Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. (a) Licensee will be responsible for all regulatory submissions and will control all regulatory activities with respect to Products in the Territory, including safety reporting, analysis and strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expenses, which shall be the responsibility of Licensor) and will, at Licensee’s request, promptly transfer all Regulatory Materials and Information in its possession or under its Control related to CX-01 or any Product to Licensee. (b) Licensee will be the primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to Products in the Field in the Territory, and Licensee will prepare and file any and all Regulatory Materials for each Product in the Field in the Territory at its sole expense in accordance with the Regulatory Plan. Licensor will assist and cooperate, at Licensee’s expense, with Licensee in connection with the preparation and filing of such Regulatory Materials, as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Licensee for Licensor Know-How needed for the Regulatory Materials. (c) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated by this Section 5.1, Licensor will not communicate with respect to any Product in the Field with any Regulatory Authority having jurisdiction in the Territory, unless so ordered by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice to Licensee of such order and all details thereof; and (ii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals for any Product in the Field in the Territory. (d) Licensee shall provide Licensor with reasonable advance notice of any scheduled significant meeting with the FDA or EMA relating to any Regulatory Approval for a [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Product, and Dr. Xxxxxxx Xxxxxx, as a representative of Licensor (or a reasonably acceptable replacement if Xx. Xxxxxx is not available), shall, to the extent permitted by the FDA or EMA, as applicable, have the right to attend any such meeting at Licensor’s expense. Licensee shall promptly inform (including by providing redacted copies upon request) Licensor about any significant interaction (oral or written) with a Regulatory Authority.

Regulatory Responsibilities. (a) Licensee Subject to the terms and conditions of this Agreement, Kaken will be responsible responsible, at its sole cost and expense, for all regulatory submissions and will control the conduct of all regulatory activities with respect required to obtain and maintain Kaken Territory Regulatory Approval of Licensed Products in the TerritoryField, including safety reporting, analysis the preparation and strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expenses, which shall be the responsibility submission of Licensor) and will, at Licensee’s request, promptly transfer all Regulatory Materials and Information in its possession or under its Control related to CX-01 or any Product to Licensee. (b) Licensee will be the primary interface with all communications and will otherwise handle all correspondence, meetings and other interactions with Regulatory Authorities, as necessary to obtain Kaken Territory Regulatory Approval of Licensed Products in the relevant Field. Kaken shall be responsible for filing each IND in the Field in the Kaken Territory for each Licensed Product. Kaken shall be responsible for filing each MAA in the Field in the Kaken Territory for each Licensed Product in Kaken’s name. The Territory Development Plan shall include the regulatory strategy for obtaining Regulatory Authorities concerning regulatory activities related to Approval of Licensed Products in the Field in the Kaken Territory, including Spruce’s Development obligations. Kaken shall use Commercially Reasonable Efforts to carry out its obligations for obtaining Regulatory Approvals of Licensed Products pursuant to such strategy. (b) Spruce shall provide all reasonable assistance and Licensee will prepare cooperation to Kaken as Kaken may reasonably request, at Kaken’s sole cost and file any expense, during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a), including (i) in connection with the preparation of Regulatory Materials, (A) making available competent personnel to attend regulatory meetings or join meetings with Regulatory Authorities by teleconference and all (B) providing documentation within Spruce’s possession and control, in each case as requested by Regulatory Authorities at Kaken’s cost, (ii) providing Kaken with additional Regulatory Materials in the Spruce Territory as requested by Regulatory Authorities in the Kaken Territory within a reasonable timeframe commensurate with the volume of Kaken’s reasonable request, (iii) using Commercially Reasonable Efforts to [***] In the event that Spruce believes that such requests are not reasonable or are otherwise unduly burdensome to Spruce, then such matter shall be promptly submitted to the JSC for each review and discussion. Without limiting the foregoing, Spruce shall provide Kaken with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Spruce has prepared a CTD for regulatory filings in the Field in the Territory at its sole expense Spruce Territory, in accordance with a manner sufficient for filing in the Regulatory PlanU.S. within [***] after completion of all such modules 2, 3, 4 and 5 of the CTD and, [***]. Licensor will assist Kaken shall provide all reasonable assistance and cooperatecooperation to Spruce as Spruce may reasonably request, at LicenseeSpruce’s sole cost and expense, with Licensee in connection with during the preparation and filing Term of such Regulatory Materialsthis Agreement, as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Licensee for Licensor Know-How needed for the Regulatory Materials. (c) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated by this Section 5.1, Licensor will not communicate with respect to any Product in regulatory activities related to the Field with any Regulatory Authority having jurisdiction in the Territory, unless so ordered by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice to Licensee of such order and all details thereof; and (ii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals for any Product in the Field in the Territory. (d) Licensee shall provide Licensor with reasonable advance notice of any scheduled significant meeting with the FDA or EMA relating to any Regulatory Approval for a Global Development Plan. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Product, and Dr. Xxxxxxx Xxxxxx, as a representative of Licensor (or a reasonably acceptable replacement if Xx. Xxxxxx is not available), shall, to the extent permitted by the FDA or EMA, as applicable, have the right to attend any such meeting at Licensor’s expense. Licensee shall promptly inform (including by providing redacted copies upon request) Licensor about any significant interaction (oral or written) with a Regulatory Authority**].

