Organization and Personnel Sample Clauses

Organization and Personnel. 4.12.1. NOF shall have adequate staffing to ensure product quality, adherence to requirements, and management oversight. 4.12.2. Personnel shall have job descriptions. 4.12.3. The Quality Unit shall have the appropriate authority to ensure product quality and compliance.
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Organization and Personnel. 2.01 Implement procedures and/or documented training to meet obligations under this Agreement X 2.02 There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containing, closures, in-process materials, packaging material labeling, and drug products, and the authority to review production records to assure that no errors have occurred or if errors have occurred, that they have been full investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. X 2.03 The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. X 2.04 Maintain a quality unit that is independent of production that fulfils both quality assurance and quality control responsibilities. X 2.05 Involve the quality unit in all quality related matters and have them review and approve all quality critical related documents. X 2.06 As it relates to this Quality Agreement, notify the other party of name change, corporate reorganization, consolidation, merger or acquisition or sale of the party’s company. Notify other party of key personnel changes. X
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Organization and Personnel. 2.1.1 Subject to Section 4.1 of the Agreement, will maintain quality control units with the responsibility and authority to approve or reject the SUBSTANCE, raw materials, intermediates, PRODUCT, master production records, and production batch records. X 2.1.2 Will ensure that all personnel engaged in the manufacturing, testing, packaging and labeling of the PRODUCT shall have the education, training and experience sufficient to perform their assigned functions in accordance with applicable Laws. X 2.1.3 Will ensure that all personnel engaged in the storage, handling, distribution, and PROMOTION of the PRODUCT shall have the education, training and experience sufficient to perform their assigned functions in accordance with applicable Laws. X X 2.1.4 Represents and warrants to AstraZeneca that Prometheus has not been debarred and is not subject to debarment and will not use in any capacity, in connection with the distribution, warehousing, marketing, PROMOTION of the PRODUCT under the Agreement, any person who has been debarred pursuant to Section 306 of the FD&C Act, or who is the subject of a conviction described in such section (or undergoes any analogous proceedings under any foreign counterpart). X
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Organization and Personnel. In this chapter, the Bidder should propose and justify the structure and composition of proposed team. Bidder should list the main disciplines of the assignment, the key expert responsible, and proposed technical and support personnel. The manpower requirement given in the RFP is an indicative minimum requirement. The Bidder should assess the specific and realistic manpower with reference to TOR
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Organization and Personnel. Subject to Section 4.1 of the Agreement, will maintain quality control units with the responsibility and authority to approve or reject the SUBSTANCE, raw materials, intermediates, PRODUCT, master production records, and production batch records. X
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Organization and Personnel. SUPPLIER shall have a Quality Assurance unit that have the responsibility for approving and rejecting all procedures or specifications that can impact the identity, strength, quality, and purity of the PRODUCT. SUPPLIER’s Quality Assurance unit shall have Standard Operating Procedures (SOP) to fulfill its responsibilities. SUPPLIER shall have documented evidence of sufficient, appropriate and qualified personnel and/or consultant(s) thru training, education, experience or a combination thereof to perform activities related to the manufacturing and supervision of PRODUCT manufacture. SUPPLIER shall ensure that all personnel engaged in GMP activities are aware and knowledgeable of their responsibilities.
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Organization and Personnel. Sanofi or its subcontractor will maintain a quality unit that is independent of the production unit and has the responsibility and authority to approve or reject the Filled Drug Product, raw materials and components for use in Manufacturing the Filled Drug Product; cGMP documents such as SOPs, Master Batch Records, deviation/investigations, out-of-specification (OOS) results and executed production batch records. Sanofi or its subcontractor will ensure that an adequate number of qualified personnel are available to Manufacture the Filled Drug Product. Personnel will be deemed qualified based on their having sufficient education, training, and experience to perform their duties. Training will include initial and on-going cGMP and process-specific technical training. Adequate training records documenting education, training and experience must be maintained for all personnel involved in Manufacturing the Filled Drug Product.
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Related to Organization and Personnel

  • Organization and Status Purchaser (a) is duly formed, validly existing and in good standing under the laws of the jurisdiction of its formation as set forth in the preamble to this Agreement, (b) is duly qualified, authorized to do business and in good standing in each other jurisdiction where the character of its properties or the nature of its activities makes such qualification necessary, and (c) has all requisite power and authority to own or hold under lease the property it purports to own or hold under lease and to carry on its business as now being conducted. Purchaser has made available to Seller complete and correct copies of the Organization Documents for Purchaser.

  • Organization and Powers Each Loan Party is a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of incorporation as specified in Schedule 5.1 annexed hereto. Each Loan Party has all requisite corporate power and authority to own and operate its properties, to carry on its business as now conducted and as proposed to be conducted, to enter into the Loan Documents and Related Agreements to which it is a party and to carry out the transactions contemplated thereby.

  • Organization and Standing; Articles and Bylaws The Company is a ---------------------------------------------- corporation duly organized and validly existing under, and by virtue of, the laws of the State of Delaware and is in good standing under such laws. The Company has the requisite corporate power to own and operate its properties and assets and to carry on its business as presently conducted and as proposed to be conducted.

  • Organization and Good Standing of the Company The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of the State of Delaware, with full corporate power and authority to own, lease and operate its properties and conduct its business in all material respects as described in the Registration Statement, the Time of Sale Information and the Prospectus. The Company is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction where the ownership or leasing of its properties or the conduct of its business requires such qualification, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, have a material adverse effect on the operations, business, prospects, properties, financial condition or results of operation of the Company and its Subsidiaries taken as a whole (a “Material Adverse Effect”).

  • Organization of the Seller The Seller is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its incorporation.

  • Organization and Good Standing Seller has been duly organized and is validly existing as a corporation in good standing under the laws of the State of Delaware, with power and authority to own its properties and to conduct its business as such properties are currently owned and such business is currently conducted, and had at all relevant times, and now has, power, authority and legal right to acquire, own and sell the Receivables and the Other Conveyed Property to be transferred to Purchaser.

  • Due Incorporation and Organization The Adviser is duly organized and is in good standing under the laws of the State of Connecticut and is fully authorized to enter into this Agreement and carry out its duties and obligations hereunder.

  • Organization of the Company The Company is a corporation duly organized and validly existing and in good standing under the laws of the State of Nevada.

  • Organization and Standing of the Company The Company is a duly organized and validly existing corporation in good standing under the laws of the State of Nevada and has all requisite corporate power and authority for the ownership and operation of its properties and for the carrying on of its business as now conducted and as now proposed to be conducted and to execute and deliver this Agreement and other instruments, agreements and documents contemplated herein (together with this Agreement, the “Transaction Documents”), to issue, sell and deliver the Shares and to perform its other obligations pursuant hereto. The Company is duly licensed or qualified and in good standing as a foreign corporation authorized to do business in all jurisdictions wherein the character of the property owned or leased or the nature of the activities conducted by it makes such licensing or qualification necessary, except where the failure to be so licensed or qualified would not have a material adverse effect on the business, operations or financial condition of the Company.

  • Organization and Existence Such Investor is a validly existing corporation, limited partnership or limited liability company and has all requisite corporate, partnership or limited liability company power and authority to invest in the Securities pursuant to this Agreement.

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