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.
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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.
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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.
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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.
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Excipients. TEST METHOD (LB SOP NO. CRITERION NUMBER) SPECIFICATION ------------------------------------------------------------------ 1.13 [ * * * ] [ * * * ] [ * * * ]
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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.
Sample 1
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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.
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Related to Excipients

  • 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.

  • Raw Materials Lonza shall procure all required Raw Materials as well as consumables other than those Raw Materials that are Customer Materials. Customer shall be responsible for payment for all consumables and Raw Materials ordered or irrevocably committed to be procured by Lonza hereunder. Upon cancellation of any Batch or termination of the Agreement, all unused Raw Materials shall be paid for by Customer within [***] days of invoice and at Customer’s option will either be (a) held by Lonza for future use for the production of Product, (b) delivered to Customer, or (c) disposed of by Lonza.

  • 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 Physical examples of materials, equipment, or workmanship that are representative of some portion of the Work and that establish the standards by which such portion of the Work will be judged. The Contractor shall furnish for approval all samples required by the Contract Documents. The Work shall be in accordance with approved samples.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • 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.

  • Labeling Upon request, Lessee will xxxx the Equipment indicating Lessor's interest with labels provided by Lessor. Lessee will keep all Equipment free from any other marking or labeling which might be interpreted as a claim of ownership.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

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