Common use of Diligence Clause in Contracts

Diligence. (a) Fibrocell shall use, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. (a) Fibrocell shall useAfter the JSC’s selection of the Lead Product, and shall require its sublicensees to use, Diligent MedCo will use Commercially Reasonable Efforts to develop (i) Develop at least one Licensed Product and Commercialize Fibrocell Products obtain Regulatory Approval of at least one Licensed Product in each Major Market Country and Improved Products. Portions herein identified by [*****] have been omitted pursuant (ii) subject to a request for confidential treatment Section 2.3.2, perform the Development activities under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange CommissionMedCo Development Plan. (b) Without limiting Alnylam will use Commercially Reasonable Efforts to perform the generality Development activities under the Initial Development Plan and, subject to Section 2.3.2, those activities under the MedCo Development Plan which Alnylam has agreed in writing to undertake; provided, however, that except as expressly provided in this Agreement or otherwise agreed to in writing by Alnylam, in no event will Alnylam be required to perform any activities under the Initial Development Plan or the MedCo Development Plan with respect to Licensed Products that would require Alnylam to incur Costs in excess of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy applicable Development Costs Cap, unless paid or payable by MedCo as Extra Early Development Costs. Alnylam will be excused from its obligation to perform its affected Development and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following Manufacturing obligations with respect to Licensed Products under the Transaction Agreements during any period of time with respect to which Alnylam cannot perform such proposed Superior Therapy: obligations to the extent that, (i) within sixty (60) days after Alnylam becomes aware that the performance of such notificationobligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Alnylam, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise Alnylam is not protected by any safe harbor provisions with respect to claims that it would CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. infringe such Patent Rights. The Parties agree to promptly discuss in good faith a mutually agreed resolution to such a situation. If the development plan as directed Parties agree in writing that MedCo will grant Alnylam a license or sublicense under such Patent Rights, then unless otherwise agreed by the JSC; Parties in writing, such Patent Rights will be considered MedCo Patent Rights, and (iii) following approval of the development plan if such Patent Rights are licensed to MedCo or its Affiliate by the JSCa Third Party, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) sublicense shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates the relevant license agreement to MedCo or its Affiliate from such Third Party and any permitted sublicensees such agreement shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5designated a MedCo In-License.

Diligence. (a) Fibrocell shall useAVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries. In addition, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without without limiting the generality of the foregoing, Intrexon AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding the basis for its belief and specifying that such notice (a “Diligence Breach Notice”) is being provided by BioMarin pursuant to this Section 3.3. If a Diligence Breach Notice is provided to AVROBIO, AVROBIO may, from time within a further period of [***] after receipt of such notice, provide a written report to time, notify Fibrocell that it BioMarin to justify why AVROBIO believes it has identified a Superior Therapy, and is not in such case Intrexon shall provide to Fibrocell its then-available information about material breach of such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapydiligence obligation. Fibrocell shall have the following obligations with respect to If no such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed report is provided by AVROBIO by the JSC; and (iii) following approval end of the development plan by the JSCsuch time period, Fibrocell BioMarin shall use Diligent Efforts be permitted to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development planterminate this Agreement pursuant to Section 8.2. If Fibrocell fails to comply with AVROBIO provides a response, the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days Parties shall then conduct an initial meeting within [***] after delivery of such a written report from AVROBIO to discuss in good faith the development plan concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute reach agreement as to whether a proposed project constitutes a Superior Therapy (as with any other dispute or not AVROBIO is in material breach of its obligations under this Agreement) Section 3.3 for an additional [***] after such initial meeting. If after such [***] period following the initial meeting, the Parties cannot reach agreement then, upon request of either Party, the matter shall be subject referred to the dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees procedure outlined under Section 11.3, which procedure shall be attributed required to: (a) determine whether there was, in fact, a material breach by AVROBIO of its diligence obligation, and (b) if it is determined that there was an uncured material breach, specify what additional efforts AVROBIO must undertake to Fibrocell cure such breach, and the time period during which such efforts must be commenced and completed (which time period shall be commercially reasonable). If such procedure determines that there was a material breach of the diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified by the arbitration result (in response to the clause (b) requirement above) by the required relevant dates, then BioMarin may terminate the Agreement pursuant to Section 8.2. All efforts of AVROBIO’s Affiliates, Third Party contractors and sublicensees will be considered efforts of AVROBIO for the purposes purpose of evaluating Fibrocelldetermining AVROBIO’s fulfillment of the compliance with its obligations set forth in under this Section 4.53.3.

Diligence. (a) Fibrocell AquaBounty shall use, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved AquaBounty Products. Portions herein identified Intrexon shall use, and shall require its sublicensees to use, Diligent Efforts in conducting any activities undertaken by [*****] have been omitted pursuant to a request Intrexon in support of any JSC-approved research plan for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange CommissionAquaculture Program. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell AquaBounty that it believes it has identified a Superior TherapyAnimal Product, and in such case Intrexon shall provide to Fibrocell AquaBounty its then-available information about such therapy animal product and reasonable written support for its conclusion that the therapy animal product constitutes a Superior TherapyAnimal Product. Fibrocell AquaBounty shall have the following obligations with respect to such proposed Superior TherapyAnimal Product: (i) within sixty (60) days after such notification, Fibrocell AquaBounty, in conjunction with the members of the JSC, shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell AquaBounty will pursue the Superior Therapy Animal Product (including a proposed budget); (ii) Fibrocell AquaBounty shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell AquaBounty shall use Diligent Efforts to pursue the development of the Superior Therapy Animal Product under the Fibroblast Aquaculture Program in accordance with such development plan. If Fibrocell AquaBounty fails to comply with the foregoing obligations, or if Fibrocell AquaBounty unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior TherapyAnimal Product; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior TherapyAnimal Product, then Intrexon shall have the termination right set forth in Section 10.2(c10.2(b) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.54.4, including any dispute as to whether a proposed project constitutes a Superior Therapy Animal Product (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities of FibrocellAquaBounty’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell AquaBounty for the purposes of evaluating FibrocellAquaBounty’s fulfillment of the obligations set forth in this Section 4.54.4, and the activities of Intrexon’s Affiliates and any permitted sublicensees shall be attributed to Intrexon for the purposes of evaluating Intrexon’s fulfillment of the obligations set forth in this Section 4.4.

