Scope of the Agreement Clause Example with 8 Variations from Business Contracts

Scope of the Agreement. 2.1. Generally. 2.1 Each Party shall: (a) shall contribute to the Study Collaboration Program such resources as are necessary to fulfill its obligations set forth in this Agreement; Agreement and (b) more specifically described in Article 7. 2.2 Each Party agrees to act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Man...ufacturing delay that is likely to adversely affect supply of its Compound as contemplated by this Agreement. Certain portions of this document have been marked "[C.I. ]" to indicate that confidential treatment has been requested for such confidential information. The confidential portions have been omitted and submitted separately with the Securities and Exchange Commission. 2.3. Compound Commitments. 2.3.1 Company Advaxis agrees to Manufacture and supply the Company Advaxis Compound for purposes of the Study Collaboration Program as set forth in accordance with Article 8, and Company Advaxis hereby represents and warrants to Merck that, at the time of Delivery of the Company Advaxis Compound, such Company Advaxis Compound shall have been Manufactured and supplied in compliance with: (a) (i) the Specifications for the Company Advaxis Compound; (b) (ii) the Clinical Quality Agreement; and (c) (iii) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study Collaboration Program as set forth in accordance with Article 8, and Merck hereby represents and warrants to Company Advaxis that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, that for clarity, Company Advaxis shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 3.3). 2.4. Delegation of Obligations. Each Party may delegate its activities under the Collaboration Program to its own Affiliates without the other Party's consent. Each Party shall have the right to delegate subcontract any portion of its obligations hereunder as follows: (a) to such Party's Affiliates; (b) to Third Party subcontractors, provided that the JDC has approved the use of such Third Parties that are in the performance of such activities as set forth in the Protocol as performing Study activities or as conducting Sample Testing for and further provided that such Party; (c) to the extent related to the Manufacture of such Party's Compound; and (d) upon the other Party's prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of such subcontractors. Notwithstanding the foregoing, either Party may, without consulting the JDC, subcontract its Affiliates and Subcontractors manufacturing activities with regards to which such Party delegates its Compound to be provided for the performance of its obligations under this Agreement. Study. Each Party shall ensure that each of its Affiliates and Subcontractors subcontractors performs such Party's its obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates subcontractors that are held by or under the control of such subcontractors and Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. Compounds. 2.5 During the Collaboration Program, Advaxis shall not, either alone or with another party, conduct any clinical trial involving the Advaxis Compound and any PD-1 Antagonist other than in furtherance of the Collaboration Program. 2.6 This Agreement does not create any obligation on the part of Merck to provide the Merck Compound for any activities other than the Study, Collaboration Program, nor does it create any obligation on the part of Company Advaxis to provide the Company Advaxis Compound for any activities other than the Study. Collaboration Program. 2.7 Except as provided in Section 2.5, nothing in this Agreement shall (i) prohibit either Party from performing studies other than the Collaboration Program relating to its own Compound, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound. Certain portions of this document have been marked "[C.I. ]" to indicate that confidential treatment has been requested for such confidential information. The confidential portions have been omitted and submitted separately with the Securities and Exchange Commission. View More

Scope of the Agreement. 2.1. Generally. Each Party shall: (a) shall contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) Agreement. 2.2. Each Party agrees to act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay (material supply or other delay) that is likely t...o adversely affect supply of its Compound as contemplated by this Agreement. 2.3. Compound Commitments. 2.3.1 Company Incyte agrees to Manufacture and supply the Company Incyte Compound for purposes of the Study as set forth in accordance with Article 8, and Company Incyte hereby represents and warrants to Merck Advaxis that, at the time of Delivery of the Company Incyte Compound, such Company Incyte Compound shall have been Manufactured and supplied in compliance with: (i) the Specifications for the Incyte Compound; (ii) the Clinical Quality Agreement; and (iii) all Applicable Law, including cGMP and health, safety and environmental protections. Advaxis agrees to Manufacture and supply the Advaxis Compound for purposes of the Study as set forth in Article 8, and Advaxis hereby represents and warrants to Incyte that, at the time of Delivery of the Advaxis Compound, such Advaxis Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company Advaxis Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, that for clarity, Company Incyte shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 3.3). 