Regulatory Activities. Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.
Regulatory Activities. Everest shall apply for and maintain, at Everest’s sole cost and expense, all Regulatory Filings relating to the Products in the Field in the Territory. All Regulatory Filings relating to the Products in the Field in the Territory shall be owned by Everest and held in Everest’s (or its Affiliates’ or Sublicensees’, as the case may be) name, provided that (a) for any Regulatory Filings, including any Marketing Approval, that are required under applicable Laws in a Region in the Territory to be filed in the name of a local agent, such Regulatory Filings may be filed and held in the name of a local agent designated by Everest; and (b) for any Regulatory Filings, including any IND or Imported Drug License, that are required under applicable Laws in the Territory to be filed in Xxxxx’x name, such Regulatory Filings will be owned by Xxxxx but shall be prepared, filed and maintained by Everest on Xxxxx’x behalf (such Regulatory Filings in the Territory owned by Xxxxx, the “Xxxxx Territory Regulatory Filings”), provided that Xxxxx shall promptly transfer and assign all Xxxxx Territory Regulatory Filings to Everest or its designee if and when permitted by applicable Laws. For the avoidance of doubt, during the period that Xxxxx is the owner of any Xxxxx Territory Regulatory Filings, (x) Everest shall have the right to Commercialize the Product; and (y) subject to the terms of Article 8 (Manufacturing and Supply), Xxxxx shall (itself or through its Affiliate or a CMO) continue to Manufacture and supply the Product for Development and Commercialization by Everest and its Affiliates and Sublicensees in the Territory, including the Manufacture and supply of the Product for any Early Access Programs, in accordance with the terms of this Agreement and the Supply Agreements; and (z) Xxxxx shall provide such other reasonable assistance to Everest, including by providing documentation or other materials, that are necessary to enable Everest to Commercialize the Products in the Territory due to the fact that Xxxxx is required under applicable Laws to be the named applicant and owner of Regulatory Filings relating thereto. Xxxxx shall, at the direction of and with the assistance of Everest, execute any documentation prepared by Everest necessary to appoint Everest, its Affiliates, or Sublicensees as Xxxxx’x exclusive local regulatory agent to perform regulatory actions on its behalf in connection with the Xxxxx Territory Regulatory Filings.
Regulatory Activities. (a) Unless otherwise agreed in writing by the Parties, New River, subject to Section 3.3.3(c), shall be responsible for preparing and filing Drug Approval Applications and seeking Regulatory Approvals for Collaboration Products in the US Territory in accordance with the applicable Development Plan, including preparing all reports necessary as part of a Drug Approval Application. All such Drug Approval Applications shall be filed in the name of New River. Each Party shall designate an alliance manager to coordinate and review filings and activities of the Parties in the US Territory described in this Section 3.3.3. New River shall provide Shire with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the US Territory that pertains to the Compound and/or Collaboration Products, including Drug Approval Applications. New River will consult in advance with Shire with respect to any substantive or material filings to be made by New River in accordance with the terms of this Section 3.3.3(a), including Drug Approval Applications, and shall consider in good faith any comments Shire may have with respect to any such filings. New River shall permit Shire access to and grant Shire the right to reference and use, for purposes of the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Regulatory Approval or other issues associated with any Collaboration Product, that is or would be relevant to Shire’s Development or Commercialization of a Collaboration Product in the US Territory. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then New River shall arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of Shire that are contemplated by this Agreement. Any information obtained by a Party pursuant to this Section 3.3.3(a) shall be deemed Confidential Information for purposes of Article 10. Notwithstanding the foregoing, Shire shall be the responsible Party for preparing and filing Drug Approval Applications and seeking Regulatory Approvals and interacting with the Governmental Authorities in the US Territory for any Unilateral Product being Developed by Shire under Section 3.6.5.
(b) New River shall provide Shire with reasonable advance notice of any meeting or substantive or material conference call with any Governmen...
