Marketing Approvals. At all times during the Initial Term and any extensions or renewals thereof, Customer shall designate an employee to act as a liaison with respect to the Program and the Cards (the “Customer Liaison”). Vendor shall work with the Customer Liaison to roll out new Program marketing programs. Vendor shall be entitled to rely on and accept the signature of the Customer Liaison as evidencing any approvals required from Customer pursuant to this Addendum, including but not limited to Vendor’s use of the Marks. Failure of the Customer Liaison to respond to Vendor’s request for approval within thirty (30) days of request shall be deemed an approval by Customer.
Marketing Approvals. Subject to the terms and conditions set forth in this Agreement, POZEN hereby grants to Licensee, a co-exclusive, royalty-free license and “Right of Reference” as that term is defined in 21 C.F.R §314.3(b) in the Territory, with the right to grant sublicenses (solely in accordance with Section 6.3), under POZEN’s and its Affiliates’ rights, title and interests in and to the NDA for the Initial Products and all other Regulatory Filings in respect of the Initial Products, to Develop, Manufacture and Commercialize in the Territory as permitted under this Agreement, which co-exclusive license and right shall automatically become an exclusive (including with regard to POZEN and its Affiliates but subject to POZEN’s “Right of Reference” in Section 4.3.2) right and license thereunder, to the extent the NDA for the Initial Products and such other Regulatory Filings are not assigned pursuant to Section 4.1.2, upon NDA Approval of the Initial Products. POZEN shall provide a signed statement to this effect if required by Licensee, in accordance with 21 C.F.R §314.50(g)(3). The licenses granted under this Section 6.1.4 shall terminate upon the effectiveness of the Regulatory Filing Transfer.
Marketing Approvals. (a) RTI represents and warrants to Zimmer that it has applied for and received Marketing Approval for certain Implants in the countries and jurisdictions specified in Exhibit E-1 and Exhibit E-2 to this Agreement, and that, to the knowledge of RTI, such approvals are in good standing. RTI will be responsible for all costs and expenses relating to the maintenance of Marketing Approvals specified in Exhibit E-1 and shall have primary responsibility for all communications, submissions and interactions with Regulatory Authorities for the purpose of maintaining such approvals. Zxxxxx will be responsible for all costs and expenses relating to the maintenance of Marketing Approvals specified in Exhibit E-2 and shall have primary responsibility for all communications, submissions and interactions with Regulatory Authorities for the purpose of maintaining such approvals. RTI agrees to cooperate with Zxxxxx and provide any necessary regulatory assistance as reasonably required by Zxxxxx in connection with the maintenance of the Marketing Approvals specified on Exhibit E-2 at no cost to Zxxxxx and agrees that such assistance shall not be counted toward time allotted for assistance to Zxxxxx in Section 6.4(d).
(b) The Parties acknowledge that existing Marketing Approvals may need to be modified or supplemented in certain countries in order to permit the rebranding and Distribution of the Implants by Zimmer. Zimmer will be responsible for obtaining and maintaining such Marketing Approvals for Zimmer to market and distribute the Implants in the Territory, and for new implants and new indications for Implants as agreed by the Parties. Zimmer will have primary responsibility for all communications, submissions and interactions with the applicable Regulatory Authorities for the purpose of obtaining and maintaining such modified, supplemented or new Marketing Approvals.
(c) To the extent permitted under Applicable Laws, RTI hereby grants to Zimmer the fully paid-up right to use any and all regulatory approvals and clearances related to the Implants in the Territory for applications in the Field owned by or licensed to RTI and existing as of the Effective Date or obtained during the Term.
Marketing Approvals. Tutogen represents and warrants to Zimmer that it has applied for and received Marketing Approval for the Products in the countries specified in Exhibit E hereto, and that such approvals are in good standing. The Parties acknowledge that existing Marketing Approvals may need to be modified or supplemented in certain countries in order to permit the rebranding and Distribution of the Products by Zimmer. At Xxxxxx'x request, to the extent that Marketing Approval has not been obtained for a Product in any country or jurisdiction within the Territory, Tutogen shall use commercially reasonable efforts to obtain Marketing Approval for such Product in such country or jurisdiction. Tutogen shall have primary responsibility for all communications, submissions and interactions with the Regulatory Authorities for the purpose of obtaining and maintaining Marketing Approvals. Tutogen shall be responsible for the cost of original registrations and maintenance of the product registration. Zimmer shall be responsible for all costs and expenses incurred during the Term relating to modification of the original registration in an effort to rebrand the products and registration of facilities. To the extent permitted under Applicable Laws, Tutogen hereby grants to Zimmer the fully paid up right to use any and all regulatory approvals and clearances related to the Products, for use in the Field of Use, owned by or licensed to Tutogen and existing as of the Effective Date or obtained during the Term.
