Common use of Development Activities Clause in Contracts

Development Activities. [***] shall have the sole 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 Distributor shall consult with Regulatory Authorities in [***] prior to initiation of the first Phase 3 Clinical Trial for the Product anywhere in the world with respect to the need to include patients from [***] in any Phase 3 Clinical Trial; (b) [***] 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 defined below) (“Additional Required Clinical Trials”), Coherus shall consult in good faith with Distributor on the feasibility 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, in which case [***] shall use Commercially Reasonable Efforts to conduct such Additional Required Clinical Trials and [***] shall promptly pay any invoices submitted by Coherus related to such Additional Required Clinical Trials; (e) if, in connection with the implementation of any [***] and such [***] are not also required outside the Territory, Coherus shall consult in good faith with Distributor on the feasibility of conducting such [***]); (f) Coherus and Distributor shall consult with Regulatory Authorities in [***] prior to initiation of such [***]; (g) if [***], then [***]; and (h) [***] shall retain final decision-making on whether to proceed with any such [***] for the Territory unless [***] agrees to pay for any such [***] for the Territory in which case [***] shall use Commercially Reasonable Efforts to conduct such [***] for the Territory, [***] shall promptly pay any invoices submitted by [***] related to such [***] and, [***]. [***] shall, on [***] reasonable request, provide assistance to [***] in conducting development of the Products in the [***] Certain information in this 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, including without limitation, any Additional Required Clinical Trials or any [***].

Development Activities. [***] (a) Alexion shall have the sole right and 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 Distributor shall consult with Regulatory Authorities in [***] prior to initiation of the first Phase 3 Clinical Trial for the Product anywhere in the world conduct Development activities with respect to the need Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos to include patients from conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a [***] in any Phase 3 Clinical Trial; accordance with Section 4.2(b). (b) [***] Except as otherwise expressly set forth herein, Eidos shall have the sole right, and will use Commercially Reasonable Efforts to include have sole discretion and control over the number Development of patients from [***] required by the applicable Licensed Compound and Licensed Product for the purpose of obtaining and maintaining Regulatory Authorities to be included Approval for the Commercialization of such Licensed Products in any Phase 3 Clinical Trial conducted by or on behalf of Coherus[***]; (c) if additional Clinical Trials are required by any Regulatory Authority the Field in connection with (e.g.the ROW Territory. Notwithstanding the foregoing, Phase 4 Clinical Trials) or following receipt of Regulatory Approval, other than Additional Manufacturing Studies (as defined below) (“Additional Required Clinical Trials”), Coherus shall consult in good faith with Distributor on the feasibility 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, in which case [***] 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 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 [***] basis, as to the status and results of the ATTRibute-CM Clinical Trial and the ATTRibute-PN Clinical Trial. In addition, Eidos shall promptly pay consider in good faith any invoices submitted comments provided by Coherus related Alexion with respect to such Additional Required the ATTRibute-CM Clinical Trials; 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 (ei) ifrequire, in connection with the implementation of any its sole discretion, that Eidos [***] and ], or request such [***] are at any time thereafter with Eidos’ written consent, not also required outside the Territoryto be unreasonably withheld, Coherus shall consult in good faith with Distributor on the feasibility of conducting such 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 [***]); (f) Coherus and Distributor shall consult with Regulatory Authorities in . If Alexion wishes to initiate a [***] prior pursuant to initiation of such [***]; this Section 4.2(b), Alexion shall provide written notice thereof to Eidos. If Alexion is requesting (grather than requiring) if [***], then [***]; and (h) within [***] of Eidos’ receipt of such notice, Eidos shall retain final decision-making on inform Alexion in writing whether to proceed with any such [***] for the Territory unless [***] Eidos agrees to pay for any such [***] for the Territory in which case [***] shall use Commercially Reasonable Efforts to conduct such [***] for the Territory, [***] shall promptly pay any invoices submitted by [***] related to such [***] and, requested [***]. [***] shallAdditionally, on [***] reasonable request, provide assistance if Eidos intends to [***] in conducting development of the Products initiate an additional Clinical Trial in the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange CommissionROW Territory (each such Clinical Trial, an “Additional Trial”), Eidos shall provide prompt written notice thereof to Alexion. Confidential treatment has been requested with respect to the omitted portions. EXECUTION COPY Territory, including without limitation, any Additional Required Clinical Trials or any 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. [***] shall have the sole 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 Distributor shall consult with Regulatory Authorities in [***] prior to initiation Licensee will not Develop or have Developed the Products (including