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Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. (a) Subject to the terms and conditions of this Agreement, 3D Medicines will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the 3D Medicines Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Field in the 3D Medicines Territory. 3D Medicines shall be responsible for filing each CTA in the Field in the 3D Medicines Territory for each Licensed Product. 3D Medicines shall be responsible for filing each MAA in the Field in the 3D Medicines Territory for each Licensed Product in 3D Medicines’ name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Field in the 3D Medicines Territory. 3D Medicines shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (b) Aravive shall provide all reasonable assistance and cooperation to 3D Medicines as 3D Medicines may reasonably request, at 3D Medicines’ sole cost and expense, during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a), including (i) in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within Aravive’s possession and control, in each case as requested by Regulatory Authorities at 3D Medicines’ cost, and (iii) providing 3D Medicines with additional Regulatory Materials in the Aravive Territory as requested by Regulatory Authorities in the 3D Medicines Territory within a reasonable timeframe commensurate with the volume of 3D Medicines’ reasonable request. In the event that Aravive believes that such requests are not reasonable or are otherwise burdensome to Aravive, then such matter shall be promptly submitted to the JSC for review and discussion. Without limiting the foregoing, Aravive shall provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Aravive has prepared a CTD for regulatory filings in the Field in the Aravive Territory, in a manner sufficient for filing in the U.S. within [***] after completion of all such modules 2, 3, 4 and 5 of the CTD. 3D Medicines shall be responsible for publishing and submitting the CTD (including modules 2, 3, 4 and 5) to the Regulatory Authority in the 3D Medicines Territory. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on 3D Medicines establishing appropriate firewalls or equivalent means designed to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, 3D Medicines shall ensure that any CMC Information provided by or on behalf of Aravive pursuant to this Section 5.1 shall only be disclosed to those identified personnel of 3D Medicines (or a designated agreed Third Party) who (x) have a need to know the same to comply with the above obligations, and (y) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. Notwithstanding anything to the contrary herein, Aravive’s obligations under this Section 5.1(b), including to provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent Aravive is Manufacturing and supplying 3D Medicines with Licensed Products.

Appears in 1 contract

Samples: Collaboration and License Agreement (Aravive, Inc.)

Regulatory Responsibilities. (a) Subject to the terms and conditions of this Agreement, 3D Medicines Hansoh will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the 3D Medicines Hansoh Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Field in the 3D Medicines Hansoh Territory. 3D Medicines shall be responsible for filing each CTA in the Field in the 3D Medicines Territory for each Licensed Product. 3D Medicines Hansoh shall be responsible for filing each MAA in the Field in the 3D Medicines Hansoh Territory for each Licensed Product in 3D Medicines’ its own name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Field in the 3D Medicines Hansoh Territory. 3D Medicines Hansoh shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (b) Aravive Keros shall provide all reasonable assistance and cooperation to 3D Medicines Hansoh as 3D Medicines Hansoh may reasonably request, at 3D Medicines’ sole cost and expense, request [***] during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a), including (i) in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within Aravive’s possession and control[***], in each case as requested by Regulatory Authorities at 3D Medicines’ costAuthorities, and (iii) providing 3D Medicines with transferring to Hansoh additional Regulatory Materials in the Aravive Keros Territory as requested required by Regulatory Authorities in the 3D Medicines Hansoh Territory within a reasonable timeframe commensurate with the volume [***] of 3D Medicines’ Hansoh’s reasonable request. In the event that Aravive Keros believes that such requests are not reasonable or are otherwise burdensome to AraviveKeros, then such matter shall be promptly submitted to the JSC JCC for review and discussion. Without limiting the foregoing, Aravive Keros shall provide 3D Medicines Hansoh with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Aravive has prepared a CTD for regulatory filings in the Field in the Aravive Territory, in a manner sufficient for filing in the U.S. within [***] as soon as reasonably practicable after completion of all such thereof. Additionally, Keros shall provide Hansoh with information sufficient for filing modules 2, 3, 4 and 5 of the CTDCTD in the Hansoh Territory. 3D Medicines Hansoh shall be responsible for publishing and submitting the CTD (including modules 2, 3, 4 and 5) to the Regulatory Authority in the 3D Medicines Hansoh Territory. In order to address questions Hansoh may receive from a Regulatory Authority in the Hansoh Territory related to modules 2, 3, 4 and 5 of the CTD, Keros will assist in the preparation of responses based on information that would be found in: various technical reports, notebooks, executed batch records, master batch records, SOPs, validation protocols and reports, vendor certificates, and Third Party study reports and other CMC related documents not otherwise included in modules 2, 3, 4 and 5 of the CTD or otherwise already provided to Hansoh. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on 3D Medicines Hansoh establishing appropriate firewalls or equivalent means designed to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and legal, Development, regulatory compliance and other related purposes which are necessary or reasonably useful for Manufacturing Licensed Product in Hansoh Territory and not for any other purpose. In furtherance of the foregoing, 3D Medicines Hansoh shall ensure that any CMC Information provided by or on behalf of Aravive Keros pursuant to this Section 5.1 shall only be disclosed to those identified personnel of 3D Medicines Hansoh (or a designated agreed Third Party) who (xa) have a need to know the same to comply with the above obligations, and (yb) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. Notwithstanding anything to the contrary herein, Aravive’s Keros’ obligations under this Section 5.1(b), including to provide 3D Medicines Hansoh with modules 2, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent Aravive Keros is Manufacturing manufacturing and supplying 3D Medicines providing Hansoh with Licensed ProductsProducts under the clinical Supply Agreement or commercial Supply Agreement. Keros agrees, to the extent CMC Data is required or requested by the Regulatory Authorities, including the NMPA, to generate such Data subject to Hansoh’s reimbursement of Keros’ [***].

