Common use of Retention of Product Registrations Clause in Contracts

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). (b) During the Term, GSK and Prometheus each will make its respective facilities available at reasonable times during business hours for inspection by representatives of Governmental Authorities relating to the manufacture, sale, marketing, promotion, distribution, or use of the Products in the Territory. GSK and Prometheus each will notify the other within twenty-four (24) hours (or, if such twenty-four (24) hour period ends on a day that is not a Business Day, then prior to noon on the next following Business Day) of receipt, and provide a copy thereof, of any notice of any FDA or other Governmental Authority inspection, investigation or other inquiry, or other material governmental notice or communication, relating to the manufacture, sale, marketing, promotion, distribution, or use of any Product in the Territory during the Term. Prometheus and GSK will cooperate with each other during any such inspection, investigation or other inquiry. Prometheus and GSK will discuss any response to observations or notifications received in connection with any such inspection, investigation or other inquiry and each will give the other an opportunity to comment upon any proposed response before it is made; provided, however, that Prometheus will be solely responsible for responding to inquiries and actions from Governmental Authorities relating to Promotional Activities and Promotional Materials as contemplated by Section 3.2. During the Term, in the event of disagreement concerning the form or content of such response, however, GSK will be responsible for deciding the appropriate form and content of any response with respect to any of its Governmental Authority cited activities and Prometheus will be responsible for deciding the appropriate form and content of any response with respect to any of its Governmental Authority cited activities. Prometheus and GSK will provide each other with copies of all correspondence received by it from, or filed by it with, any Governmental Authority to the extent pertaining to any Product in the Territory or its labeling, packaging, distribution, promotion, advertisement, marketing or sale in the Territory. Subject to Prometheus' obligation to provide correspondence with Governmental Authorities in accordance with Section 3.2(b)(ii) or this Section 6.3(b), Prometheus will not provide copies of Promotional Materials to GSK unless requested by GSK in writing as provided in Section 3.2(b)(ii). In addition, GSK will provide Prometheus copies of all material correspondence received by GSK from, or filed by GSK with, any Governmental Authority to the extent such correspondence or filing could reasonably, in GSK's opinion, have a material affect on Prometheus' ability to perform its obligations under this Agreement. (c) During the Term, GSK will have sole responsibility and authority for, and control of, all package inserts and package labeling (and any changes or supplements thereto) for the Products, and will have the responsibility at its expense for securing any approvals required by FDA to any such changes or supplements thereto. Prometheus will not at any time do, and neither will Prometheus permit its agents or representatives to do, any act in the Territory in violation of the Registration for any Product. In the event that any filings are required to be made with or approvals required to be obtained from applicable regulatory authorities in order to change or supplement the package inserts and labeling, GSK will have the sole responsibility for and authority to effect such filings and the sole right and discretion on how to effect such changes at GSK's expense. GSK will promptly, but in no event less than five (5) Business Days, advise Prometheus in writing of any changes or supplements to the package inserts and package labeling for any Product. The Parties acknowledge and agree that all Products sold during the Term will be sold under a GSK label.

Retention of Product Registrations. (a) During the Term, GSK will Luitpold/AR shall have sole responsibility for maintaining, and will shall maintain, the Product Registrations in the Territory at its expense, including without limitation filing NDA Annual Reports, Reports and paying all user fees, product fees and establishment fees associated with the Product Registrations in the Territory; [*]. Prometheus will 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 GSK Luitpold/AR with respect to obtaining and maintaining the Product Registrations, and will shall execute, acknowledge and deliver such further instruments at GSK's requestLuitpold/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. Prometheus willFUSA shall, on a timely basis and in response to requests made by GSK from time to timebasis, provide to GSK Luitpold/AR all information that Prometheus FUSA has from time to time during the Term for each of the Iron Products that is reasonably necessary and relevant to GSK's Luitpold/AR’s obligations hereunder to fulfill such Iron Product Registration maintenance requirements 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, providing sales distribution information concerning decisions, subject to Section 6.07, to recall any Iron Product) and on whether and how to communicate with the Products)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. (b) During the Term, GSK FUSA and Prometheus Luitpold/AR shall each will make its respective facilities available at reasonable times during business hours for inspection by representatives of Governmental Authorities relating to the manufacture, sale, marketing, promotion, distribution, or use of the Products in the TerritoryAuthorities. GSK FUSA and Prometheus Luitpold/AR each will shall notify the other within twenty-four (24) hours (or, if