Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. (a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.5. (b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmental Authority relating to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US Territory, and Shire shall have the right to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire notice of any such meeting or conference call, New River shall immediately thereafter provide Shire with a detailed summary of any such meeting or conference call. New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River has had with or receives from any Governmental Authority, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental Authority, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto). (c) Shire shall be primarily responsible for interfacing, corresponding, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“DDMAC”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto). (d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as of the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the Collaboration Product as soon as reasonably practicable after such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM technology under this Agreement, except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreement. (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US Territory, New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by New River. Either Party may decide, in good faith, to initiate a recall or withdrawal of Collaboration Product in the US Territory, in consultation with the JDC and JMC. Before Shire initiates a recall or withdrawal, and upon the request for a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Laws. In the event of any recall or withdrawal for Collaboration Products sold in the US Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.

Regulatory Activities. (a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), Shire shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development PlanROW Territory, including preparing all reports necessary as part of a Drug Approval Application. All The Parties intend that [*] New River shall be responsible for providing to Shire, in the Common Technical Document format (unless the FDA requires a different format or the Common Technical Document format would delay the filing of the Drug Approval Application), the data and information required to be submitted to the FDA, and such additional data and information relating to the Development activities for which it was responsible, including all clinical trials performed by it and, if applicable, all manufacturing and controls information. Shire shall be responsible for prosecuting all such Drug Approval Applications and shall be filed in the name have a right of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains cross-reference to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made Applications filed by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed such purpose. New River will take all such reasonable actions to allow such cross-reference. New River shall have the right of cross-reference to all such Drug Approval Applications filed by Shire under Section 3.6.5for the purpose of prosecuting Drug Approval Applications in the US Territory, and Shire shall, or shall cause its Affiliates to, take all such reasonable actions to allow such cross-reference. (b) In connection with all Drug Approval Applications being prosecuted by Shire hereunder, Shire agrees to provide New River with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies in each Major EU Market country that it makes hereunder. Within thirty (30) days following the end of each calendar quarter, Shire shall provide report to New River regarding the status of each pending and proposed Drug Approval Application in the ROW Territory. (c) In the event that Shire with reasonable advance notice of desires New River to participate in any meeting meeting, discussion or substantive or material telephone conference call with any Governmental Authority relating to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US ROW Territory, and Shire shall have the right to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire New River with reasonable advance notice of any such meeting meeting, discussion or conference call, call and New River shall immediately thereafter provide participate with Shire. Shire with a detailed summary of any such meeting or conference call. shall promptly furnish New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River Shire has had with or receives from any Governmental AuthorityAuthority in the Major EU Markets, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental AuthorityAuthority in the Major EU Markets, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto). (cd) Shire shall be primarily responsible for interfacingprovide to New River, correspondingon a timely basis, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“DDMAC”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto). (d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as in support of a Drug Approval Application in the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the ROW Territory for a Collaboration Product as soon as reasonably practicable after (but excluding any such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM technology under this Agreement, except to the extent necessary for Shire relating to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreementthe Manufacture of the Compound). (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US ROW Territory, Shire shall notify New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by Shire. Shire shall consult with New River. Either Party may decide, in good faith, River prior to initiate initiating a recall or withdrawal of Collaboration Product in a Major EU Market; provided that the US Territory, in consultation with the JDC and JMC. Before Shire initiates a final decision as to whether to recall or withdrawal, and upon the request for withdraw a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Lawsthe ROW Territory shall be made by Shire in its sole discretion. In the event of any recall or withdrawal for Collaboration Products sold in the US ROW Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.

Regulatory Activities. (a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. 3.3.1 New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US ROW Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) 3.3.1 shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.59. (b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmental Authority relating to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US Territory, and Shire shall have the right to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire notice of any such meeting or conference call, New River shall immediately thereafter provide Shire with a detailed summary of any such meeting or conference call. New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River has had with or receives from any Governmental Authority, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental Authority, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto). (c) Shire shall be primarily responsible for interfacing, corresponding, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“DDMAC”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto). (d) 3.3.2 Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as of the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the Collaboration Product as soon as reasonably practicable after such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) 3.3.2 shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM technology under this Agreement, except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreement. (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US Territory, New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by New River. Either Party may decide, in good faith, to initiate a recall or withdrawal of Collaboration Product in the US Territory, in consultation with the JDC and JMC. Before Shire initiates a recall or withdrawal, and upon the request for a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Laws. In the event of any recall or withdrawal for Collaboration Products sold in the US Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.

