Common use of Manufacture and Supply Clause in Contracts

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as commercially labeled to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its Designated Supply Contact(s). BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

Manufacture and Supply. BMS Novartis shall Manufacture or have Manufactured the BMS Novartis Study Drug Drugs in reasonable such quantities as reasonably needed, and at the points in time as agreed needed to by meet the Partiestimelines in the applicable Protocol in accordance with the Development Plan, for the Combined Therapy Clinical TrialTrials, and shall supply such BMS Novartis Study Drug as commercially labeled Drugs to the Recipient Olema or its designee for use solely in the Combined Therapy Clinical TrialTrials. The Recipient will at its sole expenseNovartis will, package and label [***], deliver the BMS Novartis Study Drug Drugs in accordance with the terms of the Supply Agreement to the Olema-designated location in the United States for use in the applicable Combined Therapy Clinical Trial Trial, and otherwise subject to and in accordance with the extent necessaryadditional delivery information, and qualitative and quantitative criteria specified in the Quality Documentation. The cost [***] All costs associated with the subsequent transportation, warehousing and distribution of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Novartis Study Drug for the Combined Therapy Clinical Trial shall Drugs will be borne solely by BMS, and BMS [***]. [***] shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its Designated Supply Contact(s). BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Novartis Study Drug Drugs used in the Combined Therapy Clinical TrialTrials. The BMS Novartis Study Drug Drugs shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Novartis Study Drug Drugs used by BMS Novartis for its other clinical trials of the BMS Novartis Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specificationsDrugs. Pursuant to the Supply and Quality Documentation, BMS Novartis shall be responsible for the regulatory compliance of the quality of the BMS Novartis Study Drug Drugs at the time the BMS Novartis Study Drug Drugs is delivered Delivered to Olema. Upon Delivery of Novartis Study Drugs to Olema, and with respect to the Recipient Novartis Study Drugs, Olema agrees to (i) obtain all required licenses, certificates and permits in connection with the regulatory filings subsequent transportation and storage thereof; (ii) comply with all Regulatory Approvals, including all approvals and licenses, or other requirements ​ pertaining to Novartis Study Drugs; (iii) to maintain the necessary records to comply with all Regulatory Approvals and other Applicable Laws; (iv) to not re-export the Novartis Study Drugs except as authorized in writing by Novartis and in compliance with Applicable Laws; and (v) not to sell, transfer or dispose of Novartis Study Drugs in violation of the export laws of the country from which the Novartis Study Drugs is shipped. Olema will be responsible for providing Novartis with any information reasonably necessary in order to enable Novartis to fulfill any shipment of Novartis Study Drugs and to comply with all labeling and other applicable legal requirements in the countries in the Territory where which the Combined Therapy Clinical Trial Trials will be performedconducted. [***] will pay all taxes, import duties, sales, use or privilege taxes, value-added taxes, excise or similar taxes or duties levied upon either Party or any Affiliate thereof by any jurisdiction, political subdivision or agency for the supply of Novartis Study Drugs after Delivery thereof to Olema under this Agreement. Novartis will be responsible for obtaining all required documents and approvals in order for Novartis Study Drugs to clear customs in applicable countries necessary for Delivery of Novartis Study Drugs to Olema hereunder. Olema will be responsible for obtaining all required documents and approvals in order for Novartis Study Drugs to clear customs in applicable countries in which Novartis Study Drugs will be used after Delivery thereof to Olema; provided, however, that upon Olema’s request, Novartis shall reasonably cooperate and provide Olema with any information necessary to assist Olema in obtaining such customs clearance, [***]. Subject to Section 4.44.6, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to supply or use of the BMS Novartis Study Drug Drugs in connection with this Agreement.

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its Designated Supply Contact(s)designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable such quantities as reasonably needed, and at the points in time as agreed needed to by meet the Partiestimelines in the Protocol and in Recipient’s clinical plan, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as commercially labeled or unlabeled vials to the Recipient or its designee [***] = Certain Confidential Information Omitted for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its Designated Supply Contact(s)designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.44.6, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to supply or use of the BMS Study Drug in connection with this Agreement.

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical TrialStudy, and shall supply such BMS Study Drug as commercially labeled or unlabeled vials to the Recipient or its designee for use solely in the Combined Therapy Clinical TrialStudy. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial Study to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial Study shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its Designated Supply Contact(s)designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical TrialStudy. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial Study will be performed. Subject to Section 4.4, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

Manufacture and Supply. BMS Exelixis shall Manufacture or have Manufactured the BMS Study Drug Exelixis Compound in drug product and/or drug substance form (as necessary) in reasonable quantities needed, and at the points in time as agreed to by the Parties, JDC for the each Combined Therapy Clinical Trial, and and, as applicable, shall supply such Exelixis Compound to BMS Study Drug as commercially labeled to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial Trials. As applicable, BMS will package and label the Exelixis Compound [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the extent necessarySecurities Exchange Act of 1934, as amended. for use in the Combined Therapy Trial, subject to Section 4.1(b). The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug Exelixis Compound for the Combined Therapy Clinical Trial Trials shall be borne solely by BMSExelixis, and BMS Exelixis shall bear the risk of loss for such quantities of BMS Study Drug the Exelixis Compound until delivery of such quantities of BMS Study Drug the Exelixis Compound to the Recipient common carrier for delivery to BMS or its Designated Supply Contact(s)designee. BMS Exelixis shall also be responsible for the payment of any Third Party License Payments that may be due exclusively on the supply of Exelixis Compound for the Combined Therapy Trials. Exelixis shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug Exelixis Compound used in the Combined Therapy Clinical TrialTrials. The BMS Study Drug Exelixis Compound shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug Exelixis Compound used by BMS Exelixis for its other clinical trials of the BMS Study DrugExelixis Compound. BMS Exelixis shall deliver certificates of analysis, and any other documents specified in the Supply Quality Agreement between Exelixis and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specificationsBMS. Pursuant to the Supply and Quality Documentation, BMS Exelixis shall be responsible for the regulatory compliance of the quality of the Exelixis Compound provided to BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the appropriate regulatory filings in the countries in the Territory where each of the Combined Therapy Clinical Trial will be Trials are performed, pursuant to the Quality Agreement. Subject to Section 4.4, the The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug Exelixis Compound in connection with this Agreement. Exelixis will inform BMS as to the GMP Manufacturing and testing site of bulk drug substance for the Exelixis Compound, as well as the Exelixis Compound drug product GMP Manufacturing and testing site, prior to the start of the Combined Therapy Trials and provide [ * ] advance written notice of any change to these site(s).

