will be
reimbursed to Fibrocell in accordance with Section 9.2 to the extent that
Fibrocell actually incurs such costs. 4.3 Technical Cooperation. Upon request,
each Party will provide reasonable assistance and technical expertise as
necessary to transfer appropriate technology to the other Party to support
Development of the Product under this Agreement; provided, such assistance and
technical expertise by a Party shall not exceed forty (40) hours per month. Such
assistance may include the grant of appropriate rights of access and reference
to regulatory filings to enable the Parties to assume responsibility for
Development of the Product, and participation in meetings with regulatory
agencies with respect to the Product. 4.4 Compliance with Applicable Laws. Each
Party, in performing its activities under this Agreement, will comply with all
Applicable Laws, including where applicable, then-current GCP, GLP, GMP, and
applicable Health Care Laws. 4.5 Subcontracting Permitted. (a) CCP acknowledges
and agrees that portions of the work to be performed by Fibrocell under this
Agreement may be performed on behalf of Fibrocell by Third Parties, provided
that (i) Fibrocell will first have obtained written confidentiality agreements
with any such subcontractors and written assignments of, or equivalent rights
under, all Patent rights, know-how and other intellectual property rights that
such subcontractors may develop by reason of work performed under this
Agreement, (ii) any such subcontractors must be approved by CCP in advance in
writing (such approval not to be unreasonably withheld, conditioned or delayed),
provided that the subcontractors identified on Exhibit 4.5(a) will be deemed
pre- approved, and (iii) Fibrocell will be and remain responsible to CCP for the
performance of its subcontractors. Without limiting the generality of the
foregoing, Fibrocell will include in its agreements entered into after the
Effective Date with each of its subcontractors under this Section 4.5(a), (A) a
right for CCP to receive, directly or through Fibrocell, any confidential
information of such subcontractor disclosed under or related to such subcontract
(including any information obtained in connection with any audit of such
subcontractor) that is reasonably necessary for CCP to perform its obligations
or exercise its rights under this Agreement, and (B) a right to audit the
performance of such subcontractor under such subcontract, including through
audit of any applicable books, records, data or other Information of such
subcontractor, consistent with industry practice. (b) Fibrocell acknowledges and
agrees that portions of the work to be performed by CCP under this Agreement may
be performed on behalf of CCP by Third Parties, provided that (i) CCP will first
have obtained written confidentiality agreements with any such subcontractors
and written assignments of, or equivalent rights under, all Patent rights, know-
how and other intellectual property rights that such subcontractors may develop
by reason of work performed under this Agreement, and (ii) CCP will be and
remain responsible to Fibrocell 19 US-DOCS\106669270.9

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for the performance of its subcontractors. Without limiting the generality of
the foregoing, CCP will include in its agreement with each of its subcontractors
under this Section 4.5(b), (A) a right for Fibrocell to receive, directly or
through CCP, any confidential information of such subcontractor disclosed under
or related to such subcontract (including any information obtained in connection
with any audit of such subcontractor) that is reasonably necessary for Fibrocell
to perform its obligations hereunder, and (B) a right to audit the performance
of such subcontractor under such subcontract, including through audit of any
applicable books, records, data or other Information of such subcontractor,
consistent with industry practice. 5. REGULATORY MATTERS 5.1 Pharmacovigilance
Agreement. The Parties will, within sixty (60) days after written request by the
JDC, convene a meeting to negotiate in good faith the terms and conditions of a
pharmacovigilance agreement (“Pharmacovigilance Agreement”), which will
establish all material economic, regulatory, business and technical terms under
which the Parties will, consistent with Section 5.3, collect, monitor, research,
assess and evaluate information from healthcare providers and patients on the
adverse effects, if any, of the Product for their respective territories, with a
view to identifying new information about hazards associated with the Product
and preventing harm to patients. Within ninety (90) days after the commencement
of those negotiations, the Parties will work in good faith to execute a mutually
satisfactory Pharmacovigilance Agreement. 5.2 Preparation of Regulatory Filings.
(a) The Parties will develop and agree to a detailed regulatory plan for the
Product in or for the Territory (the “Regulatory Plan”), which Regulatory Plan,
once mutually agreed by the Parties, will be deemed to form part of the
Development Plan. Unless otherwise provided in the Development Plan, each Party,
unless otherwise provided for in this Agreement, will be responsible for
preparing, filing, and maintaining, and will own, the regulatory filings
relating to the Product as set forth in Section 5.2(b). (b) Until the date of
Initial BLA Approval, Fibrocell or its designee will be responsible for all
interactions with Regulatory Authorities and will submit regulatory filings to
the respective Regulatory Authority with regard to the Product for the purpose
of filing, obtaining and maintaining Regulatory Approval thereof, and to
prepare, obtain and maintain all regulatory dossiers and Regulatory Approvals
covering the Product in the Territory. CCP or its designee will be responsible
for such interactions and filings thereafter. Fibrocell will provide CCP with a
copy of all regulatory filings, correspondence with and minutes of meetings with
Regulatory Authorities, documents included in such regulatory dossiers and
Regulatory Approvals. At all times during the term of this Agreement, (i)
Fibrocell will keep CCP informed of all regulatory filings for the Product and
will provide CCP a meaningful opportunity to review and comment on those filings
prior to submission thereof, and Fibrocell will in good faith consider
incorporating such comments into, any such regulatory filings in the Territory;
and (ii) CCP will have the opportunity, unless such Regulatory Authorities
object, to participate in all meetings with Regulatory Authorities relating to
the Product. 20 US-DOCS\106669270.9

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5.3 Notice of Communication with Regulatory Authorities. (a) Until the date of
Initial BLA Approval, Fibrocell will be responsible for reporting all adverse
events and handling all complaints and communications (including with Regulatory
Authorities) relating to the Product in the Territory. CCP or its designee will
be responsible for such interactions and filings thereafter, except to the
extent set forth in the Supply Agreement or the Quality Agreement. (b) Except as
otherwise provided for in this Section 5.3, each Party will provide monthly
summaries to the other Party of any material oral or written communications to
or from Regulatory Authorities on matters related to the Product or which would
reasonably be expected to impact Product Development, Manufacture,
Commercialization or Regulatory Approval. Notwithstanding the foregoing, each
Party will notify the other Party of any oral communications, and provide such
other Party with copies of any written communications, or internal written
memoranda, notes or summaries of oral communications, to or from Regulatory
Authorities on matters related to Products, or which may reasonably be deemed to
impact Products, within three (3) business days of receipt of such communication
(or for informal communications, as soon as reasonably practicable, if longer),
or such earlier date as required by Applicable Law or Regulatory Authority.
Moreover, in each such case, each Party will give the other Party reasonable
opportunity to review and comment on any proposed response to any such oral or
written communications to or from Regulatory Authorities prior to submitting any
response thereto, and provide such other Party with a copy of the final response
as specified herein. Each Party shall reasonably cooperate with and assist the
other Party in complying with regulatory obligations and communications,
including by providing to such other Party, in a timely manner after a request,
Information and documentation in such Party’s possession as may be necessary or
helpful for such other Party to prepare a response to an inquiry from a
Regulatory Authority, and by participating in any meeting with a Regulatory
Authority at such other Party’s reasonable request and expense. Each Party shall
provide the other Party in a timely manner with a copy of all correspondence
received from a Regulatory Authority specifically regarding the matters referred
to above. (c) If a Regulatory Authority desires to conduct an inspection or
audit of any facility of Fibrocell or any of its Affiliates or any Third Party
facility under contract with Fibrocell, in each case with regard to the Product,
then Fibrocell shall notify CCP as soon as practicably possible after receipt of
such notification of such audit or inspection and provide copies of any
materials provided to it by the applicable Regulatory Authority. In addition, if
a Regulatory Authority conducts an unannounced inspection or audit of any
facility of Fibrocell or any of its Affiliate or any Third Party facility under
contract with Fibrocell, in each case with regard to the Product, then Fibrocell
shall notify CCP within twenty-four (24) hours of (i) with respect to
Fibrocell’s facilities, commencement of such audit or inspection or (ii) with
respect to Third Party facilities, Fibrocell’s receipt of notification of such
audit or inspection. Each Party shall cooperate, and shall use reasonable
efforts to cause the contract facility to cooperate, with any Regulatory
Authority and the other Party during such inspection or audit. Following receipt
of the inspection or audit observations of such Regulatory Authority, Fibrocell
shall promptly provide CCP with a copy of the inspection or audit report and
also provide CCP with copies of any written communications received from
Regulatory Authorities with respect to such facilities in a timely manner after
receipt, to the extent such written communications relate to the Product 21
US-DOCS\106669270.9

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or the Manufacture thereof, and shall prepare the response to any such
observations. Fibrocell shall provide CCP with a copy of any proposed response
to such communications and shall implement CCP’s reasonable comments with
respect to such proposed response to the extent such comments are provided with
sufficient time to respond to such Regulatory Authorities. Fibrocell agrees to
use reasonable efforts to conform its activities under this Agreement to any
commitments made in such a response. 5.4 Regulatory Compliance. Each of
Fibrocell and CCP will reasonably cooperate with the other Party in that Party’s
efforts toward ensuring that all government price and gift reporting, fraud and
abuse, sales, marketing and promotional practices with respect to the Product
meet the standards required by Applicable Laws, including state and federal laws
and regulations and including the Physician Payments Sunshine Act and similar
state laws, as well as applicable guidelines concerning the advertising of
prescription drug products. 5.5 Regulatory Documentation. Fibrocell will own and
retain all right, title and interest in and to all Regulatory Approvals and all
regulatory documentation with respect to the Product until one (1) business day
following the date of Initial BLA Approval of the Product. 5.6 BLA Transfer.
Effective as of one (1) business day following the date of Initial BLA Approval
of the Product, Fibrocell hereby assigns to CCP the BLA and all directly related
regulatory documentation for the Product, and CCP will own all right, title and
interest in to such BLA and documentation for the Product thereafter; provided,
that, except as expressly provided in this Agreement, including Section 5.10,
CCP shall not be assigned and shall not obtain any right, title or interest in
any regulatory documentation (which, for clarity, shall not include the BLA)
that is necessary for any product other than the Product and for the Product
outside of the Territory. Within ninety (90) days of Initial BLA Approval of the
Product, Fibrocell will transfer such BLA and all related regulatory
documentation for the Product to CCP, subject to the preceding sentence. CCP
will provide copies of such documentation to Fibrocell at Fibrocell’s request to
the extent required to fulfill Fibrocell’s obligations under the Intrexon
Agreement with respect to such Product. 5.7 Product Recall. The Manufacturing
and Supply Agreement and/or related Quality Agreement will contain standard
provisions acceptable to both Parties regarding (a) a Regulatory Authority’s
issuance or request of a recall or similar action in connection with the Product
in the Territory and (b) either Party’s determination that an event, incident or
circumstance has occurred which may result in the need for a recall or market
withdrawal in the Territory. 5.8 Cooperation. Fibrocell will cooperate with CCP
in providing data and other information generated in connection with Clinical
Trials or other Development or Manufacture of Products conducted by or on behalf
of Fibrocell prior to or after the Effective Date and under Fibrocell’s
reasonable control for use in connection with Pre-Launch Activities, medical
policy development for distribution to medical directors, pharmacy directors and
other key formulary committee members for education and development of RDEB
medical policy serving both the medical and payer communities, patient access
and advocacy, managed markets and medical affairs activities, and commercial and
government payer education. 22 US-DOCS\106669270.9

