Common use of Clinical Supply Clause in Contracts

Clinical Supply. In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.

Clinical Supply. In connection Servier shall be primarily responsible for manufacturing and supplying bulk Licensed Oligos and finished Licensed Products for use in clinical studies conducted pursuant to the Development Plan in the Field in the Territory, provided that Servier may engage Miragen for such manufacture and supply as follows: At least 180 days prior to the anticipated filing of the first CTA for the first indication with the Technology Transfer, Lexicon shall transfer respect to Sanofi any usable inventory of Licensed Compound or a Licensed Product, subject Servier shall notify Miragen in writing whether it desires to Lexicon’s retention engage Miragen for such manufacture and supply. If Servier chooses to have Miragen provide such clinical supply, Servier and Miragen shall negotiate in good faith and enter into a separate supply agreement having mutually agreed terms with respect to such clinical supply, which supply shall be at Cost of reasonable requirements Goods (except for Unsponsored Work, in which case the supply shall be at Cost of such Licensed Compound or Licensed Product for its T1DM Development activities no later than Goods plus [*]). For clarity, Miragen’s manufacturing-related Development costs, as described in Section 1.27(e), [*] (or such other date = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as is agreed amended. are not included in the Cost of Goods but shall be included in Development Plan Costs and shared by the PartiesParties pursuant to Section 9.3. If Servier does not engage Miragen but elects to manufacture and supply bulk Licensed Oligos and finished Licensed Products for Development purposes, either through itself or its Third Party manufacturer, then Miragen shall have the right to purchase such bulk Licensed Oligos and finished Licensed Products from Servier at Cost of Goods (except for Unsponsored Work, in which case the supply shall be at Cost of Goods plus [*]), and Lexicon’s Manufacturing Cost paid the other terms and conditions to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne agreed upon by the Parties and set forth in accordance with Section 7.6a separate supply agreement. Prior For clarity, Miragen shall have the right to manufacture and have manufactured, anywhere in the completion of the Technology Transfer in accordance with Section 6.2world, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products Oligos and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with clinical and commercial use outside the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faithTerritory.

Clinical Supply. In connection 7.1 Until and unless TAKEDA determines to cease supplying the Compound pursuant to Sections 6.1 or 7.4, TAKEDA shall, upon the request of PENINSULA and under the terms and conditions of this Article 7, provide PENINSULA with sufficient quantities of the Technology TransferCompound meeting the Specifications to the extent reasonably required by PENINSULA in order to conduct the Development Work. PENINSULA shall use the Compound supplied under this Article 7 solely for conducting the Development Work and shall not use the same for any other purpose without the prior written consent of TAKEDA. 7.2 PENINSULA desires to have TAKEDA supply to PENINSULA [*] of Compound meeting the Specifications, Lexicon shall transfer for PENINSULA's use in performing Development Work, such supply desired to Sanofi be completed as soon as possible and in any usable event within [*] months after the Effective Date (the "Delivery Date"). PENINSULA understands that TAKEDA does not currently have sufficient inventory of Licensed the Compound or Licensed Productto provide such quantity to PENINSULA. PENINSULA has submitted a purchase order for [*] of Compound for delivery no later than the Delivery Date. TAKEDA shall use all commercially reasonable efforts to manufacture and/or have a Third Party Manufacturer manufacture and supply at least [*] of Compound meeting the Specifications to PENINSULA by the Delivery Date. TAKEDA shall supply to PENINSULA the entire amount of Compound produced by TAKEDA and/or its Third Party Manufacturer as a result of the manufacturing activities under this Section 7.2, for the price set forth in Section 7.3. If TAKEDA is unable to supply at least [*] of Compound to PENINSULA by the Delivery Date, but is able to supply at least [*] of the Compound, TAKEDA shall nonetheless supply to PENINSULA as much of the Compound as it is able to (i.e., at least [*]), and PENINSULA shall purchase and take delivery of such quantity of Compound manufactured and supplied by TAKEDA by the Delivery Date. TAKEDA's obligation to supply to PENINSULA between [*] of Compound by the Delivery Date shall be referred to herein as the "Supply Obligation". If TAKEDA, despite using its all commercially [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. reasonable efforts to do so, is unable to satisfy its Supply Obligation, PENINSULA shall elect to either (a) accept such quantity of the Compound as TAKEDA is able to supply by the Delivery Date, in full satisfaction of the Supply Obligation, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound the price reduction in Section 7.3, or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by b) cancel the Parties), purchase order and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred reject all quantities of inventory Compound delivered by TAKEDA, if any, in which event PENINSULA shall be treated have no payment obligation