Common use of Communications with Regulatory Authorities Clause in Contracts

Communications with Regulatory Authorities. 6.3.1 For purposes of this Article 6.3, “material” shall mean any ***. Servier shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Servier Territory with respect to Program DARTs and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.2), and MacroGenics shall be responsible for submissions to, and communications and interactions with, Regulatory Authorities in the MacroGenics Territory with respect to Program DARTs and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.1). In connection therewith: (a) On a Licensed Program by Licensed Program basis Servier shall keep MacroGenics reasonably informed regarding Servier’s (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the Regulatory Authorities in the Servier Territory with respect to the Program DARTs and Licensed Products for each Licensed Program, including any material changes to such strategy, submissions or communications. Servier shall provide MacroGenics with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs and Licensed Products. To the extent permitted by Regulatory Authorities, MacroGenics shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or their agents, as well as participate in internal meetings or discussions of Servier occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to Servier’s materials prepared for such meetings. MacroGenics shall also have the right to review and comment upon any correspondence with the *** or their agents related to such meetings. Servier shall provide MacroGenics regularly prepared minutes of material meetings with the *** regarding Program DARTs and Licensed Products in the Field in the Servier Territory and available material teleconference reports with the *** pertaining to Program DARTs and Licensed Products in the Field in the Servier Territory. (b) On a Licensed Program by Licensed Program basis MacroGenics shall keep Servier reasonably informed regarding MacroGenics’ (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the *** with respect to the Program DARTs and Licensed Products for each Licensed Program, including any material changes to such strategy, submissions or communications. MacroGenics shall provide Servier with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs and Licensed Products. To the extent permitted by Regulatory Authorities, Servier shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or its agents, as well as participate in internal meetings or discussions of MacroGenics occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to MacroGenics’ materials prepared for such meetings. Servier shall also have the right to review and comment upon any correspondence with the *** or its agents related to such meetings. MacroGenics shall provide Servier regularly prepared minutes of material meetings with the *** regarding Licensed Products in the Field in the MacroGenics Territory and available material teleconference reports with the *** pertaining to Licensed Products in the Field in the MacroGenics Territory. 6.3.2 If either Party or its Affiliates or subcontractors (each, an “Inspected Party”) are to be inspected by a Government Authority regarding the development, manufacture, registration or commercialization of a Licensed Product, the Inspected Party shall promptly notify the other Party of the inspection in writing as soon as reasonably practicable, and in advance, if any such inspection is a scheduled inspection. The Inspected Party shall, where practicable, permit representatives of the other Party to participate as observers with respect to such inspection, and shall provide the other Party with a written report of any such inspection, noting with specificity any records or documents reviewed by the regulatory inspector, and including copies of any FDA 483s (or their non-U.S. equivalent) or written communications provided by or to any Government Authority relating to such inspection. The Inspected Party will use Commercially Reasonable Efforts to provide an opportunity for the other Party to assist in responding to any issues or concerns relating to such inspections, and shall provide copies of all communications to and from any Government Authority relating thereto to the other Party. The Parties shall cooperate in good faith and otherwise mutually support any regulatory inspections of facilities, clinical sites, contract manufacturers or the like with respect to Licensed Products, including by using Commercially Reasonable Efforts to make available such facilities, documents, information and/or personnel as are reasonably necessary or useful for such regulatory inspections by a Government Authority.

Communications with Regulatory Authorities. 6.3.1 For purposes of this Article 6.3, “material” shall mean any ***. Servier shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Servier Territory with respect to Program DARTs Antibodies and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.2section 4.2 above), and MacroGenics shall be responsible for submissions to, and communications and interactions with, Regulatory Authorities in the MacroGenics Territory with respect to Program DARTs Antibodies and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.1section 4.1 above). In connection therewith: (a) On a Licensed Program by Licensed Program basis Servier shall keep MacroGenics reasonably informed regarding Servier’s (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the Regulatory Authorities in the Servier Territory Territory. with respect to the Program DARTs Antibodies and Licensed Products for each Licensed ProgramProducts, including any material changes to such strategy, submissions or communications. Servier shall provide MacroGenics with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs Antibodies and Licensed Products. To the extent permitted by Regulatory Authorities, MacroGenics shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or their agents, as well as participate in internal meetings or discussions of Servier occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to Servier’s materials prepared for such meetings. MacroGenics shall also have the right to review and comment upon any correspondence with the *** or their agents related to such meetings. Servier shall provide MacroGenics regularly prepared minutes of material meetings with the *** *** regarding Program DARTs Antibodies and Licensed Products in the Field in the Servier Territory and available material teleconference reports with the *** pertaining to Program DARTs Antibodies and Licensed Products in the Field in the Servier Territory. (b) On a Licensed Program by Licensed Program basis MacroGenics shall keep Servier reasonably informed regarding MacroGenics’ (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the *** with respect to the Program DARTs Antibodies and Licensed Products for each Licensed ProgramProducts, including any material changes to such strategy, submissions or communications. MacroGenics shall provide Servier with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs Antibodies and Licensed Products. To the extent permitted by Regulatory Authorities, Servier shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or its agents, as well as participate in internal meetings or discussions of MacroGenics occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to MacroGenics’ materials prepared for such meetings. Servier shall also have the right to review and comment upon any correspondence with the *** or its agents related to such meetings. MacroGenics shall provide Servier regularly prepared minutes of material meetings with the *** regarding Licensed Products in the Field in the MacroGenics Territory and available material teleconference reports with the *** pertaining to Licensed Products in the Field in the MacroGenics Territory. 6.3.2 If either Party or its Affiliates or subcontractors (each, an “Inspected Party”) are to be inspected by a Government Authority regarding the development, manufacture, registration or commercialization of a Licensed Product, the Inspected Party shall promptly notify the other Party of the inspection in writing as soon as reasonably practicable, and in advance, if any such inspection is a scheduled inspection. The Inspected Party shall, where practicable, permit representatives of the other Party to participate as observers with respect to such inspection, and shall provide the other Party with a written report of any such inspection, noting with specificity any records or documents reviewed by the regulatory inspector, and including copies of any FDA 483s (or their non-U.S. equivalent) or written communications provided by or to any Government Authority relating to such inspection. The Inspected Party will use Commercially Reasonable Efforts to provide an opportunity for the other Party to assist in responding to any issues or concerns relating to such inspections, and shall provide copies of all communications to and from any Government Authority relating thereto to the other Party. The Parties shall cooperate in good faith and otherwise mutually support any regulatory inspections of facilities, clinical sites, contract manufacturers or the like with respect to Licensed Products, including by using Commercially Reasonable Efforts to make available such facilities, documents, information and/or personnel as are reasonably necessary or useful for such regulatory inspections by a Government Authority.

