SCHERING-PLOUGH (AVONDALE) COMPANY (REGISTERED BUSINESS NAME OF SCHERING-PLOUGH (IRELAND) COMPANY) PURCHASE ORDER TERMS AND CONDITIONS 1. Preliminary Schering-Plough (Avondale) Company ( the Purchaser ) contracts with each supplier of goods and/or services ( the Supplier ) upon the terms and subject to the conditions hereinafter contained which shall exclusively govern all purchases of goods or services by or on behalf of the Purchaser, notwithstanding any purported variations from the provisions hereof contained in any conditions of sale, invoice or other correspondence submitted by the Supplier unless otherwise agreed to in writing by a duly authorised officer of the Purchaser. This purchase order shall not be valid unless signed by an authorised representative of the Purchaser. This Purchase Order constitutes an offer on the part of the Purchaser which must be accepted by or on behalf of the Supplier, either in writing by the Supplier or by actual execution of the Order by the Supplier. These terms and conditions contain the entire agreement between the parties, and save as hereinbefore provided for, no employee or agent of the Purchaser has authority to vary, add to or depart from these conditions of purchase. 2. Deliveries (a) Unless otherwise agreed all goods are to be supplied carriage paid to the Purchaser s plant or to any destination nominated by the Purchaser. (b) Risk of loss and/or damage to goods shall be assumed by the Supplier until the goods are physically delivered to the Purchasers plant or other nominated destination. If goods are rejected by the Purchaser for whatever reason, they shall be at the Supplier s risk after the expiry of 10 days of rejection notwithstanding that they may be in the possession of the Purchaser. (c) The Purchaser may refuse acceptance of goods delivered in excess of quantities ordered, and may refuse deliveries which substantially fail to meet the quality ordered or which are made more than 3 days in advance of the agreed date for delivery. Any goods rejected by the Purchaser under this Clause may be returned by the Purchaser at the expense of the Supplier.
(d) The Supplier shall within such period as may be reasonably specified by the Purchaser rectify and replace free of cost, to the Purchaser s reasonable satisfaction, all goods found faulty, below specification or in any way defective. The Purchaser reserves the right to cancel the entire order if the goods are not satisfactory. (e) Defects in or late delivery of any part of any Order shall entitle the Purchaser to cancel the entire Order. In case of strikes, industrial action, accidents, civil commotion, war or other contingencies outside the control of the Supplier delivery time may be extended at the Purchaser s option for such period(s) as may be specified by the Purchaser. (f) The signature of any of the Purchasers staff on any invoice, receipt or other document issued by the Supplier in connection with the supply of goods or services hereunder shall not be construed as an acknowledgement by the Purchaser that the goods or services have been supplied in a manner satisfactory to the Purchaser, except insofar as any such document shall relate solely to the quantity of goods delivered to the Purchaser. (g) The Purchaser may postpone any supply of goods or services hereunder by reasonable notice to the Supplier. (h) Agreed times for supply, delivery or shipping of goods or services to be supplied hereunder shall be strictly complied with by the Supplier, and time shall be of the essence in these terms and conditions. 3. Price (a) The price for goods or services ordered shall be the price printed on this Purchase Order. Where price has been omitted, it is agreed that the price payable shall be the lowest prevailing market price, but in no case shall the price be higher than the most recent quotation from the Supplier. Invoices shall be paid within 90 days of the date of receipt by the Purchaser. (b) Unless otherwise agreed in writing the price shall be payable in Euro and shall not be increased by fluctuations in the rate or rates of exchange or for any other reason nor shall the price be increased as a result of any governmental order, levy or regulation. (c) The price shall include all taxes, and other costs, charges and expenses chargeable in respect of the goods or services upon delivery or supply to the Purchaser. The Purchaser shall not however be obliged to pay any packing or cartage charges, nor for any tools, drawings, or similar items unless specifically agreed to by the Purchaser in writing and in which case any such items shall become the property of the Purchaser. The contract price shall not be increased by the Supplier unless specifically agreed to in writing by the Purchaser.
