Common use of Responsibility For Regulatory Interactions Clause in Contracts

Responsibility For Regulatory Interactions. (a) Subject to the terms and conditions of this Agreement, AstraZeneca shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in all countries and territories other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated with the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development will be undertaken by a Third Party under contract to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products. (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party shall have sole authority in the applicable country or territory with respect to (i) obtaining Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions. (c) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.

Responsibility For Regulatory Interactions. (a) Subject Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the terms Product to the extent contemplated by the Development and conditions Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. Notwithstanding anything contained in this Agreement to the contrary, Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of this Agreementany substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, AstraZeneca and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] shall be responsible for any translations of Regulatory Submissions provided by Astellas and shall bear all regulatory matters relating to Collaboration Products and Diagnostic Products costs incurred in all countries and territories other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated connection with the Parties’ activities under provision, review (and translation, if applicable) of such Regulatory [**] = Portions of this Section 4.3.1 shall be allocated as set forth in Section 5.7exhibit have been omitted pursuant to a confidential treatment request. With regard An unredacted version of this exhibit has been filed separately with the Commission. Submissions pursuant to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development foregoing. Ironwood will be undertaken by a Third Party under contract make available to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products. (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party shall have sole authority in the applicable country or territory Astellas with respect to (i) obtaining the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissionsin the Territory. (c) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.

