Common use of Regulatory Activities and Cooperation Clause in Contracts

Regulatory Activities and Cooperation. (i) The JSC shall approve the overall strategy and positioning of all material regulatory submissions and filings by Partner in the Partner Territory prior to their submission or filing, based upon reasonably detailed reports and summaries of such submissions and filings to be provided by Partner. In connection with such review, Partner shall provide to the JSC such additional information regarding a proposed material regulatory filing as either Party may reasonably request. After transfer of the initial NDA to Partner, Bioprojet shall have the right, but no obligation, to fully participate in all material meetings, conferences and discussions by Partner or its Affiliates with the FDA and other Regulatory Authorities pertaining to the Product, including without limitation having Bioprojet representatives present at such meetings, conferences or discussions. Partner shall provide Bioprojet with reasonable advance notice of all such meetings and other contact and advance copies of all related material documents and other relevant material information relating to such meetings or other contact. (ii) Partner shall provide to Bioprojet, as well as to the JSC, advance drafts of any material documents or other material correspondence pertaining to the Product NDA’s or the Product, including any proposed labeling, that Partner plans to submit to the FDA or another Regulatory Authority in the Partner Territory. The JSC and/or Bioprojet may provide comments regarding such documents and other correspondence prior to their submission, which comments Partner shall consider in good faith. Partner shall provide Bioprojet with copies of all material regulatory submissions it makes to, and all material regulatory correspondence it receives from, the FDA or another Regulatory Authority in the Partner Territory pertaining to the Product NDA’s or the Product in the Partner Territory. Notices, copies of regulatory submissions and correspondence, and other materials to be given in advance as provided in this Section 4.3(c) shall be provided at least five (5) business days in advance unless circumstances necessitate a shorter time period (i.e. three (3) day NDA Field alert reports, seven (7) day IND safety reports), and in any event not less than a reasonable time in advance under the circumstances. (iii) Bioprojet shall provide to Partner advance drafts of any material documents or other material correspondence pertaining to Product Regulatory Filings or the Product, including any proposed labeling, that Bioprojet plans to submit to any Regulatory Authority in the European Union, to the extent that such Product Regulatory Filings may have an impact on the Commercialization of the Product in the Partner Territory. Partner may provide comments regarding such documents and other correspondence prior to their submission, which comments Bioprojet shall consider in good faith. Bioprojet shall provide Partner, as well as to the JSC, with copies of all material submissions it makes to, and all material correspondence it receives from, a Regulatory Authority pertaining to Product Regulatory Filings or the Product in the Field in the European Union.

Regulatory Activities and Cooperation. Unless otherwise agreed upon by the Parties, after the Regulatory Transfer Date, Takeda shall be the lead party for all regulatory-related activities with respect to such Products and TBIL shall not communicate or correspond with any Regulatory Authority with respect to such Products without the prior written consent of Takeda unless such communication or correspondence is required to comply with Applicable Laws, in which case TBIL shall, to the extent practicable, notify Takeda and obtain Takeda’s written consent prior to engaging in such communication or submitting such correspondence; provided that, upon TBIL’s request, Takeda shall: (i) The JSC shall approve the overall strategy and positioning provide TBIL with drafts of all material regulatory submissions Regulatory Materials reasonably in advance of submission to a Regulatory Authority for TBIL’s review and filings by Partner comment and reasonably consider incorporating TBIL’s reasonable comments in the Partner Territory connection therewith, (ii) provide TBIL with a copy, in electronic form if reasonably practicable, of all material Regulatory Materials submitted to or received from a Regulatory Authority, promptly, but in no event later than [***] Business Days after receipt or submission thereof, and (iii) notify TBIL reasonably prior to their submission or filing, based upon reasonably detailed reports any material meetings and summaries of such submissions and filings to be provided by Partner. In connection with such review, Partner shall provide material conferences related to the JSC Products with Regulatory Authorities and unless precluded by Applicable Law, upon TBIL’s request, TBIL may attend and observe (and, upon Takeda’s request or written consent, which may be withheld or granted at Takeda’s sole discretion, participate in) such additional information regarding a proposed material regulatory filing as either Party may reasonably request. After transfer meetings; provided that, unless otherwise agreed to by Takeda, no more than [***] of the initial NDA to Partner, Bioprojet shall have the right, but no obligation, to fully participate in all material meetings, conferences and discussions by Partner TBIL’s employees or its Affiliates designees may attend a meeting with the FDA and no more than [***] of TBIL’s employees or its designees may attend a meeting with any other Regulatory Authorities pertaining to the ProductAuthority, including without limitation having Bioprojet representatives present at such meetingsand (iv) upon TBIL’s request, conferences or discussions. Partner shall provide Bioprojet TBIL with reasonable advance notice of all reports and minutes from all such material meetings and other contact and advance copies of all related material documents and other relevant material information relating to such meetings or other contactconferences. (ii) Partner shall provide to Bioprojet, as well as to the JSC, advance drafts of any material documents or other material correspondence pertaining to the Product NDA’s or the Product, including any proposed labeling, that Partner plans to submit to the FDA or another Regulatory Authority in the Partner Territory. The JSC and/or Bioprojet may provide comments regarding such documents and other correspondence prior to their submission, which comments Partner shall consider in good faith. Partner shall provide Bioprojet with copies of all material regulatory submissions it makes to, and all material regulatory correspondence it receives from, the FDA or another Regulatory Authority in the Partner Territory pertaining to the Product NDA’s or the Product in the Partner Territory. Notices, copies of regulatory submissions and correspondence, and other materials to be given in advance as provided in this Section 4.3(c) shall be provided at least five (5) business days in advance unless circumstances necessitate a shorter time period (i.e. three (3) day NDA Field alert reports, seven (7) day IND safety reports), and in any event not less than a reasonable time in advance under the circumstances. (iii) Bioprojet shall provide to Partner advance drafts of any material documents or other material correspondence pertaining to Product Regulatory Filings or the Product, including any proposed labeling, that Bioprojet plans to submit to any Regulatory Authority in the European Union, to the extent that such Product Regulatory Filings may have an impact on the Commercialization of the Product in the Partner Territory. Partner may provide comments regarding such documents and other correspondence prior to their submission, which comments Bioprojet shall consider in good faith. Bioprojet shall provide Partner, as well as to the JSC, with copies of all material submissions it makes to, and all material correspondence it receives from, a Regulatory Authority pertaining to Product Regulatory Filings or the Product in the Field in the European Union.