2.4. Delegation of Obligations. Each Party shall have the right to delegate subcontract any portion of its obligations hereunder as follows: (a) to subcontractors, provided that such Party's Affiliates; (b) to Third Parties that are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) to the extent related to the Manufacture of such Party's Compound; and (d) upon the other Party's prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. subcontractors. Each Party shall ensure that each of its Affiliates subcontractors is appropriately qualified and Subcontractors that appropriate regulatory notification or approval is received for the activities selected. Each Party shall further ensure that each of its subcontractors performs such Party's its obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates subcontractors that are held by or under the control of such subcontractors and Subcontractors that are required to be provided to the other Party under this Agreement. 6 Confidential 2.5. Compounds. This Agreement does not create any obligation on the part of Merck Advaxis to provide the Merck Advaxis Compound for any activities other than the Study, nor does it create any obligation on the part of Company Incyte to provide the Company Incyte Compound for any activities other than the Study. 2.6. Nothing in this Agreement shall (i) prohibit either Party from performing studies other than the Study relating to its own Compound, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound. View More

Scope of the Agreement. 2.1. Generally. 2.1 Each Party shall: (a) shall contribute to the Study such resources as are reasonably necessary to fulfill its obligations set forth in this Agreement; and (b) Agreement. 2.2 Each Party agrees to act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party Agreement, and shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to ad...versely affect supply of its Compound as contemplated by this Agreement. 2.3. Compound Commitments. 2.3.1 Company agrees to Manufacture and supply the Company Compound for purposes of the Study in accordance with Article 8, and Company hereby represents and warrants to Merck that, at the time of Delivery of the Company Compound, such Company Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, for clarity, Company shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 2.4. Delegation of Obligations. 2.3 Each Party shall have the right to delegate subcontract any portion of its obligations hereunder as follows: (a) to such Party's Affiliates; (b) to Third Parties that are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) to the extent related to the Manufacture of such Party's Compound; and (d) upon the other Party's prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, each subcontractors ("Subcontractors"). Each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Subcontractors. Each Party shall ensure that each of its Affiliates and Subcontractors subcontractors performs such Party's its obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. For clarity, to the extent that a Party has an obligation under this Agreement to perform an action or to meet a standard, and such Party subcontracts such obligation, such Party shall be responsible for any failure by such Party's Subcontractor to perform the action or meet the standard. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates Subcontractors that are held by or under the control of such Subcontractors and Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. Compounds. 2.4 This Agreement does not create any obligation on the part of Merck to provide the Merck Compound for any activities other than the Study, nor does it create any obligation on the part of Company Vaccinex to provide the Company Vaccinex Compound for any activities other than the Study. [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Note: Reference to "Merck" in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. 9 2.5 Subject to Section 3.10 below, nothing in this Agreement shall (i) prohibit either Party from performing clinical studies other than the Study relating to its own Compound, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound. View More

Scope of the Agreement. 2.1. Generally. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 7 2.1 Each Party shall: (a) shall contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) Agreement. 2.2 Each Party agrees to act in good faith in performing ...its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party Agreement, and shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound as contemplated by this Agreement. 2.3. Compound Commitments. 2.3.1 Company Representations and Warranties. 2.3.1. Syndax agrees to Manufacture and supply the Company Syndax Compound for purposes of the Study as set forth in accordance with Article 8, and Company Syndax hereby represents and warrants to Merck the Alliance that, at the time of Delivery of the Company Syndax Compound, such Company Syndax Compound shall have been Manufactured and supplied in compliance with: (i) the Specifications for the Syndax Compound; (ii) the Clinical Quality Agreements; and (iii) all Applicable Law, including cGMP and health, safety and environmental protections. The Alliance agrees to Manufacture and supply the Alliance Compound for purposes of the Study as set forth in Article 8, and the Alliance hereby represents and warrants to Syndax that, at the time of Delivery of the Alliance Compound, such Alliance Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company Alliance Compound; (b) the Clinical Quality Agreement; Agreements; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, that for clarity, Company Syndax shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 3.3). 