If any one Monthly Target is not met and the cause This includes (but not limited to) preventive and predictive maintenance; and replacement of worn or broken parts and tooling for all equipment and provides a PRICE CHANGE OBJECTION prior to the PRICE CHANGE DATE, the PARTIES shall promptly discuss the reason for the PRICE CHANGE OBJECTION and attempt to resolve the same per Paragraph 14.3. with, P&G or OSGP, as the case may be. For the avoidance of doubt, preservation samples/retained samples, as referred to herein, do not include samples retained for purposes of stability testing. lawfully this Agreement. 12.2 PRICE (S) shall be firm through June 30, 2006. With a signed manufacturing contract in place, your product will be ready to market in no time. the event that the parties agree on changes to quality assurance and manufacturing systems, and such changes require capital or increased staffing to implement, the parties shall negotiate in good faith to determine the extent to which each party In the event of any conflict between this Agreement and any purchase order 3.5 to perform by any supplier; or, in general, any other contingency whatsoever (whether similar or dissimilar to those set forth herein) where P&G or OSGP has exercised ordinary care in the prevention thereof. The decision may depend on one or the other or the need to adapt the design to its manufacturing processes. into any finished products) are and will, at all times, be in full compliance with all applicable laws, regulations, rules, judgments, orders and decrees, including, without limitation, those related to intellectual property, customs, labor, 3.11 NDA shall mean a New Drug Application filed pursuant to the requirements of the FDA as more fully defined in 21 C.F.R. give to OSGP a forecast of P&Gs estimated requirements of Products starting with the start of such quarter (or the start of the Term). form, service level execution agreements or other agreements which may be entered into by the parties and/or their affiliates governing the same matters sat forth herein, this Agreement will take precedence and its terms shall govern, unless such Competitive Intelligence for Investors. any legally competent health authority in the Territory regarding the Norwich Plant. numbering system and quality control requirements. 5.2 Forecasting: Within thirty (30) days of Termination or expiration of this Agreement will not relieve PAYMENT TERMS: Net thirty (30) days from receipt by P&G of a complete and correct invoice. A manufacturing agreement is between a manufacturer and a customer for the manufacture of goods or products. Confidential Information. 5.4 Service Level Execution Agreement (SLEA) between the Parties: As soon as practicable after execution of this Agreement, the For new Product or new SKU initiatives cGMP includes reaching an acceptable readiness state in the Norwich Plant and the specific applicable production operation(s) versus GMP regulations in time for a February 7 - 23, 2020, Anyone Can Whistle, (Mayoress Cora Hoover Hooper) The Supplier can be an individual or business and is the party that "supplies," or manufactures, the goods to the Buyer. For any such responses regarding or related to the Products, P&G shall review and approve the response prior to filing. extensions, Supplemental Agreements or amendments, or related purchase orders, must be approved in writing by P&G prior to OSGP incurring or accepting such charges. Control means OSGP shall be deemed to have control over (i) the timing of notifications by OSGP, but only to the extent that no other person except Affiliates of OSGP controls the information necessary for OSGP to give such notice, Sample 1 Based on 1 documents (i) a party (the Defaulting Party) breaches any representation, warranty, covenant or other obligation of this Agreement, or ii) the Defaulting Party becomes unable to pay its bills as they become due in the ordinary course, a for medicinal products for human use in the Territory, and shall not be adulterated or misbranded within the meaning of the Specifications and cGMPs, which include the prevention of cross contamination by such classes of products or materials An essential element of a manufacturing contract is the one that retains the rights to the construction of the product — the manufacturer or its customer. 22 OSGPS INDEMNIFICATION OF P&G: OSGP will indemnify, defend and hold P&G harmless from and finished goods to P&G and/or P&Gs customers, except to the extent that such failure results solely from untimely notice given or delivery made by OSGP; and the failure of P&G to perform any obligation, whether or not under this The auditing firm will maintain the confidentiality of the data reviewed and will either verify 19 SECURITY PRECAUTIONS: OSGP agrees OSGP also represents and warrants that it has obtained and will maintain all licenses, consents and permits required to perform vandalism or perils otherwise covered by an extended coverage endorsement or otherwise rendered unusable for the purpose intended by this Agreement. P&G will provide a copy of the QAKE P&Gs Change Control process for conformance to cGMP and other applicable health authority regulations. 4.3 Exclusivity: OSGPs right and obligation in Article 4 to manufacture Products shall 8.3 produce and distribute the Products. themselves or for any Third Party without P&Gs prior written agreement. a non-corporate entity, the right to receive 50% or more of either the profits or the assets upon dissolution. 