Document:

ex105castlecreekfibrocel

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             US-DOCS\106669270.9  

 

                                                                                                                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            US-DOCS\106669270.9  

 

                            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                                        ii           US-DOCS\106669270.9  

 

                            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                                        iii           US-DOCS\106669270.9  

 

                            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                                                  iv           US-DOCS\106669270.9  

 

                                                                                                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” has the meaning set forth in Section 11.9.              US-DOCS\106669270.9  

 

                                                                                             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.                                        2           US-DOCS\106669270.9  

 

                                                                                             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  

 

                                                                                 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  

 

                                                                                 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  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                 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  

 

                                                                                             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  

 

                                                                                             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  

 

                                                                                                   (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  

 

                                                                                 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  

 

                                                                                             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  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                             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                                        15           US-DOCS\106669270.9  

 

                                                                                 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  

 

                                                                                 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 the Development of                                        17           US-DOCS\106669270.9  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                                   (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  

 

                                                                                 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  

 

                                                                                             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  

 

                                                                                 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  

 

                                                                                             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  

 

                                                                                                   (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           US-DOCS\106669270.9  

 

                                                                                             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           US-DOCS\106669270.9  

 

                                                                                                       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  

 

                                                                                 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  

 

                                                                                             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  

 

                                                                                 (“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  

 

                                                                                 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  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                 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  

 

                                                                                             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  

 

                                                                                       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  

 

                                                                                                   (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           US-DOCS\106669270.9  

 

                                                                                 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  

 

                                                                                 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  

 

                                                                                                   (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  

 

                                                                                                   (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  

 

                                                                                 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  

 

                                                                                                   (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  

 

                                                                                 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  

 

                                                                                 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  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                 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  

 

                                                                                                   (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  

 

                                                                                 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  

 

                                                                                 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           US-DOCS\106669270.9  

 

                                                                                             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  

 

                                                                                                   (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  

 

                                                                                             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  

 

                                                                                             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           US-DOCS\106669270.9  

 

                                                                                       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  

 

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

 

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

 

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

 

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

 

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

 

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

FOURTH WAIVER AND AMENDMENT

This FOURTH WAIVER AND AMENDMENT (this “Waiver”), dated as of August 8, 2019, is entered into among Gain Capital Holdings, Inc., a Delaware corporation (the “Borrower”), certain affiliates of the Borrower named in the signature pages hereto (the “Subsidiary Guarantors”), the Lenders under the Credit Agreement referred to below (the “Lenders”) and Barclays Bank PLC, as administrative agent (in such capacity the “Administrative Agent”) and as collateral agent (in such capacity, the “Collateral Agent”) for the Lenders. 
WHEREAS, reference is made to the Credit Agreement dated as of August 2, 2017, by and among the Borrower, each of the Lenders that is a party thereto from time to time, the Administrative Agent and the Collateral Agent (as amended, modified or supplemented from time to time, the “Credit Agreement”);
WHEREAS, pursuant to Section 6.12(b) of the Credit Agreement, the Borrower is not permitted to allow the Consolidated Interest Coverage Ratio as of the end of any fiscal quarter of the Borrower to be less than 5.00 to 1.00, and the failure to do so is a Default under the Credit Agreement and an Event of Default under Section 7.01(e) of the Credit Agreement if such failure shall continue unremedied for a period of 30 or more days after notice thereof by the Administrative Agent to the Borrower (such Default and Event of Default, the “Specified Defaults”);
WHEREAS, the Borrower has requested that, subject to the terms and conditions herein, the Administrative Agent, Collateral Agent and the Lenders waive the Specified Defaults and subject to the satisfaction of the conditions precedent set forth herein, the Administrative Agent, Collateral Agent and the Required Lenders have agreed to waive the Specified Defaults; 
WHEREAS, the Borrower has requested that, subject to the terms and conditions herein, the Administrative Agent, Collateral Agent and the Lenders consent to the amendment of the Credit Agreement as of the Effective Date (defined below) as set forth herein; and
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
SECTION 1.  Definitions.  All capitalized terms used, but not otherwise defined, herein, including in the introductory and recital paragraphs above, shall have the meanings assigned thereto in Section 1.01 of the Credit Agreement.  The rules of interpretation contained in Sections 1.02 and 1.03 of the Credit Agreement shall apply to this Waiver as if set forth herein. 
SECTION 2.  Waiver of Specified Defaults.  Subject to the satisfaction of all of the conditions set forth in Section 3, the Administrative Agent, Collateral Agent and Required Lenders hereby waive the Specified Defaults solely for the Borrower’s fiscal quarter ended as of June 30, 2019.  
SECTION 3. Conditions to Waiver.  This Waiver shall become effective as of the date hereof (the “Effective Date”) only upon the satisfaction of all of the following conditions:
(a) the Borrower, the Subsidiary Guarantors, the Administrative Agent, the Collateral Agent and the Lenders constituting the Required Lenders shall have executed this Waiver, and each such Administrative Agent, Collateral Agent, Subsidiary Guarantor, the Borrower and Lender shall have delivered its executed counterpart to this Waiver; and

