cGMP Requirements; Sample Clauses

cGMP Requirements; h. 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.
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.

Related to cGMP Requirements;

  • 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. * * * * * * * *

  • FINRA Requirements (A) You represent that you are a member in good standing of FINRA, or a non-U.S. bank, broker, dealer, or institution not eligible for membership in FINRA or a Bank.

  • Minimum Requirements Consultant shall, at its expense, procure and maintain for the duration of the Agreement insurance against claims for injuries to persons or damages to property which may arise from or in connection with the performance of the Agreement by the Consultant, its agents, representatives, employees or subconsultants. Consultant shall also require all of its subconsultants to procure and maintain the same insurance for the duration of the Agreement. Such insurance shall meet at least the following minimum levels of coverage:

  • Quality Requirements Performance Indicator Heading Indicator (specific) Threshold Method of Measurement Frequency of monitoring Consequence of Breach QUALITY Patient Safety - Incidents I1 Number of incidents Adverse incidents include the following: clinical or non clinical adverse events that have potential to cause avoidable harm to a patient, including medical errors or adverse events related to medical devices or other equipment. Clinical or non- clinical accidents, accidental injuries to staff and members of the public, verbal, physical or psychological abuse or harassment, unusual or dangerous occurrences, damage to trust property, plant or equipment, fire or flood, security, theft or loss, near misses are identified as any event where under different circumstances significant injury or loss may have occurred Number of recorded incidents in the contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed I2 Number of Sis Definition of SUI according to trust policy and national guidance Number of Serious Untoward Incidents reported in contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed S1 Percentage of eligible staff received child safeguarding training at level 2 (as identified in LSCB training strategy) 95% Number received training/ Number of identified staff requiring training Monthly S2 Percentage of eligible staff received adult safeguarding awareness training at level 2 ( as identified in K&M Safeguarding Vulnerable Adults training strategy) 95% Number of staff trained/ Number of identified staff requiring training Monthly

  • Functional Requirements Applications must implement controls that protect against known vulnerabilities and threats, including Open Web Application Security Project (OWASP) Top 10 Risks and denial of service (DDOS) attacks.

  • Compliance with Regulatory Requirements Upon demand by Lender, Borrower shall reimburse Lender for Lender’s additional costs and/or reductions in the amount of principal or interest received or receivable by Lender if at any time after the date of this Agreement any law, treaty or regulation or any change in any law, treaty or regulation or the interpretation thereof by any Governmental Authority charged with the administration thereof or any other authority having jurisdiction over Lender or the Loans, whether or not having the force of law, shall impose, modify or deem applicable any reserve and/or special deposit requirement against or in respect of assets held by or deposits in or for the account of the Loans by Lender or impose on Lender any other condition with respect to this Agreement or the Loans, the result of which is to either increase the cost to Lender of making or maintaining the Loans or to reduce the amount of principal or interest received or receivable by Lender with respect to such Loans. Said additional costs and/or reductions will be those which directly result from the imposition of such requirement or condition on the making or maintaining of such Loans.

  • ERISA Requirements (a) Borrower will not engage in any transaction which would cause an obligation, or action taken or to be taken under this Loan Agreement (or the exercise by Lender of any of its rights under the Note, this Loan Agreement or any of the other Loan Documents) to be a non-exempt prohibited transaction under ERISA or Section 4975 of the Tax Code.

  • Requirements At its own expense, Supplier must maintain insurance policy(ies) in effect at all times during the performance of this Contract with insurance company(ies) licensed or authorized to do business in the State of Minnesota having an “AM BEST” rating of A- or better, with coverage and limits of insurance not less than the following:

  • Compliance with Requirements Any investment program furnished, and any activities performed, by the Manager or by a Sub-Adviser under this Section shall at all times conform to, and be in accordance with, any requirements imposed by: (1) the Act and any rules or regulations in force thereunder; (2) any other applicable laws, rules and regulations; (3) the Declaration of Trust and By-Laws of the Fund as amended from time to time; (4) any policies and determinations of the Board of Trustees of the Fund; and (5) the fundamental policies of the Fund, as reflected in its Registration Statement under the Act or as amended by the shareholders of the Fund.

  • Service Requirements Grantee shall:

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