Manufacture and Purchase. Subject to the terms and conditions of this Agreement, DPT agrees that it will manufacture for and provide to COMPANY, and COMPANY agrees that it will purchase from DPT, one hundred percent (100%) of the COMPANY’s requirements of the Products. COMPANY shall pay DPT for Products according to paragraph 2.8 below. DPT shall manufacture Products in accordance with the Specifications or pursuant to exceptions approved by COMPANY, and in sufficient quantity to meet COMPANY’s Forecasted Needs for the length of this Agreement.
Manufacture and Purchase. 7 2.1. Agreement to Manufacture................................................ 7 2.2. Exclusivity............................................................. 8 2.3. Existing Distributors of Manufacturer................................... 9 2.4. Other Cardiac-Related Devices........................................... 9
Manufacture and Purchase. (a) Except to the extent specified in Section 2.9 of this Agreement, subject to the terms and conditions of this Agreement, DPT agrees that it will manufacture for and provide to COMPANY, and COMPANY agrees that it will purchase from DPT, one hundred percent (100%) of the annual requirements of the Products identified in Schedule A attached hereto. COMPANY shall pay DPT for Products as defined in paragraph 2.8 below. DPT shall manufacture Products in accordance with the Specifications or pursuant to exceptions approved in writing by COMPANY, and in sufficient quantity to meet the COMPANY’s Forecasted Needs for the length of this Agreement.
(b) All orders for the Products shall be made pursuant to the COMPANY’s Forecasted Needs delivered to DPT in accordance with Section 2.6 hereof.
(c) DPT shall manufacture and package the Products supplied to Company in accordance with the specifications. No change in the specifications, methods, processes and/or procedures may be made unless (i) Company agrees in writing ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. thereto or (ii) such change is required by (1) any regulatory agency which has jurisdiction over Company; provided, that, DPT shall notify Company prior to making any such required change and obtain Company’s written approval of any revised Specifications before implementation.
Manufacture and Purchase. Subject to Manufacturer meeting and passing the Technical Evaluation Exhibit *as shown in the Project Plan Exhibit B, Manufacturer hereby agrees to manufacture and sell to PDI such quantities of the Product(s) for which PDI issues Purchase Orders (defined herein) pursuant to this Agreement. Manufacturer shall manufacture the Product(s) in accordance with the Specifications. Manufacturer further agrees that it shall not, without PDI’s prior written consent, sell or otherwise use the PDI Intellectual Property for any other Product(s).
Manufacture and Purchase. Subject to the terms and conditions of this Agreement, DPT agrees that it will manufacture for, and provide to, AUXILIUM, AUXILIUM’s quantity of Product ordered through the Forecasted Needs. AUXILIUM agrees that it will purchase from DPTa minimum of [**] percent of AUXILIUM’s annual requirements of the Products. AUXILIUM shall pay DPT for Products according to paragraph 2.7 below. DPT shall manufacture Products in accordance with cGMP, the Specifications or pursuant to exceptions approved in advance, in writing, by AUXILIUM, and in sufficient quantity to meet AUXILIUM’s Forecasted Needs for the length of this Agreement. In the event that any Product is moved to a third party manufacturer pursuant to the terms of this Agreement, such quantity of Product shall be considered as manufactured by DPT for the purposes of calculating AUXILIUM’s purchase requirements under this Agreement.
