Manufacture Requirements Sample Clauses

Manufacture Requirements. Products shall be Manufactured in compliance with the Specifications, this Agreement, the Quality Agreement and Applicable Law in the Territory, including, without limitation, cGMP and, for clarity if deemed a Combination Product, a Product shall be Manufactured in accordance with applicable cGMP requirements set forth in 21 CFR Parts 210 and 211, 21 CFR Parts 600-680 and such provisions of 21 CFR Part 820 specified in 21 CFR 4.4(b)(1) (collectively, the foregoing plus the requirements set forth in Section 12.2(a)(i) through (v), the “Quality Standards”).
Sample 1
AutoNDA by SimpleDocs
Manufacture Requirements. 3.1. OISHI must conduct the manufacture under suitable conditions and controls in accordance with US FDA GMP requirements as defined in 21 CFR Parts 210 and 211 and applicable guidance where local licenses are needed from the Authorities. These must be obtained by OISHI. 3.2. Oishi is responsible for carrying out, or having carried out on its behalf, an audit of the manufacturer of the active substances.
Sample 1

Related to Manufacture Requirements

  • License Requirements The Hotel’s alcoholic beverage license requires that the Hotel shall: (i) request proper identification (photo ID) of any person of questionable age and refuse alcoholic beverage service if the person is either under age or proper identification cannot be produced, and (ii) refuse alcoholic beverage service to any person who, in the Hotel’s judgment, appears to be intoxicated; and (iii) instruct its personnel to avoid encouraging patrons to consume alcoholic beverages (commonly referred to as “over-pouring”).

  • Software Requirements 7 Developer shall prepare the Project Schedule using Oracle’s Primavera P6.

  • Health Requirements A. Provider shall remain in compliance with all applicable federal, state, county, and municipal, statutes, laws, ordinances, regulations, and guidelines, as well as any Board guidelines, policies, and rules in effect now or later, and as amended from time to time related to COVID-19. B. Provider shall comply with evolving requirements to protect the health and safety of Student Participants and staff, as expressed in local, and state guidance from various government agencies. This includes, but is not limited to, adhering to all health and safety guidelines issued by CPS, IDPH, and CDPH related to COVID-19. Provider acknowledges these health and safety guidelines are subject to change. C. Required health and safety practices may vary across age groups and settings. Provider shall comply, at a minimum, with all health and safety mandates issued by the State of Illinois and the City of Chicago and guidance from the Illinois State Board of Education (“ISBE”). D. Under Chicago’s March 19 Public Health Order, congregate facilities (such as long-term care facilities, childcare settings, correctional facilities, etc.) must immediately report to CDPH clusters of COVID-19 patients, defined as two or more confirmed cases of COVID-19 occurring within 14 calendar days of each other at a facility. To report positive cases, Provider must complete the COVID-19 Online Case Report Form found at the following website: xxxxx://xxxxxx.xxx.xxxxxxxx.xxx/surveys/?s=FR7MAJAY84. A copy of the current COVID-19 Online Case Report Form is attached and incorporated into this Supplemental Scope as Attachment A. Provider must also comply with additional operational, reporting and tracing requirements established by CPS. E. As of July 13, 2020, interim guidance issued by CDPH encourages notification for every COVID-19 case. For more information, see CDPH Interim Guidance on Management of COVID 19 Cases in Childcare Settings (“CDPH Guidance”) at the following link: https://xxx.xxxxxxx.xxx/content/dam/city/depts/cdph/HealthProtectionandResponse/Interim% 20Guidance%20on%20Management%20of%20COVID 19%20Cases%20in%20Childcare%20Settings%2007.13.

  • Sublicense Requirements Any Sublicense: (A) is subject to this Agreement; (B) will reflect that any sublicensee will not further sublicense; (C) will prohibit sublicensee from paying royalties to an escrow or other similar account; (D) will expressly include the provisions of Sections 8, 9, and 10 for the benefit of Stanford; and (E) will include the provisions of Section 4.4 and require the transfer of all the sublicensee’s obligations to *****, including the payment of royalties specified in the Sublicense, to Stanford or its designee, if this Agreement is terminated. If the sublicensee is a spin-out from *****, ***** must guarantee the sublicensee’s performance with respect to the payment of Stanford’s share of Sublicense royalties.

  • Interface Requirements 2.4.5.1 The NID shall be equal to or better than all of the requirements for NIDs set forth in the applicable industry standard technical references.

  • Project Requirements 1. Project must conform to regulations under 24 CFR Part 92, commonly known as the HOME Regulations.

  • Quality Requirements Performance Indicator Heading Indicator (specific) Threshold Method of Measurement Frequency of monitoring Consequence of Breach

  • Safety Requirements The Contractor shall comply with all Federal, State, and local safety laws and regulations applicable to the Work performed under this Agreement.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!