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5.9 Priority Review Voucher. Fibrocell will retain sole ownership and control of
the Rare Pediatric Disease Priority Review Voucher issued in connection with the
Initial BLA Approval of the Product. 5.10 Rights of Reference to Regulatory
Materials. Fibrocell hereby grants to CCP a right of reference to all regulatory
materials filed with FDA by Fibrocell for the Product solely to the extent
required or useful for the purposes of the Development, including seeking,
obtaining and maintaining Regulatory Approvals for, and the Commercialization
of, the Product in the Territory in the Initial Indication. 6. COMMERCIALIZATION
6.1 Responsibility for Commercialization. As between the Parties, CCP will be
solely responsible for the Commercialization of the Product in the Territory,
including planning and implementation, detailing, booking of sales, pricing and
reimbursement. 6.2 Packaging; CCP Trademarks. Fibrocell will be responsible for
all packaging (non-commercial and commercial) and labeling of the Product. To
the extent consistent with Applicable Laws, all Product labeling and packaging,
including Product packaging and package inserts and any promotional materials
associated with the Product in the Territory will carry, in a conspicuous
location, and at CCP’s instruction, the Trademark of CCP. CCP authorizes the use
of its Trademarks pursuant to this Section 6.2. 7. MANUFACTURE AND SUPPLY OF
PRODUCT 7.1 Commercial Manufacturing. The Parties will use good faith efforts to
enter, within three (3) months after the Effective Date, into a commercial
manufacturing agreement (“Manufacturing and Supply Agreement”) and related
quality agreement (the “Quality Agreement”), which sets forth the material
economic, quality, safety, business and technical terms under which Fibrocell
will supply to CCP commercial supplies of Product for the Territory. 8.
DILIGENCE 8.1 By Fibrocell. Fibrocell will use Commercially Reasonable Efforts
to Develop the Product in the Territory in accordance with the terms of this
Agreement and to conduct the activities assigned to it under the Development
Plan. 8.2 By CCP. (a) CCP will use Commercially Reasonable Efforts to
Commercialize the Product in the Territory following receipt of Initial BLA
Approval of the Product, including in accordance with the Product Launch Plan
for the period such plan is in effect and to the extent applicable. Without
limiting the foregoing, CCP will use Commercially Reasonable Efforts to ensure
that the date of the Commercial Launch of the Product in the Territory occurs
within twelve (12) months following Initial BLA Approval of the Product. CCP
shall conduct all Commercialization activities with respect to the Product
hereunder in compliance with Applicable Laws. 23 US-DOCS\106669270.9

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(b) No later than nine (9) months prior to the anticipated date of Commercial
Launch of the Product in the Territory, CCP shall prepare and provide to
Fibrocell a preliminary Product launch plan summarizing CCP’s plans for
Pre-Launch Activities and Commercialization of the Product in the Territory for
the first eighteen (18) months following the date of the Commercial Launch in
the Territory (the “Product Launch Plan”). No fewer than ninety (90) days prior
to the end of each calendar year beginning with the first calendar year after
Commercial Launch of the Product in the Territory, CCP shall provide an annual
summary of marketing efforts in the Territory and, to the extent necessary,
updates to the Product Launch Plan. 9. PAYMENT OBLIGATIONS 9.1 Upfront Payment.
Within five (5) Business Days after the Effective Date, CCP will make a
non-refundable, non-creditable, one-time payment to Fibrocell in the amount of
seven million, five hundred thousand Dollars ($7,500,000). 9.2 Development Cost
Sharing. Subject to the oversight of the JDC and compliance with the Development
Plan and Development Budget, CCP will be solely responsible for, at its sole
expense, all Development Costs incurred in accordance with the Development Plan
and Development Budget in connection with the Development of the Product in the
Territory until the date of the initial BLA Regulatory Approval of the Product
in the Territory (such costs, “Initial Development Costs”; such approval of the
Product, “Initial BLA Approval”), up to twenty million Dollars ($20,000,000)
(the “Initial Cost Cap”). If Initial Development Costs, including as set forth
in an applicable approved Development Budget and any variances to the
Development Budget approved in accordance with Section 3.2(b), exceed the
Initial Cost Cap the Parties will each be responsible for such excess Initial
Development Costs (the “Excess Initial Development Costs”) as follows: (i) CCP
will be responsible for seventy percent (70%) of such Excess Initial Development
Costs, and (ii) Fibrocell will be responsible for thirty percent (30%) of such
Excess Initial Development Costs. Each Party will promptly notify the other
Party upon becoming aware that the actual or anticipated Development Costs to be
incurred by such Party for a given calendar year will be in excess of the
applicable Development Budget (“Cost Overruns”). The JDC shall promptly review
any projected Cost Overrun that is reported to it and thereafter may, at its
discretion, approve (a) an appropriate variance to the applicable Development
Budget, which variance shall be considered part of the approved Development
Budget, provided that any such variance or variances will be deemed approved to
the extent all such variances, in aggregate, do not cause then current
Development Budget to be increased by more than five percent (5%) or (b) such
other amendments to the approved Development Plan as may be necessary or
appropriate to bring the Development Costs within the budgetary guidelines set
forth in the applicable Development Budget (provided that such amendments do not
exceed the Development Cost Cap (as defined below)). Neither Party shall exceed
the applicable amounts set forth in the Development Budget to be incurred by
such Party without the prior approval of the JDC. Notwithstanding the foregoing,
the JDC shall not approve any changes to the Development Budget that would
result in Development Costs that exceed thirty million Dollars ($30,000,000)
(the “Development Cost Cap”) without the mutual agreement of both Parties, and,
if the Parties are unable to agree to such amendment to the Development Budget,
the last approved Development Budget shall remain in place. 24
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9.3 Profit Sharing. Commencing upon Initial BLA Approval in the Territory
through the term of this Agreement, the Parties will share all Product Gross
Profit on sales of the Product in the Territory: (i) CCP will receive seventy
percent (70%) of Product Gross Profit; and (ii) Fibrocell will receive thirty
percent (30%) of Product Gross Profit. 9.4 Method and Timing of Payments. Within
thirty (30) days after the end of each calendar quarter during the term of this
Agreement (including partial calendar quarters), each Party will provide a
report to the JDC and the other Party as follows: (a) prior to Commercial Launch
in the Territory, Fibrocell will report the Development Costs eligible for cost
sharing hereunder incurred by Fibrocell in such calendar quarter (with
appropriate supporting information); (b) following Commercial Launch in the
Territory, CCP will report CCP’s Net Sales and Fully Burdened Manufacturing
Costs necessary for the computation of Product Gross Profit for such calendar
quarter, and any Development Costs of CCP, if applicable. The reports and
payments due pursuant to this Section 9.4 for each calendar quarter will include
any reconciliations and adjustments with respect to previous quarters necessary
to effect the sharing of Product Gross Profit set forth in Section 9.3. CCP will
be responsible for the preparation of consolidated reporting, calculation of
Product Gross Profit and each Party’s share of Development Costs and Product
Gross Profit, and determination of the cash settlement. CCP will provide to
Fibrocell within thirty (30) days after its receipt of Fibrocell’s quarterly
report of Development Costs, a statement showing the calculations of Development
Costs, including Excess Initial Development Costs, and Product Gross Profit for
such calendar quarter (each, a “Balancing Statement”), in each case to the
extent eligible for sharing under this Agreement, and any cash settlement
required. Payments (including any reconciling payments for previous quarters)
will be made for each calendar quarter during the term of this Agreement
(including partial calendar quarters) within thirty (30) days after Fibrocell’s
receipt of the Balancing Statement to effect the Parties’ sharing of Excess
Initial Development Costs or Product Gross Profit, as applicable, as set forth
in this Agreement. For clarity, the Parties will conduct a final accounting in
accordance with this Section 9.4 promptly upon expiration or termination of this
Agreement, and any final balancing payment will be paid within thirty (30) days
of receipt of the final Balancing Statement. 9.5 Milestone Payments. (a) Subject
to Section 9.5(b), CCP will make the following non- refundable, non-creditable
Milestone Payments (the “Milestone Payments”) to Fibrocell, with respect to the
Product, within sixty (60) days after achievement of the relevant milestone for
the Product. The milestones in this Section 9.5 are cumulative, such that under
no circumstances is any single Milestone Payment to be deemed in lieu of, or to
be substituted for, another Milestone Payment. For clarity, each milestone in
this Section 9.5 is payable by CCP to Fibrocell only once with respect to the
achievement of any milestone under this Agreement. Milestone Event Payment
Commencement of the first Phase III Clinical Trial designed $2,500,000
consistent with end-of-Phase II Clinical Trial FDA feedback Upon the later of
(i) Initial BLA Approval with an approved label $30,000,000 25
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Milestone Event Payment indication of RDEB and (ii) Fibrocell proving and
demonstrating in CCP’s reasonable determination that it has sufficiently scaled
Product Manufacturing in accordance with the Process Validation Protocol, with
capacity of at least two hundred fifty (250) incoming biopsies per calendar year
Upon the first achievement of $250,000,000 in cumulative Net Sales $25,000,000
of the Product in the Territory by CCP or its Affiliates or Sublicensees after
BLA Regulatory Approval by FDA Upon the first achievement of $750,000,000 in
cumulative Net Sales $50,000,000 of the Product in the Territory by CCP or its
Affiliates or Sublicensees after BLA Regulatory Approval by FDA Total
$107,500,000 (b) In the event any failure by Fibrocell to comply with GMP, GLP
or GCP or other requirements under this Agreement in connection with the
Development or Manufacture of the Product that results in the delay of Initial
BLA Approval of the Product, or any disruption in commercial supply of the
Product after Initial BLA Approval, then in addition to any other remedies
available to CCP under this Agreement or the Manufacturing and Supply Agreement,
CCP shall have the right to offset against any future, unpaid milestone payments
due to Fibrocell under Section 9.5(a) an amount equal to CCP’s actual costs
incurred in connection with remediating or mitigating any such delay or
disruption, but not other losses or damages of CCP, including those associated
with lost profits or lost sales. 9.6 Disputed Payments. The Parties will confer
in good faith to resolve any payment dispute, and if such dispute is not
resolved to the satisfaction of both Parties within the sixty (60)-day period
specified above, such disputed amounts as set forth in the Balancing Statement
will nonetheless be immediately due and payable by the applicable paying Party
within thirty (30) days thereafter, it being understood that such paying Party
may also exercise its audit rights under Article 10 and/or dispute resolution
rights under Section 19.10 to receive a credit or refund of such payment upon
final resolution of the dispute. 9.7 Currency of Payment. All payments to be
made under this Agreement will be made in Dollars. 9.8 Accounting. (a) The
fiscal year with respect to this Agreement will be a calendar year. CCP will
determine Net Sales and Fully Burdened Manufacturing Costs with respect to the
Product using its standard accounting procedures, consistent with GAAP and all
other products owned or controlled by CCP, to the extent practical as if the
Product was a solely owned product of CCP, except as specifically provided in
this Agreement. In the case of amounts to be determined by Third Parties (for
example, Net Sales by Sublicensees), such amounts will be 26 US-DOCS\106669270.9

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[ex105castlecreekfibrocel032.jpg]
determined in accordance with GAAP. The Parties also recognize that such
procedures may change from time to time and that any such changes may affect the
definition of Net Sales or Fully Burdened Manufacturing Costs. The Parties agree
that, where such changes are economically material to either Party, adjustments
will be made to compensate the affected Party in order to preserve the same
economics as are reflected under this Agreement under such Party’s accounting
procedures in effect prior to such change (for example, Development or
Commercialization). Where the change is or would be material to one Party, the
other Party will provide an explanation of the proposed change and an accounting
of the effect of the change on the relevant revenue, cost, or expense category.
(b) In the event of the payment or receipt of non-cash consideration in
connection with the performance of activities under this Agreement, the Party
engaging in such non-cash transaction will advise the other Party of such
transaction, including such Party’s assessment of the fair market value of such
non-cash consideration and the basis therefor. Such transaction will be
accounted for on a cash equivalent basis, as mutually agreed by the Parties in
good faith. 9.9 Withholding Tax. Any Party required to make a payment to any
Party under this Agreement will be entitled to deduct and withhold from the
amount otherwise payable such amounts to the extent it is required to deduct and
withhold with respect to such payment under any provision of federal, state,
local or foreign tax law. Such withheld amounts will be treated for all purposes
of this Agreement as having been paid to the Party on whose behalf it was
withheld. No deduction will be made to the extent the paying Party is timely
furnished with necessary documents certifying that the payment is exempt from
tax or subject to a reduced tax rate. 10. RECORD KEEPING, RECORD RETENTION AND
AUDITS 10.1 Record Keeping. Each Party will record, and will require its
Affiliates, Sublicensees, and subcontractors to record, to the extent reasonably
practical, all Information relating to this Agreement and all research and
Development activities contemplated by this Agreement in accordance with its
internal practices and industry standards. Such records will be complete and
accurate in all material respects and will fully and properly reflect all such
work done and results achieved in sufficient detail and in good scientific
manner appropriate for regulatory purposes. Each Party will have the right to
receive and retain a copy of all such records at reasonable times, upon
reasonable prior written notice to the other Party. CCP will also have the right
to conduct reasonable quality assurance audits with respect to all facilities,
operations and laboratories (and any records related thereto) operated by
Fibrocell, its Affiliates or its subcontractors and sublicensees, where
Development or Manufacturing activities are conducted, as is reasonably
necessary solely for the purpose of verifying Fibrocell’s compliance with this
Agreement and applicable GLP, GCP, GMP and other regulatory requirements in or
for the Territory. All audits initiated by CCP will be conducted at CCP’s sole
expense, upon reasonable prior notice to Fibrocell, and during regular business
hours. To the extent practical, the notebooks of each Party for this Agreement
will be separate from notebooks documenting other research and development of
such Party. 27 US-DOCS\106669270.9

