Common use of Diligence Clause in Contracts

Diligence. Licensee agrees to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Laws.

Diligence. Licensee agrees to After the exercise of the Inhaled Option or Liquidia Respiratory Option, as applicable, GSK shall use Commercially Reasonable Efforts to diligently Develop, Manufacture develop and Commercialize the Product seek Regulatory Approval in the Territory Territory, for use the Liquidia Respiratory Product and Research Products in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayerapplicable Exercised Field(s). Without limiting the foregoing, Licensee shall: 4.1.1.1 if GSK exercises the Inhaled Option and fails to initiate any Clinical Trial on at least [***] Research Product in Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Inhaled Field within six (6) years after the Effective Date (such event, a “Development Delay”), GSK shall provide Liquidia with a written explanation of the Development Delay for the applicable Research Products. If the Development Delay was not caused solely or primarily for valid scientific reasons (which would include issues with respect to safety and efficacy as well as delays due to feedback from Regulatory Authorities, whether related to the PRINT Material used in the Research Product or the GSK Material contained in the Research Product), then Liquidia shall have the right, but not the obligation, to convert the Inhaled License to a non-exclusive license upon written notice to GSK; provided, that conversion of the Inhaled License to non-exclusive shall be Liquidia’s sole and exclusive remedy in the event of a Development Delay and Liquidia shall not have the right to terminate this Agreement in accordance with Section 15.3; and provided, further that if the Development Delay is caused by the failure of Liquidia or its contract manufacturer to provide GSK with its required supply of PRINT Materials or Research Products then Liquidia shall not have the right to convert the Inhaled License to non-exclusive. In addition, and notwithstanding anything to the contrary, GSK’s obligation to use Commercially Reasonable Efforts is agreed by the Parties to diligently carry out its respective obligations and activities specified in be dependent upon GSK’s timely receipt of GSK’s requirements of viable PRINT Materials or Research Products that meet all applicable specifications agreed to by the Development Plan including, without limitation, adhering Parties and/or Liquidia’s third party contract manufacturer. Any failure to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary timely deliver PRINT Materials or desirable Research Products to GSK as described above by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerLiquidia or a third party contract manufacturer, and in compliance in all material respects any subsequent delays or modifications to GSK’s development plans with all requirements of Applicable Laws respect to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which any Research Product resulting from such failure to supply shall not be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 deemed to be GSK’s failure to use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Section 6.2.

Diligence. Licensee 5.1 As an inducement to STANFORD to enter into this Agreement, RIGEL agrees to use Commercially Reasonable Efforts all reasonable efforts and diligence to proceed with the development, manufacture, and sale of Licensed Product(s) and to diligently Develop, Manufacture and Commercialize develop markets for the Product in Licensed Product(s). RIGEL shall demonstrate such diligence to STANFORD by achieving proof of principle through written documentation of the Territory for use in following within eighteen (18) months after the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shallEffective Date: 4.1.1.1 a) Construction of a retroviral vector library; b) Infection of cells with such vector library; c) Detection of a physiological response to such infection in an infected cell; and d) Isolation and analysis of the peptide eliciting such physiological response from the cell. 5.2 If RIGEL is unable to demonstrate proof of principle within eighteen (18) months Licensed after the Effective Date, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use Commercially Reasonable Efforts of retrovirally mediated nucleic acid libraries for drug development, drug delivery, drug screening, and target analysis and discovery, by providing written notice to diligently carry out its respective obligations RIGEL thereof. Additionally, RIGEL shall provide to STANFORD within eighteen (18) months after the Effective Date a plan for the development and activities specified in commercialization of Licensed Products (a "Development Plan"). STANFORD shall comment upon and approve such plan, which approval shall not be unreasonably withheld. After the Development Plan includingis approved by STANFORD, without limitation, adhering RIGEL shall use reasonable efforts to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee diligently perform its obligations under such Development Plan. If Stanford reasonably believes that RIGEL is not using reasonable efforts to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to perform the Development Plan, together with a copy of STANFORD may so notify RIGEL. The parties shall promptly thereafter meet to discuss RIGEL's progress under the Development Plan, as set forth in and shall develop a mutually agreeable plan for remedying any such lack of diligence ( the "Proposed Remedy"). If RIGEL fails to perform the Proposed Remedy within one hundred and eighty (180) days after the Proposed Remedy is agreed upon, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use of retrovirally mediated nucleic acid libraries for drug development, drug delivery, and target analysis and discovery by providing written notice to RIGEL. If RIGEL then fails to perform the Proposed Remedy within ninety (90) days after receiving STANFORD's notice that it has elected to so narrow the Licensed Field of Use definition, then STANFORD may elect to convert the Exclusive License granted to RIGEL pursuant to Sections 3.1 and 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans to a nonexclusive license for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale remaining term of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Agreement.

Diligence. Licensee agrees AVROBIO 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 without limiting the generality of the foregoing, 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 to diligently Developunder this Section 3.3, Manufacture and Commercialize the Product then BioMarin may so notify AVROBIO in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific mannerwriting, which notice shall be complete provide available details regarding the basis for its belief and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts specifying that such notice (a “Diligence Breach Notice”) is being provided by BioMarin pursuant to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable this Section 3.3. If a Diligence Breach Notice is provided to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDsAVROBIO, IND EquivalentsAVROBIO may, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Fieldwithin a further period of [***] after receipt of such notice, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on provide a quarterly basis, a reasonably detailed written report describing the status to BioMarin to justify why AVROBIO believes it is not in such material breach of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in such diligence obligation. If no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after such report is provided by AVROBIO by the end of each calendar year such time period, BioMarin shall be permitted to terminate this Agreement pursuant to Section 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 commencement of Phase III Clinical Trials for each Indication for which the Product concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to reach agreement as to whether or not AVROBIO is in Developmentmaterial breach of its obligations under this Section 3.3 for an additional [***] after such initial meeting. If after such [***] period following the initial meeting, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee the Parties cannot reach agreement then, upon request of either Party, the matter shall be referred to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain recordsdispute resolution procedure outlined under Section 11.3, which procedure shall be required to: (a) determine whether there was, in sufficient detailfact, 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 complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization commercially reasonable). If such procedure determines that there was a material breach of the Product diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified by the arbitration result (in response to the Territory 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 use in the Field in the form required purpose of determining AVROBIO’s compliance with its obligations under all Applicable Lawsthis Section 3.3.

Diligence. Licensee agrees to After AbbVie proceeds with the In-Licensing, AbbVie shall use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the a Licensed Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except Indications in each Major Market following receipt of Regulatory Approval therefor in each such Major Market. For purposes of clarity, AbbVie shall not be obligated to Commercialize more than one (1) Licensed Product or any Licensed Product for more than the extent that the responsibility for doing soInitial Indications in any Major Market. Ablynx acknowledges and agrees that, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs addition to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reportsi) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with 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 and serious safety and efficacy issues, and (ii) AbbVie shall have the right to satisfy its diligence obligations under this 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 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 Territory basis for use its belief, 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 Field in the form required under all Applicable LawsLicensed Product.

Diligence. Licensee agrees to (a) After the JSC’s selection of the Lead Product, MedCo will use Commercially Reasonable Efforts to diligently Develop, Manufacture (i) Develop at least one Licensed Product and Commercialize the obtain Regulatory Approval of at least one Licensed Product in the Territory for use in the Field for all commercially reasonable Indicationseach Major Market Country and (ii) subject to Section 2.3.2, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in perform the Development Plan including, without limitation, adhering to activities under the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the MedCo Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above;. 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”b) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 Alnylam will use Commercially Reasonable Efforts to perform prethe 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 then-commercialization analysisapplicable Development Costs Cap, planningunless paid or payable by MedCo as Extra Early Development Costs. Alnylam will be excused from its obligation to perform its affected Development and Manufacturing obligations with respect to Licensed Products under the Transaction Agreements during any period of time with respect to which Alnylam cannot perform such obligations to the extent that, market preparation(i) Alnylam becomes aware that the performance of such obligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Alnylam, and related marketing activities for all countries (ii) 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 Territory; 4.1.1.11 within thirty (30) Business Days after Parties agree in writing that MedCo will grant Alnylam a license or sublicense under such Patent Rights, then unless otherwise agreed by the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is Parties in Developmentwriting, furnish Bayer with reasonably detailed summary written reports on all activities conducted such Patent Rights will be considered MedCo Patent Rights, and if such Patent Rights are licensed to MedCo or its Affiliate by Licensee to Commercialize the Product for use in the Field during a Third Party, such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which sublicense shall be complete subject to the relevant license agreement to MedCo or its Affiliate from such Third Party and accurate and such agreement shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsbe designated a MedCo In-License.

Diligence. Licensee agrees (a) AquaBounty shall use, and shall require its sublicensees to use Commercially Reasonable use, Diligent Efforts to diligently Develop, Manufacture develop and Commercialize AquaBounty Products. Intrexon shall use, and shall require its sublicensees to use, Diligent Efforts in conducting any activities undertaken by Intrexon in support of any JSC-approved research plan for the Product 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 Territory for use 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 Field for all commercially reasonable Indicationsmembers of the JSC, including without limitation, the Initial Two Indications; except shall prepare and deliver to the extent 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 responsibility for doing sonature and magnitude of the opportunity presented by the Superior Animal Product, as specifically then Intrexon shall have the termination right set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering Section 10.2(b) (subject to the timelines limitation set forth therein; 4.1.1.2 prepare and file ). 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 the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of any other dispute under this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which Agreement) shall be complete subject to dispute resolution in accordance with Article 11. (c) The activities of AquaBounty’s Affiliates and accurate and any permitted sublicensees shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts be attributed to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted AquaBounty for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution purposes of evaluating AquaBounty’s fulfillment of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as obligations set forth in Sections 3.2 this Section 4.4, and 3.3.3 above; 4.1.1.9 not later than the commencement activities of Phase III Clinical Trials, prepare overview-marketing plans Intrexon’s Affiliates and any permitted sublicensees shall be attributed to Intrexon for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale purposes of evaluating Intrexon’s fulfillment of the Product for use obligations set forth in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Section 4.4.

Diligence. Licensee agrees Anthera, either on its own or through one or more Affiliates or sublicensees, shall use commercially reasonable efforts to use Commercially Reasonable Efforts to diligently Develop, Manufacture develop and Commercialize commercialize the Product Licensed Products commensurate with those efforts commonly used in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable biotechnology industry by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities reputable biotechnology companies in connection with the Regulatory Approvals for the Product in the Territory for use in the Fielddevelopment, including, without limitation, communicating withmanufacture and commercialization of a pharmaceutical product of similar market potential, and preparing and filing all reports (including, without limitation, adverse event reports) 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 Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as overall standard set forth in Sections 3.2 the first sentence of this Section 3.5. Anthera shall keep Amgen advised of all ongoing development and 3.3.3 above; 4.1.1.9 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 later than limited to information on all clinical studies involving Licensed Products). Notwithstanding the commencement foregoing, Anthera would not be deemed to have breached such diligence obligations if its development efforts are delayed as a result of Phase III Clinical Trialsevents or occurrences that are outside of Anthera’s control (provided Anthera has used commercially reasonable efforts with respect to matters within its control), prepare overview-marketing plans for including the Productfollowing: (i) any breach of this Agreement by Amgen that adversely affects Anthera’s ability to develop Licensed Products, which shall include plans related (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 pre-launchextent outside of Anthera’s control, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a using commercially reasonable efforts). If Amgen reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, believes that Anthera has breached its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved diligence obligations under this Agreement in connection with the Commercialization development, manufacture or commercialization of the Product in Licensed Product, Amgen and Anthera shall meet and agree upon a reasonable plan to minimize the Territory for use in development delay caused by such breach. Amgen shall have the Field in right to terminate this Agreement pursuant to Section 9.2 if Anthera does not initiate within [***] from the form required date on which the Parties agree to such plan, and diligently continue, efforts under all Applicable Lawssuch plan to address and minimize the delay caused by Anthera’s breach of its diligence obligations to Amgen’s reasonable satisfaction.

