Purchase Order Terms and Conditions
STANDARD PURCHASE ORDER TERMS & CONDITIONS
(revised 10 May 2021)
1. ACCEPTANCE: PURCHASE ORDERS issued by STADA Corp. ("STADA") referencing these terms and conditions shall become a binding contract when accepted by acknowledgment of SUPPLIER or commencement of performance by SUPPLIER within the time frame set forth in such PURCHASE ORDER. Any different or additional terms or conditions in any SUPPLIER quotation, acknowledgment, invoice or other communication shall constitute a counter-offer and no contract shall exist unless specifically accepted in writing by STADA or delivery of the subject goods is accepted by STADA. Nothing in these terms and conditions is intended to supersede the terms of any written agreements executed by both STADA and SUPPLIER that pre-date these terms and conditions.
2. CHANGES: STADA may direct in writing changes to any PURCHASE ORDER, and SUPPLIER agrees to perform such work as changed. If such change causes an increase or decrease in the cost of, or in the time required to perform, such work, SUPPLIER shall immediately notify and submit detailed information to STADA substantiating such claims. If warranted, an equitable adjustment shall be made to the price or time of performance, or both, by STADA in its reasonable discretion.
3. PRICE: The prices set forth in any PURCHASE ORDER shall not be increased without STADA's prior written consent. If at any time during the performance of any PURCHASE ORDER SUPPLIER shall quote or sell, at lower net prices, similar goods and/or services under similar conditions and (as to goods) in similar quantities, such lower prices shall be substituted for the prices identified in said PURCHASE ORDER.
4. INVOICING AND PAYMENT:
- SUPPLIER shall issue an invoice to STADA on or at any time after the completion of services or the delivery of goods and only in accordance with these terms and conditions. If authorized by the PURCHASE ORDER, or if SUPPLIER does not issue an invoice in due course, STADA may generate the invoice and proceed to payment accordingly. SUPPLIER shall notify STADA of any error on an invoice generated by STADA within ten (10) days, or such invoice shall be deemed final.
- If SUPPLIER is enabled to transact business with STADA electronically, SUPPLIER agrees to submit invoices in electronic form to STADA's Accounts Payable organization through the STADA approved electronic method. If SUPPLIER is not so enabled, it agrees to submit invoices to STADA's Accounts Payable organization at the "bill-to" address set forth on the PURCHASE ORDER.
- STADA shall make payment for invoices received pursuant hereto (or the undisputed portions of such invoices) within forty five (45) days from receipt of a properly prepared invoice. Where, however, other payment terms appear on the front of any PURCHASE ORDER, payment shall be made in accordance with those terms and conditions.
- All goods are subject to STADA's approval notwithstanding prior inspection or payment and, if not timely delivered in accordance with specifications may, in STADA's sole discretion, be rejected. All SUPPLIER services (including without limitation, product formulation services, safety and efficacy testing, stability testing, etc.) are subject to STADA's approval and, if not satisfactory and in accordance with specifications may, in STADA's sole discretion, be performed by STADA or its designated contractor at SUPPLIER's expense or the amounts paid therefore by STADA promptly refunded to STADA.
- SUPPLIER covenants and warrants that the goods sold pursuant to any PURCHASE ORDER shall (i) conform to all drawings, specifications, samples and other written descriptions furnished by STADA (or furnished to STADA by SUPPLIER and agreed upon by STADA in writing) or otherwise agreed upon by STADA and SUPPLIER in writing, (ii) be new and unused, (iii) comply with all applicable laws, rules and regulations, and standard industry practices, including cGMP, (iv) have been manufactured in a facility that is in compliance with all applicable laws, (v) are fit for the purpose(s) for which they are intended, and (vi) are merchantable, and free from patent or latent defects.
- If STADA chooses to accept defective or nonconforming goods and/or services, STADA may do so in writing. In such event, the price set forth in the relevant PURCHASE ORDER shall be reduced by the difference between (1) the value as set forth in the relevant PURCHASE ORDER, and (2) the value of the goods and/or services as accepted, as reasonably determined by STADA. If STADA chooses to not accept defective or nonconforming goods/services, the SUPPLIER shall at STADA's option immediately replace all such goods/services at no cost to STADA, or refund the purchase price.
