Notification of significant quality issues Sample Clauses

Notification of significant quality issues. As set forth in the Quality Agreements, the Parties shall notify each other of the occurrence of a confirmed out-of specification (“OOS”) result or major process deviation relating to the Product and/or Drug Substance for use or sale in the Territory. Auxilium agrees to inform Asahi on all quality decisions regarding any OOS result or major process deviations involving the Bulk Product and/or Drug Substance.
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Notification of significant quality issues. As set forth in the Quality Agreement, the Parties shall notify each other of the occurrence of a confirmed out-of specification (“OOS”) result or major process deviation relating to the Product whether inside the Territory or outside the Territory. The Parties agree to consult on all quality decisions regarding any OOS result or major process deviations involving the Bulk Product. All investigations regarding confirmed OOS results or major process deviations generated by the Third Party Manufacturer for Product must be completed, documented, and approved by Auxilium and Pfizer prior to issuance of a Certificate of Compliance or a Certificate of Analysis.
Notification of significant quality issues. As set forth in the Quality Agreements, the Parties shall notify each other of the occurrence of a confirmed out-of specification or out-of-trend (“OOS”) result or major process deviation relating to the Product CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. and/or Drug Substance in the Territory. The Parties agree to consult on all quality decisions regarding any OOS result or major process deviations involving the Finished Product or Bulk Product, as applicable, and/or Drug Substance that is intended for the Territory.

Related to Notification of significant quality issues

  • Certification of Meeting or Exceeding Tobacco-Free Workplace Policy Minimum Standards A. Grantee certifies that it has adopted and enforces a Tobacco-Free Workplace Policy that meets or exceeds all of the following minimum standards of: i. Prohibiting the use of all forms of tobacco products, including but not limited to cigarettes, cigars, pipes, water pipes (hookah), bidis, kreteks, electronic cigarettes, smokeless tobacco, snuff and chewing tobacco; ii. Designating the property to which this Policy applies as a "designated area,” which must at least comprise all buildings and structures where activities funded under this Grant Agreement are taking place, as well as Grantee owned, leased, or controlled sidewalks, parking lots, walkways, and attached parking structures immediately adjacent to this designated area; iii. Applying to all employees and visitors in this designated area; and iv. Providing for or referring its employees to tobacco use cessation services. B. If Grantee cannot meet these minimum standards, it must obtain a waiver from the System Agency.

  • Rectification of Safety Hazard Where, because of the existence of a safety hazard, a site has been stopped for a defined period of time and Employees sent off site by agreement between Site Managers and any combination of Union Official/s, Health and Safety Committee, those people who remain on site to do rectification work will be paid at the rate of double time for all such work.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately upon detection of (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, as applicable, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws or (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) has occurred or is otherwise proposed to occur.

  • Independence from Material Breach Determination Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG’s decision that Xxxxx has materially breached this IA, which decision shall be made at OIG’s discretion and shall be governed by the provisions in Section X.D, below.

  • PROCEDURE FOR DEALING WITH SAFETY ISSUES OR INCIDENTS 11.1 The Employer, the Employees and the Union agree that for the purposes of s. 81 of the WHS Act matters about work health and safety arising at the workplace shall be resolved in accordance with this procedure. 11.2 The Parties agree that for the purposes of this procedure and s. 81(3) of the WHS Act the following persons shall be the representatives of the following parties: (a) the Principal Contractor (as defined in the WHS Act) - Site Manager or any other person nominated by the Principal Contractor (b) the Employers - the Site Manager or any other person nominated by the Employer(s) (c) The Employees - the Union or other representatives. (Collectively referred to as "Nominated Parties”) 11.3 The Nominated Parties agree that representatives shall be entitled to: (a) inspect any work system, plant, substance, structure, or other thing relevant to resolving the issue (b) consult with relevant Employees in relation to resolving the issue (c) consult with the relevant PCBU (as defined in the WHS Act) about resolving the issue (d) inspect and take copies of any document that is directly relevant to resolving the issue; and (e) advise any person whom the representative reasonably believes to be exposed to a serious risk to his or her health and safety, emanating from an immediate and imminent exposure to a hazard of that risk. 11.4 The Nominated Parties and/or their representatives may commence the procedure by informing, either by themselves or their representative, the other Parties and/or representatives that: (a) there is an issue to be resolved; and (b) the nature and scope of the issue. 11.5 As soon as the Parties and/or their representatives are informed of the issue, the Nominated Parties and/or their representatives must meet or communicate with each other to attempt to resolve the issue. 11.6 The Nominated Parties and/or their representatives must have regard to all relevant matters including: (a) the degree and imminent risk to the Employees or other persons affected by the issue. (b) the number and location of Employees and other persons affected by the issue. (c) the measures both temporary and permanent that must be implemented to resolve the issue. (d) who will be responsible for implementing the resolution measures. (e) whether the hazard or risk can be isolated; and (f) the time that may elapse before the hazard or risk is permanently corrected. 11.7 Once the issue is resolved details of the issue and its resolution must be set out in writing with all Nominated Parties and/or their representatives to be satisfied that the agreement reflects the resolution of the issue with a copy given to all Nominated Parties and/or their representatives to the issue. The issue, once resolved, shall be recorded in the next safety committee meeting minutes with the agreed resolution. 11.8 The Nominated Parties and/or their representatives must make reasonable efforts to achieve a timely and final resolution of the issue. If within a reasonable time there is still no resolution, any of the Nominated Parties attempting to resolve the issue may then ask Work Health and Safety Queensland, and/or the QBCC, where applicable, to arrange for an inspector to attend the workplace to assist in resolving the issue. 11.9 Direction to cease work (a) If - (i) an issue concerning health or safety arises at a workplace or from the conduct of the undertaking of the Employer; and (ii) the issue concerns work which involves an immediate threat to the health or safety of any person; and (iii) given the nature of the threat and degree of risk, it is not appropriate to adopt the processes set out in clause 11.7 above (b) the Employer and/or the health and safety representative for the designated work group in relation to which the issue has arisen may, after consultation between them, direct that the work is to cease. (c) During any period for which work has ceased in accordance with such a direction, the Employer may assign any Employees whose work is affected to suitable and safe alternative work. 11.10 Fundamental to this process is a standing invitation for Union representatives to attend site to assist with all matters relating to health and safety. 11.11 Employees are not required to work in circumstances where the employee or a Union representative reasonably believes a safety law is being, or will be, contravened. Consultation between the relevant parties will occur throughout this procedure including with senior representatives of the Employer and the Union.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Certification of Funds; Budget and Fiscal Provisions; Termination in the Event of Non-Appropriation This Agreement is subject to the budget and fiscal provisions of the City’s Charter. Charges will accrue only after prior written authorization certified by the Controller, and the amount of City’s obligation hereunder shall not at any time exceed the amount certified for the purpose and period stated in such advance authorization. This Agreement will terminate without penalty, liability or expense of any kind to City at the end of any fiscal year if funds are not appropriated for the next succeeding fiscal year. If funds are appropriated for a portion of the fiscal year, this Agreement will terminate, without penalty, liability or expense of any kind at the end of the term for which funds are appropriated. City has no obligation to make appropriations for this Agreement in lieu of appropriations for new or other agreements. City budget decisions are subject to the discretion of the Mayor and the Board of Supervisors. Contractor’s assumption of risk of possible non-appropriation is part of the consideration for this Agreement. THIS SECTION CONTROLS AGAINST ANY AND ALL OTHER PROVISIONS OF THIS AGREEMENT.

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

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