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10.2 Record Retention. Fibrocell will keep complete and accurate records
pertaining to the research, Development and Manufacture of the Product in
sufficient detail to permit CCP to verify the costs related to the foregoing for
which CCP is responsible for paying, reimbursing or sharing. CCP will keep
complete and accurate records pertaining to the Net Sales of the Product and
Fully Burdened Manufacturing Costs, which documents would enable Fibrocell to
confirm the accuracy of calculations of all payments made by CCP under this
Agreement The records to be maintained by each Party under this Section 10.2
will be maintained for a minimum of five (5) years following the year in which
the corresponding efforts or payments, as the case may be, were made under this
Agreement or longer if required by Applicable Law. 10.3 Audit Request. Each
Party will, at its expense (except as provided below), have the right to audit,
not more than once during each calendar year and during regular business hours,
the records maintained by the other Party under Section 10.2, to determine with
respect to any calendar year, the accuracy of any report or payment made under
this Agreement in the five (5) preceding years. If a Party desires to audit such
records, it will engage an independent, certified public accountant reasonably
acceptable to the other Party, to examine such records under conditions of
confidentiality. Such accountant will be instructed to provide to the auditing
Party a report verifying any report made or payment submitted by the audited
Party during such period, but will not disclose to the auditing Party any
confidential Information of the audited Party not necessary therefor. The
expense of such audit will be borne by the auditing Party; provided, however,
that, if an error of more than ten percent (10%) is discovered, then such
expenses will be paid by the audited Party. If such accountant concludes that
additional payment amounts were owed to a Party during any period, the debtor
Party will pay such payment amount (including interest thereon from the date
such amounts were payable) within thirty (30) days after the date the creditor
Party delivers to the debtor Party such accountant’s written report so
concluding, unless the debtor Party notifies the creditor Party of any dispute
regarding the audit and commences proceedings under Section 19.10 within thirty
(30) days after delivery of the accountant’s report (in which case the payment
will be delayed until conclusion of the proceeding). Such auditors will not be
paid on a contingency basis. Any Information received by an auditing Party
pursuant to this Section 10.3 will be deemed to be Confidential Information of
the audited Party. 10.4 Survival. This Article 10 will survive any termination
or expiration of this Agreement for a period of five (5) years following the
final payment made by CCP or Fibrocell hereunder, or longer if required by
Applicable Law. 11. INVENTIONS, KNOW-HOW AND PATENTS 11.1 Existing Intellectual
Property. Other than as expressly provided in this Agreement, neither Party
grants to the other Party any right, title, or interest in any Patent rights,
Information, or other intellectual property right Controlled by such Party. 11.2
Ownership of Inventions. (a) Ownership of inventions arising during and in the
course of the Parties’ performance under this Agreement, and related
intellectual property rights 28 US-DOCS\106669270.9

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(“Inventions”) will be determined in accordance with U.S. rules of inventorship,
except as otherwise set forth in this Section 11.2(a). Each Party will promptly
disclose, and will cause its Sublicensees and Affiliates to disclose, to the
other Party any Inventions that it or its Affiliates or Sublicensees or their
respective employees, independent contractors or agents solely or jointly make,
conceive, reduce to practice, author, or otherwise discover. Each Party will
require its employees, consultants and contractors to disclose any Inventions
relating to this Agreement in writing promptly after conception. (b) Assignment
and Perfection of Interests. Each Party will, and will cause its Affiliates and
Sublicensees and their respective employees, independent contractors and agents
to, cooperate with the other Party and take all reasonable additional actions
and execute such agreements, instruments and documents as may be reasonably
required to perfect the other Party’s right, title and interest in and to
Inventions, Patent rights and other intellectual property rights as such other
Party has pursuant to Section 11.2(a). Each Party will also include provisions
in its relevant agreements with Affiliates and Third Parties that effect the
intent of this Section 11.2(b). 11.3 Patent Prosecution and Maintenance. (a)
Fibrocell will file and prosecute Patent Applications and maintain Patents in a
manner consistent with optimizing Patent protection on Inventions and other
inventions Controlled by Fibrocell that are disclosed and/or claimed in the
Fibrocell Patent Rights. Each Party will cause its patent counsel to confer no
less frequently than once each calendar month regarding the status of all such
Patent Applications and Patents for which it is responsible under this Section
11.3, and whether and in which countries foreign counterparts of such Patent
Applications and Patents will be filed. The Parties will set the location, date,
time and type of meeting (either in person, by teleconference, or by
videoconference) so as to be mutually agreeable to the patent counsel of each
Party. Each Party will consider the other Party’s comments in good faith and
will include any reasonable input from the other Party in any Patent filings or
communications with applicable Patent offices. (i) Fibrocell will bear the full
costs and expense of and be responsible for filing, prosecuting and maintaining
(1) Patents and Patent Applications claiming inventions it Controls as of the
Effective Date and during the term of this Agreement and those it Controls that
arise outside the Parties’ performance pursuant to this Agreement, and (2)
Patents and Patent Applications on Inventions it solely owns under this
Agreement; provided, that Fibrocell shall not be responsible for costs incurred
by CCP with respect to those Patents and Patent Applications. If Fibrocell does
not wish to file, prosecute or maintain any such Patent Applications or Patents
that relate to the Product, a component of the Product, or a method of using or
manufacturing the Product or any component thereof in or for the Territory
(“Product Patents”), Fibrocell will give CCP reasonable written notice to such
effect and, subject to any rights of Intrexon with respect to the prosecution of
such Product Patents under Section 6.2(a) of the Intrexon Agreement, will grant
CCP any necessary authority to file, prosecute and maintain such Product Patents
in CCP’s own name and at CCP’s sole expense. In such event, and subject to any
rights of Intrexon with respect to the ownership of such Product Patents under
Section 6.1 of the Intrexon Agreement, Fibrocell will assign to CCP its entire
right, title and interest in and to such Product Patents. Notwithstanding the
foregoing, after the Effective Date, Fibrocell will 29 US-DOCS\106669270.9

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file Patent Applications included within the Fibrocell Patent Rights in the
Territory and any country in which Manufacturing activities may be performed and
Fibrocell will give CCP reasonable written notice of the countries and regions
in which it will file such Patent Applications in order to permit CCP reasonable
time to file such Patent Applications in any country in which Fibrocell will not
be filing. If CCP wishes to file such Patent Applications in any additional
countries, Fibrocell will provide CCP with copies of any documents necessary to
conduct such filings and, subject to any rights of Intrexon with respect to the
prosecution of such Product Patents under Section 6.2(a) of the Intrexon
Agreement, will grant CCP any necessary authority to file, prosecute and
maintain such Patent Applications in CCP’s own name and at CCP’s sole expense.
In such event, Fibrocell will, subject to any rights of Intrexon with respect to
the ownership of such Product Patents under Section 6.1 of the Intrexon
Agreement, assign its entire right, title and interest in and to such Patent
Applications in that country to CCP. CCP will bear the full costs and expense of
and be solely responsible for prosecuting, maintaining, enforcing and defending
any Patent or Patent Application assigned to CCP under this Section 11.3(a)(i).
In the event that CCP chooses not to prosecute, maintain, enforce or defend any
such Patents or Patent Applications, Fibrocell will have the option to do so at
its sole cost and expense. (ii) CCP will bear the full costs and expense of and
be responsible for filing, prosecuting and maintaining Patents and Patent
Applications on Inventions it solely owns under this Agreement, at its sole
discretion. (iii) For jointly owned Inventions, the Parties will select a
mutually acceptable Third Party patent counsel to file, prosecute and maintain
Patents and Patent Applications thereon on behalf of both Parties (“Joint Patent
Rights”). All costs and expenses for Joint Patent Rights will be shared by the
Parties equally. If either Party does not wish to file, prosecute or maintain
any Joint Patent Rights in any country or pay its portion of any shared costs
for Joint Patent Rights in any country, that Party will give the other Party
reasonable written notice to such effect and will grant the other Party any
necessary authority to file, prosecute, maintain or defend such Joint Patent
Rights in the other Party’s own name and at the other Party’s sole expense. In
such event, the Party will assign its entire right, title and interest in and to
such Joint Patent Rights in that country to the other Party. Subject to the
foregoing, each Party will be free to exploit such Joint Patent Rights, either
itself or through the grant of licenses to Affiliates or Third Parties
throughout the world, without restriction, without the need to obtain further
consent from or provide notice to the other Party, and without any duty to
account or otherwise make any payment of any compensation to the other Party.
(b) Each Party will promptly disclose, and will cause its Sublicensees and
Affiliates to disclose, to the other in writing all Inventions. Each Party will
ensure that, to the extent permitted by Applicable Law, its Sublicensees and
Affiliates and their respective employees, independent contractors, contractors
and agents performing work pursuant to this Agreement are, and will cause its
Affiliates performing work pursuant to this Agreement to be, under an obligation
to assign to it all Inventions therein and intellectual property rights made or
arising during and in the course of and as a result of the performance of such
work or, where such obligation is not permitted in a particular country, to
exclusively license to it all such Inventions and intellectual property rights,
with the right to authorize or grant sublicenses in such country, or where
neither of the foregoing obligations is permitted in a particular country then,
to 30 US-DOCS\106669270.9