Regulatory Responsibilities. (a) Licensee Subject to the terms and conditions of this Agreement, Hansoh will be responsible responsible, at its sole cost and expense, for all regulatory submissions and will control the conduct of all regulatory activities with respect required to Products in the Territory, including safety reporting, analysis obtain and strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expenses, which shall be the responsibility maintain Regulatory Approval of Licensor) and will, at Licensee’s request, promptly transfer all Regulatory Materials and Information in its possession or under its Control related to CX-01 or any Product to Licensee. (b) Licensee will be the primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to Licensed Products in the Field in the Hansoh Territory, including the preparation and Licensee will prepare and file any and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Hansoh Territory. Hansoh shall be responsible for filing each MAA in the Hansoh Territory for each Licensed Product in its own name. The Development Plan shall include the Field regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Territory at Hansoh Territory. Hansoh shall use Commercially Reasonable Efforts to carry out its sole expense in accordance with regulatory obligations for Licensed Products pursuant to such strategy. (b) Keros shall provide reasonable assistance and cooperation to Hansoh as Hansoh may reasonably request [***] during the Regulatory Plan. Licensor will assist and cooperate, at Licensee’s expenseTerm of this Agreement, with Licensee respect to the satisfaction of its obligations under Section 5.1(a), including (i) in connection with the preparation and filing of such Regulatory Materials, (ii) providing documentation [***], in each case as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural timelines set Regulatory Authorities, and (iii) transferring to Hansoh additional Regulatory Materials in the Keros Territory as required by Regulatory Authorities in the Hansoh Territory within [***] of Hansoh’s reasonable request. In the event that Keros believes that such requests are not reasonable or are otherwise burdensome to any reasonable request from Licensee Keros, then such matter shall be promptly submitted to the JCC for Licensor Know-How needed review and discussion. Without limiting the foregoing, Keros shall provide Hansoh with modules 2, 3, 4 and 5 of the CTD in a manner sufficient for filing in the U.S. as soon as reasonably practicable after completion thereof. Additionally, Keros shall provide Hansoh with information sufficient for filing modules 2, 3, 4 and 5 of the CTD in the Hansoh Territory. Hansoh shall be responsible for publishing and submitting the CTD (including modules 2, 3, 4 and 5) to the Regulatory Materials. (c) Unless Authority in the Parties Hansoh Territory. In order to address questions Hansoh may receive from a Regulatory Authority in the Hansoh Territory related to modules 2, 3, 4 and 5 of the CTD, Keros will assist in the preparation of responses based on information that would be found in: various technical reports, notebooks, executed batch records, master batch records, SOPs, validation protocols and reports, vendor certificates, and Third Party study reports and other CMC related documents not otherwise agree included in writing: (i) except modules 2, 3, 4 and 5 of the CTD or otherwise already provided to Hansoh. Any such transfer of CMC Information as expressly contemplated by set forth in this Section 5.15.1 is conditioned on Hansoh establishing appropriate firewalls or equivalent means to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal, Licensor will not communicate with respect to any Development, regulatory compliance and other related purposes which are necessary or reasonably useful for Manufacturing Licensed Product in Hansoh Territory and not for any other purpose. In furtherance of the Field with foregoing, Hansoh shall ensure that any Regulatory Authority having jurisdiction in the Territory, unless so ordered CMC Information provided by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice or on behalf of Keros pursuant to Licensee of such order and all details thereof; and (ii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals for any Product in the Field in the Territory. (d) Licensee 5.1 shall provide Licensor with reasonable advance notice only be disclosed to those identified personnel of any scheduled significant meeting with the FDA or EMA relating to any Regulatory Approval for a [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Product, and Dr. Xxxxxxx Xxxxxx, as a representative of Licensor Hansoh (or a reasonably acceptable replacement if Xxdesignated agreed Third Party) who (a) have a need to know the same to comply with the above obligations, and (b) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. Xxxxxx is not availableNotwithstanding anything to the contrary herein, Keros’ obligations under this Section 5.1(b), shallincluding to provide Hansoh with modules 2, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent Keros is manufacturing and providing Hansoh with Licensed Products under the clinical Supply Agreement or commercial Supply Agreement. Keros agrees, to the extent permitted CMC Data is required or requested by the FDA or EMARegulatory Authorities, as applicableincluding the NMPA, have the right to attend any generate such meeting at LicensorData subject to Hansoh’s expense. Licensee shall promptly inform (including by providing redacted copies upon request) Licensor about any significant interaction (oral or written) with a Regulatory Authorityreimbursement of Keros’ [***].