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities neededCompound and shall supply, and at or cause to be supplied, the points in time as agreed to by BMS Compound for the Parties, for conduct of the Combined Therapy Clinical TrialStudy (including for any dosing pursuant to Section 12.5). If Compugen is the Sponsoring Party, BMS shall supply the BMS Compound in unlabeled or commercially labelled vials, and shall supply Compugen will be responsible for labeling or re-labeling, as applicable, such BMS Study Drug as commercially labeled to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessaryvials. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug Compound for the Combined Therapy Clinical Trial Study (excluding the cost of labeling conducted by Compugen, if applicable) shall be borne solely by BMS, and . BMS shall bear the risk of loss for such quantities the BMS Compound, except that in the case where Compugen is the Sponsoring Party, BMS shall bear the risk of loss for the BMS Study Drug Compound until delivery of such quantities of BMS Study Drug DAP (INCOTERMS 2010) to the Recipient Compugen’s, or its Designated Supply Contact(s). designee’s, location, and risk of loss for such BMS Compound shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the then transfer from BMS Study Drug used in the Combined Therapy Clinical Trialto Compugen upon such delivery. The BMS Study Drug Compound shall be manufactured Manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug Compound used by BMS for its other clinical trials of the BMS Study DrugCompound. BMS shall deliver certificates of analysis, and to Compugen any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient Compugen to compare the BMS Study Drug Compound certificate of analysis to the BMS Study Drug Compound specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug Compound in connection with this Agreement, provided that in any event BMS may utilize its established supply chain for the supply of BMS Compound.

Manufacture and Supply. BMS Compugen shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities neededCompugen Compound and shall supply, and at or cause to be supplied, the points in time as agreed to by Compugen Compound for the Parties, for conduct of the Combined Therapy Clinical TrialStudy (including for any dosing pursuant to Section 12.5). If BMS is the Sponsoring Party, Compugen shall supply the Compugen Compound in unlabeled vials, and shall supply BMS will be responsible for labeling such BMS Study Drug as commercially labeled to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessaryvials. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug Compugen Compound for the Combined Therapy Clinical Trial Study (excluding the cost of labeling conducted by BMS, if applicable) shall be borne solely by BMS, and BMS Compugen. Compugen shall bear the risk of loss for such quantities the Compugen Compound, except that in the case where BMS is the Sponsoring Party, Compugen shall bear the risk of BMS Study Drug loss for the Compugen Compound until delivery of such quantities of BMS Study Drug DAP (INCOTERMS 2010) to the Recipient BMS’, or its Designated Supply Contact(s). designee’s, location, and risk of loss for such Compugen Compound shall then transfer from Compugen to BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trialupon such delivery. The BMS Study Drug Compugen Compound shall be manufactured Manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug Compugen Compound used by BMS Compugen for its other clinical trials of the BMS Study DrugCompugen Compound. BMS Compugen shall deliver certificates of analysis, and to BMS any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient BMS to compare the BMS Study Drug Compugen Compound certificate of analysis to the BMS Study Drug Compugen Compound specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug Compugen Compound in connection with this Agreement, provided that in any event Compugen may utilize its established supply chain for the supply of Compugen Compound.

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug Compound(s) in drug substance and/or drug product form (as necessary) in reasonable quantities needed, and at the points in time as agreed to by the Parties, JDC for the each Combined Therapy Clinical Trial, and and, as applicable, shall supply such BMS Study Drug Compound(s) in unmarked vials or as commercially labeled commercial product [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Recipient Securities Exchange Act of 1934, as amended. to Exelixis or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial Trials. As applicable, Exelixis will package and label the BMS Compound(s) for use in the Combined Therapy Trial, subject to the extent necessarySection 4.2(b). The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug Compound(s) for the Combined Therapy Clinical Trial Trials shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of the BMS Study Drug Compound(s) until delivery of such quantities of the BMS Study Drug Compound(s) to the Recipient common carrier for delivery to Exelixis or its Designated Supply Contact(s)designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due to Ono or to others exclusively on the supply of BMS Compound(s) hereunder for the Combined Therapy Trials. BMS shall be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, supply and use of the BMS Study Drug Compound(s) used in the Combined Therapy Clinical TrialTrials. The BMS Study Drug Compound(s) shall be manufactured Manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug Compound(s) used by BMS for its other clinical trials of the BMS Study DrugCompound(s). BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specificationsAgreement. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered Compound(s) provided to the Recipient Exelixis with the regulatory filings in the countries in the Territory where each of the Combined Therapy Clinical Trial will be Trials are performed, pursuant to the Quality Agreement. Subject to Section 4.4, the The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug Compound(s) in connection with this Agreement. Exelixis. BMS will inform Exelixis to the GMP Manufacturing and testing site of bulk drug substance for the BMS Compound(s), as well as the BMS Compound(s) drug product GMP Manufacturing and testing site, prior to the start of the Combined Therapy Trials and provide [ * ] advance written notice of any change to these site(s).