to TAKEDA under Section 7.3 and TAKEDA shall have no further obligation to supply Compound to PENINSULA under this Article 7. In addition, if TAKEDA is unable to satisfy the Supply Obligation, PENINSULA shall, at its option, have the right, as Development Costs a sole and borne exclusive remedy for TAKEDA's inability to satisfy the Supply Obligation, to (a) terminate this Agreement pursuant to Section 17.3, (b) manufacture, or have a third party manufacture on PENINSULA's behalf, the Compound, in which event the provisions of Section 7.15 below shall apply, or (c) if PENINSULA elects to accept the quantity of the Compound delivered by TAKEDA in full satisfaction of the Parties Supply Obligation subject to the price reduction in Section 7.3, proceed to order from TAKEDA additional quantities of Compound in accordance with Section 7.6. Prior 7.5. 7.3 The supply price for the Compound supplied by TAKEDA pursuant to the completion Section 7.2 shall be a total of US $1,200,000 regardless of the Technology Transfer actual quantity delivered so long as the total quantity delivered is at least [*]. If the actual quantity of Compound delivered by the Delivery Date is less than [*] of Compound, the supply price shall be an amount equal to $[*] of Compound actually delivered to PENINSULA. PENINSULA has provided TAKEDA with a letter of credit from [*] entitling TAKEDA to receive payment for the actual quantity of Compound delivered to PENINSULA in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims 7.3 and Section 7.9 upon delivery and acceptance thereof so that TAKEDA will immediately commence activities to satisfy its supply obligations under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faithSection 7.

Clinical Supply. In connection (a) The Parties will mutually define specific quantities and timing for the manufacture and delivery of CTM for any and all Clinical Studies required during the Program and for purposes of obtaining all Applicable Permits. (b) Each shipment of CTM shall be sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to AVANIR with each such shipment of CTM a certificate of analysis stating that the Technology Transfer, Lexicon CTM meets the Specifications and has been manufactured in accordance with cGMP and Applicable Laws. (c) AVANIR may conduct its own analyses on each shipment of the CTM delivered to AVANIR pursuant to this Agreement. AVANIR shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements notify EURAND within *** Business Days after delivery of such Licensed Compound CTM if there are shortages, or Licensed Product for its T1DM Development activities no later than [within **] (* Calendar Days if the same does not meet the Specifications or terms and conditions of this Agreement, or is adulterated or misbranded within the meaning of the Act. Unless AVANIR advises EURAND that a shipment is unsatisfactory within *** Calendar Days of its receipt, or if AVANIR uses such other date as is agreed by the Parties)CTM in a Clinical Study, and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shipment shall be treated as Development Costs deemed accepted. (d) In the event any dispute arises between EURAND and AVANIR concerning the acceptability of any shipment of CTM, the Parties agree to cooperate in good faith to resolve any disputes arising therefrom and, in the event that the Parties shall be unable to resolve such dispute within *** Calendar Days from the date of AVANIR’s notice pursuant to this Section 3.1, then if the dispute involves whether or not the CTM meets the Specifications, the Parties shall submit such dispute to a mutually agreed-to independent laboratory. The determination by such laboratory shall be final and binding on the Parties and the costs therefor shall be borne by the Parties non-prevailing Party. AVANIR shall not dispose of any CTM claimed by it not to comply with the terms and conditions hereof until resolution *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. of any dispute with respect thereto. EURAND shall supply retained samples to such independent laboratory for testing. If the dispute concerning the acceptability of any shipment does not relate to whether the CTM meets the Specifications, the dispute shall be settled in accordance with Section 7.613.15 hereof. (e) EURAND shall replace, *** any CTM delivered hereunder that is rejected in good faith by AVANIR and agreed to by EURAND or that fails to satisfy the representations and warranties set forth herein, unless subject to a dispute under Section 3.1(d). Prior to the completion of the Technology Transfer in accordance with Section 6.2EURAND’S LIABILITY UNDER SUCH WARRANTY IS LIMITED TO THE REPLACEMENT OF SUCH CTM, Lexicon shall, to the extent requested by Sanofi and as mutually PROVIDED *** AND ***. (f) Unless otherwise agreed upon by the Parties, supply clinical quantities EURAND is not responsible for the conduct, costs and/or expenses of the Licensed Products Clinical Studies and/or the preparation, filing, and placebo for use by Sanofi in prosecution of the Development of Licensed Products for T2DM in accordance Regulatory Filings, with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities exception of the Licensed Products and placebo reasonably required by Lexicon DMF. (g) EURAND shall retain sole responsibility for Lexicon’s use in releasing the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (CTM to AVANIR or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required clinical sites if clinical sites have been designated for receipt of the CTM by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faithAVANIR.

