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Ecommerce Refund & Return Policy
1. Refunds are not permitted except due to West quality or manufacturing defects, which West has acknowledged and granted written credit authorization. Quality and Manufacturing defect acknowledgement can take up to 90 days after request for refund. In the event West acknowledges and agrees that there is a defect, we ask that customer destroys any remaining non-conforming product rather than returning it to West, unless otherwise instructed by West.
2. Refunds are permitted for West fulfillment errors (incorrect item shipped and/or incorrect quantity shipped In the event West acknowledges and agrees that there was a fulfillment error, West will provide a refund for the amount paid by customer for the incorrect item or incorrect quantity shipped, and in such event, we ask that customer destroys any remaining non-conforming or incorrect product rather than returning it to West, unless otherwise instructed by West.
3. Returns are not permitted for any products purchased online. Credits will only be granted for scenarios (1) and (2) above and where governed by local law.
Export Legal Restrictions
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. CONTRACT FORMATION; TERMS OF SALE; ACCEPTANCE: In the absence of a signed agreement in effect between the parties and applicable to this transaction, these terms and conditions (together with the specific terms regarding this transaction on the face of the West (defined below) order confirmation, these “Terms of Sale”) will form a contract, become a binding agreement of West Pharmaceutical Services, Inc. or its affiliated entity identified on the order confirmation (as applicable, “West”) and the party issuing the purchase order (the “Buyer”) for Products, Services, Tooling and/or Equipment (each as defined below) upon West's written acceptance of the purchase order. West's acceptance of Buyer's purchase order(s) is expressly conditioned on Buyer's assent to these Terms of Sale as the sole terms and conditions governing the transaction. West expressly rejects any of the Buyer's purchase order terms and conditions, and any such terms and conditions shall not apply, even if performance by West and/or delivery to Buyer is effected without reservation. Buyer will be deemed to have accepted and agrees to be bound by these Terms of Sale unless West receives written notice of specific objections within 10 days after Buyer's receipt, and then only with respect to those specific objections, and in any event prior to any delivery or other performance by West of Buyer's purchase order.
2. QUOTATIONS: Quotations by West will be deemed to be offers by West to sell the Products, Services, Tooling and/or Equipment described therein subject to these Terms of Sale. Purchase orders submitted by Buyer for the Products, Services, Tooling and/or Equipment quoted by West will be subject to and will be deemed to constitute acceptance of these Terms of Sale. Unless previously withdrawn, the pricing and other commercial terms in West quotations are valid until the date specified therein, or for 30 days from issuance in the event no date is specified. West may review, revise or revoke the pricing and timelines in the quotation if Buyer does not issue the purchase order within the quote validity period. For the avoidance of doubt, prices set forth in West’s online store do not constitute quotations and are subject to change at any time without notice. West reserves the right to make any corrections to prices quoted due to clerical errors or errors of omission.
3. TAXES: Each party shall be responsible for all taxes imposed on it by any applicable law and, unless otherwise, stated, all prices quoted by West are net, exclusive of taxes. For the sake of clarity and without limiting the generality of the foregoing, all value added, products and services, occupational, sales, excise, use, business, stamp, withholding, service, gross income or other taxes or surcharges associated with the sale of the Products, Services, Tooling and/or Equipment shall be paid by Buyer, and all federal and state income taxes and unemployment and other employee-related taxes imposed upon West shall be paid by West. In some countries, pallet fees will be separately charged and paid by Buyer. Responsibility for import and export duties shall be borne by West or Buyer based upon the INCOTERM (2020) applicable to the associated shipment.
4. PAYMENT TERMS: Unless otherwise agreed in writing by West, the applicable currency and payment terms are as stated on the face of the West order confirmation. West may charge Buyer a late payment fee up to the maximum amount permitted by applicable law on any unpaid amounts each month (or part thereof) such payment is late. West may make delivery in installments, which shall be separately invoiced by West and paid for by Buyer. If delivery is made in installments, the contract is severable as to any such installment such that defect in one installment does not relieve Buyer of its obligation to accept and pay for remaining deliveries.
5. CANCELLATION: Buyer may not cancel or modify any order that has been accepted by West except with West's consent; permitted order cancellations or modifications may be conditioned on Buyer's payment of West’s change/cancellation fees.