Diligence. (a) Fibrocell AbbVie shall use, and shall require its sublicensees to use, Diligent use Commercially Reasonable Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by a Licensed Product [***]; provided that (a) such obligation is expressly conditioned upon Licensor’s and its Affiliates’ performing their respective obligations hereunder, and (b) such obligation shall be delayed or suspended for as long as any failure by Licensee or its Affiliates to perform their respective obligations hereunder persists; [***]. Licensor acknowledges and agrees that, in addition to the foregoing, (a) the Commercialization of Licensed Product may be delayed, suspended or otherwise modified by AbbVie in response to circumstances outside the reasonable control of AbbVie, including force majeure events, (b) AbbVie shall have the right to satisfy its diligence obligations under this Section 4.3 through its Affiliates or Sublicensees, and (c) nothing in this Section 4.3 is intended, or shall be construed, to require AbbVie to Develop or Commercialize a specific Licensed Antibody or Licensed Product. If AbbVie decides to discontinue the development or commercialization of a Licensed Antibody or Licensed Product in favor of another Licensed Antibody or Licensed Product, its obligations under this Section 4.3 shall cease with respect to such initial Licensed Antibody or Licensed Product in favor of such other Licensed Antibody or Licensed Product. If at any time Licensor has a reasonable basis to believe that AbbVie is in material breach of its material obligations under this Section 4.3, then Licensor may so notify AbbVie, specifying the basis for its belief, and the Parties shall meet within [***] have after such notice to discuss in good faith Licensor’s concerns and AbbVie’s Commercialization plans with respect to Licensed Product. *** Certain information in this agreement has been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been and filed separately with the Securities and Exchange Commission. (b) Without limiting . [***] indicates that text has been omitted and is the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval subject of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11confidential treatment request. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. (a) Fibrocell AquaBounty shall use, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products AquaBounty Products. Intrexon shall use, and Improved Productsshall require its sublicensees to use, Diligent Efforts in conducting any activities undertaken by Intrexon in support of any JSC-approved research plan for the Aquaculture Program. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify AquaBounty that it believes it has identified a Superior Animal Product, and in such case Intrexon shall provide to AquaBounty its then-available information about such animal product and reasonable written support for its conclusion that the animal product constitutes a Superior Animal Product. AquaBounty shall have the following obligations with respect to such proposed Superior Animal Product: (i) within sixty (60) days after such notification, AquaBounty, in conjunction with the members of the JSC, shall prepare and deliver to the JSC for review and approval a development plan detailing how AquaBounty will pursue the Superior Animal Product (including a proposed budget); (ii) AquaBounty shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, AquaBounty shall use Diligent Efforts to pursue the development of the Superior Animal Product under the Aquaculture Program in accordance with such development plan. If AquaBounty fails to comply with the foregoing obligations, or if AquaBounty unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Animal Product; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Animal Product, then Intrexon shall have the termination right set forth in Section 10.2(b) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.4, including any dispute as to whether a proposed project constitutes a Superior Animal Product (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities of AquaBounty’s Affiliates and any permitted sublicensees shall be attributed to AquaBounty for the purposes of evaluating AquaBounty’s fulfillment of the obligations set forth in this Section 4.4, and the activities of Intrexon’s Affiliates and any permitted sublicensees shall be attributed to Intrexon for the purposes of evaluating Intrexon’s fulfillment of the obligations set forth in this Section 4.4. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. 3.2.1 EPIZYME shall use Commercially Reasonable Efforts (aitself or through an Affiliate or Sublicensee) Fibrocell shall useto Develop, and shall require its sublicensees to use, Diligent Efforts to develop obtain Regulatory Approval for and Commercialize Fibrocell Products and Improved Products. Portions herein identified by at least [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 in each of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with United States and the Securities and Exchange Commission. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein)Major EU Countries. For clarity, EPIZYME shall not have any dispute arising obligation to use Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for or Commercialize more than [**] in any country outside the United States and the Major EU Countries. 3.2.2 EISAI shall use Commercially Reasonable Efforts (itself or through an Affiliate or Sublicensee) to conduct Japan-Specific Development Activities for, obtain Regulatory Approval for and Commercialize at least [**] in Japan; provided that, if EPIZYME does not conduct such global Development activities (excluding Japan-Specific Development Activities) as are necessary to submit an application for Regulatory Approval for at least [**] in Japan or if EPIZYME does not comply with its obligations under Section 3.3 and the supply agreement(s) contemplated thereby, then EISAI shall, for the duration of EPIZYME’s noncompliance, be excused from its obligations under this 4.5, including any dispute as Section 3.2.2 to whether a proposed project constitutes a Superior Therapy (as with any other dispute the extent the conduct of such global Development activities or such compliance by EPIZYME is reasonably necessary for EISAI to satisfy its obligations under this Agreement) Section 3.2.2. For clarity, EISAI shall be subject not have any obligation to dispute resolution use Commercially Reasonable Efforts to conduct Japan-Specific Development Activities for, obtain Regulatory Approval for or Commercialize, more than [**] in accordance with Article 11Japan. (c) The activities of Fibrocell’s Affiliates and 3.2.3 Subject to the foregoing obligations to use Commercially Reasonable Efforts, neither Party provides any permitted sublicensees shall representation, warranty or guarantee that the Collaboration will be attributed successful or that any particular results will be achieved with respect to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5Collaboration, EZH2, or any Compound, Licensed Compound or Licensed Product hereunder.

