NDAs. The Parties agree that with respect to the confidentiality and proprietary development agreements to which the Seller Parent, Other Sellers, Seller or their Subsidiaries is a party with the Business Employees of Seller Parent or any of its Affiliates (the “NDAs”), Seller Parent, the Other Sellers, Seller or an Affiliate, as applicable, will enter into a partial assignment with respect to such NDAs, assigning that portion of the NDAs relating to the Business to Purchaser.
NDAs. (a) Upon reasonable request and with sufficient notice, Alkermes will allow KU to visit its facilities and review the VPM NDA (other than the CMC Section), including all material amendments and supplements thereto. Alkermes or an Affiliate of Alkermes is the lawful holder of all rights under the VIM NDA. As of the Effective Date, Alkermes has complied in all material respects with all applicable laws and regulations with respect to the VPM NDA, and nothing has come to the attention of Alkermes which has, or reasonably should have, led Alkermes to believe that the VPM NDA will not be approved by the FDA. Other than pursuant to this Agreement, Alkermes has neither independently marketed, nor has it made arrangements for others to market the VPM Product in the Territory.
(b) Upon reasonable request and with sufficient notice, Alkermes will allow KU to visit its facilities and review the V NDA (other than the CMC Section), including all material amendments and supplements thereto. As of the Effective Date, Alkermes is the lawful holder of all rights under the V NDA and has the authority to grant the licenses under this Agreement, including licenses held by any of its affiliates under any other NDA. As of the Effective Date, Alkermes has complied in all material respects with all applicable laws and regulations in connection with the preparation and submission to the FDA of the V NDA, and the V NDA has been approved by and nothing has come to the attention of Alkermes which has, or reasonably should have, led Alkermes to believe that the V NDA is not in good standing with the FDA. As of the Effective Date, Alkermes has filed with the FDA all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to the V NDA which are material to the ability of KU to conduct the Activities and no future action is required by the FDA to lawfully market the V Product in the Territory.
NDAs. Seller has provided Purchaser with a true and complete copy of all of the NDAs. The NDAs are legal, valid, binding, enforceable and in full force and effect. Except as set forth on Section 3.14 of the Seller Disclosure Schedules, as of the date hereof, Seller has not received or given written notice of, and to the knowledge of Seller, is not aware of, any default or claimed, purported or alleged default, breach or state of facts which, with notice or lapse of time or both, would constitute a material default or breach on the part of any party of the performance of any obligation to be performed by such party under the NDAs or would permit termination of such NDAs. To the knowledge of Seller, as of the date hereof, no other party has repudiated any provision of the NDAs.
NDAs. With respect to each country in the Shared Territory, the Company will use commercially reasonable efforts to maintain and support the NDA for the Product. The Company may supplement the NDA, add or delete package or dosage formats of the Product or change the Package Insert as it deems reasonably appropriate consistent with the Company’s normal business practice (so long as any such supplement, addition, deletion or change is in compliance with all applicable laws, rules and regulations). Lilly and ICOS each acknowledge and accept that FDA approval may be required for some or all of such matters, and Lilly and ICOS each agree to cooperate with the Company in this regard and to not use any affected materials until the Company has notified Lilly and ICOS each in writing that the Company has received FDA approval or that it is otherwise permissible to use any such affected materials. The Company will notify Lilly and ICOS of any proposed amendment to the Package Insert or other changes that might impact Lilly’s and ICOS’ obligations under this Agreement, and will provide Lilly and ICOS with at least fifteen (15) days to comment, before implementation of such amendment or change unless Lilly and ICOS each agrees in writing to some lesser amount of time in which to comment. In the event of disagreement between the Parties concerning the form or content of such amendment, the Company will have the sole right and responsibility to decide upon the appropriate form and content of such amendment or change; provided, however, if the Company is unable to make such decision, then it shall be resolved through the dispute resolution procedures set forth in Article 12 of the LLC Agreement.
NDAs. Sellers have delivered to Buyer copies of all NDAs in their possession. To the extent that Sellers (i) were not able to deliver a particular NDA or (ii) were not able to deliver an executed NDA, Sellers represent and warrant that the terms and conditions of such undelivered or unexecuted NDA are substantially similar to the terms and conditions of the executed NDAs that were delivered to Buyer.
NDAs. Xxxxx will have sole responsibility for filing an NDA for each of the Products (the “Product NDAs”) with the FDA, as well as for all other comparable filings and interactions with all appropriate Regulatory Authorities.
NDAs. Seller and Purchaser agree that with respect to the confidentiality and proprietary development agreements to which Seller or its Subsidiaries is a party with the Transferred Employees and Labs Employees (the “NDAs”), Seller will enter into a partial assignment with respect to such NDAs, assigning that portion of the NDAs relating to the Business to Purchaser.
NDAs. Each Party will comply with any written confidentiality or non-disclosure agreement signed by the Parties, if applicable.
NDAs. Prior to Distributor sharing any confidential information (including product samples and test results) described in this Section 10 with a Customer, Referral, prospective customer, Sub-Distributor, or Broker, Distributor shall first obtain IP Holder’s written approval of the same. Once written approval is received, Distributor shall obtain an executed non-disclosure agreement in the form attached hereto as Exhibit I (each an NDA) prior to the actual sharing of any confidential information with the same.
NDAs. Notwithstanding any assistance provided by OSG in acquiring approval from the FDA of any NDA, ViroPharma shall own all right, title and interest in and to each NDA.
