Controlled Documents Sample Clauses

Controlled Documents. 9.1 AMGEN shall make readily available to AKERO, upon request, only documents related to lots of the Product supplied to AKERO which shall include release documentation, summaries of change controls, complaint investigations, deviation/ nonconformances summaries, and stability summary data, as agreed between the Parties. 9.2 AMGEN shall retain controlled documents related to manufacturing and analytical data per AMGEN’s established procedures and cGMP requirements.
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Controlled Documents. Paper or electronic documents that are part of the quality system and contain data/information required by cGMPs. These documents may also be referred to as GMP documents. Such documents must be initiated and revised through document control and/or change control procedures. Examples of controlled documents are: SOPs, analytical test methods, specifications, batch records, validation protocols, forms, etc.
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Controlled Documents. 2.3.1 INyX manufacturing and analytical documentation practices shall be subject to frequent review by both parties to ensure compliance with the most current recognized interpretation of cGMPs for the appropriate phase of Product development or commercial manufacturing. 2.3.2 Standard operating procedures, specifications, test methods, and Master Batch Production Records shall be consistent with the ANDA filing and any subsequent supplements 2.3.3 Stiefel and INyX shall be jointly responsible for the approval of controlled documents (specifications, test methods, stability protocols, batch records, etc.) will be established and approved for use. 2.3.4 Stiefel shall provide all necessary source data to facilitate the completion of relevant specifications, etc. INyX shall provide for review and signature approval by Stiefel for the following documents prior xx implementation, and any subsequent changes must be made in accordance with the change control procedures set forth in Section 2.4: o Master Production Records o Specifications for Finished Product, Active Ingredient(s), Excipients, primary containers, and labeling materials. o Test methods for active drug substance, intermediate and Finished Product, cleaning evaluation o Stability protocols and monographs o Process validation and cleaning validation protocols and reports o Test methods validation protocols and reports o Technical protocols and reports specifically relating to Stiefel Products
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Controlled Documents. “Controlled Documents” shall mean the master batch record, SOPs and other quality-controlled documents applicable or referenced for the Manufacture of Product.
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Controlled Documents. All documents used in the production of the Product, from the receiving of raw material to the releasing of the Product are considered controlled documents. Controlled documents consist of the following: receiving documents, test methods, including in-process methods, SOPs, specifications, including in-process specifications, production records, batch records, testing data/records, product reports and protocols, stability protocols and stability reports, and all product support documents. These shall be under revision control (as appropriate) and shall be filed in such a manner as to be traceable. Current SOPs and test methods will be readily accessible to production personnel or QC chemists.
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Controlled Documents. 9.1 AMGEN shall make readily available to STANFORD, upon request, only documents related to lots supplied to STANFORD which shall include lot release documentation, summaries of change controls, complaint investigations, deviation/ nonconformances summaries, and stability data, as agreed between the Parties. AMGEN shall make batch records readily available during audits, and provide redacted sections of batch records upon request by STANFORD. 9.2 AMGEN shall retain controlled documents related to manufacturing and analytical data per AMGEN’s established procedures and cGMP requirements.
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Controlled Documents. None of various provisions of this Agreement shall be construed as providing for the release of reports or other information designated as "Classified" or "Unclassified Controlled Nuclear Information" (UCNI) to the Tribes, or waiving any other security requirements. Classified information includes National Security Information (10 CFR Part 1045) and Restricted Data (10 CFR Part 1016). Unclassified Controlled Nuclear Information is described in 10 CFR Ch. X, Part 1017. In the event that information requested under the provisions of this Agreement is determined by DOE to be exempt from disclosure under the Freedom of Information Act, providing the information is not Classified or UCNI, is not controlled by the Privacy Act, and does not contain proprietary information or intellectual property information, DOE may, to the
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Controlled Documents. Venture shall maintain all product specifications and product documentation, including Product Specifications, Process Management Plan, Quality Management Plans, and Product Addenda, as "controlled documents" according to Iomega's DCN procedure as provided to Venture. Duplicate copies of these documents shall be maintained at both Venture's and Iomega's facilities. Except as permitted under Section 4.6(b) (By Venture), Venture may not alter any of these controlled documents without the prior written approval of Iomega, which approval shall not be unreasonably withheld or delayed.
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Related to Controlled Documents

  • Required Documents Prior to the Closing, the Parties agree to authorize all necessary documents, in good faith, in order to record the transaction under the conditions required by the recorder, title company, lender, or any other public or private entity.

