Authorization of the Manufacturing Facility by FDA Sample Clauses

Authorization of the Manufacturing Facility by FDA. PCD shall be responsible for providing information that may be used in, or referenced by, an application filed by SPI with the U.S. Food and Drug Administration (the “FDA”) for purposes of ensuring that the PCD manufacturing facility is authorized to manufacture the Drug Substance and Drug Product to be supplied under this Agreement. SPI shall have no obligation to purchase any Drug Product from PCD if they are produced in a manufacturing facility that is not, in any material respect, in compliance with all applicable legal and regulatory requirements.
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Authorization of the Manufacturing Facility by FDA. RTU shall be responsible for providing information that may be used in, or referenced by, an application filed by SPA with the US Food and Drug Administration and other Regulatory Authorities for purposes of ensuring that the RTU manufacturing facility is authorized to manufacture the Drug Substance and Drug Product to be supplied under this Agreement. SPA shall have no obligation to purchase any Drug Substance or Drug Product from RTU if they are produced in a manufacturing facility that is not, in any material respect, in compliance with all applicable legal and regulatory requirements for the importation, registration, use or sale of Drug Substance or Drug Product in the SPA Territory.

Related to Authorization of the Manufacturing Facility by FDA

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract. a. The contractor shall notify all potential subcontractors and suppliers and lessors of their EEO obligations under this contract. b. The contractor will use good faith efforts to ensure subcontractor compliance with their EEO obligations.

  • Authorization and Application of Overtime An employee who is required to work overtime shall be entitled to overtime compensation when the overtime worked is authorized in advance.

  • Emergency Work Authorizations The State, at its sole discretion, may accept the Engineer's signature on a faxed copy of the work authorization as satisfying the requirements for executing the work authorization, provided that the signed original is received by the State within five business days from the date on the faxed copy.

  • Inspection Testing Authorization and Right of Access 2.1 Equipment Testing and Inspection 2.2 Authorization Required Prior to Parallel Operation

  • System Upgrade Facilities and System Deliverability Upgrades Connecting Transmission Owner shall design, procure, construct, install, and own the System Upgrade Facilities and System Deliverability Upgrades described in Appendix A hereto. The responsibility of the Developer for costs related to System Upgrade Facilities and System Deliverability Upgrades shall be determined in accordance with the provisions of Attachment S to the NYISO OATT.

  • Authorization Required Prior to Parallel Operation 2.2.1 The NYISO, in consultation with the Connecting Transmission Owner, shall use Reasonable Efforts to list applicable parallel Operating Requirements in Attachment 5 of this Agreement. Additionally, the NYISO, in consultation with the Connecting Transmission Owner, shall notify the Interconnection Customer of any changes to these requirements as soon as they are known. The NYISO and Connecting Transmission Owner shall make Reasonable Efforts to cooperate with the Interconnection Customer in meeting requirements necessary for the Interconnection Customer to commence parallel operations by the in-service date. 2.2.2 The Interconnection Customer shall not operate its Small Generating Facility in parallel with the New York State Transmission System or the Distribution System without prior written authorization of the NYISO. The NYISO, in consultation with the Connecting Transmission Owner, will provide such authorization once the NYISO receives notification that the Interconnection Customer has complied with all applicable parallel Operating Requirements. Such authorization shall not be unreasonably withheld, conditioned, or delayed.

  • No Physical Presence of Quorum and Participation by Audio or Video; Disaster Declaration The ability of the Board to meet in person with a quorum physically present at its meeting location may be affected by the Governor or the Director of the Ill. Dept. of Public Health issuing a disaster declaration related to a public health emergency. The Board President or, if the office is vacant or the President is absent or unable to perform the office’s duties, the Vice President determines that an in- person meeting or a meeting conducted under the Quorum and Participation by Audio or Video Means subhead above, is not practical or prudent because of the disaster declaration; if neither the President nor Vice President are present or able to perform this determination, the Superintendent shall serve as the duly authorized designee for purposes of making this determination. The individual who makes this determination for the Board shall put it in writing, include it on the Board’s published notice and agenda for the audio or video meeting and in the meeting minutes, and ensure that the Board meets every OMA requirement for the Board to meet by video or audio conference without the physical presence of a quorum.

  • 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.

  • Use of Interconnection Facilities by Third Parties 6551 Error! Hyperlink reference not valid.9.9.1 Purpose of Interconnection Facilities. 6551

  • Solicitations for Subcontracts, Including Procurement of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Local Government for work to be performed under a subcontract, including procurement of materials or leases of equipment, each potential subcontractor or supplier will be notified by the Local Government of the Local Government’s obligations under this Agreement and the Acts and Regulations relative to Nondiscrimination on the grounds of race, color, or national origin.

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