Regulatory Submissions Sample Clauses
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Regulatory Submissions.ÌýWith respect to the Governmental Approvals of the Agreement Products in the Territory:
(a) Unless otherwise required by Applicable Law, any Governmental Approvals and any Regulatory Submissions relating to Agreement Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates.
(b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval.
(c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval.
(d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval.
(e) Subject to the terms and conditions of this Agreement, EVOLUS may file any submissions that are intended to change or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft of such submission at least ten (10) business days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languages.
Regulatory Submissions.ÌýMerus shall develop, produce, oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Program 1 Product in the United States; provided that Merus shall [**] to enable Incyte to [**]. Incyte shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to: (i) except as provided above, all Regulatory Authorities with respect to the Program 1 Product, provided that Incyte shall [**] to enable Merus to [**], and (ii) all Regulatory Authorities with respect to the Program 2 Product, [**] Products, and Novel Program Products, provided that with respect to the [**] Co-Development Products and an Additional Co-Development Product, if any, Incyte shall provide Merus with copies of [**] to enable Merus to [**]. Each Party shall keep the Program 1 JDC, and Incyte shall keep the [**] JDC and Additional JDC, reasonably informed in connection with the preparation of all Regulatory Documentation, Regulatory Authority review of Regulatory Documentation, and Regulatory Approvals, annual reports, annual re-assessments, and variations and labeling, in each case with respect to the Program 1 Product, the [**] Co-Development Product, or an Additional Co-Development Product, if any, as applicable; provided that the providing Party shall have the right to redact any information to the extent not related to the Program 1 Products, the [**] Co-Development Products, or an Additional Co-Development Product, if any. Each Party shall respond within a reasonable time frame to all reasonable inquiries by the other Party with respect to any information provided pursuant to this Section 5.7(a). Unless already the Confidential Information of a Party, any information disclosed pursuant to this Section 5.7(a) shall be the Confidential Information of the Disclosing Party.
Regulatory Submissions.ÌýKnight shall be solely responsible, at its expense, for preparing, filing, and managing any Regulatory Submission and for maintaining any Regulatory Approval for the Licensed Products in the Territory. Synergy shall provide reasonable assistance to Knight in making submissions to Governmental Authorities and maintaining such Regulatory Approvals. Unless otherwise required by Applicable Law, any Regulatory Approvals shall be filed, owned and held in the name of Knight. Knight shall notify Synergy of all Regulatory Submissions that it submits.
Regulatory Submissions.ÌýAt all times, the Party preparing, filing, and/or maintaining applications for Governmental Approval, or any supplements thereto, in the Territory shall (a) inform the other Party of all material communications with the relevant Competent Authority(ies) in the Territory concerning the Licensed Product and (b) provide copies of proposed material submissions to the relevant Competent Authority(ies) in the Territory concerning the Licensed Product to the other Party prior to their submission to such Competent Authority. To the extent either Party receives material written or material oral communication from the FDA relating to any Governmental Approval or related process in the Territory with respect to any Licensed Product, the Party receiving such communication shall promptly notify the other Party and provide a copy of any written communication as soon as reasonably practicable. In addition, prior to Supplement Approval, Collegium will have a reasonable right, but not the obligation, to participate in or review and comment on, as applicable, any and all filings, meetings, responses, submissions, communications and other interactions between BDSI or any of its Affiliates and the FDA in regards to the Supplement and/or the Current Product generally, including in regards to the Supplement Approval, provided that Collegium shall not (and shall ensure that its representatives participating in any such meetings with the FDA do not) make any statements or take any actions in connection therewith that it knows or reasonably should know will have a material likelihood of adversely affecting µþ¶Ù³§±õ’s efforts to obtain Supplemental Approval or the regulatory status of the Current Product. Except as expressly set forth in the Mfg Transfer Plan, each Party will be responsible for its own costs and expenses incurred in connection with its performance of the activities set forth in this Section 2.03.
