Supply of Licensed Products. Once Licensee has provided an Operational Foundry, Licensee agrees to use commercially reasonable efforts to place itself in, and to maintain, a position to manufacture, test, sell, service, repair, and maintain Licensed Products for application in the Licensed Field in the manner necessary to supply effectively the demand therefor.
Supply of Licensed Products. 5.1. PHARMA will be the sole supplier of the Product and the Lamp. The Product and the Lamp will be purchased by INC exclusively from PHARMA according to this Agreement.
Supply of Licensed Products. As between the Parties, Licensee shall be solely responsible, at its expense, to Manufacture (or have Manufactured) and supply Licensed Compounds and Licensed Products for clinical use and commercial sale in the Licensee Territory by Licensee and its Affiliates and Sublicensees except to the extent otherwise provided in any Development Plan and Budget.
Supply of Licensed Products. No later than [***] after the Effective Date, or except as otherwise mutually agreed by the Parties, the Parties shall enter into a supply agreement pursuant to which AstraZeneca shall supply to Insmed specified quantities and dosage strengths of the Licensed Compound and Licensed Products to be used by Insmed for the conduct of the initial Phase 2 Clinical Trial under the Development Plan (the “Supply Agreement”). The Parties agree that, except as may otherwise be mutually agreed, the Supply Agreement shall comply in all material respects with the draft terms set forth in Schedule 3.1 hereof, which provide, without limitation, that Insmed shall pay [***] to Manufacture such Licensed Compound and Licensed Products in accordance with the payment terms and procedures to be set forth in the Supply Agreement. Such Supply Agreement shall be negotiated and agreed by the Parties in good faith. No later than the earlier of [***] after the Effective Date and first scheduled delivery by AstraZeneca to Insmed of Licensed Product pursuant to the Supply Agreement, AstraZeneca and Insmed shall enter into a reasonable and customary quality assurance agreement (the “Quality Agreement”) that shall set forth the terms and conditions upon which each Party will conduct its respective quality activities in connection with the Supply Agreement. Such Quality Agreement shall be negotiated and agreed by the Parties in good faith. Each Party shall duly and punctually perform all of its obligations under the Supply Agreement and the Quality Agreement. AstraZeneca shall Manufacture (or have Manufactured) all such Licensed Compound and Licensed Product in accordance with Applicable Law. Except as otherwise set forth in this Section 3.1, Insmed shall have the sole right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Compound and Licensed Products for Exploitation in or for the Territory by Insmed and its Affiliates and its or their Sublicensees.
Supply of Licensed Products. Subject to the terms of this Agreement, Misonix shall purchase from PuriCore all of its requirements for Licensed Products, and PuriCore shall supply such requirements to Misonix.
Supply of Licensed Products. Customary terms of forecasting and ordering procedures, Product Specifications, and other operational matters relating to the supply of the Licensed Product under this Section 7.2 shall be set forth in a supply agreement to be mutually agreed upon by the Parties consistent with this ARTICLE 7 to be executed by the Parties within [***] following the Effective Date (the “Supply Agreement”). In connection with such Supply Agreement, the Parties shall enter into a quality agreement governing the agreed upon specifications and other technical aspects of the Licensed Product (the “Quality Agreement”). Subject to the terms of this ARTICLE 7, the Supply Agreement and Quality Agreement, Deciphera shall, itself or through one or more CMOs, (a) [***]. Zai or its Affiliates shall (i) obtain and maintain all required import licenses, and shall serve as importer of record for all Licensed Products delivered in or into any region in the Territory pursuant to this Agreement and the Supply Agreement; and (ii) be responsible for all customs’ duties, import tariffs, taxes, freight, insurance, inspection costs and the like attributed to or for the transport and importation of the Licensed Product in or into any region in the Territory.
Supply of Licensed Products. As between the Parties, Forest shall have the sole and exclusive right, at its sole cost and expense, to Manufacture (or have Manufactured) and supply the Licensed Compounds and Licensed Products for Exploitation in the Territory by Forest and its Affiliates and Sublicensees.
Supply of Licensed Products. In order to ensure the quality of the Licensed Products to be sold by Distributor under the Trademarks, Distributor shall purchase exclusively from MPL, and MPL shall supply exclusively to Distributor, pursuant to Articles 5 and 6 hereof and subject to the other terms and conditions as set forth in this Agreement, Distributor's entire requirements of Licensed Products for marketing, sale and distribution by Distributor in the Territory during the Term.
Supply of Licensed Products. Q-Med shall supply Licensed Products for Commercial Distribution that conform to the conditions of the applicable Regulatory Approvals. Q-Med shall maintain appropriate establishment registration with the FDA and TPD when manufacturing Licensed Products supplied under this Agreement. Q-Med shall supply Licensed Products for Investigational Distribution that conform to the conditions of the applicable Regulatory Approval, including but not limited to, the quality controls described therein (or appropriate quality controls for an IDE Application deemed approved pursuant to the requirements set forth in 21 C.F.R. Part 812 or Part 3 of the Canadian Medical Device Regulations, where appropriate).
Supply of Licensed Products. 6.1.1. Subject to Section 3.1.2(ii) and the last sentence of this Section 6.1.1, Xxxxx shall have the sole right and responsibility, at its own cost and expense, for the Manufacture and supply of pre-clinical, clinical, and commercial quantities of the Licensed Compounds, Licensed Products and placebo for use by ACI and Lilly in Development and Commercialization. ACI shall supply to Lilly such commercially reasonable quantities of non-cGMP grade Licensed Compounds (other than Lilly Compounds) to the extent necessary to conduct the pre-clinical Development of the Licensed Compounds and Licensed Product(s) in accordance with the Development Plan (it being understood that (i) ACI is not required to supply Lilly any precursors or intermediates of Licensed Compounds and (ii) such supply obligation shall terminate upon the completion of the ACI Pre-Clinical and Phase 1 Activities). Without limiting the foregoing sentence, (a) upon completion by ACI of all of its activities that constitute ACI Pre-Clinical and Phase 1 Activities with respect to the Licensed Compounds, ACI shall deliver to Lilly, upon Xxxxx’x request, all of the non-cGMP grade Licensed Compounds (other than Lilly Compounds) then in ACI’s possession, and (b) upon completion by ACI of all of its activities that constitute ACI Pre-Clinical and Phase 1 Activities with respect to any Backups, ACI shall deliver to Lilly, upon Xxxxx’x request, all of the non-GMP grade Backups then in ACI’s possession; provided, that, with respect to each of the foregoing clauses (a) and (b), (x) ACI shall not be required to manufacture new Licensed Compounds or Backups, as applicable, to satisfy the foregoing obligation and (y) ACI’s obligations shall be at Xxxxx’x direct out-of-pocket cost and ACI shall not be required to pay for any indirect costs incurred by Xxxxx.
