Supply of Finished Product. During the Term, subject to Section 2.2.4, Patheon shall manufacture and supply, in accordance with the provisions of this Agreement, the Specifications, GMP and Applicable Laws, *** *** *** *** *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Supply of Finished Product. Upon Inspire’s election within ninety (90) days after Regulatory Approval of the Current Product in the United States, InSite promptly will modify the Cardinal Agreement so that the Cardinal Agreement would only be for the purpose of commercialization outside the Territory and assist Inspire in executing a new agreement with Cardinal with identical terms to the current Cardinal Agreement, except with respect to commercialization inside the Territory, in order to transition to Inspire all rights with respect to manufacture of Subject Products in finished form for commercialization inside the Territory. During the period commencing on the First Commercial Sale of any Subject Product in the United States and continuing until the first (1st) anniversary of such date, Inspire shall, at no cost to Inspire, be permitted to use, or have used for Inspire’s benefit, the equipment owned or controlled by InSite and used by Cardinal with respect to Subject Products in connection with the Cardinal Agreement. If, after the expiration of such one (1) year period, Inspire elects to continue to use or have used such equipment, Inspire shall be permitted to do so at a reasonable market rate that the Parties shall negotiate in good faith.
Supply of Finished Product. NOVACEA’s commitment to purchase Finished Product from XXXXXX XXXXX shall terminate, unless otherwise provided in the Supply Agreement.
Supply of Finished Product. (a) Commencing on the commercial launch of the Finished Product and thereafter during the term of this Agreement, subject to the terms and conditions of this Section 8, DURECT shall supply Endo with all of Endo’s and Endo’s Affiliates, Sublicensees’ and designees’ requirements for Finished Product and Implanters in the Territory pursuant to this Agreement, and Endo, its Affiliates, Sublicensee and designees shall purchase from DURECT all of such requirements for Finished Product and Implanters. Endo shall place orders for the requirements of its Affiliates, Sublicensees and designees, and DURECT shall ship directly to such Affiliates, Sublicensees or designees or to Endo for its reshipment to such Affiliates, Sublicensees or designees, as requested by Endo.
(b) DURECT shall ensure that all services, facilities and goods used in connection with such manufacture comply with the applicable Manufacturing Standards in effect from time to time.
(c) Endo and DURECT, in consultation with the JMC, shall cooperate in good faith and shall establish the Specifications for Product, Finished Product and Implanter for this Agreement.
(d) DURECT may, after consultation with the JMC, subcontract with a qualified Third Party Manufacturer in order to fulfill DURECT’s supply obligations to Endo hereunder; provided that in no event shall any such subcontract release DURECT from any of its obligations to supply Product, Finished Product or Implanters under this Agreement.
Supply of Finished Product. 8.3 Forecasts........................................................................................ 8.4
Supply of Finished Product. During the Term, subject to the Patheon Supply Commitment (as defined in Section 2.2.4), Patheon shall manufacture and supply, in accordance with the provisions of this Agreement, the Specifications, GMP and Applicable Laws, [***].
Supply of Finished Product. Subject to the terms and conditions of this Agreement, during the Manufacturing Term, Faes shall Manufacture and supply the Finished Product to Marathon, and Marathon shall acquire the Finished Product from Faes, in and for the Territory as follows:
(a) on an exclusive basis during the Exclusive Manufacturing Term; and
(b) on a non-exclusive basis during the Non-Exclusive Manufacturing Term. Faes acknowledges and agrees that the Finished Product Manufactured and supplied to Marathon during the Manufacturing Term shall constitute the only deflazacort oral suspension product manufactured or supplied by Faes or its Affiliates for use in the Territory during the Manufacturing Term. Marathon acknowledges that (except as expressly provided for under this Agreement) Marathon shall purchase exclusively from Faes all of its requirements for Marathon Suspension Product for the Territory during the Exclusive Manufacturing Term, and that (except as expressly provided for under this Agreement) Marathon shall cause Marathon’s Affiliates, subsidiaries and sub-licensees to purchase exclusively from Faes all of its requirements for Marathon Suspension Product for the Territory during the Exclusive Manufacturing Term.
Supply of Finished Product. 2.1.1 During the Term, Patheon shall manufacture and supply, in accordance with the provisions of this Agreement, the Specifications, cGMP and Applicable Laws, [* * *] *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Supply of Finished Product. HAMELN shall supply the Product to LICENSEE as a Finished Product. HAMELN warrants that the Product is manufactured according to all applicable c-GMP rules and regulations and in accordance with the current EU and United States laws and the processes and techniques laid down in the Marketing Authorization. Any intended change of manufacturer of the Product shall be approved by the Relevant Regulatory Authorities of the Territory before the first supply of the Product from HAMELN to LICENSEE. HAMELN further warrants (i) that the Products shall be free from defects in workmanship and materials; (ii) that the Products shall meet their applicable specifications set forth in the applicable Marketing Authorization; and (iii) that, upon delivery of a Product and during such time as such Product was under HAMELN’s control, the Product shall not be adulterated, misbranded, misused, contaminated, tampered with or otherwise altered, mishandled, or subjected to negligence. HAMELN shall supply Products to LICENSEE finally packed under HAMELN ´s own trade name and logo.
Supply of Finished Product. Until the end of the Phase 2 Period and subject to Section 2.2, Purchaser shall purchase, and Novartis shall supply, subject to the forecasting and ordering procedures in this Supply Agreement, the requirements of Purchaser and its Affiliates for the Product for sale in the Territory. During such Phase 2 Period, Novartis shall manufacture and supply the Product for sale in the Territory exclusively to Purchaser. Novartis’ obligation to supply the Product shall be limited to supplying the Product manufactured in the same form as it was manufactured by Novartis or on behalf of Novartis for the Territory as of the Closing Date (or during the Phase 1 Period if modified) with the exception of the [***], which for the sake of clarity shall be manufactured by Novartis and supplied to the Purchaser as from the Parties’ agreement as specified in the definition of Finished Product.