Diligence. Licensee agrees Alnylam shall use Commercially Reasonable Efforts to research, develop and commercialize a Licensed Product in the Field of Use. For purposes of this Section 8.3, the efforts of Alnylam’s Related Parties shall also be considered the efforts of Alnylam. Alnylam will be considered to have failed to meet its obligations to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in event that any of the Field for all commercially reasonable Indications, including without limitationfollowing occur: (a) [**] formulation within [**] years after [**]; or (b) [**] within [**] years after [**] covering at least [**]. In the event of a failure by Alnylam to meet its obligations under subsections (a) or (b) above, the Initial Two Indications; except to Parties will discuss Alnylam’s failure. If the extent reason for failure was the result of some factor outside Alnylam’s reasonable control and that such failure did not result from a lack of due diligence on Alnylam’s part, then the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering Parties will discuss a reasonable extension to the timelines set forth therein; 4.1.1.2 prepare in (a) and/or (b) above. If Alnylam is unable to convince both AlCana and file UBC that the reason for failure was the result of some factor outside Alnylam’s reasonable control and that such failure did not result from a lack of due diligence on Alnylam’s part, then UBC shall have the right to convert the Tekmira License to a non-exclusive license in accordance with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities includingprocedures set forth in Section 10.2.2, and AlCana shall have, without limitationfurther act by UBC, all INDs an irrevocable, perpetual, royalty-free, worldwide, non-exclusive license under the AlCana Collaboration IP. All other terms and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives conditions of this Agreement efficiently and expeditiouslythe Supplemental Agreement shall remain in full force and effect. In addition, Alnylam shall, with respect to each Licensed Product, and subject to the provisions of Article 9: (i) promptly advise UBC and AlCana of any material changes made from time to time with respect to Alnylam’s research, development and commercialization program for Licensed Products or any issues of which Alnylam becomes aware that may materially and adversely affect Alnylam’s research, development and commercialization program or its ability to research, develop, and commercialize a Licensed Product; 4.1.1.4 maintain records(ii) provide UBC and AlCana with notice in writing if any of the events in Sections 8.3(a) or (b) above occur, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in within [**] days after the form required under all Applicable Lawsoccurrence of such events; 4.1.1.5 use Commercially Reasonable Efforts to prepare (iii) provide UBC and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee AlCana with notice in writing of the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the date of First Commercial Sale of any Licensed Product in the Territory for use in the Fieldeach country; 4.1.1.6 own all INDs(iv) meet with representatives of UBC and AlCana, IND Equivalentsas often as UBC and AlCana may reasonably request, NDAs but no more frequently than [**] every [**] months, to discuss the plans for research, development and NDA Equivalents submitted for the Product in the Territory for use in the Fieldcommercialization of a Licensed Product; and (v) provide to UBC and AlCana, together with all Regulatory Approvals as often as UBC and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the FieldAlCana may reasonably request, but no more frequently than [**] every [**] months, a written summary of current plans to commercialize a Licensed Product, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution a summary of the Development Committeecurrent and proposed research, to Bayer)development, on a quarterly basiscommercialization, a reasonably detailed written report describing the status of the Development of the Product marketing and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing sales plans for the such Licensed Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Laws.

Diligence. Licensee agrees (a) 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 use, Commercially Reasonable Efforts to diligently Develop, Manufacture Develop and Commercialize 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 the Territory for use at least one Indication in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except at least one Major Market Country. Pfizer will have no other diligence obligations with respect to the extent that Development of Covered Products under this Agreement. (b) Beginning with the responsibility end of the Design/Preclinical Collaboration Term and continuing for doing sothe remainder of the Term, as specifically set forth in Sections 4.2 Pfizer will use, and 4.3 of this Agreement will cause its Affiliates and in the CMC DevelopmentSublicensees to use, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective 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 activities specified in ending with the First Commercial Sale of a Covered Product, Pfizer will provide BIND with an annual report with a summary of events related to the Development Plan including& Commercialization Program, without limitation, adhering to the timelines 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; 4.1.1.2 prepare ) will be considered Pfizer’s Confidential Information and file with will be subject to the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs confidentiality and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development use restrictions under this Agreement. Pfizer will also consider in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable faith any reasonable requests by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory BIND for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports additional information (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans extent available) related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthereto.

Diligence. Licensee agrees to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize (a) Attached hereto as EXHIBIT E are Connetics' Clinical Development Milestones (the Product in the Territory "Clinical Development Milestones") for use Licensed Products in the Field of Use and the Dates of Completion for all commercially reasonable Indicationseach such milestone. Connetics shall use its Best Efforts to adhere to the Dates of Completion as set forth in Exhibit E. Connetics shall notify Genentech in writing when it achieves a Clinical Development Milestone. (b) From time to time, Connetics may suggest modifications to the Clinical Development Milestones based on new information. Such modifications shall be effective only [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. as mutually agreed upon, in writing, by the Parties. Genentech shall consider such requested modifications in good faith and shall agree to any modifications that are reasonably necessary to achieve the overall objectives of the development of Licensed Product hereunder. (c) In the event that Connetics determines that it will be unable to meet any Date of Completion for a Clinical Development Milestone due to an event within Genentech's control, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and delay in the CMC Developmentperformance by Genentech of any of its obligations hereunder (e.g. the transfer of technology or materials, Manufacture including the supply of Interferon Gamma-1B), Connetics shall give prompt notice to Genentech of such inability and Supply Agreement, belongs to Bayershall specify the amount of delay Connetics believes resulted from such event within Genentech's control. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified Unless Genentech disagrees in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file writing on reasonable grounds with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable amount of such delay specified by Licensee Connetics, such Date of Completion will automatically be extended by the length of time of the delay. In the event Genentech disagrees in writing on reasonable grounds with the amount of delay specified by Connetics, the Parties shall negotiate a new Date of Completion in good faith. (d) In the event that Connetics determines that it will be unable to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and meet any Date of Completion for a Clinical Development Milestone due to an event which would be considered a force majeure (as described in Section 12.9), Connetics shall give prompt written notice to Genentech of such inability and the length of the delay Connetics believes resulted from such force majeure. Unless Genentech disagrees in writing on reasonable grounds with the length of such delay specified by Connetics, such Date of Completion will be automatically [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. extended by such specified length of time of the delay. In the event Genentech disagrees in writing on reasonable grounds with the length of delay specified by Connetics, the Parties shall negotiate a new Date of Completion in good scientific mannerfaith. (e) In the event that Connetics determines that it will be unable to meet any Date of Completion for a Clinical Development Milestone for reasons other than (i) force majeure and/or (ii) an event within Genentech's control, and in compliance in all material respects with all requirements Connetics shall notify Genentech of Applicable Laws to achieve such inability, identifying the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution nature of the inability with reasonable specificity and may ask Genentech for a reasonable extension of time in which to complete such Clinical Development CommitteeMilestone. In Genentech's sole discretion, Genentech may grant Connetics such an extension to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the complete such Clinical Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, Milestone. (f) Except as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than 3.2(c) or 3.2(d) or in the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which event that Genentech shall include plans related have agreed to the pre-launch, launch, marketing, promotion and sale an extension of the Product for use time to complete a Clinical Development Milestone as set forth in Section 3.2(e), if Connetics fails to complete a Clinical Development Milestone by the corresponding Date of Completion with respect to one or more of the Areas of the Field of Use (other than in the dermatological Area of the Field and which of Use as described in Section 1.12(a) above) Genentech shall include forecasts for have the number right to terminate this Agreement with respect to such Area(s) of sales representativesthe Field of Use, by providing Connetics written notice thereof, and a reasonably descriptive overview the termination of the marketing campaigns proposed Agreement with respect to be conducted (the “Marketing Plans”such Area(s) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may Field of Use shall be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within effective thirty (30) Business Days days after Connetics' receipt of such notice unless such Clinical Development Milestone shall have been met prior to the end expiration of each calendar year after such thirty (30) day period, and such [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. termination shall be Genentech's exclusive remedy for such failure of Connetics to complete such Clinical Development Milestone. Upon such termination of the commencement Agreement with respect to such Area(s) of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during of Use: (i) Genentech shall automatically have all the rights set forth in Sections 11.3(a) and (b) solely with respect to such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization Area(s) of the Product in the Territory for use in Field of Use; and (ii) any sublicense(s) granted by Connetics with respect to such Area(s) of the Field in of Use shall not automatically terminate, but instead, Genentech shall have the form required under all Applicable Lawsoption to either terminate or continue this Agreement with respect to such Area(s) of the Field of Use with such sublicensee(s).

Diligence. Licensee agrees (a) AquaBounty shall use, and shall require its sublicensees to use Commercially Reasonable use, Diligent Efforts to diligently Develop, Manufacture develop and Commercialize AquaBounty Products. Intrexon shall use, and shall require its sublicensees to use, Diligent Efforts in conducting any activities undertaken by Intrexon in support of any JSC-approved research plan for the Product 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 Territory for use 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 Field for all commercially reasonable Indicationsmembers of the JSC, including without limitation, the Initial Two Indications; except shall prepare and deliver to the extent 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 responsibility for doing sonature and magnitude of the opportunity presented by the Superior Animal Product, as specifically then Intrexon shall have the termination right set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering Section 10.2(b) (subject to the timelines limitation set forth therein; 4.1.1.2 prepare and file ). 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 the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of any other dispute under this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which Agreement) shall be complete subject to dispute resolution in accordance with Article 11. (c) The activities of AquaBounty’s Affiliates and accurate and any permitted sublicensees shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts be attributed to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted AquaBounty for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution purposes of evaluating AquaBounty’s fulfillment of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as obligations set forth in Sections 3.2 this Section 4.4, and 3.3.3 above; 4.1.1.9 not later than the commencement activities of Phase III Clinical Trials, prepare overview-marketing plans Intrexon’s Affiliates and any permitted sublicensees shall be attributed to Intrexon for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale purposes of evaluating Intrexon’s fulfillment of the Product obligations set forth in this Section 4.4. Portions herein identified by [*****] have been omitted pursuant to a request for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview confidential treatment under Rule 24b-2 of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies Securities Exchange Act of the Marketing Plans to Bayer 1934, as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end amended. A complete copy of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection this document has been filed separately with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsSecurities and Exchange Commission.