Responsibility For Regulatory Interactions. (a) The following shall apply with respect to each country within the Territory in which HUTCHMED or its Affiliate has made, or makes (in accordance with the Regulatory Transition Plan), one or more Regulatory Submissions, during the period from and after the Effective Date and until the Regulatory Submission Transfer Date for such country in the Territory: (i) HUTCHMED will coordinate all communications with applicable Regulatory Authorities with respect to the Licensed Compound and Licensed Products in the Field in such country, acting in accordance with Company’s directions to the extent such instructions do not conflict with Applicable Laws. Company will have the sole right to select the attendees at any meetings with applicable Regulatory Authorities relating to such Regulatory Submissions or otherwise relating to the Licensed Compound or Licensed Products in the Territory to the extent permitted by the applicable Regulatory Authority; provided, that Company will consult with HUTCHMED in good faith regarding Company’s selection of attendees at such meetings, and XXXXXXXX will be permitted to have at least two (2) Representatives in attendance at each such meeting; provided, further, that if the subject matter of such meeting also relates to other products of HUTCHMED or its Affiliates, Company will be permitted to participate in the portions of such meetings pertaining to such Regulatory Submissions, the Licensed Compound or Licensed Products in the Territory; provided, further, that HUTCHMED shall use its reasonable efforts to avoid scheduling such meetings that relate to such Regulatory Submissions, the Licensed Compound or Licensed Products in the Territory, on the one hand, and other products of HUTCHMED or its Affiliates, on the other hand. (ii) Without limiting the foregoing clause (i), XXXXXXXX will provide to Company for its review and comment drafts of all Regulatory Submissions to be ​ submitted to Regulatory Authorities in such country for the Licensed Compound and/or any Licensed Products prior to submission within a reasonable amount of time (but not less than [***], unless such time period is not practicable, in which case the maximum amount of time practicable) to allow Company to review and comment thereon and will adhere to Company’s directions regarding all such Regulatory Submissions, including with respect to the content thereof and when and if to file the same, to the extent such directions do not conflict with Applicable Law. In addition, XXXXXXXX will notify Company of any comments or other correspondence related thereto submitted to or received from any Regulatory Authority in such country for the Licensed Compound or any Licensed Product as soon as practicable and in any event within [***] of such receipt or submission, and will provide Company with copies thereof promptly after its submission or receipt. (iii) Within [***] after each Calendar Quarter during which activities are conducted by HUTCHMED under this Section 4.2.2(a) (Responsibility for Regulatory Interactions) and Section 4.2.3(a) (Regulatory Cooperation), HUTCHMED will invoice Company for all FTE Costs and reasonable out-of-pocket expenses incurred by HUTCHMED or its Affiliates during such Calendar Quarter that are associated with the coordination and conduct of activities under this Section 4.2.2(a) (Responsibility for Regulatory Interactions) and Section 4.2.3(a) (Regulatory Cooperation); provided, however, that in no event shall HUTCHMED invoice Company, or be entitled to compensation, for FTE Costs in connection with such activities that exceed the applicable Maximum FTE Charge. Each such invoice shall include a description of the activities conducted, a calculation of the actual FTE Costs applicable to each such individual, and any reasonable out-of-pocket expenses incurred by HUTCHMED and its Affiliates (together with supporting documentation). Company shall reimburse HUTCHMED for all such FTE Costs and reasonable out-of-pocket expenses actually incurred by XXXXXXXX and its Affiliates pursuant to the coordination and conduct of activities under this Section 4.2.2(a) (Responsibility for Regulatory Interactions) and Section 4.2.3(a) (Regulatory Cooperation), up to the applicable Maximum FTE Charge with respect to FTE Costs, within [***] of invoice. For the avoidance of doubt, the FTE Cap and Maximum FTE Charges applicable to the activities contemplated by Section 4.2.2(a) (Responsibility for Regulatory Interactions) and Section 4.2.3(a) (Regulatory Cooperation) shall not limit HUTCHMED’s obligation to perform its obligations under Section 4.2.2(a) (Responsibility for Regulatory Interactions) and Section 4.2.3(a) (Regulatory Cooperation). (b) From and after the Regulatory Submission Transfer Date for each country in the Territory, at Company’s sole cost and expense, Company will coordinate all communications with applicable Regulatory Authorities with respect to the Licensed Compound and Licensed Product in the Field in such country. Upon the written request of Company, XXXXXXXX shall make up to two (2) appropriate Representatives having suitable experience available to participate in meetings (or portions of meetings pertaining to Licensed Products) with applicable Regulatory Authorities relating to Regulatory Submissions in the Territory. (c) Subject to the roles and responsibilities of the Parties set out in Sections 4.2.2(a) and 4.2.2(b), and subject to the remaining terms and conditions of this Agreement, AstraZeneca shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in all countries and territories other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated with as between the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development will be undertaken by a Third Party under contract to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products. (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party Company shall have sole authority in the applicable country or territory Territory with respect to (i) obtaining Regulatory Approvals and Pricing Approvals for Collaboration Licensed Products ​ and subsequently maintaining such Regulatory Approvals and Pricing Approvals, in each case in the Field in the Territory, (ii) communicating with Regulatory Authorities about Collaboration Licensed Products in the Field in the Territory and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions, in each case with respect to the Licensed Product in the Field in the Territory. (cd) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.14.2.2 (Responsibility for Regulatory Interactions), including including, to the extent practicable, providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a material Regulatory SubmissionSubmissions and providing summaries of the outcomes of such meetings and any material correspondence relating thereto. (e) On and after the Execution Date until the Effective Date, providing the JSC with a copy HUTCHMED will provide to Company for its review and comment drafts of all substantive written material Regulatory Submissions to be submitted to Regulatory Authorities in the Territory for the Licensed Compound and/or any Licensed Products prior to submission within a reasonable amount of time (but not less than [***], unless such time period is not practicable, in which case the maximum amount of time practicable) to allow Company to review and comment thereon, and XXXXXXXX will consider any reasonable comments received from Company with respect to such Regulatory Submissions; provided, that XXXXXXXX shall have the right to make the final decision whether to include any such comments. In addition, XXXXXXXX will notify Company of any comments or other correspondence related thereto submitted to or received from a any Regulatory Authority involving a in such country for the Licensed Compound and/or any Licensed Product as soon as practicable and in any event within [***] of such receipt or submission and will provide Company with copies thereof promptly after its submission or receipt. In addition, the Parties will negotiate in good faith and finalize the Regulatory Submission, notifying Transition Plan as soon as practicable after the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, Execution Date and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authorityin any event within [***].

Responsibility For Regulatory Interactions. (a) Subject Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the terms Product to the extent contemplated by the Development and conditions Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. [**] = Portions of this Agreementexhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Notwithstanding anything contained in this Agreement to the contrary, AstraZeneca Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of any substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] shall be responsible for any translations of Regulatory Submissions provided by Astellas and shall bear all regulatory matters relating to Collaboration Products and Diagnostic Products costs incurred in all countries and territories other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated connection with the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard provision, review (and translation, if applicable) of such Regulatory Submissions pursuant to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development foregoing. Ironwood will be undertaken by a Third Party under contract make available to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products. (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party shall have sole authority in the applicable country or territory Astellas with respect to (i) obtaining the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissionsin the Territory. (c) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.

