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 Tengion will use commercially reasonable efforts to bring CHB Licensed Products and WFUHS Licensed Products to market through a thorough and diligent program for exploitation of the CHB Patent Rights, WFUHS Patent Rights and the Know-How. Tengion shall not be required to be researching and developing Licensed Products in all or multiple subfields within the Licensed Field simultaneously in order to be deemed in compliance with the foregoing sentence. 5.2 If WFUHS believes Tengion shall have failed to comply with the provisions of this Article 5, WFUHS shall notify Tengion of the same. 5.2.1 Upon receipt of such notice, Tengion shall have a period of sixty (60) days to (i) demonstrate to WFUHS’s reasonable satisfaction that it has complied with the provisions of Article 5.1, (ii) trigger the ADR provisions of Article 18 or (iii) notify WFUHS that it agrees to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product with WFUHS. If Tengion does not satisfy clauses (i) or (ii) above or Tengion is found in the Territory for use ADR proceedings to have not complied with Article 5.1 or if Tengion provides the notice contemplated in clause (iii) above, then Tengion shall, within the Field for all immediately following one (1) year period, exercise commercially reasonable Indicationsefforts to grant a sublicense to a third party with respect to a subfield within the Field. 5.2.2 If at the end of such one (1) year period, including without limitationTengion has failed to enter into such subfield sublicense, WFUHS may, within the Initial Two Indications; except immediately following one (1) year period negotiate the subfield field of use sublicense directly with a third party. If WFUHS negotiates such sublicense within such time, then Tengion shall enter into a subfield field of use sublicense with such third party, provided that such sublicense (a) is on terms that are substantially similar to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 terms of this Agreement (except the financial terms), (b) does not obligate Tengion to spend money or dedicate resources, (c) shall exclude any Licensed Product (or related rights to such Licensed Product) that has been or is under active development or is being commercialized by Tengion 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 (d) is restricted to the timelines set forth therein;subfield as to which Tengion has attempted, but failed, to comply with Article 5. 4.1.1.2 prepare and file with 2.1. Tengion must execute such sublicense or initiate ADR proceedings (if, for example, it believes that one or more of clauses (a) - (d) above have not been satisfied) within ten (10) days of receiving the applicable Governmental Authorities those regulatory filings negotiated field of use sublicense from WFUHS. 5.2.3 If Tengion fails exercise the sublicense or initiate ADR proceedings within such ten (10) day period, it shall be deemed necessary to have granted WFUHS an irrevocable power of attorney to execute such sublicense on its behalf. If an arbitrator finds that Tengion has initiated ADR proceedings without reasonable factual or desirable by Licensee legal basis or solely in order to undertake Development activities includingdelay further development, without limitation, all INDs and IND Equivalents, in he or she shall have to power to order 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 termination of this license under this Agreement efficiently and expeditiously;within the subfield of the Licensed Field as to which Tengion has failed to comply with Article 5.1. * Confidential Treatment Requested 14 4.1.1.4 maintain records5.2.4 If WFUHS is unable to negotiate a sublicense as contemplated above within such one (1) year period, in sufficient detail and in good scientific mannerthen Tengion’s license hereunder will continue without any change or consequence, 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 subject to the Development Committee (or, upon dissolution terms and conditions 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 4.2.1 Subject to the terms of this Agreement, BI shall use its Commercially Reasonable Efforts to progress the Non-clinical and Clinical Development of the Licensed Vaccines and Licensed Products in accordance with the respective Development Plans, including the Development Plan attached hereto as Exhibit 4.2 and as modified and amended by the JSC from time to time in accordance with Section 8 below ("CV9202 Development Plan") and to Commercialize the Licensed Products in the Territory, provided, however that Development activities listed in the CV9202 Development Plan under the heading "Life Cycle Management" shall be at Bl’s sole discretion. Notwithstanding the foregoing, after First Commercial Sale of the first Licensed Product in a Major Market Country the JSC shall discuss and decide whether such Licensed Product will be Developed in a second and/or third indication. If the JSC decides to Develop such Licensed Product in a second and/or third indication, the Parties shall amend the respective Development Plan and Bl’s diligence obligations will be increased so that BI shall use its Commercially Reasonable Efforts to also progress the Non-clinical and Clinical Development of such second and/or third indication. The Development Plans are to set forth, inter alia, (a) the Development work (including CMC Development) to be performed by BI and by CureVac under and during the term of this Agreement; (b) the activities to be performed by CureVac to support the Non-clinical and Clinical Development as further specified in Section 4.1 above; (c) the Clinical Trials to be performed for each clinical phase, including (i) the Clinical Trials to be performed for the Afatinib Vaccine; and (ii) the Clinical Trials to be performed for the Chemo-Radiation Vaccine; and (d) the time estimated for each Clinical Trial. 