Regulatory Responsibilities. (a) The Development Plan shall set forth the regulatory strategy for seeking Marketing Approval for the Compounds and Collaboration Products by the FDA, EMA and other Regulatory Authorities in [*] as agreed upon by the Parties. [*] Development under the Development Plan (including the [*] Development), [*] necessary to obtain and maintain Regulatory Approval of the Compounds and Collaboration Products in the Collaboration Indications (for [*] Activators) or the Field (for [*] Activators) throughout the world, which activities shall be conducted using Diligent Efforts and in accordance with the regulatory strategy set forth in the Development Plan. For the Development Plan, the regulatory strategy will be set by Astellas except where [*]; in such case [*]. For the Development Plan, Cytokinetics will set the regulatory strategy for [*] and other activities [*] except when [*] in the Shared Territory [*] [*]) for [*] Indications [*] in the Shared Territory, and Astellas will set the regulatory strategy for [*] Indications for the Astellas Territory. Except where [*] regulatory activities related to [*]. (b) Cytokinetics shall hold the Lead Compound IND during the conduct of the Early Stage Work. Prior to the [*], Cytokinetics shall transfer the Lead Compound IND [*] to Astellas, unless the JDC [*] as set forth in Section 6.3(b)(iii), in which case Cytokinetics shall continue to hold the Lead Compound IND and Regulatory Materials related to such Development work. (c) [*] Regulatory Materials for [*] Activators for [*] Indication to support the Development of such Compound in such Indications in the Shared Territory. If [*] Activator for [*] Indication or [*] Indication [*] Indication. [*] regulatory strategy in the Development Plan for [*] (but excluding [*] in the Shared Territory [*]) for such [*] Indications [*] in the Shared Territory. If [*] Indication, [*] regulatory activities related to [*] Activators for such Indication. If [*] the right to [*] a Collaboration Product in the Shared Territory [*] as set forth in Section [*] shall have the right to [*] pertaining to such Collaboration Product in the Shared Territory [*]. (d) In addition, [*] shall be responsible for [*] regulatory activities related to [*] Development (including [*] applicable Regulatory Authorities) until the JDC [*] the Development of [*] Indication under Section [*]. (e) [*] in connection with [*] under Sections 7.1(b), (c), and (d) will be [*] Indication [*] Indication [*], as applicable. (f) Astellas hereby grants Cytokinetics and its Affiliates and (sub)licensees the right to reference any IND and other Regulatory Materials Controlled by or on behalf of Astellas or its Affiliates for use in the Development by Cytokinetics in accordance with this Agreement, and Cytokinetics hereby grants Astellas, its Affiliates and sublicensees the right to reference any IND for Compounds and/or Collaboration Products and other Regulatory Materials Controlled by or on behalf of Cytokinetics or its Affiliates for use in the Development by Astellas, its Affiliates and sublicensees in accordance with this Agreement. Each Party hereby grants the other Party the right to use any data resulting from such Party’s activities under this Agreement to perform its obligations or to exercise its rights under this Agreement. Each Party may file its own IND(s) and other Regulatory Materials for each [*] Activator to support its Development work under this Agreement, which may cross reference the other Party’s IND(s) and other Regulatory Materials for such [*] Activator. (g) Except as set forth in Sections 7.1(b), (c) and (d) above and otherwise agreed in writing by the Parties, [*] shall be responsible, [*] for the Collaboration Products [*]. Without limiting the foregoing: (i) Astellas shall file its own IND for the Development of the Lead Compound for the activities allocated to it under the Development Plan and Astellas shall have the right to cross reference the Lead Compound IND if necessary. (ii) Astellas shall hold IND(s) and other Regulatory Materials for [*] Activators for each [*] Indication to support the Development of such Compound in such Indication in the Astellas Territory, and Astellas shall [*] for such Indication in the Astellas Territory. (iii) [*] shall be responsible for regulatory activities related to [*] Activators for each [*] Indication, unless [*] for such Indication.