6. SCOPE-SPECIFIC TERM-PRODUCTS: The following terms and conditions shall apply only to transactions for physical goods as described on West’s quotation and/or order confirmation (“Products”) and shall control in the event of any conflicting terms and conditions elsewhere in these Terms of Sale:
a. Prices: West may, by written notice, revise any price specified herein on any undelivered balance to the price applicable as of the date of shipment, such price to be provided to Buyer by way of a quotation or price list. In the event any increase in price (excluding increases arising from new or increased taxes or shipping charges) is unacceptable to Buyer, Buyer must notify West in writing within the timeframe specified on such quotation or price list, or within 10 days from issuance in the event no date is specified; otherwise, Buyer will be deemed to have accepted and agrees to be bound by to the price increase. If Buyer does object to the price increase in writing within the specified timeframe, either party shall have the right to terminate the transaction(s) contemplated by these Terms of Sale upon written notice to the other party with respect to the unshipped portion of the particular Products; provided that in the event of termination, if West requests in writing within 30 days after the effective date of such termination, Buyer shall take and pay for all such goods that shall have been manufactured or are in the process of manufacture by West prior to the date of termination at the price effective prior to such increase.
b. Delivery: Risk of Loss. Unless otherwise agreed in writing by West, all sales are made according to the INCOTERMS 2020 stated on the face of the West order confirmation. Shipping dates are estimates only; West will use commercially reasonable efforts to meet all agreed to shipping dates and will promptly notify Buyer if it expects a shipment will be delayed. Delivery variance of ten percent (10%) more or less than the confirmed quantity shall constitute fulfillment of the order; provided, however that Buyer will only be invoiced for the delivered quantity. Claims for shortage, loss, or damage or other error in delivery ("Shipping Damage") must be made in writing to West within 5 business days after receipt of shipment and failure to provide such notice will be deemed as a full acceptance and a waiver of all claims for Shipping Damages. For orders for which risk of loss transfers at West’s facility based on the applicable INCOTERMS, claims Shipping Damage by common carrier must be made to the carrier and not to West. Failure by Buyer to conduct a thorough incoming inspection and/or to notify West of any nonconformity of the Products to the warranties in these Terms of Sale within 60 days of the Products arrival at the specified destination will constitute a waiver of Buyer’s rights under such warranties.
c. Storage: If Products are not shipped within 10 days after notification has been made to Buyer that they are ready for shipping for any reason within Buyer's control, including Buyer's failure to give shipping instructions, or if Buyer otherwise refuses to accept delivery of Products, then regardless of the otherwise applicable INCOTERMS, West may elect to: (i) store the Products either on or off-site at Buyer’s risk and expense, and Buyer will promptly pay all handling, transportation and storage expenses at the prevailing commercial rates following West's submission of invoices for such amounts; and/or (ii) exercise any of the rights and remedies described in Section 11 below including those related to Buyer’s failure to make payments as required by these Terms of Sale.
d. Limitation on End Usage: Buyer acknowledges and agrees that Products shall be used for packaging medical and pharmaceutical Products and not any other end usage without the prior written consent of West, which West may withhold in its sole and absolute discretion. Buyer shall not re-sell or further distribute Products except as they are incorporated into pharmaceutical Products as contemplated herein. Buyer shall not directly or indirectly export, distribute, market, offer for sale or sell any transfer device Product outside of the territory in which sale of the product is licensed. Customer is fully liable for, and fully releases West and holds West harmless from, any and all liability arising out of Buyer’s breach of the obligations in this paragraph. West may terminate the transaction(s) contemplated by these Terms of Sale immediately in the event Buyer breaches the obligations in this paragraph.
7. SCOPE-SPECIFIC TERMS-SERVICES: The following terms and conditions shall apply only to transactions for analytical laboratory services or other expressly identified services on West’s quotation and/or order confirmation (“Services”), and shall control in the event of any conflicting terms and conditions elsewhere in these Terms of Sale:
a. Project Scheduling Requirements. Services will be scheduled by West only after West has received the following items from Buyer: (i) a written purchase order; (ii) all Buyer-supplied method(s) and standard operating procedures (if applicable); (iii) Material Safety Data Sheets for all materials to be tested and/or safe handling and disposal requirements, if available; (iv) approved and signed protocol(s) (where applicable), whether the protocol was developed by West or supplied by Buyer; and (v) sufficient sample product to complete the Services and meet all retention requirements, allowing for possible repeat testing.
b. Sample Delivery. Buyer will bear the risk of loss or damage to all samples until delivered to West. 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.
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 the instructions provided in writing by Buyer at the time the transactions is entered into; in the absence of any instructions, West shall follow its standard procedures regarding 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 or destroy unused portions of samples found or suspected to be hazardous.
d. Changes. After the initiation of Services, any requested changes or revisions to those Services must be submitted by Buyer to West in writing. West will provide a written response to Buyer’s changes or revisions, detailing any anticipated effect on the timeline for completing the Services and any effect such changes or revisions will have on the fees for the Services for Buyer’s review and approval. West will not undertake any changes or revisions to the Services until Buyer has provided written instructions to that effect and West has agreed..
e. Reports. After the Services have been completed, West will provide Buyer with a factually correct analytical report for the samples as submitted. Unless otherwise agreed to in writing, West will retain the report for 5 years. Any further retention may result in an additional storage charge. Use of West's name in connection with any unauthorized use of our reports is prohibited and the publishing of West's name without West's prior written consent is prohibited.
