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.
Marketing and Promotion The School will be responsible for marketing and promoting the Sports Facilities in accordance with the agreed aims and targets. A marketing strategy will be prepared and implemented and reviewed on an annual basis.
Regulatory Affairs From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory.
(a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling.
(b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing.
(c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided, however, that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter.
(d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly:
(i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory;
(ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views;
(iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority;
(iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory;
(v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and
(vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term.
(e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates.
(f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory.
(g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense (provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and:
(i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question;
(ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product;
(iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties;
(iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product;
(v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and
(vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice.
(h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights.
(i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory.
(j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.
Promotion and Marketing For the purpose of promotion and marketing, the Borrower hereby authorizes and consents to the reproduction, disclosure and use by the Lenders and the Agent of its name, identifying logo and the Facilities. The Borrower acknowledges and agrees that the Lenders shall be entitled to determine, in their sole discretion, whether to use such information; that no compensation will be payable by the Lenders or the Agent in connection therewith; and that the Lenders and the Agent shall have no liability whatsoever to it or any of its employees, officers, directors, affiliates or shareholders in obtaining and using such information as contemplated herein.
Training and Professional Development 11.1 The Employer will develop and maintain an employee training and development plan and provide such plan to the Union upon request. Staff training is intended to provide an opportunity for classified staff employees for training sponsored by the University Training and Development and the UW Medical Centers Organizational Development and Training. Education/Professional Leave is intended to facilitate employee access to continuing education opportunities. Training and educational/professional leave may be used for the purpose of improving job performance, maintaining and increasing proficiency, preparing staff for greater responsibility, or increasing promotional opportunities within the framework of staff positions available at the University.
11.2 Any release time for training for employees accepted for such classes shall be in accordance with the Executive Order (currently No. 52) governing this matter. In the event that two or more employees request the same training period and supervision must limit the number of persons who may participate at one time due to work requirements, the selection will be made on a mutually agreeable basis within the department.
11.3 The training program is a proper subject for discussion by either departmental or University-wide Joint Union/Management Committees.
11.4 If the Employer requires an employee to receive training, reimbursement will be provided in accordance with the University travel rules. Employee attendance at Employer required training, either during or outside working hours, will be considered time worked and compensated in accordance with the provisions of this Agreement.
11.5 Employee attendance at training not required by the Employer and not covered by Executive Order 52, either on approved leave from or outside of working hours, will be voluntary and not considered time worked.
Technology Research Analyst Job# 1810 General Characteristics
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 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.
RESEARCH AND PUBLICATION 29 CONTRACTOR shall not utilize information and/or data received from COUNTY, or arising out 30 of, or developed, as a result of this Agreement for the purpose of personal or professional research, or 31 for publication. 32
COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.