Appears in 1 contract
Samples: License and Collaboration Agreement (Cytokinetics Inc)
Regulatory Responsibilities. (a) The Development Plan shall set forth the regulatory strategy for seeking Marketing Approval Except for the Compounds Joint IND, which shall be jointly owned, Ascletis shall own all Regulatory Approvals for Product in the Field in the Territory. Ascletis shall have sole responsibility for:
(i) obtaining and Collaboration maintaining Regulatory Approvals for Products by in the FDAField in the Territory, EMA and other Regulatory Authorities in [*] as agreed upon by the Parties. [*] Development under the Development Plan (including the [*] Development), [*] necessary shall use Diligent Efforts to obtain and maintain Regulatory Approval of the Compounds and Collaboration Products Product and, upon obtaining Regulatory Approvals for the Product in the Collaboration Indications Field in the Territory, maintain such Regulatory Approvals; and
(ii) other communications with applicable Regulatory Authorities in the Territory relating to the Development and Commercialization of Compound and Product, including (i) all correspondence submitted to Regulatory Authorities in the Territory related to the design, conduct or results of non-clinical studies and clinical trials; (ii) all pricing and reimbursement approval proceedings in the Territory; and (iii) all proposed product labeling for [*] Activators) or the Product in the Field (for [*] Activators) throughout the world, which activities shall be conducted using Diligent Efforts and in accordance with the regulatory strategy set forth in the Development Plan. For the Development Plan, the regulatory strategy will be set by Astellas except where [*]; in such case [*]. For the Development Plan, Cytokinetics will set the regulatory strategy for [*] and other activities [*] except when [*] in the Shared Territory [*] [*]) for [*] Indications [*] in the Shared Territory, and Astellas will set the regulatory strategy for [*] Indications for the Astellas Territory. Except where [*] regulatory activities related to [*].
(b) Cytokinetics Ascletis shall hold provide 3-V with synopsis of all regulatory submissions and reasonable time prior to submission for review and comment if possible, and shall consider in good faith any comments received from 3-V. In addition, Ascletis shall notify 3-V of any regulatory material submitted to or received from any Regulatory Authority in the Lead Compound IND during the conduct of the Early Stage Work. Prior to the Territory and shall provide 3-V with copies thereof ([***], Cytokinetics shall transfer the Lead Compound IND ) within [*] to Astellas, unless the JDC [**] as set forth in Section 6.3(b)(iii), in which case Cytokinetics shall continue to hold the Lead Compound IND and Regulatory Materials related to such Development workdays after submission or receipt.
(c) [*] Ascletis shall provide 3-V with reasonable advance notice of any meeting or discussion with any Regulatory Materials for [*] Activators for [*] Indication to support the Development of such Compound in such Indications Authority in the Shared Territory related to Phase 2 Global Multi-Center Trial or any Phase 2 Clinical Trials or Phase 3 Clinical Trials conducted by Axxxxxxx in the Territory. If [*] Activator for [*] Indication Ascletis shall lead such meeting or [*] Indication [*] Indication. [*] regulatory strategy in the Development Plan for [*] (but excluding [*] in the Shared Territory [*]) for such [*] Indications [*] in the Shared Territory. If [*] Indicationdiscussion, [*] regulatory activities related to [*] Activators for such Indication. If [*] the right to [*] a Collaboration Product in the Shared Territory [*] as set forth in Section [*] provided however that 3-V or its designee shall have the right right, but not the obligation, to attend and participate in such meeting or discussion. If 3-V elects not to attend such meeting or discussion, Axxxxxxx shall promptly provide 3-V with a written [***] pertaining to summary of such Collaboration Product meeting or discussion. Regarding subsequent clinical trials (other Phase 2 Clinical Trials or Phase 3 Clinical Trials conducted by Ascletis) in the Shared Territory [*]Territory, Ascletis shall provide 3-V with regular updates and summaries of such meetings.
(d) In addition, [*] shall be responsible for [*] regulatory activities related to [*] Development (including [*] applicable Regulatory Authorities) until the JDC [*] the Development of [*] Indication under Section [*].
(e) [*] in connection with [*] under Sections 7.1(b), (c), and (d) will be [*] Indication [*] Indication [*], as applicable.