conducting medical or clinical trials of the first Phase 3 Clinical Trial Product or otherwise generating additional clinical data or performing additional analysis of existing clinical data for the Product anywhere Product) without the prior written approval of Allergan and pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct such studies without the prior written approval of Allergan, such approval not to be unreasonably withheld. (b) If mutually agreed upon by the Parties, Licensee shall Develop or co-Develop Products for sale in the world 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 agreed 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, it shall notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the “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 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 date upon which such New Indication shall be deemed included in the 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 National Instrument 51-102] period, or if the 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 New Indication shall not be included in the need Field and Licensee shall have no rights with respect to include patients from [***] in any Phase 3 Clinical Trial; such New Indication. (bd) [***] will Allergan shall use Commercially Reasonable Efforts to: (i) file with applicable Governmental Authorities in Canada and Switzerland all documents necessary for the Product to include be used in a single dose regimen in such countries. (ii) conduct pediatric studies of the number of patients from [***] Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities to be included in any Phase 3 Clinical Trial conducted by or on behalf of Coherus[***]; the Territory (cexcept for the Special Countries). (iii) if additional Clinical Trials are complete all post-Regulatory Approval actions for the Product in the Territory (except for the Special Countries) as 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 defined below) (“Additional Required Clinical Trials”), Coherus shall consult in good faith with Distributor on the feasibility 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, in which case [***] shall use Commercially Reasonable Efforts to conduct such Additional Required Clinical Trials and [***] shall promptly pay any invoices submitted by Coherus related to such Additional Required Clinical Trials; (e) if, in connection with the implementation of any [***] and such [***] are not also required outside the Territory, Coherus shall consult in good faith with Distributor on the feasibility of conducting such [***]); (f) Coherus and Distributor shall consult with applicable Regulatory Authorities in [***] prior to initiation of such [***]; the Territory (g) if [***], then [***]; and (h) [***] shall retain final decision-making on whether to proceed with any such [***] except for the Territory unless [***] agrees to pay for any such [***] for the Territory in which case [***] shall use Commercially Reasonable Efforts to conduct such [***] for the Territory, [***] shall promptly pay any invoices submitted by [***] related to such [***] and, [***]. [***] shall, on [***] reasonable request, provide assistance to [***] in conducting development of the Products in the [***] Certain information in this 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, including without limitation, any Additional Required Clinical Trials or any [***]Special Countries).

Development Activities. [***] shall have the sole 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 Distributor Kyowa Hakko shall consult with be responsible, at its expense, for all Development activities under the Development Plan that are reasonably necessary for the Regulatory Authorities in [***] prior to initiation Approval of the first Phase 3 Clinical Trial for the Licensed Product anywhere in the world Kyowa Hakko Territory. Neither Party may conduct Clinical Studies, Post-Approval Studies or other Development activities with respect to the need Licensed Product in the Field in the Territory of the other Party without the other Party’s prior written consent, which consent will not be unreasonably withheld or delayed. (b) The Parties expect that the 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 its Related Parties in the pre-clinical and clinical Development of the Licensed Product in the Alnylam Territory and [**]. However, the Parties acknowledge that the Regulatory Authorities in Japan may require Kyowa Hakko to include patients submit data from [**] in order to obtain Regulatory Approval of the Licensed Product in Japan. If (x) the Japanese Regulatory Authorities require Kyowa Hakko to conduct [**] in any Phase 3 Clinical Trial; order to obtain Regulatory Approval of the Licensed Product in Japan and (by) Alnylam intends to conduct [***] will use Commercially Reasonable Efforts of the Licensed Product, to include the number of patients from [***] required extent requested 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.Kyowa Hakko, Phase 4 Clinical Trials) or following receipt of Regulatory Approval, other than Additional Manufacturing Studies (as defined below) (“Additional Required Clinical Trials”), Coherus shall consult in good faith with Distributor on the feasibility 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 [***] Alnylam agrees to pay for any such Additional Required Clinical Trials, in which case [***] shall use Commercially Reasonable Efforts to conduct such Additional Required Clinical Trials and [***] shall promptly pay any invoices submitted by Coherus related to such Additional Required Clinical Trials; (e) if, in connection with the implementation of any [***] and such [***] are not also required outside the Territory, Coherus shall consult in good faith with Distributor on the feasibility of conducting such [***]); (f) Coherus and Distributor shall consult with Regulatory Authorities