Excipients Sample Clauses

Excipients. “Excipients” shall mean the raw materials, other than Active Pharmaceutical Ingredients and packaging, required to manufacture the Product in accordance with the Product Specifications, as such Excipients are listed on Exhibit 3 attached hereto, including the specifications and the analytical methodology related thereto, as such specifications may be amended from time to time by mutual agreement of the Parties.
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Excipients. Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only excipients defined in the Master Manufacturing Document. Excipients shall either comply with the most recent Pharmacopoeia monograph (EP and USP) or Strakan’ Specifications where such excipients are not included in a Pharmacopoeia monograph. In all cases, Strakan shall supply to Aptalis a control copy of the Specifications of each excipient for review and approval. Strakan shall, or shall cause its Contract Manufacturer(s), to source excipients from reputable companies previously approved by Strakan.
Excipients. UMAN shall utilise only excipients defined in the Master Manufacturing Document. Excipients shall either comply with the most recent Pharmacopoeia monograph (EP and USP) or UMAN’s Specifications where such excipients are not included in a Pharmacopoeia monograph. In all cases, UMAN shall supply to CLIENT a control copy of the Specifications of each excipient for review and approval. UMAN shall source excipients from reputable companies.
Excipients. UMAN shall utilize laboratories listed in annex III to test excipients. UMAN may use reputable sub-contractor laboratories previously approved by UMAN; such sub-contractor laboratory must be disclosed to CLIENT. UMAN QC unit shall issue final approval of the CoA and shall ensure that the results comply with the Specifications.
Excipients. Sanofi-aventis at its cost shall procure, and test in accordance with the Production Site receipt procedures, all Excipients for the manufacture of the Product in quantities sufficient to meet Horizon’s requirements of Product as further set forth herein. If the supplier of Excipient(s), and or an Excipient, is not used by sanofi-aventis or its Affiliates for the manufacture of any product other than Product, Horizon shall be responsible for the cost of any such supplier audit. Audit frequency will be determined by sanofi-aventis based on local procedures and regulatory requirements.
Excipients. Each Partner shall ensure that the vaccine formulation excipients that it uses or procures are on the FDA’s Generally Recognised as Safe (“GRAS”) excipient list. Each Partner shall promptly inform CEPI if a novel excipient, which is not on the FDA’s GRAS excipient list, is being considered by such Partner (or a third party acting on such Partner’s behalf) for use in connection with a Project Vaccine and if so, such Partner shall (or shall cause such third party to), undertake a detailed risk assessment and seek advice from the relevant Regulatory Authorities regarding such novel excipient including the extent of data required to demonstrate the safety of such novel excipient, which may include preclinical toxicology study design and data generation during clinical development. Before use of such novel excipient in connection with a Project Vaccine, the relevant Partner shall notify CEPI and provide such information regarding such excipient to CEPI as CEPI may reasonably request.
Excipients. Paddock will utilize only excipients as defined in the Master Manufacturing Document. Excipients will either comply with the most recent Pharmacopoeia monograph or Axcan specifications when such an excipients is not included in a Pharmacopoeia monograph. In all cases, Paddock will supply to Axcan a controlled copy of their specification for review and approval. Paddock will source excipients from reputable companies previously approved by Paddock. Any proposed change in the sourcing of excipients will be communicated to Axcan for approval prior to its implementation.
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Excipients. Paddock will utilize only reputable sub-contractor laboratory previously approved by Paddock and disclosed to Axcan to conduct testing of excipients. Paddock QC unit will have the responsibility for the final approval of the CoA and shall ensure that the results comply with the specification of the excipient.
Excipients. TEST METHOD (LB SOP NO. CRITERION NUMBER) SPECIFICATION ------------------------------------------------------------------ 1.13 [ * * * ] [ * * * ] [ * * * ]

Related to Excipients

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  • 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.

  • 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.

  • Labelling The distributor, on behalf of the selected vendor agrees that all supplies of articles should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. The label should contain : a. Name of the item as approved b. CMS Cat. No. c. Manufacturing date/Import date for the imported items. d. Expiry Date. (where applicable) e. Name & address of Registered Office of Manufacturers and place of manufacture. f. Manufacturing License Number. (where applicable for Manufactures) g. Batch Number (where applicable) h. Month and Year of supply. i. The label & Carton must invariably marked “W B. GOVT SUPPLY : NOT FOR SALE”. j. All Surgical items quoted/supplied by the tenderer must conform to IS /BIS /CE/USFDA. Pacemker must conform to CE & US FDA norms. In case of Drugs items quoted /supplied by tenderer MUST CONFORM TO IP, BP, or USP norms and N.F.I. –III specification as noted against the item(s) in catalogue as applicable. k. The MRP and Trade Name will not be allowed to be printed in any pack. This will lead to cancellation of candidature straightaway. However, for excisable products, insertion of writing of Govt MRP is allowed as per provision laid down in the order of the Central Excise dept. However, for imported item(s), MRP and Trade name may be allowed in addition to Generic name.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Raw Materials A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring Raw Materials as necessary to meet the Firm Commitment. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of Palatin’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause 4.2. B. In certain instances, Palatin may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent. C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry of this Agreement, Palatin shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture of other products.

  • Products Products available under this Contract are limited to Software, including Software as a Service, products and related products as specified in Appendix C, Pricing Index. Vendor may incorporate changes to their product offering; however, any changes must be within the scope of products awarded based on the posting described in Section 1.B above. Vendor may not add a manufacturer’s product line which was not included in the Vendor’s response to the solicitation described in Section 1.B above.

  • Samples The Contractor shall submit the following samples of Materials and relevant information to the Authority’s Engineer for pre-construction review: (a) manufacturer's test reports and standard samples of manufactured Materials; and (b) samples of such other Materials as the Authority’s Engineer may require.

  • 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.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

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