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:
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:
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:
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.