Production and Quality Control Sample Clauses

Production and Quality Control. Section 3 of the Original Agreement is amended and restated to read as follows: (a) PPTI warrants, represents and covenants that all Materials produced for or sold to Company shall be manufactured free from defects in materials and workmanship and in accordance with written specifications as mutually agreed upon. Further, PPTI warrants, represents and covenants that the Materials will meet the specifications in any applicable Regulatory Submissions or Regulatory Approvals, as the case may be, in effect at the time of production, including compliance with Quality System Regulations and ISO 9001 Standards as described in the applicable Regulatory Submissions, and/or such other lawful and appropriate standards as the parties may agree in writing. PPTI shall not have any responsibility for meeting any changed or new specifications or standards, including, without limitation, manufacturing methods and methods of control in Regulatory Submissions unless PPTI has reviewed and approved in writing any such changed or new specifications or standards. Company acknowledges that production specifications, including, without limitation, manufacturing methods and methods of control, may require changes to obtain and/or maintain Regulatory Approvals and/or to comply with applicable laws and regulations, and that such required changes in production specifications may increase the costs and expenses of the Company and extend the product development timetable of the Company. (b) At Company's request, PPTI shall perform one or more of the quality control procedures set forth on Amended and Restated Schedule 3 for each lot of Material provided to Company. PPTI shall deliver to Company a copy of test results for each Lot of Material supplied to Company. All Material supplied to Company shall have passed such quality control tests and PPTI shall immediately bring to the attention of Company any Material that did not meet such quality control requirements. Materials that meet such quality control requirements and which are not objected to by Company within thirty (30) days after receipt shall be presumed to be free from defects in material and workmanship, in the absence of manifest error. (c) PPTI shall retain samples of all ingredients, packaging materials, records and data as may be in accordance with the sample and record retention policies which PPTI uses in [*****] Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission...
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Production and Quality Control. ANP shall produce all Products manufactured pursuant to this Agreement according to the Specifications and in material compliance with all federal, state and local laws. ANP shall notify Customer of any process deviations or ingredients or finished products of questionable wholesomeness prior to distribution. ANP shall also notify Customer in advance of any Products or raw materials ANP has reason to believe contain suspect foreign material, or are otherwise not in compliance with the Specifications. Customer reserves the right to reject or direct further disposition of any such ingredients or Products at ANP’s sole cost.
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Production and Quality Control. 5.6.1 Surgica warrants, represents and covenants that all Product produced for or supplied to Company hereunder shall (a) be manufactured free from defects in materials and workmanship; (b) with respect to Product for Clinical Use, (i) meet the specifications in all applicable Regulatory Approvals of all applicable Regulatory Agencies including, without limitation, compliance with applicable ISO 13485 Standards, Council Directive Concerning Medical Devices 93/42/EEC, and Quality Systems Regulations in effect at the time of production and/or such other lawful and appropriate standards as the parties may agree upon in writing. Each Party acknowledges that production specifications may be modified from time to time to comply with applicable laws and regulations. 5.6.2 Surgica shall retain samples of all ingredients, packaging materials, records and data as may be in accordance with the sample and record retention policies which Surgica uses (or used) in connection with manufacture of Product for its own account; provided such retention shall at all times be in accordance with all applicable Regulatory Approvals, Quality System Regulations, Council Directive Concerning Medical Devices 93/42/EEC, and ISO 13485 Standards. Company shall have the right, no more frequently than once every six (6) months, to review Surgica's manufacturing procedures and operations and its records relating to the manufacture and shipment of Product. Additionally, Company may from time to time audit Surgica's compliance with all applicable Regulatory Approvals (including, without limitation, Quality System Regulations, Council Directive Concerning Medical Devices 93/42/EEC, and ISO 13485). Surgica shall notify Company in writing of any contemplated changes to, or modifications of, its facilities, methods, processes, specifications, or other aspect of its manufacturing operations that may have an impact on the efficacy or safety of the Product and shall seek and, subject to Company's discretion, obtain Company's written approval of such changes or modifications before implementing the contemplated changes and/or modifications. No inspection or testing of Product by Company, or failure to test or inspect, nor any audit, or failure to audit, shall relieve Surgica of its obligations hereunder. Copies of all certificates, reports, test results or other information produced by Surgica, or by a third party consultant or contractor at Surgica's request, that directly relate to lots of Product...
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Production and Quality Control. Contractor shall produce all Products manufactured pursuant to this Agreement according to the Specifications and in compliance with all federal, state and local laws. Contractor shall send production samples to PHL at PHL's expense for examination and testing to assure conformity with the Specifications. If examination of such samples reveals that the production in question fails to conform to the Specifications or the "Pure Food Guaranty" set forth below, Contractor shall dispose of such production in a manner agreed to by both parties. Any lot of Products (i.e., an entire days production, including rework and secondary products from the sampled lot) tested for the presence of pathogens shall be withheld from shipment until acceptable laboratory results are obtained. PHL may, during normal business hours and on notice, have access to Contractor's plant and production records and quality control records with respect to Contractor's performance under this Agreement.
Sample 1
Production and Quality Control. In addition to using HACCP programs to insure food safety, Dreyer’s utilizes a control point system similar to a HACCP system to define those control points which effect the quality of our products or processes. In this way, we can be sure that the proper controls and decision criteria are in place to insure consistently high quality product. The data taken at each of these points also provides an excellent indicator of the state of the process, thus enabling us to support Co-Pack partners without requiring continuous on-sight presence. Each production process must have current MCP’s in place which have been reviewed and approved by Dreyer’s/Edy’s. • An MCP flow chart must be developed for each process or product line. • An MCP analysis chart for each process or product line must be in place. • The “Characteristic” associated with each Manufacturing Control Point (MCP) must be identified.
Sample 1
Production and Quality Control. We use proprietary production processes and techniques, including strict quality controls. Our quality control group routinely tests the quality of the tobacco, flavorings, application of flavorings, premium cigarette papers, tubes and injectors, cigars, MYO cigar wraps, liquid vapor products, tobacco vaporizer products and packaging materials. We utilize sophisticated quality control to test and closely monitor the quality of our products. The high quality of our tobacco products is largely the result of using high-grade tobacco leaf and food-grade flavorings and an ongoing analysis of tobacco cut, flavorings and moisture content together with strict specifications for sourced products. Given the importance of contract manufacturing to our business, our quality control group ensures that established written procedures and standards are adhered to by each of our contract manufacturers. Responsibilities related to process control, manufacturing activities, quality control and inventory management with respect to our loose leaf were allocated between us and Swedish Match under the manufacturing agreement.
Sample 1