4.2.2 In the event BI exercises its option under Article 3 above, BI shall promptly prepare a Development Plan for the Option Vaccine, such Development Plan to meet the criteria set forth under Section 4.2.1 above, coordinate such Development Plan for approval within the JSC, and use its Commercially Reasonable Efforts to progress the Non-clinical and Clinical Development of the Option Vaccine and any Licensed Product containing such Option Vaccine in accordance with the Development Plan, and to Commercialize such Licensed Product in the Territory. For the avoidance of doubt, the diligence obligations under Section 4.2.4 below shall also apply to the Option Vaccine in the event BI exercises such option. 4.2.3 BI shall initiate the clinical development with CV9202 of: (a) [*****]; and (b) [*****], and not terminate or halt the Non-clinical and Clinical Development unless there are substantial and reasonable technical, safety, efficacy and/or regulatory reasons for doing so, and details of such technical safety, efficacy and/or regulatory have been notified to CureVac in writing through the JSC. EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL 4.2.4 The diligence obligations set forth above include the following specific activities: BI shall (a) use its Commercially Reasonable Efforts, subsequent to the respective positive Phase I and Phase II Clinical Trials referenced in Section 4.2.3 above, to initiate Phase III Clinical Trials regarding the Licensed Vaccines; (b) conduct all Non-clinical and Clinical Development activities in a timely manner and allocate such Development budgets as are reasonable and adequate to progress the Non-clinical and Clinical Development of Licensed Vaccines hereunder; (c) when appropriate based on satisfactory data obtained during the Non-clinical and Clinical Development, use its Commercially Reasonable Efforts to secure all required Regulatory Approvals in the Major Market Countries following completion of all appropriate Clinical Trials; and (d) use its Commercially Reasonable Efforts to make the First Commercial Sale of the Licensed Products in each Major Market Country following the issuance of the Regulatory Approvals as well as pricing and reimbursement approvals (if any). For the avoidance of doubt, the specific diligence obligations under (a) to (d) shall not apply outside of the Major Market Countries. 4.2.5 The Parties agree that Bl will assume all of CureVac’s rights and obligations (Vertragsubernahme) under the collaboration agreement between CureVac, the Cancer Research Institute and the Lxxxxx Institute for Cancer Research (the Cancer Research Institute and the Lxxxxx Institute for Cancer Research collectively "LICR") entered into as of October 21, 2013 ("LICR Collaboration Agreement"), and CureVac 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 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 Bayerprocure LICR’s consent thereto. Without limiting the foregoing, Licensee shall: 4.1.1.1 BI will use Commercially Reasonable Efforts and collaborate with LICR to diligently carry out its respective obligations [*****], provided, however, that BI is not obliged to (a) [*****]; or (b) perform studies with a commercially available [*****]. For purposes of this Agreement, any data and activities specified information generated by the LICR in such combination trials and not in the Development Plan including, without limitation, adhering public domain shall be considered Confidential Information of BI. BI will grant and hereby grants to CureVac a non-exclusive license to any such Confidential Information generated by the LICR and Controlled by BI with respect to the timelines set forth therein;[*****] for CureVac to use such Confidential Information in support and promotion of its RNActive technology for any purposes other than the Licensed Vaccines, provided, however, that (i) CureVac shall disclose such Confidential Information to a Third Party solely under an appropriate confidentiality agreement with such Third Party and (ii) prior to such disclosure to a Third Party CureVac shall send to BI the Confidential Information CureVac wishes to disclose and CureVac agrees to withhold disclosure of same for the time necessary to permit BI to obtain optimum patent protections such time period not to exceed [*****] except as required for coordination of such patent protection with Bl’s collaboration partners other than CureVac. CureVac shall comply with Bl's request to withhold disclosure for the time necessary to permit BI to obtain optimum patent protection. In the event CureVac is, despite its Commercially Reasonable Efforts, unable to transfer its rights and obligations regarding the Licensed Vaccines under the LICR Collaboration Agreement to BI, CureVac will exercise the LICR Collaboration Agreement with respect to the Licensed Vaccines upon the direction of BI and BI shall refund any payments to be made to LICR and any costs incurred by CureVac under the collaboration with LICR with respect to the Licensed Vaccines to CureVac. EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL 4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee 4.2.6 Subject to undertake Development activities includingSection 6.3 below, 