API sourcing Sample Clauses

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...
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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.

  • Packaging and Labeling Seller shall properly xxxx, xxxx, 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 [***].

  • Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.

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

  • Third Party Products and Services Any third-party hardware, software and/or services that is delivered by ResMed for use either standalone or in conjunction with ResMed products and/or services, shall be subject to the third-party terms and conditions and/or license agreements between Customer and the third party. Such third-party hardware, software and/or services is provided by ResMed "AS IS," without any warranty of any kind. Any representations or warranties as to such hardware, software and/or services shall only be as granted by the applicable third parties, if any, that accompany such products and/or software and/or services. Any representations, warranties, or other similar obligations with respect to such third-party hardware, software and/or services flow directly from the third party to Customer and ResMed shall have no responsibility at all for any such representations, warranties, obligations or lack thereof.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Product Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.

  • Proposed Goods and Services Proposed Goods and Services pdf D/M/WBE Certification OPTIONAL No response Warranty No response

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