Sangamo Development Responsibilities Sample Clauses

Sangamo Development Responsibilities. As between the Parties, Sangamo shall be responsible (until the IND Transition Date) for and shall use Commercially Reasonable Efforts to conduct the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study. Sangamo is the regulatory sponsor of each of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study prior to the IND Transition Date, and, subject to Section 5.2, will hold the IND therefor. Sangamo shall perform each of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study in accordance with GxP and applicable Laws, including applicable guidelines of the International Council on Harmonisation (“ICH”) to the extent [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. incorporated into FDA regulations, for investigations involving human subjects in accordance with the then-current protocol therefor, including, under the relevant JSC or JCRC:
Sample 1
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Sangamo Development Responsibilities. As between the Parties, Sangamo shall be responsible (until the IND Transition Date) for and shall use Commercially Reasonable Efforts to conduct the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study. Sangamo is the regulatory sponsor of each of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study prior to the IND Transition Date, and, subject to Section 5.2, will hold the IND therefor. Sangamo shall perform each of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study in accordance with GxP and applicable Laws, including applicable guidelines of the International Council on Harmonisation (“ICH”) to the extent incorporated into FDA regulations, for investigations involving human subjects in accordance with the then-current protocol therefor, including, under the relevant JSC or JCRC: (i) providing Pfizer for review and comment any proposed amendments to the protocol for each of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study; (ii) providing to Pfizer (i) information and transparency on all aspects of trial conduct and data generation, including Xxxxxxx’s oversight of trial conduct by CROs and clinical investigators and providing to Pfizer for review and approval Xxxxxxx’s plan for oversight of CROs and clinical investigators in conducting the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study, and (ii) any reports or findings made or received (e.g. audit report) within [*] hours of Sangamo’s receipt or identification, followed by written details and a corrective and preventative action plan within [*] days, during the course of the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long-Term Follow-Up Study; (iii) providing Pfizer timely access to all data and information at regular intervals upon Pfizer’s request, including providing Pfizer parallel data and information review during the SB-525 Phase I/II Trial and the SB-525 Phase I/II Long- Term Follow-Up Study, including, but not limited to, data outputs prepared for review by the Safety Monitoring Committee, and, subject to Section 4.4(b), using informed consent documents that will allow Xxxxxxx to comply with such obligations (for example, in the context of an audit or for use or reference in a regulatory submission); (iv) if Pfizer has inquiries or questions related to any such data provided by or on behalf of Sangamo, Sangamo shall provide written responses to said ...
Sample 1

Related to Sangamo Development Responsibilities

  • 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.

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

  • 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.

  • 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:

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

  • Joint Responsibility If the Seller determines that the Interface Problem is attributable partially to the design of a Warranted Part and partially to the design of any Supplier Part, the Seller will, if so requested by the Buyer, seek a solution to the Interface Problem through cooperative efforts of the Seller and any Supplier involved. The Seller will promptly advise the Buyer of such corrective action as may be proposed by the Seller and any such Supplier. Such proposal will be consistent with any then existing obligations of the Seller hereunder and of any such Supplier towards the Buyer. Such corrective action, unless reasonably rejected by the Buyer, will constitute full satisfaction of any claim the Buyer may have against either the Seller or any such Supplier with respect to such Interface Problem.

  • 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.

  • 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.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

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