such twenty-four (24) hour period ends on a day that is not a Business Day, then prior to noon on the next following Business Day) of receipt, and provide a copy thereof, of any notice of any FDA or other Governmental Authority inspection, investigation or other inquiry, or other material governmental notice or communication, relating to the manufacture, sale, marketing, promotion, distribution, or use of any Product Iron Products in the Territory during Field within the TermTerritory. Prometheus FUSA and GSK will Luitpold/AR shall cooperate with each other during any such inspection, investigation or other inquiry. Prometheus FUSA and GSK will Luitpold/AR shall discuss any response to observations or notifications received in connection with any such inspection, investigation or other inquiry and each will shall give the other an opportunity to comment upon any proposed response before it is made; providedmade and in particular Luitpold/AR shall notify FUSA of any issues specific to the manufacture of Iron Products that (A) could reasonably be expected to have a Material Adverse Effect on FUSA’s ability to market, however, that Prometheus will be solely responsible for responding to inquiries and actions from Governmental Authorities relating to Promotional Activities and Promotional Materials as contemplated by Section 3.2. During the Term, sell or distribute Iron Products in the event of disagreement concerning Field in the form or content of such responseTerritory, however, GSK will and (B) have regulatory implications that could reasonably be responsible for deciding expected to have a Material Adverse Effect on FUSA’s ability to distribute Iron Products in the appropriate form Field within the Territory. FUSA and content of any response with respect to any of its Governmental Authority cited activities and Prometheus will be responsible for deciding the appropriate form and content of any response with respect to any of its Governmental Authority cited activities. Prometheus and GSK Luitpold/AR will provide each other with copies of all correspondence received by it from, or filed by it with, any Governmental Authority federal, state or local regulatory authority to the extent pertaining to any Product in each of the Territory Iron Products or its its, manufacturing, labeling, packaging, distribution, promotion, advertisement, marketing or sale in the Field within the Territory. Subject to Prometheus' obligation to provide correspondence with Governmental Authorities in accordance with Section 3.2(b)(ii) or this Section 6.3(b), Prometheus will not provide copies of Promotional Materials to GSK unless requested by GSK in writing as provided in Section 3.2(b)(ii). In addition, GSK Luitpold/AR will provide Prometheus FUSA copies of all material correspondence received by GSK Luitpold/AR from, or filed by GSK Luitpold/AR 13 with, any Governmental Authority federal, state or local regulatory authority to the extent such correspondence or filing could reasonably, in GSK's opinion, reasonably have a material an affect on Prometheus' FUSA’s ability to perform its obligations under this Agreement.. [*] (c) During the Term, GSK will have Luitpold/AR shall order from time to time, at FUSA’s request, Product Packaging Materials in sufficient quantities to permit the packaging of Iron Products ordered by FUSA from time to time hereunder. Luitpold/AR shall not be liable for any Product Packaging Material to the extent that such Product Packaging Material contains the specifications, instructions, directions and/or warnings, and all such packaging labels, package inserts and other packaging materials, relating to the Product Specifications, instructions, directions and/or warnings (or any changes or additions thereto) shall be the sole responsibility and under the sole authority for, and control of, all package inserts and package labeling (and any changes or supplements thereto) for of FUSA subject to the Products, and will have the responsibility at its expense for securing any approvals required by FDA to any such changes or supplements theretoprovisions of Section 3.02. Prometheus will Luitpold/AR shall not at any time do, and neither will Prometheus shall Luitpold/AR permit its agents or representatives to do, any act in the Territory in violation of the Product Registration for any Productthe Iron Products in the Field within the Territory. In the event that in Luitpold/AR’s reasonable opinion any other or further filings are required to be made with or approvals required to be obtained from applicable regulatory authorities in order to change or supplement the package inserts and labeling, GSK will Luitpold/AR shall promptly advise FUSA in writing of any changes or supplements and shall have the sole responsibility for and authority to effect such filings and the sole right and discretion on how to effect such changes at GSK's Luitpold/AR’s expense. GSK will promptly[*], but in no event less than five (5) Business Days, advise Prometheus in writing of any changes or supplements to the package inserts and package labeling for any Product. The Parties acknowledge and agree that all Iron Products sold during after the Term Effective Date in the Field within the Territory will be sold under a GSK FUSA label, and, as soon as reasonably practicable following the Effective Date, all Iron Products in the Field within the Territory will be identified as FUSA products with such Iron Products identified as being manufactured for and distributed by FUSA pursuant to the licenses granted from Vifor and Luitpold/AR pursuant to this Agreement. In the event FUSA requests a change in labeling that would make any of the Product Packaging Materials obsolete, Luitpold/AR will, at FUSA’s option, either continue to use the obsolete materials until depleted or be reimbursed by FUSA for the cost of the obsolete materials.

