Common use of Provision of Compounds Clause in Contracts

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. 8.4.2 BioLineRx is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Compound supplied hereunder for the Study. BioLineRx shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 3 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.)

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Provision of Compounds. 8.4.1 Subject to Section 10.1.1, 8.4.1. Merck will deliver the Merck Compound [***] to BioLineRxFLX’s, or its designee’s, location as specified by BioLineRx FLX (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx FLX at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]FLX. BioLineRx FLX will, or will cause its designee to: (ia) take delivery of the Merck Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iiic) 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 (ivd) provide, from time to time at the reasonable request of Merck, the following informationinformation [***]: 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. 8.4.2 BioLineRx 8.4.2. FLX is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx FLX Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx FLX Compound supplied hereunder for the Studyhereunder. BioLineRx FLX shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx FLX Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 2 contracts

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

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, 8.3.1 Merck will deliver the Merck Compound [*] ** (Incoterms 2010)) to BioLineRxSyndax’s, or its designee’s, location as specified by BioLineRx Syndax (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx Syndax at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]**. BioLineRx 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 the Merck Compound pack, as appropriate (in accordance with Section 8.58.4 (Labeling and Packaging; Use, Handling and Storage), ) and promptly ship the Merck Compound to the Study sites for use in the Studysites, 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. 8.4.2 BioLineRx 8.3.2 Syndax is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Syndax Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Syndax Compound supplied hereunder for the Studyhereunder. BioLineRx Syndax shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Syndax Compound shall be deemed to occur when such quantity is packaged for shipment to a Study sitesite or other site as set forth herein.

Appears in 2 contracts

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

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, 8.3.1 Merck will deliver the Merck Compound to Vaccinex [***] 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 Vaccinex at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne paid by [*]**] and considered Study Costs. BioLineRx Vaccinex 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 AgreementAgreements; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), 8.4) and promptly ship the Merck Compound to the Study sites for use in as required by the Study, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements; and (iv) provide, from time to time at the reasonable request of Merck, the following informationinformation 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, Merck (to the extent within Vaccinex’s possession or control); and usage and inventory reconciliation documentation related to the Merck Compound. 8.4.2 BioLineRx 8.3.2 Vaccinex is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Vaccinex Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Vaccinex Compound supplied hereunder for the Studyhereunder. BioLineRx Vaccinex shall ensure that all such activities are conducted in Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. compliance with cGMP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements. For purposes of this Agreement, the “Delivery” delivery of a given quantity of the BioLineRx Vaccinex Compound shall be deemed to occur when such quantity is packaged for shipment delivered to a Study site, provided that all expenses paid by Vaccinex following delivery of the Vaccinex Compound to the Vaccinex DDP shall be deemed Study Costs.

Appears in 2 contracts

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

Provision of Compounds. 8.4.1 Subject Portions of this page have been omitted pursuant to Section 10.1.1, a request for Confidential Treatment and filed separately with the Commission. 8.4.1. Merck will deliver the Merck Compound [*] ** (INCOTERMS 2010) to BioLineRxAdaptimmune’s, or its designee’s, location as specified by BioLineRx Adaptimmune (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx Adaptimmune at Delivery. All costs associated with the subsequent transportation, warehousing warehousing, and distribution of Merck Compound shall be borne by [*]**. BioLineRx Adaptimmune 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*** documentation related to the Merck Compound, such other transport or storage documentation related to the Merck Compound as may be reasonably requested by Merck, and usage and inventory reconciliation documentation related to the Merck CompoundCompound and as reasonably requested by Merck. 8.4.2 BioLineRx 8.4.2. Adaptimmune is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) sufficient quantities of the BioLineRx Adaptimmune Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Adaptimmune Compound supplied hereunder for the Studyhereunder. BioLineRx Adaptimmune shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Adaptimmune Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC), Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, 8.4.1. Merck will deliver the Merck Compound [*] DAP (INCOTERMS 2010) to BioLineRx’sAntigen Express’, or its designee’s, location as specified by BioLineRx Antigen Express (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx Antigen Express at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]Antigen Express. BioLineRx Antigen Express 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. 8.4.2 BioLineRx 8.4.2. Antigen Express is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Antigen Express Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Antigen Express Compound supplied hereunder for the Studyhereunder. BioLineRx Antigen Express shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Antigen Express Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (Nugenerex Immuno-Oncology, Inc.), Clinical Trial Collaboration and Supply Agreement (Generex Biotechnology Corp)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, 8.4.1. Merck will deliver the Merck Compound [*] DAP (INCOTERMS 2010) to BioLineRxCompany’s, or its designee’s, location as specified by BioLineRx Company (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx Company at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]Company. BioLineRx Company will, or will cause its designee to: (ia) take delivery of the Merck Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iiic) 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 (ivd) 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. 8.4.2 BioLineRx 8.4.2. Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Company Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Company Compound supplied hereunder for the Studyhereunder. BioLineRx Company shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Company Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc), Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 9.3.1 Pfizer will deliver the Merck Pfizer Compound [***] (Incoterms 2010) to BioLineRxIdeaya’s, or its designee’s, location as specified by BioLineRx Ideaya (“Delivery” with respect to such Merck Pfizer Compound). Title and risk of loss for the Merck Pfizer Compound shall transfer from Merck Pfizer to BioLineRx at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by Ideaya [***]. BioLineRx [***]. Ideaya will, or will cause its designee to: (i) take delivery of the Merck Pfizer 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), 8.4) and promptly ship the Merck Pfizer Compound to the Study sites for use in the Studysites, 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 MerckPfizer, 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, Pfizer (to the extent within Ideaya’s possession or control); and usage and inventory reconciliation documentation related to the Merck 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. 8.4.2 BioLineRx 9.3.2 Ideaya is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Ideaya Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Ideaya Compound supplied hereunder for the Studyhereunder. BioLineRx Ideaya shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Ideaya Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.

