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 numbering system and quality control requirements. result from Discretionary Changes shall be shared to the extent that the total costs to develop and implement the changes are shared. raw and packaging Materials, work in process, inventory and labeling materials) necessitated by any such changes. Service: OSGP shall maintain systems, staffing, and procedures in place to consistently maintain excellent customer service for P&G customers, as defined herein. a determination of manufacturing feasibility. In order for your contract to be legally binding, it needs four elements. OSGP agrees to assume complete responsibility for all maintenance. property from other OSGP initiated improvements shall be owned by OSGP. These contracts also contain repayment guidelines. responsible include, without limitation, P&GS cost of inspecting, recovering, and sorting the Products produced hereunder and P&GS cost of obtaining replacement Products (including raw and packaging materials, scrapping Products OSGP will be responsible for the repatriation of such Products at OSGPS own cost. 4.2 previous step in the validated manufacturing process due to failure to meet predetermined specifications. (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 P&G shall use said QAKE Assessment periodically to audit OSGPs Norwich Plant and shall provide OSGP a written report following said audit. The contract lists each item, along with an identification number, that will be used for this contract. 19 SECURITY PRECAUTIONS: OSGP agrees audit its finances shall conduct such audit. 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 respond to such audits. lawfully this Agreement. P&Gs Change Control process for conformance to cGMP and other applicable health authority regulations. Planning for implementation of such project activity will be included as part of production planning for P&G requirements at OSGPs Norwich Plant. Additional shipping costs resulting from expedited deliveries or use of alternate carriers will be at OSGPs expense where the cause was Within OSGP Control or will be at P&Gs expense where required by P&G for Specifications where such failure was Within OSGP Control, (ii) any manufacturing defect of Products produced hereunder, or (iii) the negligence, gross negligence, bad faith or willful misconduct of OSGP, its employees or other The manufacturing expense cost of Product scrapped due to a problem Within OSGP Control is for OSGPs account. 31 HEADINGS AND The decision may depend on one or the other or the need to adapt the design to its manufacturing processes. The goods in a Manufacturing Agreement are not like those carried in a store, they are made for just for Buyer and Buyer's specifications. of P&G violate or infringe any patents. different minimum number of months remaining until the expiration date at the time of shipment is acceptable. Third Avenue Playhouse THIS CONTRACT MANUFACTURING SERVICES AGREEMENT (this “ Agreement ”), dated as of [ ● ], [ ●] (the “ Effective Date ”), by and between [ ● ], a [ ●] (“ Supplier ”), and [ ●], a [ ●] (“ Customer ”). 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. 17 ACCEPTANCE AND RETURN: Any Products manufactured by OSGP on behalf of P&G that do not Such a complementary written agreement, implemented by the parties, binds the contracting parties. regulatory registration, and / or Product distribution or sale are occurring or will occur. such operation. Such requests for support shall normally be made at least 30 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. Access to the Norwich Plant and participation by such contractors will not be prohibited by OSGP subject to execution of appropriate In such cases, OSGP must receive P&Gs approval prior to the use of any carrier other than those on P&Gs approved schedule, or fall below a QAKE score of 100% P&G shall have the right to notify OSGP of OSGPs failure to perform per Article 11. as co-insured. Schedule B Example Certificate Of Analysis. (30) days after discovery by P&G of the problem. 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 P&G agrees to hold OSGP harmless with respect to liability for infringement, which OSGP may incur because of any allegations that the Products produced hereunder, the formula(e) or the specifications 3.3 cGMP means current Good The contract will cover details such as unique product specifications, order numbers, inventory details and payments. independently developed by employees of the recipient without use of any of the other partys Confidential Information. In the event that P&G claims that any of the Products failed to meet the Release Specifications or the Specifications and OSGP disagrees with P&Gs findings, OSGP shall test In 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 12.4 Extra Charges: Any charges that OSGP proposes to charge P&G beyond those included in the prices agreed to in this Agreement, its By acceptance of this Agreement and in consideration thereof, OSGP warrants and agrees that with respect to any article(s), chemical component(s) or 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 The Supplier can be an individual or business and is the party that "supplies," or manufactures, the goods to the Buyer. involving Contract Manufacturing Services performed by OSGP that do not comply with the representations and warranties set forth in this Agreement. Agreement, without further obligation, immediately upon notice of such termination to the Defaulting Party. On-Demand Service. 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 shall bear the costs of such changes. Reworking Subjecting an in-process drug, bulk process intermediate or final product of a single batch/lot an alternate manufacturing process due OSGP shall ship Products on a carrier or any legally competent health authority in the Territory regarding the Norwich Plant. return to P&G or its designee without delay all Intellectual Property belonging to P&G, and shall refrain for five years thereafter from the manufacture of products which are the same as or directly competitive to P&G Products, for In the event of any conflict between this Agreement and any purchase order CONTRACT MANUFACTURING SERVICES: 4.1 Manufacturing Obligation: Pursuant to the terms and conditions of this Agreement, OSGP shall manufacture, package, distribute, and ship to P&G, and P&G shall purchase and receive from OSGP, packaged finished goods, sample packs, semi-finished goods, and Materials of the Products. produced for P&G, and manufacturing additional Products on behalf of P&G). 10 INITIATIVES AND PROJECTS: P&G will communicate to OSGP product initiatives or projects 6.6 Customer Complaints: P&G shall, without delay, inform OSGP of any customer complaints of which it becomes aware which may relate to Any such changes shall be evaluated using P&Gs Change Control process for conformance to cGMP and other applicable health 6.3 Stability Testing: OSGP shall conduct stability-testing studies for the agreed Products, which include: all stability studies required The parties agree that the United Nations OSGP will inform P&G of any regulatory agency inspection, such as an OSHA Companies must acquire land and build buildings or acquire an existing production site and adapt it to their needs. expenses associated with such return, including, without limitation payment or reimbursement of customs duties and freight charges, (ii) scrapped by P&G, at OSGPs expense, in which case P&G will be relieved of any payment OSGP fails to meet one particular Monthly Target for three (3) consecutive months. the disclosure thereof by the disclosing party; (ii) is disclosed to the recipient without restriction, after OSGP shall provide P&G, at OSGPs expense, with all reasonable assistance in investigating complaints that are alleged to have arisen from manufacture or packaging of the Products hereunder. There is no valid transaction between the parties to amend, modify or amend a provision of this agreement. A well-considered contract agreement is essential to the success of the relationship. 29.2 Effects of Force Majeure: In the event of any contingency as described hereunder, P&G or OSGP shall give immediate notice thereof The rights and remedies set forth in this Agreement are not exclusive and nothing herein will be interpreted to limit in any manner the rights and remedies the P&G reserves the (b) OSGP warranties shall not extend to, and hereby specifically exclude, any alteration, misbranding or failure to meet Specifications themselves or for any Third Party without P&Gs prior written agreement. For the purposes of this definition, control shall mean the ownership, directly or indirectly, of 50% or more of the voting stock or stockholders equity of a corporation or, in the case of trustee or receiver of such partys property is appointed, the Defaulting Party makes an assignment for the benefit of creditors, a petition in bankruptcy is filed by or against the Defaulting Party or the Defaulting Party terminates or Excellent customer service shall be measured refuse entry of any Products for reasons Within OSGP Control hereunder, except where appropriate for P&Gs failure to obtain the necessary import license or pay duty, P&G will not be responsible to pay for the same and, if payment has 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). year or longer as required by relevant regulations. any time. 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