cGMP Requirements; Sample Clauses

cGMP Requirements; reporting of Manufacturing Reportable Events; or
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cGMP Requirements;. 1. In addition to existing FDA authorities and remedies, GSK agrees to certain obligations under this Appendix relating to cGMP Requirements for GSK drug products and vaccines. These provisions are in addition to other remedies available to the FDA. 2. If the Director of Compliance at FDA’s Center for Drug Evaluation and Research (CDER), or in the case of a vaccine, the Director of Compliance at FDA’s Center for Biologics Evaluation and Research (CBER) determines that a GSK facility (or facilities) manufacturing, processing, packing, or holding a GSK drug product or vaccine is not compliant with cGMP Requirements, FDA may so notify the OIG and recommend that OIG direct GSK to undertake a Specified Action as set forth below in section III.D.3 of this Appendix. 3. If, after reviewing FDA’s notification and recommendation, OIG agrees that GSK should be directed to undertake a Specified Action as set forth in section III.D.3 of this Appendix, OIG shall notify GSK in writing of its determination and direct GSK to undertake one or more of the following actions (Specified Actions): a. Submit a report or information addressing the assertion of non-compliance to FDA and OIG within 10 days after the date of written notification from the OIG in accordance with the Notification provision in section III.D.4 below; b. In the event that OIG and/or FDA request additional or follow-up information, GSK shall submit revised, modified, or expanded report(s) or plan(s) to FDA and OIG in accordance with time frames established by the OIG and FDA; and/or c. Initiate a recall of the GSK drug product or vaccine in accordance with the instructions and time frames specified by OIG and FDA. 4. All notifications and reports required under this Section III.D shall be submitted to the following: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, X.X. Washington, DC 20201 Division of Manufacturing and Product Quality HFD-320 Center for Drug Evaluation and Research 00000 Xxx Xxxxxxxxx Xxxxxx White Oak Bldg. 51 Silver Spring, MD 20993 Xxx Xxxxxxx Vice President - GMS Compliance Officer GlaxoSmithKline GSK House (Mailstop BNG-00) 000 Xxxxx Xxxx Xxxx Brentford Middlesex TW8 9GS United Kingdom Xxxx Xxxx Vice President - Associate General Counsel Legal Operations - Global Manufacturing and Supply GlaxoSmithKline Five Xxxxx Drive Ruvane Bui...
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cGMP Requirements;. GMEL shall exercise its best efforts to ensure that Pacific provides a manufacturing process and facility for the Licensed Products that complies with United States cGMP requirements during the term of this Agreement.
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Related to cGMP Requirements;

  • System Requirements Apple Software is supported only on Apple-branded hardware that meets specified system requirements as indicated by Apple.

  • Basic Requirements To be eligible for PayPal’s Seller Protection program, all of the following basic requirements must be met, as well as any applicable additional requirements: • The primary address for your PayPal account must be in the United States. • The item must be a physical, tangible good that can be shipped, except for items subject to the Intangible Goods Additional Requirements. Transactions involving items that you deliver in person in connection with payment made in your physical store, may also be eligible for PayPal’s Seller Protection program so long as the buyer paid for the transaction in person by using a PayPal goods and services QR code. • You must ship the item to the shipping address on the Transaction Details page in your PayPal account for the transaction. If you originally ship the item to the recipient’s shipping address on the Transaction Details page but the item is later redirected to a different address, you will not be eligible for PayPal’s Seller Protection program. We therefore recommend not using a shipping service that is arranged by the buyer, so that you will be able to provide valid proof of shipping and delivery. • The shipping requirement does not apply to eligible transactions involving items that you deliver in person; provided, however, that you agree to provide us with alternative evidence of delivery or such additional documentation or information relating to the transaction that we may request. • You must respond to PayPal’s requests for documentation and other information in a timely manner as requested in our email correspondence with you or in our correspondence with you through the Resolution Center. If you do not respond to PayPal’s request for documentation and other information in the time requested, you may not be eligible for PayPal’s Seller Protection program. • If the sale involves pre-ordered or made-to-order goods, you must ship within the timeframe you specified in the listing. Otherwise, it is recommended that you ship all items within 7 days after receipt of payment. • You provide us with valid proof of shipment or delivery. • The payment must be marked “eligible” or “partially eligible” in the case of Unauthorized Transaction claims, or “eligible” in the case of Item Not Received claims, for PayPal’s Seller Protection program on the Transaction Details page. • In the case of an Unauthorized Transaction claim, you must provide valid proof of shipment or proof of delivery that demonstrates that the item was shipped or provided to the buyer no later than two days after PayPal notified you of the dispute or reversal. For example, if PayPal notifies you of an Unauthorized Transaction claim on September 1, the valid proof of shipment must indicate that the item was shipped to the buyer no later than September 3 to be eligible for PayPal’s Seller Protection program. PayPal determines, in its sole discretion, whether your claim is eligible for PayPal’s Seller Protection program. PayPal will make a decision, in its sole discretion, based on the eligibility requirements, any information or documentation provided during the resolution process, or any other information PayPal deems relevant and appropriate under the circumstances. To be eligible for PayPal’s Seller Protection program for a buyer’s Item Not Received claim, you must meet both the basic requirements and the additional requirements listed below: • Where a buyer files a chargeback with the issuer for a card-funded transaction, the payment must be marked “eligible” for PayPal’s Seller Protection on the Transaction Details page. • You must provide proof of delivery as described below.