Appears in 2 contracts

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

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck ImmunoGen will deliver the Merck ImmunoGen Compound [***] to BioLineRx’sXxxxxxxx’x, or its designee’s, location as specified by BioLineRx Xxxxxxxx (“Delivery” with respect to such Merck ImmunoGen Compound). Title and risk of loss for the Merck ImmunoGen Compound shall transfer from Merck ImmunoGen to BioLineRx at DeliveryXxxxxxxx [***]. All costs associated with the subsequent transportation, warehousing and distribution of Merck ImmunoGen Compound shall be borne by [*]Xxxxxxxx. BioLineRx Xxxxxxxx will, or will cause its designee to: (i) take delivery of the Merck ImmunoGen Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreement; and (iii) subsequently label and pack the Merck ImmunoGen Compound (in accordance with Section 8.5), and promptly ship the Merck Compound to the Study sites for use ) in the Study, in compliance accordance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement; and (iv) provide, from time to time at the reasonable request of MerckImmunoGen, 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 MerckImmunoGen, and usage and inventory reconciliation documentation related to the Merck ImmunoGen Compound. 8.4.2 BioLineRx Xxxxxxxx is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Xxxxxxxx Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Xxxxxxxx Compound supplied hereunder for the Studyhereunder. BioLineRx Xxxxxxxx shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Xxxxxxxx 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 (Shattuck Labs, Inc.)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 8.3.1. Advaxis will deliver the Merck Advaxis Compound [*] DAP (INCOTERMS 2010) to BioLineRxIncyte’s, or its designee’s, location as specified by BioLineRx Incyte (“Delivery” with respect to such Merck the Advaxis Compound). Title and risk Risk of loss Loss for the Merck Advaxis Compound shall transfer from Merck Advaxis to BioLineRx Incyte at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Advaxis Compound shall be borne shared equally by [*]the Parties. BioLineRx Incyte will, or will cause its designee to: (i) take delivery of the Merck Advaxis 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 Advaxis Compound to the Study sites for use in the Studysites, 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 MerckAdvaxis, 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 MerckAdvaxis, and usage and inventory reconciliation documentation related to the Merck Advaxis Compound. 8.4.2 BioLineRx 8.3.2. Incyte is solely responsible, at its own cost, responsible for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Incyte Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Incyte Compound supplied hereunder for hereunder. All costs associated with the Studysubsequent transportation, warehousing and distribution of Incyte Compound shall be shared equally by the Parties. BioLineRx Incyte shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Incyte Compound shall be deemed to occur when such quantity is packaged for shipment to a Study siteSite or other site as set forth herein.

