API Supply. (i) API Intermediate Testing. GSK will re-test the API Intermediate listed on Schedule 4.4(a) prior to the Closing Date and, at Closing, GSK shall notify Prometheus of any API Intermediate that is not usable and such amounts shall not be available for purchase by Prometheus or included as part of the one-time manufacture of API under Section 4.4(a). For the avoidance of doubt, all API Intermediate quantities available for purchase or manufacture under Section 4.6(b) shall not exceed the amounts identified on Schedule 4.4(a).
API Supply. Subject to the terms and conditions of this Agreement, BACHEM shall supply to XERIS, such quantities of the API as may be specified in purchase orders submitted by XERIS pursuant to Section 2.3 below from time to time during the Term. All API to be supplied under this Agreement shall be manufactured by BACHEM at the Facility, in conformance with Applicable Laws, the Specifications and the Quality Agreement.
API Supply. Subject to the terms and conditions of this Agreement, Mallinckrodt shall supply to Osm Kft such quantities of the API as may be specified in Purchase Orders submitted by Osm Kft pursuant to Section 2.4 hereof from time to time during the Term. All API to be supplied under this Agreement shall be manufactured by Mallinckrodt at Mallinckrodt’s St. Louis, Missouri manufacturing facility (the “Facility”) in conformance with Applicable Laws (including GMPs), the Specifications, this Agreement and the Quality Agreement and shall not, at the time of Delivery, be adulterated or misbranded (“Conforming API”). Upon prior written mutual agreement between the Parties, which shall be memorialized by formal amendment to this Agreement, the API to be supplied under this Agreement may be manufactured by Mallinckrodt at another facility or facilities specified in such amendment.
API Supply. Unless otherwise provided in the Project Statement of Work or this Agreement, the following provisions will apply to supplies of API by Xxxxxxx to Pfizer.
API Supply. Subject to the terms and conditions of this Agreement, CAMBREX shall supply to RAPTOR, such quantities of the API as may be specified in purchase orders submitted by RAPTOR pursuant to Section 2.3 below from time to time during the Term. All API to be supplied under this Agreement shall be manufactured by CAMBREX at the Facility, in conformance with Applicable Laws, the Specifications and the Quality Agreement. Subject to Section 2.5, RAPTOR agrees that during the Term, RAPTOR will purchase: [*****].
API Supply. Upon Bayer’s written request delivered to Isis during the first [***] months after the Effective Date, in partial consideration for the up-front payment to Isis under Section 7.1 [***], Isis will (on its own or through a CMO) supply to Bayer by a reasonable delivery date mutually agreed by the Parties (i) [***] of API (the “Initial Supply”) ([***]) using Isis’ standard form of quality agreement with such changes as mutually agreed by the Parties and in a quality complying with the provisions set forth in such quality agreement, and (ii) [***] of [***] oligonucleotides to support the activities under the Strategic Plan.
API Supply. At the request of IntelGenx, accompanied by appropriate justification therefor, Par shall provide, at Par’s expense, (i) all reasonable quantities of API required to develop the formulation and Manufacturing Processes in respect of the Product, with the exception of API required for the Pilot Bioequivalence Study; (ii) samples of the Brand Product in reasonable quantities required to develop analytical methods and conduct stability and other testing; and (iii) any reference standards reasonably obtainable by Par from the supplier of the API for purposes of analysis, including in-process impurities and degradants, required to develop stability indicating methods.
API Supply. At the request of IntelGenx, accompanied by appropriate justification thereof, Par shall provide, at Par's expense, (i) all reasonable quantities of API required to develop the formulation and Manufacturing Processes in respect of a Product; (ii) samples of the applicable Brand Product in reasonable quantities required to develop analytical methods and conduct stability and other testing; and (iii) any reference standards reasonably obtainable by Par from the supplier of the API for purposes of analysis, including in-process impurities and degradants, required to develop stability indicating methods.
API Supply. Upon GSK’s request, the Parties shall negotiate in good faith the terms of supply for API for GSK clinical development or commercialization of Licensed Product, such terms to include a supply price for API set at ***. Notwithstanding this Section 5.1, GSK reserves the right to supply its requirements of API and/or Licensed Product (which Licensed Product can be supplied either alone or from a contract manufacturer, subject to Section 2.1.2) in order to develop and commercialize Licensed Product for GSK and/or its Affiliates and sublicensees. Further, notwithstanding the license grant to GSK in Section 2.1, the Parties acknowledge that Unigene has produced, and will be responsible for additional required production of, clinical supplies of API and finished product for the Phase II clinical trial to be carried out under the Phase II Development Plan.
API Supply. Subject to the terms and conditions of this Agreement, Supplier shall supply to NeurogesX all quantities of the API ordered by NeurogesX under this Agreement. Supplier shall supply to NeurogesX the API in kilogram orders, but shall not supply the API by aggregating the excess API of batches manufactured by Supplier for third party clients. In addition, NeurogesX has the exclusive right to purchase any full batch manufactured solely for NeurogesX by submitting an Order pursuant to Section 2.4 below. In addition, Supplier shall use its best efforts to fulfill the Orders using as few manufacturing runs as possible.