(b)the representations and warranties set forth in Section 5 below shall be true and correct in all respects.
SECTION 4.  Amendment to Credit Agreement.  As of the Effective Date, the parties hereby agree that Section 6.12(b) of the Credit Agreement shall be deleted in its entirety and replaced by the following:
“(b)    Consolidated Interest Coverage Ratio.  The Borrower will not permit the Consolidated Interest Coverage Ratio as of the end of any fiscal quarter of the Borrower to be less than 5.00 to 1.00; provided that if as of the end of any fiscal quarter the Consolidated Interest Coverage Ratio is less than the ratio set forth above, then the Borrower shall nevertheless be deemed to be in compliance with this Section 6.12(b) if, for the period until such time that the Consolidated Interest Coverage Ratio is again equal to or greater than the ratio set forth above as of the end of the relevant fiscal quarter (such period being the “Interest Coverage Non-Compliance Period”), at all times (i) the sum of, without duplication, (A) amounts held in the Borrower’s Controlled Accounts, which Controlled Accounts are free and clear of all Liens other than Liens in favor of the Collateral Agent, plus (B) the Borrower’s Consolidated Net Unencumbered Liquid Assets, equals or exceeds $75,000,000, and (ii) the Total Outstandings do not exceed the amounts held in such Controlled Accounts, in the aggregate; provided further that at no time during the Interest Coverage Non-Compliance Period will the Borrower request or be permitted to make any drawings under the Loan.”
SECTION 5.  Representations and Warranties. The Borrower and each Subsidiary Guarantor hereby represent and warrant that as of the Effective Date:
(a)the execution, delivery and performance by the Borrower and each Subsidiary Guarantor of this Waiver has been duly authorized by all necessary corporate or other organizational action, and does not and will not (i) contravene the terms of any of their Organizational Documents, (ii) conflict with or result in any breach or contravention of, or the creation of any Lien under, or require any payment to be made under (A) any Contractual Obligation to which the Borrower or any Subsidiary Guarantor is a party or affecting the Borrower or any Subsidiary Guarantor or the properties of the Borrower or any Subsidiary Guarantor (other than the Lien created by the Loan Documents) or (B) any order, injunction, writ or decree of any Governmental Authority or any arbitral award to which the Borrower or each Subsidiary Guarantor or its property is subject or (iii) violate any Law;

(b)neither the Borrower nor any Subsidiary Guarantor is in default under or with respect to any Contractual Obligation that, either individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect, other than the Specified Defaults (which are hereby waived subject to the satisfaction of all the conditions set forth in Section 3); and

