Standard of Manufacture Sample Clauses

Standard of Manufacture. EURAND shall supply RELIANT with Product meeting the Specifications. All Product supplied by EURAND to RELIANT hereunder shall be consistent with the DMF and produced in a facility and in a manner compliant with cGMP and all other Applicable Laws and shall not be adulterated or misbranded within the meaning of the Act. Each shipment of Product from EURAND to RELIANT shall be sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to RELIANT with each shipment of the Product a certificate of analysis stating that the Product meets the Specifications. EURAND agrees that it shall make no changes in the production of Product without the specific written prior approval of a duly authorized representative of RELIANT unless expressly required either by cGMP or the Act.
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Standard of Manufacture. The Licensee must manufacture Licensed Products to a high standard of quality, and must comply with any standards set by any regulatory agency having authority over the Products.
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Standard of Manufacture. Subject to Section 7.2, ETHYPHARM shall manufacture and supply, or cause to be manufactured and supplied as expressly permitted hereunder, to RELIANT the Product pursuant to orders submitted by RELIANT in accordance with Sections 7.3 and 7.4 hereof. All Product supplied to RELIANT under this Agreement shall: (a) comply with the Specifications, all [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Applicable Laws and Applicable Permits; (b) be consistent with the DMF and CMC, and produced in a facility and in a manner compliant with cGMP and all other Applicable Laws; (c) not be adulterated or misbranded within the meaning of the Act; (d) be manufactured under cGMP conditions at ETHYPHARM’s facility in Chateauneuf-en-Thymerais, France, or, upon at least thirty (30) days prior written notice to RELIANT, at the Additional Manufacturing Facility, which facility shall at all times during such manufacture be an FDA-approved manufacturing facility and shall manufacture, package, label, store and handle the Product in accordance with all Applicable Laws and Applicable Permits; and (e) be in such formulation and dosage form (e.g., Bulk Product Form or Finished Dosage Form) as requested by RELIANT. All shipments of the Product to be delivered to RELIANT under this Agreement, regardless of the formulation or dosage form thereof, shall be sampled and analyzed by or on behalf of ETHYPHARM to confirm that it meets the Specifications. ETHYPHARM shall deliver or cause to be delivered to RELIANT with each shipment of the Product a certificate of analysis stating that the Product in the formulations and dosage forms provided meets the applicable Specifications. ETHYPHARM agrees that neither it nor any third party manufacturer of the Product shall make any changes in the formulation, manufacture, production, packaging, storage and/or shipment of the Product without the specific written prior approval of RELIANT unless expressly required by Applicable Law (including, without limitation, cGMP or the Act), in which case ETHYPHARM shall notify RELIANT in writing immediately of such change and the reason therefor. The responsibility for the final release of the Product delivered by ETHYPHARM to RELIANT for sale or distribution in the Territory shall remain with RELIANT.
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Standard of Manufacture. Notwithstanding anything to the contrary contained in this Agreement, Pacira will use at least the same diligence in its efforts to manufacture and supply Products to EKR pursuant to this Agreement that it uses to manufacture and supply other comparable products, whether the distributor or buyer is Pacira, an Affiliate of Pacira, a sublicensee or an unrelated third party. (signature page follows) PACIRA & EKR CONFIDENTIAL
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Standard of Manufacture. EURAND shall supply SCANDIPHARM with Product meeting the Specifications. Each shipment of Product from EURAND to SCANDIPHARM shall be sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to SCANDIPHARM with each shipment of the Product a certificate of analysis stating that the Product meets the Specifications.
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Standard of Manufacture. EURAND shall supply GLOBAL with Product meeting the Specifications. All Product supplied by EURAND to GLOBAL hereunder shall be produced in accordance with cGMP and shall not be adulterated or misbranded within the meaning of the Act. Each shipment of Product from EURAND to GLOBAL shall be sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to GLOBAL with each shipment of the Product a certificate of analysis stating that the Product meets the Specifications. EURAND shall maintain all batch records relating to the manufacture of the Product. GLOBAL may audit such batch records upon the provision of reasonable notice to EURAND.
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Standard of Manufacture. The Sensors shall be manufactured by Flexpoint in conformity with the best standard manufacturing practices all in accordance with the plans and specifications as provided by R&D.
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Standard of Manufacture. EURAND shall supply RELIANT with Product meeting the Specifications. All Product supplied by EURAND to RELIANT hereunder shall be consistent with the DMF and produced in a facility and in a manner compliant with cGMP and all other Applicable Laws and shall not be adulterated or misbranded within the meaning of the Act. Each shipment of Product from EURAND to RELIANT shall be sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. RELIANT with each shipment of the Product a certificate of analysis stating that the Product meets the Specifications. EURAND agrees that it shall make no changes in the production of Product without the specific written prior approval of a duly authorized representative of RELIANT unless expressly required either by cGMP or the Act.
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Standard of Manufacture. EURAND shall supply ECR with Product meeting the Specifications. EURAND with the prior written consent of ECR, which consent shall not be unreasonably withheld, may subcontract the manufacture of the Product to others. All Product supplied to ECR hereunder shall he produced in accordance with cGMP and shall not be adulterated or misbranded within the meaning of the Act. Each shipment of Product to ECR shall he sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to ECR with each shipment of the Product a Certificate of Analysis stating that the Product meets the Specifications.
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Related to Standard of Manufacture

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • 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.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • 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.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • 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.

  • Review of Materials During the term of this Agreement, Client shall ensure that all prospectuses, statements of additional information, registration statements, proxy statements, reports to shareholders, advertising and sales literature or other materials prepared for distribution to Fund shareholders or the public, which refer to the Subadviser in any way, prepared by employees or agents of Client or its affiliates are consistent with information previously provided by Subadviser. Subadviser shall promptly notify the Client of any changes to information pertaining to the Subadviser and stated in the materials described in this Section 6(g).

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

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