Diligence. (a) After the Effective Date, subject to MedImmune’s retained rights under Section 2.4.1 and to Section 3.3.3, and except as set forth in Section 3.3.1(d), as between the Parties, Licensee agrees shall be solely responsible for all aspects of the Development of Licensed Compounds and Licensed Products in the Field in the Territory at Licensee’s own cost and expense, including (i) obtaining any quantities of the AstraZeneca Product required for Licensee’s Development activities from commercially available channels; (ii) identifying and engaging a contract research organization or other vendor to perform testing of Licensed Compound drug substance or drug product; and (iii) sourcing an assay reagent for the performance of stability assays. *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], 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. (b) Licensee shall use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory obtain and maintain Regulatory Approvals for, Licensed Products for use in the Field for all (x) in the United States, China and the Major European Countries and (y) in other countries throughout the Territory where it is commercially reasonable Indications(consistent with the definition of Commercially Reasonable Efforts) to do so; provided that, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoingcase of any other country covered by clause (y), Licensee shall: 4.1.1.1 use shall not be required pursuant to this sentence to Develop or obtain Regulatory Approval for a Licensed Product in such country if the reasonably expected period of exclusivity for such Licensed Product in such country (whether by virtue of an anticipated Valid Claim of a Licensed Patent or the Regulatory Exclusivity Period with respect to which the Licensed Product is expected to be eligible upon receipt of Regulatory Approval or other available data or similar exclusivity) is less than five (5) years assuming the exercise of Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerDevelop, and obtain and maintain Regulatory Approval for, such Licensed Product in compliance in all material respects with all requirements of Applicable Laws to achieve such country. For clarity, the objectives of this Agreement efficiently Parties acknowledge that Developing, and expeditiously; 4.1.1.4 maintain records, in sufficient detail obtaining and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all maintaining Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDsfor, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory Licensed Products for use in the Field in the form required under all Applicable LawsUnited States and the Major European Countries is a higher timing priority in Licensee’s global development strategy than Developing, and obtaining and maintaining Regulatory Approvals for, Licensed Products for use in the Field in China, and that, accordingly, the use of Commercially Reasonable Efforts to perform such activities in (i) the U.S. and the Major European Countries, on the one hand, and (ii) China, on the other hand, does not require that such activities in China be conducted on the same or similar timeline as such activities in the U.S. and the Major European Countries. (c) In the event that Licensee achieves First Commercial Sale of a Licensed Product in the United States, a Major European Country or China on or before December 31, 2021, Licensee shall so notify MedImmune in writing and provide supporting documentation with respect thereto and the commencement of the Royalty Term shall be delayed until July 1, 2022. (d) Without limitation to the last sentence of Section 2.5.1, upon Licensee’s request, MedImmune shall (or shall cause its applicable Affiliates to) use commercially reasonable efforts to supply Licensee or its designee those quantities of existing ticagrelor active metabolite (AR-C124910XX) on the terms and conditions set forth on Schedule 3.3.1(d) for Licensee’s use in analytical assay development with respect to the Licensed Compounds and Licensed Products. (e) If Licensee elects, including pursuant to the first sentence of Section 3.3.1(b), not to Develop or seek or obtain Regulatory Approval for a Licensed Product, or to Commercialize a Licensed Product in any country or jurisdiction in the Territory where the AstraZeneca Product is being developed or commercialized by or on behalf of MedImmune or its Affiliates or its or their (sub)licensees or successors and the applicable Regulatory Authority conditions the marketing or sale of the AstraZeneca Product on the availability of a Licensed Product, Licensee shall promptly notify MedImmune in writing of such election, and, upon MedImmune’s request, the Parties shall discuss in good faith the terms and *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], 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. conditions pursuant to which MedImmune may obtain the right, but not the obligation, to Develop or obtain Regulatory Approval for and Commercialize such Licensed Product in such country or jurisdiction.

Diligence. Licensee 5.1 As an inducement to STANFORD to enter into this Agreement, RIGEL agrees to use Commercially Reasonable Efforts all reasonable efforts and diligence to proceed with the development, manufacture, and sale of Licensed Product(s) and to diligently Develop, Manufacture and Commercialize develop markets for the Product in Licensed Product(s). RIGEL shall demonstrate such diligence to STANFORD by achieving proof of principle through written documentation of the Territory for use in following within eighteen (18) months after the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shallEffective Date: 4.1.1.1 (a) Construction of a retroviral vector library; (b) Infection of cells with such vector library; (c) Detection of a physiological response to such infection in an infected cell; and (d) Isolation and analysis of the peptide eliciting such physiological response from the cell. 5.2 If RIGEL is unable to demonstrate the foregoing proof of principle within eighteen (18) months after the Effective Date, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use Commercially Reasonable Efforts of retrovirally mediated nucleic acid libraries for drug development, drug delivery, drug screening, and target analysis and discovery, by providing written notice to diligently carry out its respective obligations RIGEL thereof. Additionally, RIGEL shall provide to STANFORD within eighteen (18) months after the Effective Date a plan for the development and activities specified in commercialization of Licensed Products (a "Development Plan"). STANFORD shall comment upon and approve such plan, which approval shall not be unreasonably withheld. After the Development Plan includingis approved by STANFORD, without limitation, adhering RIGEL shall use reasonable efforts to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee diligently perform its obligations under such Development Plan. If Stanford reasonably believes that RIGEL is not using reasonable efforts to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to perform the Development Plan, together with a copy of STANFORD may so notify RIGEL. The parties shall promptly thereafter meet to discuss RIGEL's progress under the Development Plan, as set forth in and shall develop a mutually agreeable plan for remedying any such lack of diligence ( the "Proposed Remedy"). If RIGEL fails to perform the Proposed Remedy within one hundred and eighty (180) days after the Proposed Remedy is agreed upon, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use of retrovirally mediated nucleic acid libraries for drug development, drug delivery, and target analysis and discovery by providing written notice to RIGEL. If RIGEL then fails to perform the Proposed Remedy within ninety (90) days after receiving STANFORD's notice that it has elected to so narrow the Licensed Field of Use definition, then STANFORD may elect to convert the Exclusive License granted to RIGEL pursuant to Sections 3.1 and 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans to a nonexclusive license for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale remaining term of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Agreement.

Diligence. Licensee 5.1 As an inducement to STANFORD to enter into this Agreement, RIGEL agrees to use Commercially Reasonable Efforts all reasonable efforts and diligence to proceed with the development, manufacture, and sale of Licensed Product(s) and to diligently Develop, Manufacture and Commercialize develop markets for the Product in Licensed Product(s). RIGEL shall demonstrate such diligence to STANFORD by achieving proof of principle through written documentation of the Territory for use in following within eighteen (18) months after the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shallEffective Date: 4.1.1.1 (a) Construction of a retroviral vector library; (b) Infection of cells with such vector library; (c) Detection of a physiological response to such infection in an infected cell; and (d) Isolation and analysis of the peptide eliciting such physiological response from the cell. 5.2 If RIGEL is unable to demonstrate the foregoing proof of principle within eighteen (18) months after the Effective Date, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use Commercially Reasonable Efforts of retrovirally mediated nucleic acid libraries for drug development, drug delivery, drug screening, and target analysis and discovery, by providing written notice to diligently carry out its respective obligations RIGEL thereof. Additionally, RIGEL shall provide to STANFORD within eighteen (18) months after the Effective Date a plan for the development and activities specified in commercialization of Licensed Products (a "Development Plan"). STANFORD shall comment upon and approve such plan, which approval shall not be unreasonably withheld. After the Development Plan includingis approved by STANFORD, without limitation, adhering RIGEL shall use reasonable efforts to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee diligently perform its obligations under such Development Plan. If Stanford reasonably believes that RIGEL is not using reasonable efforts to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to perform the Development Plan, together with a copy of STANFORD may so notify RIGEL. The parties shall promptly thereafter meet to discuss RIGEL's progress under the Development Plan, as set forth in and shall develop a mutually agreeable plan for remedying any such lack of diligence ( the "Proposed Remedy"). If RIGEL fails to perform the Proposed Remedy within one hundred and eighty (180) days after the Proposed Remedy is agreed upon, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use of retrovirally mediated nucleic acid libraries for drug development, drug delivery, and target analysis and discovery by providing written notice to RIGEL. If RIGEL then fails to perform the Proposed Remedy within ninety (90) days after receiving STANFORD's notice that it has elected to so narrow the [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Licensed Field of Use definition, then STANFORD may elect to convert the Exclusive License granted to RIGEL pursuant to Sections 3.1 and 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans to a nonexclusive license for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale remaining term of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Agreement.

Diligence. Licensee 5.1 As an inducement to STANFORD to enter into this Agreement, LICENSEE agrees to use Commercially Reasonable Efforts commercially reasonable efforts and diligence to proceed with the development, manufacture, offering for sale, and sale or lease of Licensed Products and to diligently Developdevelop markets for the Licensed Products. 5.2 LICENSEE shall provide a development plan for each Licensed Antibody by *****. In the event that LICENSEE does not provide a development plan for ***** Licensed Antibodies, Manufacture the license rights granted hereunder with respect to such Licensed Antibody(ies) only shall become nonexclusive upon ***** notice from STANFORD. 5.3 If LICENSEE or its sublicensees have not made substantial progress on or completed preclinical studies that serve as a basis for LICENSEE’s development plan with respect to the Licensed Antibody *****, LICENSEE agrees that the license rights granted hereunder with respect to ***** only shall become nonexclusive upon ***** notice from STANFORD. If LICENSEE or its sublicensees have not made substantial progress on or completed preclinical studies that serve as a basis for LICENSEE’s development plan with respect to any other Licensed Antibody by *****, LICENSEE agrees that the license rights granted hereunder with respect to such Licensed Antibody only shall become nonexclusive upon ***** notice from STANFORD. 5.4 If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to ***** only shall become nonexclusive upon ***** notice from STANFORD. If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to such Licensed Antibody only shall become nonexclusive upon ***** notice from Stanford. 5.5 If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to ***** only shall become nonexclusive upon ***** notice from STANFORD. If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to such Licensed Antibody only shall become nonexclusive upon ***** notice from Stanford. 5.6 LICENSEE and Commercialize the Product in the Territory for use in the Field for all commercially reasonable IndicationsSTANFORD agree to meet *****, to discuss and agree upon further diligence milestones, including without limitationthe date by which a Licensed Product will first be available for commercial sale. 5.7 If neither LICENSEE nor any of its sublicensees has sold a Licensed Product for a period of ***** after such Licensed Product is first offered for commercial sale, the Initial Two Indications; except license rights granted hereunder with respect to such Licensed Product shall become nonexclusive upon ***** notice from STANFORD. 5.8 Progress Report - ***** until LICENSEE markets a Licensed Product, LICENSEE shall make a written ***** report to STANFORD covering *****, regarding the extent that the responsibility for doing soprogress of LICENSEE toward commercial use of Licensed Products. Such report shall include, as specifically set forth in Sections 4.2 a minimum, information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and 4.3 for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsArticle 5.

Diligence. Licensee agrees to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize (a) Attached hereto as Exhibit E are Connetics’ Clinical Development Milestones (the Product in the Territory “Clinical Development Milestones”) for use Licensed Products in the Field of Use and the Dates of Completion for all commercially reasonable Indicationseach such milestone. Connetics shall use its Best Efforts to adhere to the Dates of Completion as set forth in Exhibit E. Connetics shall notify Genentech in writing when it achieves a Clinical Development Milestone. (b) From time to time, Connetics may suggest modifications to the Clinical Development Milestones based on new information. Such modifications shall be effective only as mutually agreed upon, in writing, by the Parties. Genentech shall consider such requested modifications in good faith and shall agree to any modifications that are reasonably necessary to achieve the overall objectives of the development of Licensed Product hereunder. (c) In the event that Connetics determines that it will be unable to meet any Date of Completion for a Clinical Development Milestone due to an event within Genentech’s control, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and delay in the CMC Developmentperformance by Genentech of any of its obligations hereunder (e.g. the transfer of technology or materials, Manufacture including the supply of Interferon Gamma-1B), Connetics shall give prompt notice to Genentech of such inability and Supply Agreement, belongs to Bayershall specify the amount of delay Connetics believes resulted from such event within Genentech’s control. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified Unless Genentech disagrees in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file writing on reasonable grounds with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable amount of such delay specified by Licensee Connetics, such Date of Completion will automatically be extended by the length of time of the delay. In the event Genentech disagrees in writing on reasonable grounds with the amount of delay specified by Connetics, the Parties shall negotiate a new Date of Completion in good faith. (d) In the event that Connetics determines that it will be unable to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and meet any Date of Completion for a Clinical Development Milestone due to an event which would be considered a force majeure (as described in Section 12.9), Connetics shall give prompt written notice to Genentech of such inability and the length of the delay Connetics believes resulted from such force majeure. Unless Genentech disagrees in writing on reasonable grounds with the length of such delay specified by Connetics, such Date of Completion will be automatically extended by such specified length of time of the delay. In the event Genentech disagrees in writing on reasonable grounds with the length of delay specified by Connetics, the Parties shall negotiate a new Date of Completion in good scientific mannerfaith. (e) In the event that Connetics determines that it will be unable to meet any Date of Completion for a Clinical Development Milestone for reasons other than (i) force majeure and/or (ii) an event within Genentech’s control, and in compliance in all material respects with all requirements Connetics shall notify Genentech of Applicable Laws to achieve such inability, identifying the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution nature of the inability with reasonable specificity and may ask Genentech for a reasonable extension of time in which to complete such Clinical Development CommitteeMilestone. In Genentech’s sole discretion, Genentech may grant Connetics such an extension to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the complete such Clinical Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, Milestone. (f) Except as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than 3.2(c) or 3.2(d) or in the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which event that Genentech shall include plans related have agreed to the pre-launch, launch, marketing, promotion and sale an extension of the Product for use time to complete a Clinical Development Milestone as set forth in Section 3.2(e), if Connetics fails to complete a Clinical Development Milestone by the corresponding Date of Completion with respect to one or more of the Areas of the Field of Use (other than in the dermatological Area of the Field and which of Use as described in Section 1.12(a) above) Genentech shall include forecasts for have the number right to terminate this Agreement with respect to such Area(s) of sales representativesthe Field of Use, by providing Connetics written notice thereof, and a reasonably descriptive overview the termination of the marketing campaigns proposed Agreement with respect to be conducted (the “Marketing Plans”such Area(s) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may Field of Use shall be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within effective thirty (30) Business Days days after Connetics’ receipt of such notice unless such Clinical Development Milestone shall have been met prior to the end expiration of each calendar year after such thirty (30) day period, and such termination shall be Genentech’s exclusive remedy for such failure of Connetics to complete such Clinical Development Milestone. Upon such termination of the commencement Agreement with respect to such Area(s) of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during of Use: (i) Genentech shall automatically have all the rights set forth in Sections 11.3(a) and (b) solely with respect to such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization Area(s) of the Product in the Territory for use in Field of Use; and (ii) any sublicense(s) granted by Connetics with respect to such Area(s) of the Field in of Use shall not automatically terminate, but instead, Genentech shall have the form required under all Applicable Lawsoption to either terminate or continue this Agreement with respect to such Area(s) of the Field of Use with such sublicensee(s).

