Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. With respect to the Commercialization of the Sublicensed Products in the Territory: (a) Unless otherwise required by Applicable Law, any Regulatory Approvals and all Regulatory Submissions relating to Sublicensed Products in the Territory shall be filed, owned and held in the name of Knight. (b) Knight shall be solely responsible, at its expense, and shall use Commercially Reasonable Efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Sublicensed Products in the Territory, including any reports or amendments necessary to maintain Regulatory Approvals, and for seeking any revisions of the conditions of each Regulatory Approval. (c) Knight shall have sole authority and responsibility and shall use Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Sublicensed Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. Braeburn shall provide to Knight copies of all material FDA Regulatory Submissions in its possession and Control reasonably related to the Sublicensed Products. (d) Knight will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Sublicensed Products in the Territory prior to and after any Regulatory Approval. (e) Subject to the terms and conditions of this Agreement, Knight may file any submissions that are intended to change or modify Sublicensed Product Labeling or prescribing information approved by the applicable Regulatory Authority for, or the Indications of, Sublicensed Products in the Territory provided that, except as required by Applicable Laws, it provides to Braeburn a draft of such submission at least fifteen (15) Business Days prior to planned submission to the applicable Regulatory Authority and gives prompt and reasonable consideration to any comments Braeburn may have. (f) To the extent Braeburn reasonably believes that a filing or submission relating to Sublicensed Products in the Territory is required by Applicable Laws in order to sell or continue selling the Sublicensed Products, Braeburn shall notify Knight in writing. If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and Braeburn shall, acting reasonably, be entitled to prepare such filing or submission, at Knight’s sole cost and expense (provided that such costs and expenses are commercially reasonable given such filing requirements), to be filed or submitted by Knight; provided that Braeburn shall use good faith efforts to include any comments of Knight in such filing or submission. (g) Knight shall permit Braeburn to access, and shall provide Braeburn on a timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory and for Braeburn to use in connection with the development and commercialization of Sublicensed Products outside of the Territory, any and all Regulatory Submissions related to the Sublicensed Products Controlled by Knight. At the request of Braeburn and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Knight shall notify the appropriate Regulatory Authorities, as applicable, of Braeburn’s right to reference such Regulatory Submissions in regulatory submissions filed by Braeburn in accordance with this Agreement. (h) Braeburn shall permit Knight to access, and shall provide Knight on a timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory (including for Knight to use in connection with its Commercialization of Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.

Regulatory Submissions. With respect regard to Regulatory Submissions for the Product in the Licensed Territory, MTIA will be responsible for the preparation of all documentation necessary for a complete fast-track Regulatory Submissions for the Product in the Licensed Territory. MTIA shall be responsible for providing, in the format required by the Regulatory Authority, the data and information required to be submitted in connection with such fast-track Regulatory Submission required for Approval of the Product by the Regulatory Authority in the Licensed Territory. The fast-track Regulatory Submission shall be filed by MTIA in MTIA or Affiliate’s name for the Product in the Licensed Territory. The Parties shall request a joint meeting (which may either be a teleconference or face-to-face meeting) with the CFDA’s review divisions or any other similar applicable Regulatory Authority for the Product to help ensure that the Product development plans will produce sufficient data to meet the CFDA’s or any other similar applicable Regulatory Authority’s criteria for Approval of the use of the Product in the Licensed Territory. MTIA shall provide updates to the Commercialization JSC regarding the status of each pending or proposed Regulatory Submission for the Product and shall provide the JSC with copies of all correspondence MTIA receives from the Regulatory Authorities relating to the Regulatory Submission for the Product (or other communications whether written or verbal that have been reduced to writing that concern the Labeling of the Sublicensed Products in the Territory: (a) Unless otherwise required by Applicable Law, any Regulatory Approvals and all Regulatory