Regulatory Liaison Sample Clauses

Regulatory Liaison. USL shall be responsible for interfacing, corresponding and meeting with the FDA and other Regulatory Authorities in the Territory with respect to the Product. Without limiting the generality of the foregoing, USL will act as the Sponsor upon whom service of all processes, notices, orders, decisions, requirements, and other FDA communications shall be made with regard to all INDs and Product NDAs for the Product in the Territory. Orion shall have the right to participate and cooperate in such meetings (and planning therefor), as may be appropriate and reasonable.
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Regulatory Liaison. Meetings will be held at least annually between DNSR and SEPA (and other authorities as appropriate). These meetings will consider regulatory liaison, and where appropriate the detailed working of this MOU and any other associated documents. The meeting will consider issues that cannot be resolved at working level through extant regulatory liaison.
Sample 1
Regulatory Liaison. The Remediation Manager shall act as liaison to the Regulatory Agencies for purposes of access, inspection, information review, and the like, as requested by the agency and as approved by Client. Contractor shall support Remediation Manager in this role as Remediation Manager requests.
Sample 1
Regulatory Liaison. As and when requested or permitted by the Company, the Manager shall, with respect to the Subject Business only, act as a liaison between the Company and the DFS, the OIR and any other regulatory or governmental body or authority to facilitate compliance of the Company with applicable provisions of law and to submit information, reports and filings required or requested by any such body or authority.
Sample 1
Regulatory Liaison. As and when requested by the Company, the Manager shall act as a liaison between the Company and the Florida Department of Insurance (the "Department") and any other regulatory or governmental body or authority to facilitate compliance by the Company with applicable provisions of law and to submit information, reports, and filings required or requested by any such body or authority.
Sample 1

Related to Regulatory Liaison

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

  • Regulatory Responsibilities Subject to the terms and conditions of this Agreement, Licensee will be responsible, at its sole cost and expense, for all regulatory activities related to Development activities, as described in Section 4.1, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Each Party shall use Commercially Reasonable Efforts to carry out its regulatory obligations for the Specialty Product in accordance with the strategy for obtaining Regulatory Approval of the Specialty Product in the Territory as set forth in the Development Plan or otherwise approved by the JSC pursuant to Section 3.3‎3.3. Licensee, directly or through its Affiliates, shall use Commercially Reasonable Efforts to obtain Regulatory Approval in the Territory. Notwithstanding the foregoing, Licensee shall be the Party responsible for achieving the regulatory milestones set forth on Exhibit G (the “Regulatory Milestones”). If Licensee fails to achieve any Regulatory Milestone with the time periods allotted for such Regulatory Milestone in Exhibit G, other than for reasons, being judged by the commonly accepted standards or practices in pharmaceutical industry of Territory, that are commercially impracticable or outside Licensee’s control, then Teva shall have the option in its sole discretion upon written notice to Licensee to: (i) extend the time period allotted for the achievement of the applicable Regulatory Milestone; or (ii) convert the exclusive rights granted to Licensee in Section 2.1(a) with respect to the given Specialty Product into nonexclusive rights, provided however, that Teva has called for the consultation(s) on such failure to achieve any Regulatory Milestone but both Parties are still unable to reach a solution within three (3) months as from the date of the first consultation. All Regulatory Approvals and other Regulatory Materials relating to the Licensed Products in the Territory shall be submitted in the name of, and shall be owned by, Teva or its Affiliate1. Bidding. Licensee shall be responsible for bidding activities for all Licensed Products in the Territory. Licensee shall keep Teva informed (through the Alliance Managers, the JDC or other means of communication) of any material issues concerning bidding process for all Licensed Products in the Territory, including updates of any discussion and correspondence with any Regulatory Authority with respect thereto. Licensee shall reasonably consider Teva’s comments with respect to Licensee’s or its Affiliate’s bidding activities for all Licensed Products in the Territory and shall promptly notify Teva of bidding result for all Licensed Products in the Territory.

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