Regulatory Submissions.ÌýSynergy shall be solely responsible, at its expense, for preparing, filing, and managing any Regulatory Submission and for maintaining any Regulatory Approval for the Licensed Products in the Territory. Hand shall provide reasonable assistance to Synergy in making submissions to Governmental Authorities and maintaining such Regulatory Approvals. Unless otherwise required by Applicable Law, any Regulatory Approvals shall be filed, owned and held in the name of Synergy. Synergy shall notify Hand of all Regulatory Submissions that it submits.
Regulatory Submissions.ÌýFrom and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than ÀÖÌìÌÃappÏÂÔØtly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.
Regulatory Submissions.ÌýUpon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or shall provide NVCR with a right of reference with respect to such Regulatory Submissions, as NVCR determines at its reasonable discretion, at [***] cost and expense. In addition, upon NVCR’s written request, Zai shall, at [***] cost and expense, provide to NVCR copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably available to Zai, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that NVCR will assume all safety and safety database activities no later than [***] months after termination.
Regulatory Submissions.ÌýMMD shall provide TKT with copies of all submissions to United States drug regulatory authorities. Upon the reasonable request of TKT, MMD shall also provide TKT with copies of all submissions to drug regulatory authorities of other countries and the results of all clinical trials conducted by, or under the supervision of, MMD with respect to * ; provided, however, that MMD reserves the right to assess reasonable copying charges for any such materials requested by TKT which exceed approximately two cartons of material.
Regulatory Submissions.ÌýIn the event that either Party reasonably concludes that it is necessary or advisable to file this Agreement with a Governmental Entity or that a Governmental Entity is required to approve or review this Agreement or the arrangement between the Parties, the other Party shall cooperate fully in the preparation and filing of any regulatory filings which may be necessary or appropriate, including, without limitation, providing such information as may reasonably be necessary or which is requested by the Governmental Entity. Where a Party reasonably believes that information to be filed with a Governmental Authority is Proprietary Information, the Parties shall cooperate to obtain such confidential treatment from the Governmental Authority as may reasonably be secured.
Regulatory Submissions.ÌýWith regard to Regulatory Submissions for the Product in the Licensed Territory, MTIA will be responsible for the preparation of all documentation necessary for a complete fast-track Regulatory Submissions for the Product in the Licensed Territory. MTIA shall be responsible for providing, in the format required by the Regulatory Authority, the data and information required to be submitted in connection with such fast-track Regulatory Submission required for Approval of the Product by the Regulatory Authority in the Licensed Territory. The fast-track Regulatory Submission shall be filed by MTIA in MTIA or Affiliate’s name for the Product in the Licensed Territory. The Parties shall request a joint meeting (which may either be a teleconference or face-to-face meeting) with the CFDA’s review divisions or any other similar applicable Regulatory Authority for the Product to help ensure that the Product development plans will produce sufficient data to meet the CFDA’s or any other similar applicable Regulatory Authority’s criteria for Approval of the use of the Product in the Licensed Territory. MTIA shall provide updates to the JSC regarding the status of each pending or proposed Regulatory Submission for the Product and shall provide the JSC with copies of all correspondence MTIA receives from the Regulatory Authorities relating to the Regulatory Submission for the Product (or other communications whether written or verbal that have been reduced to writing that concern the Labeling of the Product), and shall keep the JSC informed on an on-going basis regarding the schedule and process for the preparation of Regulatory Submissions for the Product, and shall provide working drafts of proposed Regulatory Submissions for the Product (including, but not limited to, parts of the Regulatory Submission that concern the Labeling of the Product) to the JSC to provide Echo an opportunity to review and comment on such drafts. In accordance with the foregoing, the Parties shall be required to protect from disclosure the Regulatory Submissions and related correspondence, drafts and documentation for the Product, and treat such information as â€�Confidential Informationâ€� in accordance with the requirements of Article 9, and the Parties agree to only use such information for the purposes of this Agreement. All Regulatory Submissions and other correspondence with Regulatory Authorities by MTIA for the Product shall be subject to the prior written approval of Echo. The Labeling t...