Product Approvals. 8.1 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.
8.2 Each Product was and is being researched, developed, manufactured, marketed or sold in all material respects in accordance with the specifications and standards contained in the relevant Product Approval and the related Marketing Authorisation Data and in accordance with Applicable Law.
8.3 Neither the Seller or any of its Affiliates has received any written notice that any Governmental Entity with jurisdiction over the Products has commenced or will commence any action: (i) to withdraw the approval of any Product or otherwise revoke or materially amend any Product Approval or Marketing Authorisation Data or (ii) enjoin production, marketing or sale of any Product and, to the Seller’s knowledge, no such action has been threatened.
8.4 All application and renewal fees due and payable with respect to all material Product Approvals have been paid.
8.5 All preclinical and clinical investigations with respect to the Products are being and have been conducted in compliance with Applicable Law in all material respects. The Seller and its Affiliates have not, and to the Seller’s Knowledge, none of its Product Partners or any other third party under any Licensed Intellectual Property Contract has received since 1 January 2009, any written notices or other correspondence from any Governmental Entity with respect to any on-going clinical or pre-clinical studies or tests of any Product requiring the termination, suspension or material modification of such studies or tests.
8.6 None of the Seller or its Affiliates or, to the Seller’s Knowledge, any Product Partner or any other third parties pursuant to any Licensed Intellectual Property Contract, has any knowledge of any adverse event, arising since the date three years prior to the date of this Agreement, reportable with respect to the safety or efficacy of any Product which is or would reasonably be expected to be material.
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. 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...
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) 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.
(b) Each Product marketed or sold under a Product Approval is manufactured, marketed and sold in all material respects in accordance with the specifications and standards contained in such Product Approval and the related Marketing Authorization Data and in accordance with Applicable Laws, except, in each case, where failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(c) Neither the Seller or any of its Affiliates has received any written or, to the Seller’s Knowledge, oral notice that any Governmental Entity with jurisdiction over the Products has commenced or will commence any action: (i) to withdraw the approval of any Product or otherwise revoke or materially amend any Product Approval or Marketing Authorization Data or (ii) enjoin production, marketing or sale of any Product except, in each case, where such action would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(d) All application and renewal fees due and payable with respect to all material Product Approvals have been paid, except where the failure to make such payment would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
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.
(b) Neither Seller nor any of its Affiliates has received any written notice that the FDA has commenced or is threatening to initiate any action to withdraw any Registrations to limit the ability of the Sellers to manufacture (or to have manufactured for it by a third party) or market any Prolieve Product or to request or recommend the recall or withdrawal of any Prolieve Product, or commenced, or to the Knowledge of the Sellers, threatened to initiate any action to enjoin production of the Prolieve Products at any facility of Sellers or its Affiliates or of any third party who manufactures Prolieve Products on behalf of Sellers.
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.
(b) Sinotau shall obtain and maintain all Product Approvals in the Territory in its own name. Sinotau agrees and recognizes that FluoroPharma (or its Affiliates or designees) is the sole beneficial owner of the Product Approvals in the Territory for the Product (including all data and information contained in such Product Approvals or in any documents prepared or filed to obtain such Product Approvals) regardless of whether any of these registrations are filed, maintained or held in the name of Sinotau. Sinotau shall provide FluoroPharma for review and comment translated copies in English of all draft Regulatory Materials (other than routine correspondence) at least ten (10) business days in advance of their intended date of submission to a Regulatory Authority in the Territory and shall consider in good faith any comments thereto provided by FluoroPharma. Sinotau shall promptly notify FluoroPharma of any Regulatory Materials (other than routine correspondence) submitted to or received from any Regulatory Authority in the Territory and shall provide FluoroPharma with copies thereof, together with English translation, within ten (10) business days after submission or receipt. Sinotau shall provide FluoroPharma with reasonable advance notice of all meetings, conferences, and discussions scheduled with any Regulatory Authority in the Territory concerning the Product, and shall consider in good faith any input from FluoroPharma in preparing for such meetings, conferences or discussion. FluoroPharma shall have the right to participate in any such meetings, conferences or discussions and Sinotau shall facilitate such participation. Upon Sinotau’s reasonable request, FluoroPharma will, at its expense, attend up to three (3) meetings with CFDA and up to three (3) mee...
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’ behalf and in Spectranetics’ name for the Products. 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.