Marketing Approvals. United Therapeutics shall be responsible for any actions necessary to obtain and maintain the Marketing Approvals necessary to commercialize the Product, in accordance with the standards and diligence requirements set forth in the License Agreement, provided that United Therapeutics shall not, as result of this Agreement, carry any additional obligation to obtain Marketing Approval for or commercialize the Product.
Marketing Approvals. To the extent permitted under Applicable Laws, Brii Bio shall provide and assign to AN2 or its designee all Marketing Approvals for the Licensed Compounds (but excluding any Marketing Approvals covering Other Products). Brii Bio shall bear any costs associated with such assignment (internal or external).
Marketing Approvals. Notwithstanding any provision in the Agreement to the contrary (including Section 6.3 and Exhibits E-1 and E-2), (a) RTI will be responsible for obtaining and maintaining the Marketing Approvals for Biomet 3i to Distribute the Puros Blend Implants in [****], and, to the extent the Parties mutually agree to distribute the Puros Blend Products in the [****]; (b) Biomet 3i will be responsible for obtaining and maintaining the Marketing Approvals for Biomet 3i to Distribute the Puros Blend Implants in [****] (provided, however, that the terms of Section 6.4(b) shall apply), the [****];
Marketing Approvals. Any Marketing Approval of the Product from the FDA or the EMA shall have been revoked, rescinded, suspended, modified in an adverse manner, or not renewed in the ordinary course for a full term and such revocation, rescission, suspension, modification or non-renewal has resulted in or could reasonably be expected to result in a Material Adverse Change.
Marketing Approvals. Supplier represents and warrants to Ottobock that it has all and any regulatory Approvals, as applicable, required under any Applicable Laws for each of the Products in the United States and for the Distribution of the Products by Ottobock contemplated hereunder, and that such approvals are in good standing as of the Effective Date. Supplier further represents and warrants to Ottobock that it is and will continue to diligently seek all and any regulatory approvals, as applicable, required under any Applicable Laws for each of the Products in the Territory outside the United States and for the Distribution of the Products by Ottobock contemplated hereunder. Supplier shall be solely responsible for all communications, submissions and interactions with Regulatory Authorities for the purpose of obtaining and maintaining all Approvals, if applicable, for the Products in the Territory at its own cost and expense; provided, however, that Ottobock shall make timely and commercially reasonable efforts to cooperate and assist Supplier. In the event that any Regulatory Authority determines that any approval is required for the Manufacture or Distribution of any Product in the Territory and such Marketing Approval has not been obtained or is not obtained within sixty (60) days of notice from such Regulatory Authority, then (a) Supplier shall immediately notify Ottobock of such determination, (b) Ottobock shall cease its Distribution of such Product until such time as Supplier notifies Ottobock that the applicable Marketing Approval has been obtained, and (c) Ottobock and its Affiliates and Marketing Partners shall have the right to return all or any portion of their inventory of such Product, and Supplier shall promptly refund the Transfer Prices paid therefor, including unrecovered duties, taxes, freight and insurance. Supplier shall provide copies of all Marketing Approvals to Ottobock upon request.
Marketing Approvals. Medafor represents and warrants to CryoLife that it has applied for and received FDA approval and a CE marking for the Product under Medafor brand, and that such approval and CE marking are in good standing and have never been revoked or suspended for any reason. Medafor has no reason to believe that such approval or CE marking will be revoked or suspended for any reason. In addition, Medafor represents and warrants to CryoLife that as of March 18, 2008 it has applied for all approvals necessary in Canada, Germany, the United Kingdom and the United States to allow CryoLife to Distribute Product under a private label and that it had received all such approvals in Germany, the United Kingdom and the United States. All costs and expenses for maintaining the FDA approval and the CE marking for the Product shall be at Medafor’s expense. At CryoLife’s request, Medafor shall use its Commercially Reasonable Efforts to obtain and maintain additional Marketing Approvals for the Product (under the CryoLife brand discussed under Section 2.4) throughout the Territory (and Medafor understands that any delay in receiving such Marketing Approvals shall reduce the Annual Minimums in accordance with Section 2.2). Medafor shall have primary responsibility for all communications, submissions and interactions with the Regulatory Authorities for the purpose of obtaining and maintaining Marketing Approvals. CryoLife shall provide reasonable personnel assistance to Medafor with respect to such Marketing Approvals. Medafor hereby grants to CryoLife the fully paid-up right to use any and all regulatory approvals and clearances related to the Product owned by or licensed to Medafor and existing as of the date hereof or obtained during the Term.