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non-exclusively license to it all such Inventions and intellectual property
rights, with the right to authorize or grant sublicenses in such country. 11.4
Third Party Licenses. If the Parties mutually and reasonably determine that
certain Third Party intellectual property rights are necessary for the
Exploitation of the Product, Fibrocell or CCP will at its expense obtain a
license to such Third Party intellectual property, with the right to sublicense,
in order to permit both Parties to conduct their obligations under this
Agreement, and the expenses associated with such license, unless otherwise
expressly provided in this Agreement, will be deducted from Net Sales for
purposes of determining Product Gross Profits. If the Parties disagree on
whether rights in Third Party intellectual property are reasonably necessary for
the Exploitation of the Product, the JDC will be responsible for determining
whether rights in such Third Party Patents and Patent Applications should be
obtained and any dispute as to whether other Third Party intellectual property
rights should be obtained shall be resolved through dispute resolution pursuant
to Section 3.2(d); provided that if CCP uses its final decision making authority
to determine a dispute under this Section 11.4, Fibrocell shall retain the right
to dispute such decision pursuant to Section 19.10. 11.5 Infringement by Third
Parties. (a) Enforcement. CCP will bear the full costs and expenses of
enforcing, and will have the first right to enforce, Joint Patent Rights and,
subject to Section 3.3 of the Intrexon Agreement and any enforcement rights of
Intrexon under Section 6.3 of the Intrexon Agreement, Product Patents throughout
the Territory, which right includes the right to control and settle the
litigation (subject to the last sentence of this Section 11.5). If CCP does not
initiate an enforcement action within ninety (90) days after the Parties first
learn of such infringement, Fibrocell will have the right to enforce such
Patents. All of the costs and expenses of both Parties incurred in connection
with such proceedings will be borne by the Party bringing such action, and any
recoveries will be awarded to the enforcing Party; provided, however, that any
amounts recovered that are attributable to lost sales or lost profits shall be
treated as Net Sales and will be taken into account in the calculation of
Product Gross Profit. If, in any enforcement action taken pursuant to this
Section 11.5, the enforcing Party determines that the other Party is an
indispensable party to such action, the other Party hereby consents to be joined
in such action and, in such event, the other Party will have the right to be
represented in such action using counsel of its own choice at the enforcing
Party’s expense. Notwithstanding the foregoing, each Party’s enforcement rights
under this Section 11.5 will be subject to limitations imposed in any license
agreement with a Third Party existing as of the Effective Date relating to the
Patent to be enforced. The joint consent of CCP and Fibrocell (which consent
will not be unreasonably withheld or delayed) will be required of any
settlement, consent judgment or other voluntary final disposition of a suit
under this Section 11.5 that could adversely affect the other Party’s interest.
(b) Biosimilar Applications. Notwithstanding the provisions of Section 11.5(a),
if either Party receives a copy of a Biosimilar Application referencing the
Product, whether or not such notice or copy is provided under any Applicable
Laws (including under the BPCIA, the United States Patient Protection and
Affordable Care Act, or its successor provisions), or otherwise becomes aware
that such a Biosimilar Application has been submitted to a Regulatory Authority
for marketing authorization (such as in an instance described in 42 31
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[ex105castlecreekfibrocel037.jpg]
U.S.C. §262(l)(2)), the remainder of this Section 11.5(b) will apply, then such
Party will promptly, but in any event within ten (10) business days, notify the
other Party. The owner of the relevant Patents will then seek permission to view
the Biosimilar Application, information regarding the process or processes used
to manufacture the product that is the subject of the Biosimilar Application,
and related confidential information from the filer of the Biosimilar
Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party
receives any equivalent or similar communication or notice in the United States
or any other jurisdiction, the Party receiving such communication or notice will
within five (5) business days notify the other Party of such communication or
notice to the extent permitted by Applicable Laws. Regardless of the Party that
is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for
purposes of such Biosimilar Application: (i) CCP will designate, to the extent
permitted by Applicable Law, or otherwise Fibrocell will designate in accordance
with CCP’s instructions, the outside counsel and in-house counsel who will
receive confidential access to the Biosimilar Application, information regarding
the process or processes used to manufacture the product that is the subject of
the Biosimilar Application, and any related confidential information pursuant to
42 U.S.C. §262(l)(1)(B)(ii). (ii) In each case, after consulting with Fibrocell
and considering Fibrocell’s comments in good faith, CCP will have the right to
(a) list any patents, including those Patents within the Fibrocell Patent
Rights, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7),
(b) respond to any communications with respect to such lists from the filer of
the Biosimilar Application, (c) negotiate with the filer of the Biosimilar
Application as to whether to utilize a different mechanism for information
exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the
Patents that will be subject to the litigation procedure as described in 42
U.S.C. §262(l)(4), decide which Patent or Patents will be selected for
litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation
under 42 U.S.C. §262(l)(6). If Fibrocell is required pursuant to Applicable Law
to execute any of these tasks it will do so in accordance with CCP’s reasonable
instructions. (iii) Fibrocell will cooperate with CCP’s reasonable requests in
connection with the foregoing activities to the extent required or permitted by
Applicable Laws. CCP will consult with Fibrocell prior to identifying any
Patents within the Fibrocell Patent Rights to a Third Party as contemplated by
this Section 11.5(b). CCP will consider in good faith advice and suggestions
with respect thereto received from Fibrocell, and notify Fibrocell of any such
lists or communications promptly after they are made. (iv) Each Party will
within five (5) business days after receiving any notice of commercial marketing
provided by the filer of a Biosimilar Application pursuant to 42 U.S.C.
§262(l)(8)(A), notify the other Party. To the extent permitted by Applicable
Law, CCP will have the first right, but not the obligation, to seek an
injunction against such commercial marketing as permitted pursuant to 42 U.S.C.
§262(l)(8)(B) and to file an action for infringement. If required pursuant to
Applicable Law, upon CCP’s request, Fibrocell will assist in seeking such
injunction or filing such infringement action after consulting with CCP. Except
as otherwise provided in this Section 11.5(b), any such action will be subject
to the other terms and conditions of Section 11.5(a). 32 US-DOCS\106669270.9

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11.6 Infringement Outside the Field. As between the Parties, Fibrocell will
retain any and all rights to pursue an action against, and control all
proceedings relating to, an infringement by a Third Party of the Fibrocell
Patent Rights, except for Product Patents as otherwise provided in this Article
11, or Fibrocell Know-How that is not related to the Product, a component of the
Product, or a method of using or manufacturing the Product or any component
thereof or is exclusively outside the Field or the Territory. 11.7 Further
Actions. Each Party will cooperate with the other Party to execute all documents
and take all reasonable actions to effect the intent of this Article 11. 11.8
Intrexon Patents. Intrexon retains certain rights to prosecute and enforce
certain Patents and Patent Applications licensed to Fibrocell under the Intrexon
Agreement, and CCP’s rights to prosecute and enforce such Patents and Patent
Applications provided under Sections 11.3 and 11.5 will be subject to such
rights of Intrexon. 11.9 Change of Control. Notwithstanding anything in this
Agreement to the contrary, the Patents, Patent Applications or Information owned
or otherwise Controlled, as of the effective date of the Change of Control of a
Party (the “Acquired Party”), by any counterparty with respect to a Change of
Control (the “Acquiror”) or the Acquiror’s Affiliate, (“Acquiror Affiliate”),
shall not become subject to the license grants and other requirements of this
Agreement, provided that such Acquiror or Acquiror Affiliate is not an Affiliate
of the Acquired Party immediately prior to the closing of such transaction(s).
Any Patents, Patent Applications or Information developed, acquired or invented
by an Acquiror or Acquiror Affiliate in the Field and in the Territory following
closing of the Change of Control of the Acquired Party shall only become subject
to the license grants and other requirements of this Agreement if they are
developed, acquired or invented using the Confidential Information of the other
Party and/or practicing the licenses or rights granted to the Acquired Party or
Acquiror Affiliate by the other Party hereunder (whether by assumption of such
licenses or rights in this Agreement or the grant of a sublicense or otherwise).
12. TRADEMARKS 12.1 Product Trademark. Subject to Section 6.2, the Product,
Product packaging, promotional materials, package inserts, and labeling for the
Territory will bear one or more Trademarks chosen and owned by CCP. 12.2
Trademark Prosecution and Maintenance. CCP will select Product- specific
Trademarks for the Territory, will solely own such Trademarks in the Territory
and will be responsible for filing, prosecuting and maintaining such Trademarks.
All of the cost and expenses incurred by CCP with respect to such
Product-specific Trademarks, including those incurred in connection with the
selection, preparation, filing, prosecution, and maintenance of Trademarks used
in Commercialization of the Product, filing and maintenance fees paid to
governmental authorities, and the costs of litigation (enforcement or defense)
or other proceedings, under such Trademarks, including fees and expenses paid to
outside counsel, will be borne by CCP. 33 US-DOCS\106669270.9

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13. REPRESENTATIONS, WARRANTIES AND COVENANTS 13.1 The Parties’ Representations
and Warranties. Fibrocell and CCP (each a “Representing Party”) each hereby
represents and warrants to each other as of the Effective Date that: (a) it has
the full corporate or limited liability company power, authority to enter into
this Agreement and to carry out the provisions hereof; (b) this Agreement has
been duly executed and delivered on behalf of such Representing Party and
constitutes a legal, valid and binding obligation of such Representing Party and
is enforceable against it in accordance with its terms, except as enforcement
may be affected by bankruptcy, insolvency or other laws of general application
affecting the enforcement of creditor rights and judicial principles affecting
the availability of specific performance and general principles of equity,
whether enforceability is considered a proceeding at law or equity; (c) it has
taken all corporate or limited liability company action, as the case may be,
necessary to authorize the execution, delivery and performance of this
Agreement; (d) all necessary consents, approvals and authorizations of all
Regulatory Authorities and other Third Parties required to be obtained by such
Representing Party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder have been obtained;
(e) the execution and delivery of this Agreement and the performance of such
Representing Party’s obligations hereunder (i) do not conflict with or violate
any requirement of Applicable Law or any provision of the articles of
incorporation, bylaws, limited partnership agreement or any similar instrument
of such Representing Party, as applicable, in any material way, and (ii) do not
conflict with, violate, or breach or constitute a default or require any consent
under, any Applicable Law or any contractual obligation (including, with respect
to Fibrocell as the Representing Party, the Intrexon Agreement) or court or
administrative order by which such Representing Party is bound; (f) the
Representing Party is duly organized, validly existing and in good standing
under the laws of its jurisdiction of organization, and has full power and
authority and the legal right to own and operate its property and assets and to
carry on its business as it is now being conducted; (g) all of Representing
Party’s employees, officers, contractors and consultants who (i) develop
intellectual property relating to this Agreement or the Product have executed
agreements requiring assignment to such Representing Party of all inventions
made during the course of and as a result of their association with such
Representing Party and (ii) have access to confidential information of the
Representing Party relating to this Agreement or the Product have executed
agreements requiring each such employee, officer, contractor and consultant to
maintain as confidential the Confidential Information of such Representing
Party; and 34 US-DOCS\106669270.9

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(h) neither it nor its Affiliates nor any of their respective employees,
officers, agents, or, to the knowledge of the Representing Party, independent
contractors who have rendered services relating to this Agreement or the
Product: (i) has ever been suspended or debarred, or convicted of a crime for
which an entity or person could be suspended or debarred, under 21 U.S.C.
Section 335a, (ii) has ever been included in the List of Excluded
Individuals/Entities maintained by the HHS Office of Inspector General pursuant
to 42 U.S.C. §§ 1320a-7, 13955ccc, 1320c-5 and regulations promulgated
thereunder; (iii) has ever been under indictment for a crime for which a person
or entity could be excluded, suspended or debarred with respect to any of the
foregoing; or (iv) is or has ever been otherwise ineligible to participate in
any healthcare reimbursement or procurement program in the Territory ((i)-(iv),
collectively, “Debarred or Excluded”). 13.2 Additional Representations and
Warranties of Fibrocell. Fibrocell hereby represents and warrants to CCP as of
the Effective Date that: (a) Fibrocell has title to Patents and Patent
Applications that are (i) solely owned by Fibrocell and (ii) included within the
Fibrocell Patent Rights; and the Fibrocell Patent Rights solely owned by
Fibrocell are free and clear of any liens, charges, encumbrances, or judgments
in the Field; (b) Fibrocell is entitled to grant the rights and licenses granted
to CCP under this Agreement, and is not currently bound by any agreement with
any Third Party, or by any outstanding order, judgment, or decree of any court
or administrative agency, that restricts it in any way from granting to CCP the
rights and licenses as set forth in this Agreement; (c) the Patents and Patent
Applications listed in Exhibit 1.42 are all of the Patents and Patent
Applications Controlled by Fibrocell that are necessary for Exploiting the
Product in the Field as the Product is being Exploited, or is proposed to be
Exploited, as of the Effective Date; (d) except for the license grants in
Section 2.1, neither Fibrocell nor any of its Affiliates have assigned,
transferred, conveyed, granted, or otherwise encumbered any right, title or
interest in or to the Fibrocell Patent Rights or the Fibrocell Know-How that
would conflict with or interfere with any of the rights or licenses granted to
CCP hereunder; (e) there are no judgments or settlements against Fibrocell or
material amounts owed by Fibrocell (other than amounts owed in the ordinary
course of business or amounts owed as royalties or milestones under the Intrexon
Agreement) with respect to the Fibrocell Patent Rights or the Fibrocell
Know-How; and Fibrocell has received no written notice of any threatened or
pending actions, suits, judgments, settlements, or claims against Fibrocell
that, if determined adversely to Fibrocell, would have an adverse effect upon
(i) its ability to grant to CCP the licenses and rights granted under this
Agreement, (ii) the ability of CCP to utilize the Fibrocell Patent Rights and
the Fibrocell Know-How pursuant to this Agreement, or (iii) Fibrocell’s right to
enter into and perform its obligations under this Agreement; (f) no validity,
infringement or freedom-to-operate opinions have been prepared by Fibrocell or
its Affiliates, or on behalf of Fibrocell or its Affiliates by outside 35
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counsel, pertaining to the Product, any components thereof, or methods of use or
manufacture thereof; (g) to Fibrocell’s knowledge, there is no material prior
art or any other fact that would likely render the claims in the Fibrocell
Patents issued as of the Effective Date unpatentable, invalid, or unenforceable
in whole or in part; all inventors of any inventions included within the
Fibrocell Patent Rights or Fibrocell Know-How Controlled by Fibrocell as of the
Effective Date have assigned their entire right, title, and interest in and to
such inventions and the corresponding Patent rights to Fibrocell or the Third
Party licensor of such rights to Fibrocell; and to Fibrocell’s knowledge, no
person, other than those persons named as inventors on any Fibrocell Patent
Rights, is, or has alleged to Fibrocell to be, an inventor of the invention(s)
claimed in such Fibrocell Patent Rights; and with respect to all Fibrocell
Patent Rights prosecuted or solely owned by Fibrocell: (i) each has been
prosecuted in material compliance with all applicable rules, policies, and
procedures of the applicable patent office and (ii) each is subsisting and in
good standing; (h) Fibrocell is in compliance in all material respects with any
agreement between Fibrocell and a Third Party relating to the practice of the
Fibrocell Patent Rights in the Field, including the Intrexon Agreement, and all
such agreements are in full force and effect; (i) Fibrocell has no knowledge of
any infringement by any Third Party of any of the Fibrocell Patent Rights or
misappropriation of the Fibrocell Know-How; (j) Fibrocell has sufficient legal
and/or beneficial title under its intellectual property rights necessary for the
purposes contemplated under this Agreement and to grant the licenses contained
in this Agreement; Intrexon has not notified Fibrocell of any breach of the
Intrexon Agreement by Fibrocell or any other basis for termination of the
Intrexon Agreement; and Fibrocell has obtained, prior to the Effective Date, the
consent of Intrexon to enter into this Agreement and to grant to CCP a
sublicense under the rights licensed by Intrexon to Fibrocell as set forth in
Section 2.1; (k) all Patents and Patent Applications in which Fibrocell has an
ownership interest as of the Effective Date that claim a product, method,
apparatus, material, manufacturing process or other technology necessary to
develop, make, use, sell, offer for sale, import or export the Product in the
Field and in or for the Territory are solely owned by Fibrocell as of the
Effective Date; (l) to Fibrocell’s knowledge, the Fibrocell Patent Rights and
the Fibrocell Know-How do not include any trade secrets that have been
misappropriated from any Third Party or obtained in breach of any contractual
obligation of Fibrocell or its employees to a Third Party; (m) to Fibrocell’s
knowledge, the Exploitation of the Product in the Field in the Territory as the
Product is being Exploited or are proposed to be Exploited as of the Effective
Date will not infringe or has infringed any issued claim of any Patent rights
owned or otherwise controlled by a Third Party; and Fibrocell is not aware of
any pending or threatened (in 36 US-DOCS\106669270.9