Appears in 1 contract

Samples: License Agreement (Keros Therapeutics, Inc.)

Regulatory Responsibilities. (a) Subject to the terms and conditions of this Agreement, 3D Medicines Kaken will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Kaken Territory Regulatory Approval of Licensed Products in the Field in the 3D Medicines TerritoryField, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Kaken Territory Regulatory Approval for of Licensed Products in any Region in the Field in the 3D Medicines TerritoryField. 3D Medicines Kaken shall be responsible for filing each CTA IND in the Field in the 3D Medicines Kaken Territory for each Licensed Product. 3D Medicines Kaken shall be responsible for filing each MAA in the Field in the 3D Medicines Kaken Territory for each Licensed Product in 3D Medicines’ Kaken’s name. The Territory Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Field in the 3D Medicines Kaken Territory, including Spruce’s Development obligations. 3D Medicines Kaken shall use Commercially Reasonable Efforts to carry out its regulatory obligations for obtaining Regulatory Approvals of Licensed Products pursuant to such strategy. (b) Aravive Spruce shall provide all reasonable assistance and cooperation to 3D Medicines Kaken as 3D Medicines Kaken may reasonably request, at 3D Medicines’ Kaken’s sole cost and expense, during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a), including (i) in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings with Regulatory Authorities by teleconference and (B) providing documentation within AraviveSpruce’s possession and control, in each case as requested by Regulatory Authorities at 3D Medicines’ Kaken’s cost, and (iiiii) providing 3D Medicines Kaken with additional Regulatory Materials in the Aravive Spruce Territory as requested by Regulatory Authorities in the 3D Medicines Kaken Territory within a reasonable timeframe commensurate with the volume of 3D Medicines’ Kaken’s reasonable request. , (iii) using Commercially Reasonable Efforts to [***] In the event that Aravive Spruce believes that such requests are not reasonable or are otherwise unduly burdensome to AraviveSpruce, then such matter shall be promptly submitted to the JSC for review and discussion. Without limiting the foregoing, Aravive Spruce shall provide 3D Medicines Kaken with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Aravive Spruce has prepared a CTD for regulatory filings in the Field in the Aravive Spruce Territory, in a manner sufficient for filing in the U.S. within [***] after completion of all such modules 2, 3, 4 and 5 of the CTDCTD and, [***]. 3D Medicines Kaken shall be responsible for publishing provide all reasonable assistance and submitting cooperation to Spruce as Spruce may reasonably request, at Spruce’s sole cost and expense, during the CTD (including modules 2Term of this Agreement, 3, 4 and 5) with respect to regulatory activities related to the Regulatory Authority in the 3D Medicines TerritoryGlobal Development Plan. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on 3D Medicines establishing appropriate firewalls or equivalent means designed to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, 3D Medicines shall ensure that any CMC Information provided by or on behalf of Aravive pursuant to this Section 5.1 shall only be disclosed to those identified personnel of 3D Medicines (or a designated agreed Third Party) who (x) have a need to know the same to comply with the above obligations, and (y) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. Notwithstanding anything to the contrary herein, Aravive’s obligations under this Section 5.1(b), including to provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent Aravive is Manufacturing and supplying 3D Medicines with Licensed Products[***].