- The following shall apply to any SUPPLIER of 1) drug products, dietary supplements or any other materials or products subject to cGMP regulations promulgated by the US Food and Drug Administration; 2) wood pallets; and/or 3) any materials or products whereby STADA has previously notified SUPPLIER to comply with this Section; and SUPPLIER expressly agrees and represents, warrants and covenants that any shipment to a STADA site or location using wood pallets shall only be done if the wood pallets meet the following criteria:
- 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 STADA. No additional chemical treatments have been used on such wood pallets, including, but not limited to Methyl Bromide.
- 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 STADA to visually inspect the wood pallet, upon receipt.
- Any materials derived from humans ("Human Material") must be properly collected with all necessary approvals, consents and/or authorizations for the collection, use and/or transfer of such Human Material as contemplated by this PURCHASE ORDER without any obligation on STADA to those who contributed the Human Material. SUPPLIER shall provide documentation of such approvals, consents, and authorizations upon STADA's request.
6. DATA INTEGRITY: Any documentation or data relevant to activities performed, including without limitation any GMP documentation, must be attributable, original, accurate, legible, complete, controlled, retrievable, and safe from intentional or unintentional manipulation or loss. These items are required throughout the legally required retention period of such data / documentation.
7. SHIPMENT AND DELIVERY OF GOODS:
- Shipment of all goods shall be effected as set forth in the PURCHASE ORDER. Unless otherwise set forth in the PURCHASE ORDER, (i) all goods shall be shipped Ex Works (Incoterms 2010) SUPPLIER's manufacturing facility, (ii) SUPPLIER shall select a reputable common freight carrier to deliver the goods to the destination designated by STADA or as otherwise communicated by STADA to SUPPLIER, and (iii) SUPPLIER shall insure such products against loss. All shipping and insurance charges will be billed to STADA and listed on SUPPLIER'S invoice to STADA. SUPPLIER shall not charge STADA any extra amounts for packing, crating, or drayage of goods
- Goods constituting biologicals, pharmaceuticals or dietary supplements intended for human consumption shall have a minimum two year shelf life at time of delivery.
- All goods shall be transported in compliance with the specified storage conditions (e.g., temperature, humidity), and shall not be mixed with or contaminated by other products or materials.
- All goods shall at all times prior to shipment be protected against any unauthorized access. All goods shall be protected from falsification, tampering or modifications, and STADA shall be immediately notified in the event SUPPLIER becomes aware of same.
- All goods shall be staged and transported in clean and vermin/insect-free environments and containers. Cleaning shall be carried out according to defined written instructions and must be documented. For the transport of dietary supplements, qualified transport vehicles are to be used.
- The handling and shipment of goods constituting dietary supplement products shall be conducted by qualified, trained personnel in order to minimize the risk of wrong dispatch, damage, delays or other negative influences during staging, loading and transport. Personnel shall be trained at regular intervals and on all new requirements as soon as practical.
- All goods are to be made available for transport in appropriate packaging (e.g., cardboard box, pallets, insulated containers, cooling boxes, etc.). Standardized and validated shipping containers are to be used. The transport packaging / shipping container are to be labelled in accordance with all applicable laws (e.g., transport- and storage advice, shipping labels, etc.). In case of placing orders for transportation with third parties, transport agreements shall be fixed in writing, and Quality audits shall be performed at regular intervals to ensure that the agreements are honored and enforced.
- SUPPLIER shall notify STADA immediately of any situation that may delay or threaten to delay the timely delivery and/or performance of any PURCHASE ORDER. All or any portion of a PURCHASE ORDER may, at STADA's option, be canceled without liability by STADA if delivery is not made as or when specified in said PURCHASE ORDER and these terms and conditions.