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writing) litigation nor has Fibrocell received any written communications
alleging that Fibrocell has violated or would violate, through the manufacture,
import and/or sale of the Product hereunder, or by conducting its obligations
under this Agreement as currently proposed under this Agreement, any rights
including intellectual property rights of any Third Party; (n) Fibrocell has
made available to CCP any material written communications received from any
Regulatory Authority with respect to obtaining Regulatory Approval for the
Product; (o) Fibrocell has engaged legal counsel and, together with such
counsel, has reviewed and evaluated this Agreement and the transactions
contemplated herein in light of (i) Section 271 of the Delaware General
Corporation Law and (ii) it’s outstanding debt instruments, warrants to purchase
shares of its common stock and other equity instruments, and has determined,
upon advice of such counsel, that the entry into this Agreement and consummation
of the transactions contemplated herein (x) do not require the vote of
Fibrocell’s stockholders under Section 271 of the Delaware General Corporation
Law, nor (y) necessitate the consent of any holder of Fibrocell’s debt
instruments, warrants to purchase shares of its common stock or other equity
instruments, nor result in a default or breach of any of the foregoing; and (p)
to Fibrocell’s knowledge, Fibrocell has obtained all material licenses,
authorizations, and permissions necessary under Applicable Law for performing
its obligations under this Agreement and all such licenses, authorizations, and
permissions are in full force and effect. 13.3 Covenants of the Parties. Each
Party hereby covenants to the other Party that during the term of this
Agreement: (a) such Party will perform its obligations under this Agreement in
compliance with all material Applicable Laws; (b) such Party will not enter into
any agreement with any Third Party that will conflict with the rights granted to
the other Party under this Agreement; (c) all employees and consultants of such
Party or its Affiliates working under this Agreement will be under the
obligation to assign all right, title and interest in and to their inventions
and discoveries, whether or not patentable, if any, to such Party as the sole
owner thereof; (d) such Party will not knowingly employ (or use any
subcontractor or consultant that employs) any individual or entity that is
Debarred or Excluded, or any individual who or entity which is the subject of an
FDA debarment investigation or proceeding, in the conduct of its activities
under this Agreement. If during the term of this Agreement, such Party has
reason to believe that it or any of its Affiliates or any of their respective
employees, officers, independent contractors, or agents rendering services
relating to this Agreement or the Product satisfies or is reasonably likely to
be Debarred or Excluded, then such Party will immediately notify the other Party
of the same in writing; and 37 US-DOCS\106669270.9

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(e) such Party will maintain, all material licenses, authorizations, and
permissions necessary under Applicable Law for performing its obligations under
this Agreement. 13.4 Covenants of Fibrocell Fibrocell covenants to CCP that
during the term of this Agreement Fibrocell will: (a) maintain the Intrexon
Agreement in full force and effect with respect to Exploitation of the Product
in or for the Territory in accordance with its terms, and notify CCP if it
materially breaches the Intrexon Agreement, if Intrexon or any Intrexon
affiliate alleges that Fibrocell has materially breached the Intrexon Agreement
or if Fibrocell becomes aware of any circumstance that is reasonably likely to
lead to such an allegation or breach, and in the event of such a material
breach, alleged material breach or circumstance, (i) Fibrocell shall have the
first right to cure such breach, alleged breach or circumstance, and (ii) if
Fibrocell elects not to cure such breach, alleged breach or circumstance, CCP
shall have the right to cure such breach, alleged breach or circumstance to the
extent necessary to avoid forfeiture by, or a material adverse effect on, any
material rights of CCP under the Intrexon Agreement, including any license or
sublicense thereunder, and CCP may offset its reasonable costs and expenses
incurred in performing such cure against the milestone payments and profit
sharing payments payable under Article 9; (b) (i) exercise and enforce its
rights and Intrexon’s obligations under the Intrexon Agreement that relate to
the prosecution, maintenance, enforcement or defense of, or is reasonably likely
to adversely affect in any material respect the rights sublicensed by Fibrocell
to CCP under, the Fibrocell Patents owned by Intrexon, including pursuant to
Sections 6.2(c) and 6.3(b) of the Intrexon Agreement (such rights and
obligations, the “Intrexon Rights”) to the extent that a failure to do so would
reasonably be expected to have a material adverse effect on CCP’s rights or
interests under this Agreement; (ii) provide CCP with reasonable advance,
written notice prior to exercising or enforcing any Intrexon Right (including
rights of consultation or participation), or electing to forego such exercise or
enforcement; and (iii) use good faith efforts to obtain Intrexon’s consent to
the attendance and participation of a CCP representative at, and in any event
shall give CCP reasonable advance written notice prior to, any material
meetings, conferences and discussions scheduled between Intrexon and Fibrocell
at which any matters relevant to an Intrexon Right will be discussed; (c) comply
with its material covenants and obligations under the Intrexon Agreement; (d)
not terminate, amend or waive any right under the Intrexon Agreement as it
relates to Exploitation of the Product in or for the Territory, without CCP’s
prior written consent; (e) not transfer, delegate, grant any interest in or
assign to any Third Party, in whole or in part, the Intrexon Agreement as it
relates to Exploitation of the Product in or for the Territory, without CCP’s
prior written consent; 38 US-DOCS\106669270.9

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(f) not terminate, amend, waive any right under, or transfer, delegate, grant
any interest in or assign to any Third Party, in whole or in part, the Intrexon
Agreement as it relates to Exploitation of the Product outside the Territory, in
a manner that would reasonably be expected to increase Development Costs or
reduce Net Sales in or for the Territory; (g) keep CCP reasonably informed as to
the activities of the JSC (as defined under the Intrexon Agreement) and any
other committee or subcommittee thereunder with respect to Exploitation of the
Product in or for the Territory, and provide CCP a meaningful opportunity to
review and comment on proposed actions or decisions thereof, and act or withhold
action consistent with such comments; and (h) not assign, transfer, convey,
grant, or otherwise encumber any right, title or interest in or to the Fibrocell
Patent Rights or the Fibrocell Know-How, in a manner that would conflict with
the rights granted to CCP under this Agreement. 13.5 Covenant of CCP. CCP hereby
covenants to Fibrocell that during the term of this Agreement it will not
conduct Development of the Product for any indication other than the Initial
Indication without Fibrocell’s prior written consent, such consent not to be
unreasonably withheld, conditioned or delayed. 14. MUTUAL INDEMNIFICATION AND
INSURANCE 14.1 Fibrocell’s Right to Indemnification. CCP will indemnify, defend
and hold harmless each of Fibrocell and its Affiliates and their respective
successors, assigns, directors, officers, employees, independent contractors and
agents, from and against any and all liabilities, damages, losses, settlements,
penalties, fines, costs and expenses, including reasonable attorneys’ fees and
litigation costs (any of the foregoing to be referred to herein as “Damages”) of
whatever kind or nature (but not including taxes) arising from any Third Party
demand, investigation, claim, action or suit in the Territory to the extent
based on (a) any act, whether of omission or commission, by CCP (or its
Affiliates, Sublicensees or any of their respective directors, officers,
employees, independent contractors or agents) with respect to its failure to
properly discharge or perform its areas of responsibility under this Agreement,
including the Commercialization of the Product by CCP; (b) the gross negligence
or willful or intentional misconduct of CCP, its Affiliates or any of its
Sublicensees or their respective directors, officers, employees, independent
contractors or agents under this Agreement; (c) a material breach by CCP of any
term of this Agreement; (d) a material breach by CCP of any obligation,
representation, warranty or covenant hereunder; or (e) a violation of Applicable
Law in the performance of its duties under this Agreement by CCP, its Affiliates
or any of its Sublicensees or their respective directors, officers, employees,
independent contractors or agents, except in each case to the extent Fibrocell
has an obligation to indemnify CCP and its Affiliates pursuant to Section 14.2.
14.2 CCP’s Right to Indemnification. Fibrocell will indemnify, defend and hold
harmless each of CCP and its Affiliates and their respective successors,
assigns, directors, officers, employees, independent contractors and agents,
from and against any and all Damages of whatever kind or nature (but not
including taxes) arising from any Third Party demand, investigation, claim,
action or suit in the Territory to the extent based on (a) any act, whether of
39 US-DOCS\106669270.9