Appears in 1 contract

Samples: Collaboration and License Agreement (Spruce Biosciences, Inc.)

Regulatory Responsibilities. (a) Subject to the terms and conditions of this Agreement, 3D Medicines Licensee will be responsible, at its sole cost responsible for all regulatory submissions and expense, for the conduct of will control all regulatory activities required with respect to obtain Products in the Territory, including safety reporting, analysis and maintain strategy. Licensor will provide timely support to Licensee with respect to such regulatory activities at Licensee’s cost (other than minor consultation, clerical assistance and other assistance resulting in immaterial expenses, which shall be the responsibility of Licensor) and will, at Licensee’s request, promptly transfer all Regulatory Approval of Licensed Materials and Information in its possession or under its Control related to CX-01 or any Product to Licensee. (b) Licensee will be the primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to Products in the Field in the 3D Medicines Territory, including the preparation and submission of Licensee will prepare and file any and all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region each Product in the Field in the 3D Medicines Territory at its sole expense in accordance with the Regulatory Plan. Licensor will assist and cooperate, at Licensee’s expense, with Licensee in connection with the preparation and filing of such Regulatory Materials, as reasonably requested by Licensee. Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Licensee for Licensor Know-How needed for the Regulatory Materials. (c) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated by this Section 5.1, Licensor will not communicate with respect to any Product in the Field with any Regulatory Authority having jurisdiction in the Territory. 3D Medicines shall be responsible , unless so ordered by such Regulatory Authority, in which case Licensor will provide prompt (but in any event within 2 business days) notice to Licensee of such order and all details thereof; and (ii) except as expressly contemplated by this Section 5.1, Licensor will not submit any Regulatory Materials or seek Regulatory Approvals for filing each CTA any Product in the Field in the 3D Medicines Territory for each Licensed Product. 3D Medicines shall be responsible for filing each MAA in the Field in the 3D Medicines Territory for each Licensed Product in 3D Medicines’ name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Field in the 3D Medicines Territory. 3D Medicines shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products pursuant to such strategy. (bd) Aravive Licensee shall provide all Licensor with reasonable assistance and cooperation advance notice of any scheduled significant meeting with the FDA or EMA relating to 3D Medicines as 3D Medicines may reasonably requestany Regulatory Approval for a [*] = Certain confidential information contained in this document, at 3D Medicines’ sole cost and expensemarked by brackets, during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a), including has been omitted because it is both (i) in connection with the preparation of Regulatory Materials, not material and (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within Aravive’s possession and control, in each case as requested by Regulatory Authorities at 3D Medicines’ costwould be competitively harmful if publicly disclosed. Product, and (iii) providing 3D Medicines with additional Regulatory Materials in the Aravive Territory Dr. Xxxxxxx Xxxxxx, as requested by Regulatory Authorities in the 3D Medicines Territory within a reasonable timeframe commensurate with the volume representative of 3D Medicines’ reasonable request. In the event that Aravive believes that such requests are not reasonable or are otherwise burdensome to Aravive, then such matter shall be promptly submitted to the JSC for review and discussion. Without limiting the foregoing, Aravive shall provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Aravive has prepared a CTD for regulatory filings in the Field in the Aravive Territory, in a manner sufficient for filing in the U.S. within [***] after completion of all such modules 2, 3, 4 and 5 of the CTD. 3D Medicines shall be responsible for publishing and submitting the CTD (including modules 2, 3, 4 and 5) to the Regulatory Authority in the 3D Medicines Territory. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on 3D Medicines establishing appropriate firewalls or equivalent means designed to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, 3D Medicines shall ensure that any CMC Information provided by or on behalf of Aravive pursuant to this Section 5.1 shall only be disclosed to those identified personnel of 3D Medicines Licensor (or a designated agreed Third Party) who (x) have a need to know the same to comply with the above obligations, and (y) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent meansreasonably acceptable replacement if Xx. Notwithstanding anything to the contrary herein, Aravive’s obligations under this Section 5.1(bXxxxxx is not available), including to provide 3D Medicines with modules 2shall, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent Aravive is Manufacturing and supplying 3D Medicines permitted by the FDA or EMA, as applicable, have the right to attend any such meeting at Licensor’s expense. Licensee shall promptly inform (including by providing redacted copies upon request) Licensor about any significant interaction (oral or written) with Licensed Productsa Regulatory Authority.

