Study Candidate Selection Sample Clauses

Study Candidate Selection. ‌ Any clinic patient may be considered for study candidacy while receiving routine care for emphysema. The screening flow for study candidates, with timing of study participant enrollment, is shown in Appendix 2. Prior to initiating any study screening-related activities with individual patients, all study candidates will sign a Screening Informed Consent Form (Appendix 3), or similar, to acknowledge their willingness to participate in study screening activities. A screening log that shows all screened patients who sign the Informed Consent will be maintained. The intent of the screening log (Appendix 4) is to capture the reasons that chronic obstructive pulmonary disease (COPD) patients who are interested in the study are not eligible to participate.
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Related to Study Candidate Selection

  • 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.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • 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.

  • 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.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.

  • 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.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, 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, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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