Retention of Product Registrations. (a) During the Term, GSK will have sole responsibility for maintaining, and will maintain, the Registrations 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. Prometheus 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 requestrequest 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. Prometheus Myogen will, on a timely basis and in response to requests made by GSK from time to time, provide to GSK all information that Prometheus Myogen has from time to time during the Term for the Products 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 ProductsProduct). 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. (b) During the Term, GSK and Prometheus Myogen each will make its respective facilities available at reasonable times during business hours for inspection by representatives of Governmental Authorities relating to the manufacture, sale, marketing, promotion, distribution, or use of the Products Product in the Territory. GSK and Prometheus Myogen each will notify the other within twenty-four (24) hours (or, if such twenty-four (24) hour period ends on a day that is not a Business Day, then prior to noon Noon on the next following Business Day) of receipt, and provide a copy thereof, of any notice of any FDA or other Governmental Authority inspection, investigation or other inquiry, or other material governmental notice or communication, relating to the manufacture, sale, marketing, promotion, distribution, or use of any Product in the Territory during the TermTerritory. Prometheus Myogen and GSK will cooperate with each other during any such inspection, investigation or other inquiry. Prometheus Myogen and GSK will discuss any response to observations or notifications received in connection with any such inspection, investigation or other inquiry and each will give the other an opportunity to comment upon any proposed response before it is made; provided, however, that Prometheus (i) GSK will not be required to discuss with Myogen any issues specific to the manufacture of Product, unless it impacts Myogen's ability to distribute the Product under this Agreement, or to obtain the consent or agreement of Myogen with respect to issues related thereto, and (ii) Myogen will be solely responsible for responding to inquiries and actions from Governmental Authorities relating to Promotional Activities and Promotional Materials as contemplated by Section 3.2. During the Term, in In the event of disagreement concerning the form or content of such response, however, GSK will be responsible for deciding the appropriate form and content of any response with respect to any of its Governmental Authority governmental agency cited activities and Prometheus Myogen will be responsible for deciding the appropriate form and content of any response with respect to any of its Governmental Authority governmental agency cited activities. Prometheus Myogen and GSK will provide each other with copies of all correspondence received by it from, or filed by it with, any Governmental Authority to the extent pertaining to any Product in the Territory or its labeling, packaging, distribution, promotion, advertisement, marketing or sale in the Territory. Subject to Prometheus' obligation to provide correspondence with Governmental Authorities in accordance with Section 3.2(b)(ii) or this Section 6.3(b); provided, Prometheus however, that Myogen will not provide copies of Promotional Materials to GSK unless requested by GSK in writing as provided in Section 3.2(b)(ii3.2(a). In addition, GSK will provide Prometheus Myogen copies of all material correspondence received by GSK from, or filed by GSK with, any Governmental Authority to the extent such correspondence or filing could reasonably, in GSK's opinion, have a material an affect on Prometheus' Myogen's ability to perform its obligations under this Agreement. Nothing in this Section 4.2(b) will limit or condition the rights of either Party under Section 6.12. (c) During the Term, GSK will have sole responsibility and authority for, and control of, all package inserts and package labeling (and any changes or supplements thereto) for the ProductsProduct, and will have [..**..] = 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. the responsibility at its expense for securing any approvals required by FDA to any such changes or supplements thereto. Prometheus Myogen will not at any time do, and neither will Prometheus Myogen permit its agents or representatives to do, any act in the Territory in violation of the Product Registration for any ProductProduct in the Territory. In the event that any filings are required to be made with or approvals required to be obtained from applicable regulatory authorities in order to change or supplement the package inserts and labeling, GSK will have the sole responsibility for and authority to effect such filings and the sole right and discretion on how to effect such changes at GSK's expense. GSK will promptly, but in no event less than five (5) Business Days, advise Prometheus Myogen in writing of any changes or supplements to the package inserts and package labeling for any Product. The Parties acknowledge and agree that all Products Product sold during immediately after the Term Commencement Date will be sold under a GSK label; however, as soon as reasonably practicable following the Commencement Date, all Product will be identified as product manufactured by GSK and Myogen will be identified as the distributor thereof, including the Myogen NDC and logo. Myogen will, within thirty (30) calendar days after the Commencement Date, provide GSK with all information for Myogen's logo and NDCs.