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 CureVac shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with use 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 progress 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 CMC Development of the Product Licensed Vaccines in accordance with the respective Development Plans for the Licensed Products. In particular, CureVac shall conduct all CMC Development activities in a timely manner and summarizing all Non-Strategic Amendments made allocate such budgets as are reasonable and adequate to progress the CMC Development of Licensed Vaccines at CureVac hereunder in accordance with the Development PlanPlans. Upon CureVac's request, 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 BI 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 support CureVac in the Territory; 4.1.1.11 within thirty (30) Business Days after CMC Development by providing any information and/or documentation required by CureVac for the end of each calendar year after the commencement of Phase III Clinical Trials for each Indication for which the Product is in CMC 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 Sanofi shall use Commercially Reasonable Efforts to Commercialize the LX4211 Product in the Major Markets in the Territory for T1DM and T2DM, following receipt of Regulatory Approval for the applicable indication in the applicable country; provided that if Lexicon exercises the (Co-)Promotion Right, Sanofi’s obligation to use Commercially Reasonable Efforts shall not extend to diligently Develop, Manufacture the responsibilities allocated to Lexicon under the (Co-)Promotion Agreement and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indicationsapplicable T1DM Commercialization Plan; except provided further Sanofi shall be excused from such obligation to the extent that Lexicon fails to perform its obligations on which Sanofi’s performance depends. If Lexicon exercises the responsibility for doing so(Co-)Promotion Right, 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 Lexicon 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 analysisits obligations in the United States under the T1DM Commercialization Plan. Without limiting Sanofi’s obligations hereunder, planning, market preparation, and related marketing activities for all countries Sanofi shall promptly notify Lexicon of any decision to cease using Commercially Reasonable Efforts to Commercialize any Licensed Product in any Major Market 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 . Lexicon acknowledges and agrees that nothing in this Section 4.2 is in Developmentintended, furnish Bayer with reasonably detailed summary written reports on all activities conducted by Licensee or shall be construed, to require Sanofi to Commercialize more than one Licensed Product at any given time or to Commercialize any other Licensed Product other than the Product for LX4211 Product. If Sanofi implements and uses Commercially Reasonable Efforts to carry out its responsibilities under the T1DM Commercialization Plan pursuant to Section 4.3, Sanofi shall be deemed to have satisfied its obligation to use Commercially Reasonable Efforts under this Section 4.2 and shall have no liability resulting from any failure of the activities described 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 T1DM Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsPlan.

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 agrees During the applicable Term for a given Product and subject to the terms and conditions of this Agreement, DURA shall use Commercially Reasonable Efforts commercially reasonable efforts to diligently Develop(i) distribute, Manufacture market, sell, and Commercialize promote such Product within the Product Territory and (ii) create and maintain a market for and to increase the sales of Products in the Territory for Territory. In the performance of such obligations, DURA shall: 3.1.1 use in the Field for all commercially reasonable Indicationsefforts to maintain and provide at its expense an organization of qualified, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, professional salespersons 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 thereinSection 3.2; 4.1.1.2 prepare 3.1.2 maintain and file provide at its expense suitable storage in accordance with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee Specifications and labeling and other appropriate facilities and services reasonably satisfactory to undertake Development activities includingBMS, without limitation, all INDs as needed for the storage and IND Equivalents, in continuous sale and distribution of Products within the Territory; 4.1.1.3 3.1.3 use commercially reasonable efforts to solicit new customers and to maintain existing customers for the Products; 3.1.4 use commercially reasonable efforts to ensure that sufficient stock of each Product will be available in its inventory to fill orders from the trade in accordance with normal industry practices, including maintaining reasonable levels of inventory in light of customary industry practice and historical sales patterns; 3.1.5 use commercially reasonable efforts to conduct all Preclinical Development at its expense appropriate promotional activities for the Product sufficient for DURA to achieve adequate and Clinical Development in good scientific mannerreasonably rapid market penetration; 3.1.6 provide, at its expense, an adequate Product traceability system (e.g. lot level traceability, readily accessible format), reasonably satisfactory to BMS; 3.1.7 ensure that its sales force