Regulatory Activities. (a) Unless otherwise agreed in writing by As between the Parties, New RiverBayer, subject to Section 3.3.3(c)[***], shall have the sole right (which may be responsible for preparing exercised through any of Bayer’s Affiliates or Sublicensees) to (i) determine, plan and filing implement any regulatory plans and strategies, (ii) prepare and maintain the Company Core Data Sheet, (iii) prepare, obtain, and maintain any Drug Approval Applications and seeking other Regulatory Approvals, (iv) make all other regulatory submissions, including INDs, and (v) conduct any interactions and communications with the Regulatory Authorities including all submissions, meetings and discussions, in each case ((i) – (v)) in respect of any Licensed Products in the Territory. Bayer shall (i) inform BicycleTx of [***]. Upon Xxxxx'x request and without additional compensation (except for [***]) and subject to obligations of confidentiality that BicycleTx has to Third Parties, BicycleTx shall, and shall cause its Affiliates, to cooperate with and provide reasonable assistance to Bayer in obtaining Regulatory Approvals for Collaboration the Licensed Products (including in the US Territory in accordance connection with the applicable Development Plan, including preparing all reports necessary as part of any IND or NDA filings or any other filing with a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made by New River in accordance with the terms of this Section 3.3.3(aRegulatory Authority), including Drug Approval Applicationsproviding and executing documents or other materials reasonably required by Bayer to obtain such Regulatory Approvals, provided that such assistance pursuant to this Clause 4.4.1 (y) [***], and (z) shall consider in good faith any comments Shire may have with respect not exceed [***] per Target (beyond which BicycleTx shall provide reasonable assistance, but subject to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, customary payment by Bayer for purposes of the Collaboration Products, all data, that regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territoryassistance [***]). To the extent that any such data, regulatory filings or regulatory communications are held specifically requested by a Third PartyRegulatory Authority, then New River and specifically relating to BicycleTx’s contribution to any Licensed Product, Bayer may request that BicycleTx performs experiments of a limited scope subject to [***] and BicycleTx shall arrange direct access to the portions of reasonably consider such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.5request. (b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmental Authority All Regulatory Documentation (including all Regulatory Approvals and Product Labelling) specifically relating to any Drug Approval Application or Regulatory Approval for Collaboration Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the US Territoryname of, Bayer or its designated Affiliate, Sublicensee or designee (including third-party experts, advisors or vendors engaged by Bayer in respect of Regulatory Approvals). BicycleTx shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, documents, and Shire shall have the right to participate instruments, as may be reasonably necessary under, or as Bayer may reasonably request in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire notice of any such meeting or conference call, New River shall immediately thereafter provide Shire connection with a detailed summary of any such meeting or conference call. New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River has had with or receives from any Governmental Authority, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental Authority, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto)this Clause 4.4.1. (c) Shire shall be primarily responsible for interfacing, corresponding, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“DDMAC”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c)BicycleTx shall, and shall consider cause its Affiliates to, co-operate with Bayer, its Affiliates, Sublicensees or designees (including third-party experts, advisors or vendors engaged by Bayer in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to inspection by a Collaboration Product in the US TerritoryRegulatory Authority), and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto). (d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as of the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the Collaboration Product as soon as reasonably practicable after such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall may be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM technology under this Agreement, except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreement. (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US Territory, New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by New River. Either Party may decide, in good faith, to initiate a recall or withdrawal of Collaboration Product in the US Territory, in consultation with the JDC and JMC. Before Shire initiates a recall or withdrawal, and upon the request for a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Laws. In the event of any recall or withdrawal for Collaboration Products sold in the US Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by ShireBayer, in connection with any inspection by a ​ 289122840 v2 ​ ​ CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. Regulatory Authority relating to any Licensed Product including any inspection prior to the approval of an NDA for such Licensed Product, provided that such co-operation (i) [***], and (ii) shall not exceed [***] per Target (beyond which BicycleTx shall co-operate, but subject to [***] for that co-operation [***].