Appears in 1 contract

Samples: Clinical Study Collaboration Agreement (Advaxis, Inc.)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck Ideaya will deliver the Merck Ideaya Compound [***] (INCOTERMS 2020) to BioLineRx’s, or its designee’s, the location as specified designated by BioLineRx Amgen in the Development Plan (“Delivery” with respect to such Merck Ideaya Compound). Title and risk of loss for the Merck Ideaya Compound shall will transfer from Merck Ideaya to BioLineRx at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by Amgen [***]. BioLineRx [***] Amgen will, or will cause its designee to: (i) take delivery of the Merck Ideaya Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality Agreement; and (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.58.4 (Labeling and Packaging; Use, Handling and Storage)), and promptly ship the Merck Ideaya Compound to the Study sites for use in the Studysites, 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 MerckIdeaya, 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 MerckIdeaya, and usage and inventory reconciliation documentation related to the Merck Ideaya Compound. 8.4.2 BioLineRx is solely responsible. Ideaya shall, from time to time at its own costthe reasonable request of Amgen, for supplying 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 Manufacturingapprovals and licenses, acceptance or other requirements for importation of Ideaya Compound; (iii) to maintain the necessary records to comply with all Regulatory Approvals and release testingother Applicable Laws; (iv) to not reverse engineer, replicate, modify, analyze, export, transfer, or otherwise exploit the BioLineRx Ideaya Compound for the Study, except as authorized in writing by Ideaya and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Compound supplied hereunder for the Study. BioLineRx shall ensure that all such activities are conducted in compliance with cGMPApplicable 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, GCP Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. information reasonably necessary in order to enable Ideaya to fulfill any shipment of Ideaya Compound, and to comply with all labeling and other Applicable Law and applicable legal requirements in the Clinical Quality countries in which the Study will be conducted. Amgen will pay all taxes, 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. For purposes of this AgreementIdeaya will be responsible for obtaining all required documents and approvals in order for Ideaya Compound to clear customs from the countries from which Ideaya Compound 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 obtaining all required documents and approvals in order for Ideaya Compound to clear customs in the “Delivery” of a given quantity of the BioLineRx countries to which Ideaya Compound will be used; provided, however, that upon Amgen’s request, Ideaya shall be deemed reasonably cooperate and provide Amgen with any information necessary to occur when assist Amgen in obtaining such quantity is packaged for shipment to a Study sitecustoms clearance at Amgen’s expense.

Appears in 1 contract

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

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck MSD and/or its Affiliate(s) will deliver the Merck MSD Compound [***] to BioLineRxCompany’s, or its designee’s, location as specified by BioLineRx Company (“Delivery” with respect to such Merck MSD Compound). Title and risk of loss for the Merck MSD Compound shall transfer from Merck to BioLineRx at Delivery[***]. All costs associated with the subsequent transportation, warehousing and distribution of Merck MSD Compound shall be borne by [*]Confidential Company. BioLineRx Company will, or will cause its designee to: (ia) take delivery of the Merck MSD Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iiic) subsequently label and pack the Merck MSD Compound (in accordance with Section 8.5), ; and promptly ship the Merck 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 (ivd) provide, from time to time at the reasonable request of MerckMSD, 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 MerckMSD, and usage and inventory reconciliation documentation related to the Merck MSD Compound. 8.4.2 BioLineRx Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Compound Company Compounds for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Compound Company Compounds supplied hereunder for the Studyhereunder. BioLineRx Company shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx each Company 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 (IO Biotech, Inc.)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck will deliver the Merck Compound [*] ** to BioLineRx’sPDS’, or its designee’s, location as specified by BioLineRx PDS (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx PDS at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]PDS. BioLineRx 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 BioLineRx PDS is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx PDS Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx PDS Compound supplied hereunder for the Studyhereunder. BioLineRx 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 AgreementAgreement 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 BioLineRx 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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Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 8.3.1 The Alliance will deliver the Merck Alliance Compound [*] ** (Incoterms 2010) to BioLineRxSyndax’s, or its designee’s, location as specified by BioLineRx Syndax (“Delivery”) with respect to such Merck Alliance Compound). Title and risk of loss for the Merck Alliance Compound shall transfer from Merck the Alliance to BioLineRx Syndax at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck the Alliance Compound shall be deemed Study Costs and handled in accordance with Article 7. To the extent that such costs are not set forth on the Study Costs document they shall be borne solely by [*]**. BioLineRx Syndax will, or will cause its designee to: (i) take delivery of the Merck Alliance Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality AgreementAgreements; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), 8.4) and promptly ship the Merck Alliance Compound to the Study sites for use in the Studysites, in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements; and (iv) provide, from time to time at the reasonable request of Merckthe Alliance, the following informationinformation with respect to Alliance Compound shipped by Syndax: 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, the Alliance (to the extent within Syndax’s possession or control); and usage and inventory reconciliation documentation related to the Merck Alliance Compound. 8.4.2 BioLineRx 8.3.2 Syndax is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Syndax Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Syndax Compound supplied hereunder for the Studyhereunder. BioLineRx Syndax shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements. For purposes of this Agreement, the “Delivery” Delivery of a given quantity of the BioLineRx Syndax 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 (Syndax Pharmaceuticals Inc)