in [***] prior to initiation of such [***]; (g) if [***], then [***]; and (h) [***] shall retain final decision-making on whether to proceed with any such [***] for the Territory unless [***] agrees to pay for any such [***] for the Territory in which case [***] shall use its Commercially Reasonable Efforts to conduct such [**], 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 [**] must meet the requirements for Regulatory Approval of the Territory, Licensed Product [**] and (ii) [**] shall promptly pay any invoices submitted by [***] related have final decision-making authority with respect to all aspects of such [***] and], including whether to include any changes to the [***]. ] to accommodate the requirements of Japanese Regulatory Authorities; and provided, further, however, that in the event that Alnylam includes [***] shall, on Japanese sites in such [**], Alnylam will use its Commercially Reasonable Efforts consistent with the [**] reasonable request, provide assistance to designate Kyowa Hakko as Alnylam’s designee for the conduct of such [***] in conducting development Japan and all interactions and correspondence with Japanese Regulatory Authorities as the holder of the Products IND in the Japan. For purposes of clarity, (x) Alnylam will be responsible for all costs associated with such [**], including those costs related to the conduct of such [**] Certain information in this document has been omitted 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 conduct of such [**] and filed separately all interactions and correspondence with Japanese Regulatory Authorities as the Securities holder of the IND in Japan, and Exchange Commission. Confidential treatment has been requested (y) Kyowa Hakko shall be responsible for all other costs associated with respect to the omitted portions. EXECUTION COPY Territory[**] conducted by Kyowa Hakko, including without limitation, any Additional Required Clinical Trials or any [***].

Development Activities. (a) Licensee will not Develop or have Developed the 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 pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct such studies without the prior written approval of Allergan, such approval not to be unreasonably withheld. (b) 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 agreed 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, it shall notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the "New Indication Notice"). If Licensee is interested in such New Indication included within the Field, it shall notify Allergan within [...***...] shall have from the sole responsibility for conducting development date of the ProductsNew Indication Notice, including, without limitation, Clinical Trials related whereupon the parties shall discuss and seek to the Products, whether agree within or outside the Territory. In addition, (a) Coherus and Distributor shall consult with Regulatory Authorities in [...***...] prior to initiation from the date of the first Phase 3 Clinical Trial for New Indication Notice on (i) the Product anywhere portion of the Development costs associated with the Development of such New Indication payable by Licensee and (ii) the date upon which such New Indication shall be deemed included in the world Field. If Licensee does not make the election set forth in the preceding sentence within such [...***...] period, or if the Parties do not reach agreement on Development cost sharing with respect to the need to include patients from such New Indication within such […***…] period, then such New Indication shall not be included in any Phase 3 Clinical Trial; the Field and Licensee shall have no rights with respect to such New Indication. (bd) [***] will Allergan shall use Commercially Reasonable Efforts to: 11 (i) file with applicable Governmental Authorities in Canada and Switzerland all documents necessary for the Product to include be used in a single dose regimen in such countries. (ii) conduct pediatric studies of the number of patients from [***] Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities to be included in any Phase 3 Clinical Trial conducted by or on behalf of Coherus[***]; the Territory (cexcept for the Special Countries). (iii) if additional Clinical Trials are complete all post-Regulatory Approval actions for the Product in the Territory (except for the Special Countries) as 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 defined below) (“Additional Required Clinical Trials”), Coherus shall consult in good faith with Distributor on the feasibility 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, in which case [***] shall use Commercially Reasonable Efforts to conduct such Additional Required Clinical Trials and [***] shall promptly pay any invoices submitted by Coherus related to such Additional Required Clinical Trials; (e) if, in connection with the implementation of any [***] and such [***] are not also required outside the Territory, Coherus shall consult in good faith with Distributor on the feasibility of conducting such [***]); (f) Coherus and Distributor shall consult with applicable Regulatory Authorities in [***] prior to initiation of such [***]; the Territory (g) if [***], then [***]; and (h) [***] shall retain final decision-making on whether to proceed with any such [***] except for the Territory unless [***] agrees to pay for any such [***] for the Territory in which case [***] shall use Commercially Reasonable Efforts to conduct such [***] for the Territory, [***] shall promptly pay any invoices submitted by [***] related to such [***] and, [***]. [***] shall, on [***] reasonable request, provide assistance to [***] in conducting development of the Products in the [***] Certain information in this 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, including without limitation, any Additional Required Clinical Trials or any [***]Special Countries).