f. Operating Procedures, Certifications; Methods. Unless otherwise mutually agreed in writing at the time the transactions is entered into, West will perform all Services in accordance with West’s Standard Operating Procedures (“SOPs”) and General Operating Procedures (“GOPs”). It is Buyer’s responsibility to confirm that West’s SOPs and GOPs meet Buyer’s needs prior to the commencement of any Services by West. West encourages Buyer to review West’s SOPs and GOPs at West’s facility to ensure that they will meet Buyer’s needs. Alternatively, if mutually agreed in writing at the time the transactions are entered into, West shall perform the Services in accordance with: (i) Buyer’s methods, SOPs and/or GOPs, provided they are provided to West in writing; or (ii) compendial methods or other methods. If required and mutually agreed in writing at the time the transactions are entered into, Services may be conducted in accordance with CGMPs (“Current Good Manufacturing Practices”). If required, 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. Buyer-supplied methods must be “transferred” via an interlaboratory qualification (which must include 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. .
g. Out-of-Specification Results. Any Out-of-Specification (“OOS”) results will be handled as per West’s SOP unless otherwise mutually agreed. Once an OOS result is obtained (confirmed by preliminary investigations, eliminating the possibility of any assignable lab errors) an investigation will start and Buyer will be promptly contacted for input regarding the investigation and the number of samples to be retested. If 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 originally quoted test rate. In addition, Buyer is responsible for the cost of the investigation report at originally quoted rate.
h. Results; Intellectual Property Ownership. As used herein, “Results” means the deliverables identified for the specific Services scope 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 by West; provided, however, that Results shall specifically exclude West Intellectual Property, including without limitation any proprietary test methods of West’s and West’s proprietary potential extractable information for one or more of West’s product formulations. 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 of Sale shall own all Intellectual Property existing and owned by it or in its possession prior to the effective date of these Terms of Sale (“Pre-Existing Intellectual Property”). All Intellectual Property, whether patentable or unpatentable, that is made, conceived or developed by one or more parties in connection with activities under these Terms of Sale and that is derived from or based upon Pre-Existing Intellectual Property will vest in and inure to the sole benefit of the owner of that Pre-Existing Intellectual Property. Notwithstanding the foregoing, all Intellectual Property, whether patentable or unpatentable, that is made, conceived or developed by a party in connection with its activities under these Terms of Sale and that is not derived from or based upon Pre-Existing Intellectual Property will vest in and inure to the inventing party's 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.
i. Cancellation. In the event that Buyer terminates the transaction(s) contemplated by these Terms of Sale and/or any Services hereunder prior to West's completion of the Services, Buyer shall be liable for an early termination fee equal to twenty percent (20%) of the open order balance for the terminated Services as of the effective date of termination (the "Termination Fee"). Buyer and West acknowledge and agree that the Termination Fee is (i) a reasonable estimate of the damages that West may suffer as a result of Buyer’s early termination of the Services, which may be impractical and difficult to accurately ascertain; (ii) intended to compensate West for such damages; and (iii) not to be construed as a penalty.
8. SCOPE-SPECIFIC TERMS - TOOLING/EQUIPMENT: The following terms and conditions shall apply only to transactions for the design, development, manufacture, validation and/or delivery to the appropriate West plant of custom tooling (“Tooling”) or capital equipment (“Equipment”) as identified on West’s quotation and/or order confirmation and shall control in the event of any conflicting terms and conditions elsewhere in these Terms of Sale:
a. Timing. Estimated delivery times will be confirmed upon receipt of Buyer’s purchase order for the Tooling or Equipment. Any estimates do not include Buyer decision making or approval time. Should the Buyer reviews or approvals result in significant project delays, West reserves the right to review the costs and timelines.
b. Validations; Samples. Validations will be performed according to West specifications unless otherwise mutually agreed in writing. Validation summaries will be issued to the Buyer for acceptance prior to production with new Tooling or Equipment. West agrees to perform Tool Life Cycle Management assessments (“TLCM”) consistent with West’s Standard Operating Procedures during the useful life of the Tooling. A separate Buyer purchase order is required should Buyer require product samples for dimensional and functional testing.
c. Buyer Ownership. The Tooling or Equipment shall be the Buyer's sole property and shall be used by West solely as directed by Buyer (or its designee); provided that the Tooling created hereunder shall remain at West’s facilities at all times, regardless of any amounts paid therefor by Buyer; provided, further, that West agrees to destroy the Tooling created hereunder upon Buyer’s written request upon full completion of Buyer’s payment and Product purchase obligations related to the Tooling. For the avoidance of doubt, the Tooling or Equipment created hereunder for Buyer shall not be used by West to manufacture product for anyone other than the Buyer (or its designee) without Buyer's prior written consent. West agrees to allow the Buyer to audit the Tooling or Equipment as reasonably requested by Buyer.