Clinical Supply. In connection (a) IMMUCELL shall use commercially reasonable efforts to make available to PFIZER by March 31, 2005, but in no event later than December 31, 2005, [* * *] [* * *] Confidential Treatment Requested. The confidential portions have been filed separately with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory Securities & Exchange Commission. finished plastets of Licensed Compound or Licensed Product, subject to Lexicon’s retention Active Drug Product and [* * *] finishe[d] plastets of reasonable requirements of such Licensed Compound or Licensed Placebo Drug Product for its T1DM Development activities no later than [**] purposes of PFIZER conducting the US Clinical Study trials (or such other date as is agreed by the Partiescollectively, “Clinical Supply”), it being understood that IMMUCELL’s failure to deliver Clinical Supply prior to December 31, 2005 shall not, in and Lexicon’s Manufacturing Cost paid of itself, be deemed to Lexicon CMOs for such transferred quantities constitute a breach of inventory this Agreement. Such Clinical Supply shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior of a suitable specification to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including allow: (i) a right of Sanofi registerable efficacy trials to audit Lexicon be initiated by PFIZER and the Lexicon CMOs, (ii) coordination regarding inspections registerable VICH stability Drug Product studies to be initiated by Regulatory Authorities IMMUCELL. After delivery of the Clinical Supply, IMMUCELL shall make best efforts to furnish (subject to reimbursement by PFIZER at IMMUCELL’s cost, with no markup permitted) such additional Drug Product plastets and/or Raw Material as PFIZER may reasonably request in writing for purposes of those US Clinical Study trials. IMMUCELL shall bear the cost of all Raw Material contained within the Clinical Supply, and PFIZER shall pay IMMUCELL for the cost of manufacture of the Clinical Supply plastets and any such additional Drug Product plastets and/or Raw Material requested by PFIZER, each within 30 days from receipt of IMMUCELL’s invoice therefor. Exhibit A attached hereto shall contain mutually agreed quality requirements for the Clinical Supply. (iiib) PFIZER shall have sole responsibility for approving the exchange Contract Manufacturer to create Clinical Supply from the Raw Material, and PFIZER hereby consents to the selection of information between [* * *] as the Parties regarding the foregoing and quality issues in general. Such agreements Contract Manufacturer for such purpose. (c) IMMUCELL shall be negotiated and solely responsible for the characterization of minor nisin variants/impurities, validation of all required analytical methods agreed to by the Parties in good faithparties and transfer of such methods to PFIZER or the Contract Manufacturer, and for IMMUCELL’s costs related to these studies. IMMUCELL shall provide access to PFIZER personnel as necessary for training as part of the transfer process. IMMUCELL shall be solely responsible for conducting stability studies on Clinical Supply “Drug Product” subject to CVM guideline 73. PFIZER shall ensure that IMMUCELL receives [* * *] finished plastets for this purpose from the initial Clinical Supply.