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omission or commission, by Fibrocell (or its Affiliates or any of their
respective directors, officers, employees, independent contractors or agents)
with respect to its failure to properly discharge or perform its areas of
responsibility under this Agreement, including the Development of Product, the
Manufacture and supply of the Product (including any defect or alleged defect in
the Product provided pursuant to this Agreement or any injury or death of any
person arising out of or related to the Product provided pursuant to this
Agreement), the conduct of Clinical Trials by Fibrocell; (b) Fibrocell’s
Exploitation of the Product outside the Field or outside the Territory; (c) the
gross negligence or willful or intentional misconduct of Fibrocell, its
Affiliates or any of its Sublicensees or any of their respective directors,
officers, employees, independent contractors or agents under this Agreement; (d)
a material breach by Fibrocell of any term of this Agreement or the Intrexon
Agreement; (e) a material breach by Fibrocell of any obligation, representation,
warranty or covenant hereunder; (f) a violation of Applicable Law in the
performance of its duties under this Agreement by Fibrocell, its Affiliates or
any of its Sublicensees or their respective directors, officers, employees,
independent contractors or agents; or (g) Fibrocell’s or its Affiliates’ or
Sublicensees’ use of or reference to any data, information, Regulatory
Approvals, regulatory filings or regulatory documentation provided by CCP or
generated by or on behalf of Fibrocell under this Agreement, except in each case
to the extent CCP has an obligation to indemnify Fibrocell and its Affiliates
pursuant to Section 14.1. 14.3 Process for Indemnification. A Party’s obligation
to defend, indemnify and hold harmless the other Party under this Article 14
will be conditioned upon the following: (a) A Party seeking indemnification
under this Article 14 (the “Indemnified Party”) will give prompt written notice
of the claim to the other Party (the “Indemnifying Party”); provided, however,
that failure to so notify shall not preclude the Indemnified Party’s right to
indemnification hereunder unless the Indemnifying Party is actually prejudiced
by such failure. (b) Each Party will furnish promptly to the other, copies of
all papers and official documents received in respect of any Damages. The
Indemnified Party will cooperate as requested by the Indemnifying Party in the
defense against any Damages. (c) With respect to any Damages relating solely to
the payment of money damages and which will not result in the Indemnified
Party’s becoming subject to injunctive or other relief or otherwise adversely
affecting the business of the Indemnified Party in any manner, and as to which
the Indemnifying Party will have acknowledged in writing the obligation to
indemnify the Indemnified Party under this Article 14, the Indemnifying Party
will have the sole right to defend, settle or otherwise dispose of such Damages,
on such terms as the Indemnifying Party, in its sole discretion, will deem
appropriate. (d) With respect to Damages relating to all other matters, the
Indemnifying Party will have the sole right to control the defense of such
matter, provided that the Indemnifying Party will obtain the written consent of
the Indemnified Party, which consent will not be unreasonably withheld or
delayed, prior to ceasing to defend, settling or otherwise disposing of any
Damages if as a result thereof (i) the Indemnified Party would become subject to
injunctive or other equitable relief or any remedy other than the payment of
money by the Indemnifying Party or (ii) the business of the Indemnified Party
would be adversely affected. 40 US-DOCS\106669270.9

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(e) The Indemnifying Party will not be liable for any settlement or other
disposition of Damages by the Indemnified Party which is reached without the
written consent of the Indemnifying Party, which consent will not be
unreasonably withheld, conditioned or delayed, it being understood that if such
consent is withheld, the Indemnifying Party will be responsible for the amount
of damages or increased costs and expenses attributable to such failure to give
consent. 14.4 Insurance. During the term of this Agreement and for five (5)
years thereafter, each Party will maintain, at its sole expense, clinical trial
and product liability insurance relating to the Product that is comparable in
type and amount to the insurance customarily maintained by such Party with
respect to similar prescription pharmaceutical products that are marketed,
distributed and sold in the Territory. 15. LIMITATION OF LIABILITY AND EXCLUSION
OF DAMAGES; DISCLAIMER OF WARRANTY 15.1 EXCEPT IN THE CASE OF A BREACH OF
ARTICLE 16, AND WITHOUT LIMITING THE PARTIES’ OBLIGATIONS UNDER ARTICLE 14,
NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT,
INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING DAMAGES RESULTING FROM
LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS OR OTHER ECONOMIC
LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTY’S PERFORMANCE OR
NON-PERFORMANCE HEREUNDER. 15.2 EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT,
NEITHER PARTY PROVIDES ANY WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR
IMPLIED, REGARDING THE PRODUCT USED IN PRECLINICAL STUDIES OR CLINICAL TRIALS OR
FOR COMMERCIAL USE, AND EACH PARTY HEREBY DISCLAIMS ALL OTHER WARRANTIES,
WHETHER WRITTEN OR ORAL, EXPRESS AND IMPLIED, INCLUDING THE IMPLIED WARRANTIES
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND FREEDOM FROM
INFRINGEMENT OF THIRD PARTY RIGHTS. 16. CONFIDENTIALITY 16.1 Confidentiality;
Exceptions. Each Party will maintain in confidence all Information and materials
of the other Party disclosed or provided to it by the other Party (either
pursuant to this Agreement or the Confidential Disclosure Agreement entered into
by the Parties dated October 24, 2018 (the “Confidential Disclosure
Agreement”)), to the extent relating to this Agreement or the Products or the
Exploitation thereof (together with all embodiments thereof, the “Confidential
Information”). Confidential Information also includes Information regarding
intellectual property and confidential or proprietary Information of Third
Parties. In addition, and notwithstanding the foregoing, if under Article 11
Information constituting inventions and discoveries are to be owned by one
Party, such Information will be deemed to be Confidential Information of such
Party, even if such Information is initially generated and disclosed by the
other Party. The Fibrocell Know-How and the terms and conditions of this 41
US-DOCS\106669270.9

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Agreement and the Confidential Disclosure Agreement will be deemed Confidential
Information of both Parties. Notwithstanding the foregoing the obligations of
confidentiality and limited use set forth herein will not apply to any portion
of Information or materials that the receiving Party can demonstrate by
contemporaneous written records was (a) known to the general public at the time
of its disclosure to the receiving Party, or thereafter became generally known
to the general public, other than as a result of actions or omissions of the
receiving Party or anyone to whom the receiving Party disclosed such
Information; (b) known by the receiving Party prior to the date of disclosure by
the disclosing Party; (c) disclosed to the receiving Party on an unrestricted
basis from a source unrelated to the disclosing Party and not under a duty of
confidentiality to the disclosing Party; or (d) independently developed by the
receiving Party by personnel that did not have access to or use of Confidential
Information of the disclosing Party. Any combination of features or disclosures
will not be deemed to fall within the foregoing exclusions merely because
individual features are published or known to the general public or in the
rightful possession of the receiving Party unless the combination itself and
principle of operation thereof are published or known to the general public or
are in the rightful possession of the receiving Party. 16.2 Degree of Care;
Permitted Use. Each Party will take reasonable steps to maintain the
confidentiality of the Confidential Information of the other Party, which steps
will be no less protective than those steps that such Party takes to protect its
own Information and materials of a similar nature, but in no event less than a
reasonable degree of care. Except to the extent expressly permitted under this
Agreement, neither Party will use or permit the use of any Confidential
Information of the other Party except for the purposes of carrying out its
obligations or exercising its rights under this Agreement or the Confidential
Disclosure Agreement, and neither Party will copy any Confidential Information
of the other Party except as may be reasonably useful or necessary for such
purposes. All Confidential Information of a Party, including all copies and
derivations thereof, is and will remain the sole and exclusive property of the
disclosing Party and subject to the restrictions provided for herein. Except to
the extent expressly permitted under this Agreement, neither Party will disclose
any Confidential Information of the other Party other than to those of its and
Affiliates’ and Sublicensees’ directors, officers, employees, licensors,
independent contractors, permitted assignees, agents and external advisors that
are directly concerned with the carrying out of this Agreement, on a strictly
applied “need to know” basis, and that are subject to confidentiality and
non-use obligations at least as stringent as the confidentiality and non-use
obligations provided for in this Article 16. Except to the extent expressly
permitted under this Agreement, the receiving Party may not use Confidential
Information of the other Party in applying for Patents or securing other
intellectual property rights without first consulting with, and obtaining the
written approval of, the other Party (which approval will not be unreasonably
withheld or delayed). 16.3 Permitted Disclosures. The obligations of Sections
16.1, 16.2, and 17.1 will not apply to the extent that the receiving Party is
required to disclose Information pursuant to (a) an order of a court of
competent jurisdiction, (b) Applicable Laws, (c) regulations or rules of a
securities exchange, (d) requirement of a governmental agency for purposes of
obtaining approval to test or market the Product, (e) disclosure of Information
to a Patent office for the purposes of filing a Patent Application as permitted
in this Agreement, (f) disclosure on a need- to-know basis to any bona fide
potential or actual investor, investment banker, acquirer, 42
US-DOCS\106669270.9

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acquisition target, merger partner, licensee, licensor, or other potential or
actual financial or strategic partner; provided that in connection with such
disclosure, the disclosing Party will use reasonable efforts to inform each
disclosee of the confidential nature of such Confidential Information and cause
each disclosee to treat such Confidential Information as confidential, or (g)
the exercise or enforcement by each Party of its rights granted to it under this
Agreement or its retained rights, including the Exploitation of the Product, and
such Third Party agrees to confidentiality and non-use obligations at least as
stringent as those specified for in this Article 16; provided that the receiving
Party will provide prior written notice thereof to the disclosing Party and
sufficient opportunity for the disclosing Party to review and comment on such
required disclosure and request confidential treatment thereof or a protective
order therefor. 16.4 Irreparable Injury. The Parties acknowledge that either
Party’s breach of this Article 16 would cause the other Party irreparable injury
for which it would not have an adequate remedy at law. In the event of a breach,
the nonbreaching Party may seek injunctive relief, whether preliminary or
permanent, in addition to any other remedies it may have at law or in equity,
without necessity of posting a bond. 16.5 Return of Confidential Information.
Each Party will return or destroy, at the other Party’s instruction, all
Confidential Information of the other Party in its possession upon termination
or expiration of this Agreement, except any Confidential Information that is
necessary to allow such Party to perform or enjoy any of its rights or
obligations that expressly survive the termination or expiration of this
Agreement. 16.6 Survival of Obligations. The obligations of confidentiality and
limited use contained in this Article 16 will survive and continue through the
term of this Agreement and for a period of ten (10) years thereafter; provided
that with respect to Confidential Information comprising a trade secret of a
Party, such obligations will continue for as long as such Confidential
Information qualifies as a trade secret under Applicable Law. 17. PUBLICITY 17.1
Public Disclosure. The Parties agree that the initial public announcement of the
execution of this Agreement will be in the form of a mutually agreed upon press
release that describes the nature and scope of the collaboration including its
aggregate value (the “Initial Public Disclosure”). In connection with the
issuance of such press release, each Party will also be permitted to make any
filings required under Applicable Law, including filings with the U.S.
Securities and Exchange Commission to report the execution of this Agreement.
During the term of this Agreement, in all cases other than the announcement set
forth in the Initial Public Disclosure, each Party will submit to the other
Party (the “Non-Publishing Party”) for review and approval all proposed press
releases, academic, scientific and medical publications and public presentations
relating to the Product that have not been previously disclosed. Such review and
approval will be conducted for the purposes of preserving intellectual property
protection and determining whether any portion of the proposed publication or
presentation containing the Confidential Information of the Non-Publishing Party
should be modified or deleted, and (in the case of a disclosure that Fibrocell
wishes to make) to determine whether such disclosure is in the best interests of
the Parties in connection with the Development of the Product (such
determination to be made in CCP’s reasonable discretion). Written copies of such
proposed 43 US-DOCS\106669270.9