Diligence. Licensee agrees to (a) After the JSC's selection of the Lead Product, MedCo will use Commercially Reasonable Efforts to diligently Develop, Manufacture (i) Develop at least one Licensed Product and Commercialize the obtain Regulatory Approval of at least one Licensed Product in the Territory for use in the Field for all commercially reasonable Indicationseach Major Market Country and (ii) subject to Section 2.3.2, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in perform the Development Plan including, without limitation, adhering to activities under the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the MedCo Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above;. 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”b) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 Alnylam will use Commercially Reasonable Efforts to perform prethe 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 then-commercialization analysisapplicable Development Costs Cap, planningunless paid or payable by MedCo as Extra Early Development Costs. Alnylam will be excused from its obligation to perform its affected Development and Manufacturing obligations with respect to Licensed Products under the Transaction Agreements during any period of time with respect to which Alnylam cannot perform such obligations to the extent that, market preparation(i) Alnylam becomes aware that the performance of such obligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Alnylam, and related marketing activities for all countries (ii) 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 Territory; 4.1.1.11 within thirty (30) Business Days after Parties agree in writing that MedCo will grant Alnylam a license or sublicense under such Patent Rights, then unless otherwise agreed by the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is Parties in Developmentwriting, furnish Bayer with reasonably detailed summary written reports on all activities conducted such Patent Rights will be considered MedCo Patent Rights, and if such Patent Rights are licensed to MedCo or its Affiliate by Licensee to Commercialize the Product for use in the Field during a Third Party, such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which sublicense shall be complete subject to the relevant license agreement to MedCo or its Affiliate from such Third Party and accurate and such agreement shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsbe designated a MedCo In-License.

Diligence. Licensee agrees to 4.1 ReGenX shall use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indicationsefforts to develop, including without limitationmarket, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 promote and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayersell a Licensed Product ****. Without limiting the foregoing, Licensee shall:ReGenX shall be deemed to have satisfactorily discharged its diligence obligations hereunder as long as ReGenX and/or its Affiliates and/or sublicensees are diligently pursuing the development and/or commercialization of ****. 4.1.1.1 use Commercially Reasonable Efforts 4.2 Within **** after the Effective Date and within **** of each December 1 thereafter, ReGenX shall provide GSK with written progress reports, setting forth in such detail as GSK may reasonably request, the progress of the development, evaluation, testing and commercialization of each Licensed Product. ReGenX acknowledges that GSK is required to diligently carry out notify Penn within **** of the first commercial sale by ReGenX, its respective obligations and activities specified in Affiliates, or its or their sublicensees of each Licensed Product. Such a report (“Development Progress ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Report”), setting forth the Development Plan includingcurrent stage of development of Licensed Products, shall include, without limitation, adhering to the timelines set forth therein: 4.2.1 Date of Development Progress Report and time covered by such report; 4.1.1.2 prepare 4.2.2 Major activities and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable accomplishments completed by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’sReGenX, its Affiliates’ , and its or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar yeartheir sublicensees relating directly to the Licensed 4.2.3 Product since the last Development Progress Report; 4.1.1.10 use Commercially Reasonable Efforts 4.2.4 Significant research and development projects relating directly to perform pre-commercialization analysisthe Licensed Product currently being performed by ReGenX, planning, market preparationits Affiliates, and related marketing its or their sublicensees and projected dates of completion. 4.2.5 Future development activities for all countries in to be undertaken by ReGenX, its Affiliates or its or their sublicensees during the Territorynext reporting period relating directly to the Licensed Product; 4.1.1.11 within thirty (30) Business Days after the end 4.2.6 Projected total development remaining before product launch of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar yearLicensed Product; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with 4.2.7 Summary of significant development efforts using the Commercialization Penn Patent Rights being performed by Third Parties including the nature of the Product relationship between ReGenX and such Third Parties. 4.3 In the event that Penn and GSK modify the Penn License Agreement or any of the terms or provisions thereof (whether by formal amendment, letter agreement or other binding or applicable arrangement) where such modification has a material effect on ReGenX’s obligations under this Agreement (a “PLA Modification”), GSK shall provide notice of such PLA Modification in writing to ReGenX. The Parties shall then enter into discussions to determine whether this Agreement should be amended to reflect the PLA Modification in the Territory for use in Penn License Agreement so that ReGenX may benefit from all applicable terms of the Field in PLA Modification to the form required under all Applicable Lawsextent that the PLA Modification lessens GSK’s obligations or requirements thereunder or otherwise benefits GSK. ****.

Diligence. Licensee agrees AVROBIO 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 without limiting the generality of the foregoing, 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 to diligently Developunder this Section 3.3, Manufacture and Commercialize the Product then BioMarin may so notify AVROBIO in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific mannerwriting, which notice shall be complete provide available details regarding the basis for its belief and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts specifying that such notice (a “Diligence Breach Notice”) is being provided by BioMarin pursuant to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable this Section 3.3. If a Diligence Breach Notice is provided to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDsAVROBIO, IND EquivalentsAVROBIO may, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Fieldwithin a further period of [***] after receipt of such notice, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on provide a quarterly basis, a reasonably detailed written report describing the status to BioMarin to justify why AVROBIO believes it is not in such material breach of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in such diligence obligation. If no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after such report is provided by AVROBIO by the end of each calendar year such time period, BioMarin shall be permitted to terminate this Agreement pursuant to Section 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 commencement of Phase III Clinical Trials for each Indication for which the Product concerns raised by BioMarin and shall conduct such additional meetings as are reasonably necessary to reach agreement as to whether or not AVROBIO is in Developmentmaterial breach of its obligations under this Section 3.3 for an additional [***] after such initial meeting. If after such [***] period following the initial meeting, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee the Parties cannot reach agreement then, upon request of either Party, the matter shall be referred to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain recordsdispute resolution procedure outlined under Section 11.3, which procedure shall be required to: (a) determine whether there was, in sufficient detailfact, 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 complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization commercially reasonable). If such procedure determines that there was a material *** Confidential Treatment Requested *** breach of the Product diligence obligation hereunder, and AVROBIO does not commence or complete the cure efforts specified by the arbitration result (in response to the Territory 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 use in the Field in the form required purpose of determining AVROBIO’s compliance with its obligations under all Applicable Lawsthis Section 3.3.

Diligence. Licensee agrees Subject to Chiesi’s compliance with Section 5.3, Protalix will use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize carry out the Development Plan in order to Develop the Licensed Product in the Territory for use Field in the Field for all commercially reasonable IndicationsTerritory (subject to Section 3.2(d)). Subject to Protalix’s compliance with Section 3.6(c), including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 Chiesi will use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified seek as soon as reasonably practicable Regulatory Approval for the Licensed Product in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, Field in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 . Chiesi will use Commercially Reasonable Efforts to prepare Launch and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Licensed Product in the Territory for use Territory, promptly following such Regulatory Approval of the Licensed Product in the Field; 4.1.1.6 own all INDs. The previous sentence above notwithstanding, IND Equivalentsif, NDAs and prior to the submission of the NDA Equivalents submitted seeking Regulatory Approval for the Licensed Product in the Territory for use 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 Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating withLicensed Product, and preparing and filing all reports if, within ten (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (3010) Business Days after of receiving such written notice, Protalix provides Chiesi with written notice that Protalix desires to jointly engage a law firm to advise regarding the end same in accordance with this Section 3.5: (i) Protalix and Chiesi promptly shall jointly engage a law firm of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is reputable stature and experienced in Developmentpatent matters related to biologic products and approved by both Parties (such approval not to be unreasonably withheld, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee conditioned or delayed) to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain recordsprovide its legal opinion as to whether a judge or jury would be highly unlikely to conclude, in sufficient detailexercising its discretion in applying the applicable Laws to the facts, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with that the Commercialization Launch of the Licensed Product in the Territory for use in the Field in the form required 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 of the engagement), and (ii) in the event that such law firm does not, prior to Regulatory Approval of the Licensed Product in the Field in the Territory, render a legal opinion that 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 (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 specified Third Party Patents or Patent Applications. The Parties acknowledge and agree that (x) all communications with such law firm with respect to the 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 competent jurisdiction if reasonably necessary to enforce its rights under all Applicable Lawsthis Agreement; provided that such Party seeks the highest level of confidential treatment for 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) 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 Parties to enter into such a joint defense agreement or common interest agreement shall not be construed or deemed as evidence of any waiver by any of the Parties of any applicable legal privilege or any of its or their rights in this Agreement, or as an indication that an applicable legal privilege has not attached to any Privileged Materials.

