Common use of Development Activities Clause in Contracts

Development Activities. (a) Alexion shall have the sole right and responsibility to conduct Development activities with respect to the Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a [***] in accordance with Section 4.2(b). (b) Except as otherwise expressly set forth herein, Eidos shall have the sole right, and will have sole discretion and control over the Development of the Licensed Compound and Licensed Product for the purpose of obtaining and maintaining Regulatory Approval for the Commercialization of such Licensed Products in the Field in the ROW Territory. Notwithstanding the foregoing, Eidos shall use Commercially Reasonable Efforts to manage, conduct and complete the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial through the final dosing of the final subject in such Clinical Trials and completion of the final clinical study report for such Clinical Trials. Eidos shall keep Alexion reasonably informed, on at least [***] basis, as to the status and results of the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In addition, Eidos shall consider in good faith any comments provided by Alexion with respect to the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial, including comments on the design and any potential protocol amendments. Without limiting the foregoing, Alexion shall have the right to (i) require, in its sole discretion, that Eidos [***], or request such [***] at any time thereafter with Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed, (ii) request that Eidos [***] subject to Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed; and (iii) require that Eidos [***]. If Alexion wishes to initiate a [***] pursuant to this Section 4.2(b), Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (rather than requiring) [***], within [***] of Eidos’ receipt of such notice, Eidos shall inform Alexion in writing whether Eidos agrees to the requested [***]. Additionally, if Eidos intends to initiate an additional Clinical Trial in the ROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Upon Alexion’s written request [***]. The Parties shall decide by mutual agreement all matters relating to the conduct of the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial and the Additional Trial in the Territory, including the choice of Clinical Trial sites, and the Parties shall conduct the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial or the Additional Trial, as applicable, in the Territory in accordance with such decisions.

Development Activities. (a) Alexion [***] shall have the sole right responsibility for conducting development of the Products, including, without limitation, Clinical Trials related to the Products, whether within or outside the Territory. In addition, (a) Coherus and responsibility Distributor shall consult with Regulatory Authorities in [***] prior to conduct Development activities initiation of the first Phase 3 Clinical Trial for the Product anywhere in the world with respect to the Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos need to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a include patients from [***] in accordance with Section 4.2(b). any Phase 3 Clinical Trial; (b) Except [***] will use Commercially Reasonable Efforts to include the number of patients from [***] required by the applicable Regulatory Authorities to be included in any Phase 3 Clinical Trial conducted by or on behalf of Coherus[***]; (c) if additional Clinical Trials are required by any Regulatory Authority in connection with (e.g., Phase 4 Clinical Trials) or following receipt of Regulatory Approval, other than Additional Manufacturing Studies (as otherwise expressly set forth hereindefined below) (“Additional Required Clinical Trials”), Eidos Coherus shall have consult in good faith with Distributor on the sole rightfeasibility of conducting such Additional Required Clinical Trials ([***]); (d) [***] shall retain final decision-making on whether to proceed with any such Additional Required Clinical Trials unless [***] agrees to pay for any such Additional Required Clinical Trials, and will have sole discretion and control over the Development of the Licensed Compound and Licensed Product for the purpose of obtaining and maintaining Regulatory Approval for the Commercialization of such Licensed Products in the Field in the ROW Territory. Notwithstanding the foregoing, Eidos which case [***] shall use Commercially Reasonable Efforts to manage, conduct and complete the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial through the final dosing of the final subject in such Additional Required Clinical Trials and completion of the final clinical study report for such Clinical Trials. Eidos shall keep Alexion reasonably informed, on at least [***] basisshall promptly pay any invoices submitted by Coherus related to such Additional Required Clinical Trials; (e) if, as to in connection with the status implementation of any [***] and results of such [***] are not also required outside the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In additionTerritory, Eidos Coherus shall consider consult in good faith any comments provided by Alexion with respect to the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial, including comments Distributor on the design feasibility of conducting such [***]); (f) Coherus and any potential protocol amendments. Without limiting the foregoing, Alexion Distributor shall have the right consult with Regulatory Authorities in [***] prior to initiation of such [***]; (ig) require, in its sole discretion, that Eidos if [***], or request then [***]; and (h) [***] shall retain final decision-making on whether to proceed with any such [***] at any time thereafter with Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed, (ii) request that Eidos for the Territory unless [***] subject agrees to Eidos’ written consentpay for any such [***] for the Territory in which case [***] shall use Commercially Reasonable Efforts to conduct such [***] for the Territory, not [***] shall promptly pay any invoices submitted by [***] related to be unreasonably withheldsuch [***] and, conditioned or delayed; and (iii) require