(f) Astellas Each Party hereby grants Cytokinetics and its Affiliates and (sub)licensees to the other Party the right of reference to reference any IND and other Regulatory Materials Controlled all regulatory submissions pertaining to the Product submitted by or on behalf of Astellas or its Affiliates such Party. Ascletis may use such right of reference to 3-V’s regulatory submissions solely for use the purpose of seeking, obtaining and maintaining Regulatory Approval of the Product in Field in the Development by Cytokinetics in accordance with this Agreement, and Cytokinetics hereby grants Astellas, its Affiliates and sublicensees Territory. 3-V may use the right of reference to reference any IND Ascletis’ regulatory submissions solely for Compounds and/or Collaboration Products the purpose of seeking, obtaining and other maintaining Regulatory Materials Controlled Approval of the Product outside the Territory. For global clinical trials conducted by or on behalf of Cytokinetics or its Affiliates 3-V for use the Product in the Development by AstellasTerritory, its Affiliates and sublicensees in accordance with this Agreement. Each Party hereby grants the other Party the right to use any data resulting from such Party’s activities under this Agreement to perform its obligations or to exercise its rights under this Agreement. Each Party may file its own IND(s) and other Regulatory Materials for each [*] Activator to support its Development work under this Agreement, which may cross reference the other Party’s IND(s) and other Regulatory Materials for such [*] Activator.
(g) Except as set forth in Sections 7.1(b), (c) and (d) above and otherwise agreed in writing by the Parties, [*] 3-V shall be responsible, [*] entitled to conduct clinical audits (including on-site audits) as would be customary for the Collaboration Products [*]. Without limiting the foregoing:
(i) Astellas shall file its own IND for the Development of the Lead Compound for the activities allocated to it under the Development Plan global clinical trials and Astellas shall have the right to cross reference the Lead Compound IND if necessary.
(ii) Astellas shall hold IND(s) and other Regulatory Materials for [*] Activators for each [*] Indication to support the Development consistent with monitoring by sponsor of such Compound in such Indication in the Astellas Territory, and Astellas shall [*] for such Indication in the Astellas Territorytrials.
(iii) [*] shall be responsible for regulatory activities related to [*] Activators for each [*] Indication, unless [*] for such Indication.
Appears in 1 contract
Samples: Exclusive License and Development Agreement (Sagimet Biosciences Inc.)
Regulatory Responsibilities. (i) Eisai shall be responsible for submitting all Regulatory Approval applications and related filings relating to the Eisai Collaboration Molecules and Eisai 132539616_1 Collaboration Products in the Commercial Territory. Company shall have the right to have up to two (2) senior, experienced employees reasonably acceptable to Eisai, participate (to the extent practicable) as observers in (a) The Development Plan shall set forth the regulatory strategy for seeking Marketing Approval for the Compounds material or scheduled face-to-face meetings, video conferences and Collaboration Products by any teleconferences, with the FDA, EMA and other applicable Regulatory Authorities in [*] the Commercial Territory, and (b) any preparatory meetings for such meetings with Regulatory Authorities. Eisai shall provide Company copies of (1) Eisai’s material documentation prepared for such meetings and (2) material submissions to the FDA, EMA and other applicable Regulatory Authorities in the Territory relating to Development of, or the process of obtaining Regulatory Approval for, the applicable Eisai Collaboration Products, in each case (to the extent practicable) sufficiently in advance of the applicable meeting or submission, as applicable, to allow Company a reasonable opportunity to review and provide comment on such materials, and Eisai shall consider in good faith Company’s comments with respect thereto. Eisai shall provide Company with copies of any material correspondence from the FDA, EMA and other applicable Regulatory Authorities in the Territory relating to Development of, or the process of obtaining Regulatory Approval for, the applicable Eisai Collaboration Products, and respond within a reasonable time frame to all reasonable inquiries by Company with respect thereto.