d. Tooling or Equipment Maintenance, Replacement, and Disposal. West agrees to maintain the Tooling or Equipment in accordance with its Standard Operating Procedures. Unless otherwise expressly set forth herein, Buyer shall be liable for the cost of maintenance, repair or replacement of the Tooling or Equipment and shall promptly issue a purchase order for such replacement Tooling or Equipment promptly upon West’s notice. In the event that Buyer fails to promptly authorize the maintenance, repair or replacement of the Tooling or Equipment by issuing such purchase order: (i) West may suspend production of and/or increase pricing for the impacted Products and/or (ii) West may require Buyer to sign a deviation in the event the assets are not capable of manufacturing Product to the original specification and (iii) BUYER SHALL WAIVE ALL CLAIMS RELATING, DIRECTLY OR INDIRECTLY, TO NON-CONFORMING PRODUCT MANUFACTURED USING THE TOOLING OR EQUIPMENT TO THE EXTENT SUCH NON-CONFORMITIES WOULD HAVE BEEN ELIMINATED, REDUCED OR AMELIORATED HAD THE TOOLING OR EQUIPMENT BEEN PROPERLY MAINTAINED, REPAIRED OR REPLACED. Any Tooling held in West's plant 3 consecutive 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.
e. Intellectual Property Ownership. Any and all Intellectual Property owned and/or controlled by each party to these Terms of Sale prior to performing work related to these Terms of Sale ("Background Intellectual Property") shall remain the property and/or under the control of such party. All Intellectual Property, whether patentable or unpatentable, that is made, conceived or developed by one or more parties in connection with activities under these Terms of Sale and that is derived from or based upon Background Intellectual Property will vest in and inure to the sole benefit of the owner of that Background Intellectual Property. All Intellectual Property 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 these Terms of Sale and that is not derived from or based upon Background Intellectual Property will vest in and inure to the inventing party's sole benefit. All Intellectual Property, in addition to the foregoing, whether patentable or unpatentable, that is made, conceived or developed jointly by the parties in connection with the activities under these Terms of Sale and that is not derived from or based upon Background Intellectual Property or related to activities performed under these Terms of Sale shall inure to West. The parties acknowledge and agree that nothing contemplated in these Terms of Sale constitutes a joint development project. 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.
f. Cancellation. In addition to any cancellation charges stated on the face of the West order confirmation, if Buyer cancels prior to Tooling or Equipment being completed, West will refund or credit to the Buyer all amounts not actually earned for work performed up to the effective date of termination or reflecting non-refundable expenses and other costs reasonably incurred by West in performing or preparing to perform, and the Buyer will reimburse West for work performed up to the effective date of termination or reflecting non-refundable expenses and other costs reasonably incurred by West in performing or preparing to perform.
9. WARRANTIES:
a. Products. With respect to transactions for Products, West warrants only that as of the date of shipment, the Products shall conform to (i) any written specifications agreed to by West and Buyer, inclusive of any binding conditions issued by West and not objected to in writing by the Customer within 2 days of receipt by the Customer of such binding conditions, which shall control in the event of any conflicting terms, or, (ii) in the absence of such mutually agreed-to specifications for any Product or Product characteristic, the applicable West master specification (as applicable, the “Product Specifications”). Buyer acknowledges and agrees that all Products are sold only on the basis that it is the sole responsibility and duty of Buyer to evaluate and test the Products, assure that the Products are fit for the uses and purposes for which Buyer intends to use them, and are compatible with Buyer's particular product and its processing (including sterilization) and packaging methods. Except to the extent of any obligations expressly imposed on West pursuant to these Terms of Sale, Buyer assumes all risks whatsoever as to the result of the use of the Products, whether used singly or in combination with other products or substances.
b. Services. With respect to transactions for Services, West warrants only that the Services shall be performed in a good, competent and workperson-like manner. West does not: (i) warrant that Buyer will be satisfied with the results of the Services; (ii) warrant that any regulatory submission will be approved by any regulatory authority; or (iii) provide any warranty with respect to the manufacture, use or sale of any of the items or materials tested by West.
c. Tooling; Equipment. With respect to transactions for Tooling or Equipment, West warrants that the work provided hereunder shall be performed in a good, competent and workpersonlike manner. During the Tooling’s warranty as stated on the face of the West quote and/or order confirmation, West will cover any repairs, rebuilds, or replacements, as necessary, to maintain the Tooling in its original design condition, normal wear and tear and any high wear feature identified in the quotation excepted. Replacement parts (e.g., springs, ejector pins, rings, or the rework of nicks and scratches) are warranted to be free from defects in workmanship and materials for use in normal operation for a period of 180 days from the replacement date. For the avoidance of doubt, unless otherwise expressly stated on West’s quotation and/or order confirmation, supply of product is outside the scope of transactions for Tooling, and West does not provide any warranty with respect to the product in the context of a transaction for Tooling, including without limitation that the West product will satisfy the requirements of Buyer.
d. Warranty Exclusions. Technical information or assistance furnished by West is not a description or specification of the Products, Services, Tooling and/or Equipment delivered. Any such information or assistance is given and accepted at Buyer’s risk and West provides no warranty and assumes no liability for the information or assistance given or the results thereof. West makes no warranty with respect to materials provided or selected by Buyer or actions taken or directed in accordance with Buyer’s instructions.
