Common use of Responsibilities of BMS Clause in Contracts

Responsibilities of BMS. BMS shall be responsible for: (i) manufacturing and supplying sufficient GMP-grade quantities of BMS Compound, as further described in Article 4 above, and, where required, providing for the release by a Qualified Person (as such term will be defined in the Supply and Quality Documentation), or providing the necessary documentation in support of quality release, of the BMS Compound if such release is required for the Combined Therapy Study; (ii) cooperating with Checkmate to obtain all necessary approvals and clearances, including IRB approvals and customs clearances and to compile all necessary Combined Therapy Study Regulatory Documentation to be filed with Regulatory Authority(ies) for the Combined Therapy Study; (iii) reviewing the Protocol and Statistical Analysis Plan, and any amendments thereto, in accordance with Section 2.1(b) (with the Protocol and Statistical Analysis Plan, and any amendments thereto, to be approved in accordance with Section 2.1(b)); (iv) drafting and updating the Combined Therapy investigator’s brochure in accordance with Section 2.1(f), in the event that a new Combined Therapy investigator’s brochure is required by a Regulatory Authority for the Combined Therapy Study; (v) reviewing the template ICF and template Site Agreement, and any amendments thereto, in accordance with Section 2.1(d) (with the template ICF and template Site Agreement, and any amendments thereto, to be approved in accordance with Section 2.1(d)); (vi) providing feedback to Checkmate on the CRO/Study Site List in accordance with Section 2.1(c) (with such CRO/Study Site List to be approved by the JDC in accordance with Section 2.4(p)); (vii) to the extent necessary for the conduct of each particular Combined Therapy Study, providing a Right of Cross-Reference to the relevant Regulatory Documentation for the BMS Compound, provided that, except as provided in Section 3.2, such Right of Cross-Reference shall terminate upon the earlier of (A) the completion or termination of such Combined Therapy Study and (B) the expiration or termination of this Agreement, except that in the case of termination for a Material Safety Issue pursuant to Section 12.4(a), such Right of Cross-Reference shall remain in effect solely (1) to the extent necessary to permit Checkmate to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (2) as necessary to permit Checkmate to continue to dose subjects enrolled in the Combined Therapy Study through completion of the Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws; (viii) jointly reviewing, providing comments to Checkmate within five (5) Business Days on all substantive Combined Therapy Study Regulatory Documentation and providing Checkmate with copies of Regulatory Documentation relating to the BMS Compound and BMS Technology (“BMS Regulatory Documentation”), as both Parties agree is necessary or reasonably expected to be necessary, and is requested by BMS, (1) to obtain and maintain the IND for the Combined Therapy Study and prepare and file any Combined Therapy Study Regulatory Documentation in accordance with this Agreement, or (2) to comply with Applicable Law with regard to the Checkmate Compound and the Combined Therapy Study, which may include information regarding the pharmacokinetics, efficacy and safety of the BMS Compound alone or in combination with the Checkmate Compound; (ix) providing comment and input on the management of the Combined Therapy Study pursuant to the Protocol; (x) providing Checkmate with the investigator’s brochure for the BMS Compound (and any updates thereto), as well as all relevant Safety Information (including any SUSAR reports) for the BMS Compound in accordance with Section 2.1(g) and the Pharmacovigilance Agreement; and (xi) such other responsibilities as may be agreed to by the Parties or determined by the JDC.

Responsibilities of BMS. BMS shall be responsible for: (i) manufacturing and supplying sufficient GMP-grade quantities of BMS Compound, as further described in Article 4 above, and, where required, providing for the release by a Qualified Person (as such term will be defined in the Supply and Quality Documentation), or providing the necessary documentation in support of quality release, of the BMS Compound if such release is required for the Combined Therapy Study; (ii) cooperating with Checkmate Compugen to obtain all necessary approvals and clearances, including IRB approvals and customs clearances and to compile all necessary Combined Therapy Study Regulatory Documentation to be filed with Regulatory Authority(ies) for the Combined Therapy Study; (iii) reviewing the Protocol and Statistical Analysis Plan, and any amendments thereto, in accordance with Section 2.1(b) (with the Protocol and Statistical Analysis Plan, and any amendments thereto, to be approved in accordance with Section 2.1(b)); (iv) drafting and updating the Combined Therapy investigator’s brochure in accordance with Section 2.1(f), in the event that a new Combined Therapy investigator’s brochure is required by a Regulatory Authority for the Combined Therapy Study; (v) reviewing the template ICF and template Site Agreement, and any amendments thereto, in accordance with Section 2.1(d) (with the template ICF and template Site Agreement, and any amendments thereto, to be approved in accordance with Section 2.1(d));; [*] = 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 Securities Exchange Act of 1934, as amended. (vi) providing feedback to Checkmate Compugen on the CRO/Study Site List in accordance with Section 2.1(c) (with such CRO/Study Site List to be approved by the JDC in accordance with Section 2.4(p)); (vii) to the extent necessary for the conduct of each particular Combined Therapy Study, providing a Right of Cross-Reference to the relevant Regulatory Documentation for the BMS Compound, provided that, except as provided in Section 3.23.1(b), such Right of Cross-Reference shall terminate upon the earlier of (A) the completion or termination of such Combined Therapy Study and (B) the expiration or termination of this Agreement, provided that, except that in the case of termination for a Material Safety Issue pursuant to Section 12.4(a), such Right of Cross-Reference shall remain in effect solely (1) to the extent necessary to permit Checkmate Compugen to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (2) as necessary to permit Checkmate Compugen to continue to dose subjects enrolled in the Combined Therapy Study through completion of the Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws; (viii) jointly reviewing, providing comments to Checkmate Compugen within five (5) Business Days on all substantive Combined Therapy Study Regulatory Documentation and providing Checkmate Compugen with copies of Regulatory Documentation relating to the BMS Compound and BMS Technology (“BMS Regulatory Documentation”), as both Parties agree is necessary or reasonably expected to be necessary, and is requested by BMS, (1) to obtain and maintain the IND for the Combined Therapy Study and prepare and file any Combined Therapy Study Regulatory Documentation in accordance with this Agreement, or (2) to comply with Applicable Law with regard to the Checkmate Compugen Compound and the Combined Therapy Study, which may include information regarding the pharmacokinetics, efficacy and safety of the BMS Compound alone or in combination with the Checkmate Compugen Compound; (ix) providing comment and input on the management of the Combined Therapy Study pursuant to the Protocol; (x) providing Checkmate Compugen with the investigator’s brochure for the BMS Compound (and any updates thereto), as well as all relevant Safety Information (including any SUSAR reports) for the BMS Compound in accordance with Section 2.1(g) and the Pharmacovigilance Agreement; and (xi) such other responsibilities as may be agreed to by the Parties or determined by the JDC.