Development and Regulatory Responsibilities Sample Clauses

Development and Regulatory Responsibilities. 2.1. Section 2.1 of the Agreement is hereby amended by the addition of the following as a new second paragraph thereto: "Notwithstanding the preceding, Mylan retains the right on a co-exclusive basis with Forest (i.e., an exclusive right subject only to the rights granted to Forest hereunder) under the Licensed Patents and Licensed Know-How in the Territory for the limited purpose of Developing and Commercializing the Product (as defined in subsection (a) of Section 1.26) for the indication of [***] (the "Reserved Indication"). Such right shall not be assignable or sublicensable by Mylan and, with respect to Commercialization, may only be used for the Commercialization of Product in such dosage forms and strengths as are not reasonably likely to be substituted for dosage forms and strengths being Commercialized or Developed by Forest. In the event that sales of a Product by Mylan authorized by this paragraph are being made for indications other than the Reserved Indication during the Term ("Unauthorized Sales") as indicated by generally recognized Third Party data sources, Mylan agrees to pay Forest an amount equal to the Net Sales which Forest would have achieved if the Unauthorized Sales had been sales by Forest of the Product."
Sample 1
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Development and Regulatory Responsibilities. Unless the Parties otherwise mutually agree in writing,
Sample 1
Development and Regulatory Responsibilities. Subject to Section 3.1(c), the SCJ shall: (1) approve the Development and regulatory strategy for the Final Product, (2) provide a forum for coordination of the Parties’ Development and regulatory activities under this Agreement, and (3) as applicable, review, comment on, approve, and seek to resolve disputes with respect to, Development plans and budgets for, and the implementation of, the Development and regulatory strategy for, the Final Product. The Long-Term Development Plan, as of the Restatement Effective Date, is as set forth in Exhibit 3.1(a) hereto. The SCJ may amend or supplement the Long-Term Development Plan, and make any decision necessary to fulfill the Long-Term Development Plan in accordance with this Agreement. In particular, the SCJ shall have the following specific responsibilities with respect to the Development and registration of the Final Product in Japan:
Sample 1
Development and Regulatory Responsibilities 
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Related to Development and Regulatory Responsibilities

  • 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.

  • 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.

  • 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.

  • 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:

  • Joint Responsibilities In performing the Development Efforts, each party shall

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

  • 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).

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Client Responsibilities During the Term and subject to the provisions of this Schedule, Client shall at its expense (unless otherwise provided for herein) fulfill, or cause to be fulfilled by the Funds or otherwise, the Client obligations, if any, set forth in each Service Exhibit to this Schedule. Client hereby represents, warrants and covenants that the execution and delivery of this Schedule by Client and the performance of Client’s obligations under this Schedule have been duly authorized by all necessary action on the part of Client. Client must comply with the provisions of this Schedule. Client agrees that DST may seek relief from Client for any infringement of this Schedule such as, but not limited to, a material violation, breach, act of negligence or gross negligence, willful misconduct, misfeasance or malfeasance committed by Client or its officers, agents and assigns, in connection with Client’s obligations and responsibilities under this Schedule.

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

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