Diligence. Licensee (a) During the Research Term, Aventis shall use * to perform its Research obligations in accordance with the Research Plan. During the Term, Aventis agrees to use Commercially Reasonable Efforts * to diligently Develop, Manufacture Develop and Commercialize Collaboration Products. (b) The Parties agree that any Target presented by Avalon to the Product Research Committee in accordance with Section 3.4 which is not accepted by the Research Committee as a DRG within * shall not become a DRG or be included in the Territory for use Research Program, and all rights to such Target shall remain with Avalon. (c) The Parties agree that a DRG shall become a Reversion Target in the Field event of one or more of the following: (i) if within * after a Target that is identified by Avalon during the Research Term is accepted by the Research Committee for all commercially reasonable Indicationsinclusion in the Research Program as a DRG, including without limitation, such DRG is not selected as a SQT; or * The asterisk denotes the Initial Two Indications; except confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the extent that the responsibility for doing soSecurities Act of 1933, as specifically set forth in Sections 4.2 amended. (ii) if within * after a Target is selected as a DRG, (and 4.3 assuming that Aventis subsequently selects it as an SQT), such DRG is not selected as an Advanced SQT; or (iii) if Aventis determines not to Develop or to continue to Develop a Collaboration Product for an Advanced SQT; or (iv) if Aventis does not use * to Develop and Commercialize Collaboration Products with respect to a selected Advanced SQT; or (v) if, for any reason, Aventis determines not to Develop or to discontinue Development of this Agreement a DRG. (d) All rights to Reversion Targets shall revert to Avalon and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 Avalon may use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerany such Reversion Targets for any purpose, and in compliance in all material respects may license Reversion Targets to Third Parties or collaborate with all requirements of Applicable Laws Third Parties with respect to achieve the objectives of this Agreement efficiently Reversion Targets. (e) With respect to each SQT and expeditiously; 4.1.1.4 maintain recordseach Advanced SQT that becomes a Reversion Target, in sufficient detail and in good scientific manner, which Aventis shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection provide Avalon with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launchclinical information and data (“Aventis Target Technology”) in the Control of Aventis at the time such Target becomes a Reversion Target with respect to such Reversion Target that is useful for identifying Reversion Products by use of such Reversion Targets and the non-exclusive right and license to use and to sublicense such Aventis Target Technology with respect to Reversion Targets, launchprovided that in no event shall Aventis Target Technology include any information or data relating to compounds, marketing, promotion molecules or antibodies. * The asterisk denotes the confidential portions of this document that have been omitted and sale filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Product for use in the Field and which shall include forecasts for the number Securities Act of sales representatives1933, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsamended.

Diligence. Licensee agrees to (a) After the Effective Date, as between the Parties, Newsoara shall be 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 diligently Develop, Manufacture and Commercialize the obtain and maintain Regulatory Approvals for Licensed Product in the Territory for use Field in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Territory. (b) Without limiting the foregoing, Licensee Newsoara shall: 4.1.1.1 use : (i) [***] within [***] months after [***]; (ii) [***] within [***] months after [***]; and (iii) maintain active clinical Development for the Licensed Products through submission of the first Drug Approval Application to NMPA. For the purpose of clause (iii), “active clinical Development” shall require Newsoara to [***] during any consecutive [***] period [***]. The deadlines and time period set forth in clauses (i), (ii) and (iii) may be extended to the 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 diligently carry out its respective obligations and activities specified in [***] as soon as reasonably practicable. Failure to meet the Development Plan including, without limitation, adhering to the timelines deadlines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee above due to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives delay outside Newsoara’s reasonable control shall not be considered a breach of this Agreement efficiently by itself. (c) Subject to the terms and expeditiously; 4.1.1.4 maintain recordsconditions of this Agreement, Newsoara may elect, in sufficient detail and in good scientific mannerits sole discretion, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in at any time during the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution Term of the Development Committeethis Agreement, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Develop any Derived Molecule and Derived Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsTerritory at Newsoara’s own cost and expense. Newsoara shall have no diligence obligations with respect to any 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 ensure that (i) [***]; (ii) [***]; and (iii) Newsoara shall [***].

Diligence. Licensee 5.1 As an inducement to STANFORD to enter into this Agreement, RIGEL agrees to use Commercially Reasonable Efforts all reasonable efforts and diligence to proceed with the development, manufacture, and sale of Licensed Product(s) and to diligently Develop, Manufacture and Commercialize develop markets for the Product in Licensed Product(s). RIGEL shall demonstrate such diligence to STANFORD by achieving proof of principle through written documentation of the Territory for use in following within eighteen (18) months after the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shallEffective Date: 4.1.1.1 a) Construction of a retroviral vector library; b) Infection of cells with such vector library; c) Detection of a physiological response to such infection in an infected cell; and d) Isolation and analysis of the peptide eliciting such physiological response from the cell. 5.2 If RIGEL is unable to demonstrate proof of principle within eighteen (18) months after the Effective Date, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use Commercially Reasonable Efforts of retrovirally mediated nucleic acid libraries for drug development, drug delivery, drug screening, and target analysis and discovery, by providing written notice to diligently carry out its respective obligations RIGEL thereof. Additionally, RIGEL shall provide to STANFORD within eighteen (18) months after the Effective Date a plan for the development and activities specified in commercialization of Licensed Products (a "Development Plan"). STANFORD shall comment upon and approve such plan, which approval shall not be unreasonably withheld. After the Development Plan includingis approved by STANFORD, without limitation, adhering RIGEL shall use reasonable efforts to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee diligently perform its obligations under such Development Plan. If Stanford reasonably believes that RIGEL is not using reasonable efforts to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to perform the Development Plan, together with a copy of STANFORD may so notify RIGEL. The parties shall promptly thereafter meet to discuss RIGEL's progress under the Development Plan, as set forth in and shall develop a mutually agreeable plan for remedying any such lack of diligence ( the "Proposed Remedy"). If RIGEL fails to perform the Proposed Remedy within one hundred and eighty (180) days after the Proposed Remedy is agreed upon, STANFORD may elect to narrow the definition of the Licensed Field of Use to include only the use of retrovirally mediated nucleic acid libraries for drug development, drug delivery, and target analysis and discovery by providing written notice to RIGEL. If RIGEL then fails to perform the Proposed Remedy within ninety (90) days after receiving STANFORD's notice that it has elected to so narrow the Licensed Field of Use definition, then STANFORD may elect to convert the Exclusive License granted to RIGEL pursuant to Sections 3.1 and 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans to a nonexclusive license for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale remaining term of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Agreement.

Diligence. Licensee agrees to (a) Pfizer shall use Commercially Reasonable Efforts to diligently Developdevelop, Manufacture obtain Regulatory Approval for and Commercialize the Launch a Licensed Product in ***. (b) Notwithstanding any provision of this Agreement to the Territory contrary, Pfizer will be relieved of all diligence obligations under Section 5.8(a) to the extent that: (i) Pfizer or Lpath receives or generates any safety, tolerability or other data reasonably indicating, as measured by Pfizer’s safety and efficacy evaluation criteria and methodology, or signaling that a Licensed Product has or would have an unacceptable risk-benefit profile for use in the Field or is otherwise not reasonably suitable for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 initiation or continuation of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use clinical studies in the Field; 4.1.1.6 own all INDs(ii) Pfizer or Lpath receive any notice, IND Equivalents, NDAs and NDA Equivalents submitted for the information or correspondence from any applicable Regulatory Authority or any applicable Regulatory Authority takes any action that reasonably indicates that a Licensed Product in the Territory for use is unlikely to receive Regulatory Approval in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for . (c) Pfizer’s achievement of the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit Event Milestone relating to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, *** as set forth in Sections 3.2 Section 6.1, entitling Lpath to receive the corresponding Event Milestone Payment, will be conclusive evidence that Pfizer has satisfied all diligence obligations under Section 5.8(a) up to the date that such Event Milestone is achieved. In addition, Pfizer’s achievement of the Event Milestones relating to the *** as set forth in Section 6.1, entitling Lpath to receive the corresponding Event Milestone Payments, will be conclusive evidence that Pfizer has satisfied all diligence obligations under Section 5.8(a); *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. (d) If Lpath is aware, becomes aware or reasonably should be aware of facts that might form a reasonable basis to allege that Pfizer has failed to meet any of its obligations under Section 5.8(a), then Lpath will promptly notify Pfizer in writing of such potential alleged performance failure (each such potential alleged performance failure, a “Diligence Issue”). Promptly upon Pfizer’s receipt of any notice of a Diligence Issue pursuant to this Section 5.8(d), the Pfizer Alliance Manager will contact the Lpath Alliance Manager to discuss the specific nature of such Diligence Issue and 3.3.3 above; 4.1.1.9 not seek to identify an appropriate corrective course of action. If, no later than *** days after Pfizer’s receipt of such a notice, (a) the commencement Parties have not reached consensus regarding whether Pfizer has failed to satisfy its obligations pursuant to Section 5.8(a), and (b) the Parties’ respective Alliance Managers have not agreed upon an appropriate corrective course of Phase III Clinical Trialsaction for such Diligence Issue, prepare overviewthen such Diligence Issue will be escalated and resolved by a Vice President of Pfizer (or his or her designee who shall have appropriate decision-marketing plans for making authority) and the ProductChief Executive Officer of Lpath (or his or her designee who shall have appropriate decision-making authority). If Lpath fails to notify Pfizer of a Diligence Issue pursuant to this Section 5.8(d) within *** days after the date that Lpath first discovers, or based on the information provided by Pfizer reasonably should have discovered, such Diligence Issue, then Pfizer will be deemed to have satisfied its obligations under Section 5.8(a) with respect to such Diligence Issue. (e) If Pfizer materially breaches its obligations under Section 5.8(a) and fails to remedy such breach within *** days of Pfizer’s receipt of notice of such breach from Lpath, then Lpath may, in its sole discretion, elect to either ***. Lpath acknowledges and agrees that the elections set forth in this Section 5.8(e): (i) have been negotiated by the Parties to fully address any harm that Lpath may incur as a result of Pfizer’s material breach of Pfizer’s obligations under Section 5.8(a); and (ii) constitute Lpath’s sole and exclusive remedies with respect to any breach by Pfizer of Pfizer’s obligations under Section 5.8(a), and Pfizer acknowledges and agrees that this sentence shall not be construed to limit or preclude such recoveries or other remedies to which shall include plans related Lpath may be entitled at law or equity with respect to the pre-launch, launch, marketing, promotion breaches of this Agreement by Pfizer other than material breach of Pfizer’s obligations under Section 5.8(a). (f) If Pfizer makes a formal decision to discontinue all development and sale commercialization of the Product for use Licensed Products in the Field and which shall include forecasts for the number Major Market Countries, or in fact discontinues development and commercialization of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use Licensed Products in the Field during for the Major Market Countries (and does not intend to resume such calendar year; and 4.1.1.12 maintain recordsmaterial activities within *** months after such discontinuation), Pfizer agrees to notify Lpath in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved writing within *** days of such formal decision or discontinuation in connection fact. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsCommission.

Diligence. Licensee agrees to LICENSEE will, and will cause its Affiliates and each of its Sublicensees to, use Commercially Reasonable Efforts to diligently Develop, Manufacture develop and Commercialize the Product commercialize Licensed Product(s) in the Territory for use in Major Markets as soon as practicable. Beginning on the Field for all commercially reasonable Indications[***] of the Agreement Date and continuing [***] until [***], including without limitationLICENSEE will, and will cause its Affiliates and each of its Sublicensees to provide annual summary updates to BCM summarizing the Initial Two Indications; except activities undertaken by LICENSEE, its Affiliates and each of its Sublicensees to continue the extent development and commercialization of the Licensed Products. In the event that the responsibility for doing so, as specifically set forth in Sections 4.2 BCM determines that LICENSEE or its Affiliates and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use its Sublicensees have not used Commercially Reasonable Efforts to diligently carry out continue the development and commercialization of Licensed Products, BCM will have the right to provide a written request to LICENSEE to provide further written evidence that LICENSEE, its respective obligations Affiliates and each of its Sublicensees has undertaken continual and regular activities specified in to continue the Development Plan includingLicensed Products development and commercialization. In the event that LICENSEE is unable to show that it, without limitationits Affiliates and/or each of its Sublicensees have undertaken such continual regular activities to develop and commercialize the Licensed Products, adhering then LICENSEE (on behalf of it and its Affiliates and each of its Sublicensees) will have an obligation to provide a detailed development plan to BCM for the timelines set forth therein; 4.1.1.2 prepare continued development and file with commercialization of the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerLicensed Products, and in compliance in all material respects with all requirements would thereafter provide summary updates of Applicable Laws activities every [***]. If such activities thereafter continued to achieve the objectives show a lack of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts for the development and commercialization of the Licensed Products, then BCM would have the right to prepare terminate the license. The Parties agree that if they are unable to agree as to whether the evidence provided by LICENSEE (on behalf of it and file those NDAs its Affiliates and NDA Equivalents each of its Sublicensees) shows continual and other regulatory filings deemed necessary or desirable by Licensee with regular activities to continue the appropriate Governmental Authorities in Licensed Product development and commercialization, a third-party arbitrator would be jointly retained to review the Territory evidence and obtain all Regulatory Approvals make an independent determination and such determination will be final. [***] Notwithstanding the foregoing, the Parties acknowledge that Licensee deems necessary or desirable it might be commercially reasonable, under certain circumstances, for LICENSEE to Commercialize the determine not to launch a Licensed Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating witha specific country, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit failure under such circumstances to the Development Committee (or, upon dissolution launch such Licensed Product shall not be a breach of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Agreement.