Diligence. (a) Fibrocell shall useAfter the JSC's selection of the Lead Product, and shall require its sublicensees to use, Diligent MedCo will use Commercially Reasonable Efforts to develop (i) Develop at least one Licensed Product and Commercialize Fibrocell Products obtain Regulatory Approval of at least one Licensed Product in each Major Market Country and Improved Products. Portions herein identified by [*****] have been omitted pursuant (ii) subject to a request for confidential treatment Section 2.3.2, perform the Development activities under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange CommissionMedCo Development Plan. (b) Without limiting Alnylam will use Commercially Reasonable Efforts to perform the generality Development activities under the Initial Development Plan and, subject to Section 2.3.2, those activities under the MedCo Development Plan which Alnylam has agreed in writing to undertake; provided, however, that except as expressly provided in this Agreement or otherwise agreed to in writing by Alnylam, in no event will Alnylam be required to perform any activities under the Initial Development Plan or the MedCo Development Plan with respect to Licensed Products that would require Alnylam to incur Costs in excess of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy applicable Development Costs Cap, unless paid or payable by MedCo as Extra Early Development Costs. Alnylam will be excused from its obligation to perform its affected Development and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following Manufacturing obligations with respect to Licensed Products under the Transaction Agreements during any period of time with respect to which Alnylam cannot perform such proposed Superior Therapy: obligations to the extent that, (i) within sixty (60) days after Alnylam becomes aware that the performance of such notificationobligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Alnylam, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise Alnylam is not protected by any safe harbor provisions with respect to claims that it would infringe such Patent Rights. The Parties agree to promptly discuss in good faith a mutually agreed resolution to such a situation. If the development plan as directed Parties agree in writing that MedCo will grant Alnylam a license or sublicense under such Patent Rights, then unless otherwise agreed by the JSC; Parties in writing, such Patent Rights will be considered MedCo Patent Rights, and (iii) following approval of the development plan if such Patent Rights are licensed to MedCo or its Affiliate by the JSCa Third Party, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) sublicense shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates the relevant license agreement to MedCo or its Affiliate from such Third Party and any permitted sublicensees such agreement shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5designated a MedCo In-License.

Diligence. (a) Fibrocell shall use3.5.1 In carrying out the Development and in seeking Regulatory Approval, OMP agrees to use such commercially reasonable and diligent efforts as are commensurate with the level of time, effort and funding expended by OMP on other projects at a similar stage of development, with a target market of a similar size, patient population and importance, and as otherwise consistent with its overall business strategy. OMP does not in any way represent or warrant that a Collaboration Compound hereunder shall require its sublicensees be the only compound that OMP will at the same time develop or commercialize for identical or similar therapeutic uses. Without limitation to usethe foregoing, Diligent Efforts non-achievement of the following development milestones within the Time to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by Complete set forth below shall be an objective measure of OMP’s non-performance for the time periods specified: [***] [***] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 OMP shall promptly notify ADDEX upon the accomplishment of each of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commissionforegoing Milestones. (b) Without limiting the generality 3.5.2 If, notwithstanding OMP’s exercise of the foregoingefforts recited in Article 3.5.1 above, Intrexon may, from time OMP is unable to time, notify Fibrocell meet or anticipates that it believes it has identified may not be able to make a Superior TherapySelection or to meet any of the Milestones within the Time to Complete set forth above, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell OMP shall have the right to request an extension for such Milestone(s), which shall not be unreasonably refused. Without limitation, the following obligations shall be examples of instances in which OMP shall be entitled to such extension: [***], to the extent that [***]. In addition, Parties recognize that OMP may, after discussion with the JDC, need to discontinue the Development of a Collaboration Compound for reasons outside its reasonable control, in which case the following shall apply, depending on the stage of Development: (i) If OMP prior to [***] OMP has initiated [***] of a Collaboration Compound and such Collaboration Compound fails during such studies, for reasons outside of OMP’s reasonable control, then the time periods set forth in Article 3.5.1 above shall be extended for a period [***] (ii) If OMP initiates [***] with respect to a Collaboration Compound and such proposed Superior Therapy: (i) Collaboration Compound fails [***], for reasons outside of OMP’s reasonable control, the time periods specified in Article 3.5.1 above shall be extended for a period [***]; 3.5.3 If the Parties disagree as to whether OMP is entitled to an extension of the time to make a Selection under Article 2.8 or to the Time to Complete as set forth in 3.5.2 above for any Milestone specified in 3.5.1 above, or whether or not OMP is complying with its obligations under 3.5.1 above, then, upon the written request by either Party, such matter shall be resolved in accordance with Article 18. However, notwithstanding any other provision of Article 18 and Appendix C, the mediation procedure of Section 1.1 of Appendix C shall not apply. Moreover the arbitration shall be concluded within sixty (60) [***] calendar days after such notificationthe Panel of Arbitrators has been appointed in accordance with Section 1.2 of Appendix C, Fibrocell and the time periods recited in Appendix C shall prepare be reset accordingly to achieve the [***] day completion date. Subsection (c) of Section 1.2 of Appendix C shall not apply. As circumstances may warrant the Parties will seek arbitrators with appropriate commercial and deliver technical backgrounds to resolve disputes under this Article. 3.5.4 In the JSC for review event that OMP or its Affiliate or Sublicensee in charge of Early Stage Development of a Collaboration Compound fails to make a Selection or achieve the Milestones set forth in Article 3.5.1 within the Times to Complete with respect to [***] with any applicable extensions under Article 3.5.2 and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval any disputes of the development plan by fact having been resolved under Article 3.5.3 and determine that OMP or its Affiliate or Sublicensee did not comply with its obligations under Article 3.5.1, then OMP shall have [***] calendar days to provide a written election which at its sole discretion of the JSCtwo remedies set forth below in Articles 3.6 and 3.7 to offer ADDEX, Fibrocell provided, however, these remedies shall use Diligent Efforts not be available to pursue ADDEX if [***]. If OMP fails to elect within said [***] days, ADDEX shall have the right to elect which of the two remedies set forth below in Articles 3.6 and 3.7 that ADDEX wishes to pursue. If neither Party elects to elect a remedy, then OMP’s failure of diligence under Article 3.5.1 shall be waived and OMP will have the right to proceed with the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan Collaboration Compound that gave rise to the JSC; failure of diligence or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (replacement thereto subject to the limitation set forth therein)diligence requirements of Article 3.5. For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) The remedies provided by Article 3.6 and Article 3.7 [***] and such failure [***] 3.5.5 [***] OMP’s diligence obligation shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.[***]

Diligence. (a) Fibrocell AlgoRx shall useexercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the AlgoRx Named Products in order to retain such product as an AlgoRx Named Product, and shall require expend (or its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [licensee shall expend) at least **** per **] have been omitted pursuant ** in research and development to support such efforts per AlgoRx Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Named Product in a closely-related class of AlgoRx Named Products that are established by agreement of the Parties as provided at the end of Section 2.3(a). PRL shall exercise commercially reasonable efforts to develop, or to license to a request for confidential treatment under Rule 24b-2 Third Party to develop, each of the Securities Exchange Act PowderJect Named Products in order to retain such product as an PowderJect Named Product, and shall expend (or its licensee shall expend) at least **** per **** in research and development to support such efforts per PowderJect Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Named Product in a closely-related class of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without limiting the generality PowderJect Named Products that are established by agreement of the foregoingParties as provided at the end of Section 2.3(b). Twelve (12) months after designation of an Selectable Product as either an AlgoRx Named Product or a PowderJect Named Product (and once every subsequent twelve-month period), Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon the designating Party shall provide to Fibrocell the other Party an annual summary of its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations diligence with respect to such proposed Superior Therapy: product. If, with respect to a particular Named Product, the designating Party (ior its Affiliate or sublicensee) within sixty (60has, during the applicable twelve-month period, expended the required amount of development funds, then the designating Party shall be deemed to have satisfied its diligence obligations under this Section 2.4(c) days after with respect to such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development planNamed Product. If Fibrocell fails to comply with the foregoing obligationsdesignating Party (or its Affiliate or sublicensee) has not expended the required amount of development funding on, or if Fibrocell unreasonably exercises its casting vote at the JSC is not otherwise continuing to either (x) prevent the approval of use commercially reasonable efforts to develop, a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapyparticular Named Product, then Intrexon such Named Product shall cease to be the designating Party's Named Product, and the non-designating Party shall have the termination right set forth in Section 10.2(c) (subject co-exclusive rights to pursue such product and shall also be free to designate such product as its own Named Product under the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities above terms of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.52.3.

