BLA and PRV Sample Clauses

BLA and PRV. (i) With respect to the BLA and the PRV, the application of the PRV was submitted on September 4, 2020 and true and complete copies of all notices submissions and material communications with the FDA in connection thereto are contained in the Data Room. (ii) The studies, tests and preclinical and clinical trials conducted by or on behalf of the Corporations in relation to the Product were conducted in accordance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable Laws; the descriptions of the results of such studies, tests and trials contained in the Data Room fairly present in all material respects the data derived from such studies, tests and trials; except to the extent disclosed in the Data Room, the Corporations are not aware of any studies, tests or trials the results of which the Corporations believe reasonably call into question the study, test, or trial results described or referred to in the Data Room when viewed in the context in which such results are described and the clinical state of development; and the Corporations have not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any current or active studies, tests or preclinical or clinical trials conducted by or on behalf of the Corporations. (iii) Except as disclosed in Schedule 5.1(dd)(iii) or in the Data Room, there are no studies, tests, preclinical or clinical trials, compassionate use programs or other similar activities conducted, pending or in progress by or on behalf of the Corporations, or which impose financial or regulatory obligations on the part of the Corporations.
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Related to BLA and PRV

  • Proposed Policies and Procedures Regarding New Online Content and Functionality By October 31, 2017, the School will submit to OCR for its review and approval proposed policies and procedures (“the Plan for New Content”) to ensure that all new, newly-added, or modified online content and functionality will be accessible to people with disabilities as measured by conformance to the Benchmarks for Measuring Accessibility set forth above, except where doing so would impose a fundamental alteration or undue burden. a) When fundamental alteration or undue burden defenses apply, the Plan for New Content will require the School to provide equally effective alternative access. The Plan for New Content will require the School, in providing equally effective alternate access, to take any actions that do not result in a fundamental alteration or undue financial and administrative burdens, but nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the same benefits or services as their nondisabled peers. To provide equally effective alternate access, alternates are not required to produce the identical result or level of achievement for persons with and without disabilities, but must afford persons with disabilities equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person’s needs. b) The Plan for New Content must include sufficient quality assurance procedures, backed by adequate personnel and financial resources, for full implementation. This provision also applies to the School’s online content and functionality developed by, maintained by, or offered through a third-party vendor or by using open sources. c) Within thirty (30) days of receiving OCR’s approval of the Plan for New Content, the School will officially adopt, and fully implement the amended policies and procedures.

  • Course Materials The adoption of any course materials, print or electronic, after a Course Agreement is signed will require an agreed and signed addendum.

  • Contract Database Metadata Elements Title: Great Neck Union Free School District and Great Neck Paraprofessionals Association (2011) Employer Name: Great Neck Union Free School District Union: Great Neck Paraprofessionals Association Local: Effective Date: 07/01/2011 Expiration Date: 06/30/2015 PERB ID Number: 5132 Unit Size: Number of Pages: 28 For additional research information and assistance, please visit the Research page of the Catherwood website - xxxx://xxx.xxx.xxxxxxx.xxx/library/research/ For additional information on the ILR School - xxxx://xxx.xxx.xxxxxxx.xxx/ ARTICLE# TITLE PAGE# Preamble 2 Article 1 Association Rights 2 Article 2 Board-Administration-Association Relationship and Procedures 4 Article 3 Exchange of Proposals 6 Article 4 Professionals Duties and Responsibilities of Paraprofessionals 7 Article 5 Work Assignments 8 Article 6 Annual Appointment 10 Article 7 Selection and Promotion 10 Article 8 Evaluations and Standards 11 Article 9 Procedures for Termination of Employment 11 Article 10 Conferences 12 Article 11 Human Resource File 12 Article 12 Professional Growth 13 Article 13 Sick Leave 14 Article 14 Personal Leave 16 Article 15 Other Leaves 17 Article 16 Grievance Procedures 18 Article 17 Legal Assistance 19 Article 18 Conformity to Law 19 Article 19 Health Insurance 20 Article 20 Retirement Plan 20 Article 21 Salary Schedule 21 Article 22 Seniority Policy 23 Article 23 Compensation for Financial Loss 24 Article 24 Duration of Agreement 25 Appendix A Determination of Negotiating Unit 25 Appendix B Payroll Deduction Authorization 26 Appendix C Bus Aides 26 Appendix D Salary Schedules 27

  • CONTRACTOR NAME CHANGE An amendment is required to change the Contractor's name as listed on this Agreement. Upon receipt of legal documentation of the name change the State will process the amendment. Payment of invoices presented with a new name cannot be paid prior to approval of said amendment.

  • Přetrvávající platnost Tento odstavec 1.3 “Zdravotní záznamy a Studijní data a údaje” zůstane závazný i v případě zániku platnosti či vypršení platnosti této Smlouvy.

  • Foreign-Owned Companies in Connection with Critical Infrastructure If Texas Government Code, Section 2274.0102(a)(1) (relating to prohibition on contracts with certain foreign-owned companies in connection with critical infrastructure) is applicable to this Contract, pursuant to Government Code Section 2274.0102, Contractor certifies that neither it nor its parent company, nor any affiliate of Contractor or its parent company, is: (1) majority owned or controlled by citizens or governmental entities of China, Iran, North Korea, Russia, or any other country designated by the Governor under Government Code Section 2274.0103, or (2) headquartered in any of those countries.

  • Changes in Equipment, Systems, Etc USBFS reserves the right to make changes from time to time, as it deems advisable, relating to its systems, programs, rules, operating schedules and equipment, so long as such changes do not adversely affect the services provided to the Trust under this Agreement.

  • Course Curriculum, Instruction, and Grading X. Xxxx College courses offered as dual credit, regardless of where they are taught, follow the same syllabus, course outline, textbook, grading method, and other academic policies as the courses outlined in the Hill College catalog. B. Approved courses being taught for dual credit must follow the approved master syllabus of the discipline and of Hill College. C. Textbooks should be identical to those approved for use by Hill College. Should an instructor propose an alternative textbook, the textbook must be approved in advance by the appropriate instructional department of Hill College and the Vice President of Instruction. Other instructional materials for dual credit/concurrent courses must be identical or at an equivalent level to materials used by Hill College. D. Courses which result in college‐level credit will follow the standard grading practices of Hill College, as identified by college policy and as identified in the appropriately approved course syllabus. The grades used in college records are A (excellent), B (above average), C (average), D (below average), F (failure), I (incomplete), W (withdrawn), WC (withdrawn COVID). The lowest passing grade is D. Grade point averages are computed by assigning values to each grade as follows: A = 4 points, B = 3 points, C = 2 points, D = 1 point, and F = 0 points. Grading criteria may be devised by Hill College and the ISD to allow faculty the opportunity to award high school credit only or high school and college credit depending upon student performance. E. Faculty, who are responsible for teaching dual credit/concurrent classes, are responsible for keeping appropriate records, certifying census date rosters, providing interim grade reports, certifying final grade reports at the end of the semester, certifying attendance, and providing other reports and information as may be required by Hill College and/or the School District.

  • Přetrvající platnost This Section 3 “

  • PRICE LISTS AND PRODUCT INFORMATION Contractors should provide an electronic version of the proposed price list in an Excel format or pdf on a jump drive. Also provide a dealer list, if applicable in an Excel format with "read and write" capabilities on the same jump drive. No costs or expenses associated with providing this information in the required format shall be charged to the State of Arkansas. At the time of contract renewal contractor will furnish OSP with an updated dealer list and published price list.

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