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Destination Control Statement
These items are controlled by the U.S. Government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.
Terms and Conditions of Sale
1. ACCEPTANCE OF ORDERS: Acceptance by West Pharmaceutical Services, Inc. or its affiliates ("West") of Buyer's order(s) is expressly conditioned on Buyer's assent to all of the following terms and conditions and/or those on the face and reverse side of West’s quotation, if any, and in attachments thereto ("Terms and Conditions"). Any different or additional terms of Buyer's order are objected to and hereby rejected by West. Buyer will be deemed to have assented to such Terms and Conditions unless West receives written notice of any objection within 15 days after Buyer's receipt of this form and in all events prior to any delivery or other performance by West of Buyer's order. All orders will be subject to approval by West.
2. QUOTATIONS: Any quotations by West will be deemed to be offers by West to sell the goods or services described therein subject to these Terms and Conditions, and acceptance of such offers is expressly limited to acceptance by Buyer of all of these Terms and Conditions within 15 days from the date of the quotation. Orders submitted by Buyer of the goods or services quoted by West will be subject to and will be deemed to constitute acceptance of these Terms and Conditions.
3. PRICES: With respect to orders for goods, West may, without notice, revise any price specified herein on any undelivered balance, and discount and any allowance of any kind or nature which affects the total consideration passing between Buyer and West. In the event any increase in price, other than an increase arising from new or increased taxes, is unacceptable to Buyer, Buyer within ten days after receiving notice of such increase shall have the right to terminate this contract on written notice with respect to the unshipped portion of the particular goods, effective upon receipt by West; provided that, if within 30 days after the effective date of such cancellation, West so requests, Buyer shall take, within 60 days after notice that the articles are ready for shipment, and pay for, at the price effective prior to such increase, all articles that shall have been manufactured or are in the process of manufacture by West under this contract prior to the date of cancellation.
4. TAXES: All occupational, sales, use, gross income or other taxes, and import and export duties levied by any Government body, except Federal and State income taxes, as well as the collection or withholding thereof, including penalties and interest which West may incur, shall be paid by the Buyer.
5. TERMS OF PAYMENT: Except for export shipments mentioned below, payments terms are net 30 days from date of shipment and invoice unless otherwise stated or agreed in writing by West. For export shipments, payment shall be made by irrevocable sight letter of credit confirmed by and payable at any prime U.S. bank to be established in West's favor at the time of packing order, in U.S. funds upon presentation of shipping documents. If several shipments are made on the same order, settlement shall be made for each shipment or invoice on the above basis. If during the period of performance of an order, the financial position of the Buyer is determined by West not to justify the terms of payment specified, West may demand full or partial payment in advance before proceeding with the work, or satisfactory security or guarantees that invoices will be promptly paid when due, or, at its option without prejudice to other lawful remedies, may defer delivery or performance or cancel this contract. If Buyer defaults in any payment when due, or in the event any voluntary or involuntary bankruptcy or insolvency proceedings involving Buyer are initiated by or against Buyer, then the whole contract price shall immediately become due and payable upon demand, or West, at its option without prejudice to its other lawful remedies, may defer delivery or performance or cancel this contract. If delivery is deferred, the goods may be stored as provided in Section 8 and West may submit a new estimate of cost for completion based upon prevailing conditions. Pro rata payments will become due as shipments are made or services are performed. If shipments are delayed by the Buyer for any cause, payments will become due from the date on which West is prepared to make shipment and storage shall be at the Buyer's risk and expense as provided in Section 8 hereof. If manufacture is delayed by the Buyer for any cause, a partial payment based upon the proportion of the order completed will become due from the date on which West is notified of the delay.
6. DELIVERY; RISK OF LOSS: All sales are F.O.B. point of manufacture. Shipping dates are estimates only which are not guaranteed and are based upon prompt receipt from Buyer of all necessary shipping and other information. Delivery of ten percent more or less than the quantity specified shall constitute fulfillment of the order. West reserves the right to make delivery in installments, which shall be separately invoiced and paid for by Buyer when due per invoice, without regard to subsequent deliveries. Claims for shortages or other errors in delivery must be made in writing to West within 10 days after receipt of shipment and failure to give such notice will constitute unqualified acceptance and a waiver of all such claims by Buyer. Claims for loss or damage to equipment in transit by common carrier must be made to the carrier and not West.