(d) In the event of an alteration of instructions by the Purchaser to the Supplier in respect of the goods or services, the Supplier shall inform the Purchaser of any adjustment in price within 10 days of such alteration, and where the Purchaser agrees to the alteration of price, it shall issue to the Supplier a new Purchase Order containing details of such altered price. 4. Suppliers Warranties (a) The Supplier warrants that it has the right to sell the goods agreed to be purchased hereunder, that the goods are free from any charge or incumbrance in favour of any third party, and that the Purchaser shall enjoy quiet possession of the goods. (b) In addition to any warranty implied by law, the Supplier expressly warrants all goods supplied (including goods supplied in connection with a supply of services by the Supplier) to be free from defects in design, workmanship and materials, to conform strictly with applicable specifications, drawings and approved samples, if any, and to be fit and of sufficient quality for the purpose intended and to be merchantable. Where goods are sold by description or sample, the Supplier warrants that the goods shall correspond with any such description or sample. Such warranties, together with all other service warranties of the Supplier, shall enure to the benefit of the Purchaser, its successors, assigns and customers. All warranties shall survive inspection, test, acceptance and payment by the Purchaser. The Purchaser shall have the option to return for credit or require prompt correction or replacement of defective or non conforming goods or to receive a refund therefor from the time the Purchaser (in its sole discretion) reasonably forms the opinion that the Supplier will not or cannot correct the Order or replace the defective or otherwise non-conforming goods to the Purchasers satisfaction. (c) Where this Order relates to the supply of services to the Purchaser, the Supplier hereby warrants that it has the necessary skill to render the service, that it will supply the service with due skill, care and diligence, and where materials are used in relation to the provision of the service that such materials will be fit for the purpose for which they are required. (d) All of the above warranties shall continue in force notwithstanding the failure of the Purchaser to enforce same from time to time, and such warranties shall not be deemed to be varied by any course of dealing established between the parties hereto, or otherwise. (e) The Supplier shall keep detailed records of all things done by it in relation to the provision of services hereunder and, at the Purchasers request, shall make such records available for inspection and/or provide copies to the Purchaser. 5. Patents and Trade Marks/Confidentiality
(a) The Supplier warrants that goods supplied do not infringe any patent, trade mark, registered design, copyright or any other like protection or the provisions of any statute, statutory instrument or regulation for the time being in force, and without prejudice to the generality of the foregoing, that the Purchaser shall have the right to use the goods for any purpose of which the Supplier is, or should reasonable be, aware without interference from any third party on the grounds of infringement of any rights in industrial property. (b) The Supplier agrees that all records of Confidential Information (which shall include all information relating to the Purchaser s existing and contemplated products, manufacturing procedures, methods, machines, compositions, technology, formulae, trade marks, know-how, research and development programmes, inventions, discoveries, improvements and ideas) made or prepared by him or which may come into his possession during the supply of goods or services hereunder or in relation to any matter within the scope of the Purchaser s dealings or affairs are the property of the Purchaser and that the Supplier shall not permit any such records to be used at any time otherwise than for the benefit of the Purchaser and that when this Order shall terminate for whatever reason all such records and all copies thereof shall be left with the Purchaser or otherwise disposed of as directed by the Purchaser. (d)(c) The Supplier agrees that he will not at any time hereafter directly or indirectly use the confidential Information for his own use or disclose to others any Confidential Information without the prior written consent of the Purchaser. The Supplier further agrees that he will not use the Confidential Information save for the benefit of the Supplier. The Supplier shall furthermore take all reasonable precautions to prevent inadvertent disclosure of Confidential Information. Such Confidential Information will not be disclosed by the Supplier to employees of the Supplier or any other parties unless a need-to-know basis is established. (d) The obligations of the parties under this clause shall survive the performance, expiry or termination (for whatever reason) of this Order. (e) The Purchaser shall have the right to disclose any information to a regulatory agency (including, but not limited to, quality audit reports relating to the Supplier) to the extent required or requested by such agency in connection with any regulatory filing, inspection or otherwise. 6. Indemnity (a) The Supplier agrees at all times to indemnify save and keep harmless the Purchaser from and against any and all loss, damage, costs, (including legal, litigation, or arbitration costs), charges, expenses or claims whatsoever whether in respect of personal injuries, damage to