that Eidos [***]. If Alexion wishes to initiate a [***] pursuant shall, on [***] reasonable request, provide assistance to [***] in conducting development of the Products in the [***] Certain information in this Section 4.2(b)document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. EXECUTION COPY Territory, Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (rather than requiring) including without limitation, any Additional Required Clinical Trials or any [***], within [***] of Eidos’ receipt of such notice, Eidos shall inform Alexion in writing whether Eidos agrees to the requested [***]. Additionally, if Eidos intends to initiate an additional Clinical Trial in the ROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Upon Alexion’s written request [***]. The Parties shall decide by mutual agreement all matters relating to the conduct of the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial and the Additional Trial in the Territory, including the choice of Clinical Trial sites, and the Parties shall conduct the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial or the Additional Trial, as applicable, in the Territory in accordance with such decisions.

Development Activities. (a) Alexion shall Licensee will not Develop or have Developed the sole right Products (including conducting medical or clinical trials of the Product or otherwise generating additional clinical data or performing additional analysis of existing clinical data for the Product) without the prior written approval of Allergan and responsibility pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct Development activities with respect such studies without the prior written approval of Allergan, such approval not to the Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a [***] in accordance with Section 4.2(b)be unreasonably withheld. (b) Except If mutually agreed upon by the Parties, Licensee shall Develop or co-Develop Products for sale in the Territory via participation in clinical trials conducted by Allergan outside of the Territory, via stand-alone trials within the Territory, via investigator-initiated clinical trials within the Territory or otherwise as otherwise expressly set forth hereinagreed to by the Parties. (c) If Allergan has finalized a development plan and budget to develop the Product for any New Indication for Regulatory Approval in the United States, Eidos it shall have notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the sole right“New Indication Notice”). If Licensee is interested in such New Indication included within the Field, it shall notify Allergan within [redacted in accordance with Section 12.2(3) of National Instrument 51-102] from the date of the New Indication Notice, whereupon the parties shall discuss and will have sole discretion and control over seek to agree within [redacted in accordance with Section 12.2(3) of National Instrument 51-102] from the date of the New Indication Notice on (i) the portion of the Development costs associated with the Development of such New Indication payable by Licensee and (ii) the Licensed Compound and Licensed Product for date upon which such New Indication shall be deemed included in the purpose Field. If Licensee does not make the election set forth in the preceding sentence within such [redacted in accordance with Section 12.2(3) of obtaining and maintaining Regulatory Approval for National Instrument 51-102] period, or if the Commercialization Parties do not reach agreement on Development cost sharing with respect to such New Indication within such [redacted in accordance with Section 12.2(3) of National Instrument 51-102] period, then such Licensed Products New Indication shall not be included in the Field in the ROW Territory. Notwithstanding the foregoing, Eidos and Licensee shall have no rights with respect to such New Indication. (d) Allergan shall use Commercially Reasonable Efforts to manage, conduct and complete the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial through the final dosing of the final subject in such Clinical Trials and completion of the final clinical study report for such Clinical Trials. Eidos shall keep Alexion reasonably informed, on at least [***] basis, as to the status and results of the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In addition, Eidos shall consider in good faith any comments provided by Alexion with respect to the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial, including comments on the design and any potential protocol amendments. Without limiting the foregoing, Alexion shall have the right to to: (i) require, file with applicable Governmental Authorities in its sole discretion, that Eidos [***], or request such [***] at any time thereafter with Eidos’ written consent, not Canada and Switzerland all documents necessary for the Product to be unreasonably withheld, conditioned or delayed, used in a single dose regimen in such countries. (ii) request that Eidos [***] subject to Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed; and conduct pediatric studies of the Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in the Territory (except for the Special Countries). (iii) require that Eidos [***]. If Alexion wishes to initiate a [***] pursuant to this Section 4.2(b), Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (rather than requiring) [***], within [***] of Eidos’ receipt of such notice, Eidos shall inform Alexion in writing whether Eidos agrees to complete all post-Regulatory Approval actions for the requested [***]. Additionally, if Eidos intends to initiate an additional Clinical Trial in the ROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Upon Alexion’s written request [***]. The Parties shall decide by mutual agreement all matters relating to the conduct of the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial and the Additional Trial in the Territory, including the choice of Clinical Trial sites, and the Parties shall conduct the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial or the Additional Trial, as applicable, Product in the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in accordance with such decisionsthe Territory (except for the Special Countries).

