Responsibility for Regulatory Affairs Sample Clauses

Responsibility for Regulatory Affairs. Nuvios shall be responsible for all regulatory affairs in the Territory related to Licensed Compound and Licensed Product, including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to manufacture, or have manufactured, Licensed Compound or Licensed Product. Nuvios shall file all such applications in its own name, or that of its Affiliate. Nuvios shall provide Ipsen with copies of all correspondence and final filings (including, without limitation, IND filings and NDA Filings) related to Licensed Product with regulatory authorities for Ipsen and/or Teijin’, provided that Ipsen has complied with all of its obligations in the next sentence. Ipsen shall provide, or cause Teijin to provide, Nuvios with copies of all correspondence and final filings (including, without limitation, IND filings and NDA Filings) made by Teijin related to Licensed Product with regulatory authorities in Japan.
Sample 1Sample 2Sample 3See All (6)
AutoNDA by SimpleDocs
Responsibility for Regulatory Affairs. Licensors shall be responsible for all regulatory affairs related to obtaining the initial Market Authorization of the Licensed Product including the Initial Product in the countries in the Territory. For each country in the Territory, the obligations of Licensors in such country shall include the preparation and filing of applications for Marketing Authorizations in such country. Licensor shall use Diligent Efforts to file and obtain the initial Market Authorization of the Initial Product, as well as supplementary Marketing Authorization for the 2nd generation of the Initial Product (i.e., the planned new syringe and attendant needle protection system to be filed as a supplement after the approval of the Initial Product), in its own name or that of its Affiliates, but any failure to so obtain Marketing Authorization in any given country of the Territory shall not constitute a material breach of this Agreement. Upon obtaining of Marketing Authorizations and subject to applicable laws, Licensors shall promptly appoint Licensee as Licensors’ regulatory agent to perform, on behalf of but at no cost to Licensors, those activities that are the responsibility of the Licensor as Marketing Authorization holder. Following the date of the grant of the Marketing Authorization, Licensee shall (a) consult with Licensors regarding the regulatory strategy in the Territory and consider in good faith Licensors’ comments regarding the same, (b) promptly provide Licensors with copies of all correspondence received by Licensee from Regulatory Authorities within the Territory, copies of any draft response and (c) consider in good faith Licensors’ comments thereon prior to filing any such response. The Parties agree to initiate promptly following the Effective Date, through the JSC or a sub-group established by the JSC, discussion and analysis of the handling of regulatory matters with respect to the Licensed Product in the Territory and specific determination of the role of Licensee in acting as Licensors’ regulatory agent in the Territory. Licensee will be solely responsible, at its own cost, for conducting at its cost all formalities, steps and negotiation with Regulatory Authorities or any governmental entity in establishing the resale pricing and acquiring reimbursement for the Licensed Product in the Territory. The Parties shall cooperate with each other in supplying data or documents that may be requested or required by the other Party with respect to government regulati...
Sample 1
Responsibility for Regulatory Affairs. From and after the date of transfer of the INDs to Roche, and consistent with the Development Plan, Roche shall be responsible for all regulatory affairs in the Territory related to Target Product, including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to manufacture, or have manufactured, Target Product. Roche shall file all such applications in its own name, or that of its Affiliate. Roche and shall provide a copy of any BLA filing for RRP in the US for a Target Product to Stressgen for its comment prior to filing with the FDA. In addition, Roche shall provide to Stressgen reasonable written notice of all meetings and conference telephone calls with the FDA related to Target Products for the United States and for RRP Stressgen shall have a right have one person attend as a silent observer. Roche shall provide to Stressgen copies of all correspondence and final filings (including, without limitation, IND filings and BLA Filings) related to Target Product with regulatory authorities in all countries of the Territory promptly (and in any event within thirty (30) days) following receipt or filing, as applicable.
Sample 1
Responsibility for Regulatory Affairs 
Sample 1Sample 2

Related to Responsibility for Regulatory Affairs

  • Regulatory Affairs Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory.

  • Responsibility for Contract Administration The Servicer will have the sole obligation to manage, administer, service and make collections on the Contracts and perform or cause to be performed all contractual and customary undertakings of the holder of the Contracts to the Obligor. The Owner Trustee, at the written request of a Servicing Officer, shall furnish the Servicer with any powers of attorney or other documents necessary or appropriate in the opinion of the Owner Trustee to enable the Servicer to carry out its servicing and administrative duties hereunder. The Servicer is hereby appointed the servicer hereunder until such time as any Service Transfer may be effected under Article VIII.

  • Regulatory Responsibility (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities.

  • Regulatory Responsibilities Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

  • Responsibility for documentation Neither the Agent nor the Arranger:

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Responsibility of PFPC (a) PFPC shall be under no duty to take any action on behalf of the Fund except as specifically set forth herein or as may be specifically agreed to by PFPC in writing. PFPC shall be obligated to exercise care and diligence in the performance of its duties hereunder, to act in good faith and to use its best efforts in performing services provided for under this Agreement. PFPC shall be liable for any damages arising out of PFPC's failure to perform its duties under this Agreement to the extent such damages arise out of PFPC's willful misfeasance, bad faith, negligence or reckless disregard of such duties.

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

  • Responsibility for Costs The Servicer is responsible for collection from such Borrower of any recording or similar costs or expenses incidental to the granting of relief with respect to a delinquent Mortgage Loan.

  • 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).

Time is Money Join Law Insider Premium to draft better contracts faster.