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 [***].
Appears in 2 contracts
Sources: Distribution Agreement (Coherus BioSciences, Inc.), Distribution Agreement (Coherus BioSciences, Inc.)
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.
Appears in 2 contracts
Sources: License Agreement (BridgeBio Pharma, Inc.), License Agreement (Eidos Therapeutics, Inc.)
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 [***].
Appears in 1 contract
Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Development Activities. [***] shall have the 5.1.1 Cidara shall, at its sole responsibility for conducting development of the Productsexpense except as expressly set forth below, 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 conduct the number of patients from [***] required by activities, including 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”including the ReSPECT Trial), Coherus shall consult set forth 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 TrialsDevelopment Plan in the Territory. Without limiting the foregoing, in which case [***] Cidara shall use Commercially Reasonable Efforts to conduct such Additional Required Clinical Trials and [***] shall promptly pay any invoices submitted complete all Development activities that are required by Coherus related to such Additional Required Clinical Trials; (e) if, FDA for Marketing Approval for the Current Product for the Lead Indications in connection with the implementation of any [***] and such [***] are not also required outside the Territory, Coherus shall consult including reasonably responding to and remediating any items raised in good faith with Distributor on a Complete Response Letter from the feasibility of conducting such [***])FDA; subject to the following:
(f) Coherus and Distributor shall consult with Regulatory Authorities in [***] prior to initiation of such [***]; (g) if [***], then [***]; and (ha) [**]
(b) If the Current Product does not receive Marketing Approval in the Additional Indication in the Territory or [*] In no event shall retain final decision-making on whether Cidara be obligated to proceed with any such perform [***] ].
5.1.2 If the FDA requires the conduct, prior to the Transfer Date, of any post-marketing requirement (“PMR”) or post-marketing commitment (“PMC”), including but not limited to, a surveillance study of the Current Product in the Target Indication as a condition to obtaining or maintaining Marketing Approval for the Territory unless [***] agrees Current Product in the Target Indication in the Territory, then (i) the parties shall discuss in good faith, and the JSC shall approve, an amendment to pay for any the Development Plan to add such [***] for the Territory in which case [***] PMR or PMC if such PMR or PMC qualifies as a Clinical Study, and (ii) Cidara shall use Commercially Reasonable Efforts to conduct perform such PMR or PMC at Cidara’s sole expense. For clarity, Cidara shall not be responsible for performing any Clinical Study of the Current Product in pediatric patients unless such Clinical Study is required by the FDA to obtain or maintain Marketing Approval of the Current Product in the Target Indication in the Territory.
5.1.3 Until such time as Cidara has completed all activities allocated to it in the Development Plan, Cidara shall provide Melinta with [**] reports [*] for that include [*]. Cidara shall also provide Melinta reports of [*].
5.1.4 Melinta shall have the right to periodically review through the JSC and provide reasonable input on Development activities in connection with or related to the Clinical Studies set forth in the Development Plan, which Cidara shall consider in good faith. Cidara shall promptly notify Melinta of any changes to the protocol or other Development activities in connection with the ReSPECT Trial in the Territory, [***] which shall promptly pay any invoices submitted by [***] related be discussed between the parties acting reasonably and in good faith through the JSC.