8. FORCE MAJEURE: Each of the parties will be excused from their respective performance obligations under any Purchase Order and these terms and conditions to the extent such performance is prevented by acts of God, fire, explosion, flood, wind-storm, earthquake, unusually severe weather, riots, wars, acts of terrorism, pandemic, any law or lawful demand of any governmental authority to suspend or reduce operations, or other circumstances beyond the reasonable control of the Party seeking excuse from performance (each, a "Force Majeure"); provided, however, that (i) the party immediately gives notice to the other of such event or occurrence along with its good faith estimate of the likely length of delay (updated immediately as new information becomes available), and (ii) the party promptly takes all available commercially reasonable actions to reduce or eliminate the effect of the Force Majeure to the fullest extent possible and with all dispatch. If an event or occurrence of Force Majeure has prevented or is likely to prevent either party from performing its obligations under an open PURCHASE ORDER for a period of more than one hundred and twenty (120) days, then the other party may terminate this Agreement upon written notice at any time after expiry of the said period, but before full performance has resumed by the party claiming Force Majeure.
9. ASSIGNMENT; USE OF SUBCONTRACTORS: SUPPLIER shall not assign, in whole or in part, to any person or entity any of its rights, interests or obligations under any PURCHASE ORDER without STADA's prior written consent, which may be withheld in its sole discretion. Any such attempted assignment shall be deemed void. SUPPLIER shall not utilize the services of subcontractors without the prior written consent of STADA given in each instance. Regardless of any such STADA consent, SUPPLIER shall be full responsible and liable for all actions and omissions of any of its assignees, subcontractors, agents or representatives in regards to any STADA PURCHASE ORDER.
10. RECORDS AND AUDIT RIGHTS: STADA shall have the right to examine and audit the books and records and conduct in-person audits of any manufacturing facility of SUPPLIER at any reasonable time upon ten days prior notice. All books and records will be maintained for four (4) years or as otherwise required by law and will be adequate to enable determination and substantiation of: (1) the accuracy of any payments required to be made under the relevant PURCHASE ORDER; and (2) compliance with the provisions of the relevant PURCHASE ORDER, and (3) compliance with applicable laws, rules and regulations.
11. CONFIDENTIAL INFORMATION: In the course of providing goods and/or while performing services for STADA, SUPPLIER will not use for itself or for others, or disclose to any third party, any confidential or proprietary information, knowledge or data of or regarding STADA, respecting any product, apparatus, process, formula, manufacturing method, or manner of doing business that may be used, developed, or investigated by SUPPLIER or may come to SUPPLIER's attention in the course of providing the goods and/or performing the services ("Confidential Information"), for a period of five years after conclusion of the delivery of any goods or the provision of any services under any PURCHASE ORDER (except that SUPPLIER shall never use or disclose trade secrets of STADA). The obligations in this Section shall not apply to any Confidential Information in the public domain, is already known to SUPPLIER at the time of disclosure, or that is independently developed by SUPPLIER by persons with no access to Confidential Information, as shown by contemporaneous records kept in the ordinary course of business. SUPPLIER shall promptly notify STADA of any order or request by a governmental authority for INFORMATION and shall provide reasonable assistance requested by STADA in preparing and filing any request for confidentiality with such governmental authority. If so requested by STADA, SUPPLIER further agrees to require its employees to execute a nondisclosure agreement prior to providing goods and/or performing any services pursuant to a PURCHASE ORDER. SUPPLIER understands and agrees that any use or disclosure of INFORMATION in violation of these terms and conditions will cause STADA irreparable harm without an adequate legal remedy and shall therefore entitle STADA to injunctive relief from any court having jurisdiction without the requirement of posting any bond.
12. DATA PRIVACY AND SECURITY: In the course of providing goods and/or while performing services pursuant hereto, SUPPLIER agrees that when collecting, accessing or using any personal information that can identify an individual, SUPPLIER will only collect, access, use and disclose the minimum information necessary to enable SUPPLIER to perform its obligations and that it will do so only in accordance with STADA's instructions or where disclosure is required by law; which required disclosure shall be reported to STADA by SUPPLIER in sufficient time prior to any such disclosure as to allow STADA to take any protective action if it deems necessary. SUPPLIER agrees to protect such information from loss, misuse, unauthorized access, disclosure, alteration or destruction and promptly notify STADA of any loss, misuse unauthorized access, disclosure, alteration or destruction to such information of which SUPPLIER becomes aware.