Regulatory Activities. 4.1.1 IMPATIENTS shall have the sole and exclusive right to make contact with patients and physicians relating to the EAP of Product, and to file applications for Early Access Approvals therefor (including the setting of the overall regulatory strategy therefor), and to communicate with the Regulatory Authorities to secure Early Access Approvals for Product in the Territory. HEMISPHERX shall support IMPATIENTS as may be reasonably necessary in obtaining Early Access Approvals for the Product, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Early Access Approvals, in each case in accordance with the terms and conditions of this Agreement.
4.1.2 HEMISPHERX shall collaborate with IMPATIENTS to provide IMPATIENTS with (a) access to or copies of all material written or electronic correspondence (other than regulatory filings) relating to the development of Product in the Field received by HEMISPHERX or its Affiliates, collaborators or licensees from, or filed by HEMISPHERX or its Affiliates, collaborators or licensees with, the Regulatory Authorities, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by HEMISPHERX or its Affiliates, collaborators or licensees with the Regulatory Authorities relating to the development or commercialization of Product in the Field, including copies of all contact reports produced by HEMISPHERX or its Affiliates or licensees, in each case ((a) and (b)) within fifteen (15) Business Days of its receipt, forwarding or production of the foregoing, as applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory Approval or Early Access Approval for Product in the Field, the prohibition or suspension of the supply of a Product in the Field, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety and quality of a Product in the Field, the notified Party shall notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable.
4.1.3 HEMISPHERX shall, in accordance with the Quality Agreement, make every reasonable effort to notify IMPATIENTS promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, mar...
Regulatory Activities. (i) As between the Parties, Receptos shall have the sole responsibility, at Receptos’ sole expense, for preparing, obtaining, and maintaining INDs and other related submissions or approvals (e.g., from any Institutional Review Board, Independent Ethics Committee or analogous authority), and for conducting communications with the Regulatory Authorities, in connection with any human clinical trial involving ABT-308 in the Lead Indication to be conducted or being conducted pursuant to the Development Plan and Budget. *** AbbVie agrees to provide reasonable regulatory assistance to Receptos, upon Receptos’ reasonable request and Receptos’ reasonable expense, regarding any modifications to any existing IND or other regulatory submissions that may be necessary or advisable in respect of the activities under the Development Plan and Budget.
(ii) Receptos shall provide AbbVie with *** opportunity to review and comment on all filings and documents with Regulatory Authorities (including INDs and Regulatory Authority meeting requests) made pursuant to the Development Plan and Budget and this Agreement. Receptos shall, and shall cause its Affiliates to*** any reasonable comments of AbbVie.
(iii) Receptos shall notify AbbVie promptly (but in no event later than *** hours) following its determination that any event, incident, or circumstance has occurred that may reasonably be expected to result in the need for a withdrawal of ABT-308, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie shall have the right to make the final determination whether to voluntarily implement any such withdrawal; provided that prior to any implementation thereof, AbbVie shall consult with Receptos and shall consider Receptos’ comments in good faith. If a withdrawal is mandated by a Regulatory Authority, Receptos shall initiate such withdrawal in compliance with Applicable Law. For all withdrawals undertaken pursuant to this Section 2.2.1(iii), Receptos shall be solely responsible for the execution and all costs thereof; provided, however, that if any such withdrawal is a result of any material breach of this Agreement by AbbVie or any of its Affiliates (including a material breach of any representation or warranty), then AbbVie shall be solely responsible for all costs thereof.
(iv) During the Term, Receptos represents and warrants that no Drug Approval Application for a Licensed Compound will be filed with any Regulatory Agency anywhere...