personnel do not make representations or claims with respect to the safety, efficacy or uses for a Product that are not contained within such Product's applicable Product Registration and/or labeling and/or that are not permitted by applicable law; 3.1.8 market and sell Products only on the basis of quality, service, price and other legitimate marketing attributes, and in compliance in without the payment of bribes or any similar inducements; 3.1.9 observe and perform all material respects provisions of this Agreement, and comply with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently pertinent laws and expeditiously; 4.1.1.4 maintain records, regulations 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 force in the form required under all Applicable Laws;Territory; and 4.1.1.5 3.1.10 use Commercially Reasonable Efforts commercially reasonable efforts not to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with take any action which would have a material adverse impact on (i) the appropriate Governmental Authorities commercialization of the Products in the Territory or (ii) the then existing business of BMS, its Affiliates 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 licensees 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 respect to the Development Committee (or, upon dissolution Products in other countries of the Development Committee, to Bayerworld (taken as a whole), 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. In the event Monsanto Canada exercises the Call Option and either acquires all of the outstanding capital stock of Licensee agrees to use Commercially Reasonable Efforts to diligently Developor receives from Licensee an assignment of all of Licensee’s rights and obligations under this Agreement then, Manufacture and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitationfollowing such acquisition or assignment, 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 shallfollowing provisions shall apply: 4.1.1.1 use Commercially Reasonable Efforts (a) Subject to diligently carry out its respective obligations and activities specified in Section 2.6(c) below, during the Development Plan including, without limitation, adhering period of time beginning upon termination of Protiva’s obligation to provide 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 PlanServices, as set forth in Sections 3.2 Section 4.4 below, and 3.3.3 above; 4.1.1.9 not later than ending on 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 expiration of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview 10-year period following Commercial Launch of the marketing campaigns proposed first Product or earlier date of payment to be conducted Protiva pursuant to Section 3.3(a) below (the “Marketing PlansDiligence Period”) ), Licensee shall provide copies use commercially reasonable efforts to Develop, Manufacture, and Commercialize a Product. (b) Whether certain efforts by Licensee are deemed to be “commercially reasonable” for purposes of this Section 2.6 shall be determined in light of all relevant factors in all 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 relevant jurisdictions in the Territory;, taken as a whole, including but not limited to: the perceived market potential of any Product (including anticipated or actual profit margin); the anticipated level of regulatory approval that may be available for such Product (including any restrictions on the use thereof); the level of intellectual property protection of such Product; the presence of third-party intellectual property that may impact the marketability of such Product (including any claims made or threatened by third parties that the manufacture, marketing or sale of such Product infringes, violates or misappropriates the intellectual property of such third parties); the presence or absence of particularly difficult manufacturing issues; and the expected competitive position of such Product vis-à-vis other products that may have been or may be developed, marketed and sold for the same or similar use, including with respect to the expected or actual efficacy and cost of such Product when compared to such other products. Licensee shall not be deemed to be in breach of this Section 2.6(b) for any particular period unless Licensee’s efforts with respect to Products during such period, taken as a whole, or in combination with efforts in prior periods, taken as a whole, are not commercially reasonable. 4.1.1.11 within thirty (30c) Business Days after Licensee may terminate its obligations under this Section 2.6 at any time prior to the end expiration of each calendar year after the commencement Diligence Period, effective immediately upon payment to Protiva of Phase III Clinical Trials for each Indication for which an amount equal to [Redacted – amount] (the Product is “Diligence Buyout Payment”). In addition, upon such payment, Protiva’s rights and Licensee’s obligations under Section 3.3 shall terminate and, in Developmentno event, furnish Bayer shall any payments be made to Protiva pursuant to Section 3.3(a). The amount of the Diligence Buyout Payment shall be reduced, if applicable, in accordance with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use Monsanto’s right of set off and/or any reduction in the Field during such calendar year; and 4.1.1.12 maintain recordsamount of the Diligence Buyout Payment as a result of a Change of Control of Protiva or Tekmira, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with each case under the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsOption Agreement.