e. Warranty Disclaimer. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAWS, WEST’S UNDERTAKINGS, REPRESENTATIONS, WARRANTIES AND CONDITIONS SET FORTH IN THESE TERMS OF SALE ARE IN LIEU OF ALL OTHER EXPRESS AND IMPLIED WARRANTIES, UNDERTAKINGS, REPRESENTATIONS, GUARANTEES, AND CONDITIONS, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF RIGHTS, ALL OF WHICH ARE EXPRESSLY DISCLAIMED. THE UNDERTAKINGS, REPRESENTATIONS, WARRANTIES AND CONDITIONS IN THESE TERMS OF SALE ARE GIVEN ONLY TO THE PARTIES HERETO.
10. REMEDIES OF BUYER:
a. Products. West will replace any of the Products shown to be nonconforming to the limited Products warranty in Section 9(a) or, at Buyer's option, provide Buyer with a credit for the amount paid for the nonconforming Products, provided a claim is made within the timeframes specified in Section 6(b). Purportedly nonconforming Products shall not be returned without West's prior written approval. West may request that Buyer destroy nonconforming Products at West’s expense, such destruction to be certified in writing by an appropriate officer of Buyer.
b. Services. West will reperform any Services shown to be nonconforming to the limited Services warranty in Section 9(b) or, at Buyer's option, provide Buyer with a credit for the amount paid for the nonconforming Services.
c. Tooling; Equipment. If West breaches the limited warranty in Section 9(c), West will replace or repair such Tooling or, at West's option, provide a credit for the amount paid for same. Notwithstanding anything to the contrary herein, the Buyer acknowledges and agrees that West is not the manufacturer of the Equipment, and that in the event of Equipment defect, West shall use reasonable efforts to assist Buyer in obtaining sellers’ or manufacturers’ warranties applicable to the Equipment, consistent with the warranties obtained from such sellers or manufacturers by West.
d. Limitation of Liability. WHETHER IN TORT (INCLUDING NEGLIGENCE), CONTRACT, WARRANTY OR ANY OTHER LEGAL THEORY OF LIABILITY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW: (I) THE PROVISIONS OF THIS SECTION 10 SET FORTH BUYER’S EXCLUSIVE REMEDY AND WEST'S AND ITS AFFILIATES’ SOLE LIABILITY FOR ANY CLAIM RELATING TO SERVICES, PRODUCT OR SUPPLY DEFECT, DELAY OR NONCONFORMITY OR OTHERWISE ARISING OUT OF OR IN CONNECTION TO THIS AGREEMENT; AND (II) IN NO EVENT SHALL WEST OR ITS AFFILIATES BE LIABLE FOR: (A) INDIRECT, INCIDENTAL, PUNITIVE, SPECIAL, EXEMPLARY AND/OR CONSEQUENTIAL LOSS OR DAMAGES; OR, (B) FOR LOSS OF PROFITS, LOSS OF REVENUE, LOSS OF SALES OR BUSINESS OPPORTUNITY, LOSS OF AGREEMENTS OR CONTRACTS, LOSS OF ANTICIPATED SAVINGS, WASTED EXPENDITURE, COST OF RECALL, COST OF COVER, LOSS OF USE OR CORRUPTION OF SOFTWARE, DATA OR INFORMATION, OR LOSS OF OR DAMAGE TO GOODWILL IN EACH CASE ARISING OUT OF OR IN CONNECTION TO THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGES. THESE TERMS OF SALE DO NOT EXCLUDE OR LIMIT WEST’S OR ITS AFFILIATES’ LIABILITY IN THE CASE OF: (i) DEATH OR PERSONAL INJURY CAUSED BY THE WEST’S OR ITS AFFILIATES’ NEGLIGENCE; OR (ii) WEST’S OR ITS AFFILIATES’ FRAUD, INTENTIONAL OR WILLFUL MISCONDUCT, OR GROSS NEGLIGENCE. BUYER AGREES THAT NO CLAIMS ARISING OUT OF WEST’S PERFORMANCE OR NON-PERFORMANCE SHALL BE VALID AGAINST WEST UNLESS COMMENCED WITHIN ONE YEAR OF SUCH PERFORMANCE OR NON-PERFORMANCE IN RESPECT OF WHICH THE CLAIM ARISES.
11. REMEDIES OF WEST: Without prejudice to its other available remedies, West shall have the right to defer delivery of Products, Services, Tooling and/or Equipment, revise Buyer’s payment terms to require payment in advance and/or terminates the transaction(s) contemplated by these Terms of Sale and the transaction immediately: (i) if during the period of performance of a purchase order the financial position of the Buyer is determined by West not to justify the specified terms of payment; (ii) If Buyer defaults on any payment when due, whether in relation to these Terms of Sale or otherwise; or (ii) in the event Buyer becomes insolvent or bankrupt, makes an assignment for the benefit of creditors, or otherwise becomes subject to a plan of reorganization.