Related to Production and Quality Control

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • Formation and Qualification (a) Each Borrower is duly incorporated and in good standing under the laws of the state listed on Schedule 5.2(a) and is qualified to do business and is in good standing in the states listed on Schedule 5.2(a) which constitute all states in which qualification and good standing are necessary for such Borrower to conduct its business and own its property and where the failure to so qualify could reasonably be expected to have a Material Adverse Effect on such Borrower. Each Borrower has delivered to Agent true and complete copies of its certificate of incorporation and by-laws and will promptly notify Agent of any amendment or changes thereto. (b) The only Subsidiaries of each Borrower are listed on Schedule 5.2(b).

  • Diversification and Qualification 6.1. The Fund will invest the assets of each Designated Portfolio in such a manner as to ensure that the Contracts will be treated as annuity or life insurance contracts, whichever is appropriate, under the Code and the regulations issued thereunder (or any successor provisions). Without limiting the scope of the foregoing, the Fund will, with respect to each Designated Portfolio, comply with Section 817(h) of the Code and Treasury Regulation §1.817-5, and any Treasury interpretations thereof, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts, and any amendments or other modifications or successor provisions to such Section or Regulations. In the event of a breach of this Article VI by the Fund, it will take all reasonable steps (a) to notify the Company of such breach and (b) to adequately diversify the affected Designated Portfolio so as to achieve compliance within the grace period afforded by Treasury Regulation §1.817-5. 6.2. The Fund represents that each Designated Portfolio is or will be qualified as a Regulated Investment Company under Subchapter M of the Code, and that it will make every effort to maintain such qualification (under Subchapter M or any successor or similar provisions) and that it will notify the Company immediately upon having a reasonable basis for believing that a Designated Portfolio has ceased to so qualify or that it might not so qualify in the future. 6.3. The Company represents that the Contracts are currently, and at the time of issuance shall be, treated as life insurance or annuity insurance contracts, under applicable provisions of the Code, and that it will make every effort to maintain such treatment, and that it will notify the Fund and the Underwriter immediately upon having a reasonable basis for believing the Contracts have ceased to be so treated or that they might not be so treated in the future. The Company agrees that any prospectus offering a contract that is a "modified endowment contract" as that term is defined in Section 7702A of the Code (or any successor or similar provision), shall identify such contract as a modified endowment contract.

  • Use; Quality Control a. Neither party may alter the other party’s trademarks from the form provided and must comply with removal requests as to specific uses of its trademarks or logos. b. Each party agrees to use, and to cause its Permitted Sublicensees to use, the other party’s trademarks only in good faith and in a dignified manner consistent with such party’s use of the trademarks. Upon written notice to the breaching party, the breaching party has 30 days of the date of the written notice to cure the breach or the license will be terminated.

  • Organization and Qualifications Customer and each of its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is engaged and (iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is engaged in business and is required to be so qualified.

  • Organization and Qualification of the Company The Company is a corporation duly organized, validly existing and in good standing under the Laws of the state of Delaware and has full corporate power and authority to own, operate or lease the properties and assets now owned, operated or leased by it and to carry on its business as it has been and is currently conducted. Section 3.01 of the Disclosure Schedules sets forth each jurisdiction in which the Company is licensed or qualified to do business, and the Company is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the properties owned or leased by it or the operation of its business as currently conducted makes such licensing or qualification necessary.

  • Organization and Qualification The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

  • Existence and Qualification; Power; Compliance With Laws Borrower is a corporation duly formed, validly existing and in good standing under the Laws of the State of California. Borrower is duly qualified or registered to transact business and is in good standing in the State of California, and each other jurisdiction in which the conduct of its business or the ownership or leasing of its Properties makes such qualification or registration necessary, except where the failure so to qualify or register and to be in good standing could not reasonably be expected to have a Material Adverse Effect. Borrower has all requisite power and authority to conduct its business, to own and lease its Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. The chief executive offices of Borrower are located in San Dimas, California. All outstanding capital stock of Borrower is duly authorized, validly issued, fully paid and non-assessable, and no holder thereof has any enforceable right of rescission under any applicable state or federal securities or other Laws. Borrower is in compliance with all Laws and other legal requirements applicable to its business, has obtained all authorizations, consents, approvals, orders, licenses and permits from, and has accomplished all filings, registrations and qualifications with, or obtained exemptions from any of the foregoing from, any Governmental Agency that are necessary for the transaction of its business, except where the failure so to comply with Laws and other legal requirements applicable to its business, obtain authorizations, etc., file, register, qualify or obtain exemptions could not reasonably be expected to have a Material Adverse Effect.

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