Diligence. Licensee agrees (a) Subject to Section 10.3, ONCOMED shall use Commercially Reasonable Efforts commercially reasonable efforts to diligently Developdevelop, Manufacture test, obtain regulatory approval of, market and Commercialize the Product sell [***] with respect to each Commercial Therapeutic License, as a prudent business person would undertake. At a minimum, ONCOMED shall use commercially reasonable efforts and diligence, for each Commercial Therapeutic License, to: [***]. MORPHOSYS agrees that in the Territory for use in event ONCOMED or its Sublicensee is not able to meet the Field for all commercially reasonable Indicationsforegoing milestones, including without limitation, the Initial Two Indications; except then MORPHOSYS and ONCOMED will convene a discussion to review and approve changes to the extent time schedules for the diligence milestones based on [***] and taking into account 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 [***] directed to the timelines set forth therein; 4.1.1.2 prepare and file with [***]. Should the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee Parties fail to undertake Development activities including, without limitation, all INDs and IND Equivalents, in agree to changes to 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 time schedules for the Product in diligence milestones then Section 12.13 shall govern. For each Commercial Therapeutic License for which the Territory for use in the Fieldfee under Section 6.1(c) has been paid, 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 FieldONCOMED shall provide to MORPHOSYS, 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 basisannually, a reasonably detailed written development report describing covering the status preceding twelve (12) months and a summary of estimated development for the Development forthcoming twelve (12) months, which report shall first be due within [***] after such payment under Section 6.1(c). (b) MORPHOSYS shall use commercially reasonable efforts (i) to provide the MORPHOSYS Customer Support in accordance with Section 2.3(b), and (ii) should ONCOMED elect MORPHOSYS to carry out the objective of applying its MORPHOSYS Antibody Affinity Optimization Technology to a HuCAL Antibody selected by ONCOMED, to apply the Product and summarizing all Non-Strategic Amendments made MORPHOSYS Antibody Affinity Optimization Technology to optimize the Development Plan, together with a copy of the Development PlanHuCAL Antibody selected by ONCOMED, 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 specified 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 LawsCollaboration Plan.

Diligence. Licensee agrees to 7.1 Oxxon shall use Commercially Reasonable and Diligent Efforts to diligently Develop, Manufacture develop and Commercialize the Product commercially exploit Licensed Product(s) in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except Territory. 7.2 [_] 7.3 Without prejudice to the extent that generality of Oxxon's obligations under Clause 7.1, Xenova may terminate this Agreement from time to time with respect to a Selected Indication (but not with respect to other Indications): (a) If Oxxon is in breach of its obligations under Clause 7.1 with respect to such Selected Indication; or (b) In any event, and without prejudice to the responsibility generality of Oxxon's obligations under this Clause 7, if Oxxon substantially abandons its development work with respect to such Selected Indication for doing so, as specifically set forth in Sections 4.2 and 4.3 a period of two years. 7.4 If Xenova considers at any time during the period of this Agreement that Oxxon has without legitimate reason failed to use Reasonable and Diligent Efforts to develop and commercially exploit Licensed Product(s) in accordance with this Clause 7, Xenova shall, prior to exercising any right of termination under Clause 7, refer to an independent expert (or experts) the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shallfollowing questions: 4.1.1.1 (a) whether Oxxon has used Reasonable and Diligent Efforts; and if not (b) whether the proposals submitted by Oxxon to such expert are adequate to meet Oxxon's requirement to use Commercially Reasonable Efforts and Diligent Efforts, and if not (c) what actions the expert proposes Oxxon should take in order to diligently carry out its respective obligations meet the requirement to use Reasonable and activities specified Diligent Efforts. 7.5 The independent expert (or experts) shall be appointed in the Development Plan including, without limitation, adhering to the timelines set forth therein; 4.1.1.2 prepare and file accordance with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee provisions of Schedule 4. 7.6 If the expert(s) determines that Oxxon has failed 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 mannercomply with its obligations under this Clause 7, and if Oxxon fails to take the actions proposed by Oxxon pursuant to Clause 7.4(b) or suggested by the expert(s) pursuant to Clause 7.4(c) (as appropriate) within 6 months of the expert(s) giving his/their decision in compliance in all material respects accordance with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously; 4.1.1.4 maintain recordsSchedule 4, in sufficient detail and in good scientific manner, which Xenova 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 entitled, 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 INDsgiving, 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 at any time within thirty (30) Business Days 3 months after the end of each calendar year after that 6 month period, not less than 3 months' notice to terminate this Agreement as a whole or in relation to a Selected Indication (as appropriate). 7.7 The provisions of Clauses 7.2 to 7.6, and the commencement exercise of Phase III Clinical Trials for each Indication for which the Product rights under those clauses, shall be without prejudice to any rights that Xenova may have to claim damages in the event that Oxxon is in Developmentbreach of any of its obligations under Clause 7. 1. In the event of a damages claim, 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 any finding of the Product in expert under Clause 7.4(a) shall not be binding on the Territory for use in the Field in the form required under all Applicable LawsParties.