12. INTELLECTUAL PROPERTY: . “Intellectual Property” means any and all intellectual and industrial property of any kind whatsoever including inventions, discoveries, technical improvements, specifications, formulations, compositions, know-how, patent applications, patents, utility models, drawings, chemical structures, designs, samples, prototypes, data, information, ideas, methods, patterns, processes, process parameters, reports of any kind or nature, documentation, trade secrets, trade dress, logos, trademarks, service marks, domain names, copyrights, business or technical information, plans, software, databases, and business or technical results. As between West and Buyer, all Intellectual Property made, conceived, developed, or acquired by West in connection with procuring and/or executing Buyer's purchase order shall be owned solely by West. These Terms of Sale do not grant, expressly or impliedly, a license to or transfer of ownership Intellectual Property except as otherwise stated herein. Buyer is fully liable for, and fully releases West and holds West harmless from, any and all liability arising out of: (a) information, designs, specifications, components, materials, and/or products, including Buyer drug product, provided by Buyer (“Buyer Materials”); (b) the combination of Products with any other component or product not designed or provided by West, including Buyer drug product; and (c) modifications of Products (other than assembly) by Buyer after delivery of such Products specifications. Buyer represents and warrants that neither the Buyer Materials nor West’s use thereof in furtherance of the transaction shall infringe or misappropriate any third-party intellectual property rights. West may terminate these the transaction(s) contemplated by these Terms of Sale and the transaction immediately in the event Buyer breaches the obligations in this paragraph and/or in the event West reasonably believes the manufacture, sale, or use of the Products, Services, Tooling and/or Equipment may result in infringement or misappropriation of any third-party intellectual property rights.
13. CONFIDENTIALITY: “Confidential Information” means all confidential or proprietary information, documents and materials, whether printed or in machine-readable form or otherwise, including but not limited to, these Terms of Sale, processes, hardware, software, inventions, ideas, designs, research, know-how, business methods, production plans, marketing plans, quantitative and qualitative formula information, and scientific, clinical, regulatory, financial and commercial information, data or results and all other proprietary and intangible rights, property and assets. Confidential Information also includes confidential or proprietary information obtained or acquired by visual observation of a party’s facilities or processes. Buyer shall maintain in confidence, not disclose to any third party, and not use (except for the specific purpose of performing under these Terms of Sale), any Confidential Information furnished to it by West in connection with these Terms of Sale, as a result of discussions, negotiations, or other communications with West in relation to the Products, Services, Tooling and/or Equipment, or derived from West in performance of these Terms of Sale, and shall return to West, upon request, all copies then in Buyer’s possession of West’s Confidential Information. Except to the extent required by law, Buyer shall make no reference, advertisement or promotion regarding West or West's sale of the Products, Services, Tooling and/or Equipment covered by these Terms of Sale without the prior written consent of West. Buyer acknowledges that remedies at law may be inadequate to protect West against breach of the confidentiality obligations of this section, and agrees in advance that West will be entitled, in addition to any monetary damages and other remedies available at law or in equity, to specific performance and injunctive relief in the event of such breach. To the extent the parties have entered into a separate confidentiality and non-disclosure agreement (“CDA”) and there is a conflict between the CDA and these Terms of Sale, the terms of the CDA will control.
14. BUYER SURVEYS: All questionnaires, surveys, and similar requests for information (collectively, "Surveys") must be submitted by Buyer to West via email to Global.CustomerSuccessOperations@westpharma.com with a copy to Buyer’s account manager. All information provided by West in response to any Survey is West’s Confidential Information and will be governed by the confidentiality provisions of these Terms of Sale. West reserves the right in its sole discretion to reject, in whole or in part, Surveys: (a) submitted via third parties, such as Buyer auditors or consultants; (b) that are unreasonable, excessive, duplicative, overly burdensome, or not relevant to Buyer’s business with West; (c) requiring trade secret disclosure; (d) requesting publicly available information, including public securities filings and reports available on West’s websites; or (e) due to confidentiality or cybersecurity risk, including Surveys requiring submission through third-party or Buyer portals. For lengthy or complex Surveys, West may apply reasonable fees, communicated in writing before work begins. West will use commercially reasonable efforts to respond promptly (dependent on survey length and complexity) and to ensure the accuracy of information as of the reporting date but is under no obligation to update such information. Buyer does not have the right to audit the provided information. West disclaims any and all liability for errors or omissions to the fullest extent permitted by law and will not be liable for any damages resulting from Buyer’s use of the information.