Diligence. Licensee agrees 3.1 NEPHROGENEX shall use its commercially reasonable efforts to bring one or more Licensed Products to market through a thorough and diligent program for exploitation of the Licensed Patent Rights and to continue marketing efforts for one or more Licensed Products throughout the life of this Agreement. 3.2 NEPHROGENEX shall have been deemed to have fulfilled its diligence obligations under Paragraph 3.1 above if NEPHROGENEX uses commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to adhere to the following milestones: (i) NEPHROGENEX shall use Commercially Reasonable Efforts commercially reasonable efforts to diligently Developmaintain issued patents and prosecute pending patent applications, Manufacture continuations, continuations in part, divisionals, continued prosecution applications, or reissued thereof, and Commercialize any foreign counterpart consistent with NEPHROGENEX’s business development plan for the commercialization of the Products; (ii) NEPHROGENEX shall use commercially reasonable efforts to establish a research program within one year of the date of this agreement to support efforts to further characterize the action of pyridoxamine in radiation protection and chemo-resistant applications, and acute renal failure; (iii) NEPHROGENEX shall complete IND enabling preclinical studies on either the radiation protection, chemo-resistant or acute renal failure applications within a commercially reasonable time, but no longer than three (3) years from the date of this Agreement, that incorporates the use of the Licensed Product; and (iv) NEPHROGENEX shall initiate a Phase I or Phase IIa clinical trial within one (1) year after filing an IND that incorporates the use of the Licensed Product for indications in the Territory for use in Field. For the Field for all commercially reasonable Indicationspurposes of this Paragraph 3.2, including without limitation, VANDERBILT will consider the Initial Two Indications; except to efforts of Affiliates and sublicensees of NEPHROGENEX as the extent that the responsibility for doing so, as specifically efforts of NEPHROGENEX. 3.3 The milestones set forth in Sections 4.2 and 4.3 of this Agreement and in Paragraph 3.2 above may be adjusted by mutual agreement by the CMC Developmentparties, Manufacture and Supply Agreementwhich agreement will not be unreasonably withheld by VANDERBILT, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in if NEPHROGENEX can demonstrate that good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws faith efforts were made to achieve the objectives milestones and that the failure to achieve the milestones was due to scientific, technical or regulatory reasons beyond the reasonable control of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsNEPHROGENEX.

Diligence. Licensee agrees to use After the Closing Date, InterMune has sole responsibility for all aspects of developing, obtaining Regulatory Approval for, manufacturing and commercializing the Initial Product throughout the Territory. InterMune will devote Commercially Reasonable Efforts (as defined in the following sentence) to diligently Develop, Manufacture obtain and Commercialize maintain Regulatory Approval for the Initial Product in a specific country consistent with the Territory for use Development Plan or to commercialize Initial Product in a specific country consistent with the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 Commercialization Plan. For purposes of this Agreement section only, "Commercially Reasonable Efforts" means the level of effort, expertise and in the CMC Developmentresources required to commercialize Product that a similarly situated biopharmaceutical company would typically devote to a product of similar marketing potential, Manufacture and Supply Agreementprofit potential or strategic value, belongs to Bayerbased on conditions then prevailing. Without limiting the foregoing, Licensee shall: 4.1.1.1 use If Lilly believes that InterMune is not devoting Commercially Reasonable Efforts to diligently carry out for the Initial Product in any country, Lilly will notify InterMune in writing detailing its respective obligations specific concerns and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerrecommendations, and in compliance in all material respects with all requirements the Parties will meet within [*] of Applicable Laws such written notice to achieve discuss such concerns and recommendations. After the objectives last of this Agreement efficiently and expeditiously; 4.1.1.4 maintain recordssuch meeting(s), in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with InterMune will have [*] to devote its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 above. If InterMune subsequently defaults and 3.3.3 above; 4.1.1.9 does not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use devote Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Initial Product in any country, Lilly will have the Territory right to terminate the licenses granted in this Agreement to InterMune for use such specific country pursuant to Section 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 the Field in the form required under all Applicable Lawssuch country. [*] CERTAIN 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. Licensee agrees to (a) ZENYAKU shall use Commercially Reasonable Efforts to diligently Developdevelop, Manufacture seek Regulatory Approval for and Commercialize 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 approval in the ZENYAKU Territory for use 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 Field Joint Development Plan. Accordingly, if ANTHERA fails to conduct the activities within the Joint Development Plan necessary to generate the data for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except Indication, or fails to conduct the extent that CHABLIS-SC1 Study or the responsibility activities within the Joint Development Plan necessary to generate the data for doing soSLE, as specifically then ZENYAKU’s ability to develop and seek Regulatory Approval in the ZENYAKU Territory may be harmed and ZENYAKU shall not to be deemed in breach of its diligence obligation set forth in Sections 4.2 and 4.3 the first sentence of this Agreement Section. *** Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (b) Should ZENYAKU choose to develop the Product for any other Indication, it must so notify ANTHERA in writing (e.g., through the CMC Developmentprocess described above for updating the ZENYAKU Development Plan). If ANTHERA has any concerns, Manufacture the parties shall convene a meeting of the JDC to discuss the matter, and Supply Agreement, belongs ZENYAKU shall reasonably consider ANTHERA’s concerns. ZENYAKU shall not have any obligation to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use devote Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified for any Indication other than the Initial Indication (express or implied, at law or in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerequity), and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted obligations for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit Initial Indication are subject to the Development Committee (or, upon dissolution of the Development Committee, to Bayerlimitations and conditions above in Section 4.5(a), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Laws.

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 (to the extent Licensee receives rights under the AGE-Inhibitor Patent Rights hereunder) 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 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 reasonable efforts to effect the introduction of Pyridorin Products and AGE-Inhibitor Products, Licensee agrees to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize maintain an active commercialization effort defined as meeting any one of the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except following criteria: (1) Funding research or product development programs that directly contribute to the extent commercialization of 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 responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 terms of this Agreement) the product rights licensed or assigned hereunder to another company directed to the development and commercialization of a product that incorporates Pyridorin or an AGE- Inhibitor. 3.3 Subject to the cure period discussed below, BioStratum shall have the right to terminate this Agreement and in the CMC Developmenteffective upon written notice if Licensee does not close a Qualified Series A Financing on or before June 30, Manufacture and Supply Agreement, belongs to Bayer2006. Without limiting Notwithstanding the foregoing, if BioStratum enters into a strategic partnership pursuant to which BioStratum receives nonrefundable proceeds of at least $2,000,000 by June 30, 2006, then the period of time for Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified close a Qualified Series A Financing shall be extended to December 31, 2006. In the event Licensee has not closed a Qualified Series A Financing nor entered into a strategic partnership (as described in the Development Plan includingpreceding sentence) by June 30, without limitation2006, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with receipt of the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, written termination notice described in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives first sentence of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which Section 3.3 shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports trigger a forty-five (including, without limitation, adverse event reports45) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted day cure period (the “Marketing PlansCure 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 provide copies 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 in no event shall BioStratum enter into such discussions during such cure period with a venture 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 Cure Period, then this Agreement shall terminate upon the expiration of the Marketing Plans Cure Period. For purposes of clarification, Licensee shall only be permitted to Bayer take advantage of one Cure Period, unless otherwise consented by BioStratum. 3.4 BioStratum shall have the right to terminate 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) initiate a new Phase II clinical trial of Pyridorin Product as soon as practicable after preparation and as frequently as may be required based upon Licensee’sa treatment for diabetic nephropathy, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30ii) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication enter into a contract with a strategic partner for which provides funding reasonably sufficient to support the development of a Pyridorin Product is in Developmentas a treatment for diabetic nephropathy, furnish Bayer or (iii) close a Qualified Series B Financing. Upon Licensee's request, BioStratum may provide Licensee with reasonably detailed summary written reports on all activities conducted by Licensee an additional 90 day period to Commercialize meet the Product for use in the Field during foregoing requirement. Approval of such calendar year; and 4.1.1.12 maintain recordsrequest shall not be unreasonably withheld, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsconditioned or delayed.

Diligence. Licensee agrees to LICENSEE will, and will cause its Affiliates and each of its Sublicensees to, use Commercially Reasonable Efforts to diligently Develop, Manufacture develop and Commercialize the Product commercialize Licensed Product(s) in the Territory for use in Major Markets as soon as practicable. Beginning on [***] of the Field for all commercially reasonable IndicationsAgreement Date and continuing [***] until the [***], including without limitationLICENSEE will, and will cause its Affiliates and each of its Sublicensees to provide annual summary updates to BCM summarizing the Initial Two Indications; except activities undertaken by LICENSEE, its Affiliates and each of its Sublicensees to continue the extent development and commercialization of the Licensed Products. In the event that the responsibility for doing so, as specifically set forth in Sections 4.2 BCM determines that LICENSEE or its Affiliates and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use its Sublicensees have not used Commercially Reasonable Efforts to diligently carry out continue the development and commercialization of Licensed Products, BCM will have the right to provide a written request to LICENSEE to provide further written evidence that LICENSEE, its respective obligations Affiliates and each of its Sublicensees has undertaken continual and regular activities specified in to continue the Development Plan includingLicensed Products development and commercialization. In the event that LICENSEE is unable to show that it, without limitationits Affiliates and/or each of its Sublicensees have undertaken such continual regular activities to develop and commercialize the Licensed Products, adhering then LICENSEE (on behalf of it and its Affiliates and each of its Sublicensees) will have an obligation to provide a detailed development plan to BCM for the timelines set forth therein; 4.1.1.2 prepare continued development and file with commercialization of the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerLicensed Products, and in compliance in all material respects with all requirements would thereafter provide summary updates of Applicable Laws activities every [***]. If such activities thereafter continued to achieve the objectives show a lack of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts for the development and commercialization of the Licensed Products, then BCM would have the right to prepare terminate the license. The Parties agree that if they are unable to agree as to whether the evidence provided by LICENSEE (on behalf of it and file those NDAs its Affiliates and NDA Equivalents each of its Sublicensees) shows continual and other regulatory filings deemed necessary or desirable by Licensee with regular activities to continue the appropriate Governmental Authorities in Licensed Product development and commercialization, a third-party arbitrator would be jointly retained to review the Territory evidence and obtain all Regulatory Approvals make an independent determination and such determination will be final[***]. Notwithstanding the foregoing, the Parties acknowledge that Licensee deems necessary or desirable it might be commercially reasonable, under certain circumstances, for LICENSEE to Commercialize the determine not to launch a Licensed Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating witha specific country, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit failure under such circumstances to the Development Committee (or, upon dissolution launch such Licensed Product shall not be a breach of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsthis Agreement.