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. In the event Monsanto Canada exercises the Call Option and either acquires all of the outstanding capital stock of Licensee agrees to use Commercially Reasonable Efforts to diligently Developor receives from Licensee an assignment of all of Licensee’s rights and obligations under this Agreement then, Manufacture and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitationfollowing such acquisition or assignment, 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 shallfollowing provisions shall apply: 4.1.1.1 use Commercially Reasonable Efforts (a) Subject to diligently carry out its respective obligations and activities specified in Section 2.6(c) below, during the Development Plan including, without limitation, adhering period of time beginning upon termination of Protiva’s obligation to provide 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 PlanServices, as set forth in Sections 3.2 Section 4.4 below, and 3.3.3 above; 4.1.1.9 not later than ending on 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 expiration of the Product for use in the Field and which shall include forecasts for the number of sales representatives, and a reasonably descriptive overview 10-year period following Commercial Launch of the marketing campaigns proposed first Product or earlier date of payment to be conducted Protiva pursuant to Section 3.3(a) below (the “Marketing PlansDiligence Period”) ), Licensee shall provide copies use commercially reasonable efforts to Develop, Manufacture, and Commercialize a Product. (b) Whether certain efforts by Licensee are deemed to be “commercially reasonable” for purposes of this Section 2.6 shall be determined in light of all relevant factors in all 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 relevant jurisdictions in the Territory;, taken as a whole, including but not limited to: the perceived market potential of any Product (including anticipated or actual profit margin); the anticipated level of regulatory approval that may be available for such Product (including any restrictions on the use thereof); the level of intellectual property protection of such Product; the presence of third-party intellectual property that may impact the marketability of such Product (including any claims made or threatened by third parties that the manufacture, marketing or sale of such Product infringes, violates or misappropriates the intellectual property of such third parties); the presence or absence of particularly difficult manufacturing issues; and the expected competitive position of such Product vis-à-vis other products that may have been or may be developed, marketed and sold for the same or similar use, including with respect to the expected or actual efficacy and cost of such Product when compared to such other products. Licensee shall not be deemed to be in breach of this Section 2.6(b) for any particular period unless Licensee’s efforts with respect to Products during such period, taken as a whole, or in combination with efforts in prior periods, taken as a whole, are not commercially reasonable. 4.1.1.11 within thirty (30c) Business Days after Licensee may terminate its obligations under this Section 2.6 at any time prior to the end expiration of each calendar year after the commencement Diligence Period, effective immediately upon payment to Protiva of Phase III Clinical Trials for each Indication for which an amount equal to [***] (the Product is “Diligence Buyout Payment”). In addition, upon such payment, Protiva’s rights and Licensee’s obligations under Section 3.3 shall terminate and, in Developmentno event, furnish Bayer shall any payments be made to Protiva pursuant to Section 3.3(a). The amount of the Diligence Buyout Payment shall be reduced, if applicable, in accordance with reasonably detailed summary written reports on all activities conducted by Licensee to Commercialize the Product for use Monsanto’s right of set off and/or any reduction in the Field during such calendar year; and 4.1.1.12 maintain recordsamount of the Diligence Buyout Payment as a result of a Change of Control of Protiva or Tekmira, in sufficient detail, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with each case under the Commercialization of the Product in the Territory for use in the Field in the form required under all Applicable LawsOption Agreement.

Diligence. Licensee agrees (a) Sage shall (i) use at least Commercially Reasonable Efforts, and shall further require its Affiliates and Sublicensees to use at least Commercially Reasonable Efforts Efforts, to diligently Developdevelop each of the Licensed Products, Manufacture to seek Regulatory Approval of each of the Licensed Products in all countries and Commercialize regions where it is commercially reasonable to so seek, and to commercialize each of the Licensed Products in each respective country and region following Regulatory Approval of such Licensed Product in such respective country/region, and (ii) subject to Section 6.1(b), comply with 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 requirements set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs Exhibit D hereto. If Sage is unable 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 comply 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 Exhibit D hereto (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 extended pursuant to Section 6.1(b)) due to unanticipated events or changed circumstances that are beyond the reasonable control of Sage, including delays caused by changes to the development plan that are 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 PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. required based upon Licensee’sin the exercise of sound scientific or commercial judgment due to new information regarding the development of product candidates or changes to the applicable regulatory requirements, then the parties shall meet and make reasonable extensions to the deadlines provided on Exhibit D. For clarity, Sage may meet the requirements of this Section 6.1 through its or through its Affiliates’ or Sublicensees’’ activities, usual marketing campaign cycleswhich, but with respect to the Allo Licensed Products, may be 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 just one of the Product in Subfields. In the Territory for use in event that Sage fails to meet the Field in requirements of this Section 6.1(a) (as may be extended pursuant to Section 6.1(b)) with respect to the form required under Allo Licensed Products or the SAGE-689 Licensed Products, as applicable, CyDex shall have the right to terminate this Agreement with respect to all Applicable LawsAllo Licensed Products or all SAGE-689 Licensed Products, respectively, pursuant to Section 13.2 hereof.

