Right to Review Processes Sample Clauses

Right to Review Processes. Chiron shall maintain all quality assurance manufacturing records, batch production records and other records directly related to Product manufacture, as required by applicable regulations. BMPI personnel shall have the right to review such records at the Facilities during regular business hours and upon at least ** days advance written request to Chiron's Corporate Regulatory Compliance Group, for the sole purpose of auditing Chiron's compliance with cGMPs and the Procedures in manufacturing Product; provided, however, that Chiron may delay such inspection for a period of up to ** days if, in its good faith judgment, such delay is necessary to avoid a significant disruption in Chiron's business. In the event that a regulatory inspection occurs during a time schedule for a BMPI audit, Chiron may reschedule the audit to a date within ** days of the originally-scheduled audit. Each BMPI audit shall be completed within three (3) days and shall be conducted by no more than three reviewers, who shall comply with all reasonable Chiron policies and procedures regarding the Facilities. BMPI shall be entitled to one such audit per year during the term of this Agreement and one during the year following expiration or termination of this Agreement, at no charge. Chiron shall respond to all audit findings, in writing, within ** days of receipt or as otherwise agreed by the parties, in writing. All information obtained by BMPI pursuant to this Section 6.1 shall be subject to the confidentiality provisions of Article 7.
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Right to Review Processes. RPI shall maintain all quality assurance manufacturing records and batch production records directly related to the manufacture of Exogenous Ribozyme Products, or copies thereof, as required by FDA or other applicable regulation. Schering's personnel have the right to review and audit compliance with manufacturing specifications during regular business hours at reasonable intervals, and shall have the right to visit and inspect each RPI site at such times as required for the purpose of review of batch records and manufacturing and quality assurance procedures with respect to Exogenous Ribozyme Products, provided that such review or audit does not impede RPI's manufacture and release processes. Schering personnel shall not have access to any records, information, or data concerning other RPI products and Schering personnel having access to any RPI site shall execute reasonable confidentiality agreements to prevent disclosure of such information that may be discovered inadvertently. Schering's personnel may make general inquiries the Confidential portions ( [ ] ) have been omitted pursuant to regulation 240.25b-2(b) of the Securities Exchange Act of 1934 and have been filed separately with the Commission. 38 answers to which will be held in confidence by them, concerning such matters as manufacturing scheduling, and equipment cleaning of any other RPI's site to insure that Exogenous Ribozyme Products is being manufactured under GMP.
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Right to Review Processes. Novartis shall maintain all quality assurance manufacturing records, batch production records and other records directly related to Product manufactured in accordance with the Quality Agreement. The requirements for Inspections and Audits are defined in the Quality Agreement. All information obtained by BMTI pursuant to this Section 6.2 shall be subject to the confidentiality provisions of Article 7.
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Right to Review Processes. Chiron shall maintain all quality assurance manufacturing records and batch production records directly related to the manufacture of Betaseron, or copies thereof, as required by FDA or other applicable regulations. Schering shall own all quality assurance manufacturing records and batch production records directly related to the manufacture of Betaseron. Schering's personnel have the right to review and audit compliance with Manufacturing Specifications during regular business hours at reasonable intervals, and shall have the right to visit and inspect each Chiron Site at such times as required for the purpose of review of batch records and manufacturing and quality assurance procedures with respect to Betaseron, provided that such review or audit does not impede Chiron's manufacture and release processes. Schering personnel shall not have access to any records, information, or data concerning other Chiron products (other than Products hereunder), and Schering personnel having access to any Chiron Site shall execute reasonable confidentiality agreements to prevent disclosure of such information that may be discovered inadvertently. Schering's personnel may make general inquiries the answers to which will be held in confidence by them, concerning such matters as manufacturing scheduling, and equipment cleaning in the shared areas of the PDU and CMF or of any other Chiron Site to insure that Betaseron is being manufactured under GMP. 8.9
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Right to Review Processes. BMTI shall maintain all quality assurance manufacturing records, batch production records and other records directly related to Product manufacture, as required by applicable regulations. BMTI shall audit Novartis on a regular basis, subject to Section 6.1 of the Novartis Supply Agreement, and shall use commercially reasonable efforts to ensure that manufacture of the Product complies with Specifications and regulatory requirements. BMTI shall promptly produce, and provide Luitpold with copies of, reports reflecting the results of its audits of Novartis.
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Right to Review Processes. RPI shall maintain all quality assurance manufacturing records and batch production records directly related to the manufacture of Exogenous Ribozyme Products, or copies thereof, as required by FDA or other applicable regulation. Schering's personnel have the right to review and audit compliance with manufacturing specifications during regular business hours at reasonable intervals, and shall have the right to visit and inspect each RPI site at such times as required for the purpose of review of batch records and manufacturing and quality assurance procedures with respect to Exogenous Ribozyme Products, provided that such review or audit does not impede RPI's manufacture and release processes. Schering personnel shall not have access to any records, information, or data concerning other RPI products and Schering personnel having access to any RPI site shall execute reasonable confidentiality agreements to prevent disclosure of such information that may be discovered inadvertently. Schering's personnel may make general inquiries the
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Related to Right to Review Processes

