Common use of Diligence Clause in Contracts

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall use commercially reasonable efforts to develop and commercialize the Licensed Products commensurate with those efforts commonly used in the biotechnology industry by reputable biotechnology companies in connection with the development, manufacture and commercialization of a pharmaceutical product of similar market potential, and shall in particular use commercially reasonable efforts to initiate within [***] of the Effective Date a [***] of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfaction.

Diligence. AntheraAfter AbbVie proceeds with the In-Licensing, either on its own or through one or more Affiliates or sublicensees, AbbVie shall use commercially reasonable efforts Commercially Reasonable Efforts to develop and commercialize the Licensed Products commensurate with those efforts commonly used in the biotechnology industry by reputable biotechnology companies in connection with the development, manufacture and commercialization of a pharmaceutical product of similar market potential, and shall in particular use commercially reasonable efforts to initiate within [***] of the Effective Date a [***] of Commercialize a Licensed ProductProduct for the Initial Indications in each Major Market following receipt of Regulatory Approval therefor in each such Major Market. Whether particular development efforts are commercially reasonable For purposes of clarity, AbbVie shall not be measured on a country-by-country basis obligated to Commercialize more than one (1) Licensed Product or any Licensed Product for more than the Initial Indications in accordance with the overall standard set forth any Major Market. Ablynx acknowledges and agrees that, in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect addition to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach the Commercialization of this Agreement Licensed Product may be delayed, suspended or otherwise modified by Amgen that adversely affects Anthera’s ability AbbVie in response to develop Licensed Productscircumstances outside the reasonable control of AbbVie, including force majeure events and serious safety and efficacy issues, and (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or AbbVie shall have the ability right to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached satisfy its diligence obligations under this Agreement Section 4.2 through its Affiliates or Sublicensees. If AbbVie decides to discontinue the Development or Commercialization of a Licensed Compound or Licensed Product in connection favor of another Licensed Compound or Licensed Product, its obligations under this Section 4.2 shall cease with respect to such initial Licensed Compound or Licensed Product in favor of such other Licensed Compound or Licensed Product. If at any time Ablynx has a reasonable basis to believe that AbbVie is in material breach of its obligations under this Section 4.2, then Ablynx shall so notify AbbVie, specifying the developmentbasis for its belief, manufacture or commercialization of and the Parties shall meet within […***…] after such notice to discuss in good faith Ablynx’s concerns and AbbVie’s Commercialization plans with respect to the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfaction.

Diligence. Anthera, either on its own or through AVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Affiliates or sublicensees, shall use commercially reasonable efforts to develop and commercialize the Licensed Products commensurate with those efforts commonly used in the biotechnology industry by reputable biotechnology companies United States and in connection with the developmentMajor European Countries. In addition, manufacture and commercialization without limiting the generality of the foregoing, AVROBIO shall initiate an IND-enabling pharmacology/toxicology study of a pharmaceutical product of similar market potential, and shall in particular use commercially reasonable efforts to initiate Licensed Product within [***] of the Effective Date 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, within a further period of [***] after receipt of such notice, provide a Licensed Productwritten report to BioMarin to justify why AVROBIO believes it is not in such material breach of such diligence obligation. Whether particular development efforts are commercially reasonable If no such report is provided by AVROBIO by the end of such time period, BioMarin shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right permitted to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate 8.2. If AVROBIO provides a response, the Parties shall then conduct an initial meeting within [***] after delivery of such a written report from AVROBIO to discuss in good faith the date on which the Parties agree concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to such plan, and diligently continue, efforts under such plan reach agreement as to address and minimize the delay caused by Anthera’s whether or not AVROBIO is in material breach of its obligations under this 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 referred to the dispute resolution procedure outlined under Section 11.3, which procedure shall be 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 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 purpose of determining AVROBIO’s compliance with its obligations to Amgen’s reasonable satisfactionunder this Section 3.3.