7. UNAVOIDABLE DELAYS: West assumes no responsibility for any loss or damage occurring by reason of delay or inability to deliver caused by fires, strikes, lockouts, accident, delays of common carriers, shortage of customarily used transportation, equipment or suitable substitute or from any other cause which is unavoidable or beyond West's reasonable control. Should any of such events occur, West, at its option, may cancel Buyer's order with respect to any undelivered goods or services or extend the delivery date for a period equal to the time lost because of delay. If West elects to so cancel the order, West will be released from all liability for failure to deliver the goods or services. If shipping or progress of the work is delayed or interrupted by Buyer directly or indirectly, Buyer will pay West for all resulting additional charges.
8. STORAGE: If the goods are not shipped within 30 days after notification has been made to Buyer that they are ready for shipping for any reason beyond West's control, including Buyer's failure to give shipping instructions, West may store the goods at Buyer's risk and expense in a warehouse or upon West's premises, and Buyer will pay all handling, transportation and storage costs at the prevailing commercial rates promptly following West's submission of invoices for such costs.
(a) Goods. The goods sold hereunder shall conform to the specifications contained on the face hereof and/or any attachments hereto and to any other specifications agreed to in writing by West. All goods are sold only on the basis that it is the sole responsibility and duty of Buyer to evaluate and test goods, assure that the products sold hereunder are fit for the uses and purposes for which Buyer intends to use them, and are compatible with the Buyer's particular product and processing and packaging methods. Buyer assumes all risks whatsoever as to the result of the use of the goods, whether used singly or in combination with other goods or substances.
(b) Services. West shall perform the services in a professional, competent and workpersonlike manner consistent with applicable state and federal laws and regulations.
(c) Disclaimer. THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER EXPRESS AND IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY OR REPRESENTATION AS TO THE RESULTS TO BE EXPECTED FROM ANY SERVICES PERFORMED HEREUNDER OR FROM THE MANUFACTURE, USE OR SALE OF ANY OF THE ITEMS OR MATERIALS TESTED BY WEST. WEST SHALL HAVE NO RESPONSIBILITY TO BUYER OR OTHERS UNDER ANY LEGAL PRINCIPLE FOR THE QUALITY OR PERFORMANCE OF ANY PRODUCT TESTED BY WEST. THE WARRANTIES SET FORTH IN THIS AGREEMENT RUN SOLELY TO BUYER.
10. REMEDIES OF BUYER: If any of the goods or services sold hereunder shall be proved to West's satisfaction to be defective or nonconforming, West will replace such defective goods or reperform such defective services, as applicable, or at West's option, provide Buyer with a credit for the amount paid by Buyer for such defective goods or services, provided a claim is made within 60 days after receipt of the goods or services deliverables by Buyer. Goods claimed to be defective shall not be returned without West's prior written approval. West may request that Buyer destroy defective or nonconforming goods, such destruction to be certified in writing by an appropriate officer of Buyer. THE PROVISIONS OF THIS SECTION 10 SET FORTH BUYER'S EXCLUSIVE REMEDY AND WEST'S SOLE LIABILITY ON ANY CLAIM, WHETHER IN TORT (INCLUDING NEGLIGENCE), CONTRACT, OR WARRANTY ARISING OUT OF THIS CONTRACT AND IN NO EVENT SHALL WEST BE LIABLE FOR INDEMNIFICATION OF BUYER ON ACCOUNT OF ANY CLAIM ASSERTED AGAINST BUYER OR FOR ANY OTHER FURTHER DAMAGE, COST, EXPENSE OR LIABILITY OF ANY KIND WHATSOEVER, WHETHER DIRECT OR
INDIRECT, INCLUDING WITHOUT LIMITATION, INCIDENTAL, CONSEQUENTIAL PUNITIVE, OR EXEMPLARY DAMAGES TO BUYER OR ITS CUSTOMERS ARISING FROM ANY DEFECT IN MATERIALS OR WORKMANSHIP, WORK OR SERVICES OR DELAY IN PERFORMANCE OR DELIVERY AND FURTHER INCLUDING WITHOUT LIMITATION ANY COSTS OF RECALL, even if West has been advised of the possibility of such damages.
11. REMEDIES OF SELLER: In the event of a breach by Buyer, Seller shall be entitled to exercise all remedies provided by law and the exercise of any one remedy shall not preclude the exercise of any other remedy.