  • Program Requirements The parties shall comply with the Disadvantaged Business Enterprise Program requirements established in 49 CFR Part 26.

  • Tax Requirements The Participant is hereby advised to consult immediately with his or her own tax advisor regarding the tax consequences of this Agreement. The Company or, if applicable, any Subsidiary (for purposes of this Section 28, the term “Company” shall be deemed to include any applicable Subsidiary), shall have the right to deduct from all amounts hereunder paid in cash or other form, any Federal, state, local, or other taxes required by law to be withheld in connection with this Award. The Company may, in its sole discretion, also require the Participant receiving shares of Common Stock issued under the Plan to pay the Company the amount of any taxes that the Company is required to withhold in connection with the Participant’s income arising with respect to this Award. Such payments shall be required to be made when requested by the Company and may be required to be made prior to the delivery of any certificate representing shares of Common Stock. Such payment may be made (i) by the delivery of cash to the Company in an amount that equals or exceeds (to avoid the issuance of fractional shares under (iii) below) the required tax withholding obligations of the Company; (ii) if the Company, in its sole discretion, so consents in writing, the actual delivery by the exercising Participant to the Company of shares of Common Stock other than (A) Restricted Stock, or (B) Common Stock that the Participant has not acquired from the Company within six (6) months prior to the date of exercise, which shares so delivered have an aggregate Fair Market Value that equals or exceeds (to avoid the issuance of fractional shares under (iii) below) the required tax withholding payment; (iii) if the Company, in its sole discretion, so consents in writing, the Company’s withholding of a number of shares to be delivered upon the exercise of the Stock Option other than shares that will constitute Restricted Stock, which shares so withheld have an aggregate fair market value that equals (but does not exceed) the required tax withholding payment; or (iv) any combination of (i), (ii), or (iii). The Company may, in its sole discretion, withhold any such taxes from any other cash remuneration otherwise paid by the Company to the Participant.

  • Time Requirements The Independent Contractor will not be required to follow or establish a regular or daily work schedule, but shall devote during the term of this Agreement the time, energy and skill as necessary to perform the services of this engagement and shall, periodically or at any time upon the request of the Company, submit information as to the amount of time worked and scope of work performed.

  • 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.

  • E-Verify Requirements To the extent applicable under ARIZ. REV. STAT. § 41- 4401, the Contractor and its subcontractors warrant compliance with all federal immigration laws and regulations that relate to their employees and their compliance with the E-verify requirements under ARIZ. REV. STAT. § 23-214(A). Contractor’s or its subcontractor’s failure to comply with such warranty shall be deemed a material breach of this Agreement and may result in the termination of this Agreement by the City.

  • Specific Requirements compensation insurance with statutory limits required by South Dakota law. Coverage B-Employer’s Liability coverage of not less than $500,000 each accident, $500,000 disease-policy limit, and $500,000 disease-each employee.

  • Work Requirements The following Partner(s) is/are required to work for the Partnership: (choose one) ☐ - No Partners. No Partners are required to work for the Partnership. ☐ - Specific Partners. The following Partner(s) are required to work for the Partnership: [PARTNER(S')] NAME(S)]. Compensation, if any, shall be agreed to in a separate document.

  • Check Requirements Any image of a check that I transmit to you must accurately and legibly provide all the information on the front and back of the check at the time presented to me by the drawer. Prior to capturing the original check, I will indorse the back of the original check. My endorsement will include "For Directions E- Deposit Only" in addition to my signature. The image of the check transmitted to you must accurately and legibly provide, among other things, the following information: (1) the information identifying the drawer and the paying bank that is preprinted on the check, including complete and accurate MICR information and the signature(s); and (2) other information placed on the check prior to the time an image of the check is captured, such as any required identification written on the front of the check and any endorsements applied to the back of the check. The image quality for the check will meet the standards for image quality established by the American National Standards Institute ("ANSI"), the Board of Governors of the Federal Reserve, and any other regulatory agency, clearing house or association. Rejection of Deposit. You are not liable for any service or late charges levied against me due to your rejection of any item. In all cases, I am responsible for any loss or overdraft plus any applicable fees to my Account due to an item being returned. Items Returned Unpaid. A written notice will be sent to me of transactions you are unable to process because of returned items. With respect to any item that I transmit to you for remote deposit that you credit to my Account, in the event such item is dishonored, I authorize you to debit the amount of such item from the Account.

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