Clinical Supply. In connection with Through the Technology Transferrights granted to Orano Med under Section 4.1, Lexicon Orano Med shall transfer have the exclusive right to Sanofi any usable inventory Manufacture the First Product (and other subsequent Collaboration Products) using Molecular Partners’ supplied DARPin proteins during the Term. With regard to the Manufacture and supply of Licensed Compound or Licensed Product, subject to Lexicon’s retention pre-clinical supply and of reasonable requirements clinical batches of such Licensed Compound or Licensed a Collaboration Product for its T1DM Development activities no later than [**] (the performance of Clinical Trials until a Registration Enabling Trial has successfully completed in each country to which an R&D Program applies, or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually otherwise agreed by the Parties in writing, but nothing the Parties shall negotiate in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon good faith and Sanofi shall enter into a pre-clinical and clinical supply agreement (“Clinical Supply Agreement”) no later than [***] following the Effective Date in accordance with the terms set forth in Exhibit D. (a) Orano Med shall make Commercially Reasonable Efforts to Manufacture (as defined in Schedule D) and supply the Collaboration Product (in finished product form) in the countries and in quantities sufficient for the conduct of the Clinical Trials set forth in an R&D Plan(s). Orano Med shall make Commercially Reasonable Efforts to develop a reasonable reliable, safe and customary Quality secure logistics solution for supply and delivery of the finished Collaboration Product to customers. (b) Molecular Partners shall make Commercially Reasonable Efforts to supply DARPin proteins to Orano Med for the Manufacturing of Collaboration Products. For clarity, the Parties may agree in the Clinical Supply Agreement that [***]. (c) Each Party shall set forth respectively comply with Applicable Laws and Applicable Standards throughout the terms pre-clinical/clinical manufacturing phase and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such scale up to commercial supply, and shall share the required Regulatory Documentation with the other Party. Orano Med will be responsible for ensuring that Collaboration Product complies with all local requirements under local Nuclear Activity Laws, including with respect to labelling, packaging, transport, handling and other related activities and will use Commercially Reasonable Efforts to ensure all facilities in the Collaboration Product’s supply chain (iother than those managed by Molecular Partners) a right of Sanofi to audit Lexicon are GMP compliant and the Lexicon CMOsappropriately licensed, authorised or approved (iias applicable) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faithfor any Nuclear Activities.

Clinical Supply. In connection 7.1 Until and unless TAKEDA determines to cease supplying the Compound pursuant to Sections 6.1 or 7.4, TAKEDA shall, upon the request of PENINSULA and under the terms and conditions of this Article 7, provide PENINSULA with sufficient quantities of the Technology TransferCompound meeting the Specifications to the extent reasonably required by PENINSULA in order to conduct the Development Work. PENINSULA shall use the Compound supplied under this Article 7 solely for conducting the Development Work and shall not use the same for any other purpose without the prior written consent of TAKEDA. 7.2 PENINSULA desires to have TAKEDA supply to PENINSULA [ * ] of Compound meeting the Specifications, Lexicon shall transfer for PENINSULA's use in performing Development Work, such supply desired to Sanofi be completed as soon as possible and in any usable event within [ * ] months after the Effective Date (the "Delivery Date"). PENINSULA understands that TAKEDA does not currently have sufficient inventory of Licensed the Compound or Licensed Productto provide such quantity to PENINSULA. PENINSULA has submitted a purchase order for [ * ] of Compound for delivery no later than the Delivery Date. TAKEDA shall use all commercially reasonable efforts to manufacture and/or have a Third Party Manufacturer manufacture and supply at least [ * ] of Compound meeting the Specifications to PENINSULA by the Delivery Date. TAKEDA shall supply to PENINSULA the entire amount of Compound produced by TAKEDA and/or its Third Party Manufacturer as a result of the manufacturing activities under this Section 7.2, for the price set forth in Section 7.3. If TAKEDA is unable to supply at least [ * ] of Compound to PENINSULA by the Delivery Date, but is able to supply at least [ * ] of the Compound, TAKEDA shall nonetheless supply to PENINSULA as much of the Compound as it is able to (i.e., at least [ * ]), and PENINSULA shall purchase and take delivery of such quantity of Compound manufactured and supplied by TAKEDA by the Delivery Date. TAKEDA's obligation to supply to PENINSULA between [ * ] of Compound by the Delivery Date shall be referred to herein as the "Supply Obligation". If TAKEDA, despite using its all commercially reasonable efforts to do