5.1.5 Subject to such [***] andSections 3.4.2, [***]. [***] shall3.5.3, on [***] reasonable request5.1.6, provide assistance 5.1.8, 5.3.1, 5.3.2, 5.3.6, 5.3.7, Melinta shall have the right, but not the obligation, 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 conduct Development activities with respect to Compound and Product in the omitted portions. EXECUTION COPY Territory, including without limitationand to initiate, sponsor, or conduct (a) GLP Studies of Compound and (b) Clinical Studies of the Product, in each case (clauses (a) and (b)), in the Territory and at ▇▇▇▇▇▇▇’s sole cost and expense (each, a “Melinta Independent Study”); provided that: (i) the protocol for each such Melinta Independent Study shall be subject to the approval by the Global JSC in accordance with Article 3 of the Mundipharma Agreement; (ii) Cidara shall have the right to disclose all final protocols and final reports of such Melinta Independent Study, and all Data with respect to Compound or Product disclosed by Melinta to Cidara pursuant to Section 3.4.2, to Mundipharma pursuant to the Mundipharma Agreement or a Third Party licensee of Cidara pursuant to any Additional Required Clinical Trials Qualified Cidara Out-License; provided, however, that neither Cidara, nor Mundipharma, nor any Third Party licensee of Cidara under a Qualified Cidara Out-License shall have any license or right to use any Melinta Expanded Product Independent Efficacy Data generated by or on behalf of Melinta or its Affiliates in support of any Product Filing or in the Commercialization of Product outside of the Territory, except, on a Melinta Expanded Product Independent Study-by-Melinta Expanded Product Independent Study basis as expressly set forth in Section 5.1.6; (iii) Melinta shall keep Cidara reasonably informed of the plans for, and the status, progress and results of, all Development and regulatory activities related to Compound, Product or any Melinta Independent Study, and Cidara shall have the right to disclose such information to Mundipharma pursuant to the Mundipharma Agreement or a Third Party licensee of Cidara pursuant to any Qualified Cidara Out-License, (iv) Melinta shall provide Cidara true and complete copies of all Product Filings pursuant to Section 5.3.3, and Cidara shall have the right to disclose such Product Filings to Mundipharma pursuant to the Mundipharma Agreement or a Third Party licensee of Cidara pursuant to any Qualified Cidara Out-License; (v) Melinta shall timely provide to Cidara all information, data and documentation required under Section 4.4 or 4.5 of the Mundipharma Agreement and Cidara shall have the right to disclose such information, data and documentation for Mundipharma to exercise any of its options thereunder, and (vi) Melinta shall provide to Cidara such additional information, documentation and records within Melinta’s Control that are reasonably necessary for Cidara to comply with its obligations under the Redacted Mundipharma Agreement. For clarity, Melinta Independent Study shall not include any studies that fall within Medical Affairs Activities.
5.1.6 At least [*] prior to the initiation of any Melinta Expanded Product Independent Study, Melinta shall offer to Cidara (which offer Cidara may extend to any Cidara Ex-Territory Licensee) the right to bear a share of the costs of such Melinta Expanded Product Independent Study based on the relative market sizes for Product in the respective territories of Cidara or such Cidara Ex-Territory Licensee and Melinta (to be mutually agreed in good faith) in exchange for the right to use the Melinta Expanded Product Independent Efficacy Data from such Melinta Expanded Product Independent Study in support of Product Filings outside of the Territory or in the Commercialization of Product outside of the Territory; provided, however, that Cidara shall have no obligation to contribute to the costs of any Melinta Expanded Product Independent Study. If, prior to initiation of any Melinta Expanded Product Independent Study, Melinta, on the one hand, and Cidara, Mundipharma and/or another Cidara Ex Territory Licensee, on the other hand, enter into any agreement to share the costs of such Melinta Expanded Product Independent Study, then the Melinta Expanded Product Independent Efficacy Data for such Melinta Expanded Product Independent Study shall be included in the Melinta Grantback Know-How and Cidara shall have the right, and the right to grant to Cidara Ex-Territory Licensees the right, to use such Melinta Expanded Product Independent Efficacy Data in support of any Product Filing outside of the Territory or in the Commercialization of Product outside of the Territory. If no such agreement is entered into with respect to a Melinta Expanded Product Independent Study, and any efficacy endpoint of such Melinta Expanded Product Independent Study is achieved, then, within [**].] after the first availability of top-line results from such Melinta Expanded Product Independent Study, Melinta shall deliver such
Appears in 1 contract
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).
Appears in 1 contract
Sources: License Agreement
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).
Appears in 1 contract
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).
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