Regulatory Activities. (a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), Shire shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development PlanROW Territory, including preparing all reports necessary as part of a Drug Approval Application. All The Parties intend that [*]. New River shall be responsible for providing to Shire, in the Common Technical Document format (unless the FDA requires a different format or the Common Technical Document format would delay the filing of the Drug Approval Application), the data and information required to be submitted to the FDA, and such additional data and information relating to the Development activities for which it was responsible, including all clinical trials performed by it and, if applicable, all manufacturing and controls information. Shire shall be responsible for prosecuting all such Drug Approval Applications and shall be filed in the name have a right of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains cross-reference to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made Applications filed by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed such purpose. New River will take all such reasonable actions to allow such cross-reference. New River shall have the right of cross-reference to all such Drug Approval Applications filed by Shire under Section 3.6.5for the purpose of prosecuting Drug Approval Applications in the US Territory, and Shire shall take all such reasonable actions to allow such cross-reference. (b) In connection with all Drug Approval Applications being prosecuted by Shire hereunder, Shire agrees to provide New River with a copy (which may be wholly or partly in electronic form) of all filings to regulatory agencies in each Major EU Market country that it makes hereunder. Within thirty (30) days following the end of each calendar quarter, Shire shall provide report to New River regarding the status of each pending and proposed Drug Approval Application in the ROW Territory. (c) In the event that Shire with reasonable advance notice of desires New River to participate in any meeting meeting, discussion or substantive or material telephone conference call with any Governmental Authority relating to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US ROW Territory, and Shire shall have the right to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire New River with reasonable advance notice of any such meeting meeting, discussion or conference call, call and New River shall immediately thereafter provide participate with Shire. Shire with a detailed summary of any such meeting or conference call. shall promptly furnish New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River Shire has had with or receives from any Governmental AuthorityAuthority in the Major EU Markets, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental AuthorityAuthority in the Major EU Markets, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto). (cd) Shire shall be primarily responsible for interfacingprovide to New River, correspondingon a timely basis, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“DDMAC”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto). (d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as in support of a Drug Approval Application in the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the ROW Territory for a Collaboration Product as soon as reasonably practicable after (but excluding any such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM technology under this Agreement, except to the extent necessary for Shire relating to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreementthe Manufacture of the Compound). (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US ROW Territory, Shire shall notify New River shall notify Shire of such communication immediately, but in no event later than within one (1) Business Day, after Day of receipt by Shire. Shire shall consult with New River. Either Party may decide, in good faith, River prior to initiate initiating a recall or withdrawal of Collaboration Product in a Major EU Market; provided that the US Territory, in consultation with the JDC and JMC. Before Shire initiates a final decision as to whether to recall or withdrawal, and upon the request for withdraw a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Lawsthe ROW Territory shall be made by Shire in its sole discretion. In the event of any recall or withdrawal for Collaboration Products sold in the US ROW Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.

Regulatory Activities. 3.3.1 Prior to the Expiration of the Review Period. Prior to the expiration of the Review Period, VALEANT (aor its designated Affiliate) Unless otherwise agreed in writing will continue to hold and maintain all Regulatory Approvals and other filings with Regulatory Authorities for the Products and Additional Products; provided, however, that VALEANT shall, as directed by the PartiesJoint Steering Committee, New Rivertake all reasonable actions to make available to GSK the benefits of such Regulatory Approvals to the extent required by GSK in connection with its activities under this Agreement. Further, subject prior to Section 3.3.3(c)the expiration of the Review Period, shall VALEANT will be responsible for preparing filing and filing Drug Approval Applications obtaining XXXx with the Regulatory Authorities for the development, use and seeking Regulatory Approvals for Collaboration commercialization of Products and Additional Products in the US Territory in accordance with Territory, as directed by the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval ApplicationJoint Steering Committee and using Commercially Reasonable Efforts to seek such approvals. All such Drug Approval Applications activity shall be filed done in full consultation with the Joint Steering Committee. All such filings will be in the name of New RiverVALEANT, except where otherwise required by applicable Law in any country within the Territory. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with With respect to any substantive Regulatory Approval maintained by VALEANT as provided herein or material filings any MAA to be made filed by New River VALEANT as provided herein, VALEANT shall provide GSK with: (a) reasonable advanced notice (and in accordance no event less than twenty (20) days’ advance notice whenever feasible) of substantive meetings with the terms of this Section 3.3.3(a)FDA, including Drug Approval Applications, and shall consider in good faith the EMEA or any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for other Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications Authority that are relevant either scheduled with, or initiated by or under the authority of, VALEANT or its Affiliates relating to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking such Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.5.or XXXx; (b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmental Authority relating an opportunity to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US Territory, and Shire shall have the right up to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire notice of any such meeting or conference call, New River shall immediately thereafter provide Shire with a detailed summary of any such meeting or conference call. New River shall promptly, but in no event more than two (2) Business Days after receiptrepresentatives attend and to actively participate in, furnish Shire with copies of all substantive or material documents or correspondence New River has had with or receives from any Governmental Authority, and contact reports concerning substantive or material conversations or substantive meetings with the FDA, the EMEA or any Governmental Authority, in each case other Regulatory Authority relating to such Regulatory Approvals and XXXx; and in any Drug Approval Application or case, VALEANT shall keep the Joint Steering Committee informed as to all material interactions with Regulatory Approval (including without limitation any minutes from a meeting with respect thereto).Authorities relating to such Regulatory Approvals and XXXx; (c) Shire shall be primarily responsible for interfacinga copy of any material documents, corresponding, making required filings information and meeting with the Division of Drug Marketing, Advertising and Communications of correspondence submitted to the FDA or the EMEA or any other Regulatory Authority relating to such Regulatory Approvals as soon as reasonably practicable, together with English translations and summaries thereof, to the extent such translations and summaries exist; and (“DDMAC”d) at least two (2) months prior to an anticipated filing of an MAA for a Product, a copy of such all documents and information intended to be included in such MAA for review and comment by GSK, which comments will be reasonably considered by VALEANT, and, with respect to the marketing and promotion United States, all information reasonably requested by GSK to determine the listing of the Collaboration Products patents (i.e., in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of ShireOrange Book) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any for such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto)United States. (d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as of the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the Collaboration Product as soon as reasonably practicable after such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM technology under this Agreement, except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreement. (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US Territory, New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by New River. Either Party may decide, in good faith, to initiate a recall or withdrawal of Collaboration Product in the US Territory, in consultation with the JDC and JMC. Before Shire initiates a recall or withdrawal, and upon the request for a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Laws. In the event of any recall or withdrawal for Collaboration Products sold in the US Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.

