Deviations and Investigations Sample Clauses

Deviations and Investigations. Any deviation during manufacture or OOS result shall be promptly investigated and documented by Nastech. A full written [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] investigation report thereof will be promptly provided to LICENSEE by Nastech and shall be subject to LICENSEE's written approval.
Sample 1
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Deviations and Investigations. In the event that a material deviation occurs during the course of the Manufacture, including Packaging, storage and analytical testing, of any batch of Product for Achieve under this Supply Agreement, Sopharma shall immediately provide Achieve with a detailed written description of any such deviation and undertake all reasonable and appropriate actions to investigate the cause of such deviation and to correct the same. A completed written report of the results of any such investigation will be provided to Achieve for such batch.
Sample 1
Deviations and Investigations. Any deviations from the process during manufacture, including but not limited to, batch record execution, environmental monitoring excursions or aseptic processing procedures shall be documented. Any such deviation which may impact the safety, identity, strength, purity, or quality of the Products shall be promptly reported to Cadence and fully investigated as provided in the Quality Agreement.
Sample 1
Deviations and Investigations. 6.2.1 Will investigate and document specific DEVIATIONS form the MASTER BATCH RECORDS and SPECIFICATIONS according to PPL-SD QUALITY SYSTEM X
Sample 1
Deviations and Investigations. A deviation is defined as any abnormal event that may occur during the processing of a batch, or is a departure from Specifications, approved Master Batch Record or Method of testing. Any deviation that occurs must be documented in the batch record. The significant deviations will be forwarded to UCB in conjunction with the Certificate of Conformity / Analysis). Excepted as provided in sections “Complaints” and “Stability”, CONTRACT ACCEPTOR must notify UCB within five (5) Business Days of the occurrence of a confirmed out-of specification (“OOS”) result or major process deviation (deviations potentially effecting product quality, safety, identity, purity or efficacy) relating to the PRODUCT. A confirmed OOS result is defined as a result from a raw material, in-process, or finished product testing which does not meet specifications. All Quality decisions regarding any such out-of-specification result or major process deviation involving the PRODUCT shall be made by CONTRACT ACCEPTOR in consultation with UCB. In all cases, UCB will have the final review and decision making responsibility as to the impact of the deviation(s) on the PRODUCT; this includes the disposition of the affected batch. Reworking or reprocessing protocols require UCB approval prior to execution. All investigations must be completed, documented and approved by CONTRACT ACCEPTOR prior to issuance of a Certificate of Compliance or a Certificate of Conformance. A copy of the completed investigation must be provided to UCB prior to PRODUCT release by CONTRACT ACCEPTOR. CONTRACT ACCEPTOR will notify UCB in writing of any batch of PRODUCT rejected by CONTRACT ACCEPTOR. CONTRACT ACCEPTOR will notify UCB in writing of any problems that may impact or invalidate a batch previously shipped to UCB or its Affiliates or Agents. Some deviations or investigations may require additional testing, stability or validation be conducted. This work will be performed as agreed by both parties.
Sample 1
Deviations and Investigations. In the event that a material deviation occurs during the course of the Manufacture, including Packaging, storage and analytical testing, of any batch of Product(s) for Buyer under this Manufacturing Agreement, Supplier shall immediately provide Buyer with a detailed written description of any such deviation. In addition, Supplier shall undertake all reasonable and appropriate actions to investigate the cause of such deviation and to correct the same as set forth in the Quality Agreement. A completed written report of the results of any such investigation will be provided to Buyer along with the COA/COC for such batch.
Sample 1
Deviations and Investigations. 6.2.1 Any deviation from the process and SOPs during manufacture, storage or testing must be appropriately explained, investigated, documented, and approved in the batch records or analytical records. The deviation documentation must identify the cause and the corrective action, where appropriate, and must assess product impact with respect to product quality.
Sample 1
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Deviations and Investigations. 7.1 Millennium shall or shall request its Authorized Contractor to, subject to the terms of the relevant Third Party Agreement, investigate thoroughly any unplanned deviation from approved procedure or out of specification test result. The investigation must adhere to an approved, written procedure and be documented. Review and approval of the investigation by Millennium's Quality Unit is required prior to disposition of the Product. In the case of deviation investigation by Millennium's Authorized Contractor, Millennium QA will review and approve such investigations prior to release of the batch to Schering, in accordance with Millennium batch review and supplier qualification procedures. No Product involved in an investigation may be released to Schering until the investigation is completed.
Sample 1
Deviations and Investigations 
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Related to Deviations and Investigations

  • Complaints and Investigations 1. This article applies to complaints or allegations made externally and not from normal supervisory activities.

  • Litigation and Investigations Promptly after (i) the occurrence thereof, notice of the institution of or any material adverse development in any material action, suit or proceeding or any governmental investigation or any arbitration, before any court or arbitrator or any governmental or administrative body, agency or official, against any Consolidated Company, or any material property of any thereof, or (ii) actual knowledge thereof, notice of the threat of any such action, suit, proceeding, investigation or arbitration;

  • Corporate Examinations and Investigations Prior to the Closing Date, the parties acknowledge that they have been entitled, through their employees and representatives, to make such investigation of the assets, properties, business and operations, books, records and financial condition of the other as they each may reasonably require. No investigations, by a party hereto shall, however, diminish or waive any of the representations, warranties, covenants or agreements of the party under this Agreement.