property, infringement of property rights, royalties or otherwise howsoever arising (including without prejudice to the generality of the foregoing any loss, damage, costs, charges, expenses and claims suffered or made by the Supplier, its employees, servants, agents or representatives) which the Purchaser may suffer or sustain or be in any way subjected to (including but without limitation any economic loss or other loss of turnover, profits, business or goodwill) on account of or connected with the performance or non-performance by the Supplier, its employees, servants, agents or representatives of this Order or on account of or connected with the goods or services supplied hereunder. Where the Purchaser is joined as party to legal proceedings in connection with any such loss, damage, costs, charges, expenses and claims, the Supplier will at it s own expense if requested so to do by the Purchaser defend any and all actions or proceedings and/or provide all assistance to the Purchaser to enable it to defend same. (b) The Supplier s employees, servants, agents or representatives engaged in the supply of goods and/or services hereunder shall at all times be deemed to be the Suppliers employees, servants, agents or representatives as appropriate and not the Purchasers whether such personnel are at the Purchasers premises or anywhere else. (c) The Supplier undertakes and agrees to take out adequate insurance cover with an insurance office of repute acceptable to the Purchaser to cover the liability accepted by it in this Clause and at the Purchasers request agrees to produce a copy of the insurance policy or policies and relevant renewal receipts for inspection by the Purchaser. Should the Supplier fail to comply with any such request of the Purchaser or (in the sole opinion of the Purchaser) have inadequate insurance, then the Purchaser may, at its absolute discretion refuse to accept any supply of goods or services from the Supplier. 7. Inspection The Purchaser may at all reasonable times inspect on the Supplier s premises, the manufacture and workmanship of all goods to be supplied, and the manner in which any service is being provided by the Supplier, and, where any item is being manufactured or any service is being provided on other premises, the Supplier shall obtain for the Purchaser permission to inspect, and shall give to the Purchaser reasonable notice of the dates on and the place at which the goods or services may be inspected or tested and shall, at the Supplier s own cost, give the Purchaser all assistance (by supply of labour, materials and power or otherwise) as may be reasonably necessary to carry out inspections or tests effectively. Such inspection or testing shall not relieve the Supplier from his obligations arising from the supply of the goods or services. 8. Waivers
The failure by the Purchaser from time to time to enforce any of these Terms and Conditions shall not be construed as a waiver of the Purchaser s rights hereunder 9. Sub-contracting The Supplier shall not sub-contract the performance of this Purchase Order or any part thereof without the prior written consent of the Purchaser. 10. Assignment This Order shall be binding upon and enure to the benefit of the parties hereto and their respective successors, assigns, heirs and legal representatives, providing that neither party shall assign rights arising nor delegate performance required herein except to a successor in ownership of substantially the whole of its business. 11. Cancellations All Orders are subject to suspension or variation or cancellation by the Purchaser in the event that the Purchaser is unable to accept all or any part of the goods or services to be supplied hereunder due to acts of God, government orders, strikes or other industrial action by workers or employers, accidents, vehicle or plant breakdowns, war, civil commotion or any other circumstances beyond the control of the Purchaser. 12. Non-Performance by Supplier The Purchaser shall have the right to terminate this Agreement forthwith by notice to the Supplier if the Supplier shall have been prevented by illness, injury or otherwise howsoever from providing services for a period of 3 days. 13. Governing Law These conditions and all contracts to which they relate (including collateral contracts) shall be governed by and construed in accordance with the laws of Ireland and the Supplier agrees to submit to the non-exclusive jurisdiction of the Courts of Ireland in relation to any matter concerning goods or services supplied hereunder, or any other matter connected with this contract.
