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.
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 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 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 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.
8.5.2. Collaborator is solely responsible for supplying (including all Manufacturing, acceptance and release testing) the Collaborator Compound for the Collaborator Clinical Trial and the subsequent handling, storage, transportation, warehousing and distribution of all such Collaborator Compound. Collaborator shall ensure that all such activities are conducted in compliance with Applicable Law and, with respect to the MSD Compound Study, the Clinical Quality Agreement.
Provision of Compounds. 8.3.1 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.
8.3.2 Ideaya is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Ideaya Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Ideaya Compound supplied hereunder. Ideaya shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law and the Quality Agreement. For purposes of this Agreement, the “Delivery” of a given quantity of the Ideaya Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.
Provision of Compounds. 11 ARTICLE III - LICENSE; DEVELOPMENT AND COMMERCIALIZATION ................................... 12 3.1
Provision of Compounds. 8.4.1. MSD will deliver the MSD Compound [***] (INCOTERMS 2020) to Company’s, or its designee’s, location as specified by Company (“Delivery” with respect to such MSD Compound). [***].
8.4.2. Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Company Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Company Compound supplied hereunder. 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 Company Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.
Provision of Compounds. 8.5.1. MSD will Deliver the MSD Compound to the location specified by Collaborator. [***].
8.5.2. Collaborator is solely responsible for supplying (including all Manufacturing, acceptance and release testing) the Collaborator Compound for the Collaborator Clinical Trial and the subsequent handling, storage, transportation, warehousing and distribution of all such Collaborator Compound. Collaborator shall ensure that all such activities are conducted in compliance with Applicable Law and, with respect to the MSD Compound Study, the Clinical Quality Agreement.
Provision of Compounds. Lilly will deliver the Lilly Compound DAP (Incoterms 2020) to Sponsor's, or its designee's, location as mutually agreed ("Delivery" with respect to such Lilly Compound). Title and risk of loss for the Lilly Compound shall transfer from Lilly to Sponsor at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Lilly Compound shall be borne by CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 15 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly disclosed.
Provision of Compounds. 8.3.1 Merck will deliver the Merck Compound DAP (INCOTERMS 2010) to Advaxis’, or its designee’s, location as specified by Advaxis (“Delivery” with respect to such Merck Compound). Risk of Loss for the Merck Compound shall transfer from Merck to Advaxis at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Merck Compound shall be borne by Advaxis. Advaxis will: (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 (in accordance with Section 8.5), and promptly ship the Merck 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 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.
8.3.2 Advaxis is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Advaxis Compound for the Collaboration Program, and the subsequent handling, storage, transportation, warehousing and distribution of the Advaxis Compound supplied hereunder. Advaxis 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 Advaxis Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site or other site as set forth herein.
Provision of Compounds. 8.3.1 Menarini will use its Commercially Reasonable Efforts to deliver, at its own cost, the Menarini Compound to Context's, or its designee's, location as specified by Context in the written order (“Delivery” with respect to such Menarini Compound). Title and risk of loss for the Menarini Compound shall transfer from Menarini to Context at Delivery. All costs associated with the subsequent transportation, warehousing and distribution of Menarini Compound shall be borne by Context. Context will, or will cause its designee to: (i) take delivery of the Menarini Compound supplied hereunder; (ii) subsequently label and pack (in accordance with Section 8.4) and promptly ship the Menarini Compound to the Study sites, in compliance with cGMP, GCP and other Applicable Law; and (iii) provide, from time to time at the reasonable request of Menarini, 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 Menarini (to the extent within Context's possession or control); and usage and inventory reconciliation documentation related to the Menarini Compound.
8.3.2 Context is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Context Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Context Compound supplied hereunder. Context shall ensure that all such activities are conducted in compliance with cGMP, GCP and other Applicable Law. For purposes of this Agreement, the “Delivery” of a given quantity of the Context Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.
Provision of Compounds. 8.4.1. Merck will deliver the Merck Compound **** (INCOTERMS 2010) to Company’s, or its designee’s, location as specified by Company (“Delivery” with respect to such Merck Compound). ****.
8.4.2. Company is solely responsible, at its own cost, for supplying (including all Manufacturing, acceptance and release testing) the Company Compound for the Study, and the subsequent handling, storage, transportation, warehousing and distribution of the Company Compound supplied hereunder. 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 Company Compound shall be deemed to occur when such quantity is packaged for shipment to a Study site.