2.4. Delegation of Obligations. Each Party shall have the right to delegate subcontract any portion of its obligations hereunder as follows: (a) to such Party's Affiliates; (b) to Third Parties that are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) to the extent related to the Manufacture of such Party's Compound; and (d) upon the other Party's prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, each subcontractors ("Subcontractors"). Each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Subcontractors. Each Party shall ensure that each of its Affiliates and Subcontractors subcontractors performs such Party's its obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. For clarity, to the extent that a Party has an obligation under this Agreement to perform an action or to meet a standard, and such Party subcontracts such obligation, such Party shall be responsible for any failure by such Party's Subcontractor to perform the action or meet the standard. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates Subcontractors that are held by or under the control of such Subcontractors and Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. Compounds. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 8 2.5 This Agreement does not create any obligation on the part of Merck the Alliance to provide the Merck Alliance Compound for any activities other than the Study, nor does it create any obligation on the part of Company Syndax to provide the Company Syndax Compound for any activities other than the Study. 2.6 Subject to Section 3.10 below, nothing in this Agreement shall (i) prohibit either Party from performing clinical studies other than the Study relating to its own Compound, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound. View More

Scope of the Agreement. 2.1. Generally. 2.1 Each Party shall: (a) shall contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) Agreement. 2.2 Each Party agrees to act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party Agreement, and shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely aff...ect supply of its Compound as contemplated by this Agreement. 2.3. Compound Commitments. 2.3 Representations and Warranties. 2.3.1 Company Lilly agrees to Manufacture and supply the Company Lilly Compound for purposes of the Study as set forth in accordance with Article 8, and Company Lilly hereby represents and warrants to Merck Athenex that, at the time of Delivery of the Company Lilly Compound, such Company Lilly Compound shall have been Manufactured and supplied in compliance with: (a) (i) the Specifications for the Company Lilly Compound; (b) the Clinical Quality Agreement; and (c) (ii) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, that for clarity, Company Athenex shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 2.4. Delegation of Obligations. 3.3). 2.4 Each Party shall have the right to delegate subcontract any portion of its obligations hereunder as follows: (a) hereunder: (i) to its own Affiliates, without the other Party's written consent; or (ii) to third parties, provided that with respect to third parties that are directly involved in the conduct of the clinical trial that is subject of the Study, the Parties have approved (in a written document) the use of such third parties in the performance of such activities, and provided further that no consent shall be necessary for either Party's delegation to or use of contract research organizations or other third parties that are already conducting clinical trials of such Party's Affiliates; (b) to Third Parties that Compound and are set forth in the Protocol as performing such Study activities or as conducting Sample Testing for such Party; (c) to the extent related to the Manufacture of such Party's Compound; and (d) upon the other Party's prior written consent. Any and all Third Parties to whom a Party delegates activities. In any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, event, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. subcontractors. Each Party shall ensure that each of its Affiliates and Subcontractors subcontractors performs such Party's its obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates subcontractors that are held by or under the control of such subcontractors and Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. Compounds. 2.5 This Agreement does not create any obligation on the part of Merck Athenex to provide the Merck Athenex Compound for any activities other than the Study, nor does it create any obligation on the part of Company Lilly to provide the Company Lilly Compound for any activities other than the Study. 2.6 Nothing in this Agreement shall (i) prohibit either Party from performing clinical studies other than the Study relating to its own Compound, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound. 6 *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. View More