Regulatory Responsibilities. (a) Licensee will be responsible Except for all regulatory submissions and will control all regulatory activities with respect to Products in the Territory, including safety reporting, analysis and strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expensesJoint IND, which shall be the responsibility of Licensor) and willjointly owned, at Licensee’s request, promptly transfer Ascletis shall own all Regulatory Materials and Information Approvals for Product in its possession or under its Control related to CX-01 or any Product to Licensee.the Field in the Territory. Ascletis shall have sole responsibility for: (bi) Licensee will be the primary interface with obtaining and will otherwise handle all correspondence, meetings and other interactions with the relevant maintaining Regulatory Authorities concerning regulatory activities related to Approvals for Products in the Field in the Territory, and Licensee will prepare and file any and all shall use Diligent Efforts to obtain Regulatory Materials Approval of the Product and, upon obtaining Regulatory Approvals for each the Product in the Field in the Territory at its sole expense in accordance with the Regulatory Plan. Licensor will assist and cooperateTerritory, at Licensee’s expense, with Licensee in connection with the preparation and filing of maintain such Regulatory Materials, as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural timelines set by Approvals; and (ii) other communications with applicable Regulatory Authorities in the Territory relating to any reasonable request from Licensee for Licensor Know-How needed for the Regulatory Materials. (c) Unless the Parties otherwise agree in writing: Development and Commercialization of Compound and Product, including (i) except as expressly contemplated by this Section 5.1, Licensor will not communicate with respect all correspondence submitted to any Product Regulatory Authorities in the Field with any Regulatory Authority having jurisdiction Territory related to the design, conduct or results of non-clinical studies and clinical trials; (ii) all pricing and reimbursement approval proceedings in the Territory, unless so ordered by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice to Licensee of such order and all details thereof; and (iiiii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals all proposed product labeling for any the Product in the Field in the Territory. (db) Licensee Ascletis shall provide Licensor 3-V with synopsis of all regulatory submissions and reasonable time prior to submission for review and comment if possible, and shall consider in good faith any comments received from 3-V. In addition, Ascletis shall notify 3-V of any regulatory material submitted to or received from any Regulatory Authority in the Territory and shall provide 3-V with copies thereof ([***]) within [***] days after submission or receipt. (c) Ascletis shall provide 3-V with reasonable advance notice of any scheduled significant meeting or discussion with the FDA or EMA relating to any Regulatory Approval for Authority in the Territory related to Phase 2 Global Multi-Center Trial or any Phase 2 Clinical Trials or Phase 3 Clinical Trials conducted by Ascletis in the Territory. Ascletis shall lead such meeting or discussion, provided however that 3-V or its designee shall have the right, but not the obligation, to attend and participate in such meeting or discussion. If 3-V elects not to attend such meeting or discussion, Ascletis shall promptly provide 3-V with a written [***] = Certain confidential information contained summary of such meeting or discussion. Regarding subsequent clinical trials (other Phase 2 Clinical Trials or Phase 3 Clinical Trials conducted by Ascletis) in this documentthe Territory, marked Ascletis shall provide 3-V with regular updates and summaries of such meetings. (d) Each Party hereby grants to the other Party the right of reference to all regulatory submissions pertaining to the Product submitted by bracketsor on behalf of such Party. Ascletis may use such right of reference to 3-V’s regulatory submissions solely for the purpose of seeking, has been omitted because it is both obtaining and maintaining Regulatory Approval of the Product in Field in the Territory. 3-V may use the right of reference to Ascletis’ regulatory submissions solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Product outside the Territory. For global clinical trials conducted by 3-V for the Product in the Territory, 3-V shall be entitled to conduct clinical audits (iincluding on-site audits) not material and (ii) as would be competitively harmful if publicly disclosed. Product, customary for global clinical trials and Dr. Xxxxxxx Xxxxxx, as a representative consistent with monitoring by sponsor of Licensor (or a reasonably acceptable replacement if Xx. Xxxxxx is not available), shall, to the extent permitted by the FDA or EMA, as applicable, have the right to attend any such meeting at Licensor’s expense. Licensee shall promptly inform (including by providing redacted copies upon request) Licensor about any significant interaction (oral or written) with a Regulatory Authoritytrials.