Development Activities. (a) Alexion Kyowa Hakko shall have be responsible, at its expense, for all Development activities under the sole right and responsibility to Development Plan that are reasonably necessary for the Regulatory Approval of the Licensed Product in the Kyowa Hakko Territory. Neither Party may conduct Clinical Studies, Post-Approval Studies or other Development activities with respect to the Licensed Compound and the Licensed Products Product in the Field in the Territory in its sole discretionof the other Party without the other Party’s prior written consent, except as necessary for Eidos to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial which consent will not be unreasonably withheld or any Additional Clinical Trial in the Territory following a [***] in accordance with Section 4.2(b)delayed. (b) Except as otherwise expressly set forth herein, Eidos shall have The Parties expect that the sole right, Development activities under the initial Development Plan will entail the Development by Kyowa Hakko of the Licensed Product for Regulatory Approval in Japan utilizing data generated by Alnylam and will have sole discretion its Related Parties in the pre-clinical and control over the clinical Development of the Licensed Compound Product in the Alnylam Territory and [**]. However, the Parties acknowledge that the Regulatory Authorities in Japan may require Kyowa Hakko to submit data from [**] in order to obtain Regulatory Approval of the Licensed Product for in Japan. If (x) the purpose of obtaining and maintaining Japanese Regulatory Authorities require Kyowa Hakko to conduct [**] in order to obtain Regulatory Approval for of the Commercialization Licensed Product in Japan and (y) Alnylam intends to conduct [**] of such the Licensed Products in Product, to the Field in the ROW Territory. Notwithstanding the foregoingextent requested by Kyowa Hakko, Eidos shall Alnylam agrees to use its Commercially Reasonable Efforts to manage, conduct and complete the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial through the final dosing of the final subject in such Clinical Trials and completion of the final clinical study report for such Clinical Trials. Eidos shall keep Alexion reasonably informed, on at least [***] basis, as to the status and results of the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In addition, Eidos shall consider in good faith any comments provided by Alexion with respect to the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial, including comments on the design and any potential protocol amendments. Without limiting the foregoing, Alexion shall have the right to (i) require, in its sole discretion, that Eidos [***], or request at Alnylam’s expense, in such a manner as to accommodate the requirements for Japanese Regulatory Approval as described to Alnylam by Kyowa Hakko such that Kyowa Hakko is not required to conduct [**], including conducting some portion of [**]; provided, however, that (i) any such [***] at any time thereafter with Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed, (ii) request that Eidos must meet the requirements for Regulatory Approval of the Licensed Product [***] subject to Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed; and (iii) require that Eidos [***]. If Alexion wishes to initiate a [***] pursuant to this Section 4.2(b), Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (rather than requiringii) [**] shall have final decision-making authority with respect to all aspects of such [**], within including whether to include any changes to the [***] to accommodate the requirements of Eidos’ receipt of such noticeJapanese Regulatory Authorities; and provided, Eidos shall inform Alexion further, however, that in writing whether Eidos agrees to the requested event that Alnylam includes [***]. Additionally, if Eidos intends to initiate an additional Clinical Trial ] Japanese sites in the ROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Upon Alexion’s written request [**], Alnylam will use its Commercially Reasonable Efforts consistent with the [**] to designate Kyowa Hakko as Alnylam’s designee for the conduct of such [**] in Japan and all interactions and correspondence with Japanese Regulatory Authorities as the holder of the IND in Japan. For purposes of clarity, (x) Alnylam will be responsible for all costs associated with such [**]. The Parties shall decide by mutual agreement all matters relating , including those costs related to the conduct of such [**] in Japan; provided, however, that Kyowa Hakko shall be responsible for any of its own expenses incurred in connection with Kyowa Hakko serving as Alnylam’s designee in Japan for the ATTRibute-CM Clinical Trialconduct of such [**] and all interactions and correspondence with Japanese Regulatory Authorities as the holder of the IND in Japan, ATTRibute-PN Clinical Trial and the Additional Trial in the Territory(y) Kyowa Hakko shall be responsible for all other costs associated with [**] conducted by Kyowa Hakko, including the choice of Clinical Trial sites, and the Parties shall conduct the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial or the Additional Trial, as applicable, in the Territory in accordance with such decisions[**].