Manufacture and Purchase. Subject to the terms and conditions of this Project Agreement, the Agreement, the Quality Agreement, and the batch records approved by ViroPharma, and beginning on the Commencement Date, OSG Norwich shall manufacture from Active Pharmaceutical Ingredient and supply to ViroPharma, and ViroPharma shall purchase from OSG Norwich, Product for commercial sale in the Territory. Except as provided below, during the period that OSG Norwich’s “Product Manufacturing Capacity” (as defined below) equals or exceeds ViroPharma’s commercial requirements for finished cartons of the Product (as reflected in the first [***] Calendar Quarters of ViroPharma’s most recent forecast for the Product delivered to OSG Norwich pursuant to Section 4.1(b) of the Agreement, the “Commercial Requirements”), ViroPharma shall purchase at least [***] of its Commercial [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Requirements for Product in the Territory during each such [***] Calendar Quarter period exclusively from OSG Norwich, provided that,:
Manufacture and Purchase. Subject to the terms and conditions of this Agreement, Supplier agrees that it will, on a non-exclusive basis (but exclusive for supply of the Product in the United States of America including Puerto Rico and the U.S. Virgin Islands), Manufacture (directly or through a designee) for and provide and supply to CUTANEA, and CUTANEA agrees that it will purchase exclusively from Supplier, all of its requirements of the Products as follows: Supplier shall supply Products in accordance with the Specifications and in sufficient quantity to meet CUTANEA’s Forecasted Needs for the length of this Agreement. All deviations from the Specifications must be approved by CUTANEA, in writing, prior to Supplier Manufacturing the Product.
Manufacture and Purchase. Subject to the Company’s acceptance of the applicable Purchase Orders, Company agrees to manufacture and sell to Sonim such quantities of the Products or spare parts for which Sonim issues Purchase Orders pursuant to this Agreement.
Manufacture and Purchase. (i) Subject to the terms and conditions of this Agreement and the Krele Supply Agreement, Supplier shall Manufacture and supply the API exclusively to Tonix, Krele, their Affiliates and their contract manufacturers for use in ICA, and Tonix shall purchase the API for use in ICA exclusively from Supplier, in such quantities as Tonix may order from time to time. Tonix shall use API exclusively in ICA or products that use API alone for use in headache treatment or pain management.
(ii) Supplier shall not provide API to any Third Party (other than a Third Party manufacturing pharmaceutical products on Tonix’s behalf as expressly instructed by Tonix) for use in ICA, and before supplying API to any Third Party, Supplier shall confirm in writing or in e-mail that the Third Party will not use the API in ICA.
(iii) Tonix shall be under no obligation to purchase API hereunder if Tonix does not receive, for any reason, an NDA or other desired regulatory approvals for ICA, nor shall Tonix be under any obligation to purchase any minimum quantity of API.
(iv) Supplier shall Manufacture all API in accordance with all Applicable Laws.
(v) Unless otherwise agreed by Tonix in writing, Supplier shall Manufacture all API from the Facility.
(vi) Supplier warrants, covenants and agrees with Tonix that, at all times, Supplier will ensure that its manufacturing capacity shall be adequate to meet Tonix’s forecasts. Supplier acknowledges that it is critical that Tonix and its Affiliates be ensured of a continuous supply of API. Accordingly, nothing herein shall restrict Tonix from identifying, establishing and validating alternative second source manufacturers of API. Notwithstanding anything to the contrary contained herein, if at any time Supplier is in breach of this Agreement or is unable to meet Tonix’s demand for API, Tonix may purchase API from one or more alternative sources.
Manufacture and Purchase. During the Term and subject to the terms and conditions of this Agreement, DPT agrees that it will manufacture and provide Product to COMPANY. COMPANY agrees to purchase from DPT, at least [***] ([***]) units from DPT. If COMPANY fails to purchase the Minimum Volume in any contract year, then within [***] ([***]) days after the end of such contract year, COMPANY shall pay DPT such dollar amount equal to the difference between the Minimum Volume less the actual number of units purchased by COMPANY from DPT for such contract year. DPT shall use commercially reasonable efforts to manufacture Product in accordance with the Specifications therefor, and in sufficient quantity to meet COMPANY’s Forecasted Needs. For the avoidance of doubt, it is clarified that, during the Initial Term of this Agreement and any subsequent renewal periods, DPT may not conduct any formulation development, but may manufacture and supply products utilizing Roflumilast as an active pharmaceutical ingredient (including performing a site transfer for such products, if needed), either by itself or through its Affiliates, for and/or to Third Parties, if and only if, DPT does not utilize any of Company’s Roflumilast active pharmaceutical ingredient or Company’s associated intellectual property (if any), in the process of such manufacture and supply.
