Manufacture of PARI Products Sample Clauses

Manufacture of PARI Products. PARI shall manufacture all PARI Product(s) in accordance with the applicable Device Specifications and Applicable Laws and Standards. Within 180 days after submission to a Regulatory Authority for Marketing Approval in any given country of the Serendex Product, the Parties will enter into two substantially equivalent quality agreements (one to cover the US/Canada and the other for ROW) on the change control processes, GMP, quality inspection rights, quality system regulations, other standards and procedures for manufacturing and supplying the Device and the Device Accessories as required by Applicable Laws and Standards customary for similar agreements (each a “Quality Agreement”).
Sample 1
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Manufacture of PARI Products. PARI shall Manufacture all PARI Product(s) in accordance with this Agreement, the Quality Agreements, the applicable Device Specifications and Applicable Laws and Standards. Within *** days from the Effective Date, the Parties will enter into two substantially equivalent agreements (one to cover the US/Canada and the other for the ROW) governing the change control processes, cGMP, quality system regulations, other standards and procedures for manufacturing and supplying the Device and the Device Accessories as required by Applicable Laws and Standards and Regulatory Requirements customary for similar agreements (“Quality Agreements”). Upon their execution, the Quality Agreements will be attached as Exhibit F. Any modification(s) to the Device Specifications that could: (i) affect the Regulatory Approval of the Device or Device Accessories, as applicable, or (ii) have a material adverse effect on the development of the PARI Products and the manufacture thereof, including the quality, reliability, robustness or user interface of the Device or which would otherwise have an adverse effect on the INSMED Product when used with the Device or Device Accessories, as applicable, shall be subject to the Parties’ written agreement prior to their implementation provided, however, that if INSMED has not responded to PARI in writing within *** (***) Business Days of receipt of PARI’s notice regarding such modifications, then INSMED shall be deemed to have approved such modifications. PARI shall promptly inform the JSC of any other PARI Product modification(s) that could give rise to questions on the part of end-users or others involved in Device distribution.
Sample 1
Manufacture of PARI Products. PARI shall manufacture all PARI Product(s) in accordance with the applicable Device Specifications and Applicable Laws. Within [***] days after submission to a Regulatory Authority for marketing approval in any given country of the RAPTOR Product, the Parties will enter, with respect to such country, into an agreement governing the change control processes, good manufacturing practices, quality system regulations, other standards and procedures for manufacturing and supplying the Device and the Device Accessories as required by Quality Standards and Regulatory Requirements customary for similar agreements (each a “Quality Agreement”). Any significant modification(s) to the Device Specifications which lead to the change of the article number or the revision status of at least one (1) of the following assemblies: (i) the Device, (ii) the connection cord, (iii) the controller, (iv) the AC power supply, (vii) the folding carton and/or (viii) the instructions for use, shall be subject to the Parties’ written agreement prior to the implementation of such significant modifications, provided, however, that if RAPTOR has not responded to PARI in writing within [***] business days of receipt of PARI’s notice regarding such modifications, then RAPTOR shall be deemed to have approved such modifications. PARI shall promptly inform the JSC of any other PARI Product modification(s) that could give rise to questions on the part of end-users or others involved in Device distribution.
Sample 1

Related to Manufacture of PARI Products

  • 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.

  • 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.

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

  • Manufacture (a) Manufacturer shall only manufacture the specific number of Products as requested by Company and at no time shall manufacture excess goods or overruns. Manufacturer shall not sell any Products bearing the Trademarks to any third parties without the express written consent of Company.

  • 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.

  • 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.

  • Product The term “

  • 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”):

  • Additional Products Throughout the Term, Rockwell shall provide to DaVita and the DaVita Facilities the right to purchase and/or lease all current or new products manufactured, utilized, licensed, sold or distributed by Rockwell or any of its Affiliates (including products and product lines acquired by Rockwell or any of its Affiliates as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates) that are or that become Commercially Available and which are not already covered by this Agreement or by any other agreement, whether written or oral, between the parties hereto (such products are collectively referred to as “Additional Products” and individually as an “Additional Product”). Rockwell agrees to include DaVita in all of its and its Affiliates distributions of customer announcements regarding Rockwell’s or its Affiliates’ Additional Products. The purchase price for any such Additional Products shall be negotiated by the parties hereto in good faith and the agreed upon purchase price shall be memorialized in writing as a supplement or amendment to this Agreement. Rockwell covenants and agrees that it shall only make an offer for the sale of any Additional Product(s) to DaVita’s Vice-President of Clinical Operations, Chief Medical Officer, or Vice-President of Purchasing, and not to any DaVita Facility directly; provided that the purchase of any Additional Product by DaVita or any DaVita Facility through a Rockwell product catalog made generally available to the dialysis community shall not be a breach by Rockwell of this Section 8.1. If Rockwell or any of its Affiliates acquires any Additional Product(s) as a result of an acquisition, merger or other transaction involving Rockwell or any of its Affiliates with a Person with which DaVita or a DaVita Facility, as applicable, already has a purchase or rebate arrangement whether written or oral (a “Prior Agreement”), Rockwell or such Affiliate covenants and agrees that it shall continue to abide by all of the terms and conditions of such Prior Agreement or if DaVita requests, such Additional Product(s) shall be included in this Agreement on terms to be negotiated and determined by the parties hereto as provided in this Section 8.1.

  • 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.

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