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall use commercially reasonable efforts to develop and commercialize (a) After the Licensed Products commensurate with those efforts commonly used in the biotechnology industry by reputable biotechnology companies in connection with the development, manufacture and commercialization of a pharmaceutical product of similar market potential, and shall in particular use commercially reasonable efforts to initiate within [***] JSC's selection of the Effective Date a [***] Lead Product, MedCo will use Commercially Reasonable Efforts to (i) Develop at least one Licensed Product and obtain Regulatory Approval of a at least one Licensed Product. Whether particular development efforts are commercially reasonable shall Product in each Major Market Country and (ii) subject to Section 2.3.2, perform the Development activities under the MedCo Development Plan. (b) Alnylam will use Commercially Reasonable Efforts to perform the 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 measured on a country-by-country basis in accordance with required to perform any activities under the overall standard set forth in Initial Development Plan or the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities MedCo Development Plan with respect to Licensed Products (including but not limited that would require Alnylam to information on all clinical studies involving Licensed Products)incur Costs in excess of the then-applicable Development Costs Cap, unless paid or payable by MedCo as Extra Early Development Costs. Notwithstanding the foregoing, Anthera would not Alnylam will be deemed excused from its obligation to have breached such diligence perform its affected Development and Manufacturing obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control)Licensed Products under the Transaction Agreements during any period of time with respect to which Alnylam cannot perform such obligations to the extent that, including the following: (i) any breach Alnylam becomes aware that the performance of this Agreement such obligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Amgen that adversely affects Anthera’s ability to develop Licensed ProductsAlnylam, and (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) 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 development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability mutually agreed resolution to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts)such a situation. If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to in writing that MedCo will grant Alnylam a license or sublicense under such planPatent Rights, then unless otherwise agreed by the Parties in writing, such Patent Rights will be considered MedCo Patent Rights, and diligently continueif such Patent Rights are licensed to MedCo or its Affiliate by a Third Party, efforts under such plan sublicense shall be subject to address the relevant license agreement to MedCo or its Affiliate from such Third Party and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionsuch agreement shall be designated a MedCo In-License.

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, Sanofi shall use commercially reasonable efforts Commercially Reasonable Efforts to develop and commercialize Commercialize the Licensed Products commensurate with those efforts commonly used LX4211 Product in the biotechnology industry by reputable biotechnology companies Major Markets in connection with the developmentTerritory for T1DM and T2DM, manufacture following receipt of Regulatory Approval for the applicable indication in the applicable country; provided that if Lexicon exercises the (Co-)Promotion Right, Sanofi’s obligation to use Commercially Reasonable Efforts shall not extend to the responsibilities allocated to Lexicon under the (Co-)Promotion Agreement and commercialization applicable T1DM Commercialization Plan; provided further Sanofi shall be excused from such obligation to the extent Lexicon fails to perform its obligations on which Sanofi’s performance depends. If Lexicon exercises the (Co-)Promotion Right, Lexicon shall use Commercially Reasonable Efforts to perform its obligations in the United States under the T1DM Commercialization Plan. Without limiting Sanofi’s obligations hereunder, Sanofi shall promptly notify Lexicon of a pharmaceutical product of similar market potentialany decision to cease using Commercially Reasonable Efforts to Commercialize any Licensed Product in any Major Market in the Territory. Lexicon acknowledges and agrees that nothing in this Section 4.2 is intended, and or shall in particular use commercially reasonable efforts be construed, to initiate within [***] of require Sanofi to Commercialize more than one Licensed Product at any given time or to Commercialize any other Licensed Product other than the Effective Date a [***] of a Licensed LX4211 Product. Whether particular development efforts are commercially reasonable If Sanofi implements and uses Commercially Reasonable Efforts to carry out its responsibilities under the T1DM Commercialization Plan pursuant to Section 4.3, Sanofi shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if satisfied its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect obligation to matters within its control), including the following: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations use Commercially Reasonable Efforts under this Agreement in connection with the development, manufacture or commercialization Section 4.2 and shall have no liability resulting from any failure of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize activities described in the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionT1DM Commercialization Plan.