(ii) Eisai may delegate to Company its responsibility for interfacing, corresponding and meeting with Regulatory Authorities with respect to an Eisai Collaboration Product in one or more countries in the Commercial Territory, as may be mutually agreed upon by the Parties. [*] Development under the Development Plan (including the [*] Development), [*] necessary to obtain and maintain Regulatory Approval of the Compounds and Collaboration Products in the Collaboration Indications (for [*] Activators) or the Field (for [*] Activators) throughout the world, which activities shall be conducted using Diligent Efforts and in accordance with the regulatory strategy set forth in the Development Plan. For the Development Plan, the regulatory strategy will be set by Astellas except where [*]; in such case [*]. For the Development Plan, Cytokinetics will set the regulatory strategy for [*] and other activities [*] except when [*] in the Shared Territory [*] [*]) for [*] Indications [*] in the Shared Territory, and Astellas will set the regulatory strategy for [*] Indications for the Astellas Territory. Except where [*] regulatory activities related to [*].
(b) Cytokinetics shall hold the Lead Compound IND during the conduct of the Early Stage Work. Prior to the [*], Cytokinetics shall transfer the Lead Compound IND [*] to Astellas, unless the JDC [*] as set forth in Section 6.3(b)(iii), in which case Cytokinetics shall continue to hold the Lead Compound IND and Regulatory Materials related to such Development work.
(c) [*] Regulatory Materials for [*] Activators for [*] Indication to support the Development of such Compound in such Indications in the Shared Territory. If [*] Activator for [*] Indication or [*] Indication [*] Indication. [*] regulatory strategy in the Development Plan for [*] (but excluding [*] in the Shared Territory [*]) for such [*] Indications [*] in the Shared Territory. If [*] Indication, [*] regulatory activities related to [*] Activators for such Indication. If [*] the right to [*] a Collaboration Product in the Shared Territory [*] as set forth in Section [*] shall have the right to [*] pertaining to such Collaboration Product in the Shared Territory [*].
(d) In addition, [*] shall be responsible for [*] regulatory activities related to [*] Development (including [*] applicable Regulatory Authorities) until the JDC [*] the Development of [*] Indication under Section [*].
(e) [*] in connection with [*] under Sections 7.1(b), (c), and (d) will be [*] Indication [*] Indication [*], as applicable.
(f) Astellas hereby grants Cytokinetics and its Affiliates and (sub)licensees the right to reference any IND and other Regulatory Materials Controlled by or on behalf of Astellas or its Affiliates for use in the Development by Cytokinetics in accordance with this Agreement, and Cytokinetics hereby grants Astellas, its Affiliates and sublicensees the right to reference any IND for Compounds and/or Collaboration Products and other Regulatory Materials Controlled by or on behalf of Cytokinetics or its Affiliates for use in the Development by Astellas, its Affiliates and sublicensees in accordance with this Agreement. Each Party hereby grants the other Party the right to use any data resulting from such Party’s activities under this Agreement to perform its obligations or to exercise its rights under this Agreement. Each Party may file its own IND(s) and other Regulatory Materials for each [*] Activator to support its Development work under this Agreement, which may cross reference the other Party’s IND(s) and other Regulatory Materials for such [*] Activator.
(g) Except as set forth in Sections 7.1(b), (c) and (d) above and otherwise agreed in writing by the Parties, [*] shall be responsible, [*] for the Collaboration Products [*]. Without limiting the foregoing:
(i) Astellas shall file its own IND for the Development of the Lead Compound for the activities allocated to it under the Development Plan and Astellas shall have the right to cross reference the Lead Compound IND if necessary.
(ii) Astellas shall hold IND(s) and other Regulatory Materials for [*] Activators for each [*] Indication to support the Development of such Compound in such Indication in the Astellas Territory, and Astellas shall [*] for such Indication in the Astellas Territory.
(iii) [*] shall be responsible for regulatory activities related to [*] Activators for each [*] Indication, unless [*] for such Indication.
Appears in 1 contract
Regulatory Responsibilities. (a) The Development Plan shall set forth the regulatory strategy for seeking Marketing Approval for the Compounds and Collaboration Products by the FDA, EMA and other Regulatory Authorities in [*] as agreed upon by the Parties. [*] Development under the Development Plan (including the [*] Development), [*] necessary to obtain and maintain Regulatory Approval of the Compounds and Collaboration Products in the Collaboration Indications (for [*] Activators) or the Field (for [*] Activators) throughout the world, which activities shall be conducted using Diligent Efforts and in accordance with the regulatory strategy set forth in the Development Plan. For the Development Plan, the regulatory strategy will be set by Astellas except where [*]; in such case [*]. For the Development Plan, Cytokinetics will set the regulatory strategy for [*] and other activities [*] except when [*] in the Shared Territory [*] [*]) for [*] Indications [*] in the Shared Territory, and Astellas will set the regulatory strategy for [*] Indications for the Astellas Territory. Except where [*] regulatory activities related to [*].-A.