14. Severance If any provision of these conditions shall be determined by a Court of competent jurisdiction to be void or unenforceable the same shall be severed without in any way affecting the validity and enforceability of the remaining provisions. 15. Headings Paragraph headings are for ease of reference only and shall not be considered as part of or affect the construction or interpretation of these Terms and Conditions. 16. Ethics/Conflict of Interest (a) In its performance of this Agreement, the Supplier shall adhere to business practices that are in accordance with the letter and spirit of applicable laws and ethical principles as follows: (i) All transactions in connection with this Agreement shall be accurately reflected in the Supplier s records, and no funds or other assets shall be paid directly or indirectly to government officials or persons acting on their behalf or to representatives of the other businesses for the purpose of influencing government decisions or actions with respect to the Purchaser's business (ii) The Supplier shall conduct its activities hereunder so as to avoid loss or embarrassment to the Purchaser due to any real or apparent conflict of interest, and to require that all subcontractors comply with such policy in connection with this Agreement (iii) The Purchaser shall have the right to terminate this Agreement, without any penalty or obligation to pay damages, upon violation of the business practices mentioned in this clause by the Supplier, its employees, agents, representatives, sub-contractors or consultants. (b) Without limiting any of the Supplier s other obligations under this Agreement, the Purchaser expects that the Supplier will abide by the letter and spirit of the Purchaser s Supplier Performance Expectations and Business Partner Code of Conduct (the Code ), copies of which are available at http://www.merck.com/about/how-we-operate/code-of-conduct/home.html, in its performance of this Agreement.
17. Excluded Entities (a) For the purpose of this clause 15, the term Violation shall mean that either the Supplier, or any of its officers or directors has been: (1) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/fraud/exclusions/authorities.asp); (2) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (http://oig.hhs.gov/fraud/exclusions.asp) or the U.S. General Services Administration's list of Parties Excluded from Federal Programs (http://www.epls.gov); or (3) listed by any US Federal agency as being suspended, debarred, excluded, or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/) (each of (1), (2) and (3) collectively the Exclusions Lists ). (b) The Supplier represents and warrants that prior to the date of this Agreement, it has screened itself, and its officers and directors against the Exclusions Lists and that it has informed the Purchaser whether it, or any of its officers or directors has been in Violation. After the execution of the Agreement, the Supplier shall notify the Purchaser in writing immediately if any such Violation occurs or comes to its attention. The Purchaser shall also have the right, in its sole discretion, to terminate this Agreement immediately in the event of any such Violation. 18. Data Privacy and Security (a) Personal Information shall mean any information or set of information that identifies, or is used by, or on behalf of, the Purchaser to identify an individual, including without limitation, the Purchaser s employees. (b) The Supplier represents and warrants that in the event that the Supplier provides Personal Information to the Purchaser, including, without limitation, any individually identifiable health information, it has obtained all necessary consents, approvals and authorisations to provide the Personal Information to the Purchaser, and it is not violating any laws, rules or regulations, or the rights of any individual or entity, by providing such Personal Information to the Purchaser. Upon request by the Purchaser, the Supplier shall provide documentation of any applicable
consents, approvals and authorizations. No Personal Information, other than the Personal Information necessary for the Supplier to supply goods and services hereunder, shall be provided by the Supplier to the Purchaser under this Agreement. 19. Use of Wood Pallets in Shipments (a) This clause shall apply only to the supply of: i) GMP materials or products that will be used by the Purchaser in manufacturing; ii) wood pallets; and/or iii) non-gmp materials or products where the Purchaser has notified the Supplier in advance that compliance with this clause is required. (b) The Supplier expressly agrees and represents, warrants and covenants that any shipment to a Purchaser site or location using wood pallets shall only be done if the wood pallets meet the following criteria: i) Certified heat treated wood pallets, in accordance with the International Standards for Phytosanitary Measures (ISPM) 15 "Regulation of Wood Packaging Materials in International Trade", developed by the International Plant Protection Convention (IPPC), as amended; provided, however, that nothing herein or therein shall permit the use of any chemical on wood pallets to be supplied to the Purchaser. ii) No additional chemical treatments have been used on such wood pallets, including, but not limited to Methyl Bromide. iii) Contain the heat-treatment certification (stamped "HT"), the country of origin two-letter designator, the regional identifier and a registration number in accordance with ISPM, and such stamp, designator and number will be located on the wood pallet to allow the Purchaser to visually inspect the wood pallet, upon receipt.
(c) The Purchaser reserves the right to reject any shipment that does not meet the aforementioned criteria and any costs associated with the rejection of such shipment due to a failure to meet these criteria shall be for the sole cost and expense of the Supplier. TC Rathdrum 030513260613