15. COMPLIANCE:
a. Compliance with Laws. Buyer warrants that it shall comply with all applicable laws and regulations concerning its purchase and use of the Products, Services, Tooling and/or Equipment, including but not limited to the United States Food, Drug and Cosmetic Act and comparable laws or regulations in other countries.
b. Denied Party Screening. Each of West and Buyer shall verify that their respective third-party business partners related to the contract business are not on government lists of restricted parties, including the European Union European External Action Service (“EEAS”) Consolidated Financial Sanctions List, the U.S. Denied Persons List (“DPL”), the U.S. Entities List (“EL”), the U.S. Specially Designated Nationals (“SDN”) and Blocked Persons List, the OFAC non-SDN Consolidated Sanctions List and the U.S. Unverified List (“UVL”).
c. Certification Regarding Exclusion. Each party certifies that it and its employees, directors and officers are not a person or entity are restricted from doing business with under the regulations of the Office of Foreign Asset Control (“OFAC”) of the Department of Treasury (including those named on OFAC’s Specially Designated and Blocked Persons list) or under any statute, executive order, the USA Patriot Act, Brazil’s International Sanctions Law, EU’s Common Foreign Security Policy, UK Anti-Money Laundering Act 2018, Australia’s Consolidated Sanctions List, or other governmental action or regulations in any of the countries in which West operate. Each party shall provide immediate written notice to the other party if, at any time prior to the execution of or during the term of these Terms of Sale, it becomes aware of an exclusion or sanction, or a threatened exclusion or sanction. The certification in this provision is a material representation of fact upon which reliance was placed when entering into these Terms of Sale. Notwithstanding any provision to the contrary in these Terms of Sale, if it is later determined that either party knowingly rendered an erroneous certification or such certification becomes erroneous by reason of changed circumstances, the other party may terminate the transaction(s) contemplated by these Terms of Sale and the transaction immediately.
d. Anti-bribery. In all undertakings each party agrees it will make no payments of money, or anything of value, nor will such be offered or promised, directly or indirectly, to any foreign officials, political parties, party officials, candidates for public or political party office, or either party’s personnel, to influence the acts of such persons in their official capacity, or to induce them to use their influence to obtain or retain business or gain an improper advantage in connection with any business venture or contract in which such party is a participant. Buyer understands that it is West’s policy to comply with the provisions of the Foreign Corrupt Practices Act of 1977 (“FCPA”), the United Kingdom Bribery Act of 2010 (“U.K. Bribery Act”) and any other applicable comparable laws or regulations. Each party agrees to maintain accurate books and records for purposes of complying with the FCPA, the U.K. Bribery Act, China’s Anti-Unfair Competition Law (AUCL) 2017 & 2019, Singapore’s Prevention of Corruption Act (PCA), and any other applicable comparable laws or regulations in the jurisdictions where the parties operate. The parties agree that any violation of the FCPA, the U.K. Bribery Act or any other applicable comparable laws or regulations by a party, is a material breach of these Terms of Sale, which may then result in immediate termination, with no notice or opportunity to cure.
e. Code of Conduct. Each party represents and warrants that they each have a respective Code of Conduct. Each party and its employees, directors and officers will abide by their respective Code of Conduct. The parties agree that any actual or potential violation of a Code of Conduct will be reported promptly via email to the other party’s respective compliance officer (for West via integrity@westpharma.com).
f. Data Privacy. “Personal Data” means any information from which a natural person (“data subject”) can be identified, directly or indirectly, by reference to an identifier such as a name, an identification number, location data, an online identifier such as an email address or to one or more other factors specific to that natural person. The parties agree that in the performance of these Terms of Sale, Personal Data in the form of business contact information of one or more of the parties’ employees or business partners will be exchanged. The parties agree to use this Personal Data only as necessary to perform under these Terms of Sale and/or as may be required by applicable law, and further agree to implement reasonable security measures to protect this Personal Data. The parties agree that no other use will be made of this Personal Data unless all necessary agreements to implement appropriate measures for the international transfers or processing of Personal Data and the protection of the data subjects are executed in accordance with applicable data protection laws.
g. Data Security. Each party shall promptly and without undue delay notify the other party in writing about any actual or reasonably suspected data breach they become aware of that may impact any of the other party’s information and/or data and use best efforts to contain, remediate, and protect against the reoccurrence of such breach. Each party shall further summarize in reasonable detail the impact to the other party related to the breach and corrective actions taken and shall assist the other party in remediating and further protecting its data and responding to all inquiries or filings such party is obligated to respond to.
h. Certification Regarding Healthcare Debarment. Each party certifies, to the best of its knowledge and belief, that it and its employees, directors and officers are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any federal agency, including but not limited to 21 U.S.C. § 335a, disqualified under 21 C.F.R. § 312.70 or § 12.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C § 1320a-7b(f)), or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program in the U.S. or pursuant to a comparable law outside the U.S. and will not during the performance of its obligations in connection with these Terms of Sale, employ or use the Services of any person or entity that is debarred. Each party shall provide immediate written notice to the other party if, at any time prior to the execution of or during the term of these Terms of Sale, it becomes aware of debarment or a threatened debarment. The certification in this provision is a material representation of fact upon which reliance was placed when entering into these Terms of Sale. Notwithstanding any provision to the contrary in these Terms of Sale, if it is later determined that either party knowingly rendered an erroneous certification or such certification becomes erroneous by reason of changed circumstances, the other party may terminate the transaction(s) contemplated by these Terms of Sale and the transaction immediately.