(bi) Cytokinetics shall hold the Lead Compound IND during the conduct of the Early Stage Work. Prior to the [*], Cytokinetics shall transfer the Lead Compound IND [*] to Astellas, unless the JDC [*] as set forth in Section 6.3(b)(iii), in which case Cytokinetics shall continue to hold the Lead Compound IND and Regulatory Materials related to such Development work.
(c) [*] Regulatory Materials for [*] Activators for [*] Indication to support the Development of such Compound in such Indications in the Shared Territory. If [*] Activator for [*] Indication or [*] Indication [*] Indication. [*] regulatory strategy in the Development Plan for [*] (but excluding [*] in the Shared Territory [*]) for such [*] Indications [*] in the Shared Territory. If [*] Indication, [*] regulatory activities related to [*] Activators for such Indication. If [*] the right to [*] a Collaboration Product in the Shared Territory [*] as set forth in Section [*] shall have the right to [*] pertaining to such Collaboration Product in the Shared Territory [*].
(d) In addition, [*] Otsuka shall be responsible for [*] regulatory activities all Regulatory Activities related to [*] Development Products in Territory-A, subject to the remainder of this sub-clause (including [*] applicable Regulatory Authoritiesa) until the JDC [*] the Development of [*] Indication under and Section [*].
(e) [*] in connection with [*] under Sections 7.1(b4.1(a), (c), Section 5.2 and (d) will be [*] Indication [*] Indication [*], as applicable.
(f) Astellas hereby grants Cytokinetics and its Affiliates and (sub)licensees the right to reference any IND and other Regulatory Materials Controlled by or on behalf of Astellas or its Affiliates for use in the Development by Cytokinetics in accordance with this Agreement, and Cytokinetics hereby grants Astellas, its Affiliates and sublicensees the right to reference any IND for Compounds and/or Collaboration Products and other Regulatory Materials Controlled by or on behalf of Cytokinetics or its Affiliates for use in the Development by Astellas, its Affiliates and sublicensees in accordance with this Agreement. Each Party hereby grants the other Party the right to use any data resulting from such Party’s activities under this Agreement to perform its obligations or to exercise its rights under this Agreement. Each Party may file its own IND(s) and other Regulatory Materials for each [*] Activator to support its Development work under this Agreement, which may cross reference the other Party’s IND(s) and other Regulatory Materials for such [*] Activator.
(g) Except as set forth in Sections 7.1(b), (c) and (d) above and otherwise agreed in writing by the Parties, [*] shall be responsible, [*] for the Collaboration Products [*]. Without limiting the foregoing:
(i) Astellas shall file its own IND for the Development of the Lead Compound for the activities allocated to it under the Development Plan and Astellas shall have the right to cross reference the Lead Compound IND if necessarySection 5.3.
(ii) Astellas Aurinia shall hold IND(sbe responsible for preparing the filing dossiers for the MAA(s) and other Regulatory Materials for [*] Activators the Product for each [*] Indication to support the Development of such Compound in such Initial Indication in Territory-A, based on the Astellas TerritoryUS existing version of the NDA for the Product prepared by Aurinia, and Astellas shall [*] in close consultation with Otsuka; provided that, if the Parties fail to agree on a plan for such filing for the regulatory dossiers, Otsuka may assume responsibility for same. Subject to Section 3.4, Otsuka will have final decision-making authority over all Regulatory Activities for the Product for the Initial Indication in Territory-A, including the Astellas Territorycontent and strategy with respect to such filing dossiers.
(iii) Otsuka will file the MAA for the Product for the Initial Indication (and any material amendment or update thereto) in Territory-A in the name of Otsuka or its Affiliate, and Otsuka or its Affiliate will be the holder and official applicant thereof.
