We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

Implementation Batches Sample Clauses

Implementation Batches. 6.6.1 After the FEASIBILITY STUDY and the performance of the CONFIRMATORY BATCHES, BI Austria shall produce two (2) ** working volume IMPLEMENTATION BATCHES for DRUG SUBSTANCE, media fills and two (2) IMPLEMENTATION BATCHES for DRUG PRODUCT. Pursuant to the mutually agreed production requirements set forth in Exhibit 20 BI Austria shall establish a ** fermentation scale and for purification a scale with a yield of ** grams DRUG SUBSTANCE per sublot. 6.6.2 The IMPLEMENTATION BATCHES shall be produced in the GMP production units at BI Austria to ensure the technical equipment is qualified with respect to the specific requirements for the later GMP manufacture of DRUG PRODUCT. 6.6.3 BI Austria shall ferment and purify each IMPLEMENTATION BATCH in accordance with the process description which shall be established in a MASTER BATCH RECORD, to be drawn up by BI Austria, reviewed by Corautus and released by BI Austria Quality Management. 6.6.4 BI Austria shall conduct in-process control testing on each manufacturing run and also conduct release testing of the IMPLEMENTATION BATCHES according to the DRUG PRODUCT SPECIFICATIONS. Corautus will conduct any release testing for methods not transferred to BI Austria. 6.6.5 BI Austria shall warehouse DRUG PRODUCT produced in the IMPLEMENTATION BATCHES as requested by Corautus. Corautus shall decide on either disposing, or, provided the DRUG PRODUCT meets SPECIFICATIONS, shipping such DRUG PRODUCT to Corautus. 6.6.6 As the DRUG PRODUCT from the IMPLEMENTATION BATCHES is of experimental nature and does not meet all GMP requirements, Corautus warrants that it shall not use such DRUG PRODUCT in humans. 6.6.7 The PARTIES shall consider the yield and purity of the IMPLEMENTATION BATCHES and if the IMPLEMENTATION BATCHES do not meet the expected purity standards or expected yields based on the DRUG PRODUCT SPECIFICATIONS the PARTIES will come to an agreement on further steps. In such events both PARTIES shall use commercially reasonable efforts to arrive at a mutually acceptable solution. For work packages in Exhibit 16 which are not marked as “estimates” prices shall be final prices. However, if the scope of certain work packages is changed upon written agreement by both PARTIES prices shall be adjusted accordingly. ** Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

Related to Implementation Batches

  • Project Implementation The Borrower shall:

  • 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.

  • Implementation Services Vendor shall provide the Implementation Services, if any, described in Exhibit A. The Services Fees for any Implementation Services shall be described in Exhibit A.

  • 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

  • Implementation Plan The Authority shall cause to be prepared an Implementation Plan meeting the requirements of Public Utilities Code Section 366.2 and any applicable Public Utilities Commission regulations as soon after the Effective Date as reasonably practicable. The Implementation Plan shall not be filed with the Public Utilities Commission until it is approved by the Board in the manner provided by Section 4.9.

  • Implementation and Review The Parties shall consult annually, or as otherwise agreed, to review the implementation of this Chapter and consider other matters of mutual interest affecting trade in services. (10) 10 Such consultations will be addressed under Article 170 (Free Trade Commission) of Chapter 14 (Administration of the Agreement).

  • COOPERATION IN IMPLEMENTATION On demand of the other Spouse and without undue delay or expense, each Spouse shall execute, acknowledge, or deliver any instrument, furnish any information, or perform any other acts reasonably necessary to carry out the provisions of this Agreement. If a Spouse fails to execute any document as required by this provision, the court may appoint the court clerk or his or her authorized designee to execute the document on that Xxxxxx’s behalf.

  • Implementation Arrangements Institutional Arrangements

  • Implementation of Agreement Each Party must promptly execute all documents and do all such acts and things as is necessary or desirable to implement and give full effect to the provisions of this Agreement.

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.