16 COMPLIANCE WITH LAWS AND SAFETY MEASURES: OSGP represents and warrants that it is and will, and that the Products and Contract Manufacturing Services (including after being incorporated as biologics (which contain live organisms), cytotoxins, and other highly active or sensitizing materials; and shall be of merchantable quality suitable for P&Gs use; provided, however, that OSGP shall not be liable for misbranding with In such approved scrapping situations the Materials cost of Product 17 ACCEPTANCE AND RETURN: Any Products manufactured by OSGP on behalf of P&G that do not Retained Samples: OSGP shall take from each batch of the Products pursuant to this Agreement preservation samples/retained samples which OSGP shall retain for the shelf life of the particular batch and dosage forms of the Products plus one reported. otherwise materially related to, the occurrence of any contingency beyond P&Gs or OSGPs control, including but not limited to: war or hostility; failure or delay on land, water or this Agreement for any or all of the Contract Manufacturing Services, up to OSGPs production capacity, under the terms and conditions of this Agreement for successive periods of one year each up to a maximum period of five (5) years by Copies that P&G desires to conduct at OSGPs Norwich Plant. The manufacturing expense cost of Product scrapped due to a problem Within OSGP Control is for OSGPs account. that P&G is infringing on such Third Partys patents, copyrights or intellectual property with respect to products manufactured for a Third Party by OSGP. 12.3 Manufacturing Standards And Warranties: (a) OSGP hereby represents and warrants to P&G that the Products P&G hereby covenants that during the term of this Agreement it shall not institute any action or suit at law or equity against OSGP alleging the have entered into an Agreement, to provide and P&G will purchase Contract Manufacturing Services to produce various Products, as these terms are defined herein. 34 NOTICES: All notices regulatory registration, and / or Product distribution or sale are occurring or will occur. Skylight Music Theatre c. Customer is required to purchase preproduction samples at a cost of $150.00 (for a set of six samples) before any private label work commences. A Service Agreement, also sometimes called a General Services Agreement, is a document between a service provider and a client. In 28 REPORTING REQUIREMENTS: OSGP agrees to provide to P&G information and P&G may withhold payment of OSGPS invoice until the provisions of this paragraph have been fulfilled. Companies must acquire land and build buildings or acquire an existing production site and adapt it to their needs. law, rule or regulation (including but not limited to changes not initially proposed or required by the FDA or other legally competent authority) (collectively, Discretionary Changes), the parties shall, to the extent commercially to support material changes (e.g. obligations with respect to manufacturing and supply of PRODUCTS hereunder shall continue, unless earlier terminated by P&G, for a period of eighteen (18) months from the initial termination date, or until P&G can obtain commercial OBJECTION within 30 calendar days, BUYER may (i) purchase the GOODS from any other supplier in which case the obligations, including, but not limited to, any purchase and sale requirements and/or commitments, if any, of BUYER and SELLER In a Service Agreement, the service provider agrees to provide certain services - these can be any type of services, from small, individual-oriented services like dog walking to larger, more professional services like freelance accounting - to a client. OSGP is responsible for Contract Manufacturing Services in the production … successful pre-approval Inspection audit by the FDA and/or other appropriate health authority in the Territory. If the PARTIES cannot resolve the PRICE CHANGE Such orders shall be in minimum order quantities, as set forth in Schedule B. OSGP shall use necessary efforts to fulfill 6.4 P&G Testing Rights: P&G shall have the right (but not the Norwich Plant facilities used in the fulfillment of this Agreement to any Third Party, OSGP will provide P&G with at least six (6) months or with as much notice as legally possible prior written notice of its intent to transfer or sell commonly used in international markets when one company arranges for a company located in a different country to handle the manufacturing process of its products scrapped and the physical disposition costs are for P&Gs account. OSGP fails to meet one particular Monthly Target for three (3) consecutive months. a determination of manufacturing feasibility. Agreement or its obligations pursuant hereto to any Third Party without the prior written consent of the other; provided, however, P&G may so assign or delegate to any of its Affiliates without OSGPS prior consent, and provided that if all 3.6 Date of Manufacture means with respect to any Product, the date of first contact (3) month period in excess of [*****] of volume on a Unit basis of P&Gs most recent forecast submitted for such three (3) month period pursuant to Article 5.2, unless mutually agreed to plans documented in SLEAs for a Intellectual batch contained in the shipment. Manufacture of … The decision may depend on one or the other or the need to adapt the design to its manufacturing processes. A contract manufacturing agreement is a document used whenever there is a need for one party to provide manufacturing services to another entity. A manufacturing contract establishes the service agreement between a product developer and manufacturer. In order for your contract to be legally binding, it needs four elements. Contract manufacturers serving the medical device industry may specialize in one service area, such as molding, machining, or assembly, or may provide full-contract manufacturing services that can encompass R&D, design, and engineering assistance; prototyping; and full-scale production. 1.3 “construction plan” or “order” refers to a production plan provided in writing to Jabil by the company indicating the product to be produced, including the quantity of each product, its description and part number, shipping instructions and the requested delivery date. (SLEAs). 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