Compliance Concerning Finished Dosage Form Products Sample Clauses

Compliance Concerning Finished Dosage Form Products. Each of Schein and Cheminor shall, with respect to each Finished Dosage Form Product supplied by it hereunder, (i) submit to the appropriate Regulatory Authorities an Application for Regulatory Approval, use all reasonable efforts to obtain such Regulatory Approval and, if issued, shall maintain, such application for Regulatory Approval (ANDA or non-U.S. equivalent) for each Finished Dosage Form Product in each jurisdiction as to which the other party has Distribution Rights to that Finished Dosage Form Product; (ii) permit the appropriate Regulatory Authorities to inspect its manufacturing, packaging, storage and distribution facilities for each Finished Dosage Form Product in connection with the review and approval of each application for Regulatory Approval; (iii) manufacture, package, store and distribute in conformity with the applicable application for Regulatory Approval (ANDA or non-U.S. equivalent) for the Finished Dosage Form Product and with all Applicable Law (including without limitation the FD&C Act) and with the Specifications; (iv) assure that such Finished Dosage Form Product is not adulterated or misbranded within the meaning of Applicable Law, including the FD&C Act, or be a product which would violate any section of Applicable Law if introduced into interstate commerce; (v) develop such Finished Dosage Form Product in accordance with Applicable Law; (vi) assure that all laboratory, scientific, technical and/or other data submitted by or on its behalf relating to a Finished Dosage Form Product shall be true and correct and shall not contain any deliberate or negligent falsification, misrepresentation or omission; (vii) assure that the manufacturing, packaging, storage and distribution facilities shall conform in all respects to Applicable Law, and shall be adequate to produce the quantities of each Finished Dosage Form Product committed to be supplied by either party pursuant to this Agreement; and (viii) assure that its marketing, sales and distribution activities relating to the Finished Dosage Form Product or Cheminor Bulk Substances, as the case may be, shall conform in all respects to Applicable Law governing the marketing, sales and distribution of Finished Dosage Form Products or Cheminor Bulk Substances, as the case may be.
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Compliance Concerning Finished Dosage Form Products. 28 ----------------------------------------------------- Section 8.2

Related to Compliance Concerning Finished Dosage Form Products

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Product The term “

  • Promotional Materials In the event that the Fund or the Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Adviser will install and maintain, or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.

  • Products 1.1. The information (including but not limited to the quantity, rated hashrate, unit price (“Unit Price”), total price for one item (“Total Price (One Item)”), total price for all the items (“Total Purchase Price”) of Products to be purchased by Party B from Party A is as follows (“Products”):

  • 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.

  • Packaging and Labeling 11.1 Company shall provide packaging and labeling specifications that call out clear labeling requirements.

  • Promotional Material In the event that the Fund or the Investment Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Investment Adviser will install and maintain or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • 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.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

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