  • Investigations and Remediations Lessor shall retain the responsibility and pay for any investigations or remediation measures required by governmental entities having jurisdiction with respect to the existence of Hazardous Substances on the Premises prior to the Start Date, unless such remediation measure is required as a result of Lessee's use (including "Alterations", as defined in Paragraph 7.3(a) below) of the Premises, in which event Lessee shall be responsible for such payment. Lessee shall cooperate fully in any such activities at the request of Lessor, including allowing Lessor and Lessor's agents to have reasonable access to the Premises at reasonable times in order to carry out Lessor's investigative and remedial responsibilities.

  • Access and Investigation (a) During the period commencing on the Agreement Date and ending at such time as designees of Parent first constitute at least a majority of the Company Board pursuant to Section 1.3(a), the Company shall, and shall cause its Subsidiaries and Representatives to: (i) provide Parent and Parent’s Representatives with reasonable access, upon reasonable notice and during normal business hours, to the Company’s Representatives, properties, books, records, Tax Returns, material operating and financial reports, work papers and other documents and information relating to the Company and its Subsidiaries (including the Company Owned IP); (ii) provide Parent and Parent’s Representatives with such copies of the books, records, Tax Returns, work papers and other documents and information relating to the Company and its Subsidiaries, and with such additional financial, operating and other data and information regarding the Company and its Subsidiaries, as Parent may reasonably request; and (iii) permit Parent’s officers and other employees to meet, upon reasonable notice and during normal business hours, with the chief financial officer and other officers and managers of the Company responsible for the Company’s financial statements and the internal controls of the Company and its Subsidiaries to discuss such matters as Parent may reasonably deem necessary or appropriate in order to enable Parent to satisfy its obligations under the Xxxxxxxx-Xxxxx Act or similar act applicable thereto and the rules and regulations relating thereto or otherwise in connection with the Offer and the Merger. No information or knowledge obtained by Parent or its Representatives in any investigation conducted pursuant to this Section 5.1(a) shall affect or be deemed to modify any representation or warranty of the Company set forth herein or the conditions to the obligations of Parent and Purchaser to consummate the transactions contemplated hereby (including the Offer and the Merger), or the remedies available to the parties hereunder. Notwithstanding anything to the contrary herein, neither Company nor any of its Subsidiaries shall be required to provide access to or to disclose information to the extent such access or disclosure would jeopardize the attorney-client privilege of such Person or violate any applicable Law.

  • Investigations and Proceedings The parties to this Agreement agree to cooperate fully in any securities regulatory investigation or proceeding or any judicial proceeding with respect to each party’s activities under this Agreement and promptly to notify the other party of any such investigation or proceeding.

  • Other Information and Inspections In each case subject to the last sentence of this Section 6.3, each Restricted Person will furnish to each Lender any information which Administrative Agent or any Lender may from time to time request concerning any covenant, provision or condition of the Loan Documents or any matter in connection with Restricted Persons' businesses and operations. In each case subject to the last sentence of this Section 6.3, each Restricted Person will permit representatives appointed by Administrative Agent (including independent accountants, auditors, agents, attorneys, appraisers and any other Persons) to visit and inspect during normal business hours any of such Restricted Person's property, including its books of account, other books and records, and any facilities or other business assets, and to make extra copies therefrom and photocopies and photographs thereof, and to write down and record any information such representatives obtain, and each Restricted Person shall permit Administrative Agent or its representatives to investigate and verify the accuracy of the information furnished to Administrative Agent or any Lender in connection with the Loan Documents and to discuss all such matters with its officers, employees and, upon prior notice to Borrower, its representatives. Each of the foregoing inspections shall be made subject to compliance with applicable safety standards and the same conditions applicable to any Restricted Person in respect of property of that Restricted Person on the premises of Persons other than a Restricted Person or an Affiliate of a Restricted Person, and all information, books and records furnished or requested to be furnished, or of which copies, photocopies or photographs are made or requested to be made, all information to be investigated or verified and all discussions conducted with any officer, employee or representative of any Restricted Person shall be subject to any applicable attorney-client privilege exceptions which the Restricted Person determines is reasonably necessary and compliance with conditions to disclosures under non-disclosure agreements between any Restricted Person and Persons other than a Restricted Person or an Affiliate of a Restricted Person and the express undertaking of each Person acting at the direction of or on behalf of any Lender Party to be bound by the confidentiality provisions of Section 10.6 of this Agreement.

  • Information and Inspection Pledgor shall (i) promptly furnish Bank any information with respect to the Collateral requested by Bank; (ii) allow Bank or its representatives to inspect and copy, or furnish Bank or its representatives with copies of, all records relating to the Collateral and the Obligation; and (iii) promptly furnish Bank or its representatives with any other information Bank may reasonably request.

  • Investigations The respective representations and warranties of the Parties contained in this Agreement or any certificate or other document delivered by any Party at or prior to the Closing and the rights to indemnification set forth in Article XI shall not be deemed waived or otherwise affected by any investigation made, or knowledge acquired, by a Party.

  • Access to Information; Independent Investigation Prior to the execution of this Agreement, the Subscriber has had the opportunity to ask questions of and receive answers from representatives of the Company concerning an investment in the Company, as well as the finances, operations, business and prospects of the Company, and the opportunity to obtain additional information to verify the accuracy of all information so obtained. In determining whether to make this investment, Subscriber has relied solely on Subscriber’s own knowledge and understanding of the Company and its business based upon Subscriber’s own due diligence investigation and the information furnished pursuant to this paragraph. Subscriber understands that no person has been authorized to give any information or to make any representations which were not furnished pursuant to this Section 2 and Subscriber has not relied on any other representations or information in making its investment decision, whether written or oral, relating to the Company, its operations and/or its prospects.

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