Regulatory Activities a) As between the Parties, Xynomic shall have the sole responsibility and discretion for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). All Regulatory Approvals relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Xynomic or its designated Affiliate. Pharmacyclics hereby assigns to Xynomic all of Pharmacyclics’ (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Pharmacyclics (or its Affiliates) and held in Pharmacyclics’ name (or its Affiliates) as of the Effective Date or generated in the “winding up” activities after the Effective Date and shall deliver all Regulatory Documentation as well as embodiments of all Regulatory Documentation to Xynomic within sixty (60) days after the Effective Date.
b) Xynomic shall notify the Pharmacyclics Alliance Manager promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Xynomic (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Xynomic shall consult with Pharmacyclics and shall consider Pharmacyclics’ comments in good faith. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Xynomic (or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 2.2.1.b), Xynomic (or its Sublicensee) shall be solely responsible for the e...
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. (a) As between the Parties, Adapt shall be responsible for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Products (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities), in each case in accordance with the terms of this Agreement and otherwise in Adapt’s sole discretion. All Regulatory Approvals applied for or received after the Effective Date relating to Products shall be owned by and held in the name of, Adapt. At Adapt’s request, Lightlake shall transfer ownership of the IND in respect of the initial Product to Adapt at no cost and shall take such action as is necessary to confirm such transfer with the FDA.
(b) Adapt shall notify Lightlake promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Product, and shall include in such notice the reasoning behind such determination, and any supporting facts. Adapt (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority, Adapt (or its Sublicensee) shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken, Adapt (or its Sublicensee) shall be solely responsible for the execution and all costs thereof. IRS Employer Identification No. 40-0000000 Confidential treatment requested with respect to certain portions hereof denoted with “*** REDACTED ***”
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. (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.
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) Except as detailed in Section 5.1(b), Licensee shall be responsible for conducting all Development activities related to Regulatory Materials and Regulatory Approvals in the Field and in the Territory. Licensee shall be responsible for preparing and submitting the NDAs in the Territory and in the Field for all indications for the Product. Licensee shall file and own all right, title and interest in all regulatory filings designed to obtain or support Regulatory Approval in the Territory.
(b) Upon Licensee’s reasonable request, MTI shall assist Licensee in conducting all (or certain) Manufacturing Development activities related to Regulatory Materials and Regulatory Approvals in the Field and in the Territory, [***]. Licensee shall be responsible for preparing and submitting those portions of the NDAs relating to Manufacturing Development (including the Chemistry Manufacturing and Controls sections) in the Territory and in the Field for all indications for the Product.
(c) Upon Licensee’s reasonable request, MTI shall assist Licensee in responding in a timely manner all queries and requests received by Licensee from the Regulatory Authority in the Territory.
Regulatory Activities. Awardee shall pursue the regulatory activities described in the iPDP.
