Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck will deliver the Merck Compound [*] to BioLineRx’s, or its designee’s, location as specified by BioLineRx (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]. BioLineRx will, or will cause its designee to: (i) take delivery of the Merck Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreement; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), and promptly ship the Merck Compound to the Study sites for use in the Study, 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 Merck, 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 Merck, and usage and inventory reconciliation documentation related to the Merck Compound.
Provision of Compounds. 8.3.1 Merck will deliver Merck Compound to Vaccinex [***] with respect to such Merck Compound. Title and risk of loss for Merck Compound shall transfer from Merck to Vaccinex at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be paid by [***] and considered Study Costs. Vaccinex will, or will cause its designee to: (i) take delivery of Merck Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreements; (iii) subsequently label and pack (in accordance with Section 8.4) and ship Merck Compound to the Study sites as required by the Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreements; and (iv) provide, from time to time at the reasonable request of Merck, the following information with respect to Merck Compound shipped by Vaccinex: 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 Merck (to the extent within Vaccinex’s possession or control); and usage and inventory reconciliation documentation related to Merck Compound.
Provision of Compounds. 9.3.1 Pfizer will deliver the Pfizer Compound [***] (Incoterms 2010) to Ideaya’s, or its designee’s, location as specified by Ideaya (“Delivery” with respect to such Pfizer Compound). Title and risk of loss for the Pfizer Compound shall transfer from Pfizer to Ideaya [***]. [***]. Ideaya will, or will cause its designee to: (i) take delivery of the Pfizer Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Quality Agreement; (iii) subsequently label and pack (in accordance with Section 8.4) and promptly ship the Pfizer Compound to the Study sites, in compliance with cGMP, GCP and other Applicable Law and the Quality Agreement; and (iv) provide, from time to time at the reasonable request of Pfizer, 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 Pfizer (to the extent within Ideaya’s possession or control); and usage and inventory reconciliation documentation related to the Pfizer Compound. [***] 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.
Provision of Compounds. 8.3.1 Merck will deliver the Merck Compound *** (Incoterms 2010)) to Syndax’s, or its designee’s, location as specified by Syndax (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to Syndax at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by ***. Syndax will, or will cause its designee to: (i) take delivery of the Merck Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreement; and (iii) subsequently label and pack, as appropriate (in accordance with Section 8.4 (Labeling and Packaging; Use, Handling and Storage)) and promptly ship the Merck Compound to the Study sites, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement.
Provision of Compounds. Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Provision of Compounds. 8.4.1 Merck will deliver the Merck Compound *** to PDS’, or its designee’s, location as specified by PDS (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to PDS at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by PDS. PDS will, or will cause its designee to: (i) take delivery of the Merck Compound supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), and promptly ship the Merck Compound to the Study sites for use in the Study, 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 Merck, 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 Merck, and usage and inventory reconciliation documentation related to the Merck Compound. *** Portions of this page have been omitted pursuant to a request for 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 Study, and the subsequent handling, storage, transportation, warehousing and distribution of the PDS Compound 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 Section 8.4.2 shall include but are not limited to site audits of Subcontractors utilized in the 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.
Provision of Compounds. 8.4.1. MSD will deliver the MSD Compound [***] to Intensity’s, or its designee’s, location as specified by Intensity (“Delivery” with respect to such MSD Compound). Title and risk of loss for the MSD Compound shall transfer from [***]. All costs associated with the subsequent transportation, warehousing and distribution of MSD Compound shall be borne by Intensity. Intensity will, or will cause its designee to: (a) take delivery of the MSD Compound supplied hereunder; (b) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (c) subsequently label and pack the MSD Compound (in accordance with Section 8.5); and promptly ship the MSD Compound to the Study sites for use in the Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement; and (d) provide, from time to time at the reasonable request of MSD, 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 MSD, and usage and inventory reconciliation documentation related to the MSD Compound.
Provision of Compounds. 8.3.1 Ideaya will deliver the Ideaya Compound [***] (INCOTERMS 2020) to the location designated by Amgen in the Development Plan (“Delivery” with respect to such Ideaya Compound). Title and risk of loss for the Ideaya Compound will transfer from Ideaya to Amgen [***]. [***] 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...
Provision of Compounds. 8.3.1 The Alliance will deliver the Alliance Compound to Vaximm Ex Works (Alliance Compound Manufacturing Site) (Incoterms 2010) (“Delivery”) with respect to such Alliance Compound. Title and risk of loss for the Alliance Compound shall transfer from the Alliance to Vaximm at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of the Alliance Compound shall be borne by Vaximm. Vaximm will, or will cause its designee to: (i) take Delivery of the Alliance Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreements; (iii) subsequently label and pack (in accordance with Section 8.4) and promptly ship the Alliance Compound to the Study sites, in compliance with cGMP, GDP, GCP and other Applicable Law and the Clinical Quality Agreements; and (iv) provide, from time to time at the reasonable request of the Alliance, the following information with respect to Alliance Compound shipped by Vaximm: 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 the Alliance (to the extent within Vaximm’s possession or control); and usage and inventory reconciliation documentation related to the Alliance Compound.
Provision of Compounds. 11 ARTICLE III - LICENSE; DEVELOPMENT AND COMMERCIALIZATION ................................... 12 3.1