Diligence. (a) Fibrocell ArQule shall useuse Reasonable Diligence in proceeding with the development of the Optioned Compounds in the Field, except that ArQule's obligation hereunder shall expire upon the earlier of the Option Exercise, if any, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 the expiration of the Securities Exchange Act of 1934Option Term. From and after the Option Exercise, as amended. A complete copy of this document has been filed separately Roche shall use Reasonable Diligence in proceeding with the Securities development of at least one Product, including obtaining required Regulatory Approvals, and Exchange Commissionmanufacturing, marketing and selling such Product or Products in the Major Market Countries. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it If either Party believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion good faith that the therapy constitutes a Superior Therapyother Party has failed to utilize Reasonable Diligence as required by this Section 3.1, then such Party may give the other Party written notice of such alleged failure, identifying the Optioned Compounds or Product (if known) and giving specific detailed reasons supporting such allegation. Fibrocell Within * following the other Party's receipt of any such notice ("Response Period"), the other Party shall have the following obligations right to provide such Party with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notificationa written response specifying, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing in reasonable detail, how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan it has used Reasonable Diligence as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11required hereby. (c) The activities If the other Party has failed to provide within the Response Period a written response, in reasonable detail, indicating the manner in which it is in compliance with its obligations under this Section 3.1 or in which it has remedied any breach thereof, or the other Party has failed within the Response Period to remedy any breach of Fibrocell’s Affiliates and its obligations under this Section 3.1, then the Party alleging failure of Reasonable Diligence shall have the right to terminate this Agreement upon written notice to such Party effective as of the end of the Response Period, in addition to any permitted sublicensees other rights it may have under this Agreement as a result of such breach. (d) In the event of a dispute between the Parties with respect to whether either Party has complied with its obligation under this Section 3.1, then such dispute shall be attributed to Fibrocell for the purposes resolved in accordance with Article 18. The consequences of evaluating Fibrocell’s fulfillment of the obligations any termination under this Section 3.1 are set forth in Section 17.6. (e) Roche acknowledges that ArQule may subcontract, and is permitted to subcontract, ArQule's obligations under this Section 4.5Agreement. However, prior to entering into any material subcontracts, ArQule shall first solicit the advice and input of Roche with respect to such subcontract.

Diligence. If during the term of this Agreement COMPANY and its sublicensees cease to market, promote and sell (other than for safety or other regulatory reasons) all of the Licensed Products previously Registered in all of the Major Market Countries for a period of [ * ], then within [ * ] of ROYALTY PHARMA’s written request, COMPANY [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. shall meet with ROYALTY PHARMA to discuss COMPANY’s future commercialization plans for such Licensed Products. Notwithstanding the foregoing, the [ * ] period described in the preceding sentence shall be extended for so long as COMPANY experiences a suspension of manufacturing of Licensed Product for reasons not within its control and COMPANY is using reasonable commercial efforts to have such manufacturing resumed. If within [ * ] of COMPANY’s receipt of such written request, COMPANY shall have failed to provide reasonable evidence to ROYALTY PHARMA of COMPANY’s marketing and sale of any one or more Licensed Products in any one or more of the Major Market Countries, then effective upon written notice from ROYALTY PHARMA: (a) Fibrocell all of the rights and obligations of COMPANY hereunder (including all obligations to LICENSOR) shall use, be immediately and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant irrevocably transferred to a request new licensee designated by ROYALTY PHARMA (“New Licensee”), whose identity is subject to the prior written consent of LICENSOR, which consent shall not be unreasonably withheld or delayed, with New Licensee becoming “COMPANY” hereunder for confidential treatment under Rule 24b-2 of such purposes, provided that COMPANY shall not be required to transfer any rights to intellectual property other than the Securities Exchange Act of 1934, Licensed Patents except as amended. A complete copy of provided below in this document has been filed separately with the Securities and Exchange Commission.Section 10.5; (b) Without limiting COMPANY shall no longer be a party to this Agreement and shall have no rights or obligations hereunder, other than as provided pursuant to this Section 10.5 and those accrued prior to delivery of such written notice; (c) LICENSOR shall not make or otherwise advance any claim or other position that diminishes or otherwise impairs the generality rights afforded ROYALTY PHARMA by the preceding Sections 10.5(a) and 10.5(b); and (d) following the transfer in subsection (a), New Licensee’s right to assign the rights of COMPANY hereunder shall be subject to the prior written consent of LICENSOR, which consent shall not be unreasonably withheld or delayed. In the event of any transfer of the foregoinglicense and rights pursuant to this Section 10.5, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, ROYALTY PHARMA and COMPANY shall negotiate in such case Intrexon shall provide to Fibrocell its then-available information about such therapy good faith and agree upon commercially reasonable written support terms for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notificationthe transfer of technology, Fibrocell shall prepare intellectual property rights, including patents and deliver to the JSC for review trademarks, manufacturing contracts and approval a development plan detailing how Fibrocell will pursue the Superior Therapy rights, regulatory filings and approvals (including a proposed budgetNDAs and drug master files), and such other matters as ROYALTY PHARMA and COMPANY agree are necessary and appropriate to transfer to New Licensee to enable New Licensee and its Affiliates and sublicensees to manufacture, have manufactured, use, sell, offer for sale, market, import and promote Licensed Compounds; (ii) Fibrocell [ * ]; and other relevant factors); (iii) [ * ] to the extent that ROYALTY PHARMA and COMPANY agree that COMPANY shall revise the development plan as directed by the JSC[ * ]; and (iiiiv) following approval of [ * ] (to the development plan extent those matters are not already addressed by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either preceding clause (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth thereinii)). For clarityNotwithstanding the foregoing, [ * ] pursuant to this Section 10.5). [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. ROYALTY PHARMA shall promptly reimburse LICENSOR for all reasonable expenses LICENSOR incurs in connection with any dispute assignments described in Sections 10.5(a) and (d). The foregoing provisions of this Section 10.5 are without prejudice to any other rights or remedies ROYALTY PHARMA or LICENSOR may have arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any Agreement or other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11applicable law. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. Subject to Chiesi’s compliance with Section 5.3, Protalix will use Commercially Reasonable Efforts to carry out the Development Plan in order to Develop the Licensed Product in the Field in the Territory (a) Fibrocell shall usesubject to Section 3.2(d)). Subject to Protalix’s compliance with Section 3.6(c), Chiesi will use Commercially Reasonable Efforts to seek as soon as reasonably practicable Regulatory Approval for the Licensed Product in the Field in the Territory. Chiesi will use Commercially Reasonable Efforts to Launch and Commercialize the Licensed Product in the Territory, promptly following such Regulatory Approval of the Licensed Product in the Field. The previous sentence above notwithstanding, if, prior to the submission of the NDA seeking Regulatory Approval for the Licensed Product in the Territory, Chiesi notifies Protalix in writing of any specific Competing Product Patents that, in Chiesi’s good faith evaluation may pose risks in relation to Chiesi’s Launch of the Licensed Product, and shall require its sublicensees if, within ten (10) Business Days of receiving such written notice, Protalix provides Chiesi with written notice that Protalix desires to use, Diligent Efforts jointly engage a law firm to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of advise regarding the Securities Exchange Act of 1934, as amended. A complete copy of same in accordance with this document has been filed separately with the Securities and Exchange Commission. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior TherapySection 3.5: (i) Protalix and Chiesi promptly shall jointly engage a law firm of reputable stature and experienced in patent matters related to biologic products and approved by both Parties (such approval not to be unreasonably withheld, conditioned or delayed) to provide its legal opinion as to whether a judge or jury would be highly unlikely to conclude, in exercising its discretion in applying the applicable Laws to the facts, that the Launch of the Licensed Product in the Field in the Territory would infringe the Third Party Patent(s) or Patent Application(s) (which the law firm concludes could reasonably be issued within eighteen (18) months of the anticipated Regulatory Approval for the Licensed Product in the Territory) specified in such notice (with each Party paying an equal share of all costs, fees and expenses to be paid to such law firm therefor, and the law firm shall be instructed to try to provide such opinion within sixty (60) days after such notificationof the engagement), Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise in the development plan as directed by the JSC; and (iii) following approval event that such law firm does not, prior to Regulatory Approval of the development plan by Licensed Product in the JSCField in the Territory, Fibrocell shall use Diligent Efforts render a legal opinion that a judge or jury would be highly unlikely to pursue conclude, in exercising its discretion in applying the development applicable Laws to the facts, that the Launch of the Superior Therapy under Licensed Product in the Fibroblast Program Field in the Territory would infringe the Third Party Patent(s) or Patent Application(s) (which the law firm concludes could reasonably be issued within eighteen (18) months of the anticipated Regulatory Approval for the Licensed Product in the Territory) specified in such notice (including where Protalix fails to provide written notice that it desires to jointly engage a law firm in accordance with this Section 3.5), Chiesi will have the ultimate decision-making authority on the timing of the Launch (subject to Section 12.1(f)), based upon Chiesi’s good faith evaluation of any risks associated with such development planspecified Third Party Patents or Patent Applications. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either The Parties acknowledge and agree that (x) prevent all communications with such law firm with respect to the approval foregoing, such law firm’s related work product, and such opinion (the “Privileged Materials”) shall be privileged and confidential and shall not be disclosed to anyone other than the Parties, except that a Party may disclose the Privileged Materials in confidence to a court, tribunal or other authority of a development plan competent jurisdiction if reasonably necessary to enforce its rights under this Agreement; provided that such Party seeks the highest level of confidential treatment for a Superior Therapy; such Privileged Materials and limits the disclosure to the portion of the Privileged Material reasonably necessary to enforce its rights under this Agreement, and (y) delay such approval more than sixty (60) days after delivery prior to engaging the law firm, the Parties shall enter into a reasonable and customary joint defense agreement or common interest agreement; provided that, for the avoidance of doubt, the failure of the development plan Parties to the JSC; enter into such a joint defense agreement or (z) approve a development plan that is insufficient in view common interest agreement shall not be construed or deemed as evidence of any waiver by any of the nature and magnitude Parties of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth any applicable legal privilege or any of its or their rights in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject , or as an indication that an applicable legal privilege has not attached to dispute resolution in accordance with Article 11any Privileged Materials. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. (a) Fibrocell ZENYAKU shall useuse Commercially Reasonable Efforts to develop, seek Regulatory Approval for and commercialize the Product for the Initial Indication and for SLE in the ZENYAKU Territory; provided that ANTHERA shall be responsible for activities within the Joint Development Plan with respect to clinical trials for the Initial Indication and CHABLIS-SC2 Study contained therein, as well as to conduct the CHABLIS-SC1 Study. It is understood and agreed that ZENYAKU’s regulatory package to seek approval for the Initial Indication and SLE will include, and shall require its sublicensees approval in the ZENYAKU Territory for the Initial Indication and SLE will depend upon, respectively (x) the data for the Initial Indication that will be generated by ANTHERA for this indication under the Joint Development Plan, and (y) the data for SLE that will be generated by ANTHERA in conducting the CHABLIS-SC1 Study and the CHABLIS-SC2 Study in the Joint Development Plan. Accordingly, if ANTHERA fails to useconduct the activities within the Joint Development Plan necessary to generate the data for the Initial Indication, Diligent Efforts or fails to conduct the CHABLIS-SC1 Study or the activities within the Joint Development Plan necessary to generate the data for SLE, then ZENYAKU’s ability to develop and Commercialize Fibrocell Products seek Regulatory Approval in the ZENYAKU Territory may be harmed and Improved ProductsZENYAKU shall not to be deemed in breach of its diligence obligation set forth in the first sentence of this Section. Portions herein identified *** Confidential Information, indicated by [*****] have ], has been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of from this document has been filing and filed separately with the Securities and Exchange Commission. (b) Without limiting Should ZENYAKU choose to develop the generality Product for any other Indication, it must so notify ANTHERA in writing (e.g., through the process described above for updating the ZENYAKU Development Plan). If ANTHERA has any concerns, the parties shall convene a meeting of the foregoing, Intrexon may, from time JDC to time, notify Fibrocell that it believes it has identified a Superior Therapydiscuss the matter, and ZENYAKU shall reasonably consider ANTHERA’s concerns. ZENYAKU shall not have any obligation to devote Commercially Reasonable Efforts for any Indication other than the Initial Indication (express or implied, at law or in such case Intrexon shall provide to Fibrocell equity), and its then-available information about such therapy and reasonable written support Commercially Reasonable Efforts obligations for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (Initial Indication are subject to the limitation set forth thereinlimitations and conditions above in Section 4.5(a). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. (a) Fibrocell After the Effective Date, as between the Parties, Newsoara shall usebe solely responsible for all aspects of the Development of the Licensed Viruses and the Licensed Products in the Field in the Territory at Newsoara’s own cost and expense. Newsoara shall use Commercially Reasonable Efforts to Develop, and shall require its sublicensees to use, Diligent Efforts to develop obtain and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request maintain Regulatory Approvals for confidential treatment under Rule 24b-2 of Licensed Product in the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with Field in the Securities and Exchange CommissionTerritory. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior TherapyNewsoara shall: (i) [***] within sixty (60) days [***] months after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget)[***]; (ii) Fibrocell shall revise the development plan as directed by the JSC[***] within [***] months after [***]; and (iii) following approval maintain active clinical Development for the Licensed Products through submission of the development plan by first Drug Approval Application to NMPA. For the JSCpurpose of clause (iii), Fibrocell “active clinical Development” shall use Diligent Efforts require Newsoara to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan[***] during any consecutive [***] period [***]. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature The deadlines and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right time period set forth in Section 10.2(cclauses (i), (ii) and (subject iii) may be extended to the limitation extent that Newsoara’s inability to [***] is caused by delay outside of Newsoara’s reasonable control, including [***]; provided that Newsoara shall immediately notify Genelux of any such delay, and shall promptly undertake and continue all Commercially Reasonable Efforts necessary to [***] as soon as reasonably practicable. Failure to meet the deadlines set forth therein). For clarity, any dispute arising under above due to delay outside Newsoara’s reasonable control shall not be considered a breach of this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11Agreement by itself. (c) The activities Subject to the terms and conditions of Fibrocellthis Agreement, Newsoara may elect, in its sole discretion, at any time during the Term of this Agreement, to Develop any Derived Molecule and Derived Product in the Field in the Territory at Newsoara’s Affiliates own cost and expense. Newsoara shall have no diligence obligations with respect to any permitted sublicensees Derived Molecules or Derived Product, but any decision or efforts by Newsoara to Develop or Exploit any Derived Molecules and Derived Products must not reduce the efforts, resources, and other commitments devoted by Newsoara to the Development and Commercialization of Olvi-Vec in the Field in the Territory, and Newsoara may not prioritize the Development or Commercialization of any Derived Molecule or Derived Product over the Development and Commercialization of Olvi-Vec. (d) If Newsoara conducts clinical Development of other Oncolytic Virus product, in order to ensure that Newsoara prioritizes the Development of Olvi-Vec over other Oncolytic Virus products, Newsoara shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5ensure that (i) [***]; (ii) [***]; and (iii) Newsoara shall [***].

Diligence. (a) Fibrocell Calithera will use Commercially Reasonable Efforts to Develop and to obtain Marketing Approvals for at least one Licensed Product in the Field [*], as soon as reasonably practicable. Calithera shall useprovide notice to Symbioscience if at any time during the Term it decides to abandon the further Development and Commercialization of all Licensed Compounds and Licensed Products. Any such notice shall constitute notice by Calithera to terminate, and will result in termination of, the Agreement pursuant to Section 10.3. In the event that Symbioscience believes Calithera is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.4, then Symbioscience may so notify Calithera in writing, which notice shall require provide available details regarding the basis for its sublicensees belief and specifying that such notice (a “Diligence Breach Notice”) is being provided by Symbioscience pursuant to usethis Section 3.4. If a Diligence Breach Notice is provided to Calithera, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by Calithera may, within a further period of [****] days after its receipt of such notice, provide a written report to Symbioscience to justify why Calithera believes it is not in such material breach of such diligence obligation. If no such report is provided by Calithera by the end of such time period, Symbioscience shall be permitted to terminate this Agreement pursuant to Section 9.3. If Calithera provides a response, the Parties shall then conduct an initial meeting within [*] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of such a written report from Calithera to discuss in good faith the development plan concerns raised by Symbioscience and shall conduct such additional meetings as are reasonably necessary to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute reach agreement as to whether a proposed project constitutes a Superior Therapy (as with any other dispute or not Calithera is in material breach of its obligations under this Agreement) Section 3.4 for an additional [*] days after such initial meeting. If after such [*] day period following the initial meeting, the Parties cannot reach agreement then, upon request of either Party, the matter shall be subject referred to the dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees procedure outlined under Section 13.3, which procedure shall be attributed required to: (a) determine whether there was, in fact, a material breach by Calithera of its diligence obligation, and (b) if it is determined that there was an uncured material breach, specify what additional efforts Calithera must undertake to Fibrocell cure such breach, and the time period during which such efforts must be commenced and completed (which time period shall be commercially reasonable). If such procedure determines that there was a material breach of the diligence obligation hereunder, and Calithera does not commence or complete the cure efforts specified by the arbitration result (in response to the clause (b) requirement above) by the required relevant dates, then Symbioscience may terminate the Agreement pursuant to Section 9.3. All efforts of Calithera’s Affiliates, Third Party contractors and Sublicensees will be considered efforts of Calithera for the purposes purpose of evaluating Fibrocelldetermining Calithera’s fulfillment of the compliance with its obligations set forth in under this Section 4.53.4.