Regulatory Activities. (a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory or ROW Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.53.5.5. (b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmental Authority relating to any Drug Approval Application or Regulatory Approval for Collaboration Products in the US Territory, and Shire shall have the right to participate in any such meeting or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide Shire notice of any such meeting or conference call, New River shall immediately thereafter provide Shire with a detailed summary of any such meeting or conference call. New River shall promptly, but in no event more than two (2) Business Days after receipt, furnish Shire with copies of all substantive or material documents or correspondence New River has had with or receives from any Governmental Authority, and contact reports concerning substantive or material conversations or substantive meetings with any Governmental Authority, in each case relating to any Drug Approval Application or Regulatory Approval (including without limitation any minutes from a meeting with respect thereto). (c) Shire shall be primarily responsible for interfacing, corresponding, making required filings and meeting with the Division of Drug Marketing, Advertising and Communications of the FDA (“DDMAC”) with respect to the marketing and promotion of the Collaboration Products in the US Territory. New River will provide a letter to the FDA (to be prepared with assistance of Shire) notifying the FDA that Shire has been designated as the agent of New River upon whom all DDMAC communications should be made on behalf of New River with respect to Collaboration Products in the US Territory. Shire, through the JMC, shall provide New River with drafts of any substantive or material documents or correspondence to be submitted to DDMAC in the US Territory that pertains to a Collaboration Product. Shire, through the JMC, will consult in advance with New River with respect to any substantive or material filings to be made by Shire in accordance with the terms of this Section 3.3.3(c), and shall consider in good faith any comments New River may have with respect to any such filings. Shire shall provide New River with reasonable advance notice of any meeting or substantive or material conference call with DDMAC relating to a Collaboration Product in the US Territory, and New River shall have the right to participate in any such meeting or substantive or material conference call as well as have the right to participate in all substantive or material preparation, internal caucus, and debriefing sessions related to such meetings or conference calls. If it is not possible to provide New River notice of any such meeting or conference call, Shire shall immediately thereafter provide New River with a detailed summary of any such meeting or conference call. Shire shall promptly, but in no event more than two (2) Business Days after receipt, furnish New River with copies of all substantive or material documents or correspondence Shire has had with or receives from DDMAC, and contact reports concerning substantive or material conversations or substantive or material meetings with DDMAC, in each case relating to a Collaboration Product (including without limitation any minutes from a meeting with respect thereto). (d) Within thirty (30) days after the Effective Date, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled as of the Effective Date with respect to the Collaboration Product, including any final versions of any study reports and any drafts then-outstanding of any study reports. Thereafter, New River shall provide to Shire copies of all substantive or material Manufacturing, pre-clinical and clinical data compiled with respect to the Collaboration Product as soon as reasonably practicable after such data or results become available or compiled, including any drafts and final versions of any study reports. All disclosures under this Section 3.3.3(d) shall be delivered in electronic format. For clarity, New River shall not be required to disclose New River’s proprietary CarrierwaveTM Carrierwave™ technology under this Agreement, except to the extent necessary for Shire to exercise its rights and perform its obligations under this Agreement or as otherwise specifically provided in this Agreement. (e) In the event that any Governmental Authority threatens or initiates any action to remove a Collaboration Product from the market in the US Territory, New River shall notify Shire of such communication immediately, but in no event later than one (1) Business Day, after receipt by New River. Either Party may decide, in good faith, to initiate a recall or withdrawal of Collaboration Product in the US Territory, in consultation with the JDC and JMC. Before Shire initiates a recall or withdrawal, and upon the request for a recall or withdrawal by either Party, the Parties shall promptly and in good faith discuss the reasons therefor and the allocation of the costs of any such recall or withdrawal. Under no circumstances shall either Party unreasonably object to a recall or withdrawal requested by the other Party, and neither Party shall have any right to object to a recall or withdrawal requested by the other Party for failure of a Collaboration Product to meet the applicable specifications, for material safety concerns, or for the Manufacture of such Collaboration Product in a manner that does not comply with applicable Laws. In the event of any recall or withdrawal for Collaboration Products sold in the US Territory, Shire shall implement any necessary action, with assistance from New River as reasonably requested by Shire.