SUPPLIER shall, in connection with each PURCHASE ORDER, at its sole expense, maintain in effect at all times the following insurance coverage with limits as follows:
- Commercial General Liability - Occurrence Form: Coverage for Bodily Injury/Property Damage-Each Occurrence, Personal and Advertising Injury, Products/Completed Operations, Contractual Liability $2,000,000; General Aggregate $5,000,000
- Product Liability (including Manufacturers E&O for Contract Manufacturing – must be listed as a separate policy from Commercial General Liability): $10,000,000
- Cyber/Network/Privacy Liability, Comprehensive cyber/network/privacy liability $1,000,000
SUPPLIER shall deliver to STADA, prior to commencement of work pursuant to any PURCHASE ORDER, Certificates of Insurance, as evidence that policies providing such coverage and limits of insurance are in full force and effect, with insurers with an A. M. Best rating of A- or better. These Certificates shall provide that not less than thirty (30) calendar days advance notice will be given in writing to STADA of any cancellation, nonrenewal, or material alteration of said insurance policies. All policies shall name STADA as an additional insured and shall waive all rights of subrogation against STADA. SUPPLIER's insurance shall be primary with no contributions by STADA's insurers.
14. RESPONSIBILITY FOR PRODUCT DEFECTS:
A. Indemnification. SUPPLIER shall defend, reimburse, indemnify and hold harmless STADA, its affiliates and their respective officers, directors, employees and representatives (collectively, "STADA Parties"), from and against (i) all Losses arising in respect of any Recalls to the extent the same are the result of the actions or omissions of SUPPLIER, its affiliates, or its assignees, agents, contractors or representatives (collectively, "SUPPLIER Parties"), (ii) all Losses arising out of any breach of any representation or warranty of SUPPLIER contained in these terms and conditions, and (iii) all Losses with respect to any Third Party Claims made against the STADA Parties to the extent arising from, (a) the manufacture, storage, handling, or transportation of the goods by the SUPPLIER Parties; (ii) SUPPLIER'S breach of any covenant, guarantee, representation or warranty in the applicable PURCHASE ORDER or these terms and conditions; (iii) the negligence or willful misconduct of the SUPPLIER Parties concerning the goods or services that are the subject of any PURCHASE ORDER; or (iv) any allegation that any goods, or any manufacture of such goods, infringe any patent, copyright, trademark right, trade secret, or other proprietary right of any Third Party to the extent such allegation is attributable to the SUPPLIER Parties' claimed Intellectual Property rights. "Losses" means any and all losses, liabilities, damages, claims, demands, judgments, interest, fines, penalties, costs, settlements or settlement amounts and expenses (including all reasonable attorney, consultant, expert witness, accountant or similar fees). "Third Party Claim" means any demand, claim, suit, proceeding or action brought against any of the STADA Parties by any third party.
B. Procedure for Third Party Claims. STADA will provide SUPPLIER with prompt notice of any Third Party Claim for which it seeks indemnification, provided that the failure to do so will not excuse SUPPLIER of its obligations hereunder except to the extent it's prejudiced by such failure or delay. SUPPLIER will have the right to control the defense and settlement of the Third Party Claim, provided that SUPPLIER may not, without STADA'S written consent, enter into any settlement that admits guilt, liability or culpability on the part of STADA or requires it to take any action or incur any expense. STADA will provide reasonable cooperation, information and assistance to SUPPLIER in defending any Third Party Claim.
15. GOVERNING LAW: These terms and conditions and any contract created by any PURCHASE ORDER shall be governed by the laws of the State of New Jersey without reference to its conflict of law rules. The United Nations Convention on the International Sale of Goods shall not apply to any PURCHASE ORDER.
16. ARBITRATION: All conflicts or disputes arising out of any PURCHASE ORDER or these terms and conditions shall be settled exclusively by binding arbitration. Either party may submit a dispute to binding arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce, with the venue for any such arbitration being in Morristown, New Jersey. The arbitration shall be conducted by three (3) arbitrators, one chosen by SUPPLIER, one chosen by STADA and the third chosen by such two arbitrators. All arbitration proceedings shall be conducted in the English language. Any arbitration award shall be in writing, and may include injunctive relief (including preliminary injunctive relief), an award of damages (including any Losses), and/or an award of attorneys' fees and costs arising out of the arbitration. The award of the arbitration tribunal shall be final and binding upon the Parties and may be enforced in any court of competent jurisdiction.