Diligence. Licensee agrees 3.4.1 Delta shall use, and shall procure that any Person to use whom it sub-contracts its obligations pursuant to Section 3.5 uses, its Commercially Reasonable Efforts to diligently Developcarry out each Preclinical Program Development Plan and to deliver the relevant Preclinical Program Data Package as soon as reasonably practicable. Delta shall provide Ares with [***] written reports describing the progress of its activities under each Preclinical Program Development Plan. 3.4.2 The Parties acknowledge and agree that, Manufacture and Commercialize notwithstanding that reasonable efforts have been taken to set out in each Preclinical Program Development Plan appropriate details of the Product work to be undertaken in the Territory for use in the Field for all commercially reasonable Indications, including without limitationrespect of each Subject mAb², the Initial Two Indications; except Preclinical Program Development Plans do not set out every action, obligation or step which an F-star Party may need to take or fulfil in order to give effect to the extent objectives, or to fulfil the requirements, *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 subject of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayera confidential treatment request. Without limiting the foregoing, Licensee shallTable of Contents of each Preclinical Program Development Plan. The Parties accordingly agree that: 4.1.1.1 (a) each Preclinical Program Development Plan shall be deemed to include (and each Party shall use its Commercially Reasonable Efforts to diligently carry out) any additional actions, obligations or steps which could reasonably have been expected to have been required of that F-star Party in order to carry out its respective obligations and activities specified the work set out in the that Preclinical Program Development Plan including(for the avoidance of doubt, without limitationany further payment being required to Delta by Xxxx); and (b) no Party shall unreasonably refuse consent to any amendments, adhering changes or additions to a Preclinical Program Development Plan that would not extend either the timelines set forth therein;costs or timeline of that Preclinical Program Development Plan in any material respect. 4.1.1.2 prepare 3.4.3 The Parties acknowledge and file with agree that no outcome or success of any Development carried out pursuant to this Agreement is or can be assured and that 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 failure of Applicable Laws a Subject mAb² to achieve the objectives results desired of it will not in and of itself constitute a breach or default of any obligation in 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 LawsAgreement.

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 XXXX xxxxx; 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 4.5.1 Geron shall use Commercially Reasonable Efforts to perform the activities set forth in the Clinical Development Plan with respect to a Licensed Product containing ANG1005. Geron shall have an obligation to use Commercially Reasonable Efforts to diligently Developdevelop and commercialize only one Licensed Product, Manufacture and Commercialize for so long as Geron is using Commercially Reasonable Efforts to develop and commercialize a Licensed Product containing ANG1005, this diligence obligation shall be satisfied. If, despite the Product in exercise of Commercially Reasonable Efforts to perform 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 activities set forth in Sections 4.2 the Clinical Development Plan, Geron, its Affiliates and 4.3 Sublicensees cease the development or commercialization of this Agreement a Licensed Product containing ANG1005 (as demonstrated by (a) written notice by Geron to AngioChem that it has ceased such development, or (b) the cessation, by Geron, its Affiliates and Sublicensees of the allocation of funds, personnel or other resources to the continued development or commercialization of a Licensed Product containing ANG1005 in accordance with the CMC DevelopmentClinical Development Plan for a period of two (2) consecutive Calendar Quarters), Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall: 4.1.1.1 then Geron shall use Commercially Reasonable Efforts to diligently carry out its respective obligations develop and activities commercialize a Further Licensed Product, including the provision of a research plan to AngioChem as specified in Section 4.3.2 within thirty (30) days after delivery of notice by Geron under subclause (a) of this Section, or the end of two (2) consecutive Calendar Quarters of inactivity as described in subclause (b) of this Section. The obligations of Geron with respect to any Licensed Product under this Section 4.5 are expressly conditioned upon the continuing absence of any adverse condition or event relating to the safety or efficacy of the Licensed Product, and the obligation of Geron to develop or market any such Licensed Product shall be delayed or suspended so long as any such condition or event exists. If such an adverse condition or event arises, Geron shall promptly inform AngioChem upon becoming aware of such adverse condition or event, and the Parties shall make reasonable efforts to promptly (and in any event within twenty (20) business days) convene a JDC meeting. At such JDC meeting, Geron shall provide the JDC with the details of such adverse condition or event and a description of actions planned by Geron in good faith to resolve the cause of such delay or suspension. 