Commercial Supply; Exclusivity; Forecasting; Order Sample Clauses

Commercial Supply; Exclusivity; Forecasting; Order. During the Term of this Agreement, SAG shall grant RTU the exclusive right to manufacture and supply Drug Substance and Drug Product to SAG for commercial purposes subject to appropriate marketing authorization in any country of the SAG Territory in respect of the Drug Substance and Drug Product and subject to Article 2.14. Commencing from the date of filing of the first NDA for a particular Drug Product after the Effective Date, SAG shall provide RTU in writing a 12 month forecast of its requirements for Drug Product which forecast will be updated quarterly until SAG's first commercial sale. Thereafter, SAG shall provide RTU a forecast in accordance with the following:
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Commercial Supply; Exclusivity; Forecasting; Order a written communication from SPA to RTU of SPA’s order for purchase of a specified amount of Unoprostone or Licensed Product at a delivery date, delivery price and delivery location set forth in such written purchase order communication. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of The Securities Exchange Act of 1934, as amended.
Sample 1
Commercial Supply; Exclusivity; Forecasting; Order. During the term of this Agreement, SPI shall grant PCD the exclusive right to manufacture and supply Drug Product to SPI for commercial purposes subject to appropriate marketing authorization in the United States or any counterpart marketing authorization in any country of the SPI Territory in respect of the Drug Product. Commencing from the date of rxxxxx of the first NDA for a particular Drug Product, SPI shall provide to PCD in writing a 12 month forecast of its requirements for Drug Product which forecast will be updated quarterly until SPI’s first commercial sale. Thereafter, SPI shall provide a rolling 12 month forecast, updated monthly. The monthly update provided to PCD 3 months prior to the actual supply need shall constitute SPI’s supply Order to PCD, which, subject to the terms and conditions of this Agreement, PCD agrees to supply.
Sample 1
Commercial Supply; Exclusivity; Forecasting; Order. During the term of this Agreement, SPE shall grant RTU the exclusive right to manufacture and supply Drug Product to SPE for commercial purposes subject to appropriate marketing authorization in the United Kingdom or any counterpart marketing authorization in any country of the SPE Territory in respect of the Drug Product. Commencing from the date of filing of the first NDA for a particular Drug Product, SPE shall provide to RTU in writing a 12 month forecast of its requirements for Drug Product which forecast will be updated quarterly until SPE’s first commercial sale. Thereafter, SPE shall provide a rolling 12 month forecast, updated monthly. The monthly update provided to RXX 0 months prior to the actual supply need shall constitute SPE’s supply Order to RTU, which, subject to the terms and conditions of this Agreement, RTU agrees to supply.
Sample 1
Commercial Supply; Exclusivity; Forecasting; Order. During the Term of this Agreement, RTU shall have the exclusive right to manufacture and supply Commercial Product upon Order for SPA for commercial purposes subject to appropriate Regulatory Approval in any country of the SPA Territory in respect of the Commercial Product. SPA shall provide to RTU in writing a twenty-four (24) month forecast of its requirements for Commercial Product which forecast will be updated quarterly and the first 90 days shall constitute SPA’s supply Order to RTU, which, subject to the terms and conditions of this Agreement, RTU agrees to supply. The minimum number of Commercial Product units per Order is [*] bottles.
Sample 1
Commercial Supply; Exclusivity; Forecasting; Order and shall be priced per Order Year as follows: For Glaucoma and/or Ocular Hypertension Use: For bottles [*] ordered by SPA in an Order Year US$[*] per bottle of 5 mL of 0.15% formulation of Drug Product (payable in Japanese Yen, converted at the spot rate at the close of Business Day in which Order invoice is paid) For bottles [*] ordered by SPA in an Order Year US$[*] per bottle of 5 mL of 0.15% formulation of Drug Product (payable in Japanese Yen, converted at the spot rate at the close of Business Day in which Order invoice is paid) For bottles [*] and over ordered by SPA in an Order Year US$[*] per bottle of 5 mL of 0.15% formulation of Drug Product (payable in Japanese Yen, converted at the spot rate at the close of Business Day in which Order invoice is paid) For Other Indication Use: For bottles [*] ordered by SPA in an Order Year US$[*] per bottle of 5 mL of 0.15% formulation of Drug Product (payable in Japanese Yen, converted at the spot rate at the close of Business Day in which Order invoice is paid) For bottles [*] and over ordered by SPA in an Order Year US$[*] per bottle of 5 mL of 0.15% formulation of Drug Product (payable in Japanese Yen, converted at the spot rate at the close of Business Day in which Order invoice is paid) Payment issued under this Section 4.3.1 shall be considered payment-in-full of all cost-of-goods plus royalties.
Sample 1
Commercial Supply; Exclusivity; Forecasting; Order. During the term of this Agreement, SPL shall grant RTU the exclusive right to manufacture and supply Drug Product to SPL for commercial purposes subject to appropriate marketing authorization in Japan or any counterpart marketing authorization in any country of the SPL Territory in respect of the Drug Product. Commencing from the date of filing of the first NDA for a particular Drug Product, SPL shall provide to RTU in writing a 12 month forecast of its requirements for Drug Product which forecast will be updated quarterly until SPL’s first commercial sale. Thereafter, SPL shall provide RTU a forecast in accordance with the following:
Sample 1
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Commercial Supply; Exclusivity; Forecasting; Order. During the term of this Agreement, SPE shall grant RTU the exclusive right to manufacture and supply Drug Product to SPE for commercial purposes subject to appropriate marketing authorization in the United Kingdom or any counterpart marketing authorization in any country of the SPE Territory in respect of the Drug Product. Commencing from the date of filing of the first NDA for a particular Drug Product, SPE shall provide to RTU in writing a 12 month forecast of its requirements for Drug
Sample 1

Related to Commercial Supply; Exclusivity; Forecasting; Order

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Marketing Plan The MCP shall submit an annual marketing plan to ODM that includes all planned activities for promoting membership in or increasing awareness of the MCP. The marketing plan submission shall include an attestation by the MCP that the plan is accurate is not intended to mislead, confuse or defraud the eligible individuals or ODM.

  • Commercial Supply Celgene shall Manufacture and supply all Commercial Supplies.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

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