Appears in 1 contract

Samples: License and Development Agreement (Chimerix Inc)

Regulatory Responsibilities. (a) Subject to the terms and conditions of this Agreement, 3D Medicines Licensee will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required related to obtain and maintain Regulatory Approval of Licensed Products Development activities, as described in the Field in the 3D Medicines TerritorySection 4.1, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in any Region Authorities in the Field in Territory with respect to the 3D Medicines Territorysame. 3D Medicines shall be responsible for filing each CTA in the Field in the 3D Medicines Territory for each Licensed Product. 3D Medicines shall be responsible for filing each MAA in the Field in the 3D Medicines Territory for each Licensed Product in 3D Medicines’ name. The Development Plan shall include the regulatory strategy for obtaining Regulatory Approval of Licensed Products in the Field in the 3D Medicines Territory. 3D Medicines Each Party shall use Commercially Reasonable Efforts to carry out its regulatory obligations for Licensed Products the Specialty Product in accordance with the strategy for obtaining Regulatory Approval of the Specialty Product in the Territory as set forth in the Development Plan or otherwise approved by the JSC pursuant to Section 3.3‎3.3. Licensee, directly or through its Affiliates, shall use Commercially Reasonable Efforts to obtain Regulatory Approval in the Territory. Notwithstanding the foregoing, Licensee shall be the Party responsible for achieving the regulatory milestones set forth on Exhibit G (the “Regulatory Milestones”). If Licensee fails to achieve any Regulatory Milestone with the time periods allotted for such strategy. Regulatory Milestone in Exhibit G, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control, then Teva shall have the option in its sole discretion upon written notice to Licensee to: (bi) Aravive shall provide all reasonable assistance and cooperation extend the time period allotted for the achievement of the applicable Regulatory Milestone; or (ii) convert the exclusive rights granted to 3D Medicines as 3D Medicines may reasonably request, at 3D Medicines’ sole cost and expense, during the Term of this Agreement, Licensee in Section 2.1(a) with respect to the satisfaction given Specialty Product into nonexclusive rights, provided however, that Teva has called for the consultation(s) on such failure to achieve any Regulatory Milestone but both Parties are still unable to reach a solution within three (3) months as from the date of its obligations under Section 5.1(a), including (i) the first consultation. All Regulatory Approvals and other Regulatory Materials relating to the Licensed Products in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within Aravive’s possession and control, Territory shall be submitted in each case as requested by Regulatory Authorities at 3D Medicines’ costthe name of, and (iii) providing 3D Medicines with additional Regulatory Materials in the Aravive Territory as requested by Regulatory Authorities in the 3D Medicines Territory within a reasonable timeframe commensurate with the volume of 3D Medicines’ reasonable request. In the event that Aravive believes that such requests are not reasonable or are otherwise burdensome to Aravive, then such matter shall be promptly submitted to the JSC for review and discussionowned by, Teva or its Affiliate1. Without limiting the foregoing, Aravive shall provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD for any formulation of Licensed Product for which Aravive has prepared a CTD for regulatory filings in the Field in the Aravive Territory, in a manner sufficient for filing in the U.S. within [***] after completion of all such modules 2, 3, 4 and 5 of the CTDBidding. 3D Medicines Licensee shall be responsible for publishing bidding activities for all Licensed Products in the Territory. Licensee shall keep Teva informed (through the Alliance Managers, the JDC or other means of communication) of any material issues concerning bidding process for all Licensed Products in the Territory, including updates of any discussion and submitting the CTD (including modules 2, 3, 4 and 5) to the correspondence with any Regulatory Authority with respect thereto. Licensee shall reasonably consider Teva’s comments with respect to Licensee’s or its Affiliate’s bidding activities for all Licensed Products in the 3D Medicines Territory and shall promptly notify Teva of bidding result for all Licensed Products in the Territory. Any such transfer of CMC Information as set forth in this Section 5.1 is conditioned on 3D Medicines establishing appropriate firewalls or equivalent means designed to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, 3D Medicines shall ensure that any CMC Information provided by or on behalf of Aravive pursuant to this Section 5.1 shall only be disclosed to those identified personnel of 3D Medicines (or a designated agreed Third Party) who (x) have a need to know the same to comply with the above obligations, and (y) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means. Notwithstanding anything to the contrary herein, Aravive’s obligations under this Section 5.1(b), including to provide 3D Medicines with modules 2, 3, 4 and 5 of the CTD and such other information or assistance specified in this Section 5.1(b), shall apply solely to the extent Aravive is Manufacturing and supplying 3D Medicines with Licensed Products.

Appears in 1 contract

Samples: License, Collaboration and Distribution Agreement