Regulatory Responsibilities. 3.4.1 Prior to receipt of Regulatory Approval in the Territory for the Initial Indication for Contrave: (a) Licensee will be responsible for Orexigen shall prepare, file, maintain, and own all regulatory submissions and will control all regulatory activities with respect to Products in the TerritoryRegulatory Filings, including safety reporting, analysis the IND and strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expenses, which shall be the responsibility of Licensor) and will, at Licensee’s request, promptly transfer all Regulatory Materials and Information in its possession or under its Control related to CX-01 or any Product to Licensee. (b) Licensee will be the primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to Products in the Field NDA for Contrave in the Territory, and Licensee will prepare and file any and all Regulatory Materials for each Product related submissions with respect to Contrave in the Field Territory; and (b) Orexigen shall promptly notify Takeda of all material Regulatory Filings with respect to Contrave that it proposes to submit to Regulatory Authorities, or that it receives from Regulatory Authorities, in the Territory at its sole expense (including all substantive correspondence with such Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and other materials relating to interactions with such Regulatory Authorities, and summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities), and shall promptly provide Takeda with a copy (which may be wholly or partly in accordance with the Regulatory Plan. Licensor will assist and cooperate, at Licensee’s expense, with Licensee in connection with the preparation and filing electronic form) of such Regulatory MaterialsFilings for review by Takeda. Takeda shall provide any comments promptly, but in no event later than […***…] ([…***…]) Business Days after receiving such Regulatory Filings, Orexigen shall reasonably consider and give due consideration to any such comments provided by Takeda, and, as reasonably requested necessary, it shall discuss such comments with Takeda, and each Party shall use good faith efforts to mutually agree on the content of any communications that relate to or contain commitments made or to be made by Licensee. Such cooperation will include promptly responding within procedural timelines set by Orexigen to Regulatory Authorities to any reasonable request from Licensee for Licensor Know-How needed for the purpose of obtaining Regulatory Materials. (c) Unless the Parties otherwise agree in writing: Approvals; provided, however, (i) except as expressly contemplated by this Section 5.1, Licensor will not communicate Orexigen shall retain the right to make any final decisions with respect to the content of any Product such communications, which shall be compliant with the Development Plan, this Agreement and applicable Law, and (ii) in the Field event any interaction with any a Regulatory Authority having jurisdiction in is time-sensitive, Orexigen shall have the Territory, unless so ordered right to communicate with such Regulatory Authority within the time frame requested by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice to Licensee of such order and all details thereof; and (ii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals for any Product in the Field in the Territory. (d) Licensee . Orexigen shall provide Licensor Takeda with reasonable advance notice of any scheduled significant meeting with the FDA or EMA any Regulatory Authority relating to the Product or any Regulatory Approval in the Territory, and Takeda shall have the right to have up to […***…] ([…***…]) individuals attend and participate in any such meeting; provided, however, Orexigen will retain the lead role and responsibility in any such meetings. 3.4.2 The Parties acknowledge and agree that as of the Amended and Restated Effective Date, Orexigen has transferred all Regulatory Filings relating to Contrave in the Territory, including the IND and the NDA for Contrave in the Territory, into the name of Takeda and provided Takeda with a copy of all such Regulatory Filings. Takeda is responsible for (a): preparing, filing, maintaining and owning all Regulatory Filings and related submissions, including the IND and the NDA for Contrave in the Territory, with respect to Products in all Indications in the Territory, and (b) leading discussions and meetings with all Regulatory Authorities regarding Products in all Indications in the Territory; provided, however, […***…] = Certain confidential ([…***…]) representatives of Orexigen shall be entitled to participate in any such discussions and meetings with Regulatory Authorities, and, if an appropriate Orexigen representative(s) is requested by Takeda to attend a discussion or meeting with a Regulatory Authority regarding the Products in the Indications in the Territory, Orexigen will use Commercially Reasonable Efforts to arrange for such individual(s) to participate in such discussions or meetings. 