Diligence. Licensee agrees to (a) Pfizer shall use Commercially Reasonable Efforts to diligently Developdevelop, Manufacture obtain Regulatory Approval for and Commercialize the Launch a Licensed Product in ***. (b) Notwithstanding any provision of this Agreement to the Territory contrary, Pfizer will be relieved of all diligence obligations under Section 5.8(a) to the extent that: (i) Pfizer or Lpath receives or generates any safety, tolerability or other data reasonably indicating, as measured by Pfizer’s safety and efficacy evaluation criteria and methodology, or signaling that a Licensed Product has or would have an unacceptable risk-benefit profile for use in the Field or is otherwise not reasonably suitable for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 initiation or continuation of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use clinical studies in the Field; 4.1.1.6 own all INDs(ii) Pfizer or Lpath receive any notice, IND Equivalents, NDAs and NDA Equivalents submitted for the information or correspondence from any applicable Regulatory Authority or any applicable Regulatory Authority takes any action that reasonably indicates that a Licensed Product in the Territory for use is unlikely to receive Regulatory Approval in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for . (c) Pfizer’s achievement of the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit Event Milestone relating to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, *** as set forth in Sections 3.2 Section 6.1, entitling Lpath to receive the corresponding Event Milestone Payment, will be conclusive evidence that Pfizer has satisfied all diligence obligations under Section 5.8(a) up to the date that such Event Milestone is achieved. In addition, Pfizer’s achievement of the Event Milestones relating to the *** as set forth in Section 6.1, entitling Lpath to receive the corresponding Event Milestone Payments, will be conclusive evidence that Pfizer has satisfied all diligence obligations under Section 5.8(a); *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. 22 (d) If Lpath is aware, becomes aware or reasonably should be aware of facts that might form a reasonable basis to allege that Pfizer has failed to meet any of its obligations under Section 5.8(a), then Lpath will promptly notify Pfizer in writing of such potential alleged performance failure (each such potential alleged performance failure, a “Diligence Issue”). Promptly upon Pfizer’s receipt of any notice of a Diligence Issue pursuant to this Section 5.8(d), the Pfizer Alliance Manager will contact the Lpath Alliance Manager to discuss the specific nature of such Diligence Issue and 3.3.3 above; 4.1.1.9 not seek to identify an appropriate corrective course of action. If, no later than *** days after Pfizer’s receipt of such a notice, (a) the commencement Parties have not reached consensus regarding whether Pfizer has failed to satisfy its obligations pursuant to Section 5.8(a), and (b) the Parties’ respective Alliance Managers have not agreed upon an appropriate corrective course of Phase III Clinical Trialsaction for such Diligence Issue, prepare overviewthen such Diligence Issue will be escalated and resolved by a Vice President of Pfizer (or his or her designee who shall have appropriate decision-marketing plans for making authority) and the ProductChief Executive Officer of ▇▇▇▇▇ (or his or her designee who shall have appropriate decision-making authority). If Lpath fails to notify Pfizer of a Diligence Issue pursuant to this Section 5.8(d) within *** days after the date that Lpath first discovers, or based on the information provided by Pfizer reasonably should have discovered, such Diligence Issue, then Pfizer will be deemed to have satisfied its obligations under Section 5.8(a) with respect to such Diligence Issue. (e) If Pfizer materially breaches its obligations under Section 5.8(a) and fails to remedy such breach within *** days of Pfizer’s receipt of notice of such breach from Lpath, then Lpath may, in its sole discretion, elect to either ***. Lpath acknowledges and agrees that the elections set forth in this Section 5.8(e): (i) have been negotiated by the Parties to fully address any harm that Lpath may incur as a result of Pfizer’s material breach of Pfizer’s obligations under Section 5.8(a); and (ii) constitute Lpath’s sole and exclusive remedies with respect to any breach by Pfizer of Pfizer’s obligations under Section 5.8(a), and Pfizer acknowledges and agrees that this sentence shall not be construed to limit or preclude such recoveries or other remedies to which shall include plans related Lpath may be entitled at law or equity with respect to the pre-launch, launch, marketing, promotion breaches of this Agreement by Pfizer other than material breach of Pfizer’s obligations under Section 5.8(a). (f) If Pfizer makes a formal decision to discontinue all development and sale commercialization of the Product for use Licensed Products in the Field and which shall include forecasts for the number Major Market Countries, or in fact discontinues development and commercialization of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use Licensed Products in the Field during for the Major Market Countries (and does not intend to resume such calendar year; and 4.1.1.12 maintain recordsmaterial activities within *** months after such discontinuation), Pfizer agrees to notify Lpath in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved writing within *** days of such formal decision or discontinuation in connection fact. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Laws.Commission. 23

Diligence. Licensee agrees 3.1.1 From and after the Licence Agreement Effective Date Amgen shall: (a) use diligent and timely efforts to satisfactorily complete Research of Licensed Antibody Products and obtain in [*] for a Licensed Antibody Product an IND. For the avoidance of doubt, nothing in this Licence Agreement shall preclude Amgen from filing INDs in [*]; (b) use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in the Field for satisfactorily complete all commercially reasonable Indications, including without limitation, the Initial Two IndicationsDevelopment activities with respect to a Licensed Antibody Product; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall:and 4.1.1.1 (c) use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified obtain Regulatory Approval to Commercialise a Licensed Antibody Product; in each case for the Development Plan including[*] or if the [*] is dropped, without limitation, adhering to the timelines set forth therein;[*]; and 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 (d) use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the maximise Net Sales of each Licensed Antibody Product in the Territory for use 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 Field;Collaboration Agreement. 4.1.1.6 own all INDs, IND Equivalents, NDAs 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 NDA Equivalents submitted obtaining Regulatory Approvals to Commercialise such Licensed Antibody Product for the Product in [*] (or if the Territory for use [*] is dropped, [*]) in the Field, together with all Regulatory Approvals and other regulatory filings to Commercialise such Licensed Antibody Product [*]. For the avoidance of doubt, Development and approvals for Commercialisation in each instance includes the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, manufacture and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution supply of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status Licensed Antibody Product. If Amgen decides that deployment of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts does not justify it making continued, ongoing efforts towards this objective it shall promptly notify Celltech in writing. 3.1.3 Amgen shall not be in breach of any obligation under this Licence Agreement to the extent its inability to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end such obligation is caused by Celltech’s failure to perform any of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required its obligations under all Applicable Laws.this Licence Agreement or under Article 14.9

Diligence. Licensee agrees 3.1.1 From and after the Licence Agreement Effective Date Amgen shall: (a) use diligent and timely efforts to satisfactorily complete Research of Licensed Antibody Products and obtain in [*] for a Licensed Antibody Product an IND. For the avoidance of doubt, nothing in this Licence Agreement shall preclude Amgen from filing INDs in [*]; (b) use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in the Field for satisfactorily complete all commercially reasonable Indications, including without limitation, the Initial Two IndicationsDevelopment activities with respect to a Licensed Antibody Product; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall:and 4.1.1.1 (c) use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified obtain Regulatory Approval to Commercialise a Licensed Antibody Product; in each case for the Development Plan including[*] or if the [*] is dropped, without limitation, adhering to the timelines set forth therein;[*]; and 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 (d) use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the maximise Net Sales of each Licensed Antibody Product in the Territory for use 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 Field;Collaboration Agreement. 4.1.1.6 own all INDs, IND Equivalents, NDAs 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 NDA Equivalents submitted obtaining Regulatory Approvals to Commercialise such Licensed Antibody Product for the Product in [*] (or if the Territory for use [*] is dropped, [*]) in the Field, together with all Regulatory Approvals and other regulatory filings to Commercialise such Licensed Antibody Product [*]. For the avoidance of doubt, Development and approvals for Commercialisation in each instance includes the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, manufacture and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution supply of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status Licensed Antibody Product. If Amgen decides that deployment of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts does not justify it making continued, ongoing efforts towards this objective it shall promptly notify Celltech in writing. 3.1.3 Amgen shall not be in breach of any obligation under this Licence Agreement to the extent its inability to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end such obligation is caused by Celltech's failure to perform any of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required its obligations under all Applicable Laws.this Licence Agreement or under Article 14.9

Diligence. Licensee agrees Except as limited by Section 2.4(c), effective as of the Effective Date, Schering and its Affiliates shall, at Schering’s expense, use commercially reasonable efforts to use Commercially Reasonable Efforts obtain Regulatory Approval for and to diligently Develop, Manufacture and Commercialize commercialize the Product Product(s) in the Field in the Territory for use such indications as Schering determines are desirable. The Parties acknowledge and agree that nothing herein shall be construed as obligating Schering to obtain Regulatory Approval for and/or to commercialize more than [***] in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture Territory. The Parties further acknowledge and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan agree that all business decisions including, without limitation, adhering decisions relating to Schering’s research, development, registration, manufacture, sale, commercialization, design, pricing, distribution, marketing and promotion of Products covered under this Agreement, shall be within the timelines set forth therein; 4.1.1.2 prepare sole discretion of Schering. Accordingly, Schering shall be responsible, at its cost and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific mannerexpense, and in compliance in its sole judgment, for all material respects with all requirements of Applicable Laws activities that are necessary to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain recordsobtain [***] 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 UNDER THE SECURITIES EXCHANGE ACT OF 1934, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all AS AMENDED. Regulatory Approvals that Licensee deems necessary or desirable to Commercialize Approval for the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted any post-approval studies required as a condition of obtaining any Regulatory Approval for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities Field in the Territory; 4.1.1.8 submit to . Schering shall also be responsible, at its cost and expense, and in its sole judgment, for determining the Development Committee (orappropriate regulatory strategy for obtaining and maintaining all Regulatory Approvals, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product including any pricing and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans reimbursement approvals required for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use Products in the Field in the form required Territory. Schering shall own the Business Information, the R&D Results, and all other data and information arising out of any and all studies or other research and development or commercial activities performed by or on behalf of Schering under all Applicable Lawsthis Agreement. Each Regulatory Approval, including pricing and reimbursement approvals, shall be owned by and held in the name of Schering or its designated Affiliate. ViroPharma acknowledges that Schering is in the business of developing, manufacturing and selling pharmaceutical products and nothing in this Agreement shall be construed as restricting such business or imposing on Schering the duty to market and/or sell and exploit Compound or Products for which royalties are payable hereunder to the exclusion of, or in preference to, any other product, or in any way other than in accordance with its normal commercial practices. The Parties acknowledge and agree that nothing in this Section 4.2 shall be construed as obligating Schering or its Affiliates to any greater diligence obligations for the Products in the Territory than those expressly provided for under Section 4.4 of the SaSy Agreement.

