Retention of Product Registrations. (a) During the Term, GSK will have sole responsibility for maintaining, and will maintain, the Registrations in the Territory at its expense, including without limitation filing NDA Annual Reports, and paying all user fees, product fees and establishment fees associated with the Registrations in the Territory. Prometheus will cooperate with GSK with respect to obtaining and maintaining the Registrations, and will execute, acknowledge and deliver such further instruments at GSK's request, and use Commercially Reasonable Efforts to do all such other acts, as promptly as possible, which may be necessary or appropriate to obtain and maintain the Registrations in the Territory. Prometheus will, on a timely basis and in response to requests made by GSK from time to time, provide to GSK all information that Prometheus has from time to time during the Term for the Products that is reasonably necessary and relevant to GSK's obligations hereunder to fulfill such Registration maintenance requirements (including, but not limited to, providing sales distribution information concerning the Products).
Retention of Product Registrations. (a) During the Term, Luitpold/AR shall have sole responsibility for maintaining, and shall maintain, the Product Registrations in the Territory at its expense, including without limitation filing NDA Annual Reports and paying all product fees and establishment fees associated with the Product Registrations in the Territory; [*]. Luitpold/AR shall keep FUSA informed on a timely basis as to any developments that would have a Material Adverse Effect on a Product Registration. FUSA shall cooperate with Luitpold/AR with respect to obtaining and maintaining the Product Registrations, and shall execute, acknowledge and deliver such further instruments at Luitpold/AR’s request and expense, and use Commercially Reasonable Efforts to do all such other acts, as promptly as possible, which may be necessary or appropriate to obtain and maintain the Product Registrations in the Territory. FUSA shall, on a timely basis, provide to Luitpold/AR all information that FUSA has from time to time during the Term for each of the Iron Products that is reasonably necessary and relevant to Luitpold/AR’s obligations hereunder to fulfill such Iron Product Registration maintenance requirements. [*], FUSA and Luitpold/AR shall have joint decision-making authority in every case on whether and how to supplement, amend or otherwise alter the Product Registrations and any other issues in connection with such Product Registrations (including, but not limited to, decisions, subject to Section 6.07, to recall any Iron Product) and on whether and how to communicate with the FDA and other applicable governmental agencies or authorities in connection with such Product Registrations related to the Iron Products within the Field for the Territory.
Retention of Product Registrations. (a) GSK will have sole responsibility for maintaining, and will maintain, the Product Registration in the Territory at its expense, including without limitation filing NDA Annual Reports, with copies to Myogen, and paying all user fees, product fees and establishment fees associated with the Product Registrations in the Territory. GSK will keep Myogen informed on a timely basis as to any developments that may have a material adverse effect on a Product Registration. Myogen will cooperate with GSK with respect to obtaining and maintaining the Product Registrations, and will execute, acknowledge and deliver such further instruments at GSK's request and expense, and use Commercially Reasonable Efforts to do all such other acts, as promptly as possible, which may be necessary or appropriate to obtain and maintain the Product Registrations in the Territory. Myogen will, on a timely basis and in response to requests made by GSK from time to time, provide to GSK all information that Myogen has from time to time during the Term for the Product that is reasonably necessary and relevant to GSK's [..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. obligations hereunder to fulfill such Product Registration maintenance requirements (including, but not limited to, providing sales distribution information concerning the Product). GSK will have the final decision-making authority in every case on whether and how to supplement, amend or otherwise alter the Product Registrations and any other issues in connection with such Product Registrations (including, but not limited to, decisions, subject to Section 6.8, to recall the Product) and on whether and how to communicate with the FDA and other applicable governmental agencies or authorities in connection with such Product Registrations.
