Manufacture of Bulk API Clause Samples

The 'Manufacture of Bulk API' clause defines the responsibilities and standards for producing the active pharmaceutical ingredient (API) in large quantities. It typically outlines the manufacturing processes, quality control measures, and compliance with regulatory requirements that the manufacturer must follow. For example, it may specify the use of approved facilities, adherence to Good Manufacturing Practices (GMP), and documentation of production batches. The core function of this clause is to ensure that the bulk API is consistently produced to meet agreed quality and safety standards, thereby minimizing risks related to product quality and regulatory compliance.
Manufacture of Bulk API. ▇▇▇▇▇▇ ▇▇▇▇▇ will manufacture the Bulk API in accordance with the API Specifications, cGMPs and other applicable rules and regulations of the FDA and other governmental or regulatory agencies within the Licensed Territory with jurisdiction over the manufacture, use or sale of the API, as then in effect. The parties shall promptly notify each other of any new instructions or specifications required by the FDA, and of other applicable United States rules and regulations. The parties shall confer with each other with respect to the best means to comply with such requirements and ▇▇▇▇▇▇ ▇▇▇▇▇ will bear the costs for implementing such changes.
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Related to Manufacture of Bulk API

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Supply of Product Salix shall use reasonable efforts to supply the Product during the Co-Promotion Period in sufficient quantities to satisfy the levels of Product sales forecasted in the then current Marketing Plan. Salix shall maintain reasonable inventory levels of the Product in order to ensure their ability to fulfill this obligation. Salix shall have the sole responsibility and right to fill orders with respect to the Product. Altana shall not solicit orders for the Product but, if for any reason, Altana shall receive an order for the Product, Altana shall promptly forward to Salix any such orders. All orders for Product shall be subject to acceptance by Salix, in its sole discretion, which acceptance shall not be unreasonably withheld. Salix may cancel any order for Product at any time after acceptance without incurring any liability to Altana. Salix shall be solely responsible for responding to requests from Target Physicians for individual patients who need the Product but are unable to afford it. Any such request shall be forwarded by Altana to Salix for processing. Salix shall have the sole right and responsibility for establishing and modifying the terms and conditions of the sale of the Product, including (a) the price at which the Product will be sold, (b) whether the Product will be subject to trade or quantity discounts, (c) whether any discount will be provided for payments on accounts receivable, (d) whether the Product will be subject to rebates, returns and allowances or retroactive price reductions, (e) the channels of distribution of the Product, and (f) whether credit [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. is to be granted or refused in connection with any sale of Product. In the event that Salix fails to supply the Product as required pursuant to this Agreement for any reason other than a Force Majeure, which such failure results in lost sales for Altana, the Parties shall meet and attempt to negotiate a mutually agreeable and commercially reasonable solution. If the Parties cannot reach such an agreement within a reasonable period of time, the issue will be dealt with as contemplated under Section 4.4 of this Agreement.