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publications and presentations (other than press releases) will be submitted to
the Non- Publishing Party no later than sixty (60) days (or, if less, as far in
advance as is reasonably practicable) before submission for publication or
presentation; provided that, for general disclosure of program status to
investors or analysts, or in public conference or earnings calls (“General
Disclosure”) such sixty (60) day period will be shortened to ten (10) business
days (or, if less, as far in advance as is reasonably practicable). Subject to
Applicable Law, written copies of proposed press releases will be submitted to
the Non-Publishing Party no later than seventy-two (72) hours (or, if less, as
far in advance as is reasonably practicable) before release. The Non-Publishing
Party will provide its comments, if any, and (if it so chooses) its approval
within (a) two (2) business days, in the case of a press release, and (b) ten
(10) business days of its receipt of any other written copy. With respect to
matters other than press releases, the review period may be extended for an
additional thirty (30) days, or for General Disclosures ten (10) business days,
in the event the Non-Publishing Party can demonstrate reasonable need for such
extension, including the preparation and filing of Patent Applications. This
period may be further extended by mutual written agreement of the Parties.
Fibrocell and CCP will each comply with standard academic practice regarding
authorship of scientific publications and recognition of contribution of other
parties in any publications. 17.2 Use of Marks. Neither Party will use any
Trademark owned or controlled by the other Party or any derivation of the other
Party’s name without the advance express written consent of the other Party,
which consent may be granted or withheld in the other Party’s sole discretion.
18. TERM AND TERMINATION 18.1 Term. The term of this Agreement will commence as
of the Effective Date and, unless sooner terminated as provided in this Article
18, will continue in effect until the later of (a) expiration of the last to
expire Valid Claim of any Fibrocell Patent Rights in the Territory, or (b) forty
(40) years from the date of Initial BLA Approval. Upon expiration of this
Agreement, the licenses granted to CCP hereunder will be royalty-free and fully
paid-up. 18.2 Termination by CCP. (a) CCP will have the right to terminate this
Agreement at will upon one hundred eighty (180) days’ prior written notice. (b)
CCP will have the right to terminate this Agreement, at any time, upon one
hundred eighty (180) days’ prior written notice to Fibrocell in the event (i)
CCP determines, in its reasonable discretion, that further Development or
Commercialization of Products is not commercially viable, or (ii) that CCP
determines that Development or Commercialization of Products must be terminated
because of safety issues outside of CCP’s reasonable control (either of (i) or
(ii), an “Unanticipated Development”). If CCP terminates this Agreement for an
Unanticipated Development, then CCP and Fibrocell will continue to bear their
respective share of noncancellable costs and expenses becoming due after the
effective date of such termination, to the extent such costs and expenses were
set forth in a relevant Plan; provided that the Parties will use reasonable
efforts to minimize expenditures after the effective date of such termination.
Upon request by Fibrocell, CCP will provide documentation to support 44
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its determination of the occurrence of an Unanticipated Development and meet
with Fibrocell upon request to explain the basis for such determination. 18.3
Termination for Material Breach. If either Party (the “Non-Breaching Party”)
believes the other Party (the “Breaching Party”) is in material breach of a
material obligation under this Agreement, it may give notice of such breach to
the Breaching Party, and the Breaching Party will have sixty (60) days in which
to remedy such breach, or thirty (30) days in the case of breach (whether
material or not) of any payment obligation hereunder. Such sixty (60) day period
will be extended in the case of a breach not capable of being remedied in such
sixty (60) day period so long as the Breaching Party uses diligent efforts to
remedy such breach and is pursuing a course of action that, if successful, will
effect such a remedy, but in no event shall a Party have more than one hundred
twenty (120) days to remedy such breach. If such alleged breach is not remedied
in the time period set forth above, the Non-Breaching Party will be entitled,
without prejudice to any of its other rights conferred on it by this Agreement,
and in addition to any other remedies available to it by law or in equity, to
terminate this Agreement upon written notice to the Breaching Party. In the
event of a dispute regarding any payments due and owing hereunder, all
undisputed amounts will be paid when due, and the balance, if any, will be paid
promptly after settlement of the dispute, including any accrued interest
thereon. Notwithstanding the foregoing, if the allegedly breaching Party
disputes in good faith the existence or materiality of such breach and provides
notice to the other Party of such dispute within such cure period, such other
Party will not have the right to terminate this Agreement in accordance with
this Section 18.3 unless and until it has been determined in accordance with
Section 19.10 that this Agreement was materially breached by the allegedly
breaching Party and failed to cure such breach within the applicable cure
period. It is understood and acknowledged that during the pendency of such a
dispute, all of the terms and conditions of this Agreement will remain in effect
and the Parties will continue to perform all of their respective obligations
hereunder. The Parties further agree that any payments that are made by one
Party to the other Party pursuant to this Agreement pending resolution of the
dispute will be promptly refunded if a court determines pursuant to Section
19.10 that such payments are to be refunded by one Party to the other Party 18.4
Termination upon Insolvency. Either Party may terminate this Agreement if, at
any time, the other Party: (a) files in any court or agency pursuant to any
statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the appointment of
a receiver or trustee of that Party or of its assets; (b) proposes a written
agreement of composition or extension of its debts; (c) is served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition will not be dismissed within forty-five (45) days after the filing
thereof; (d) passes a resolution for its winding up or proposes to be or is a
party to any dissolution or liquidation; or (e) if the other Party will make an
assignment for the benefit of its creditors. 18.5 Termination by CCP pursuant to
Section 18.2 or Fibrocell pursuant to Section 18.3 or 18.4. In the event that
CCP terminates this Agreement under Section 18.2 or Fibrocell terminates this
Agreement under Section 18.3 or 18.4, then, as of the effective date of such
termination, subject to the rights of any Sublicensee pursuant to Section
2.2(b), the following terms and conditions will apply: 45 US-DOCS\106669270.9

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(a) The license granted to CCP under Section 2.1 will terminate and all rights
with respect thereto will revert in their entirety to Fibrocell. (b) Fibrocell
shall have the first right to prosecute, maintain and enforce the Joint Patent
Rights to the extent they claim the Product. If Fibrocell decides not to, or to
cease, prosecution, maintenance or enforcement of any such Joint Patent Right,
Fibrocell shall provide prompt notice to CCP of such decision (but in any event
no later than ninety (90) days prior to the date any filing or payment is due
with respect thereto), and CCP shall have the right to assume prosecution,
maintenance or enforcement thereof. Each Party shall retain its right to exploit
the Joint Patent Rights to the extent they do not claim the Product in
accordance with their ownership interest therein, and Section 11.3(a)(iii) will
survive and apply with respect thereto. (c) CCP shall grant and hereby grants to
Fibrocell, a perpetual, non- exclusive, irrevocable license, with the right to
grant sublicenses (including through multiple tiers of sublicenses), under the
Patents, Patent Applications and Information owned or controlled by CCP to the
extent they claim the Exploitation of Product, in accordance with the applicable
Regulatory Approval for the Product as of the effective date of such
termination. CCP shall, as soon as practicable after such termination, transfer
to Fibrocell, at Fibrocell’s request and at CCP’s cost, such Information. (d)
CCP shall (i) promptly return to Fibrocell, at no cost to Fibrocell, all
tangible Fibrocell Know-How and Confidential Information of Fibrocell that
Fibrocell has transferred to CCP, (ii) assign and transfer to Fibrocell the
Initial BLA Approval, and (iii) transfer to Fibrocell any Regulatory Approval
that is obtained by or on behalf of CCP, directly or indirectly, in connection
with CCP’s activities under this Agreement that is applicable solely to the
Product. Any costs and expenses incurred by CCP in connection with the
assignments and transfers made by CCP under this Section 18.5 shall be borne by
Fibrocell. (e) If CCP has placed any purchase orders for biopsy kits or finished
Product prior to termination that have not been fulfilled, Fibrocell shall
fulfill such purchase orders on behalf of CCP, subject to the payment to
Fibrocell of any amounts due under Article 9 with respect to such orders. (f) In
consideration for Fibrocell’s use of the Information (including data) and other
intellectual property rights transferred or licensed to Fibrocell by CCP under
this Section 18.5, Fibrocell shall upon first commercial sale by Fibrocell, its
Affiliates or licensees in the Territory pay to CCP an amount equal to five
percent (5%) of Product Gross Profit in respect of sales of the Product in the
Territory by Fibrocell, its Affiliates or licensees in the Initial Indication
and any additional indications developed or commercialized by the Parties as of
the effective date of termination. Fibrocell will keep complete and accurate
records pertaining to the Net Sales of the Product and Fully Burdened
Manufacturing Costs, which documents would enable CCP to confirm the accuracy of
the calculations of payments made to CCP under this Section 18.5(f). The terms
and conditions set forth in Sections 9.6-9.9 and Article 10, including the
applicable definitions used therein, shall apply to Fibrocell with respect to
such payments on Net Sales of the Product by Fibrocell, its Affiliates or
licensees in the same manner they would apply to CCP prior to such termination.
Following reversion of rights to Fibrocell pursuant to 46 US-DOCS\106669270.9

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this Section 18.5, Fibrocell shall be required to use Commercially Reasonable
Efforts to Develop and Commercialize the Product in the Territory. (g) Upon
Fibrocell’s request, CCP will transfer to Fibrocell, and Fibrocell will have the
right to use, all materials, results, analyses, reports, websites, marketing
materials, technology, know-how, regulatory filings and other Information,
reasonably required by Fibrocell, in whatever form developed, controlled or
generated as of the effective date of such termination by or on behalf of CCP,
its Affiliates or Sublicensees with respect to the Product. Additionally, CCP
will grant to Fibrocell any rights of reference or access to regulatory filings
necessary to practice the rights granted to it under this Section 18.5. All
transfers described in this Section 18.5(g) will be at Fibrocell’s expense. (h)
CCP shall cooperate with Fibrocell to facilitate an orderly transition and
uninterrupted Development, Manufacturing and Commercialization of all Product,
including by assigning or otherwise transferring (to the extent permissible) to
Fibrocell all right, title and interest in all Third Party contracts (or
portions thereof) that are assignable by CCP to the extent they are necessary
for the Commercialization solely of the Product in the Territory, as reasonably
requested by CCP; provided that Fibrocell shall use good faith efforts to enter
into its own commercial or government contracts related thereto as soon as
reasonably practicable following the effective date of such termination. (i)
Except where expressly provided for otherwise in this Agreement, termination of
this Agreement by CCP pursuant to Section 18.2 or by Fibrocell pursuant to
Section 18.3, will not relieve the Parties of any liability, including any
obligation to make payments that accrued hereunder prior to the effective date
of such termination, nor preclude any Party from pursuing all rights and
remedies it may have hereunder or at law or in equity with respect to any breach
of this Agreement, nor prejudice any Party’s right to obtain performance of any
obligation to be performed hereunder. In the event of such termination, this
Section 18.5 will survive in addition to others specified in Section 18.7 or
otherwise in this Agreement to survive in the event of termination. 18.6
Termination by CCP Pursuant to Section 18.3 or 18.4. In the event that CCP
terminates this Agreement under Section 18.3 or 18.4, then as of the effective
date of such termination, the following terms and conditions will apply: (a) The
license granted to CCP under Section 2.1 shall become perpetual and irrevocable,
provided that CCP makes the payments payable to Fibrocell under and in
accordance with Section 18.6(b) and, to the extent such license is granted under
the Fibrocell Patents owned by Intrexon, such license shall be subject to the
terms and conditions of the Intrexon Agreement. (b) CCP’s obligations to share
in Product Gross Profit pursuant to Section 9.3 and to pay Fibrocell milestones
pursuant to Section 9.5 will survive; provided that all such payments required
to be paid pursuant to Sections 9.3 and 9.5 will be equitably reduced by an
amount and/or a percentage commensurate with the actual economic harm suffered
by CCP as a result of the material breach by Fibrocell, subject to the
limitations set forth in Section 15.1. Any dispute regarding the magnitude of
such payment reduction will be resolved in accordance 47 US-DOCS\106669270.9

