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Updates; Candidate Selection Sample Clauses

Updates; Candidate SelectionBy September 30 of each year, the JSC shall update the R&D Plan to reflect a strategy, plan and Budget for the next calendar year (or other period agreed upon by the JSC) and shall submit such R&D Plan for approval by the parties. Each party shall use commercially reasonable efforts to approve an updated R&D Plan within thirty (30) days of receipt. In addition, when the JSC designates a compound as a candidate to be the subject of an IND filing as either a BT Product or an MD Product, the responsible party (i.e., Ercole in the case of a BT Product or AVI in the case of an MD Product) shall promptly prepare and submit to the JSC for review and approval a proposed plan for the clinical development of such Product, which will be incorporated into the Budget.

Related to Updates; Candidate Selection

  • Site Selection 5.1.1 If the parties have not designated the street address of the Franchised Location on Exhibit A on the Effective Date, Franchisee shall identify, submit and obtain Franchisor’s prior written approval of the Franchised Location meeting the requirements of this Agreement prior to entering a lease or sublease for the Franchised Location. Franchisee shall provide Franchisor all information required by Franchisor, as determined by Franchisor in Franchisor’s sole determination, necessary for Franchisor to evaluate the Franchised Location. Franchisor shall have ten (10) business days to review Franchisee’s written site proposal for the Franchised Location and notify Franchisee of its approval or disapproval in writing. Franchisor’s failure to respond within ten (10) business days shall signify Franchisor’s disapproval of the site. Franchisor shall not unreasonably withhold Franchisor’s approval of a proposed site for the Franchised Location. 5.1.2 Franchisee must have a site for the Franchised Location approved by Franchisor, receive the opening notice from Franchisor described in Section 5.4 below, and open Franchisee’s Franchised Business for business within six (6) months from the Effective Date, except as otherwise provided in Section 5.1.3 All matters related in any way to Franchisee’s site are Franchisee’s sole responsibility, regardless of any assistance Franchisor may choose to provide. Franchisee is responsible for obtaining any architectural and engineering services required for Franchisee’s facility and for ensuring its compliance with local law. Neither Franchisor, nor any other person or company associated with Franchisor shall have any liability for any site‐related matter. Xxxxxxxxxx agrees not to make any claims against Franchisor and/or any of Franchisor’s affiliates or associates with regard to such matters. 5.1.4 If Franchisor makes a loan to Franchisee for (i) Franchisee’s purchase of the franchise for the Franchised Business; (ii) the remodeling of the Franchised Location; (iii) the transfer of any interest in this franchise or this Agreement; or (iv) any other purpose; Franchisee shall open (or re‐open, as the case may be), the Franchised Business for business within sixty (60) days from the loan origination date.

  • Selection Criteria Each Contract is secured by a new or used Motorcycle. No Contract has a Contract Rate less than 1.00%. Each Contract amortizes the amount financed over an original term no greater than 84 months (excluding periods of deferral of first payment). Each Contract has a Principal Balance of at least $500.00 as of the Cutoff Date.

  • Shift Selection Employee assignments within the Patrol Bureau will occur between approximately April 1-15 and shall be awarded based upon seniority. Approximately three (3) months before then the Department will publish a call for written requests on shift assignment. Employees will make their first three (3) choices known. Employees will learn of the assignment, including days off associated with their assignment, immediately after the bidding process is completed. Assignments will take effect on the schedule immediately following July 1st. Residence Hall assignments will be made prior to all others. No officer will be required to work a Residence Hall assignment in consecutive years. Assignment of the remaining officers will begin with selection(s) for day and night shifts. The bid for assignments will continue until all positions are filled. The following general rules apply to assignments: 1. During the term of this Agreement, no employee will be reassigned to a different shift other than the shift awarded by seniority except in situations where the University cannot continue to provide police services. In the event a shift reassignment must occur, it will be offered to volunteers based on seniority. If there are no volunteers it will be assigned to the least senior officer in the department. 2. Shift selection shall be an appropriate subject for the Joint Labor/Management Committee. 3. If a shift becomes available as a result of trainees being released for duty, and if there is at least four (4) months until the next shift change, the shift will be posted and awarded by seniority. The new trainee released for duty will take the senior officers shift. If no employee desires the shift, the trainee scheduled for assignment will be assigned that shift. The parties recognize that for the betterment of the Department it may be necessary to assign a trainee to a specific shift. 4. Voluntary shift trades will be allowed as long as overtime costs are not incurred. 5. Except in a bona fide emergency, no employee shall be assigned to work more than sixteen (16) hours in a twenty-four (24) hour period, provided however employees may volunteer to work up to eighteen (18) hours in a twenty-four (24) hour period.

  • 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.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Desirable Selection Criteria Post registration qualification in the area of specialty or evidence of significant progression towards one.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Commercialization Plan At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved by the JGC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as part of the U.S. Development & Commercialization Program. (d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.

  • Single Source Selection Services for tasks in circumstances which meet the requirements of paragraph 3.10 of the Consultant Guidelines for Single Source Selection, may, with the Association's prior agreement, be procured in accordance with the provisions of paragraphs 3.9 through 3.13 of the Consultant Guidelines.

  • Joint Commercialization Committee (i) The JCC shall oversee Commercialization of JAK Licensed Products in the Field worldwide. As soon as practicable following the Effective Date (but in no event more than thirty (30) days following the Effective Date), each Party shall designate its initial three (3) representatives on the JCC. The JCC shall be composed of appropriate and key executives of Novartis together with an equal number of appropriate and key executives from Incyte. Novartis and Incyte shall each appoint a person from among its representatives on the JCC to serve as the co-chairperson of the JCC. The co-chairpersons shall not have any greater authority than any other representative on the JCC and shall conduct the following activities of the JCC: (A) calling meetings of the JCC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter; (C) preparing and circulating an agenda for the upcoming meeting; and (D) ensuring that any decision-making delegated to the JCC is carried out in accordance with Section 3.5. (ii) The JCC shall be responsible for: (A) overseeing, reviewing and coordinating the Commercialization of JAK Licensed Products in the Field worldwide; (B) developing and overseeing the Global Branding Strategy; (C) setting overall strategic objectives and plans related to Commercialization of JAK Licensed Products in the Field worldwide; (D) reviewing, commenting on and approving the Promotional Plan; (E) reviewing Commercialization issues for JAK Licensed Products in the Field in the Novartis Territory that will have an impact on Commercialization of JAK Licensed Products in the Field in the Incyte Territory; (F) reviewing Commercialization issues for JAK Licensed Products in the Field in the Incyte Territory that will have an impact on Commercialization of JAK Licensed Products in the Field in the Novartis Territory; (G) providing a forum for the Parties to discuss the Commercialization of JAK Licensed Products in the Field worldwide; and (H) such other responsibilities as may be assigned to the JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.