Development Activities. (a) Alexion shall Licensee will not Develop or have Developed the sole right Products (including conducting medical or clinical trials of the Product or otherwise generating additional clinical data or performing additional analysis of existing clinical data for the Product) without the prior written approval of Allergan and responsibility pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct Development activities with respect such studies without the prior written approval of Allergan, such approval not to the Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a [***] in accordance with Section 4.2(b)be unreasonably withheld. (b) Except If mutually agreed upon by the Parties, Licensee shall Develop or co-Develop Products for sale in the Territory via participation in clinical trials conducted by Allergan outside of the Territory, via stand-alone trials within the Territory, via investigator-initiated clinical trials within the Territory or otherwise as otherwise expressly set forth hereinagreed to by the Parties. (c) If Allergan has finalized a development plan and budget to develop the Product for any New Indication for Regulatory Approval in the United States, Eidos it shall have notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the sole right"New Indication Notice"). If Licensee is interested in such New Indication included within the Field, it shall notify Allergan within [...***...] from the date of the New Indication Notice, whereupon the parties shall discuss and will have sole discretion and control over seek to agree within [...***...] from the date of the New Indication Notice on (i) the portion of the Development costs associated with the Development of such New Indication payable by Licensee and (ii) the Licensed Compound and Licensed Product for date upon which such New Indication shall be deemed included in the purpose of obtaining and maintaining Regulatory Approval for Field. If Licensee does not make the Commercialization of election set forth in the preceding sentence within such Licensed Products [...***...] period, or if the Parties do not reach agreement on Development cost sharing with respect to such New Indication within such […***…] period, then such New Indication shall not be included in the Field in the ROW Territory. Notwithstanding the foregoing, Eidos and Licensee shall have no rights with respect to such New Indication. (d) Allergan shall use Commercially Reasonable Efforts to manage, conduct and complete the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial through the final dosing of the final subject in such Clinical Trials and completion of the final clinical study report for such Clinical Trials. Eidos shall keep Alexion reasonably informed, on at least [***] basis, as to the status and results of the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In addition, Eidos shall consider in good faith any comments provided by Alexion with respect to the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial, including comments on the design and any potential protocol amendments. Without limiting the foregoing, Alexion shall have the right to to: (i) require, file with applicable Governmental Authorities in its sole discretion, that Eidos [***], or request such [***] at any time thereafter with Eidos’ written consent, not Canada and Switzerland all documents necessary for the Product to be unreasonably withheld, conditioned or delayed, used in a single dose regimen in such countries. (ii) request that Eidos [***] subject to Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed; and conduct pediatric studies of the Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in the Territory (except for the Special Countries). (iii) require that Eidos [***]. If Alexion wishes to initiate a [***] pursuant to this Section 4.2(b), Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (rather than requiring) [***], within [***] of Eidos’ receipt of such notice, Eidos shall inform Alexion in writing whether Eidos agrees to complete all post-Regulatory Approval actions for the requested [***]. Additionally, if Eidos intends to initiate an additional Clinical Trial in the ROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Upon Alexion’s written request [***]. The Parties shall decide by mutual agreement all matters relating to the conduct of the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial and the Additional Trial in the Territory, including the choice of Clinical Trial sites, and the Parties shall conduct the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial or the Additional Trial, as applicable, Product in the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in accordance with such decisionsthe Territory (except for the Special Countries).