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall use Licensee will exercise commercially reasonable efforts and diligence in Developing and commercializing Licensed Products and in undertaking investigations and actions required to develop and commercialize obtain Regulatory Approvals necessary to market Licensed Products in the Licensed Products commensurate with those efforts commonly used Field in the biotechnology industry by reputable biotechnology companies Territory, including achieving the applicable regulatory milestones for Royalty Products in connection the Commercialization Plan, and the sales milestones for Licensed Products set forth in this Agreement, such reasonable efforts and diligence to be in accordance with the developmentefforts and resources Licensee would use for a product candidate owned by it or to which it has rights, manufacture and commercialization of a pharmaceutical product which is of similar market potentialpotential as the applicable Licensed Product, taking into account the competitiveness of the marketplace, the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, the profitability of the applicable Licensed Product, and shall in particular other relevant factors including, without limitation, technical, legal, scientific or medical factors (“Commercially Reasonable Efforts”). In the event that Licensee fails to use commercially reasonable efforts to initiate within [***] of the Effective Date a [***] of Commercially Reasonable Efforts as required hereunder, then on a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a -by-Licensed Product and country-by-country basis in accordance with as to the overall standard set forth Licensed Product in the first sentence of this country in which Licensee has failed to use Commercially Reasonable Efforts as required hereunder, Licensor may, in its sole discretion (a) terminate the licenses granted under Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach 2 of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, for breach under Section 9.2 below (iiincluding the notice and cure provisions therein) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (ivb) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or convert the ability to scale up manufacturing processes (in each case, to the extent outside licenses granted under Section 2 of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement from exclusive licenses to non-exclusive licenses, in connection with either case only as such licenses apply to such Licensed Product in such country, which termination or conversion, as the developmentcase may be, manufacture or commercialization shall be effective upon expiration of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to cure period specified in Section 9.2 if Anthera does not initiate below provided that such failure remains uncured upon such expiration. Such efforts shall consist of achieving the following objectives within [***] from the date on which time period designated below following the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionTransaction Commencement Date.

Diligence. AntheraAbbVie shall use Commercially Reasonable Efforts to Commercialize a Licensed Product [***]; provided that (a) such obligation is expressly conditioned upon Licensor’s and its Affiliates’ performing their respective obligations hereunder, either on and (b) such obligation shall be delayed or suspended for as long as any failure by Licensee or its own 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 one or more its Affiliates or sublicenseesSublicensees, and (c) nothing in this Section 4.3 is intended, or shall use commercially reasonable efforts be construed, to develop and commercialize require AbbVie to Develop or Commercialize a specific Licensed Antibody or Licensed Product. If AbbVie decides to discontinue the Licensed Products commensurate with those efforts commonly used in the biotechnology industry by reputable biotechnology companies in connection with the development, manufacture and development or commercialization of a pharmaceutical product Licensed Antibody or Licensed Product in favor of similar market potentialanother 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 in particular use commercially reasonable efforts to initiate meet within [***] of 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 and filed separately with the Effective Date a Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionconfidential treatment request.

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall use commercially reasonable efforts to develop and commercialize the Licensed Products commensurate with those efforts commonly used in the biotechnology industry by reputable biotechnology companies in connection (a) Beginning with the developmentend of the Design/Preclinical Collaboration Term and continuing for the remainder of the Term, manufacture Pfizer will use, and commercialization will cause its Affiliates and Sublicensees to use, Commercially Reasonable Efforts to Develop and seek Regulatory *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Marketing Approval for at least one Covered Product in at least one Indication in at least one Major Market Country. Pfizer will have no other diligence obligations with respect to the Development of Covered Products under this Agreement. (b) Beginning with the end of the Design/Preclinical Collaboration Term and continuing for the remainder of the Term, Pfizer will use, and will cause its Affiliates and Sublicensees to use, Commercially Reasonable Efforts to Commercialize each Covered Product in each Major Market Country where it receives Regulatory Marketing Approval. Pfizer will have no other diligence obligations with respect to the Commercialization of Covered Products under this Agreement. (c) Beginning with the end of the Design/Preclinical Collaboration Term and ending with the First Commercial Sale of a pharmaceutical product of similar market potentialCovered Product, and shall in particular use commercially reasonable efforts to initiate within [***] of the Effective Date a [***] of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen Pfizer will provide BIND with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result summary of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect related to matters within its control)the Development & Commercialization Program, including a listing of any Regulatory Approvals achieved for Agreement Compounds or Covered Products. Any and all such reports (and all data and information set forth therein) will be considered Pfizer’s Confidential Information and will be subject to the following: confidentiality and use restrictions under this Agreement. Pfizer will also consider in good faith any reasonable requests by BIND for additional information (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionavailable) related thereto.

