Regulatory Filings and Regulatory Approvals. 5.1.1 Immatics Pre-Clinical Studies, Immatics CMC Activities, and Immatics GDP Trial.
(a) Immatics will be responsible for the preparation of all Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject to the prior review and approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) shall be responsible for any submissions to Regulatory Authorities related to the Immatics Generated Data.
(b) Immatics shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior to submission thereof, and (ii) any correspondence received from any Regulatory Authority).
(c) At BMS’ written request following the completion of the Immatics GDP Trial, Immatics shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly ([**]) any and all Regulatory Materials for the Licensed Product, including providing true, accurate and complete hard and electronic copies thereof to BMS, provided Immatics may retain copie...
Regulatory Filings and Regulatory Approvals. (a) Existing Regulatory Filings and Regulatory Approvals. BRIDGE shall promptly transfer and assign to ALGORX any Regulatory Filings and Regulatory Approvals (including any data or information contained or referenced therein), including but not limited to any draft IND documents and IND filings, and copies of all correspondence with Regulatory Authorities regarding any Compound or any Licensed Product. BRIDGE agrees to perform within sixty (60) days of the Effective Date all such acts, and execute such further instruments, documents or certificates, as may be required to more effectively transfer the Regulatory Filings to which reference is made above. EXECUTION COPY
Regulatory Filings and Regulatory Approvals. Before making any submission to any Regulatory Authority, the Sponsor Party shall consult with and provide the other Party the opportunity to review draft Regulatory Filings with respect to a Joint Global Study (e.g., Type B meeting packages, key documents in INDs, NDAs, fast track, breakthrough designation and orphan drug application) to be submitted to the Regulatory Agency in its Sponsored Territory in advance of submission. Such other Party shall provide any comments within [***] ([***]) Business Days after receipt, but such Sponsor Party shall not be required to delay any planned submissions if it does not receive timely comments from such other Party. As between the Parties, AxxxXxxx shall prepare the first draft of the global submission dossier for the Parties’ review and comments.
Regulatory Filings and Regulatory Approvals. With respect to each Licensed Antibody Product, in a manner consistent with its obligations set out in this Licence Agreement, Amgen shall have the sole and full control, discretion authority and right to prepare, file and pursue and shall own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to each said Licensed Antibody Product in the Territory.
Regulatory Filings and Regulatory Approvals. With respect to each Licensed Product, at its discretion Hyseq will prepare, file and own all right, title and interest in Regulatory Filings and Regulatory Approvals relating to each said Licensed Product in the Territory.
Regulatory Filings and Regulatory Approvals. All Regulatory Filings and Regulatory Approvals will be held in the name of Amgen. On behalf of Amgen, BeiGene shall be responsible for obtaining and maintaining Regulatory Filings and Regulatory Approvals, including any renewal thereof, via the Amgen systems.
Regulatory Filings and Regulatory Approvals. 4.2.1 General Responsibilities; Ownership of Regulatory Approvals. Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Patient Information Leaflets, labeling and packaging for the Product in the Field in the Territory) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. For clarity, to the extent allowed by Applicable Laws, all Regulatory Approvals for the Product in the Field in the Territory shall be held and owned by Licensee in its name.
Regulatory Filings and Regulatory Approvals. Note 1; the table below does not list all documents nor gives it the same level of detail on document groups in order to keep the table easier to review. All regulatory documents available to Novartis will be shared.
Regulatory Filings and Regulatory Approvals. 5.1.1 General Responsibilities; Ownership of Regulatory Approvals. [***].
Regulatory Filings and Regulatory Approvals. (a) In accordance with the Global Development Plan, [Seres] shall be responsible for [***].
(b) [***] and [***] shall have [***] for regulatory matters in countries in [***], subject to the terms and conditions of this Agreement, (ii) subject to clause (c) below, [***] or sublicensees shall own all Regulatory Filings and Regulatory Approvals in respect of [***] and [***] shall have [***] for regulatory matters in countries in [***], subject to the terms and conditions of this Agreement.
(c) All Regulatory Filings in the European Union shall [***]; provided, however, that until such time as Regulatory Approval for a particular Collaboration Product is received in the European Union, [***]. [***] shall pay directly or reimburse [***].
(d) It is anticipated that, in most cases, BLAs or other similar Regulatory Filings by the Parties to obtain Regulatory Approval for a given indication will be based upon a Global Registration Dossier to be prepared by the Parties and which is generally intended to comply with applicable United States, Canadian and EU Laws. The specific Regulatory Filings to be made in each country or jurisdiction [***], as modified and/or supplemented to comply with applicable Laws in such country. Such Party’s responsibilities will also include: (i) [***]; (ii) [***]; and (iii) [***]. All such activities shall be undertaken and performed in accordance with the applicable Development Plan and the global regulatory strategy [***].