3.4.3 Upon request, Takeda will provide the JSC with copies of all Regulatory Filings and related material correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to Products in all Indications in the Territory. Takeda will promptly furnish, but in no event later than […***…] ([…***…]) Business Days after receipt or generation, Orexigen with copies of all such Regulatory Filings (including all substantive correspondence with such Regulatory Authorities, responses from such Regulatory Authorities, requests for information from such Regulatory Authorities, briefing documents and other materials relating to interactions with such Regulatory Authorities, and summaries of outputs resulting from substantive correspondence/conversations or meetings with such Regulatory Authorities). In addition, prior to making a Regulatory Filing relating to Contrave or responding to any such Regulatory Authority correspondence or interactions, except to the extent impracticable with respect to expedited safety reports, timelines imposed by Regulatory Authorities, Takeda SOPs and other similar time-sensitive issues, Takeda shall provide to the JDC and JSC a complete draft copy for its review and comment. Takeda shall give due consideration to any comments of the JDC and JSC with respect thereto. 3.4.4 Notwithstanding any transfer of Regulatory Filings or ownership thereof to Takeda, Orexigen shall have, on behalf of itself, its Affiliates, and licensees and sublicensees, the right to access and reference data and information contained in this documentany Regulatory Filings to the extent useful or necessary in connection with (a) Product regulatory filings outside the Territory and/or (b) any Clinical Trial of a Product conducted in the Territory by Orexigen or its Affiliates, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Productlicensees, and Dr. Xxxxxxx Xxxxxxsublicensees for the Territory or for outside the Territory. Orexigen hereby grants to Takeda, its Affiliates and Sublicensees, the right to access and reference data and information contained in any of Orexigen’s, or its Affiliates’, licensees’ and sublicensees’ Product regulatory filings outside the Territory to the extent useful or necessary in connection with Regulatory Filings in or for the Territory. Each Party agrees to provide letters of authorization and take any other actions as reasonably necessary for the other Party to exercise its right to access and reference data and information as permitted under this Section 3.4.4. 3.4.5 If a representative of Licensor (Regulatory Authority desires to conduct an inspection or audit of, or sends a reasonably acceptable replacement if Xx. Xxxxxx is not available)communication to, shallTakeda or Orexigen or any Third Party engaged by either Party to perform activities under the Development Plan or Commercialization Plan with regard to any Product or this Agreement, Takeda and Orexigen each agrees to cooperate with the Regulatory Authority and the other Party during such inspection or audit, including by allowing, to the extent permitted by practicable, a representative of the FDA other Party to be present during the applicable portions of such inspection or EMAaudit. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the responsible Party will immediately provide to the other Party), as applicablethe responsible Party will prepare the response to any observation that concerned this Agreement. The other Party agrees to fully cooperate when it prepares such a response, have the right to attend any such meeting at Licensor’s expense. Licensee shall promptly inform (including by providing redacted copies upon to the responsible Party, within […***…] ([…***…]) Business Days after its request, such information and documentation in the Party’s possession as may be necessary for the responsible Party to prepare such response. Before submitting the response to the Regulatory Authority, the responsible Party agrees to give the other Party a reasonable opportunity to comment on it. 3.4.6 Each Party (and its Third Party subcontractors) Licensor about any significant interaction shall notify the other Party within […***…] (oral or written[…***…]) with Business Day of receipt of notification from a Regulatory AuthorityAuthority of the intention of such Regulatory Authority to audit or inspect a Party’s facilities with respect to any Product, including facilities being used for Manufacture of any Product. Each Party (and its Third Party subcontractors) shall also provide the other Party with copies of any written communications received from Regulatory Authorities with respect to such facilities within […***…] ([…***…]) Business Days of receipt. Such Party shall provide the other Party with an opportunity to review and provide input on any proposed response by such Party (or Third Party subcontractor) to such communications.