12. LIMITATIONS OF LIABILITY: Buyer agrees that no claims arising out of the performance or non-performance of any of these Terms and Conditions shall be valid against West unless commenced within one year of delivery of the goods or services deliverables. Nothing herein contained shall be construed to limit the time for commencement of an action by West to recover all or any part of the purchase price.
13. INSURANCE: Until payment in full of the purchase price, Buyer shall maintain insurance covering all goods sold by West to Buyer in such amounts and against such risks as is customary by companies engaged in the same or similar business and similarly located, and shall, upon West's request, furnish evidence of such insurance satisfactory to West.
14. TOOLING: Tooling (including molds and dies) and post-production processing equipment which contain West designs or components will not be returned to Buyer under any circumstances. Other tooling supplied by Buyer will be returned only with West's prior consent and will be shipped F.O.B. West's plant and subject to normal packing charge. All tooling held in West's plant three years after completion of the most recent production order will be considered obsolete and may be disposed of by West as it deems necessary or advisable without notice to Buyer.
15. DRAWINGS; OTHER DESIGN DATA: All specifications, drawings, design, data, information, ideas, methods, patterns, and/or inventions made, conceived, developed or acquired by West in connection with procuring and/or executing Buyer's order will vest in and inure to West's sole benefit notwithstanding any charges therefore which may have been or may be imposed by West
16. DISCLOSURE AND USE OF TRADE SECRETS AND CONFIDENTIAL DATA: Buyer agrees to protect and keep confidential trade secrets and other confidential information disclosed to Buyer and identified in writing as being confidential, and Buyer further agrees to protect the same against disclosure to unauthorized persons. In addition, Buyer agrees not to use, directly or indirectly, any such confidential information or trade secrets for its own benefit or for the benefit of any other person, firm or corporation. Without the prior written consent of West, Buyer will not analyze, have analyzed or otherwise attempt to determine the composition or structure of any West product or technology. The above obligations are accepted upon the understanding Buyer would not be liable for the disclosure or use of West's confidential information or trade secrets which are already in the public domain, or which hereafter are placed in the public domain by any party other than Buyer, or which are disclosed to Buyer by any other person, firm or corporation. Buyer agrees to return or destroy all data or otherwise dispose of same as requested by West at the termination of performance under these Terms and Conditions or any other contract which may be entered into at a future date or, in the event that no contract is consummated, at the termination of negotiations between the parties. Any data destroyed at West's request will be confirmed in writing by Buyer to West or its duly authorized representative.
17. PATENT INDEMNIFICATION: When West produces parts to Buyer's supplied design, Buyer agrees to indemnify and hold West harmless from and against any damages, loss, cost or expense resulting from infringement of patents or trademarks.
18. ASSIGNMENT: None of the Buyer's rights under any order shall be assigned by the Buyer to any other person, whether by operation of law or otherwise, without West's prior written approval.
19. CANCELLATION ACCOMMODATIONS:
(a) Goods. Orders for goods are not subject to cancellation, change, reduction in amount or suspension of deliveries, except with West's consent, and upon terms that indemnify West against loss. Goods returned for Buyer accommodation may be subject to a 30% (of sales value) restocking charge.
(b) Services. After the initiation of the services, any changes or revisions must be submitted by Buyer to West in writing and Buyer must accept payment responsibility for these changes as well as changes to the timing of the services. Services may be terminated: (i) by mutual written consent at any time; (ii) by West or Buyer upon written notice given not less than 30 days prior to the effective date of termination; (iii) by West or Buyer, upon written notice to the other in the event of a default by the other in the due observance or performance of any covenant, condition or limitation of these Terms and Conditions, but only if the defaulting party shall not have remedied its default within 30 days after receipt of written notice of such default from the non-defaulting party; or (iv) by West or Buyer, upon written notice to the other if the other is adjudicated as bankrupt, if insolvency, bankruptcy, reorganization, debt adjustment or liquidation proceedings are instituted against it and not dismissed within 60 days after the institution thereof, if a receiver or trustee is appointed for it and its assets, or if it makes a general assignment for the benefit of its creditors. In the event of early termination of the services by Buyer for any reason, Buyer is still responsible for all sums due to West up to the point of termination. In the event that Buyer terminates the services pursuant to (ii) above prior to West's completion of the services, Buyer shall be liable for an early termination fee equal to twenty percent (20%) of the aggregate amount payable to West for the services (the "Termination Fee"); provided, the Termination Fee shall be waived if (i) the amount paid to West for the services through the effective date of termination exceeds the Termination Fee or (ii) Buyer is discontinuing the marketing of the drug product that is the subject of the services; otherwise, the Termination Fee shall be reduced by amounts paid by Buyer relating to the services.