Provision of Compounds. 8.4.1 Subject 8.5.1. MSD will Deliver the MSD Compound 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)Collaborator. Title and risk of loss for the Merck MSD Compound shall transfer from Merck MSD to BioLineRx at DeliveryCollaborator [***]. 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 Merck MSD Compound shall be borne by [*]Collaborator. BioLineRx Collaborator will, or will cause its designee to: (i) take delivery Delivery of the Merck MSD Compound supplied hereunder; (ii) perform the acceptance (including testing) procedures allocated to it under the Clinical Supply Quality Agreement; (iii) subsequently label and pack package the Merck MSD Compound (in accordance with Section 8.58.6 (Labeling and Packaging; Use, Handling and Storage), ); and promptly ship the Merck MSD 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) providekeep complete and accurate records pertaining to the use and disposition of MSD Compound, from time including records relating to time at the reasonable request of Merckits storage, the following information: any applicable chain of custody formsshipping (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 receipt verification documentation, such other transport or storage documentation as may be reasonably requested by Merck, MSD available for review by MSD for the purpose of conducting investigations for the determination of MSD Compound safety or efficacy and usage and inventory reconciliation documentation related Collaborator’s compliance with this Agreement with respect to the Merck MSD Compound. 8.4.2 BioLineRx 8.5.2. Collaborator is solely responsible, at its own cost, responsible for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Collaborator Compound for the Study, Collaborator Clinical Trial and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Compound supplied hereunder for the Studyall such Collaborator Compound. BioLineRx Collaborator shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and and, with respect to the MSD Compound Study, the Clinical Supply Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx 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 (IDEAYA Biosciences, Inc.)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 8.3.1 The Alliance and Checkmate will each deliver the Merck Alliance Compound [*] and Checkmate Compound, as applicable, to BioLineRx’sPfizer Ex Works (Alliance Compound Manufacturing Site or Checkmate Compound Manufacturing Site, or its designee’s, location as specified by BioLineRx applicable) (Incoterms 2010) (“Delivery”) with respect to such Merck Alliance Compound and Checkmate Compound), as applicable. Title and risk of loss for the Merck Alliance Compound and Checkmate Compound, as applicable, shall transfer from Merck the Alliance and Checkmate, as applicable to BioLineRx Pfizer at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck the Alliance Compound and Checkmate Compound, as applicable, shall be borne by [*]Pfizer. BioLineRx Pfizer will, or will cause its designee to: (i) take delivery of the Merck Alliance Compound and Checkmate Compound, as applicable, supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality AgreementAgreements; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), 8.4) and promptly ship the Merck Alliance Compound and Checkmate Compound, as applicable, to the Study sites for use in the Studysites, in compliance with cGMP, GDP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements; and (iv) provide, from time to time at the reasonable request of Merckthe Alliance and Checkmate, as applicable, the following informationinformation with respect to Alliance Compound and Checkmate Compound, as applicable, shipped by Pfizer: 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 Merckthe Alliance and Checkmate, as applicable, (to the extent within Pfizer’s possession or control); and usage and inventory reconciliation documentation related to the Merck Alliance Compound and Checkmate Compound, as applicable. 8.4.2 BioLineRx 8.3.2 Pfizer is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Pfizer Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Pfizer Compound supplied hereunder for the Studyhereunder. BioLineRx Pfizer shall ensure that all such activities are conducted in compliance with cGMP, GDP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements. For purposes of this Agreement, the “Delivery” Delivery of a given quantity of the BioLineRx Pfizer Compound shall be deemed to occur when such quantity is packaged for shipment to a the Study site.

