Other Regulatory Responsibilities Sample Clauses

Other Regulatory Responsibilities. At the time when the first Phase I Study is completed for any Clinical Development Candidate, Angiotech thereafter shall be responsible for (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each regulatory authority with respect to such Clinical Development Candidate and any resulting Cell Therapy Product(s); (b) interfacing, corresponding and meeting with each regulatory authority; (c) maintaining all regulatory filings; (d) responding to any action by a regulatory authority that would prohibit the marketing or the continued marketing of a Cell Therapy Product, or that would result in any shortage or projected shortage of a Cell Therapy Product; and (e) filing all adverse event reports. Using its Commercially Reasonable Efforts, Athersys shall cooperate with Angiotech and assist Angiotech in the performance of all such activities, and shall provide Angiotech with any information in Athersys’ possession or control that Angiotech or Athersys reasonably deems to be relevant to any such activities. To the extent either Party or its Affiliate has or receives any information regarding any new adverse event or any serious adverse event that may be relevant to the use of any Clinical Development Candidate or Cell Therapy Product, such Party shall immediately contact the other Party and provide the other Party with all such information in accordance with the adverse event reporting procedures established by Angiotech from time to time.
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Other Regulatory Responsibilities. Except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any Ancillary Agreement, from and after the Closing, Buyer shall have the sole right and responsibility for (and shall bear the cost of) preparing, obtaining and maintaining all Regulatory Approvals, and for conducting communications with Governmental Authorities of competent jurisdiction, for the Subject Products in the Territory. Without limitation of the foregoing, promptly following the Closing, but in any event within such periods required by applicable Law, Buyer shall obtain, with respect to the Territory, such Regulatory Approvals as are necessary for Buyer’s own labeling of the Product and shall comply with such Regulatory Approvals upon receipt thereof.
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Other Regulatory Responsibilities. (a) From and after the date the Parties have filed the Buyer FDA Transfer Letters and the Sellers FDA Transfer Letters (the “NDA Transfer Date”), Buyer shall have the sole right and responsibility for (and shall bear the cost of) preparing, obtaining and maintaining all Regulatory Approvals, and for conducting communications with Governmental Authorities of competent jurisdiction, for the Products in the Territory. Without limitation of the foregoing, promptly following the Closing, but in any event within such periods required by applicable Law, Buyer shall obtain, with respect to the Territory, such Regulatory Approvals as are necessary for Buyer’s own Product labeling and shall comply with such Regulatory Approvals upon receipt thereof. Prior to the NDA Transfer Date, Sellers shall (at Buyer’s cost and expense) comply with Buyer’s reasonable directions with respect to the Regulatory Approvals for the Products in the Territory; provided that it no event shall Sellers be obligated to take any action or refrain from taking any action that is inconsistent with Sellers’ respective internal compliance policies or that Sellers reasonably believe would violate applicable Law. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential Portions are marked: [***]
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Other Regulatory Responsibilities. From and after the Full Participation Point, except as expressly provided in Section 5.1(a) and (b), BioMarin CF shall be responsible for filing, obtaining and maintaining, in its own name, all other INDs, Marketing Applications, Marketing Approvals and other regulatory filings related to the development and commercialization of Products within the Territory, provided that La Jolla will fully support and cooperate with BioMarin CF in connection with such activities to the extent requested by BioMarin CF. BioMarin CF shall also obtain any export approvals required by the FDA to import or export Products to any country within the Territory outside the United States. All such filings will be in the name of BioMarin CF, except where otherwise required by local law.
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Other Regulatory Responsibilities. (a) Except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any Ancillary Agreement, from and after the date on which the Purchased Regulatory Approval is transferred to Buyer, Buyer shall have the sole right and responsibility for (and shall bear the cost of) preparing, obtaining and maintaining all Regulatory Approvals, and for conducting communications with Governmental [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH CONFIDENTIAL TREATMENT REQUEST. Authorities of competent jurisdiction, for the Product in the Territory. Without limitation of the foregoing, promptly following the Closing, but in any event within such periods required by applicable Law, Buyer shall obtain, with respect to the Territory, such Regulatory Approvals as are necessary for Buyer’s own Product labeling and shall comply with such Regulatory Approvals upon receipt thereof.
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Other Regulatory Responsibilities. Except as set forth in this Agreement, Vivus shall be responsible for obtaining and maintaining all Regulatory Approvals for the Product both within and outside the Sanofi Territory.
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Related to Other Regulatory Responsibilities