Development Activities. (a) Licensee will not Develop or have Developed the 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 pursuant to a mutually agreed upon clinical development program. In the case of studies required for Pricing Approval, Licensee may not conduct such studies without the prior written approval of Allergan, such approval not to be unreasonably withheld. (b) 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 agreed 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, it shall notify Licensee in writing and provide such development plan and budget for such New Indication to Licensee (the "New Indication Notice"). If Licensee is interested in such New Indication included within the Field, it shall notify Allergan within [...***...] shall have from the sole responsibility for conducting development date of the ProductsNew Indication Notice, including, without limitation, Clinical Trials related whereupon the parties shall discuss and seek to the Products, whether agree within or outside the Territory. In addition, (a) Coherus and Distributor shall consult with Regulatory Authorities in [...***...] prior to initiation from the date of the first Phase 3 Clinical Trial for New Indication Notice on (i) the Product anywhere portion of the Development costs associated with the Development of such New Indication payable by Licensee and (ii) the date upon which such New Indication shall be deemed included in the world Field. If Licensee does not make the election set forth in the preceding sentence within such [...***...] period, or if the Parties do not reach agreement on Development cost sharing with respect to the need to include patients from such New Indication within such […***…] period, then such New Indication shall not be included in any Phase 3 Clinical Trial; the Field and Licensee shall have no rights with respect to such New Indication. (bd) [***] will Allergan shall use Commercially Reasonable Efforts to: (i) file with applicable Governmental Authorities in Canada and Switzerland all documents necessary for the Product to include be used in a single dose regimen in such countries. (ii) conduct pediatric studies of the number of patients from [***] Product for the Territory (except for the Special Countries) as required by the applicable Regulatory Authorities to be included in any Phase 3 Clinical Trial conducted by or on behalf of Coherus[***]; the Territory (cexcept for the Special Countries). (iii) if additional Clinical Trials are complete all post-Regulatory Approval actions for the Product in the Territory (except for the Special Countries) as 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 defined below) (“Additional Required Clinical Trials”), Coherus shall consult in good faith with Distributor on the feasibility 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, in which case [***] shall use Commercially Reasonable Efforts to conduct such Additional Required Clinical Trials and [***] shall promptly pay any invoices submitted by Coherus related to such Additional Required Clinical Trials; (e) if, in connection with the implementation of any [***] and such [***] are not also required outside the Territory, Coherus shall consult in good faith with Distributor on the feasibility of conducting such [***]); (f) Coherus and Distributor shall consult with applicable Regulatory Authorities in [***] prior to initiation of such [***]; the Territory (g) if [***], then [***]; and (h) [***] shall retain final decision-making on whether to proceed with any such [***] except for the Territory unless [***] agrees to pay for any such [***] for the Territory in which case [***] shall use Commercially Reasonable Efforts to conduct such [***] for the Territory, [***] shall promptly pay any invoices submitted by [***] related to such [***] and, [***]. [***] shall, on [***] reasonable request, provide assistance to [***] in conducting development of the Products in the [***] Certain information in this 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, including without limitation, any Additional Required Clinical Trials or any [***]Special Countries).