Scope of the Agreement. 2.1. Generally. Each Party shall: (a) contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound as contemplated by this Agreement.... In providing such notification each Party shall provide information on the nature of such delay and the likely impact on supply of Compound for use in accordance with the Protocol (including estimates as to when such adverse affect will cease to impact supply), provided that there shall be no obligation on the relevant Party under this Section 2.2 to provide any of its or any Third Party's proprietary Manufacturing information or technology information. 2.3. Compound Commitments. 2.3.1 Company 8 (a) Adaptimmune agrees to Manufacture and supply the Company Adaptimmune Compound for purposes of the Study in accordance with Article 8, and Company Adaptimmune hereby represents and warrants to Merck that, at the time of Delivery of the Company Adaptimmune Compound, such Company Adaptimmune Compound shall have been Manufactured and supplied in compliance with: (a) (i) the Specifications for the Company Adaptimmune Compound; (b) (ii) the Clinical Quality Agreement; and (c) (iii) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 (b) Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company Adaptimmune that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) (i) the Specifications for the Merck Compound; (b) (ii) the Clinical Quality Agreement; and (c) (iii) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 (c) Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, for clarity, Company Adaptimmune shall be responsible for obtaining Regulatory Approvals for the conduct of the Study as set forth in Section 3.4). 2.4. Delegation of Obligations. Each Party shall have the right to delegate any portion of its obligations hereunder as follows: (a) to such Party's Affiliates; (b) to contract research organizations or other Third Parties that (i) are conducting clinical trials of such Party's Compound as of the Effective Date and are set forth in the Protocol as performing such Study activities or as (ii) are conducting Sample Testing for such Party; Party, (iii) are engaging in the analysis or testing of Clinical Data for such Party or (iv) are set forth on Schedule 2.4; (c) to the extent related to the Manufacture of such Party's Compound; *** and (d) upon the written consent of the other Party's prior written consent. Party such consent not to be unreasonably withheld or delayed. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Each Party shall ensure that each of its Affiliates and Subcontractors performs such Party's obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates and use reasonable efforts to obtain and have maintained documents relating to the obligations performed by such Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. Compounds. This Except as expressly set forth in Section 3.15, this Agreement does not create any obligation on the part of Merck to provide the Merck Compound for any activities other than the Study, nor does it create any obligation on the part of Company Adaptimmune to provide the Company Adaptimmune Compound for any activities other than the Study. View More

Scope of the Agreement. 2.1. Generally. 2.1 Each Party shall: (a) shall contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) Agreement. 2.2 Each Party agrees to act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. Manufacturing Delay. Each Party Agreement, and shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely aff...ect supply of its Compound as contemplated by this Agreement. 2.3. Compound Commitments. 2.3.1 Company Obligations, Representations and Warranties. 2.3.1. Syndax agrees to Manufacture and supply the Company Syndax Compound for purposes of the Study as set forth in accordance with Article 8, 8 (Supply and Company Use of the Compounds), and Syndax hereby represents and warrants to Merck that, at the time of Delivery of the Company Syndax Compound, such Company Syndax Compound shall have been Manufactured and supplied in compliance with: (a) (i) the Specifications for the Company Syndax Compound; (b) (ii) the Clinical Quality Agreement; and (c) (iii) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study as set forth in accordance with Article 8, 8 (Supply and Use of the Compounds), and Merck hereby represents and warrants to Company Syndax that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 2.3.3 2.3.2 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound in accordance with Applicable Law (provided that, that for clarity, Company Syndax shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 3.3). 2.4. Delegation of Obligations. Each Party shall have the right to delegate subcontract any portion of its obligations hereunder as follows: (a) hereunder: (i) to such Party's Affiliates; (b) to Third Parties that are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) to the extent related to the Manufacture of such Party's Compound; and (d) upon its own Affiliates, without the other Party's prior written consent. Any and all consent; or (ii) to Third Parties, provided that the JDC has approved (in a written document) the use of such Third Parties in the performance of such activities, and provided further that no consent shall be necessary for either Party's delegation to whom a Party delegates or use of Third Parties *** (such Third Parties described in clause (ii), "Subcontractors"). In any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, event, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Each Party shall ensure that each of its Affiliates and Subcontractors performs such Party's obligations pursuant to the *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 7 terms of this Agreement, including the Appendices and Schedules attached hereto. For clarity, to the extent that a Party has an obligation under this Agreement to perform an action or to meet a standard, and such Party subcontracts such obligation, such Party shall be responsible for any failure by such Party's Subcontractor to perform the action or meet the standard. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates subcontractors that are held by or under the control of such Subcontractors and Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. Compounds. 2.5 This Agreement does not create any obligation on the part of Merck to provide the Merck Compound for any activities other than the Study, Study (except as provided in Section 6.12), nor does it create any obligation on the part of Company Syndax to provide the Company Syndax Compound for any activities other than the Study. Study (except as provided in Section 6.12). 2.6 Nothing in this Agreement shall (i) prohibit either Party from performing clinical studies relating to its own Compound, either individually or in combination with any other compound or product, in any therapeutic area, or (ii) create an exclusive relationship between the Parties with respect to any Compound. View More

Scope of the Agreement. 2.1. 2.1 Generally. Each Party shall: (a) contribute to the Study such resources as are necessary to fulfill its obligations set forth in this Agreement; and (b) act in good faith in performing its obligations under this Agreement and each Related Agreement to which it is a Party. 2.2. 2.2 Manufacturing Delay. Each Party shall notify the other Party as promptly as possible in the event of any Manufacturing delay that is likely to adversely affect supply of its Compound Compound(s) as contemplate...d by this Agreement. 2.3. 2.3 Compound Commitments. 2.3.1 Company agrees to Manufacture and supply the Company Compound Compounds for purposes of the Study in accordance with Article 8, and Company hereby represents and warrants to Merck MSD that, at the time of Delivery of the Company Compounds, such Company Compounds shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company Compounds; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 MSD and/or its Affiliate(s) agrees to Manufacture and supply the MSD Compound for purposes of the Study in accordance with Article 8, and MSD and/or its Affiliate(s) hereby represents and warrants to Company that, at the time of Delivery of the MSD Compound, such Company MSD Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Company MSD Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 2.3.2 Merck agrees to Manufacture and supply the Merck Compound for purposes of the Study in accordance with Article 8, and Merck hereby represents and warrants to Company that, at the time of Delivery of the Merck Compound, such Merck Compound shall have been Manufactured and supplied in compliance with: (a) the Specifications for the Merck Compound; (b) the Clinical Quality Agreement; and (c) all Applicable Law, including cGMP and health, safety and environmental protections. 8 CONFIDENTIAL 9 Confidential 2.3.3 Without limiting the foregoing, each Party is responsible for obtaining all regulatory approvals (including facility licenses) that are required to Manufacture its Compound Compound(s) in accordance with Applicable Law (provided that, for clarity, Company shall be responsible for obtaining Regulatory Approvals for the Study as set forth in Section 3.4). 2.4. 2.4 Delegation of Obligations. Each Party shall have the right to delegate any portion of its obligations hereunder as follows: (a) to such Party's Affiliates; (b) to Third Parties that are set forth on Schedule 2.4 or are set forth in the Protocol as performing Study activities or as conducting Sample Testing for such Party; (c) to the extent related to Third Parties solely in connection with the Manufacture of such Party's Compound; Compound(s); and (d) upon the other Party's prior written consent. Any and all Third Parties to whom a Party delegates any of its obligations hereunder are referred to as "Subcontractors". Notwithstanding any delegation of its obligations hereunder, each Party shall remain solely and fully liable for the performance of its Affiliates and Subcontractors to which such Party delegates the performance of its obligations under this Agreement. Each Party shall ensure that each of its Affiliates and Subcontractors performs such Party's obligations pursuant to the terms of this Agreement, including the Appendices and Schedules attached hereto. Each Party shall use reasonable efforts to obtain and maintain copies of documents relating to the obligations performed by such Affiliates and Subcontractors that are required to be provided to the other Party under this Agreement. 2.5. 2.5 Compounds. This Agreement does not create any obligation on the part of Merck MSD and/or its Affiliate(s) to provide the Merck MSD Compound for any activities other than the Study, nor does it create any obligation on the part of Company to provide the Company Compound Compounds for any activities other than the Study. View More