(c)both at the time of and immediately after giving effect to this Waiver, no Default or Event of Default other than the Specified Default (which are hereby waived subject to the satisfaction of all the conditions set forth in Section 3) shall have occurred and be continuing.
SECTION 6.  Miscellaneous. 
(a)The waiver provided in Section 2 hereof shall be applicable solely with respect to those matters expressly provided therein and no other amendments, releases, waivers or consents may be construed or implied;

(b)the Borrower shall promptly pay all reasonable legal fees and expenses incurred by the Administrative Agent in connection with this Waiver in accordance with Section 9.03 of the Credit Agreement;

(c)The parties hereto agree that this Waiver shall constitute a Loan Document;

(d)Except as expressly provided herein, each Loan Document is and shall remain unchanged and in full force and effect and nothing contained in this Waiver shall abrogate, prejudice, diminish or otherwise affect any powers, right, remedies or obligations of any Person arising before the date of this Waiver;   

(e)THIS WAIVER AND ANY CLAIMS, CONTROVERSY, DISPUTE OR CAUSE OF ACTION (WHETHER IN CONTRACT OR TORT OR OTHERWISE) BASED UPON, ARISING OUT OF OR RELATING TO THIS WAIVER SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK;

(f)This Waiver may be executed in counterparts (and by different parties hereto in different counterparts), each of which shall constitute an original, but all of which when taken together shall constitute a single contract. This Waiver constitutes the entire contract among the parties relating to the subject matter hereof and supersedes any and all previous agreements and understandings, oral or written, relating to the subject matter hereof; and 

(g)The provisions of this Waiver shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns permitted under the Credit Agreement.
[Signature Pages Follow]

IN WITNESS WHEREOF, the parties hereto have caused this Waiver to be duly executed and delivered by their proper and duly authorized officers as of the day and year first above written.
GAIN CAPITAL HOLDINGS, INC., as Borrower

By: /s/ Glenn Stevens       
Name: Glenn Stevens 
Title: Chief Executive Officer

GAIN HOLDINGS, LLC, as Subsidiary Guarantor

By: /s/ Glenn Stevens     
Name: Glenn Stevens 
Title: Sole Manager

GLOBAL FUTURES & FOREX, LTD, as Subsidiary Guarantor

By: /s/ Alex Bobinski     
Name: Alex Bobinski 
Title: EVP & Chief Compliance Officer

GFT SECURITIES LLC, as Subsidiary Guarantor
By: GLOBAL FUTURES & FOREX, LTD., its sole member

By: /s/ Alex Bobinski     
Name: Alex Bobinski 
Title: EVP & Chief Compliance Officer

S.L. BRUCE FINANCIAL CORPORATION, as Subsidiary Guarantor

By: /s/ Glenn Stevens     
Name: Glenn Stevens 
Title: Chief Executive Officer

GCAM, LLC, as Subsidiary Guarantor

By: /s/ Glenn Stevens     
Name: Glenn Stevens 
Title: Sole Manager

GAIN CAPITAL HOLDINGS INTERNATIONAL, LLC, as Subsidiary Guarantor

By: /s/ Glenn Stevens 
Name: Glenn Stevens 
Title: Sole Manager

BARCLAYS BANK PLC, as Administrative Agent

By: /s/ Ashley Jay         
Name: Ashley Jay 
Title: Vice President

BARCLAYS BANK PLC, as Collateral Agent

By: /s/ Ashley Jay         
Name: Ashley Jay 
Title: Vice President

BARCLAYS BANK PLC, as Lender

By: /s/ Kevin T. Murphy         
Name: Kevin T. Murphy 
Title: Director

STERLING NATIONAL BANK, as Lender

By: /s/ Mark R. Smith     
Name: Mark R. Smith 
Title: Managing Director

SIGNATURE BANK, as Lender

By: /s/ Richard Ohl     
Name: Richard Ohl 
Title: Sr. Vice President, Sr. Lender

PEAPACK-GLADSTONE BANK, as Lender

By: /s/ Pamela Winski     
Name: Pamela Winski 
Title: Senior Vice President

ny-1705917

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00299-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00299-of-00352.parquet"}]]