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall 3.1.1 From and after the Licence Agreement Effective Date Amgen shall: (a) use commercially reasonable diligent and timely efforts to develop satisfactorily complete Research of Licensed Antibody Products and commercialize the Licensed Products commensurate with those efforts commonly used obtain in the biotechnology industry by reputable biotechnology companies in connection with the development, manufacture and commercialization of a pharmaceutical product of similar market potential, and shall in particular use commercially reasonable efforts to initiate within [***] for a Licensed Antibody Product an IND. For the avoidance of the Effective Date a doubt, nothing in this Licence Agreement shall preclude Amgen from filing INDs in [***] of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of ]; (b) use Commercially Reasonable Efforts to satisfactorily complete all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing Development activities with respect to a Licensed Products Antibody Product; and (including but c) use Commercially Reasonable Efforts to obtain Regulatory Approval to Commercialise a Licensed Antibody Product; in each case for the [*] or if the [*] is dropped, [*]; and (d) use Commercially Reasonable Efforts to maximise Net Sales of each Licensed Antibody Product in the Territory. For the avoidance of doubt, the Parties acknowledge that the diligence obligations may have been met, in whole or in part, by activity conducted under the Collaboration Agreement. 3.1.2 Amgen acknowledges that using Commercially Reasonable Efforts requires it to take ongoing actions that are consistent with a good faith intention to achieve the objective of Developing a Licensed Antibody Product and obtaining Regulatory Approvals to Commercialise such Licensed Antibody Product for the [*] (or if the [*] is dropped, [*]) in the Field, and to Commercialise such Licensed Antibody Product [*]. For the avoidance of doubt, Development and Commercialisation in each instance includes the manufacture and supply of Licensed Antibody Product. If Amgen decides that deployment of Commercially Reasonable Efforts does not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoingjustify it making continued, Anthera would ongoing efforts towards this objective it shall promptly notify Celltech in writing. 3.1.3 Amgen shall not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any in breach of any obligation under this Licence Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside its inability to perform such obligation is caused by Celltech's failure to perform any of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Licence Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfaction.Article 14.9

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall 3.1.1 From and after the Licence Agreement Effective Date Amgen shall: (a) use commercially reasonable diligent and timely efforts to develop satisfactorily complete Research of Licensed Antibody Products and commercialize the Licensed Products commensurate with those efforts commonly used obtain in the biotechnology industry by reputable biotechnology companies in connection with the development, manufacture and commercialization of a pharmaceutical product of similar market potential, and shall in particular use commercially reasonable efforts to initiate within [***] for a Licensed Antibody Product an IND. For the avoidance of the Effective Date a doubt, nothing in this Licence Agreement shall preclude Amgen from filing INDs in [***] of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the overall standard set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of ]; (b) use Commercially Reasonable Efforts to satisfactorily complete all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing Development activities with respect to a Licensed Products Antibody Product; and (including but c) use Commercially Reasonable Efforts to obtain Regulatory Approval to Commercialise a Licensed Antibody Product; in each case for the [*] or if the [*] is dropped, [*]; and (d) use Commercially Reasonable Efforts to maximise Net Sales of each Licensed Antibody Product in the Territory. For the avoidance of doubt, the Parties acknowledge that the diligence obligations may have been met, in whole or in part, by activity conducted under the Collaboration Agreement. 3.1.2 Amgen acknowledges that using Commercially Reasonable Efforts requires it to take ongoing actions that are consistent with a good faith intention to achieve the objective of Developing a Licensed Antibody Product and obtaining Regulatory Approvals to Commercialise such Licensed Antibody Product for the [*] (or if the [*] is dropped, [*]) in the Field, and to Commercialise such Licensed Antibody Product [*]. For the avoidance of doubt, Development and Commercialisation in each instance includes the manufacture and supply of Licensed Antibody Product. If Amgen decides that deployment of Commercially Reasonable Efforts does not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoingjustify it making continued, Anthera would ongoing efforts towards this objective it shall promptly notify Celltech in writing. 3.1.3 Amgen shall not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any in breach of any obligation under this Licence Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside its inability to perform such obligation is caused by Celltech’s failure to perform any of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Licence Agreement in connection with the development, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfaction.Article 14.9