Submissions relating to Sublicensed Products in the Territory shall be filed, owned and held in the name of Knight. (b) Knight shall be solely responsible, at its expenseProduct), and shall use Commercially Reasonable Efforts to timely prepare, file, prosecutekeep the JSC informed on an on-going basis regarding the schedule and process for the preparation of Regulatory Submissions for the Product, and maintain all shall provide working drafts of proposed Regulatory Submissions relating for the Product (including, but not limited to, parts of the Regulatory Submission that concern the Labeling of the Product) to Sublicensed Products in the TerritoryJSC to provide Echo an opportunity to review and comment on such drafts. In accordance with the foregoing, including any reports or amendments necessary the Parties shall be required to maintain protect from disclosure the Regulatory ApprovalsSubmissions and related correspondence, drafts and documentation for the Product, and for seeking any revisions treat such information as “Confidential Information” in accordance with the requirements of the conditions of each Regulatory Approval. (c) Knight shall have sole authority and responsibility and shall use Commercially Reasonable Efforts to develop, modify, seek and/or obtain any necessary Regulatory Approvals of any Sublicensed Product Labeling, packaging, advertising or other promotional or informational materials used in connection with Sublicensed Products in the TerritoryArticle 9, and Promotional Materials and the Parties agree to only use such information for determining whether the same requires Regulatory Approval. Braeburn shall provide to Knight copies of all material FDA Regulatory Submissions in its possession and Control reasonably related to the Sublicensed Products. (d) Knight will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Sublicensed Products in the Territory prior to and after any Regulatory Approval. (e) Subject to the terms and conditions purposes of this Agreement, Knight may file any submissions that are intended . All Regulatory Submissions and other correspondence with Regulatory Authorities by MTIA for the Product shall be subject to change or modify Sublicensed Product the prior written approval of Echo. The Labeling or prescribing information approved to be submitted in a Regulatory Submission and/or Approved by the applicable Regulatory Authority for, or for the Indications of, Sublicensed Products in the Territory provided that, except as required by Applicable Laws, it provides to Braeburn a draft of such submission at least fifteen (15) Business Days prior to planned submission Product shall be subject to the applicable Regulatory Authority and gives prompt and reasonable consideration to any comments Braeburn may have. (f) To the extent Braeburn reasonably believes that a filing or submission relating to Sublicensed Products in the Territory is required by Applicable Laws in order to sell or continue selling the Sublicensed Products, Braeburn shall notify Knight in writing. If Knight decides not to prepare such filing or submission, it shall promptly notify Braeburn of such decision and Braeburn shall, acting reasonably, be entitled to prepare such filing or submission, at Knight’s sole cost and expense (provided that such costs and expenses are commercially reasonable given such filing requirements), to be filed or submitted by Knight; provided that Braeburn shall use good faith efforts to include any comments of Knight in such filing or submission. (g) Knight shall permit Braeburn to access, and shall provide Braeburn on a timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory and for Braeburn to use in connection with the development and commercialization of Sublicensed Products outside prior written approval of the Territory, any and all Regulatory Submissions related to the Sublicensed Products Controlled by Knight. At the request of Braeburn and to the extent legally permitted and JSC in accordance with the terms and conditions of this Agreement, Knight shall notify the appropriate Regulatory Authorities, as applicable, of Braeburn’s right to reference such Regulatory Submissions in regulatory submissions filed by Braeburn in accordance with this AgreementArticle 3. (h) Braeburn shall permit Knight to access, and shall provide Knight on a timely basis with the right to cross-reference and use in exercising its rights and performing its obligations hereunder with respect to Sublicensed Products in the Territory (including for Knight to use in connection with its Commercialization of Sublicensed Products in the Territory), any and all Regulatory Submissions related to the Sublicensed Products Controlled by Braeburn. At the request of Knight and to the extent legally permitted and in accordance with the terms and conditions of this Agreement, Braeburn shall notify the appropriate Regulatory Authorities in the Territory of Knight’s right to reference such Regulatory Submissions in regulatory submissions filed by Knight in accordance with this Agreement.