Required Further Development of Initial Product in the United States Sample Clauses

Required Further Development of Initial Product in the United States. (i) The JDC is using reasonable efforts to agree on the Development Plans (consistent with Section 3.4) and Regulatory Strategy for conducting the FDA CVOT Study and the FDA Pediatric Studies, and the Parties acknowledge that such development work shall be conducted according to the terms of this Section 3.2(a) and Section 3.5. If the JDC (and thereafter the JSC and the Senior Executives pursuant to Section 4.1(f)) are unable to agree on such Development Plans or Regulatory Strategy (or any amendments thereto) by [...***...], then thereafter Eisai shall have final decision-making authority, subject to and in accordance with Section 4.1(f), with respect to such Development Plans and Regulatory Strategy (and any amendments thereto) for conducting the FDA CVOT Study and the FDA Pediatric Studies. (ii) If the FDA requires Post-Approval Required U.S. Development in addition to the FDA CVOT Study and the FDA Pediatric Studies, Eisai (or one of its Affiliates) shall notify Arena of such additional Post-Approval Required U.S. Development, and the Parties shall, through the JDC, promptly meet to discuss in good faith and seek to agree on the Development Plan (consistent with Section 3.4) and Regulatory Strategy for such additional Post-Approval Required U.S. Development; provided, that, unless the Parties otherwise agree in writing: (i) the Parties shall conduct, or cause their Affiliates to conduct, such Post-Approval Required U.S. Development in accordance with the applicable Development Plan pursuant to Section 3.5 and; (ii) if the JDC (and thereafter the JSC and the Senior Executives pursuant to 31 ***Confidential Treatment Requested Section 4.1 (f)) are unable to agree on such Development Plan or Regulatory Strategy (or any amendments thereto) , neither Party shall have final decision-making authority with respect to such Development Plan or Regulatory Strategy (or any amendments thereto) until [...***...], after which time Eisai shall have final decision-making authority subject to and in accordance with Section 4.1(f) with respect to such Development Plan and Regulatory Strategy for conducting such Post-Approval Required U.S. Development (and any amendments thereto). (iii) Eisai shall bear 90% and Arena shall bear 10% of the Development Expenses with respect to all Post-Approval Required U.S. Development, except that (A) the Parties shall share equally the Development Expenses with respect to pediatric or adolescent studies required by the FDA under Section ...
Sample 1
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Related to Required Further Development of Initial Product in the United States

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • 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.

  • Drug Free Work Place Grantee shall establish and maintain a drug-free work place policy.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

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

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Placement of DNS probes Probes for measuring DNS parameters shall be placed as near as possible to the DNS resolvers on the networks with the most users across the different geographic regions; care shall be taken not to deploy probes behind high propagation-­‐delay links, such as satellite links.

  • 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.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

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