  • Regulatory Responsibilities The Parties will share responsibility for leading regulatory matters relating to the SYNGAP1 Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each SYNGAP1 Co-Co Product, Acadia shall (x) lead the overall strategy for obtaining Regulatory Approval of such SYNGAP1 Co-Co Product (including labeling for such SYNGAP1 Co-Co Product), including by selecting the jurisdictions within which XXXx will be pursued and Execution Version the timing and order in which such approvals will be sought (“Regulatory Strategy”), and will be the Lead Regulatory Party with respect to such strategic activities with respect to such SYNGAP1 Co-Co Product, (y) be the Lead Regulatory Party with respect to the submission of any MAA for such SYNGAP1 Co-Co Product, and (z) following the first Regulatory Approval of such SYNGAP1 Co-Co Product, be the Lead Regulatory Party in connection with such SYNGAP1 Co-Co Product and with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the foregoing, the JSC shall designate a Party to lead all other pre-Regulatory Approval regulatory matters relating to each SYNGAP1 Co-Co Product in accordance with the applicable SYNGAP1 Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Party with respect to such activities). The Lead Regulatory Party shall be responsible for (i) filing for in its name, and owning, all Regulatory Materials relating to regulatory activities with respect to such SYNGAP1 Co-Co Product in the relevant country, (ii) overseeing, monitoring, and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and (iii) interfacing, corresponding, and meeting with each Regulatory Authority with respect to such activities, in each case consistent with the Regulatory Strategy and applicable SYNGAP1 Co-Development Plan or SYNGAP1 Co-Commercialization Plan.

  • Regulatory Responsibility The preparation, filing, prosecution and maintenance of INDs, BLAs and other regulatory filings required to be filed with any Regulatory Authority with regard to each Product will be in the name of and the responsibility of Alexion. Alexion shall own the Regulatory Approvals. The costs incurred by the Parties in the preparation, filing and submission of such regulatory filings will be deemed Development Expenses and subject to the terms of Section 3.6. Except as otherwise provided in an applicable Development Plan, Alexion shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to Regulatory Authorities with respect to each Product and shall give XOMA a reasonable opportunity for prior review of all such material communications, filings and submissions.

  • Primary Responsibility The Company acknowledges that to the extent Indemnitee is serving as a director on the Company’s board of directors at the request or direction of a venture capital fund or other entity and/or certain of its affiliates (collectively, the “Secondary Indemnitors”), Indemnitee may have certain rights to indemnification and advancement of expenses provided by such Secondary Indemnitors. The Company agrees that, as between the Company and the Secondary Indemnitors, the Company is primarily responsible for amounts required to be indemnified or advanced under the Company’s certificate of incorporation or bylaws or this Agreement and any obligation of the Secondary Indemnitors to provide indemnification or advancement for the same amounts is secondary to those Company obligations. To the extent not in contravention of any insurance policy or policies providing liability or other insurance for the Company or any director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, the Company waives any right of contribution or subrogation against the Secondary Indemnitors with respect to the liabilities for which the Company is primarily responsible under this Section 15. In the event of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Company’s certificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee for indemnification or advancement of expenses under the Company’s certificate of incorporation or bylaws or this Agreement or, to the extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to the amounts paid. The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15.

  • Company Responsibilities The Company will undertake responsibilities as set forth below:

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

  • Other Responsibilities The Responsibility factors also take account of any responsibility the jobholder may have through the provision of advice and guidance on policies and procedures, research or the adaptation or development of existing or new policies and procedures. An assessment tool has been developed to help ensure that advisory, policy and similar ‘hands off’ responsibilities, such as research or democratic services, are correctly measured and allocated to the appropriate Responsibility factor. It is recommended that jobs are first evaluated on their ‘hands on’ responsibilities under each Responsibility factor and that an assessment is then made of the level of advisory/policy responsibilities and the factor to which it should be allocated.

  • ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:

  • Joint Responsibilities 2.1.1 University and Affiliate each will identify, and notify each other of, a person responsible for serving as its liaison during the course of this affiliation. The appointment of liaisons shall be subject to mutual approval of the parties.

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • Additional Responsibilities You agree to: reasonably clean and maintain Covered Items; not harm/damage a Covered Item or Component; provide a safe working environment for Contractors; not damage property of a Contractor; and not threaten/harm us or a Contractor via phone, email, personal interaction, internet, social media or otherwise.

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