Research Development and Regulatory Sample Clauses

Research Development and Regulatory. 4.1 With respect to a Project each Party that has not become an Opt-Out Party agrees to perform the work assigned to that Party under a Research and Development Plan for that Project. All such work will be conducted, in a professional manner and at a level of quality appropriate to major biotechnology companies. 4.2 Each Party shall prepare a written report prior to a scheduled meeting of the JDT with respect to the work performed by such Party under a Research and Development Plan and deliver such report to the JDT prior to the scheduled meeting. 4.3 In preparing a research and development plan and subsequent approval thereof by the JDT or JCT pursuant to this Agreement, work thereunder shall be assigned to a Party based upon the respective Parties ability to perform such activity. Subject to the preceding sentence, the Parties contemplate that Infinity will have primary responsibility for activities involving expertise in development of small molecules such as lead identification and optimization, medicinal chemistry, preclinical development, early translational clinical development through initial evidence of safety and efficacy in humans, process chemistry and development and manufacturing scale-up, and that MedImmune shall have primary responsibility for pivotal clinical trials, for obtaining worldwide Regulatory Approval and for commercialization. (a) Infinity will file, own and maintain the INDs with respect to a given Product until the earlier of the end of a Phase II Clinical Trial meeting with the FDA or immediately prior to the initiation of the first Pivotal Trial in any country with respect to such Product. At the earlier of the end of a Phase II Clinical Trial meeting with the FDA or immediately prior to initiation of the first Pivotal Trial for a given Product in any country Infinity will transfer all INDs with respect to such Product to MedImmune in all countries in which MedImmune is the Selling Party and thereafter the Selling Party in a country will file, own and maintain all INDs and Regulatory Approvals for such Product in such country. The owner of the IND in the United States shall be responsible for the global product safety database for tracking safety issues with respect to the Product. (b) The owner of the IND shall within the time permitted under applicable regulations, file or cause to be filed with the FDA and any other applicable Regulatory Authority, all notices, assignments, documents or other materials required by the laws...
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Research Development and Regulatory 

Related to Research Development and Regulatory

  • Research and Development (i) Advice and assistance in relation to research and development of Party B; (ii) Advice and assistance in strategic planning; and

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members. (b) Information collected as part of this program shall be the sole property of the faculty member. This information or any judgments arising from this program shall not be used to determine non-renewal or termination of a faculty member's contract, suspension or dismissal of a faculty member, denial of advancement on the salary scale, nor affect any other administrative decisions pertaining to the promotion or employment status of the faculty member. (c) A joint advisory committee consisting of three regular faculty members who shall be elected by and are P.D. Committee Chairpersons and three administrators shall make recommendations for the operation, financing and management of the Professional Development Program.

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • Technology Research Analyst Job# 1810 General Characteristics

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • PROFESSIONAL DEVELOPMENT AND EDUCATIONAL IMPROVEMENT A. The Board of Education agrees to pay the actual tuition costs of courses taken by a teacher at accredited colleges or universities up to three courses per two (2) year fiscal periods from July 1, 2006 to June 30, 2008 and July 1, 2008 to June 30, 2010 respectively, except as follows: 1. No teacher may be reimbursed for courses taken during the first year of teaching in Vineland. 2. Teachers taking courses in the second and third years of employment in Vineland will not receive remuneration until tenure has been secured. The remuneration will then be retroactive and will be paid to the teacher in a lump sum within sixty (60) days after the teacher has secured tenure. 3. All courses must be pre-approved by the Superintendent or his designee subject to the following requirements: (a) A teacher must provide official documentation that he/she has obtained a grade of B or better; (b) Reimbursement shall be paid only for courses directly related to teacher’s teaching field which increase the teacher’s content knowledge and are related to the teacher’s current certification, as determined by the Superintendent or his/her designee in his/her sole discretion; no reimbursement shall be paid for courses leading to a post graduate or professional degree in a field other than education or teaching. Further, effective September 1, 2010, all newly hired teachers shall not be eligible for reimbursement until they are tenured, and they shall not be eligible for retroactive reimbursement upon gaining tenure for courses taken prior to being tenured. (c) The maximum total payments to be made by the Board shall not exceed $130,000.00. Courses shall be applied for no earlier than the following dates: Summer Session - April 1 Fall/Winter Session - June 1 Spring Session - October 1 Courses must, as set forth hereinabove in this sub-article 18.A.3, be pre-approved by the Superintendent or his designee, prior to the teacher commencing the course(s); and (d) Teacher taking courses shall sign a contract requiring them to reimburse the Board for all tuition paid for a course if the teacher shall voluntarily leave the employ of the Board within one (1) full school/academic year of completion of said course, except that reimbursement shall not be required when the teacher shall voluntarily leave the employ of the Board due to a significant, documented life change. 4. Tuition reimbursement costs shall be a sum not to exceed the actual cost of college credits charged in an accredited public State college/University of the State of New Jersey. B. When the Superintendent initiates in-service training courses, workshops, conferences and programs designed to improve the quality of instruction, the cooperation of the Vineland Education Association will be solicited. Notwithstanding the above, the initiation of in-service training courses, workshops, conferences and programs shall be determined solely at the discretion of the Board. C. One professional leave day may be granted to a teacher upon request, according to the following guidelines: 1. The professional day may be for attendance at a workshop, seminar or visit to another school for the expressed purpose of self professional improvement for the job. 2. The request shall arrive in the office of the Superintendent of Schools at least ten (10) working days prior to the date requested and shall be reviewed by the immediate supervisor prior to submission. The Board reserves the right to deny a professional leave day before or immediately following a holiday or on a day which by its nature suggests a hardship for providing a substitute. 3. No more than two teachers from any one elementary school or from any one department in the secondary schools may be granted a professional leave for a given day. 4. The teacher may be required to submit a report to the Superintendent of Schools, Assistant Superintendent, supervisor (s), principal and staff regarding the activity of the professional day. 5. Costs incurred by the teacher for the professional day authorized under this Section shall be the teacher’s responsibility. 6. A maximum of 90 professional leave days may be authorized for the school year which shall be apportioned as follows: elementary, 35; grades seven and eight, 20; and high school, 35. D. If the Board initiates a teacher’s attendance at a professional workshop, seminar or visit, the expenses shall be the responsibility of the Board. Further, this day shall not be subtracted from the 90 professional leave days granted to teachers of the Association. E. The Board agrees to pay the full cost of courses taken by secretaries related to skills and knowledge improvement when such courses are required and approved by the Board. F. The Board and the Association agree that it is important to communicate when developing and implementing current and future learning technologies, including but not limited to distance and on-line learning.

  • Project Development a. Collaborate with COUNTY and project clients to identify requirements and develop a project Scope Statement. a. Develop a Work Breakdown Structure (WBS) for each project. b. Evaluate Scope Statement to develop a preliminary cost estimate and determinate whether project be vendor bid or be executed under a Job Order Contract (JOC).

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