(iv) Prior to receipt of the first Regulatory Approval from EMA for the Product for the Initial Indication in Territory-A, the Parties shall collaborate and work closely together, through the Europe JCC (or any regulatory subcommittee to which the Europe JCC may delegate such authority), to communicate with and coordinate responses to questions, comments and other correspondence from the EMA and any other Regulatory Authority regarding the MAA for the Product for the Initial Indication in Territory-A, and the Parties shall participate jointly (unless the Parties agree that Otsuka or its Affiliate will solely participate) in meetings with the EMA and any other Regulatory Authorities in Territory-A regarding such MAA.
(v) Following receipt of the first Regulatory Approval from EMA for the Product for the Initial Indication in Territory-A, Otsuka will be responsible, directly or through its Affiliates or Sublicensees, for maintaining the MAA and for preparing, filing and maintaining all other Regulatory Filings for Products in Territory-A.
(vi) The Parties will pursue Regulatory Approval for the Initial Indication in Territory-A using the EMA’s centralized authorization procedure. If the milestone event for the first Regulatory Approval by EMA of the first Product for the Initial Indication set out in Section 8.2(a) (milestone event (1)) is not considered achieved because the First Approved SmPC contains one or more Limitations, then, until the date that is [*time period redacted] shall be responsible after the first Regulatory Approval by EMA of the first Product for regulatory activities related to [*] Activators for each [*] the Initial Indication, unless [*] Otsuka will use Commercially Reasonable Efforts (taking into consideration that regulatory exclusivity will begin to run from the first approval) to perform Regulatory Activities (which, for such Indicationpurposes of this Section 5.1(a)(vi), includes engagement of KOLs) to achieve the Removal Condition. For clarity, Otsuka shall not be obliged pursuant to this Section 5.1(a)(vi) to conduct any Non-Clinical Studies or Clinical Trials.
Appears in 1 contract
Samples: Collaboration and License Agreement (Aurinia Pharmaceuticals Inc.)
Regulatory Responsibilities. (ai) Generally. The Development Plan shall set forth the Parties’ joint regulatory strategy for seeking Marketing Approval for the Compounds and Collaboration Products by the FDA, EMA and other Regulatory Authorities in [*] as agreed upon by the Parties. [*] Development under with respect to the Development of the Memantine-Donepezil FDC Products for Commercialization in the Field in the Territory is as specified in the Regulatory Plan (including and further detailed in the [*] DevelopmentDevelopment Plan. Notwithstanding anything to the contrary in this Section 4.2(e), [*] necessary all substantive submissions and communications made to obtain and maintain Regulatory Approval Authorities in the Territory (including the FDA) with respect to any Memantine-Donepezil FDC Product shall be subject to the prior approval of the Compounds JDC in writing and Collaboration Products in shall be provided to the Collaboration Indications (for JDC at least [*] Activators(or less time as may be required by Regulatory Authorities in the Territory) prior to the intended date of submission or the Field communication.
(for ii) Interaction with Regulatory Authorities. Forest shall be responsible for[*] Activators) throughout (subject to the world, which activities shall be conducted using Diligent Efforts and in accordance with oversight of the regulatory strategy set forth in the Development Plan. For the Development Plan, the regulatory strategy will be set by Astellas except where JDC [*]; ), interactions with Regulatory Authorities in such case [*]. For the Territory (including the FDA) with respect to the Development Plan, Cytokinetics will set of the regulatory strategy Memantine-Donepezil FDC Products for [*] and other activities [*] except when [*] Commercialization in the Shared Territory [*] [*]) for [*] Indications [*] in the Shared TerritoryField. Notwithstanding the foregoing, and Astellas will set the regulatory strategy for [*] Indications for the Astellas Territory. Except where [*] regulatory activities related to [*].