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with Section 19.10. Following such termination, CCP shall be required to use
Commercially Reasonable Efforts to Develop and Commercialize the Product in the
Territory. (c) Fibrocell will, without additional consideration, assign to CCP
all of its right, title and interest, if any, in and to any Product-specific
Trademark filed during the course of and pursuant to this Agreement. CCP will
bear, in its sole discretion, the full costs and expense of and be solely
responsible for prosecuting, maintaining, enforcing and defending any
Product-specific Trademark in the Territory after the effective date of
termination. (d) Upon CCP’s request, Fibrocell will transfer to CCP, and CCP
will have the right to use, all materials, results, analyses, reports, websites,
marketing materials, technology, know-how, regulatory filings and other
Information, reasonably required by CCP, in whatever form developed, controlled
or generated as of the effective date of such termination by or on behalf of
Fibrocell, its Affiliates or licensees with respect to the Product.
Additionally, Fibrocell will grant to CCP any rights of reference or access to
regulatory filings necessary to practice the rights granted to it under this
Section 18.6. All transfers described in this Section 18.6(d) will be at CCP’s
expense. (e) If such termination is pursuant to Section 18.3, Fibrocell will
supply CCP’s or its designee’s requirements of the Product at commercially
reasonable prices until the earlier of CCP’s qualification of alternate supply
sources, or twenty-four (24) months after termination. (f) Surviving Rights.
Except where expressly provided for otherwise in this Agreement, termination of
this Agreement pursuant to Section 18.3 for Fibrocell’s breach will not relieve
the Parties of any liability, including any obligation to make payments
hereunder, which accrued hereunder prior to the effective date of such
termination, nor preclude any Party from pursuing all rights and remedies it may
have hereunder or at law or in equity with respect to any breach of this
Agreement, nor prejudice any Party’s right to obtain performance of any
obligation. In the event of such termination, the Manufacturing and Supply
Agreement, the Quality Agreement, and the following provisions of this Agreement
will survive in addition to others specified in Section 18.7 or otherwise in
this Agreement to survive in the event of termination: Articles 11, and 12 and
Sections 2.1, 2.2, 2.5, 2.6, 5.3, 5.6 (solely to the extent that the effective
date of termination is prior to the transfer of the Initial BLA Approval),
5.8–5.10, 8.2, 9.2–9.9, 13.4, and 18.6. 18.7 General Surviving Obligations. The
rights and obligations set forth in this Agreement will extend beyond the
expiration or termination of this Agreement only to the extent expressly
provided for herein, or to the extent that the survival of such rights or
obligations are necessary to permit their complete fulfillment or discharge. In
the event of expiration or termination of this Agreement for any reason, the
following provisions will survive in addition to others specified in this
Agreement to survive in such event. Additionally, the rights and obligations of
the Parties under Sections 5.9, 18.7, 18.8, 19.1, and 19.9–19.15, and Articles
1, 10, 14, 15, and 16 as of the effective date of expiration or termination date
will survive the termination or expiration of this Agreement. 48
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18.8 Accrued Rights, Surviving Obligations. Termination or expiration of this
Agreement will not relieve either Party from obligations that are expressly
indicated to survive termination or expiration of this Agreement. Except as
otherwise provided for in this Agreement, termination by a Party will not be an
exclusive remedy, and all other remedies will be available to the terminating
Party, in equity and at law. 18.9 Rights in Bankruptcy. All rights and licenses
granted under or pursuant to this Agreement by Fibrocell or CCP are, and will
otherwise be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of right to “intellectual property” as defined under
Section 101 of the United States Bankruptcy Code. The Parties agree that the
Parties, as licensees of such rights under this Agreement, will retain and may
fully exercise all of their rights and elections under the United States
Bankruptcy Code. The Parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against either Party under the
United States Bankruptcy Code, the Party that is not a party to such proceeding
will be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in the non- subject Party’s
possession, will be promptly delivered to it (a) upon any such commencement of a
bankruptcy proceeding upon the non-subject Party’s written request therefor,
unless the Party subject to such proceeding elects to continue to perform all of
its obligations under this Agreement or (b) if not delivered under clause (a)
above, following the rejection of this Agreement by or on behalf of the Party
subject to such proceeding upon written request therefor by the non-subject
Party. 19. MISCELLANEOUS 19.1 Agency. Neither Party is, nor will be deemed to
be, an employee, agent, co-venturer or legal representative of the other Party
for any purpose. Neither Party will be entitled to enter into any contracts in
the name of, or on behalf of the other Party, nor will either Party be entitled
to pledge the credit of the other Party in any way or hold itself out as having
the authority to do so. 19.2 Assignment; Change of Control. (a) Except as
otherwise provided in this Agreement, neither this Agreement nor any interest
hereunder will be assignable by any Party without the prior written consent of
the other Party (which consent will not be unreasonably withheld or delayed);
provided, however, (i) either Party, without such consent, may assign its rights
and delegate its duties hereunder to an Affiliate of such Party without
obtaining such consent, provided that the assigning Party agrees to remain
primarily (and not secondarily or derivatively) liable for the full and timely
performance by such Affiliate of all its obligations hereunder, (ii) either
Party, without such consent, may assign or transfer this Agreement in connection
with a Change of Control, and (iii) either Party, without such consent, may
assign its rights and delegate its duties hereunder to a successor-in-interest
in the sale of all or substantially all of its assets or that portion of its
business to which this Agreements relates; provided that the Licensed
Intellectual Property, Manufacturing and Supply Agreement, Pharmacovigilance
Agreement, and any other agreement that the Parties enter into under this
Agreement are also assigned or transferred to the same Third Party to which this
Agreement is assigned or transferred. 49 US-DOCS\106669270.9

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(b) This Agreement will be binding upon and inure to the successors and
permitted assignees of the Parties and the name of a Party appearing herein will
be deemed to include the names of such Party’s successor’s and permitted assigns
to the extent necessary to carry out the intent of this Agreement. Any
assignment not in accordance with this Section 19.2 will be void. 19.3 Further
Actions. Each Party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate
in order to carry out the purposes and intent of this Agreement. 19.4 Force
Majeure. Neither Party will be liable or responsible to the other Party for loss
or damages, nor will it have any right to terminate this Agreement for any
default or delay attributable to any event beyond its reasonable control and
without its fault or negligence, including but not limited to acts of God, acts
of government (including injunctions), fire, flood, earthquake, strike, lockout,
labor dispute, breakdown of plant, shortage of critical equipment, loss or
unavailability of manufacturing facilities or material, casualty or accident,
civil commotion, acts of public enemies, acts of terrorism or threat of
terrorist acts, blockage or embargo and the like (a “Force Majeure Event”);
provided, however, that in each such case the Party affected will use reasonable
efforts to avoid such occurrence and to remedy it promptly. The Party affected
will give prompt notice of any such cause to the other Party. The Party giving
such notice will thereupon be excused from such of its obligations hereunder as
it is thereby disabled from performing for so long as it is so disabled and for
sixty (60) days thereafter and the Party receiving notice will be similarly
excused from its respective obligations which it is thereby disabled from
performing; provided, however, that such affected Party commences and continues
to take reasonable and diligent actions to cure such cause. Notwithstanding the
foregoing, nothing in this Section 19.4 will excuse or suspend the obligation to
make any payment due hereunder in the manner and at the time provided. 19.5
Notices. All notices and other communications hereunder will be in writing and
will be deemed given if delivered personally or by facsimile transmission
(receipt verified), mailed by registered or certified mail (return receipt
requested), postage prepaid, or sent by express courier service, to the Parties
at the following addresses (or at such other address for a Party as will be
specified by like notice; provided that notices of a change of address will be
effective only upon receipt thereof): If to CCP, addressed to: Castle Creek
Pharmaceuticals, LLC 6 Century Blvd. Parsippany, New Jersey 07054 Attention:
Greg Wujek If to Fibrocell, addressed to: Fibrocell Science, Inc. 405 Eagleview
Boulevard Exton, PA 19341 50 US-DOCS\106669270.9

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Attn: Chief Executive Officer 19.6 Amendment. No amendment, modification or
supplement of any provision of this Agreement will be valid or effective unless
made in writing and signed by a duly authorized officer of each Party. 19.7
Waiver. No provision of this Agreement will be waived by any act, omission or
knowledge of a Party or its agents or employees except by an instrument in
writing expressly waiving such provision and signed by a duly authorized officer
of the waiving Party. 19.8 Counterparts. This Agreement may be executed in
counterparts, and each such counterpart hereof will be deemed to be an original
instrument, but all such counterparts together will constitute but one
agreement. Delivery of an executed counterpart of a signature page of this
Agreement by PDF, facsimile or other electronic transmission will be effective
as delivery of a manually executed original counterpart of this Agreement. 19.9
Construction. The descriptive headings of this Agreement are for convenience
only, and will be of no force or effect in construing or interpreting any of the
provisions of this Agreement. Except where the context otherwise requires,
wherever used the singular will include the plural, the plural the singular, the
use of any gender will be applicable to all genders. The terms “including” and
“inclusive of” will mean “including without limitation.” The language of this
Agreement will be deemed to be the language mutually chosen by the Parties and
no rule of strict construction will be applied against either Party. 19.10
Governing Law. This Agreement will be governed by and interpreted in accordance
with the substantive laws of the State of New York, U.S.A. without regard to its
or any other jurisdiction’s laws, rules or principles that would result in the
application of the laws of any jurisdiction other than the State of New York.
Any disputes under this Agreement will be brought in the state or federal courts
located in Manhattan or the Southern District of New York, U.S.A. The Parties
irrevocably accept the exclusive jurisdiction of such courts solely and
specifically for the purpose of adjudicating disputes arising out of or in
connection with this Agreement and any other agreement entered into pursuant to
this Agreement or in connection with this Agreement (including matters regarding
the construction, interpretation and enforceability of such agreements), and in
no event will any Party be deemed to have consented to such jurisdiction for any
other purpose. Each Party further agrees that such courts provide a convenient
forum for any such action, and waives any objections or challenges to venue with
respect to such courts. 19.11 Severability. Whenever possible, each provision of
this Agreement will be interpreted in such manner as to be effective and valid
under Applicable Law, but if any provision of this Agreement is held to be
prohibited by or invalid under Applicable Law, such provision will be
ineffective only to the extent of such prohibition or invalidity, without
invalidating the remainder of this Agreement. In the event of such invalidity,
the Parties will seek to agree on an alternative enforceable provision that
preserves the original purpose of this Agreement. 51 US-DOCS\106669270.9

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19.12 Compliance with Applicable Law. Each Party will comply with all Applicable
Law in performing its obligations and exercising its rights hereunder. Nothing
in this Agreement will be deemed to permit either Party to export, re-export or
otherwise transfer any Information transferred hereunder or Product manufactured
therefrom without complying with Applicable Law. 19.13 Entire Agreement of the
Parties. This Agreement and the Exhibits attached hereto, and the Manufacturing
and Supply Agreement, constitute and contain the complete, final and exclusive
understanding and agreement of the Parties, and cancel and supersede any and all
prior or contemporaneous negotiations, correspondence, understandings and
agreements, whether oral or written, between the Parties respecting the subject
matter of this Agreement (including the Confidential Disclosure Agreement), and
neither Party will be liable or bound to any other Party in any manner by any
representations, warranties, covenants, or agreements except as specifically set
forth herein or therein. Nothing in this Agreement, express or implied, is
intended to confer upon any Party, other than the Parties and their respective
successors and assigns, any rights, remedies, obligations, or liabilities under
or by reason of this Agreement, except as expressly provided herein. To the
extent that anything set forth in an exhibit attached hereto conflicts with the
terms of this Agreement, the terms of this Agreement will control. 19.14
Performance by Affiliates. (a) Fibrocell recognizes that CCP may perform some or
all of its obligations under this Agreement through Affiliates; provided,
however, that CCP will remain responsible for the performance by its Affiliates
and will cause its Affiliates to comply with the provisions of this Agreement in
connection with such performance. (b) CCP recognizes that Fibrocell may perform
some or all of its obligations under this Agreement through Affiliates;
provided, however, that Fibrocell will remain responsible for the performance of
its Affiliates and will cause its Affiliates to comply with the provisions of
this Agreement in connection with such performance. 19.15 Non-Solicitation.
While the Parties are performing research, Development and Commercialization
activities under this Agreement and for a period of two (2) years thereafter,
neither Party will, without the express written consent of the other Party,
recruit, solicit or induce any employee of the other Party to terminate his or
her employment with such other Party. The foregoing provision will not, however,
restrict either Party or its Affiliates from advertising employment
opportunities in any manner that does not directly target the other Party or its
Affiliates or from hiring any persons who respond to such generalized public
advertisements. [REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK] 52
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of
the Effective Date by their duly authorized representatives as set forth below:
CASTLE CREEK PHARMACEUTICALS, LLC By: /s/ Gregory F. Wujek Name: Gregory F.
Wujek Title: Chief Executive Officer FIBROCELL SCIENCE, INC. By: /s/ John M.
Maslowski Name: John M. Maslowski Title: President and Chief Executive Officer
53 US-DOCS\106669270.9

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EXHIBIT 1.41 FIBROCELL KNOW-HOW [**] US-DOCS\106669270.9

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EXHIBIT 1.42 FIBROCELL PATENT RIGHTS [**] US-DOCS\106669270.9

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EXHIBIT 1.45 FULLY BURDENED MANUFACTURING COSTS [**] US-DOCS\106669270.9

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EXHIBIT 4.2(a)(i) DEVELOPMENT PLAN [**] US-DOCS\106669270.9

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EXHIBIT 4.2(a)(ii) DEVELOPMENT BUDGET [**] US-DOCS\106669270.9

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EXHIBIT 4.5(a) APPROVED SUBCONTRACTORS [**] US-DOCS\106669270.9

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