i. Export Controls. Notwithstanding any other provision of these Terms of Sale, West will not export, re-export, or transfer any Products, goods, technology, or software, or cause the export, re-export, or transfer of any Products, goods, technology, or software, with Buyer listed as the principal party in interest or exporter, or otherwise in Buyer’s name, without the valid, written authorization of Buyer’s Export Compliance organization. Likewise, Buyer will not export, re-export, or transfer any Products, goods, technology, or software, or cause the export, re-export, or transfer of any Products, goods, technology, or software, with West listed as the principal party in interest or exporter, or otherwise in West’s name, without the valid, written authorization of West’s Corporate Trade Compliance organization. In no event will either West or Buyer export, re-export, or transfer any Products, goods, technology, or software if doing so would cause either party or any other person to violate the U.S. Export Administration Regulations (15 C.F.R. Part 730 et seq.), the U.S. Foreign Trade Regulations (15 C.F.R. Part 30), the U.S. Foreign Trade Regulations (15 C.F.R. Part 30), any trade or economic sanctions regulations (including those administered by OFAC (31 C.F.R. Ch.V)) or any other applicable law. Buyer and West each reserves the right to revoke any such export authorization at any time and for any reason.
16. MISCELLANEOUS
a. Force Majeure. West assumes no responsibility for any loss or damage occurring by reason of delay or inability to perform its obligations hereunder or deliver caused by fire, flood, strike, accident, pandemic (including material new developments relating to COVID-19 following the Effective Date), act of nature, government act, act of war or rebellion, act of terrorism, insufficient or failure of regular sources of supply or labor, failure of machinery, delay of common carriers or from any other cause which is unavoidable or beyond its reasonable control (“Force Majeure”). For the avoidance of doubt, the decision of a government to change its vaccination policy will not constitute Buyer's Force Majeure. Should any Force Majeure events occur, West, at its option after giving prior written notice, may cancel Buyer's order with respect to any undelivered Products, Services, Tooling and/or Equipment 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 Products, Services, Tooling and/or Equipment. 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.
b. Entire Agreement; Amendment. These Terms of Sale constitute the entire agreement between the parties concerning the subject matter contained herein and supersedes all written or oral prior agreements or understandings with respect thereto. No course of dealing, usage of trade or course of performance will be relevant to explain or supplement any of these Terms of Sale. No amendment or modification to or waiver of the terms to these Terms of Sale shall be effective unless it is in writing and executed by West's authorized representative. Failure by West to enforce any rights under these Terms of Sale shall not be construed as a waiver of such rights nor shall a waiver in one or more instances be construed as constituting a continuing waiver or as a waiver in other instances. The paragraph headings herein are for convenience only and shall not affect the meaning or interpretation of these Terms of Sale.
c. Assignment; Subcontracting. Buyer shall not assign its rights under these Terms of Sale, whether by operation of law or otherwise, without West's prior written consent. Any purported assignment to the contrary shall be void. West may subcontract any performance obligation under this Agreement with Buyer’s prior consent, provided that subcontracting any performance obligation to another West affiliated entity does not require Buyer consent.
d. Governing Law. These Terms of Sale and the construction, validity, enforcement and interpretation thereof and performance hereunder shall be controlled and governed exclusively in accordance with: (i) the laws of the Commonwealth of Pennsylvania (and United States federal law to the extent applicable) or (ii) only in the event that (i) is held invalid, illegal or unenforceable, the laws of the principal place of business of the particular West affiliated entity issuing the order confirmation in response to Buyer's purchase order, in either case regardless of the laws governing the principles of conflicts of laws applicable thereto. The United Nations Convention on Contracts for the International Sale of Goods shall not apply. Buyer hereby submits to the jurisdiction of the courts of that state or location of that West affiliated entity, as applicable, for purposes of resolving any dispute.
e. Severability. If any term or provision of these Terms of Sale shall for any reason be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other term or provision hereof, and these Terms of Sale shall be interpreted and construed as if such term or provision, to the extent the same shall have been held to be invalid, illegal or unenforceable, had never been contained herein.
f. Independent Contractor Status. The relationship of West and Buyer established by these Terms of Sale is that of independent contractors, and neither party has the authority to bind the other or otherwise act in any way as the representative as the other unless otherwise expressly agreed to in a writing executed by the parties’ respective authorized representatives. Nothing contained in these Terms of Sale shall be construed to constitute West or Buyer as a partner, agent, or joint venturer with the other party or as a participant in a joint or common undertaking with the other party.
g. Survival. Termination or expiration for any reason shall not affect the rights and obligations of the parties that accrued prior to the effective date of such termination or expiration, including without limitation under Sections 1, 4-5, 9-10, 12-13, and 16.
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