Diligence. Licensee agrees 4.1 LICENSEE accepts that commercialization of the Licensed Product or Licensed Services is of utmost importance to MSK. LICENSEE shall use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indicationsefforts to achieve all Milestone Activities for the first Licensed Product or Licensed Service on or prior to the Expected Completion Date listed below. If LICENSEE is unable to meet such milestones, including without limitationit shall notify MSK as far in advance as practical of the likely inability, and the Parties shall discuss in good-faith modification of the schedule; if technical, scientific, or regulatory (but not economic or financial) impediments beyond the control of LICENSEE were the substantial cause of the delay, MSK will agree to a reasonable modification. Further, LICENSEE shall have the option of unilaterally extending any of the following milestones by [*] upon payment to MSK of [*], plus an additional [*] upon payment to MSK of an additional [*], but no more than [*] in total for each milestone, e.g., the Initial Two Indications; except first milestone could be extended at LICENSEE’s option to within [*] of the Effective Date and then again to within [*] by making such payments, but not beyond that date. Without limiting the generality of the foregoing, it shall be inconsistent with the exercise of commercially reasonable efforts for LICENSEE [*]. [*] if LICENSEE cannot provide proof of its commercially reasonable efforts towards the development of a Licensed Product or Licensed Service or fails to achieve a Development Milestone Activity associated with the development of said Licensed Product or Licensed Service on or prior to the extent Expected Completion Date. Development Milestone Activities may be modified and Expected Completion Dates extended with MSK’s written approval and, upon LICENSEE’s request, the Parties shall discuss and negotiate in good faith any reasonable extensions of the applicable Expected Completion Dates that may be necessary despite LICENSEE’s use of its commercially reasonable efforts towards the responsibility development of a Licensed Product or Licensed Service. (a) LICENSEE shall use commercially reasonable efforts to (i) bring at least one (1) Licensed Product or Licensed Service to market through a thorough, vigorous and diligent program for doing soexploitation of the Licensed Rights, as specifically set forth and (ii) following the first commercial sale of a Licensed Product or Licensed Service in Sections 4.2 any country of the Territory, continue active, diligent marketing efforts for such Licensed Product or Licensed Service and 4.3 make continuing sales of this Agreement such Licensed Product and Licensed Service in such country throughout the CMC Development, Manufacture and Supply Agreement, belongs to BayerTerm. Without limiting the foregoing, Licensee shall:such commercially reasonable efforts shall include achieving the following milestones: [*] Within [*] of Effective Date [*] Within [*] of Effective Date [*] Within [*] of Effective Date [*] Within [*] of Effective Date [*] Within [*] of Effective Date 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations (b) LICENSEE shall give MSK written notice and activities specified evidence within [*] of the achievement of each of the above specific diligence obligations. [*] = Certain confidential information contained in the Development Plan includingthis document, without limitationmarked by brackets, adhering to the timelines set forth therein; 4.1.1.2 prepare has been omitted and file filed separately with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee Securities and Exchange Commission pursuant to undertake Development activities includingRule 406 of the Securities Act of 1933, without limitation, all INDs and IND Equivalents, in the Territory;as amended. 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted (c) LICENSEE’s detailed business plan for the Product in development of the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the FieldLicensed Rights, including, without limitationfor example, communicating withrelevant schedules of capital investments needed to implement the plan, financial, equipment, facility plans, number and preparing kind of personnel and filing all reports (includingtime planned for each phase of development of the Licensed Rights for a [*] period, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (orextent formed by LICENSEE, upon dissolution will be provided by LICENSEE within [*] of the Development CommitteeEffective Date and will be annexed hereto and made part of this Agreement. LICENSEE shall provide similar reports to MSK annually to relay update and status information on LICENSEE’s business, to Bayer)research and development progress, on a quarterly basis, a reasonably detailed written report describing the status including projections of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans activity anticipated for the Productnext reporting year. (d) LICENSEE shall be solely responsible, which shall include plans related to the pre-launchat its sole cost and expense, launchfor securing any necessary governmental or regulatory approvals for development, marketingmanufacture, promotion and sale of Licensed Products and performance of Licensed Services (“Regulatory Approval”). LICENSEE shall advise MSK, through annual reports described in Section 4.1(c) above, of its program of development for obtaining said Regulatory Approvals. (e) LICENSEE shall perform the Product for use Feasibility Study diligently and at its sole cost and expense. LICENSEE shall conclude the Feasibility Study as promptly as possible and in all events within [*] after the Field and which Effective Date. During the Feasibility Study, LICENSEE shall include forecasts for the number regularly share any data generated with MSK. Should any data be generated by MSK under Exhibit D funded by LICENSEE, MSK will likewise regularly share such data with LICENSEE. The recipient shall treat such data as confidential in accordance with Section 9 of sales representatives, and a reasonably descriptive overview this Agreement. If results of the marketing campaigns proposed Feasibility Study do not indicate that [*], LICENSEE can terminate this Agreement upon [*] prior written notice to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after MSK. At the end of each calendar year after the commencement Feasibility Study, LICENSEE shall notify MSK in writing whether or not it will exercise its rights to terminate this Agreement pursuant to the foregoing sentence. Without limitation to Section 16.8, termination under this Section 4.1 (e) shall not relieve LICENSEE from obligations (x) that have already been accrued prior to the termination date and/or (y) in respect of Phase III Clinical Trials for each Indication for which costs and/or commitments that cannot be cancelled. 4.2 If LICENSEE is the subject of a demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product is in Developmentor Licensed Service that (i) by its terms directs or contemplates, furnish Bayer or may reasonably be expected to require or relate to, suspension or cessation of manufacturing, sale, development, or marketing of Licensed Products or Licensed Services efforts, (ii) concerns a recall or potential recall of Licensed Products or Licensed Services, (iii) concerns a loss of life or material issue of safety, or (iv) may reasonably be expected to prevent LICENSEE’s compliance with its diligence obligations, then LICENSEE shall provide a copy to MSK without delay and keep MSK reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization apprized of the Product in the Territory for use in the Field in the form required under all Applicable Lawsits response.

Diligence. Licensee agrees to CASI shall use Commercially Reasonable Efforts to diligently Develop, Manufacture (a) Develop the Licensed Product according to the CASI Development Plan and Commercialize (b) Develop the Licensed Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, [***] Indications in the Territory; 4.1.1.3 conduct all Preclinical , which shall be selected by CASI pursuant to Section 4.1(c) or Section 4.1(d). CASI shall maintain and utilize qualified staff, laboratories, offices and other facilities as needed to Develop the Licensed Product and shall use personnel with skills and experience as may be required to accomplish efficiently and expeditiously such tasks and objectives of the CASI Development and Clinical Development Plan in a good scientific manner, manner and in compliance in all material respects with all requirements Applicable Laws, and cGLP, cGCP and cGMP standards, as applicable. CASI shall, as part of its obligations hereunder (i) obtain all required Regulatory Authority and ethic committee and independent review board approvals prior to conducting any Clinical Trials involving human subjects and (ii) obtain all the consents required by Applicable Laws Law from the human subjects participating in any Clinical Trials conducted by CASI. In particular, with regards to the first Indication, CASI shall achieve the milestones set out in Exhibit D. Any anticipated failure to achieve any such milestones shall be discussed within the objectives JSC, which has the authority, pursuant to Section 3.2, to adjust such milestone in the 22 ​ CASI Development Plan. Each of the deadlines for the Development milestones provided above will be extended by the duration of any delays that are encountered during the course of Development and caused by events outside of the control of CASI, including: (a) Force majeure; (b) An Adverse Event reported pursuant to the Safety and Pharmacovigilance Agreement; (c) Unforeseen bona fide regulatory delays; (d) Any delay by BioInvent in completing the Initial Technology Transfer in accordance with Section 4.3(a); (e) Any delay by BioInvent in achieving its covenant set forth in and in accordance with Section 11.2(n); (f) Any delay by BioInvent in achieving its covenant set forth in and in accordance with Section 11.2(p); (g) The failure of BioInvent or its Third Party licensees or sublicensees to fulfill its obligations under this Agreement efficiently and expeditiouslyor to supply the required Licensed Products to CASI with timelines provided in the Supply Agreement with such failure resulting in a ▇▇▇▇ ▇▇▇▇▇; 4.1.1.4 maintain records(h) Any extension agreed upon in writing by both Parties, in sufficient detail and in good scientific mannerfor example, coincidentally with an amendment to the CASI Development Plan; and (i) Any other event that caused an actual delay for which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all CASI is not responsible or accountable for (including, e.g., changes to Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection requested consultation meetings with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities Authority in the Territory; 4.1.1.8 submit to the Development Committee (, or, upon dissolution of if a Regulatory Authority places a BioInvent product on regulatory hold outside the Development CommitteeTerritory, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth resulting in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans regulatory hold being put in place for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries CASI in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Laws).

Diligence. Licensee agrees to LICENSEE shall use Commercially Reasonable Efforts to diligently Developresearch, Manufacture develop and Commercialize the commercialize a Licensed Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form Territory. For purposes of this Section 4.3, the efforts of LICENSEE’s Related Parties shall also be considered the efforts of LICENSEE. LICENSEE will be deemed to have demonstrated Commercially Reasonable Efforts if, within [**] years of the Effective Date, LICENSEE has (a) achieved the Additional License Agreements Milestone or (b) established a scientific program, including a research plan and budget, with respect to a protein-based interleukin-1 antagonist program. Within [**] months of the first to occur of the achievement by LICENSEE of either (a) or (b) above and the [**] anniversary of the Effective Date, the Parties will negotiate in good faith and agree upon a set of diligence milestones to be achieved by LICENSEE with respect to the development and commercialization of Licensed Products, which will be included in writing as an Appendix to this Agreement. In the event LICENSEE determines that it is unable to meet, or otherwise fails to meet, a diligence milestone, LICENSEE will notify LICENSOR in writing and provide an explanation of the reasons that the diligence milestone has not or will not be met. The Parties will promptly negotiate in good faith an amendment to the diligence milestone which may include a reasonable extension of the time required under all Applicable Lawsto achieve the milestone based on the circumstances and LICENSEE’s explanation and an obligation of LICENSEE to provide periodic status reports to LICENSOR with respect to its efforts to develop and commercialize Licensed Products, which amendment will be included as an update to the relevant Appendix to this Agreement.

Diligence. Licensee agrees a. Company (itself or through its Affiliates or Sublicensees) shall use commercially reasonable efforts to use Commercially Reasonable Efforts to diligently Developresearch, Manufacture discover, develop and Commercialize the market at least one (1) Tianeptine Product and at least one (1) Mitragynine Product for commercial sale and distribution in the Territory for use Territory. Company shall be deemed to meet such “commercially reasonable efforts” in the Field for event it achieves all commercially reasonable Indications, including without limitation, of the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically due diligence milestones set forth in Sections 4.2 this Article 6. Company shall achieve the following due diligence milestones (“Milestones”) for at least one Tianeptine Product and 4.3 at least one Mitragynine Product by the dates (“Achievement Dates”) as set forth below: i. Due Diligence Milestones for the Tianeptine Products: ii. Due Diligence Milestones for the Mitragynine Products: b. In the event that Company is unable to achieve the diligence milestones in Section 6a(i), Columbia may exercise its right in accordance with Section 15 solely to terminate the license under the Tianeptine Patents and Tianeptine Technical Information granted to Company in Section 2, but not under the Mitragynine Patents or Mitragynine Technical Information. In the event that Company is unable to achieve the diligence milestones in Section 6a(ii), Columbia may exercise its right in accordance with Section 15 solely to terminate the license under Mitragynine Patents and Mitragynine Technical Information granted to Company in Section 2, but not under the Tianeptine Patents or Tianeptine Technical Information. Notwithstanding any other provisions of this Agreement, if Company does not achieve any of Company’s diligence obligations under this Section, Columbia may terminate all of the licenses granted under Section 2 in accordance with Section 16 of this Agreement, or Columbia may convert any or all of such exclusive licenses to non-exclusive licenses with no right to sublicense and no right to initiate legal proceedings under Section 11; provided that Company may first request a reasonable extension to the performance period of the above milestones and Columbia shall reasonably grant such extension if Company has exercised commercially reasonable efforts to achieve the target completion date and has a plan to achieve it within the extension period. c. No less often than every twelve (12) months after the Effective Date of this Agreement and until the date of the first bona fide commercial sale of a Product, Company shall report in writing to Columbia on progress made toward the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines diligence objectives set forth therein; 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee above, using Exhibit D to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory; 4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in or an equivalent to Exhibit D to make the form required under all Applicable Laws; 4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field; 4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field; 4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territory; 4.1.1.8 submit to the Development Committee (or, upon dissolution of the Development Committee, to Bayer), on a quarterly basis, a reasonably detailed written report describing the status of the Development of the Product and summarizing all Non-Strategic Amendments made to the Development Plan, together with a copy of the Development Plan, as set forth in Sections 3.2 and 3.3.3 above; 4.1.1.9 not later than the commencement of Phase III Clinical Trials, prepare overview-marketing plans for the Product, which shall include plans related to the pre-launch, launch, marketing, promotion and sale of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview of the marketing campaigns proposed to be conducted (the “Marketing Plans”) Licensee shall provide copies of the Marketing Plans to Bayer as soon as practicable after preparation and as frequently as may be required based upon Licensee’s, its Affiliates’ or Sublicensees’, usual marketing campaign cycles, but in no case less than once each calendar year; 4.1.1.10 use Commercially Reasonable Efforts to perform pre-commercialization analysis, planning, market preparation, and related marketing activities for all countries in the Territory; 4.1.1.11 within thirty (30) Business Days after the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in Development, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use in the Field during such calendar year; and 4.1.1.12 maintain records, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable Lawsreport.