NT Pharma Responsibilities Sample Clauses

NT Pharma Responsibilities. Subject to Clause 3.1, NT Pharma shall have the exclusive right to control and shall be responsible for (i) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product in the Territory; (ii) all pharmacovigilance activities with respect to Product in the Territory; and (iii) all medical investigations and evaluations and the reporting of adverse events related to Product in the Territory, in each case (clauses (i) - (iii)) as required under Applicable Law or by any Regulatory Agency in the applicable jurisdictions (collectively, the “Commitment Activities”). NT Pharma shall bear the expense of all Commitment Activities.
Sample 1
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NT Pharma Responsibilities. (i) Within ninety (90) days after the Effective Date, the Executive Steering Committee (by consensus of the Parties and without regard to any final decision-making authority of either Party as set forth in Section 7.4(b)(i) and Section 7.4(b)(ii)) shall determine and set forth in writing a timeline listing the key activities of, and the milestones to be achieved by Pfenex and NT Pharma, respectively, with respect to the development of and Regulatory Approval for Product in Mainland China and the targeted completion date for each such activity and milestone (the “Timeline”); however, it is understood that such activities and milestones for which Pfenex is responsible under the Timeline shall be limited to delivery of appropriate sections of the NDA pursuant to Section 3.1(b), the manufacture of Product for clinical development (if applicable) pursuant to Section 5.1, and the other activities or obligations of Pfenex as expressly provided in this Agreement. The Parties acknowledge that one Party’s commencement or completion of certain activities or milestones may be conditioned on the other Party’s completion of certain activities or provision of certain items, as may be specified in the Timeline. NT Pharma shall use Commercially Reasonable Efforts to develop Product as necessary to obtain and maintain, at its own cost, Regulatory Approvals for Product in each country within the Territory, in accordance with the Timeline in the case of Mainland China. (ii) NT Pharma shall develop the Product in the Territory (including the conduct of the China Clinical Study, if required) in a good scientific manner and in accordance with cGxP of the applicable jurisdiction to the extent cGxP is applicable to such activities, to achieve such objectives efficiently and expeditiously, in compliance with all Applicable Laws. NT Pharma shall keep Pfenex reasonably informed as to NT Pharma’s (and its Affiliates’) planned activities (including written development plans with estimated timelines) and progress with respect to the development and regulatory affairs relating to Product through quarterly updates to the Executive Steering Committee. (iii) Pfenex will have the right to terminate this Agreement and receive a termination fee in the amount of [***] in accordance with Section 10.2(a)(iii), should NT Pharma fail to comply with the Timeline, unless such failure is due to circumstances outside of NT Pharma’s reasonable control or due to Pfenex’s breach of this Agreement. (iv) NT...
Sample 1
NT Pharma Responsibilities. NT Pharma shall have the exclusive right to control and shall be responsible for (i) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product in the Territory; (ii) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (iii) all medical investigations and evaluations and the reporting of adverse events related to Product in the Territory, in each case (clauses (i) – (iii)) as required under Applicable Law or by any Regulatory Agency in [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. the applicable jurisdictions (collectively, the “Commitment Activities”). NT Pharma shall bear the expense of all Commitment Activities.
Sample 1

Related to NT Pharma Responsibilities

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.

  • Licensee’s Responsibilities Licensee will be responsible for any and all damage to or relocation of existing facilities. Further, Licensee shall reimburse the City for all costs of replacing or repairing any property of the City, or of others, that is damaged by or on behalf of Licensee as a result of activities under this Agreement.

  • IRO Responsibilities The IRO shall: 1. perform each Claims Review in accordance with the specific requirements of the CIA;

  • Client’s Responsibilities (a) Client agrees to advise Consultant regarding Client's Project requirements and to provide all relevant information, surveys, data and previous reports accessible to Client which Consultant may reasonably require. (b) Client shall designate a Project Representative to whom all communications from Consultant shall be directed and who shall have limited administrative authority on behalf of Client to receive and transmit information and make decisions with respect to the Project. Said representative shall not, however, have authority to bind Client as to matters of governmental policy or fiscal policy, nor to contract for additions or obligations exceeding a value which is the lesser of $5000 or 5% of the maximum contract price. (c) Client shall examine all documents presented by Consultant, and render decisions pertaining thereto within a reasonable time. The Client's approval of any drawings, specifications, reports, documents or other materials or product furnished hereunder shall not in any way relieve Consultant of responsibility for the professional adequacy of its work. (d) Client shall perform its obligations and render decisions within a reasonable time under the circumstances presented. Based upon the nature of Client and its requirements, a period of 14 days shall be presumed reasonable for any decision not involving policy decision or significant financial impact, when all information reasonably necessary for Client to responsibly render a decision has been furnished. A period of 46 days shall be presumed reasonable for Client to act with respect to any matter involving policy or significant financial impact. The above periods of presumed reasonableness shall be extended where information reasonably required is not within the custody or control of Client but must be procured from others.