Regulatory Activities and Cooperation. (i) The JSC shall approve the overall strategy and positioning of all material regulatory submissions and filings by Partner Harmony in the Partner Harmony Territory prior to their submission or filing, based upon reasonably detailed reports and summaries of such submissions and filings to be provided by PartnerXxxxxxx. In connection with such review, Partner each Party shall provide to the JSC such additional information regarding a proposed material regulatory filing as either the other Party may reasonably request. After transfer Prior to and after grant of the initial NDA to PartnerHarmony, Bioprojet shall have the right, but no obligation, to fully participate in all material meetings, conferences and discussions by Partner Harmony or its Affiliates with the FDA and other Regulatory Authorities in the Harmony Territory pertaining to the ProductProduct(s), including without limitation having Bioprojet representatives present at such meetings, conferences or discussions. Partner Harmony shall provide Bioprojet with reasonable advance notice of all such meetings and other contact and advance copies of all related material documents and other relevant material information relating to such meetings or other contact. (ii) Partner With respect to a given Product, Harmony shall provide to Bioprojet, as well as to the JSC, advance drafts of any material documents or other material correspondence pertaining to the Product Product’s NDA’s or the Product, including any proposed labeling, that Partner Harmony plans to submit to ​ ​ the FDA or another Regulatory Authority in the Partner Harmony Territory. The JSC and/or Bioprojet may provide comments regarding such documents and other correspondence prior to their submission, which comments Partner Harmony shall consider in good faith. Partner Harmony shall provide Bioprojet with copies of all material regulatory submissions it makes to, and all material regulatory correspondence it receives from, the FDA or another Regulatory Authority in the Partner Harmony Territory pertaining to the Product Product’s NDA’s or the Product in the Partner Harmony Territory. Notices, copies of regulatory submissions and correspondence, and other materials to be given in advance as provided in this Section 4.3(c4.9(c) shall be provided at least five (5) business days Business Days in advance unless circumstances necessitate a shorter time period (i.e. three (3) day NDA Field alert reports, seven (7) day IND safety reports), and in any event not less than a reasonable time in advance under the circumstances. (iii) Bioprojet shall provide to Partner Harmony advance drafts of any material documents or other material correspondence pertaining to Product Regulatory Filings or the a Product, including any proposed labeling, that Bioprojet plans to submit to EMA or any other Regulatory Authority in outside the European UnionHarmony Territory, to the extent that such Product Regulatory Filings may have an any adverse impact on the Commercialization of the such Product in the Partner Harmony Territory. Partner Harmony may provide comments regarding such documents and other correspondence prior to their submission, which comments Bioprojet shall consider in good faith. Bioprojet shall provide PartnerHarmony, as well as to the JSC, with copies of all material submissions it makes to, and all material correspondence it receives from, a EMA and any other Regulatory Authority pertaining to Product Regulatory Filings or the such Product in the Field in the European UnionBioprojet Territory.