Batch Documentation and Master Batch Record Sample Clauses

Batch Documentation and Master Batch Record. Prior to the Manufacture of any Licensed Product, CIMA shall prepare a form of master batch record, which must be approved by Schering in writing before any Manufacture of any Licensed Product. Such documentation shall include, without limitation, copies of batch records, a statement setting forth that the batch of Licensed Product was Manufactured in compliance with GMP's, release information and recertification dates for all Active Ingredient and Raw Materials, batch reconciliation and yield calculations, applicable variance reports, and such other information as may be reasonably requested by Schering from time to time ("Batch Documentation"). An authorized employee in CIMA's Quality Assurance department shall sign all Batch Documentation, and print his or her name, title and contact information.
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Related to Batch Documentation and Master Batch Record

  • Project Implementation Manual The Recipient, through the PCU, shall: (i) take all action required to carry out Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4 (ii) of the Project in accordance with the provisions and requirements set forth or referred to in the Project Implementation Manual; (ii) submit recommendations to the Association for its consideration for changes and updates of the Project Implementation Manual as they may become necessary or advisable during Project implementation in order to achieve the objective of Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4(ii) of the Project; and (iii) not assign, amend, abrogate or waive the Project Implementation Manual or any of its provisions without the Association’s prior agreement. Notwithstanding the foregoing, if any of the provisions of the Project Implementation Manual is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall prevail and govern.

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Review of Documentation The Depositor, by execution and delivery hereof, acknowledges receipt of the Mortgage Files pertaining to the Mortgage Loans listed on the Mortgage Loan Schedule, subject to review thereof by Xxxxx Fargo Bank National Association, LaSalle Bank National Association, Deutsche Bank National Trust Company and U.S. Bank National Association as applicable (each, a “Custodian” and, together, the “Custodians”), for the Depositor. Each Custodian is required to review, within 45 days following the Closing Date, each applicable Mortgage File. If in the course of such review the related Custodian identifies any Material Defect, the Seller shall be obligated to cure such Material Defect or to repurchase the related Mortgage Loan from the Depositor (or, at the direction of and on behalf of the Depositor, from the Trust Fund), or to substitute a Qualifying Substitute Mortgage Loan therefor, in each case to the same extent and in the same manner as the Depositor is obligated to the Trustee and the Trust Fund under Section 2.02(c) of the Trust Agreement.

  • Implementation Report Within 150 days after the Effective Date, Ensign Group shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, address, phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names and positions of the members of the Board of Directors who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. a copy of Ensign Group’s Code of Conduct required by Section III.B.1; 5. the number of individuals required to complete the Code of Conduct certification required by Section III.B.1, the percentage of individuals who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG upon request); 6. a summary of all Policies and Procedures required by Section III.B (copies of the Policies and Procedures shall be made available to OIG upon request); 7. the following information regarding each type of training required by Section III.C: a. a description of such training, including a summary of the topics covered, the length of sessions, and a schedule of training sessions; b. the number of individuals required to be trained, percentage of individuals actually trained, and an explanation of any exceptions. A copy of all training materials and the documentation supporting this information shall be made available to OIG upon request. 8. a description of the Disclosure Program required by Section III.E; 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Ensign Group and the IRO; and (e) a certification from the IRO regarding its professional independence and objectivity with respect to Ensign Group; 10. a description of the process by which Ensign Group fulfills the requirements of Section III.F regarding Ineligible Persons; 11. a list of all of Ensign Group’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location’s Medicare and state Medicaid program provider number and/or supplier number(s); and the name and address of each Medicare and state Medicaid program contractor to which Ensign Group currently submits claims; 12. a description of Ensign Group’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and

  • Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. Claims can arise, under certain types of insurance contract, long after the expiry of the policy. It is therefore important that you retain and keep safely all documents associated with your policy.

  • Documentation and Record Keeping 1. Records to be Maintained Subrecipient shall maintain all records required by the Federal regulations specified in 24 CFR 570.506 that are pertinent to the activities to be funded under this Contract. Such records shall include, but not be limited to: a. Records providing a full description of each activity undertaken; b. Records demonstrating that each activity undertaken meets the one of the National Objectives of the CDBG program; c. Records required to determine the eligibility of activities; d. Records required to document the acquisition, improvement, use, or disposition of real property acquired or improved with CDBG assistance; e. Records documenting compliance with the fair housing and equal opportunity components of the CDBG program; f. Financial records as required by federal regulations 24 CFR 570.502, and 24 CFR 84.21-28; and g. Other records necessary to document compliance with Subpart K of 23 CFR.

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Project Implementation The Borrower shall:

  • Commercial Operation Date Testing and Modifications Prior to the Commercial Operation Date, the Connecting Transmission Owner shall test the Connecting Transmission Owner’s Attachment Facilities and System Upgrade Facilities and System Deliverability Upgrades and Developer shall test the Large Generating Facility and the Developer Attachment Facilities to ensure their safe and reliable operation. Similar testing may be required after initial operation. Developer and Connecting Transmission Owner shall each make any modifications to its facilities that are found to be necessary as a result of such testing. Developer shall bear the cost of all such testing and modifications. Developer shall generate test energy at the Large Generating Facility only if it has arranged for the injection of such test energy in accordance with NYISO procedures.

  • End User Agreement This publication is distributed under the terms of Article 25fa of the Dutch Copyright Act. This article entitles the maker of a short scientific work funded either wholly or partially by Dutch public funds to make that work publicly available for no consideration following a reasonable period of time after the work was first published, provided that clear reference is made to the source of the first publication of the work. Research outputs of researchers employed by Dutch Universities that comply with the legal requirements of Article 25fa of the Dutch Copyright Act, are distributed online and free of cost or other barriers in institutional repositories. Research outputs are distributed six months after their first online publication in the original published version and with proper attribution to the source of the original publication. You are permitted to download and use the publication for personal purposes. All rights remain with the author(s) and/or copyrights owner(s) of this work. Any use of the publication other than authorised under this licence or copyright law is prohibited. If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the University Library know, stating your reasons. In case of a legitimate complaint, the University Library will, as a precaution, make the material inaccessible and/or remove it from the website. Please contact the University Library through email: xxxxxxxxx@xxx.xx.xx. You will be contacted as soon as possible. University Library Radboud University

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