Common use of Provision of Compounds Clause in Contracts

Provision of Compounds. 8.5.1. MSD will Deliver the MSD Compound to the location specified by Collaborator. Title for the MSD Compound shall transfer from MSD to Collaborator [***]. All costs [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. associated with the subsequent transportation, warehousing and distribution of MSD Compound shall be borne by Collaborator. Collaborator will, or will cause its designee to: (i) take Delivery of the MSD Compound supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Supply Quality Agreement; (iii) subsequently label and package the MSD Compound (in accordance with Section 8.6 (Labeling and Packaging; Use, Handling and Storage)); and promptly ship the MSD Compound to the MSD Compound Study sites for use in the MSD Compound Study, in compliance with Applicable Law and the Clinical Supply Quality Agreement; (iv) keep complete and accurate records pertaining to the use and disposition of MSD Compound, including records relating to its storage, shipping (cold chain), in-transport temperature recorder(s), receipt verification, chain-of-custody activities and usage and inventory reconciliation; (v) make the records described in subsection (iv) and such other documentation as may be reasonably requested by MSD available for review by MSD for the purpose of conducting investigations for the determination of MSD Compound safety or efficacy and Collaborator’s compliance with this Agreement with respect to the MSD Compound.

Appears in 1 contract

Samples: Supply Agreement (IDEAYA Biosciences, Inc.)

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Provision of Compounds. 8.5.1. MSD will Deliver 8.4.1 Merck will, at its own cost, deliver the MSD Merck Compound to the location specified by Collaborator. Title for the MSD Compound shall transfer from MSD to Collaborator [***]. All costs [***] Certain information in this document has been excluded pursuant to Regulation S-KRexahn’s, Item 601(b)(10or its designee’s, location as specified by Rexahn (“Delivery” with respect to such Merck Compound). Such excluded information is not material Title and would likely cause competitive harm risk of loss for the Merck Compound shall transfer from Merck to the registrant if publicly disclosedRexahn at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of MSD Merck Compound shall be borne by CollaboratorRexahn. Collaborator Rexahn will, or will cause its designee to: (ia) take Delivery delivery of the MSD Merck Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Supply Quality Agreement; (iiic) subsequently label and package pack the MSD Merck Compound (in accordance with Section 8.6 (Labeling and Packaging; Use8.5), Handling and Storage)); and promptly ship the MSD Merck Compound to the MSD Compound Study sites for use in the MSD Compound Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Supply Quality Agreement; and (ivd) keep complete and accurate records pertaining provide, from time to time at the use and disposition reasonable request of MSD CompoundMerck, including records relating to its storage, shipping (cold chain)the following information: any applicable chain of custody forms, in-transport temperature recorder(s), records and receipt verificationverification documentation, chain-of-custody activities and usage and inventory reconciliation; (v) make the records described in subsection (iv) and such other transport or storage documentation as may be reasonably requested by MSD available for review by MSD for the purpose of conducting investigations for the determination of MSD Compound safety or efficacy Merck, and Collaborator’s compliance with this Agreement with respect usage and inventory reconciliation documentation related to the MSD Merck Compound. [***] 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 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Appears in 1 contract

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

Provision of Compounds. 8.5.1. MSD will Deliver the MSD Compound to the location specified by Collaborator. Title for the MSD Compound shall transfer from MSD to Collaborator [***]at Delivery. All costs [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. associated with the subsequent transportation, warehousing and distribution of MSD Compound shall be borne by Collaborator. Collaborator will, or will cause its designee to: (i) take Delivery of the MSD Compound supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Supply Quality Agreement; (iii) subsequently label and package the MSD Compound (in accordance with Section 8.6 (Labeling and Packaging; Use, Handling and Storage)); and promptly ship the MSD Compound to the MSD Compound Study sites for use in the MSD Compound Study, in compliance with Applicable Law and the Clinical Supply Quality Agreement; (iv) keep complete and accurate records pertaining to the use and disposition of MSD Compound, including records relating to its storage, shipping (cold chain), in-transport temperature recorder(s), receipt verification, chain-of-custody activities and usage and inventory reconciliation; (v) make the records described in subsection (iv) and such other documentation as may be reasonably requested by MSD available for review by MSD for the purpose of conducting investigations for the determination of MSD Compound safety or efficacy and Collaborator’s compliance with this Agreement with respect to the MSD Compound.

Appears in 1 contract

Samples: Supply Agreement (AUM Biosciences LTD)