so, is unable to satisfy its Supply Obligation, PENINSULA shall elect to either (a) accept such quantity of the Compound as TAKEDA is able to supply by the Delivery Date, in full satisfaction of the Supply Obligation, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound the price reduction in Section 7.3, or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by b) cancel the Parties), purchase order and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred reject all quantities of inventory Compound delivered by TAKEDA, if any, in which event PENINSULA shall be treated have no payment obligation to TAKEDA under Section 7.3 and TAKEDA shall have no further obligation to supply Compound to PENINSULA under this Article 7. In addition, if TAKEDA is unable to satisfy the Supply Obligation, PENINSULA shall, at its option, have the right, as Development Costs a sole and borne [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. exclusive remedy for TAKEDA's inability to satisfy the Supply Obligation, to (a) terminate this Agreement pursuant to Section 17.3, (b) manufacture, or have a third party manufacture on PENINSULA's behalf, the Compound, in which event the provisions of Section 7.15 below shall apply, or (c) if PENINSULA elects to accept the quantity of the Compound delivered by TAKEDA in full satisfaction of the Parties Supply Obligation subject to the price reduction in Section 7.3, proceed to order from TAKEDA additional quantities of Compound in accordance with Section 7.6. Prior 7.5. 7.3 The supply price for the Compound supplied by TAKEDA pursuant to the completion Section 7.2 shall be a total of US $1,200,000 regardless of the Technology Transfer actual quantity delivered so long as the total quantity delivered is at least [ * ]. If the actual quantity of Compound delivered by the Delivery Date is less than [ * ] of Compound, the supply price shall be an amount equal to $[ * ] of Compound actually delivered to PENINSULA. PENINSULA has provided TAKEDA with a letter of credit from [ * ] entitling TAKEDA to receive payment for the actual quantity of Compound delivered to PENINSULA in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims 7.3 and Section 7.9 upon delivery and acceptance thereof so that TAKEDA will immediately commence activities to satisfy its supply obligations under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faithSection 7.

Clinical Supply. In connection (a) As between the Parties, from the License Effective Date until the Manufacturing Transition Date, Mersana will (either itself or with or through an Affiliate or a Third Party subcontractor) Clinically Manufacture and supply the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or and Licensed ProductProducts as required for the performance of all Development under the Initial Development Plan and all Shared Global Development Activities and GSK Development Activities, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by applicable. To the Parties), and Lexicon’s -66- extent the Manufacturing Cost paid to Lexicon CMOs Costs for such transferred quantities of inventory shall be treated supply are included as Development Costs and borne under the Joint Development Budget or described in Section 3.2.3 (Expedited Dispute Resolution) or Section 5.2.3(b), such Manufacturing Costs will be shared by the Parties in accordance with Section 7.65.2.4 (Shared Development Costs) and Section 11.4 (Sharing of Development Costs). Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi Such Clinical Manufacturing and as mutually agreed by the Parties, supply clinical quantities of the Licensed Compound and Licensed Products by Mersana to GSK will be pursuant to, and placebo for use subject to the terms of, the applicable Clinical Supply Agreement to be entered into by Sanofi the Parties pursuant to Section 7.2.2(c). Without limiting the foregoing, in connection with Mexxxxx’s Clinical Manufacture and supply of the Development of Licensed Compound and Licensed Products for T2DM in accordance with the conduct of any activities under the Collaboration (including for the conduct of any Shared Global Development Activities for which Mersana is responsible under the Joint Development Plan), and Lexicon’s Manufacturing Cost incurred in connection therewith Mersana shall be treated as Development Costs. After the Technology Transferprovide to GSK (A) qualified person declaration, Sanofi shall supply clinical quantities per Directive 2001/83/EC of the European Parliament (“QP Declaration”), in a form reasonably acceptable to GSK, for the complete GMP supply chain (as described in applicable guidance, e.g., EMA/196292/2014)of the Licensed Compound and Licensed Products supplied by or on behalf of Mersana to GSK, (B) necessary and placebo reasonably required by Lexicon for Lexicon’s use available supporting documentation with respect to such QP Declaration as demonstrated in the Development of most recent quality control audits, (C) access to all audit reports related to quality control for the Licensed Compound and Licensed Products for T1DM in accordance with the Development Plan supplied by or on behalf of Mersana to