Product Approvals. 11.1 The Seller or one of its Affiliates is the registered holder of each of the Product Approvals. All material Product Approvals held by Seller or its Affiliates are in full force and effect. No material deficiencies have been asserted by any applicable Government Entity with respect to any Product Approval or Product Filing, nor, to the Seller’s knowledge, are there any facts or circumstances that would be likely to lead to such assertions being made.
Product Approvals. The Licensor shall reserve the right to review and approve all elements of the Licensed Products prior to production, distribution, marketing or sale. Licensee agrees to submit sample Products and Product documentation to the Licensor for review. Licensee agrees to include any and all Product changes requested in writing by Licensor.
Product Approvals. Except as set forth on Schedule 5.6: (i) the Product Approvals are valid and in full force and effect; and (ii) the Seller has not received written notice that any Governmental Entity has taken, or intends to take, any action to limit, suspend, modify or revoke any Product Approval and, to the Seller's Knowledge, no Governmental Entity is considering such action.
Product Approvals. Seller represents and warrants to Buyer that it shall obtain, and will continue to maintain, in good standing, all safety and regulatory Product approvals for all Seller Products sold under this Agreement. In the event that any of the Seller Product approvals falls into default or non-compliance, Seller shall take immediate steps to rectify same.
Product Approvals. (a) Sinotau shall use Commercially Reasonable Efforts to obtain the Product Approvals for the Product at its expense and will develop, with FluoroPharma’s assistance, the regulatory strategy or strategies for filing for Product Approval with CFDA and Health Canada. Such regulatory strategy or strategies will be subject to FluoroPharma’s written approval and will include the clinical trial plan and protocols and the quantities of Product Precursor needed for the clinical trials. Sinotau will be responsible for conducting the clinical trials at its expense. Sinotau shall retain in any event the ultimate control of any strategic decision regarding the regulatory strategy in the Territory for the Product.
Product Approvals. DISTRIBUTOR shall use its commercially reasonable efforts to obtain, at its own expense (except as otherwise provided herein), all “Lui Betsu Kyoka,” “Me-too” or “Kairyo Iryoyogu” Sxxxxx (as defined below) from the MHLW needed to market the Products in the Territory. DISTRIBUTOR shall be under no obligation to conduct or perform any clinical trial for purposes of obtaining any Sxxxxx or marketing the Products in the Territory. For the purposes of this section, “Lui Betsu Kyoka,” “Me-too” and “
Product Approvals. (a) All manufacturing operations conducted by the Sellers and their Affiliates (or, to the Knowledge of the Sellers, by third parties on behalf of the Sellers and their Affiliates) relating to the manufacturing of the Prolieve Products are being conducted in material compliance with current Good Manufacturing Practices and the quality system regulations of the United States Food and Drug Administration.
Product Approvals. (a) The Seller or one of its Affiliates is the registered or beneficial holder of each of the Product Approvals. All Product Approvals held by Seller or its Affiliates are in full force and effect, except, in each case, where failure to be in full force and effect would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Product Approvals. KNC shall have the responsibility for seeking the FDA Approvals (but not for CE Marking or for Approvals outside of the United States) on Spectranetics’s behalf and in Spectranetics’s name for the Products and funding the Development and Regulatory Costs in connection therewith. Upon obtaining any FDA Approval, KNC will transfer to Spectranetics copies of related regulatory filings and correspondence, and to the extent not already granted, title to such filings, and correspondence, including without limitation complete submission files relating to such Approvals in agreed upon formats.
Product Approvals. Prior to (i) manufacturing a new SHELF-STABLE PRODUCT for general distribution and sale or (ii) making a material change to the Finished Product Specifications (as said capitalized term is described hereinbelow) of any SHELF-STABLE PRODUCT previously approved by ConAgra, Dial shall obtain the approval of ConAgra, which approval shall not be unreasonably withheld, in accordance with the provisions set forth herein. Contemporaneously herewith, Dial has furnished to ConAgra a copy of all Finished Product Specifications for the SHELF-STABLE PRODUCTS sold as of the date of the execution of this License Agreement (a list of all such products is set forth in Schedule 10(a) hereto and includes a product description for each complete with the respective SKU or UPC for each), all of which are hereby approved. In order to obtain approval for modifications to the foregoing or for new SHELF-STABLE PRODUCTS, Dial shall deliver a written description of the finished product including the Finished Product Specifications in the format substantially identical to the Exhibit D product specifications used in connection with the 1983 LICENSING AGREEMENT and, as appropriate, a written specification of any proposed change in the said specifications for such product to ConAgra, along with a specific request for approval (together, the “Product Request”). If requested by ConAgra, Dial shall also provide a product sample. Product Requests shall be delivered in accordance with the terms of Section 10(e) below, and may be mailed using first class, registered, certified or overnight mail service. If delivered by first class mail, receipt by ConAgra shall be presumed on the fifth business day following posting. If within fifteen (15) days from the date ConAgra receives such Product Request it does not approve the Product Request in writing, it shall be presumptively deemed that ConAgra has approved the Product Request. Any objection by ConAgra to a Product Request shall be in writing, sent to Dial within fifteen (15) days from the date ConAgra receives such Product Request and shall include the reason(s) for ConAgra’s objection, and shall include, as appropriate, suggestions for modifications or changes which, if adopted, would render the proposed product acceptable to ConAgra. When time is of the essence and Dial so notes on the Product Request, then ConAgra’s suggestions for modifications or changes may be deemed approval of a modified or changed version or form of product that is con...
