Biovest Responsibilities Sample Clauses

Biovest Responsibilities. 1. Subject to the provisions of Articles 8.4, 8.10 and 13.1 hereunder, effective April 29, 2004, the Collaborator will be responsible for: adverse event monitoring and reporting, drug distribution, clinical data collection, and protocol amendments for NCI Protocol #00-C-0050 (P-92). 2. Upon execution of the CRADA, Collaborator will perform vaccine production step 3 and provide hybridoma supernatants in the production of Id-KLH indolent follicular lymphoma vaccine in support of NCI Protocol #00-C-0050 (P-92). 3. Effective April 29, 2004, Collaborator will be responsible for supply of Immunex/Berlex GM-CSF for NCI Protocol #00-C-0050 (P-92). 4. Effective April 29, 2004, Collaborator will perform vaccine production steps 1, 2, 3 and 4 in the production of Id-KLH indolent follicular lymphoma vaccine in support of NCI Protocol #00-C-0050 (P-92). 5. Collaborator will conduct studies as necessary with the goal of optimizing and automating vaccine production and refining and validating production procedures as required by the FDA. 6. Subject to the provisions of Articles 8.4, 8.10 and 13.1 hereunder, Collaborator will develop an electronic archive for storage and retrieval of study-related data as required by the FDA for submission of data in support of a BLA. 7. Effective April 29, 2004, Collaborator will be responsible for conduct of data monitoring activities related to NCI Protocol #00-C-0050 (P-92). 8. Collaborator will provide long-term patient monitoring to determine overall survival outcomes. 9. Collaborator will arrange, host and provide support for: meetings associated with the Protocol Steering Committee and the Oversight Committee and; quarterly site visits by appropriate NCI and Biovest staff to each clinical consortium site and; clinical investigators meetings as needed (anticipated every 6-12 months).
AutoNDA by SimpleDocs
Biovest Responsibilities. 1. Subject to the provisions of Articles 8.4, 8.10 and 13.1 hereunder, effective April 29, 2004, the Collaborator will be responsible for: adverse event monitoring and reporting, drug distribution, clinical data collection, and protocol amendments for NCI Protocol #00-C-0050 (P-92). 2. Effective April 29, 2004, Collaborator will be responsible for supply of Immunex/Berlex GM-CSF for NCI Protocol #00-C-0050 (P-92). 3. Effective April 29, 2004, Collaborator will perform vaccine production steps 1, 2, 3, and 4 in the production of Id-KLH indolent follicular lymphoma vaccine in support of NCI Protocol #00-C-0050 (P-92). NCI CRADA 01030 4. Collaborator will conduct studies as necessary with the goal of optimizing and automating vaccine production and refining and validating production procedures as required by the FDA. 5. Subject to the provisions of Articles 8.4, 8.10 and 13.1 hereunder, Collaborator will develop an electronic archive for storage and retrieval of study-related data as required by the FDA for submission of data in support of a BLA. 6. Effective April 29, 2004, Collaborator will be responsible for conduct of data monitoring activities related to NCI Protocol #00-C-0050 (P-92). 7. Collaborator will provide long-term patient monitoring to determine overall survival outcomes and will furnish such data to NCI. This responsibility will survive termination of the CRADA. 8. Collaborator will arrange, host and provide support for: meetings associated with the Protocol Steering Committee and the Oversight Committee and; quarterly site visits by appropriate NCI and Biovest staff to each clinical consortium site and; clinical investigators meetings as needed (anticipated every 6-12 months). 9. For activities conducted pursuant to this CRADA in the United States of America, Collaborator, to the extent it engages in applicable conduct, agrees to comply with all appropriate DHHS regulations relating to Human Subjects Use, all U.S. Department of Agriculture regulations, the decisions of the NCI Data Safety and Monitoring Board, and all Public Health Service policies relating to the use and care of laboratory animals. For activities conducted pursuant to this CRADA outside of the United States of America, Collaborator shall conduct such in accordance with Good Laboratory Practices (GLPs) and all applicable rules, regulations and statutes, both local and national, governing such activity in that country. 10. Biovest will seek, with NCI approval, to accelerate pa...
Biovest Responsibilities. (a) BIOVEST will be responsible, at its sole cost and expense, for the development, promotion, marketing, sales and commercialization of the Sublicensed Rights in connection with each of the Sublicense Indications. (b) BIOVEST will during the term of this Sublicense Agreement use commercially reasonable efforts to continuously develop, promote, sale, market and commercialize the Sublicensed Products for each of the Sublicense Indications. (c) Subject to Section 3.3 and Article 6 hereof, BIOVEST shall share with REVIMMUNE all proprietary and clinical data and information related to the Sublicensed Products, Sublicensed Rights and any related clinical trial which data and information may be used by REVIMMUNE in support of the development and commercialization of products for indications other than the Sublicense Indications. (d) BIOVEST shall maintain all information and data related to the Sublicensed Products and Sublicensed Rights confidential. (e) BIOVEST shall not develop or commercialize any product or treatment that could reasonably be considered to be in competition with Revimmune Licensed Rights for indications other than the Sublicense Indications. (f) BIOVEST shall promptly pay all Royalties required by this Sublicense Agreement. (g) BIOVEST shall maintain insurance pursuant to Article 7 and shall cause such insurance to name REVIMMUNE as a coinsured.

