API sourcing Clause Samples

API sourcing. It is estimated that sufficient quantities of fully released GMP clarithromycin API and GMP clofazimine API are available at Corealis and the Client at its own cost will ship to Corealis sufficient quantities of GMP rifabutin API (collectively the clarithromycin API, the clofazimine API and the rifabutin API are called “APIs” and individually “API”). Upon reception of the GMP rifabutin API Corealis will execute a full release testing of the material according to GMP requirements. Should additional APIs be required, the sourcing will be the exclusive responsibility of the Client. Upon request by the Client, Corealis could characterize and analyze the APIs which will be considered Extra Work. Cost: [****] * It is estimated that sufficient quantities of each of GMP clarithromycin API and GMP clofazimine API are available at Corealis to execute the manufacture of the CTM. However the Client will source and ship to Corealis sufficient quantities of GMP rifabutin API for the manufacture of the Drug product included in this Agreement. The cost includes: • the reception of one lot of GMP rifabutin API (i.e., documentation review, material registration in Corealis inventory, and material sampling following GMP requirements) (If API lot is in more than one container then the sampling and ID testing of each of the additional containers will be considered Extra Work at 200$/additional container), • the full testing for the release of one lot of GMP rifabutin API using validated method. (Client will ship the GMP rifabutin API to Corealis with the complete certificate of analysis and related documentation to assure API conformity to the appropriate regulatory authorities), • the GMP warehousing of the Client’s Materials (e.g., API, raw material, objects, inactive ingredients) for the period where the Project is active and for a volume not exceeding 1 m3. If the material need to be stored for a longer period of time or the volume of the material is more than 1 m3 then the storage cost will be considered Extra Work or the material shipped at Client. The cost does not include: • The purchase of the analytical reference materials to be used as a standard, if needed, reference impurities (synthesis by-products, Related Substances, metabolites) of known purity, HPLC columns, and any dedicated peripherals (e.g., guard column) and reagents. • The release testing of any additional material (i.e., additional API) should the Client change the drug product material specifications o...
API sourcing. Unless otherwise agreed in writing between the Parties, and to assure consistency and quality of the API, Midatech will be responsible for all sourcing of API for Product Manufacturing under this Agreement.

Related to API sourcing

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • 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.

  • Required Procurement Procedures for Obtaining Goods and Services The Grantee shall provide maximum open competition when procuring goods and services related to the grant- assisted project in accordance with Section 287.057, Florida Statutes.

  • Packaging and Labeling Seller shall properly ▇▇▇▇, ▇▇▇▇, and ship Goods and provide Buyer with shipment documentation showing the Order number, Seller’s identification number for the subject Goods, the quantity of goods in shipment and the number of cartons or containers in the shipment.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].