  • User Responsibilities i. Users are required to follow good security practices in the selection and use of passwords; ii. Users shall ensure that unattended equipment is protected; and iii. Users shall adopt a clear desk policy for papers and removable storage media and a clear screen policy for information processing facilities.

  • Supplier’s Responsibilities 14.1 The Supplier shall supply all the Goods and Related Services included in the Scope of Supply in accordance with GCC Clause 12, and the Delivery and Completion Schedule, as per GCC Clause 13.

  • University Responsibilities 4.1 The University will provide a room accommodation to The Resident for a period of one academic year or the portion of the academic year remaining when occupancy begins (limited to the subsequent fall and spring semesters) exclusive of the Winter Recess period unless The Resident is assigned to a facility that remains open during this time or is approved to live on-campus during Winter Recess. Services provided by the University begin on the official check-in dates for the specific area and include access to the assigned building and room. 4.2 In accordance with University policy, the University will provide staff that will help facilitate a living experience that complements the academic mission of the University. 4.3 Exclusive of unanticipated weather events and building system failures that may disrupt service and subject to the availability of applicable resources, the University will provide adequate light, heat, electricity, hot water and telecommunication services (limited to video and internet connection) to residents. Student rooms shall be furnished.

  • Vendor Responsibilities Note: NO EXCEPTIONS OR REVISIONS WILL BE CONSIDERED IN C-M, O-S, V-W. Indemnification

  • COUNTY’S RESPONSIBILITIES A. A County program liaison will monitor the submission of all correspondence required in this Agreement, including, but not limited to: 1. Quarterly Treatment Reports; 2. Financial reports such as annual budgets, cost allocation plans, and cost reports; 3. Incident reports; 4. Outcome data; 5. Monthly XXXXX Reports 6. Other requested reports B. A County program liaison may visit Contractor during the contract term. The visits shall be for the purpose of reviewing any aspect of Contractor’s program operations. The visit may include, but is not limited to: 1. Review all pertinent participant records. 2. Conduct appropriate interviews/discussions with participants served by Contractor. 3. Review and monitor all correspondence and reports submitted by Contractor related to Contractor’s services provided under this Agreement. 4. Meet with appropriate program management and operations staff. 5. Conduct site visit(s) to Contractor’s program(s) at least once during the term of the Agreement to review all aspects of program operations. Site visit(s) may include a review of Contractor’s programmatic and fiscal documentation related to required reports on services specified in the Exhibits. a. Provide a written site review report documenting areas of compliance and any necessary corrective action(s) required. 6. A County program liaison may attend an organized activity of a selected component or selected components of Contractor’s program(s) at least once during the contract term. C. AODS will conduct periodic mandatory treatment provider meetings with representatives of all contracted service providers and appropriate staff. D. Provide ongoing technical assistance as needed. E. AODS shall act as intermediary on behalf of each contracted alcohol and drug service provider in the submission of the California Outcomes Measurement System (CalOMS) data submissions to the State of California. I. GENERAL ADMINISTRATIVE REQUIREMENTS A. Attend each of the following meetings: 1. Contractor shall attend periodic mandatory meetings; and 2. Drug and Alcohol Information System for You (DAISY) User Group meeting. 3. Other meetings as required by the County B. Contractor shall acknowledge the San Mateo County Alcohol and Other Drug Services (AODS) and/or the County of San Mateo as a funding source on newly developed promotional materials. C. Subcontracting requirements: 1. Pursuant to paragraph 12 of the body of this Agreement, Contractor may subcontract for provision of services described in this Agreement with written approval of the Director of the Human Services Agency or her designee. If Contractor subcontracts for any services under this Agreement, Contractor will guarantee that any and all subcontractors have and maintain the same level of insurance coverage required of the Contractor under this Agreement. Contractor and County will be listed as additional insured on all applicable insurance of subcontractor.

  • Joint Responsibilities The relationship between SAE ITC, the Activities and its Members shall be, and at all times, advisory only, and no party shall have the authority to enter into any contract or commitment in the name of, or on behalf of, any other party. Nothing in this Agreement shall be construed to confer upon either party the status of employee, agent, partner, joint venturer or legal representative of the other, it being intended by all parties to remain independent legal entities solely responsible for its own actions.

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