Related to Biovest Responsibilities

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • Student Responsibilities The school provided Chromebook for the student is an important learning tool to be used for educational purposes. In order to use the device each day, the student must be willing to accept the following responsibilities: ● I understand that district officials have the ability to monitor my use of the device AT ALL TIMES IN AND OUT OF SCHOOL and that communications, files, internet search activities, and any other actions using the device are not considered to be private. Note: RCCSD does not have the ability to and will not remotely operate the camera on the device. However, students can cover it when not in use to ensure others are not. ● I understand that the device assigned to me is on loan from Red Clay Consolidated School District. All accounts, programs, and files are subject to inspection at any time without notice. ● I will be responsible for ALL damage or loss of the device due to NEGLECT OR ABUSE including dropping it, getting it wet, and spills of food or drink. ● I will not try to repair my Chromebook. ● At ALL times when using my Chromebook, I will follow the Acceptable Use, Internet Safety Policy, and Student Code of Conduct, and related policies adopted by the Board of Education, and abide by all local, state, and federal laws. ● I will talk with my parent/guardian about their ground rules for going online when not at school. ● I will notify the school principal and my parents of any damage to the device as soon as possible. ● I will charge the Chromebook battery each night and will bring my Chromebook to school every day or be prepared for remote learning. ● I will keep my Chromebook clean. ● I will not lend my device to anyone. This includes family members and friends. Note: I could be held responsible for any inappropriate content on the District issued Chromebook. ● I will keep all passwords assigned to me secure. ● I will only use my account credentials to sign into my Chromebook. ● I am allowed to connect to non-district printers and wireless networks at home and in public places. ● I agree that e-mail or any other computer communication should be used only for appropriate, legitimate, and responsible communication. ● I agree not to share personal information about myself (full name, address, etc.) or about my family, friends or anyone else. ● I agree not to search for, download, display, post, or distribute vulgar, offensive material or images described in applicable district policies. (See the student handbook and/or the district's Acceptable Use Agreement.) ● I agree to abide by all school rules that address electronic device procedures. ● I will return the device when requested, at the end of the school year or upon my withdrawal. ● I agree to not deface or destroy this property in any way. Inappropriate use of the machine may result in the student losing their right to use the Chromebook. ● I understand that identification labels have been placed on the Chromebook. These labels are not to be removed or modified. Additional stickers, labels, tags, or markings of any kind are NOT to be added to the machine.

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

  • 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.

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

  • 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 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.

  • Management Responsibilities The exclusive representative recognizes the right and obligation of the School Board to efficiently manage and conduct the operation of the School District within its legal limitations and with its primary obligation to provide educational opportunity for the students of the School District.

  • 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.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!