Responsibility For Regulatory Interactions. (a) Subject to the terms and conditions of this Agreement, AstraZeneca shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in all countries and territories other than China, and Xxxxxxxxx shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Xxxxxxxxx shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated with the Parties’ activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard to the Development of a Diagnostic Product, it is the Parties’ current intention that such Development will be undertaken by a Third Party under contract to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products.
(b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party shall have sole authority in the applicable country or territory with respect to (i) obtaining Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions.
(c) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.
Responsibility For Regulatory Interactions. ASLAN shall be responsible for the preparation and filing of any and all regulatory process, health technology assessments, negotiation, interaction, application and activity which could be necessary to carry out the activities set out in the Development Plan, All such regulatory documents will be filed in ASLAN’s name and on its behalf. Notwithstanding the above, ALMIRALL will have the right to review and comment on any substantive regulatory communications, and to the extent permitted by law, to participate in substantive meetings with any competent regulatory authority.
Responsibility For Regulatory Interactions. Regulatory strategy for the Product and all decision-making with respect thereto shall be determined by the Parties through the JDC. The Parties shall use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development Plan. Certain agreed [**] are set forth on Schedule 4.1.1 hereto. The costs incurred by the Parties in carrying out their assigned responsibilities pursuant this Section 4.2.1 [**].
Responsibility For Regulatory Interactions. As of and after the date upon which the transfer described in Section 5.1 is effected, Celgene shall have sole responsibility for all Regulatory Interactions with Regulatory Authorities with respect to each Licensed Product. As used herein, the term “Regulatory Interactions” means (a) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Development, Manufacture and Commercialization of Licensed Products and Companion Diagnostics and (b) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Licensed Products and Companion Diagnostics.
Responsibility For Regulatory Interactions. Subject to the terms and conditions of this Agreement, Shionogi shall be responsible for all regulatory matters relating to Products in the Field in the Territory, including payment of all costs associated with obtaining Regulatory Approvals for Products in the Territory.
Responsibility For Regulatory Interactions. BIOGENETICS shall be responsible for the preparation and filing of any and all Regulatory Filings. ASLAN shall use Commercially Reasonable Efforts to provide BIOGENETICS with appropriate documents and data required, and general cooperation, to enable the dossiers and other documentation required for MFDS submissions and other Regulatory Filings to be completed. All such Regulatory Filings will be filed in BIOGENETICS’ name and/or on its behalf. BIOGENETICS shall promptly notify ASLAN of all Regulatory Filings submitted or received by BIOGENETICS or its Affiliates with respect to Products, and upon ASLAN’s request, shall provide to ASLAN one paper copy or electronic file of all such regulatory Filings. Additionally, BIOGENETICS will upon ASLAN’s request, to the extent reasonably required to confirm BIOGENETICS’ compliance with its obligations hereunder, provide ASLAN with reasonable additional information and data generated by or on behalf of BIOGENETICS in such semi-annual period, it being understood that ASLAN shall keep such information and data in strict confidence. Notwithstanding the foregoing, prior to any application for determination of NHIP for Products, BIOGENETICS and ASLAN shall discuss the range of target pricing to seek in such application, including a lowest acceptable price, and ASLAN’s prior approval (not to be unreasonably withheld or delayed) shall be obtained before such application is made. Any formal acceptance by BIOGENETICS of a NHIP price proposed by the relative government authorities which is lower than the lowest acceptable price agreed with ASLAN beforehand, shall require prior discussion with ASLAN and ASLAN’s prior approval, which shall not be unreasonably withheld or delayed.
Responsibility For Regulatory Interactions. The Parties shall have joint responsibility for all Regulatory Interactions with Regulatory Authorities with respect to each Licensed Product, as and to the extent Developed under a Development Plan or under an Additional Study for which the Non-Proposing Party is co-funding. As used herein, the term “Regulatory Interactions” means (i) monitoring and coordinating all regulatory actions, preparing, submitting and coordinating all communications and filings with, and submissions to, all Regulatory Authorities with respect to the Development, Manufacture and Commercialization of Licensed Candidates, Licensed Products and Licensed Diagnostic Products and (ii) interfacing, corresponding and meeting with the Regulatory Authorities with respect to the Licensed Candidates, Licensed Products and Licensed Diagnostic Products. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Responsibility For Regulatory Interactions. Regulatory strategy for the Product and all decision-making with respect thereto will be determined by the Parties through the JDC. Partner will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development Plan. Partner will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. Notwithstanding anything contained in this Agreement to the contrary, Partner acknowledges and agrees that Ironwood is required to [**]. Partner will provide Ironwood with advanced copies of any substantive Regulatory Submissions made in the Territory reasonably in advance of submission to a Regulatory Authority, and will not [**] to the extent they are related to issues potentially affecting [**]. Partner will not submit any Regulatory Submissions unless the Parties have complied with the preceding two sentences with respect to such Regulatory Submissions. Ironwood will make available to Partner with respect to the Licensed Compound or Products any Regulatory Submissions made pursuant to the Forest Agreement. Partner will own all right, title, and interest in all Regulatory Submissions and Regulatory Approvals for Products in the Territory.
Responsibility For Regulatory Interactions. Regulatory strategy for the Product in the Territory and all decisionmaking with respect thereto will be determined by Astellas consistent with the Development and Regulatory Plan. Astellas will use Commercially Reasonable Efforts to obtain in a timely manner Regulatory Approvals with respect to the Product to the extent contemplated by the Development and Regulatory Plan. Astellas will be solely responsible for conducting all activities relating to obtaining Regulatory Approvals with respect to the Product, including without limitation, preparing and submitting Regulatory Submissions and attending meetings with Regulatory Authorities. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Responsibility For Regulatory Interactions. Except otherwise expressly stated in this Agreement, MTPC shall be responsible for all regulatory matters relating to Products in the Territory, including payment of all costs associated with obtaining Regulatory Approvals for Products in the Field in the Territory. MTPC shall have sole authority in the Territory with respect to (a) obtaining Regulatory Approvals for Products in the Field and subsequently maintaining such Regulatory Approvals; (b) communicating with Regulatory Authorities about Products in the Field; and (c) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions. MTPC shall keep Viela reasonably (but at least on a quarterly basis) informed regarding the status and progress of such activity, including, without limitation, providing Viela with advance notice as reasonably practicable of all meetings scheduled with a Regulatory Authority involved in such Regulatory Submission, providing Viela with a copy of all written correspondence from a Regulatory Authority involved in such Regulatory Submission, and providing Viela with an abstract of oral correspondence from a Regulatory Authority involved in such Regulatory Submission.