Diligence. (a) Fibrocell AlgoRx shall useexercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the AlgoRx Named Products in order to retain such product as an AlgoRx Named Product, and shall require expend (or its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [licensee shall expend) at least *****] have been omitted pursuant ** per **** in research and development to support such efforts per AlgoRx Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Named Product in a closely-related class of AlgoRx Named Products that are established by agreement of the Parties as provided at the end of Section 2.3(a). PRL shall exercise commercially reasonable efforts to develop, or to license to a request for confidential treatment under Rule 24b-2 Third Party to develop, each of the Securities Exchange Act PowderJect Named Products in order to retain such product as an PowderJect Named Product, and shall expend (or its licensee shall expend) at least ******* per **** in research and development to support such efforts per PowderJect Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Named Product in a closely-related class of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without limiting the generality PowderJect Named Products that are established by agreement of the foregoingParties as provided at the end of Section 2.3(b). Twelve (12) months after designation of an Selectable Product as either an AlgoRx Named Product or a PowderJect Named Product (and once every subsequent twelve-month period), Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon the designating Party shall provide to Fibrocell the other Party an annual summary of its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell shall have the following obligations diligence with respect to such proposed Superior Therapy: product. If, with respect to a particular Named Product, the designating Party (ior its Affiliate or sublicensee) within sixty (60has, during the applicable twelve-month period, expended the required amount of development funds, then the designating Party shall be deemed to have satisfied its diligence obligations under this Section 2.4(c) days after with respect to such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell shall use Diligent Efforts to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development planNamed Product. If Fibrocell fails to comply with the foregoing obligationsdesignating Party (or its Affiliate or sublicensee) has not expended the required amount of development funding on, or if Fibrocell unreasonably exercises its casting vote at the JSC is not otherwise continuing to either (x) prevent the approval of use commercially reasonable efforts to develop, a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapyparticular Named Product, then Intrexon such Named Product shall cease to be the designating Party's Named Product, and the non-designating Party shall have the termination right set forth in Section 10.2(c) (subject co-exclusive rights to pursue such product and shall also be free to designate such product as its own Named Product under the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities above terms of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.52.3.

Diligence. (a) Fibrocell 7.1 The Parties acknowledge that failure to use their respective Diligent Efforts in Development and/or Commercialization of a Collaboration Product will diminish the value of this Agreement to both HGS and GSK. Accordingly, HGS and GSK shall use, and shall require each use its sublicensees to use, respective Diligent Efforts to develop perform the obligations assigned to each Party under the Agreement. 7.2 Each Party shall perform, or cause to be performed, any and Commercialize Fibrocell Products all of its obligations as set forth in this Agreement, including, without limitation, those obligations identified in this Article 7, in good scientific manner and Improved Productsin compliance in all material respects with all applicable laws. 7.3 The Parties will work together, through either the JDC, the RJMC, the GMJC or the JMC, as applicable, to reduce costs associated with the Development, Manufacturing, and Commercialization of a Collaboration Product, where possible, consistent with the terms of this Agreement and applicable Law, in order to maximize Net Profits. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 of the Securities Exchange Act of UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 7.4 Should a Party materially fail to apply its respective Diligent Efforts as amended. A complete copy required under this Section 7, then such failure to use Diligent Efforts shall be considered a material breach of this document has been filed separately with Agreement and the Securities and Exchange Commission. (b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Fibrocell that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Fibrocell its thennon-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell breaching Party shall have the following obligations with respect right to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver terminate the rights granted to the JSC for review and approval breaching Party under Article 2 in accordance with Article 12. 7.5 In addition to other diligence requirements in this Article 7, a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Fibrocell Party shall use Diligent Efforts to pursue Commercialize the development Collaboration Product in [***] to the extent the Collaboration Product is being Commercialized by both Parties in such country. Should a Party not exercise its obligations under this Section 7.5 with respect to [***], the other Party shall have the right to terminate the other Party’s rights with respect to the Collaboration Product under this Agreement in that respective country or in the case of the Superior Therapy under country in the Fibroblast Program European Union, that Region, in accordance with such development planSection 12.3. If Fibrocell fails to comply with the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.ARTICLE 8 REGULATORY MATTERS

Diligence. 3.1 Licensee shall use its commercially reasonable efforts consistent with other opportunities of similar scope to establish the commercial feasibility of bringing Pyridorin Products and AGE-Inhibitor Products (ato the extent Licensee receives rights under the AGE-Inhibitor Patent Rights hereunder) Fibrocell shall into commercial sale and use, and upon establishing such feasibility, to bring such products into commercial sale and use as quickly as is reasonably possible. This Agreement and the licenses granted herein shall require be subject to, and Licensee shall comply with, all applicable terms, requirements, and obligations of the KUMCRI Agreement and USC Agreement, including but not limited to the diligence requirements included therein. 