Common use of Supply of the Compounds Clause in Contracts

Supply of the Compounds. Syndax and Merck will each supply, or cause to be supplied, the quantities of its respective Compound set forth on Appendix B on the timelines set forth in Appendix B, in each case, for use in the Study. In the event that Syndax determines that the quantities of Compounds set forth on Appendix B are not sufficient to complete the Study (due, for example, to the addition of Study sites or countries), Syndax shall so notify Merck, and the Parties shall discuss in good faith regarding additional quantities of Compounds to be provided and the schedule on which such additional quantities may be provided. Each Party shall also provide to the other Party a contact person for the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying its Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10 (Shortage; Allocation), then the other Party shall have no obligation to supply its Compound, or may allocate proportionally. Within *** from the Effective Date of this Agreement, the Parties shall enter into a “Clinical Quality Agreement” that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study. *** 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.

Appears in 2 contracts

Samples: Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc), Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)

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Supply of the Compounds. Syndax (a) Vaccinex and Merck will each supply, or cause to be supplied, the quantities of its respective Compound set forth on Appendix B on the timelines set forth in Appendix B, in each case, for use in the Study. In the event that Syndax Vaccinex determines that the quantities of Compounds set forth on Appendix B are not sufficient to complete the Study (due, for example, to the addition of Study sites or countries), Syndax Vaccinex shall so notify Merck, and the Parties shall discuss in good faith regarding additional quantities of Compounds to be provided and the schedule on which such additional quantities may be provided. Each Party shall also provide to the other Party a contact person for the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying its Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10 (Shortage; Allocation)8.10, then the other Party shall have no obligation to supply its Compound, or may allocate proportionally. Within *** from the Effective Date of this Agreement, the Parties shall enter into a “Clinical Quality Agreement” that shall address and govern issues related its Compound proportionally to the quality of clinical drug supply to be supplied by the Parties for use in the Study. [*** *] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED 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.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.), Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.)

Supply of the Compounds. Syndax and Merck will each GSK shall supply, or cause to be supplied, at its sole cost and expense, cGMP-grade quantities of the GSK Compound for use in the Sub-Study, and in accordance with the terms of this Article 12. SpringWorks shall supply, or cause to be supplied, at its sole cost and expense, cGMP-grade quantities of SpringWorks Compound for use in the Sub-Study, in the quantities of its respective Compound set forth on Appendix B and on the timelines set forth in on Appendix B, and in each case, for use in accordance with the Studyterms of this Article 12. In the event that Syndax GSK determines that the quantities of Compounds the SpringWorks Compound set forth on Appendix B are not sufficient to complete the Study (dueSub-Study, for example, to the addition of Study sites or countries), Syndax GSK shall so notify MerckSpringWorks, and the Parties shall discuss agree in good faith regarding on additional quantities of Compounds SpringWorks Compound to be provided to complete the Sub-Study and the schedule on which such additional quantities may shall be provided. Each Party shall also notify the other Party promptly in the event of any Manufacturing or supply issues, including any delay in supply of its Compound, that is reasonably likely to adversely affect the conduct or timelines of the Sub-Study as contemplated by this Agreement. Each Party shall, within [***] days of the Effective Date, provide to the other Party the name and contact details of a contact person responsible for assisting with coordinating, and facilitating the resolution of any issues or concerns arising in connection with the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying its Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10 (Shortage; Allocation)12.11, then the other Party shall have no obligation to supply its Compound, or may allocate proportionally. Within Each Party shall ensure that all activities conducted by such Party, its Affiliates and its permitted (sub)contractors and (sub)licensees under this Article 12 are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement and applicable safety and environmental protocols. [*** *] Certain information in this document has been omitted from the Effective Date of this Agreement, the Parties shall enter into a “Clinical Quality Agreement” that shall address exhibit because it is both (i) not material and govern issues related to the quality of clinical drug supply to (ii) would be supplied by the Parties for use in the Study. *** 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 AMENDEDcompetitively harmful if publicly disclosed.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)

Supply of the Compounds. Syndax and Merck the Alliance will each supply, or cause to be supplied, the quantities of its respective Compound set forth on Appendix B on the timelines set forth in Appendix B, in each case, for use in the Study. In the event that Syndax determines that the quantities of Compounds set forth on Appendix B are not sufficient to complete the Study (due, for example, to the addition of Study sites or countries), Syndax shall so notify Merckthe Alliance, and the Parties shall discuss in good faith regarding additional quantities of Compounds to be provided and the schedule on which such additional quantities may be provided. Each Party shall also provide to the other Party a contact person for the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying its Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10 (Shortage; Allocation), then the other Party shall have no obligation to supply its Compound, or may allocate proportionally. Within *** from the Effective Date of this Agreement, the Parties shall enter into a “Clinical Quality Agreement” that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study. *** 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. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either Party is not supplying its Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10, then the other Party shall have no obligation to supply its Compound, or may allocate proportionally.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)

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Supply of the Compounds. Syndax Subject to the terms and conditions of this Agreement, each of Rexahn and Merck will each use commercially reasonable efforts to supply, or cause to be supplied, the quantities of its respective Compound as are set forth on Appendix B in Exhibit B, on the timelines set forth in Appendix Exhibit B, in each case, case for use in the Study; provided, however, that no Merck Compound shall be Delivered until after an IND has been obtained by Rexahn in accordance with Section 3.1. In If the event Protocol is changed in accordance with Article 4 in such a manner that Syndax determines that may affect the quantities of Compounds set forth on Appendix B are not sufficient Compound to complete be provided or the Study (duetiming for providing such quantities, for example, to the addition of Study sites or countries), Syndax shall so notify Merck, and the Parties shall discuss in good faith regarding additional quantities of Compounds amend Exhibit B to reflect any changes required to be provided and consistent with the schedule on which such additional quantities may be providedProtocol. Each Party shall also provide to the other Party a contact person for the supply of its Compound under this Agreement. Notwithstanding the foregoing, or anything to the contrary herein, in the event that either a Party is is: (a) not supplying its Compound in accordance with the terms of this Agreement, or is allocating under Section 8.10 (Shortage; Allocation), then the other Party shall have no obligation to supply its Compound; or (b) allocating under Section 8.10, or then the other Party may allocate proportionally. Within [*** from the Effective Date of this Agreement, the Parties shall enter into a “Clinical Quality Agreement” that shall address and govern issues related to the quality of clinical drug supply to be supplied by the Parties for use in the Study. *** ] 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 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 19331934, AS AMENDED.

Appears in 1 contract

Samples: Trial Collaboration and Supply Agreement (Rexahn Pharmaceuticals, Inc.)

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