Provision of Compounds. 8.5.1. MSD 8.3.1 Ideaya will Deliver deliver the MSD Ideaya Compound [***] (INCOTERMS 2020) to the location specified designated by CollaboratorAmgen in the Development Plan (“Delivery” with respect to such Ideaya Compound). Title and risk of loss for the MSD Ideaya Compound shall will transfer from MSD Ideaya to Collaborator Amgen [***]. All costs [***] Amgen will: (i) take delivery of the Ideaya Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreement; and (iii) subsequently label and pack (in accordance with Section 8.4 (Labeling and Packaging; Use, Handling and Storage)), and ship the Ideaya Compound to the Study sites, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement; and (iv) provide, from time to time at the reasonable request of Ideaya, the following information: any applicable chain of custody forms, in-transport temperature recorder(s), records and receipt verification documentation, such other transport or storage documentation as may be reasonably requested by Ideaya, and usage and inventory reconciliation documentation related to the Ideaya Compound. Ideaya shall, from time to time at the reasonable request of Amgen, provide Amgen the following information: any applicable chain of custody forms, in-transport temperature recorder(s), records and receipt verification documentation, such other transport or storage documentation as may be reasonably requested by Amgen, and usage and inventory reconciliation documentation related to the Ideaya Compound. Amgen agrees (i) to obtain all required licenses, certificates and permits in connection with the shipment of Ideaya Compound to Amgen; (ii) to comply with all Regulatory Approvals, including all approvals and licenses, or other requirements for importation of Ideaya Compound; (iii) to maintain the necessary records to comply with all Regulatory Approvals and other Applicable Laws; (iv) to not reverse engineer, replicate, modify, analyze, export, transfer, or otherwise exploit the Ideaya Compound except as authorized in writing by Ideaya and in compliance with Applicable Laws; and (v) not to transfer or dispose of Ideaya Compound in violation of the export laws of the country from which the Ideaya Compound is shipped. Amgen will be responsible for providing Ideaya with any [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. associated information reasonably necessary in order to enable Ideaya to fulfill any shipment of Ideaya Compound, and to comply with all labeling and other applicable legal requirements in the subsequent transportationcountries in which the Study will be conducted. Amgen will pay all taxes, warehousing 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 Ideaya Compound under this Agreement. Ideaya will be responsible for obtaining all required documents and distribution of MSD Compound shall be borne by Collaborator. Collaborator will, or will cause its designee to: (i) take Delivery of the MSD Compound supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Supply Quality Agreement; (iii) subsequently label and package the MSD Compound (approvals in accordance with Section 8.6 (Labeling and Packaging; Use, Handling and Storage)); and promptly ship the MSD order for Ideaya Compound to clear customs from the MSD countries from which Ideaya Compound Study sites will be shipped; provided, however, that upon Ideaya’s request, Amgen shall reasonably cooperate and provide Ideaya with any information necessary to assist Ideaya in obtaining such customs clearance at Ideaya’s expense. Amgen will be responsible for use obtaining all required documents and approvals in order for Ideaya Compound to clear customs in the MSD countries to which Ideaya Compound Studywill be used; provided, however, that upon Amgen’s request, Ideaya shall reasonably cooperate and provide Amgen with any information necessary to assist Amgen in compliance with Applicable Law and the Clinical Supply Quality Agreement; (iv) keep complete and accurate records pertaining to the use and disposition of MSD Compound, including records relating to its storage, shipping (cold chain), in-transport temperature recorder(s), receipt verification, chain-of-custody activities and usage and inventory reconciliation; (v) make the records described in subsection (iv) and obtaining such other documentation as may be reasonably requested by MSD available for review by MSD for the purpose of conducting investigations for the determination of MSD Compound safety or efficacy and Collaboratorcustoms clearance at Amgen’s compliance with this Agreement with respect to the MSD Compoundexpense.

Appears in 1 contract

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

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Provision of Compounds. 8.5.1. MSD 8.4.1 Merck will Deliver deliver the MSD Merck Compound *** to the PDS’, or its designee’s, location as specified by CollaboratorPDS (“Delivery” with respect to such Merck Compound). Title and risk of loss for the MSD Merck Compound shall transfer from MSD Merck to Collaborator [***]PDS at Delivery. All costs [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. associated with the subsequent transportation, warehousing and distribution of MSD Merck Compound shall be borne by CollaboratorPDS. Collaborator PDS will, or will cause its designee to: (i) take Delivery delivery of the MSD Merck Compound supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Supply Quality Agreement; (iii) subsequently label and package pack the MSD Merck Compound (in accordance with Section 8.6 (Labeling and Packaging; Use8.5), Handling and Storage)); and promptly ship the MSD Merck Compound to the MSD Compound Study sites for use in the MSD Compound Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Supply Quality Agreement; and (iv) keep complete and accurate records pertaining provide, from time to time at the use and disposition reasonable request of MSD CompoundMerck, including records relating to its storage, shipping (cold chain)the following information: any applicable chain of custody forms, in-transport temperature recorder(s), records and receipt verificationverification documentation, chain-of-custody activities and usage and inventory reconciliation; (v) make the records described in subsection (iv) and such other transport or storage documentation as may be reasonably requested by MSD available Merck, and usage and inventory reconciliation documentation related to the Merck Compound. *** Portions of this page have been omitted pursuant to a request for review by MSD Confidential Treatment filled separately with the Commission. 8.4.2 PDS is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the PDS Compound for the purpose Study, and the subsequent handling, storage, transportation, warehousing and distribution of conducting investigations for the determination of MSD PDS Compound safety or efficacy and Collaborator’s supplied hereunder. PDS shall use diligent efforts to ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement such diligent efforts for purposes of this Agreement with respect Section 8.4.2 shall include but are not limited to site audits of Subcontractors utilized in the MSD Manufacture, warehousing and transportation of PDS Compound. For purposes of this Agreement, the “Delivery” of a given quantity of the PDS Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 1 contract

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

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