  • Delivered Documents On the Amendment Effective Date, the Buyer shall have received the following documents, each of which shall be satisfactory to the Buyer in form and substance: (a) this Amendment, executed and delivered by duly authorized officers of the Buyer, the Seller and the Guarantors; and (b) such other documents as the Buyer or counsel to the Buyer may reasonably request.

  • Referenced Documents 2.3.1 Unless the context shall otherwise specifically require, and subject to Section 21, whenever any provision of this Agreement refers to a technical reference, technical publication, CLEC Practice, SBC-13STATE Practice, any publication of telecommunications industry administrative or technical standards, or any other document specifically incorporated into this Agreement (collectively, a “Referenced Instrument”), it will be deemed to be a reference to the then-current version or edition (including any amendments, supplements, addenda, or successors) of each Referenced Instrument that is in effect, and will include the then-current version or edition (including any amendments, supplements, addenda, or successors) of any other Referenced Instrument incorporated by reference therein.

  • Required Documentation The AGENCY is responsible for ensuring that all documents required by this Contract are current and available for the COUNTY’S review upon request. These documents may include, but are not limited to, certificate(s) of insurance, job descriptions and background check confirmations of staff.

  • Bid Documents The terms and conditions of the Invitation to Bid attached hereto and made a part hereof as Exhibit "B" shall be incorporated herein as a part of this Agreement.

  • Fund Documents The Fund has provided the Distributor with properly certified or authenticated copies of the following Fund related documents in effect on the date hereof: the Fund's organizational documents, including Articles of Incorporation and by-laws; the Fund's Registration Statement on Form N-1A, including all exhibits thereto; the Fund's most current Prospectus and Statement of Additional Information; and resolutions of the Fund's Board of Trustees authorizing the appointment of the Distributor and approving this Agreement. The Fund shall promptly provide to the Distributor copies, properly certified or authenticated, of all amendments or supplements to the foregoing. The Fund shall provide to the Distributor copies of all other information which the Distributor may reasonably request for use in connection with the distribution of Shares, including, but not limited to, a certified copy of all financial statements prepared for the Fund by its independent public accountants. The Fund shall also supply the Distributor with such number of copies of the current Prospectus, Statement of Additional Information and shareholder reports as the Distributor shall reasonably request.

  • Related Documents The words "Related Documents" mean all promissory notes, credit agreements, loan agreements, environmental agreements, guaranties, security agreements, mortgages, deeds of trust, security deeds, collateral mortgages, and all other instruments, agreements and documents, whether now or hereafter existing, executed in connection with the Loan.

  • Formation Documents With respect to the Issuing Entity, the Certificate of Trust and the Trust Agreement, (ii) with respect to the Grantor Trust, the Grantor Trust Certificate of Trust and the Grantor Trust Agreement, and (iii) with respect to the Depositor, the certificate of formation of the Depositor filed in Delaware, dated as of January 4, 2019 and the amended and restated limited liability company agreement of the Depositor, dated as of March 27, 2019, made by the Sponsor, as member.

  • Required Loan Documents The Collateral Custodian will not dispose of any documents constituting the Required Loan Documents in any manner that is inconsistent with the performance of its obligations as the Collateral Custodian pursuant to this Agreement and will not dispose of any Collateral Portfolio except as contemplated by this Agreement.

  • Operative Documents On or before the Closing Date, each of the Operative Documents to be delivered at the Closing shall have been duly authorized, executed and delivered by the parties thereto in substantially the form attached as an Exhibit hereto, shall each be in full force and effect, and executed counterparts of each shall have been delivered to each of the parties hereto.

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