Development Activities. (a) Alexion shall Licensee will not Develop or have Developed the sole right Products (including conducting medical or clinical trials of the Product or otherwise generating additional clinical data or performing additional analysis of existing clinical data for the Product) without the prior written approval of Allergan and responsibility pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct Development activities with respect such studies without the prior written approval of Allergan, such approval not to the Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a [***] in accordance with Section 4.2(b)be unreasonably withheld. (b) Except If mutually agreed upon by the Parties, Licensee shall Develop or co-Develop Products for sale in the Territory via participation in clinical trials conducted by Allergan outside of the Territory, via stand-alone trials within the Territory, via investigator-initiated clinical trials within the Territory or otherwise as otherwise expressly set forth hereinagreed to by the Parties. (c) If Allergan has finalized a development plan and budget to develop the Product for any New Indication for Regulatory Approval in the United States, Eidos it shall have notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the sole right"New Indication Notice"). If Licensee is interested in such New Indication included within the Field, it shall notify Allergan within [...***...] from the date of the New Indication Notice, whereupon the parties shall discuss and will have sole discretion and control over seek to agree within [...***...] from the date of the New Indication Notice on (i) the portion of the Development costs associated with the Development of such New Indication payable by Licensee and (ii) the Licensed Compound and Licensed Product for date upon which such New Indication shall be deemed included in the purpose of obtaining and maintaining Regulatory Approval for Field. If Licensee does not make the Commercialization of election set forth in the preceding sentence within such Licensed Products [...***...] period, or if the Parties do not reach agreement on Development cost sharing with respect to such New Indication within such […***…] period, then such New Indication shall not be included in the Field in the ROW Territory. Notwithstanding the foregoing, Eidos and Licensee shall have no rights with respect to such New Indication. (d) Allergan shall use Commercially Reasonable Efforts to manage, conduct and complete the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial through the final dosing of the final subject in such Clinical Trials and completion of the final clinical study report for such Clinical Trials. Eidos shall keep Alexion reasonably informed, on at least [***] basis, as to the status and results of the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In addition, Eidos shall consider in good faith any comments provided by Alexion with respect to the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial, including comments on the design and any potential protocol amendments. Without limiting the foregoing, Alexion shall have the right to to: 11 (i) require, file with applicable Governmental Authorities in its sole discretion, that Eidos [***], or request such [***] at any time thereafter with Eidos’ written consent, not Canada and Switzerland all documents necessary for the Product to be unreasonably withheld, conditioned or delayed, used in a single dose regimen in such countries. (ii) request that Eidos [***] subject to Eidos’ written consent, not to be unreasonably withheld, conditioned or delayed; and conduct pediatric studies of the Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in the Territory (except for the Special Countries). (iii) require that Eidos [***]. If Alexion wishes to initiate a [***] pursuant to this Section 4.2(b), Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (rather than requiring) [***], within [***] of Eidos’ receipt of such notice, Eidos shall inform Alexion in writing whether Eidos agrees to complete all post-Regulatory Approval actions for the requested [***]. Additionally, if Eidos intends to initiate an additional Clinical Trial in the ROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Upon Alexion’s written request [***]. The Parties shall decide by mutual agreement all matters relating to the conduct of the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial and the Additional Trial in the Territory, including the choice of Clinical Trial sites, and the Parties shall conduct the ATTRibute-CM Clinical Trial, ATTRibute-PN Clinical Trial or the Additional Trial, as applicable, Product in the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities in accordance with such decisionsthe Territory (except for the Special Countries).