Appears in 1 contract

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

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 8.4.1. MSD will deliver the Merck MSD Compound [***] to BioLineRxIntensity’s, or its designee’s, location as specified by BioLineRx Intensity (“Delivery” with respect to such Merck MSD Compound). Title and risk of loss for the Merck MSD Compound shall transfer from Merck to BioLineRx at Delivery[***]. All costs associated with the subsequent transportation, warehousing and distribution of Merck MSD Compound shall be borne by [*]Intensity. BioLineRx Intensity will, or will cause its designee to: (ia) take delivery of the Merck MSD Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iiic) subsequently label and pack the Merck MSD Compound (in accordance with Section 8.5), ; and promptly ship the Merck 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 (ivd) provide, from time to time at the reasonable request of MerckMSD, 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 MerckMSD, and usage and inventory reconciliation documentation related to the Merck MSD Compound. 8.4.2 BioLineRx 8.4.2. Intensity is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Intensity Compound for the StudyIntensity Clinical Trial, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Intensity Compound supplied hereunder for the Studyhereunder. BioLineRx Intensity shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Intensity 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 (Intensity Therapeutics, Inc.)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 8.3.1 The Alliance will deliver the Merck Alliance Compound [*] to BioLineRx’s, or its designee’s, location as specified by BioLineRx Vaximm Ex Works (Alliance Compound Manufacturing Site) (Incoterms 2010) (“Delivery”) with respect to such Merck Alliance Compound). Title and risk of loss for the Merck Alliance Compound shall transfer from Merck the Alliance to BioLineRx Vaximm at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck the Alliance Compound shall be borne by [*]Vaximm. BioLineRx Vaximm will, or will cause its designee to: (i) take delivery Delivery of the Merck Alliance Compound supplied hereunder; (ii) perform the acceptance procedures allocated to it under the Clinical Quality AgreementAgreements; (iii) subsequently label and pack the Merck Compound (in accordance with Section 8.5), 8.4) and promptly ship the Merck Alliance Compound to the Study sites for use in the Studysites, in compliance with cGMP, GDP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements; and (iv) provide, from time to time at the reasonable request of Merckthe Alliance, the following informationinformation 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 Merck, the Alliance (to the extent within Vaximm’s possession or control); and usage and inventory reconciliation documentation related to the Merck Alliance Compound. 8.4.2 BioLineRx 8.3.2 Vaximm is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Vaximm Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Vaximm Compound supplied hereunder for the Studyhereunder. BioLineRx Vaximm shall ensure that all such activities are conducted in compliance with cGMP, GDP, GCP and other Applicable Law and the Clinical Quality AgreementAgreements. For purposes of this Agreement, the “Delivery” Delivery of a given quantity of the BioLineRx Vaximm 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

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck will deliver the Merck Compound [*] * to BioLineRxCompany’s, or its designee’s, location as specified by BioLineRx Company (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx Company at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]Company. BioLineRx Company will, or will cause its designee to: (ia) take delivery of the Merck Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iiic) 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 (ivd) 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. *Confidential material redacted and filed separately with the Commission. 8.4.2 BioLineRx Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Company Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Company Compound supplied hereunder for the Studyhereunder. BioLineRx Company shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Company 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 (ONCOSEC MEDICAL Inc)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1Merck will, Merck will at its own cost, deliver the Merck Compound [***] to BioLineRxRexahn’s, or its designee’s, location as specified by BioLineRx Rexahn (“Delivery” with respect to such Merck Compound). Title and risk of loss for the Merck Compound shall transfer from Merck to BioLineRx Rexahn at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by [*]Rexahn. BioLineRx Rexahn will, or will cause its designee to: (ia) take delivery of the Merck Compound supplied hereunder; (iib) perform the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement; (iiic) 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 (ivd) 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. 8.4.2 BioLineRx Rexahn is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Rexahn Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Rexahn Compound supplied hereunder for the Studyhereunder. BioLineRx Rexahn shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Rexahn 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 (Rexahn Pharmaceuticals, Inc.)

Provision of Compounds. 8.4.1 Subject to Section 10.1.1, Merck 8.4.1. Company will deliver the Merck unlabeled Company Compound [*] DAP (INCOTERMS 2010) to BioLineRxMerck’s, or its designee’s, location as specified by BioLineRx Merck (“Delivery” with respect to such Merck Company Compound). Title and risk of loss for the Merck Company Compound shall transfer from Company to Merck to BioLineRx at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Company Compound (including shipment to clinical trial sites) shall be borne by [*]Merck. BioLineRx Merck will, or will cause its designee to: (i) take delivery of the Merck unlabeled Company 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 Company Compound (in accordance with Section 8.5), and promptly ship the Merck Company 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 MerckCompany, 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 MerckCompany, and usage and inventory reconciliation documentation related to the Merck Company Compound. 8.4.2 BioLineRx 8.4.2. Merck is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the BioLineRx Merck Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the BioLineRx Merck Compound supplied hereunder for the Studyhereunder. BioLineRx Merck shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the BioLineRx Merck 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 (Array Biopharma Inc)

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