(b) Cytokinetics shall hold the Lead Compound IND during the conduct of the Early Stage Work. Prior to the [*], Cytokinetics Forest shall transfer promptly provide Adamas with prior written or email notice of all meetings, conferences and discussions scheduled with the Lead Compound IND FDA concerning all Memantine-Donepezil FDC Products (including advisory committee meetings and any other meeting of experts convened with the FDA concerning the Memantine-Donepezil FDC Products) within [*] after Forest or its Affiliate first receives notice of the scheduling of such meeting, conference or discussion (or within such shorter period as may be practicable and necessary in order to Astellasgive Xxxxxx a reasonable opportunity to attend such meetings, unless the JDC conferences and discussions). Adamas shall be entitled to have representatives of Adamas (or its Affiliates) with appropriate expertise [*] as set forth in Section 6.3(b)(iii)at all such meetings, in conferences or discussions with the FDA relating to Memantine-Donepezil FDC Products, which case Cytokinetics at a minimum shall continue to hold the Lead Compound IND mean that Adamas and Regulatory Materials related to such Development work.
(c) [*] Regulatory Materials for [*] Activators for [*] Indication to support the Development of such Compound in such Indications in the Shared Territory. If [*] Activator for [*] Indication or [*] Indication [*] Indication. [*] regulatory strategy in the Development Plan for [*] (but excluding [*] in the Shared Territory [*]) for such [*] Indications [*] in the Shared Territory. If [*] Indication, [*] regulatory activities related to [*] Activators for such Indication. If [*] the right to [*] a Collaboration Product in the Shared Territory [*] as set forth in Section [*] its Affiliates shall have the right to have [*]. Forest shall provide Adamas with reasonable advance notice, as set forth above, of all such meeting, conferences or discussions with the FDA and [*] pertaining = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. advance copies of all substantive submissions and written communications to the FDA in advance of such meetings, conferences or discussions, as well as any written correspondence received by Forest from the FDA with respect to such Collaboration Product in meetings, conferences or discussions. Xxxxxx shall promptly forward to Xxxxxx copies of all minutes thereof and summaries of all such meetings, conferences and discussions with the Shared Territory [*].
(d) In additionFDA, [*] shall be responsible for [*] regulatory activities related to [*] Development (including [*] applicable Regulatory Authorities) until the JDC [*] the Development copies of [*] Indication under Section [*].
(e) [*] in connection with [*] under Sections 7.1(b), (c), and (d) will be [*] Indication [*] Indication [*], as applicable.
(f) Astellas hereby grants Cytokinetics and its Affiliates and (sub)licensees the right to reference any IND and other Regulatory Materials Controlled all contact reports produced by or on behalf of Astellas Forest or its Affiliates for use Affiliates. Forest shall consider in good xxxxx Xxxxxx’ reasonable proposals or comments to any substantive submissions or communications made by Forest to Regulatory Authorities in the Territory (including the FDA) with respect to the Development by Cytokinetics in accordance with this Agreement, and Cytokinetics hereby grants Astellas, its Affiliates and sublicensees the right to reference any IND of Memantine-Donepezil FDC Products for Compounds and/or Collaboration Products and other Regulatory Materials Controlled by or on behalf of Cytokinetics or its Affiliates for use Commercialization in the Development by Astellas, its Affiliates and sublicensees Territory in accordance with this Agreement. Each Party hereby grants the other Party the right to use any data resulting from such Party’s activities under this Agreement to perform its obligations or to exercise its rights under this Agreement. Each Party may file its own IND(s) and other Regulatory Materials for each Field [*] Activator Xxxxxx’ proposal or comments with respect to support its Development work under this Agreement, which may cross reference the other Party’s IND(s) and other any such submissions or communications made by Forest to Regulatory Materials for such [*] Activator.
(g) Except as set forth in Sections 7.1(b), (c) and (d) above and otherwise agreed in writing by the Parties, [*] shall be responsible, [*] for the Collaboration Products [*]. Without limiting the foregoing:
(i) Astellas shall file its own IND for the Development of the Lead Compound for the activities allocated to it under the Development Plan and Astellas shall have the right to cross reference the Lead Compound IND if necessary.
(ii) Astellas shall hold IND(s) and other Regulatory Materials for [*] Activators for each [*] Indication to support the Development of such Compound in such Indication Authorities in the Astellas Territory, and Astellas shall [*] for such Indication in the Astellas Territory.
(iii) [*] shall be responsible for regulatory activities related to [*] Activators for each [*] Indication, unless [*] for such Indication.
Appears in 1 contract