Responsibility For Regulatory Interactions. (a) Subject to the terms and conditions of this Agreement, AstraZeneca Ajinomoto shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in the Field in the Territory, including payment of all countries and territories other than China, and Xxxxxxxxx shall be responsible costs associated with obtaining Regulatory Approvals for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be Field in the Regulatory Submission Party for the ROW Territory. The costs and expenses associated with the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development will be undertaken by a Third Party under contract to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products. (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party Ajinomoto shall have sole authority in the applicable country or territory Territory with respect to (i) obtaining Regulatory Approvals for Collaboration Products in the Field and subsequently maintaining such Regulatory Approvals, ; (ii) communicating with Regulatory Authorities about Collaboration Products in the Field; and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event adverse event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions. (c) Each Party . Ajinomoto shall keep the JSC Albireo reasonably (but at least on a [***] basis) informed regarding the status and progress of its activities conducted such activity, including, Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to this Section 4.3.1the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, including as amended. without limitation, providing the JSC Albireo with as much advance notice as possible of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a involved in such Regulatory Submission, providing the JSC Albireo with a copy of copy, and English abstract of, all substantive written correspondence from a Regulatory Authority involving a involved in such Regulatory Submission, notifying the JSC and providing Albireo with an abstract of all oral substantive correspondence from a Regulatory Authority involving a involved in such Regulatory Submission. Ajinomoto shall provide Albireo with any data Controlled by Ajinomoto necessary to comply with requirements from Regulatory Authorities outside the Territory, with respect to the Product in the Field, and promptly providing the JSC with each Regulatory Submission submitted if reasonably requested by Albireo, English translations of all pre-clinical and clinical study reports related to a Regulatory Authoritysuch data.

Responsibility For Regulatory Interactions. ​ (a) Subject to the terms and conditions of this Agreement, including Section 4.3.1(d) AstraZeneca shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in all countries and territories ​ ​ ​ other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated with the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development will be undertaken by a Third Party under contract to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products.. ​ (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, including Section 4.3.1(d), the Regulatory Submission Party shall have sole authority in the applicable country or territory with respect to (i) obtaining Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory SubmissionsSubmissions (including with respect to Phase IV Clinical Trials and Post-Approval Clinical Trials, in each case as approved in accordance with Section 4.5.1). Xxxxxxxxx shall give AstraZeneca a reasonable opportunity and reasonable time to review and comment on regulatory submissions in China pertaining to safety, Phase IV Clinical Trials, and Post-Approval Clinical Trials before such submissions are submitted to the China Health Authority, and shall reflect any reasonable comments offered by AstraZeneca. (c) Notwithstanding anything to the contrary in this Agreement, in the event the Parties pursue Development and/or Commercialization of (i) a Collaboration Product in combination with an AstraZeneca-proprietary product, or (ii) a Combination Collaboration Product that contains an AstraZeneca-proprietary product as an active ingredient (collectively, an “AZ Proprietary Combination Product”), AstraZeneca shall be responsible for all regulatory matters relating to such AZ Proprietary Combination Product in the Territory and shall be the Regulatory Submission Party for the AZ Proprietary Combination Product in the Territory. ​ (d) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.. ​ ​ ​ ​

Responsibility For Regulatory Interactions. (a) Subject Regulatory strategy for the Product in the Territory and all decision-making with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the terms Product to the extent contemplated by the Development and conditions Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. Notwithstanding anything contained in this Agreement to the contrary, Astellas acknowledges and agrees that [**]. Astellas will provide Ironwood with advanced copies of this Agreementany substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, AstraZeneca and will not [**] to the extent they are related to issues potentially affecting the [**] and are communicated to Astellas in a reasonably prompt manner and in no event later than 30 Business Days, or such shorter timeline as is reasonably determined by Astellas in order to timely file such Regulatory Submission, from Astellas’s provision of such copies. Astellas will not submit any Regulatory Submissions unless it has complied with its obligations pursuant to the foregoing with respect to such Regulatory Submissions. In no event shall Astellas be required to delay the filing of any Regulatory Submission beyond the applicable timeline for comments. Ironwood [**] shall be responsible for any translations of Regulatory Submissions provided by Astellas and shall bear all regulatory matters relating to Collaboration Products and Diagnostic Products costs incurred in all countries and territories other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated connection with the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard provision, review (and translation, if applicable) of such Regulatory Submissions pursuant to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development foregoing. Ironwood will be undertaken by a Third Party under contract make available to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products. (b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party shall have sole authority in the applicable country or territory Astellas with respect to (i) obtaining the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Astellas will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissionsin the Territory. (c) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.