  • Right to Review After receiving written notice of the denial of a claim, a claimant or his representative shall be entitled to:

  • Right to Review Tax Returns The Responsible Company with respect to any Tax Return shall make such Tax Return and related workpapers available for review by the other Company, if requested, to the extent (a) such Tax Return relates to Taxes for which the requesting party may be liable, (b) such Tax Return relates to Taxes for which the requesting party may be liable in whole or in part or for any additional Taxes owing as a result of adjustments to the amount of Taxes reported on such Tax Return, (c) such Tax Return relates to Taxes for which the requesting party may have a claim for Tax Benefits under this Agreement, or (d) the requesting party reasonably determines that it must inspect such Tax Return to confirm compliance with the terms of this Agreement. The Responsible Company shall make such Tax Return available for review as required under this paragraph at least thirty (30) days prior to the due date for filing such Tax Returns to provide the requesting party with a meaningful opportunity to analyze and comment on such Tax Returns and have such Tax Returns modified before filing. The Companies shall attempt in good faith to resolve any issues arising out of the review of such Tax Returns. Issues that cannot be resolved by the Companies shall be resolved in the manner set forth in Section 14; provided, however, that such Tax Return shall be timely filed in the manner prepared by the Responsible Company if the issues cannot be resolved prior to the time required by law (including extensions) for the filing of such Tax Return.

  • Review Procedures A request for review of a denied claim must be made in writing to Plan Administrator within sixty (60) days after receiving notice of denial (one hundred eighty (180) days in the case of a claim involving Disability Retirement Benefits). The decision upon review will be made within sixty (60) days after Plan Administrator’s receipt of a request for review (forty-five (45) days in the case of a claim involving Disability Retirement Benefits), unless special circumstances require an extension of time for processing, in which case a decision will be rendered not later than one hundred twenty (120) days after receipt of a request for review (ninety (90) days in the case of a claim for Disability Retirement Benefits). A notice of such an extension must be provided to the Claimant within the initial sixty (60) day period (the initial forty-five (45) day period in the case of a claim for Disability Retirement Benefits) and must explain the special circumstances and provide an expected date of decision. The reviewer shall afford the Claimant an opportunity to review and receive, without charge, all relevant documents, information and records and to submit issues and comments in writing to Plan Administrator. The reviewer shall take into account all comments, documents, records and other information submitted by the Claimant relating to the claim regardless of whether the information was submitted or considered in the benefit determination. Upon completion of its review of an adverse initial claim determination, Plan Administrator will give the Claimant, in writing or by electronic notification, a notice containing:

  • Review Procedure If the Plan Administrator denies part or all of the claim, the claimant shall have the opportunity for a full and fair review by the Plan Administrator of the denial, as follows:

  • Claims and Review Procedures 6.1 For all claims other than Disability benefits:

  • Claims and Review Procedure In the event that any claim for benefits that must initially be submitted in writing to the Board of Directors, is denied (in whole or in part) hereunder, the claimant shall receive from First Charter a notice of denial in writing within 60 days, written in a manner calculated to be understood by the claimant, setting forth the specific reasons for denial, with specific reference to pertinent provisions of this Supplemental Agreement. Any disagreements about such interpretations and construction shall be submitted to an arbitrator subject to the rules and procedures established by the American Arbitration Association. The arbitrator shall be acceptable to both First Charter and the Executive (or Beneficiary); if the parties cannot agree on a single arbitrator, the disagreement shall be heard by a panel of three arbitrators, with each party to appoint one arbitrator and the third to be chosen by the other two. No member of the Board of Directors shall be liable to any person for any action taken under Article VIII except those actions undertaken with lack of good faith.

  • Access to Review Materials The Servicer will give the Asset Representations Reviewer access to the Review Materials for all of the Subject Receivables within sixty (60) calendar days after receipt of the review notice in one or more of the following ways in the Servicer’s reasonable discretion: (i) by electronic posting of Review Materials to a password-protected website to which the Asset Representations Reviewer has access, (ii) by providing originals or photocopies of documents relating to the Subject Receivables at one of the properties of the Servicer or (iii) in another manner agreed by the Servicer and the Asset Representations Reviewer. The Servicer may redact or remove PII from the Review Materials so long as all information in the Review Materials necessary for the Asset Representations Reviewer to complete the Asset Review remains intact and unchanged.

  • Review of Materials During the term of this Agreement, Client shall ensure that all prospectuses, statements of additional information, registration statements, proxy statements, reports to shareholders, advertising and sales literature or other materials prepared for distribution to Fund shareholders or the public, which refer to the Subadviser in any way, prepared by employees or agents of Client or its affiliates are consistent with information previously provided by Subadviser. Subadviser shall promptly notify the Client of any changes to information pertaining to the Subadviser and stated in the materials described in this Section 6(g).

  • Review and Procedure Limitations The Asset Representations Reviewer will have no obligation (i) to determine whether a Delinquency Trigger has occurred, (ii) to determine whether the required percentage of Noteholders has voted to direct a Review, (iii) to determine which Receivables are subject to a Review, (iv) to obtain or confirm the validity of the Review Materials, (v) to obtain missing or insufficient Review Materials (except to the extent set forth in Section 3.04), or (vi) to take any action or cause any other party to take any action under any of the Basic Documents to enforce any remedies for breaches of any Eligible Representations. The Asset Representations Reviewer will only be required to perform the Tests provided in Exhibit A and will have no obligation to perform additional testing procedures on any ARR Receivables or to consider any additional information provided by any party. The Asset Representations Reviewer will have no obligation to provide reporting or information in addition to that described in Section 3.07. However, the Asset Representations Reviewer may review and report on additional information that it determines in good faith to be material to its performance under this ARR Agreement and may re-perform a Review with respect to an ARR Receivable as contemplated by Section 3.09. The Issuing Entity expressly agrees that the Asset Representations Reviewer is not advising the Issuing Entity or any Noteholder or any investor or future investor concerning the suitability of the Notes or any investment strategy. The Issuing Entity expressly acknowledges and agrees that the Asset Representations Reviewer is not an expert in accounting, tax, regulatory, or legal matters, and that the Asset Representations Reviewer is not providing legal advice as to any matter.

  • Opportunity to Review; Reliance The Stockholder has had the opportunity to review the Merger Agreement and this Agreement with counsel of its own choosing. The Stockholder understands and acknowledges that Parent and Merger Sub are entering into the Merger Agreement in reliance upon the Stockholder’s execution, delivery and performance of this Agreement.

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