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. 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. (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. Zimmer 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 Zimmer and provide any necessary regulatory assistance as reasonably required by Zimmer in connection with the maintenance of the Marketing Approvals specified on Exhibit E-2 at no cost to Zimmer and agrees that such assistance shall not be counted toward time allotted for assistance to Zimmer in Section 6.4(d).
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. 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. NuPathe or its Affiliates shall be responsible for obtaining and maintaining Marketing Approvals of the NuPathe Patch and shall update LTS on a regular basis on obtained approvals. If NuPathe reasonably requests LTS to undertake such activities, LTS shall use its Commercially Reasonable Efforts to support NuPathe’s efforts to obtain and maintain Marketing Approvals for the NuPathe Patch, provided, however, that NuPathe shall pay for all labor costs of such activities at the then current man-hour rates of LTS and reimburse LTS for third party costs incurred with respect thereto, in each case as requested by NuPathe. NuPathe shall furnish LTS with all information in NuPathe’s possession, including any revisions to any regulatory filings or approvals that may reasonably affect the Manufacture of the Drug Product. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT 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.
Marketing Approvals. Section 2(a)(1) of the Existing Marketing Agreement is amended by adding the following sentence at the end of the existing text: “Bank may revoke its approval of any marketing or promotional materials referencing the Bank and/or the Program upon written notice to Company, for any reason, provided, that, Bank shall use good faith efforts to provide reasonably prompt notice of any revocation following its approvals .”
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. Exhibit E-1 to the Agreement is hereby amended by adding the Marketing Approvals for the New Implants set forth on Exhibit E-1 to this Amendment.