17. PRODUCT RECALLS: If STADA determines in its discretion that a recall or market withdrawal (each, a "Recall") of any goods is required or appropriate under applicable law or to prevent harm to the public, STADA shall to the extent feasible notify SUPPLIER and the parties shall promptly consult with each other and collaborate in good faith to facilitate such Recall. STADA shall have sole responsibility to organize, manage and administer any Recall, including issuing notifications for any Recall to (i) any governmental authorities, and (ii) any distributor, retailer or end-user/customer of the goods.
18. TERRITORY: SUPPLIER acknowledges that any products or services ordered under any STADA PURCHASE ORDER shall be for performance or use in, or for ultimate sale in, the United States ("Territory"). All reference to "applicable laws" herein shall be deemed to be the applicable laws, rules, regulations, standard industry guidelines or practices (including cGMP) of or concerning (i) the Territory, and (ii) the country where SUPPLIER manufactures any portion of the products that are the subject of a STADA PURCHASE ORDER. Without limiting the generality of the foregoing, SUPPLIER acknowledges that all rules, regulations and orders of the FDA shall be applicable to any STADA PURCHASE ORDER and SUPPLIER'S performance thereof.
19. INTELLECTUAL PROPERTY: The parties shall not acquire any of the Intellectual Property rights of the other, and each party owns or controls all Intellectual Property Rights belonging to or controlled by such Party that are in existence prior to the date of any applicable PURCHASE ORDER, or that is conceived or developed independently of any PURCHASE ORDER. STADA is and shall remain the exclusive owner of all Product Formulas and all Intellectual Property Rights related thereto. "Intellectual Property" means all patents, patent applications, trademarks, copyrights, materials and other works that may be subject to copyright, trade secrets, and any other intellectual property, as well as all patentable and unpatentable inventions, ideas, know-how, concepts, object and source code, documentation, domain names, website content, improvements, or discoveries. "Product Formula" means the formulas, ingredient lists (including the proportions thereof) and other information provided by STADA to SUPPLIER in respect of any goods that are the subject of a PURCHASE ORDER, including without limitation the flavor, color and/or smell profile, and any other defining characteristics of such goods.
20. SUBSIDIARIES/AFFILIATES: If a subsidiary or affiliate of STADA is identified in the "Ship to" address in the relevant PURCHASE ORDER, then: (1) said PURCHASE ORDER shall be and be deemed to have been placed by such subsidiary or affiliate; and (2) the references to STADA in the NOTE TO SUPPLIERS REGARDING TERMS AND CONDITIONS SECTION of said PURCHASE ORDER shall be and be deemed to be references to such subsidiary or affiliate; and (c) the references to STADA herein shall be and be deemed to be references to said subsidiary or affiliate.
21. MISCELLANEOUS: Subject to SECTION 1, the terms and conditions contained herein, together with the relevant PURCHASE ORDER, represent the entire agreement between STADA and SUPPLIER with respect to the goods and/or services set forth in said PURCHASE ORDER and supersede any inconsistent or additional provisions heretofore made by SUPPLIER. The headings of the provisions of these terms and conditions are inserted for convenience only and shall not constitute a part hereof. In the event that any provision of these terms and conditions or any PURCHASE ORDER shall be found to be void or unenforceable, such finding shall not be construed to render any other provision of such instruments void or unenforceable, and all other provisions shall remain in full force and effect. Neither these terms and conditions nor any PURCHASE ORDER placed by STADA hereunder may be altered except in a subsequent writing executed by STADA. A failure or delay by a Party to exercise any right or remedy it has by law or the applicable PURCHASE ORDER shall not constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict any further exercise of that or any other right or remedy. No single or partial exercise of any right or remedy provided under the applicable PURCHASE ORDER or by law shall prevent or restrict the further exercise of that or any other right or remedy.