Diligence. AntheraAfter the Closing Date, either on its own or through one or more Affiliates or sublicenseesInterMune has sole responsibility for all aspects of developing, shall use commercially reasonable efforts to develop obtaining Regulatory Approval for, manufacturing and commercialize commercializing the Licensed Products commensurate with those efforts commonly used Initial Product throughout the Territory. InterMune will devote Commercially Reasonable Efforts (as defined in the biotechnology industry by reputable biotechnology companies following sentence) to obtain and maintain Regulatory Approval for the Initial Product in connection a specific country consistent with the developmentDevelopment Plan or to commercialize Initial Product in a specific country consistent with the Commercialization Plan. For purposes of this section only, manufacture "Commercially Reasonable Efforts" means the level of effort, expertise and commercialization of resources required to commercialize Product that a pharmaceutical similarly situated biopharmaceutical company would typically devote to a product of similar market marketing potential, profit potential or strategic value, based on conditions then prevailing. If Lilly believes that InterMune is not devoting Commercially Reasonable Efforts for the Initial Product in any country, Lilly will notify InterMune in writing detailing its specific concerns and shall in particular use commercially reasonable efforts to initiate recommendations, and the Parties will meet within [**] of such written notice to discuss such concerns and recommendations. After the last of such meeting(s), InterMune will have [*] of the Effective Date a [***] of a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a country-by-country basis in accordance with the overall standard to devote its Commercially Reasonable Efforts as set forth in the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, (ii) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (iv) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or the ability to scale up manufacturing processes (in each case, to the extent outside of Anthera’s control, using commercially reasonable efforts)above. If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement InterMune subsequently defaults and does not devote Commercially Reasonable Efforts for the Initial Product in connection with the developmentany country, manufacture or commercialization of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall Lilly will have the right to terminate the licenses granted in this Agreement to InterMune for such specific country pursuant to Section 9.2 if Anthera does not initiate within 9.1(c), below, [**] and InterMune will grant to Lilly an exclusive license to all rights, InterMune Technology and data that are useful and necessary for Lilly to obtain (or maintain) Regulatory Approval to commercialize the Initial Product in such country. [*] from the date on which the Parties agree to such plan, and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionCERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Diligence. Anthera, either on its own or through one or more Affiliates or sublicensees, shall use Licensee will exercise commercially reasonable efforts and diligence in developing and commercializing Licensed Products and in undertaking investigations and actions required to develop and commercialize obtain Regulatory Approvals necessary to market Licensed Products in the Licensed Products commensurate with those efforts commonly used Field in the biotechnology industry by reputable biotechnology companies Territory, such reasonable efforts and diligence to be in connection accordance with the developmentefforts and resources Licensee would use for a product candidate owned by it or to which it has rights, manufacture and commercialization of a pharmaceutical product which is of similar market potentialpotential as the applicable Licensed Product, taking into account the financial wherewithal of Licensee, the competitiveness of the marketplace, the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, the profitability of the applicable Licensed Product, and shall in particular other relevant factors including, without limitation, technical, legal, scientific or medical factors. In the event that Licensee fails to use commercially reasonable efforts to initiate within [***] due diligence as required hereunder at a time Licensor is not an Affiliate of the Effective Date a [***] of Licensee, then on a Licensed Product. Whether particular development efforts are commercially reasonable shall be measured on a -by-Licensed Product and country-by-country basis in accordance with as to the overall standard set forth Licensed Product in the first sentence of this country in which Licensee has failed to use due diligence as required hereunder, Licensor may, in its sole discretion (a) terminate the licenses granted under Section 3.5. Anthera shall keep Amgen advised of all ongoing development and manufacturing activities by providing Amgen with an annual update report summarizing Anthera’s development and manufacturing activities with respect to Licensed Products (including but not limited to information on all clinical studies involving Licensed Products). Notwithstanding the foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of events or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), including the following: (i) any breach 2 of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, for breach under Section 9.2 below (iiincluding the notice and cure provisions therein) regulatory holds or new regulatory requirements, (iii) an event of force majeure, or (ivb) a development issue involving safety, toxicity, efficacy or pharmacokinetics, or convert the ability to scale up manufacturing processes (in each case, to the extent outside licenses granted under Section 2 of Anthera’s control, using commercially reasonable efforts). If Amgen reasonably believes that Anthera has breached its diligence obligations under this Agreement from exclusive licenses to non-exclusive licenses, in connection with either case only as such licenses apply to such Licensed Product in such country, which termination or conversion, as the developmentcase may be, manufacture or commercialization shall be effective upon expiration of the Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the development delay caused by such breach. Amgen shall have the right to terminate this Agreement pursuant to cure period specified in Section 9.2 if Anthera does not initiate within [***] from the date on which the Parties agree to below provided that such plan, failure remains uncured upon such expiration. Licensor acknowledges and diligently continue, efforts under such plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfactionagrees that Licensee may develop one Licensed Product at a time.