20. LABORATORY TESTING SERVICES: The following terms and conditions will apply to all orders for laboratory testing services:
(a) Project Scheduling Requirements. Services will be scheduled by West when West has received the following items from Buyer: (i) a written purchase order; (ii) all Buyer-supplied method(s); (iii) Material Safety Data Sheets and/or safe handling and disposal requirements for all materials to be tested, if available; (iv) approved and signed protocol(s) (where applicable), whether the protocol was developed by West or supplied by Buyer; (v) any Buyer-supplied standard operating procedures and (vi) sufficient sample product to complete the services and meet all retention requirements, allowing for possible repeat testing. If all samples cannot be run at one-time, multiple instrument set up and sample preparation charges will be applied. West reserves the right to amend the fees if any sample requires additional preparation or other unforeseen work.
(b) Sample Delivery. All shipping charges, brokerage fees and related expenses will be the responsibility of Buyer. Buyer will bear the risk of loss or damage to all samples until delivered to a West employee. West will notify Buyer if any samples are missing or appear damaged, contaminated or improperly preserved when delivered and Buyer will bear the risk of loss for that sample. West reserves the right to refuse acceptance or to rescind acceptance of any sample, which West believes is likely to pose an unreasonable risk in handling. Buyer represents and warrants that it will: (i) inform West of any known safety hazards associated with the test samples; (ii) assume full responsibility for taking all necessary health and safety precautions in delivering the materials to be tested; and (iii) any sample containing any hazardous substance to be delivered to West will be packaged, labeled, transported and delivered in accordance with all applicable laws and regulations. All samples containing drug product must be accompanied by an MSDS. If an MSDS is not received by West with the shipment or within 24 hours of receipt, the shipment will be returned at Buyer’s expense.
(c) Sample Retention. After the services have been completed and a report has been delivered, samples can either be returned, destroyed or retained by West, depending on what instruction Buyer has provided to West; in the absence of any instructions, West shall follow its SOPs regrading samples. West may charge a fee for long-term storage of samples. At West’s sole discretion, and at Buyer’s sole expense, West may return to Buyer unused portions of samples found or suspected to be hazardous.
(d) Reports. After the services have been completed, West will provide Buyer with a factually correct analytical report in standard contract lab analytical test format for the samples as submitted. Unless otherwise agreed to in writing, West will retain the report for five years. Any retention beyond this period may result in an additional storage charge. Use of West’s name in connection with any unauthorized use of West reports is prohibited and the publishing of West’s name without West’s prior written consent is prohibited.
(e) Operating Procedures; Certifications; Methods. West will perform all services in accordance with West’s Standard Operating Procedures (“SOPs”) and General Operating Procedures (“GOPs”). It is Buyer’s sole responsibility to confirm that West’s SOPs and GOPs meet Buyer’s needs prior to the commencement of the services by West. West encourages Buyer to review West’s SOPs and GOPs at West’s corporate headquarters to ensure that they will meet Buyer’s needs. Alternatively, if stated in the quotation and when provided to West in writing, West may perform the services in accordance with Buyer’s SOPs and GOPs. If applicable and when detailed in the quotation, the services may be conducted in accordance with CGMPs (Current Good Manufacturing Practices). If applicable, a Certification of Compliance to CGMPs may be provided for any regulatory agencies. A debarment statement may be provided if required for a submission to the United States Food and Drug Administration. West may use compendial methods or other methods when performing the services; however, Buyer must notify West in writing prior to the start of the services to specify which methods are to be used. Buyer supplied methods must be “transferred” via an interlaboratory qualification which includes a written protocol. This will provide for appropriate equipment use and analyst training to ensure reproducible results, particularly for methods which require specific instrumentation and technique.