Regulatory Activities. The following shall apply with respect regulatory activities relating to each Collaboration Program:
(a) Subject to Section 4.4.2(c) below, the then-Regulatory Lead shall have the lead role and responsibility with respect to the preparation, obtaining and maintenance of all Regulatory Documentation necessary to perform the applicable activities under the applicable Development Plan or Commercialization Plan. The Non-Regulatory Lead shall support the Regulatory Lead, as may be reasonably necessary, in the preparation, obtaining and maintenance of such Regulatory Documentation, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain such Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, to the extent the Regulatory Lead is not the same Party as the Manufacturing Lead, the Manufacturing Lead shall prepare the CMC Module 3 of the Common Technical Document in English for the Optioned Product, and the Regulatory Lead will modify as appropriate, such module for use in Regulatory Approvals in the Territory. Notwithstanding anything to the contrary in this Section 4.4.2(a), during the period of time when (i) Denali is the Regulatory Lead pursuant to Section 4.4.1(a), Takeda shall, to the extent permissible under Applicable Law and notwithstanding Section 4.4.2(d), have the right to interact directly with the respective Regulatory Authority on an interaction directly related to the filing and preparation of Regulatory Documentation for the Late Stage Development Activities, subject to prior notification and coordination with Denali, and (ii) Takeda is the Regulatory Lead pursuant to Section 4.4.1(b), if Denali is to be the Commercial Lead in the United States with respect to a Collaboration Program, (A) Denali shall, to the extent permissible under Applicable Law, have the right to interact directly with the FDA on the Product Labeling for each Optioned Product in such Collaboration Program, subject to prior notification and coordination with Takeda, (B) Takeda shall not conduct any scheduled discussions, meetings, and conferences with the FDA on Product Labelling for Optioned Products included in such Collaboration Program without prior notification and coordination with Denali, and (C) notwithstanding Section 4.4.2(d), Denali shall have the right to have [***], or more i...
Regulatory Activities. With respect to each Included Target, from and after the Inclusion Date for such Included Target, AbbVie shall, as between the Parties, have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with the Regulatory Authorities in the Territory for the Licensed Products that contain a Licensed Compound Directed to such Included Target. Morphic shall support AbbVie, as may be reasonably necessary, in obtaining Regulatory Approvals for such Licensed Products and in the activities in support thereof, including providing all documents or other materials in the possession or control of Morphic or any of its Affiliates as may be necessary or useful for AbbVie or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for such Licensed Products.
Regulatory Activities. ZAI shall apply for (and maintain), at ZAI’s cost and expense, all Regulatory Approvals of Licensed Products in the ZAI Territory. ZAI shall be responsible for the preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the Licensed Products in the ZAI Territory, both prior to and subsequent to Regulatory Approval. ZAI shall file all required regulatory dossiers to obtain (and maintain) Regulatory Approvals of the Licensed Products in the ZAI Territory, and will be the holder of such Regulatory Approvals.
Regulatory Activities. (a) Telix (or its designated Affiliates, contractors or sublicensees) will prepare, submit and hold all Applications for Regulatory Approval for the Licensed Product in the Field in the Territory.
(b) Telix (or its designated Affiliates, contractors or sublicensees) will be responsible for interactions with Regulatory Authorities in the Territory with respect to the Licensed Product in the Field and will bear related expenses.
(c) Telix will be responsible for obtaining Regulatory Approvals for development, use, and Commercialization of the Licensed Product from the Regulatory Authorities in the Territory and will use Commercially Reasonable Efforts to obtain such approvals. Telix will pay or cause the payment of all costs and expenses necessary to obtain such approvals, including all costs of human clinical trials and all costs of drafting and filing Applications for Regulatory Approval in the Territory.
(d) As between the Parties, the development and commercialization of the Licensed Product in the Field to be conducted under the terms and conditions of this Agreement shall be under sole control of Telix.
Regulatory Activities. Subject to, and in accordance with, the terms and conditions of this Agreement (including Section 6.3), and all requirements of applicable laws, rules, and regulations, CUBIST shall be responsible for filing and obtaining Regulatory Approvals for Products in the Territory. XTL shall not be entitled to engage in any regulatory activities with respect to any Product without the prior written consent of CUBIST. XTL shall use Commercially Reasonable Efforts to assist CUBIST in complying with all requirements of applicable laws, rules, and regulations related to Regulatory Approval of Product in the Territory. Notwithstanding anything in this Section 6 or elsewhere in this Agreement to the contrary, XTL shall cease any regulatory activity and all attempts to Obtain Regulatory Approval with respect to any Product upon receipt of written notice from CUBIST to cease such activity, or as soon as practicable thereafter.