3.2 As evidence of its sublicensees reasonable efforts to use, Diligent Efforts to develop and Commercialize Fibrocell effect the introduction of Pyridorin Products and Improved AGE-Inhibitor Products. Portions herein identified by [*****] have been omitted pursuant , Licensee agrees to a request for confidential treatment under Rule 24b-2 maintain an active commercialization effort defined as meeting any one of the Securities Exchange Act following criteria: (1) Funding research or product development programs that directly contribute to the commercialization of 1934, as amended. A complete copy the Pyridorin Products and AGE-Inhibitor Products at the Licensee or through sponsored research/development agreements with research institutions or contract research organizations directed to the development and commercialization of a product that incorporates Pyridorin or an AGE-Inhibitor; (2) Assigning or sublicensing (each in accordance with the terms of this document has been filed separately with Agreement) the Securities product rights licensed or assigned hereunder to another company directed to the development and Exchange Commissioncommercialization of a product that incorporates Pyridorin or an AGE- Inhibitor. (b) Without limiting 3.3 Subject to the generality of cure period discussed below, BioStratum shall have the right to terminate this Agreement effective upon written notice if Licensee does not close a Qualified Series A Financing on or before June 30, 2006. Notwithstanding the foregoing, Intrexon mayif BioStratum enters into a strategic partnership pursuant to which BioStratum receives nonrefundable proceeds of at least $2,000,000 by June 30, from 2006, then the period of time for Licensee to timeclose a Qualified Series A Financing shall be extended to December 31, notify Fibrocell 2006. In the event Licensee has not closed a Qualified Series A Financing nor entered into a strategic partnership (as described in the preceding sentence) by June 30, 2006, the receipt of the written termination notice described in the first sentence of this Section 3.3 shall trigger a forty-five (45) day cure period (the “Cure Period”), during which time (i) Licensee may continue to work towards either closing a Qualified Series A Financing or entering into such a strategic partnership and (ii) BioStratum shall be free to enter into discussions regarding a transaction or transactions involving AGE-Inhibitors, AGE-Inhibitor Know- How, AGE-Inhibitor Patent Rights, AGE-Inhibitor Products, Pyridorin, Pyridorin Know-How, Pyridorin Patent Rights and/or Pyridorin Products, including but not limited to a sale, license or strategic partnership, provided, however, that it believes it has identified in no event shall BioStratum enter into such discussions during such cure period with a Superior Therapyventure capital investment fund. If Licensee closes a Qualified Series A Financing during such Cure Period, BioStratum shall withdraw its written termination notice and this Agreement shall continue in full force and effect. If Licensee does not close a Qualified Series A Financing during such case Intrexon Cure Period, then this Agreement shall provide terminate upon the expiration of the Cure Period. For purposes of clarification, Licensee shall only be permitted to Fibrocell its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Fibrocell take advantage of one Cure Period, unless otherwise consented by BioStratum. 3.4 BioStratum shall have the following obligations with respect right to such proposed Superior Therapyterminate this Agreement effective upon written notice if Licensee does not, within 18 months of the closing of the Qualified Series A Financing, accomplish at least one of the following: (i) within sixty (60) days after such notificationinitiate a new Phase II clinical trial of Pyridorin Product as a treatment for diabetic nephropathy, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise enter into a contract with a strategic partner for which provides funding reasonably sufficient to support the development plan of a Pyridorin Product as directed by the JSC; and a treatment for diabetic nephropathy, or (iii) following approval of the development plan by the JSCclose a Qualified Series B Financing. Upon Licensee's request, Fibrocell shall use Diligent Efforts BioStratum may provide Licensee with an additional 90 day period to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development plan. If Fibrocell fails to comply with meet the foregoing obligationsrequirement. Approval of such request shall not be unreasonably withheld, conditioned or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11delayed. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees shall be attributed to Fibrocell for the purposes of evaluating Fibrocell’s fulfillment of the obligations set forth in this Section 4.5.

Diligence. (a) Fibrocell shall useAVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries. In addition, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize Fibrocell Products and Improved Products. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. (b) Without without limiting the generality of the foregoing, Intrexon AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a Licensed Product within [***] of the Effective Date. In the event that BioMarin believes AVROBIO is in material breach of its obligation to use Commercially Reasonable Efforts under this Section 3.3, then BioMarin may so notify AVROBIO in writing, which notice shall provide available details regarding the basis for its belief and specifying that such notice (a “Diligence Breach Notice”) is being provided by BioMarin pursuant to this Section 3.3. If a Diligence Breach Notice is provided to AVROBIO, AVROBIO may, from time within a further period of [***] after receipt of such notice, provide a written report to time, notify Fibrocell that it BioMarin to justify why AVROBIO believes it has identified a Superior Therapy, and is not in such case Intrexon shall provide to Fibrocell its then-available information about material breach of such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapydiligence obligation. Fibrocell shall have the following obligations with respect to If no such proposed Superior Therapy: (i) within sixty (60) days after such notification, Fibrocell shall prepare and deliver to the JSC for review and approval a development plan detailing how Fibrocell will pursue the Superior Therapy (including a proposed budget); (ii) Fibrocell shall revise the development plan as directed report is provided by AVROBIO by the JSC; and (iii) following approval end of the development plan by the JSCsuch time period, Fibrocell BioMarin shall use Diligent Efforts be permitted to pursue the development of the Superior Therapy under the Fibroblast Program in accordance with such development planterminate this Agreement pursuant to Section 8.2. If Fibrocell fails to comply with AVROBIO provides a response, the foregoing obligations, or if Fibrocell unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days Parties shall then conduct an initial meeting within [***] after delivery of such a written report from AVROBIO to discuss in good faith the development plan concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute reach agreement as to whether a proposed project constitutes a Superior Therapy (as with any other dispute or not AVROBIO is in material breach of its obligations under this Agreement) Section 3.3 for an additional [***] after such initial meeting. If after such [***] period following the initial meeting, the Parties cannot reach agreement then, upon request of either Party, the matter shall be subject referred to the dispute resolution in accordance with Article 11. (c) The activities of Fibrocell’s Affiliates and any permitted sublicensees procedure outlined under Section 11.3, which procedure shall be attributed required to: (a) determine whether there was, in fact, a material breach by AVROBIO of its diligence obligation, and (b) if it is determined that there was an uncured material breach, specify what additional efforts AVROBIO must undertake to Fibrocell cure such breach, and the time period during which such efforts must be commenced and completed (which time period shall be commercially reasonable). If such procedure determines that there was a material *** Confidential Treatment Requested *** breach of the diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified by the arbitration result (in response to the clause (b) requirement above) by the required relevant dates, then BioMarin may terminate the Agreement pursuant to Section 8.2. All efforts of AVROBIO’s Affiliates, Third Party contractors and sublicensees will be considered efforts of AVROBIO for the purposes purpose of evaluating Fibrocelldetermining AVROBIO’s fulfillment of the compliance with its obligations set forth in under this Section 4.53.3.