4.5.2 In the event that (i) Geron, its Affiliates and Sublicensees cease the development or commercialization of a Licensed Product containing ANG1005 (as demonstrated by (a) written notice by Geron to AngioChem that it has ceased such development, or (b) the cessation, by Geron, its Affiliates and Sublicensees of the allocation of funds, personnel or other resources to the continued development or commercialization of a Licensed Product containing ANG1005 in accordance with the Clinical Development Plan for a period of two (2) consecutive Calendar Quarters), and (ii) either (x) Geron fails to deliver a research plan as specified in Section 4.3.2 for a Further Licensed Product within thirty (30) days after such notice or cessation; or (y) Geron delivers such plan, but Geron, its Affiliates and Sublicensees cease the development or commercialization of a Further Licensed Product (as demonstrated by (a) written notice by Geron to AngioChem that it has ceased such development, or (b) the cessation, by Geron, its Affiliates and Sublicensees of the allocation of funds, personnel or other resources to the continued development or commercialization of such Further Licensed Product in accordance with such research plan for a period of two (2) consecutive Calendar Quarters), and does not deliver a research plan as specified in Section 4.3.2 for another Further Licensed Product within thirty (30) days after such notice or cessation, then AngioChem may terminate this Agreement on written notice to Geron, and subject to Section 10.2.2, Section 4.5.3 shall apply. 4.5.3 (i) If, despite its exercise of Commercially Reasonable Efforts to develop a Licensed Product as set forth in Section 4.5.1, Geron elects to terminate this Agreement pursuant to Section 10.3 and Geron is not in material breach of this Agreement, or (ii) if AngioChem elects to terminate this Agreement as set forth in Section 4.5.2 and provided that AngioChem is not in material breach of this Agreement (provided that any dispute as to whether either Party is or is not in material breach of this Agreement shall be subject to arbitration under Section 12.6), the licenses granted by Geron in Section 2.4 shall survive, and Geron shall, upon request by AngioChem made within one hundred eighty (180) days after the Section 4.5.3 End Date (as defined below), and subject to (a) the terms and conditions of this Agreement, (b) sublicenses granted to any Sublicensees whose sublicense survives termination in accordance with Section 10.4.4, and (c) any other non-exclusive license or option rights granted by Geron as of the effective date of termination, (x) grant to AngioChem an exclusive, worldwide license to develop and commercialize Licensed Products in the Field, including the right to grant sublicenses, under all Patent Rights that claim a Licensed Product (or any component thereof) and Know-How Controlled by Geron (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 Geron’s interest in Joint Intellectual Property) necessary or desirable actually used by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in Geron at 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 time 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 termination for the Product in the Territory for use research, development and/or commercialization of Licensed Products (or any component thereof) as single agents, in the Field, together with all Regulatory Approvals and other (y) shall promptly transfer to AngioChem data, regulatory filings and approvals technology as set forth in Section 10.4.2, and (z) comply with the provisions of Section 10.3 with respect to human clinical trials. In consideration of the foregoing grant of license and transfer of data, regulatory filings and technology by Geron to AngioChem, Geron shall be entitled to receive royalties in the amount of * percent (*%) of Net Sales of Licensed Products by AngioChem, its Affiliates and any sublicensees of AngioChem or its Affiliates greater than * dollars (U.S.$*) in any Calendar Year, until such time as Geron has received an amount (the “Reimbursement Amount”) determined by the following formula: * Within sixty (60) days following the Section 45.3 End Date, Geron will advise AngioChem of Geron’s calculation of the Reimbursement Amount, together with reasonable supporting details. If AngioChem disputes such calculation, the matter will be resolved pursuant to Section 11.6. Notwithstanding the foregoing, if, prior to termination under this Section 4.5.3, the Parties have executed a written amendment to this Agreement setting forth mutually acceptable economic terms payable under this Agreement after exercise by Geron of the Buy-Out/Buy-Down Option pursuant to Section 3.5.1, then no payment shall be due by AngioChem to Geron for the Product in Territory for use in grant of 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 Fieldlicense and transfer of data, regulatory filings and technology under this Section 4.5.3, including, without limitation, communicating with, payment of the Reimbursement Amount. ____________________ * Certain information on this page has been omitted and preparing and filing all reports (including, without limitation, adverse event reports) filed separately with the Governmental Authorities in the Territory; 4.1.1.8 submit Commission. Confidential treatment has been requested with respect 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 Lawsomitted portions.

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