GSK; and for its own use in the Development (D) upon release of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO any batches of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound supplied by or on behalf of Mersana to GSK for the conduct of any Clinical Trials for the Licensed Product within reasonable timelines to be for which GSK is the sponsor, a QP Declaration covering Manufacture of unlabeled vials referencing any applicable Regulatory Filings. (b) Following the Manufacturing Transition Date, as between the Parties, except as otherwise expressly provided under this Agreement or mutually agreed by the Parties in writinga Clinical Supply Agreement entered into pursuant to Section 7.2.2(c), but nothing GSK shall be solely responsible for all Clinical Manufacture and supply of the Licensed Compound (including any component piece thereof for the Manufacturing of the Licensed Compound and any Licensed Products for Development and Commercialization in this the Field in the Territory, subject to the Mersana Retained Rights and Mersana’s and its Affiliates’ and (sub)licensees’ reserved right to Manufacture or have Manufactured such components for other purposes that are consistent with Mexxxxx’s obligations under Section 6.1.1 shall limit Lexicon’s liability 4.5 (Exclusivity)) and Licensed Products throughout the Territory (including for Third Party Claims under ARTICLE 11the performance of all Shared Global Development Activities or GSK Development Activities, as applicable), [**]. At either Party’s optionNotwithstanding anything to the contrary in the foregoing, Lexicon and Sanofi shall enter into a clinical if, following the Manufacturing Transition Date, Mersana requests supply agreement and a reasonable and customary Quality Agreement that shall set forth of Licensed Compound or Licensed Products from GSK for the terms and conditions upon which Lexicon and conduct of any Shared Global Development Activities by or on behalf of Mexxxxx (or any of its Affiliates will conduct their quality activities in connection or Third Party subcontractors) hereunder, then, with respect to any such supplyLicensed Compound or Licensed Product that is Clinically Manufactured and supplied to Mersana (or its Affiliate or Third Party subcontractor) by -67- or on behalf of GSK (or any of its Affiliates or Sublicensees), including (i) a right of Sanofi such Licensed Compound or Licensed Product shall be supplied pursuant to, and subject to audit Lexicon and the Lexicon CMOsterms of, (ii) coordination regarding inspections the applicable Clinical Supply Agreement to be entered into by Regulatory Authorities and (iii) the exchange of information between the Parties regarding pursuant to Section 7.2.2(c). To the foregoing and quality issues extent the Manufacturing Costs for such supply are included as Development Costs under the Joint Development Budget or described in general. Such agreements shall Section 3.2.3 (Expedited Dispute Resolution) or Section 5.2.3(b), such Manufacturing Costs will be negotiated and agreed shared by the Parties in accordance with Section 5.2.4 (Shared Development Costs) and Section 11.4 (Sharing of Development Costs). Without limiting the foregoing, in connection with GSK’s Clinical Manufacture and supply of the Licensed Compound and Licensed Products to Mersana, GSK shall provide to Mersana (A) a QP Declaration, in a form reasonably acceptable to Mersana, for the complete supply chain of the Licensed Compound and Licensed Products supplied by or on behalf of GSK to Mersana, (B) necessary and available supporting documentation with respect to such QP Declaration as demonstrated in the most recent quality control audits, (C) access to all audit reports related to quality control for the Licensed Compound and Licensed Products supplied by or on behalf of GSK to Mersana; and (D) upon release of any batches of Licensed Compound or Licensed Product supplied by or on behalf of GSK to Mersana for the conduct of any Clinical Trials for the Licensed Product for which Mersana is the sponsor, a QP Declaration covering Manufacture of unlabeled vials referencing any applicable Regulatory Filings. [**]. (c) With respect to Party’s obligation to Clinically Manufacture and supply the Licensed Compound and Licensed Products pursuant to Section 7.2.2(a) or Section 7.2.2(b), following the License Effective Date, the Parties shall negotiate in good faithfaith and enter into one or more mutual clinical supply agreement(s) (each such supply agreement, together with any related quality agreement(s), a “Clinical Supply Agreement”); provided that each Clinical Supply Agreement shall include terms for the required lead time from the date the Party supplying Licensed Products receives the purchase order from the other Party and the requested delivery date in the purchase order and will be on terms customary for supply agreements between collaboration partners with respect to Development of products and be consistent with any key terms as may be agreed between the Parties prior the License Effective Date pursuant to Section 3.3.2 (Technology Transfer Planning) and this Section 7.2.2 (Clinical Supply).