(f) Out-of-Specification Results. Any Out-of-Specification (“OOS”) results will be handled as per West’s SOP unless otherwise directed by Buyer in writing. Once an OOS result is obtained (confirmed by preliminary investigations, eliminating the possibility of any assignable laboratory errors) an investigation will start and Buyer will be contacted promptly for their input regarding the investigation and the number of samples to be retested. If the Buyer does not want any further investigation and retesting, the investigation will be closed and the OOS results will be reported. Buyer will not be charged for this preliminary investigation. If Buyer wants further investigation and retesting of samples, West will complete the investigations and perform 3 retests at no cost, provided that the problem was found to be laboratory related although not assignable. If it is determined that West was not the cause of the error, Buyer will pay for all retesting at the quoted test rate. In addition, Buyer is also responsible for the cost of the investigation report at the quoted rate. Additional testing as directed by Buyer will be charged at the standard unit cost.
(g) Litigation. Buyer will pay all costs West incurs to comply with any subpoena or other official request for documents, for testimony in a court of law, or for any other purpose relating to services West performs for Buyer.
(h) Laboratory Visits. Buyer’s authorized representatives may visit those portions of West’s facilities used to perform the services, upon advanced notice and at reasonable times during West’s normal working hours.
(i) Subcontracting. West may subcontract any of the services under this Agreement with Buyer’s prior consent.
(j) Results; Ownership. As used herein, “Results” means the deliverables specified in the quotation or online services description, as applicable, including, but not limited to, a compilation of the information, data, results and all reports generated directly and solely from the performance of the services or work by West; provided, however, that Results shall not include the following: (i) any proprietary test methods of West’s; (ii) West’s Pre-Existing I.P., and (iii) West’s proprietary potential extractable information for one or more of West’s product formulations ((i)–(iii) collectively, “West’s Proprietary Information”). West’s Proprietary Information is excluded from the definition of Results. The parties agree that West’s Proprietary Information is and shall remain West’s property and shall be treated by Buyer as West’s confidential information in accordance with Section 16 hereof. Any and all materials and information that Buyer provides to West, shall be and remain at all times Buyer’s property. Each party to these Terms and Conditions shall own all intellectual property, specifications, drawings, design, data, information, ideas, methods, patterns, know-how and/or inventions including, without limitation, validation reports, process parameters and documentation (collectively, "I.P.") existing and in its possession prior to the date of this Agreement (“Pre-Existing I.P.”). All I.P., whether patentable or unpatentable, that is made, conceived or developed by one or more parties in connection with activities under this Agreement and that is derived from or based upon Pre-Existing I.P. will vest in and inure to the sole benefit of the owner of that Pre-Existing I.P. All I.P. in addition to the foregoing, whether patentable or unpatentable, that is made, conceived or developed solely by a party in connection with its activities under this Agreement and that is not derived from or based upon Pre-Existing I.P. will vest in and inure to the inventing party's sole benefit. All I.P., whether patentable or unpatentable, that is made, conceived or developed jointly by both parties in connection with activities under this Agreement and that is not derived from or based upon Pre-Existing I.P. will vest in and inure to Buyer’s sole benefit. Subject to the foregoing, ownership of Results will vest in and inure to the sole benefit of Buyer. Each of the parties will take any action or execute any document necessary to perfect, record, establish, or otherwise give effect to the other party’s rights specified herein and will do so without further consideration, other than reimbursement of reasonable out-of-pocket expenses incurred at the written request of the other.
21. GENERAL: These Terms and Conditions, and the contract of sale between West and Buyer, shall be governed by and construed in accordance with the internal laws of the Commonwealth of Pennsylvania, U.S.A., without regard to the conflicts of laws principles thereof. The invalidity, in whole or in part, of any of the provisions of these Terms and Conditions, shall not affect the enforceability of any of the other provisions hereof. All headings are for convenience of reference only and will in no way be used in the interpretation of any of these Terms and Conditions. Nothing contained herein will be construed as creating any agency, partnership, or other form of joint enterprise between the parties.
22. EXCLUSIVE CONTRACT TERMS: The Terms and Conditions and the West quotation, if any, constitute the entire agreement between West and Buyer with respect to the sale of the goods, equipment and/or services described herein and supersede all previous agreements between the parties and all terms in any printed forms exchanged or which may be exchanged in the future. No modification, amendment, waiver or other change of any of the Terms and Conditions, or any of West's rights or remedies there under, will be binding on West unless expressly accepted in writing by West. No course of dealing, usage of trade or course of performance will be relevant to explain or supplement any of these Terms and Conditions. In cases of conflict between these Terms and Conditions and those contained on the face side of the West quotation, if any, or in attachments thereto, the latter shall control.