Communications with Regulatory Authorities. 6.3.1 For purposes of this Article 6.3, “material” shall mean any ***. Servier shall be responsible for all submissions to, and communications and interactions with, Regulatory Authorities in the Servier Territory with respect to Program DARTs and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.2), and MacroGenics shall be responsible for submissions to, and communications and interactions with, Regulatory Authorities in the MacroGenics Territory with respect to Program DARTs and Licensed Products (unless otherwise agreed by the JRDC on the basis of Section 4.1). In connection therewith: (a) On a Licensed Program by Licensed Program basis Servier shall keep MacroGenics reasonably informed regarding Servier’s (or its Affiliate’s or Sublicensee’s) *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. regulatory strategy, planned regulatory submissions and material communications with the Regulatory Authorities in the Servier Territory with respect to the Program DARTs and Licensed Products for each Licensed Program, including any material changes to such strategy, submissions or communications. Servier shall provide MacroGenics with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs and Licensed Products. To the extent permitted by Regulatory Authorities, MacroGenics shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or their agents, as well as participate in internal meetings or discussions of Servier occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to Servier’s materials prepared for such meetings. MacroGenics shall also have the right to review and comment upon any correspondence with the *** or their agents related to such meetings. Servier shall provide MacroGenics regularly prepared minutes of material meetings with the *** regarding Program DARTs and Licensed Products in the Field in the Servier Territory and available material teleconference reports with the *** pertaining to Program DARTs and Licensed Products in the Field in the Servier Territory. (b) On a Licensed Program by Licensed Program basis MacroGenics shall keep Servier reasonably informed regarding MacroGenics’ (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and material communications with the *** with respect to the Program DARTs and Licensed Products for each Licensed Program, including any material changes to such strategy, submissions or communications. MacroGenics shall provide Servier with copies of material regulatory submissions to, and material communications with the *** relating to the Program DARTs and Licensed Products. To the extent permitted by Regulatory Authorities, Servier shall have the right to have a senior, experienced employee participate as an observer in meetings with the *** or its agents, as well as participate in internal meetings or discussions of MacroGenics occurring immediately before or after, and related to, such meetings, and shall be provided with advance access to MacroGenics’ materials prepared for such meetings. Servier shall also have the right to review and comment upon any correspondence with the *** or its agents related to such meetings. MacroGenics shall provide Servier regularly prepared minutes of material meetings with the *** regarding Licensed Products in the Field in the MacroGenics Territory and available material teleconference reports with the *** pertaining to Licensed Products in the Field in the MacroGenics Territory. 6.3.2 If either Party or its Affiliates or subcontractors (each, an “Inspected Party”) are to be inspected by a Government Authority regarding the development, manufacture, registration or commercialization of a Licensed Product, the Inspected Party shall promptly notify the other Party of the inspection in writing as soon as reasonably practicable, and in advance, if any such inspection is a scheduled inspection. The Inspected Party shall, where practicable, permit representatives of the other Party to participate as observers with respect to such inspection, and shall provide the other Party with a written report of any such inspection, noting with specificity any records or documents reviewed by the regulatory inspector, and including copies of any FDA 483s (or their non-U.S. equivalent) or written communications provided by or to any Government Authority relating to such inspection. The Inspected Party will use Commercially Reasonable Efforts to provide an opportunity for the other Party to assist in responding to any issues or *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. concerns relating to such inspections, and shall provide copies of all communications to and from any Government Authority relating thereto to the other Party. The Parties shall cooperate in good faith and otherwise mutually support any regulatory inspections of facilities, clinical sites, contract manufacturers or the like with respect to Licensed Products, including by using Commercially Reasonable Efforts to make available such facilities, documents, information and/or personnel as are reasonably necessary or useful for such regulatory inspections by a Government Authority.