The terms and conditions set forth herein are applicable to the Purchase Order ("PO") issued by The United States Pharmacopeial Convention ("USP"), and by accepting the Purchase Order Supplier agrees that it has read, understand, and agrees to be bound by these terms and conditions.
Any communications transmitted electronically (e.g., via facsimile or email) (i) shall be considered a "writing" or "in writing," (ii) shall be deemed "signed" if a signature is affixed that is valid in accordance with applicable law (including a valid electronic signature), and (iii) will constitute an "original" when printed. Communications introduced as evidence on paper will be admissible to the same extent and under the same conditions as other business records originated and maintained in documentary form and admissibility shall not be contested on the basis that the communication was not originated or maintained in documentary form.
- Notices. All communications from Supplier to USP relating to the PO and these terms and conditions shall be addressed to USP's representative identified on the PO.
- Supplier Responsibilities. Supplier shall use commercially reasonable efforts (i) to provide to USP the goods and services ordered in accordance with the terms stipulated in the PO and the applicable, if any, supply, service or other agreement pursuant to which the PO was issued; (ii) to keep USP advised of the status of the PO; (iii) to permit duly authorized representatives of USP to review and observe, from time to time upon reasonable notice, the delivery of the goods and services; (iv) to provide USP with such reports as are appropriate to the nature of the goods and services ordered and as may be reasonably requested by USP from time to time; and (v) to keep, for orders requiring payment based on hours worked, cost of materials used and/or expenses incurred, records of hours worked, cost of materials used, and reasonable out-of-pocket expenses incurred in fulfilling the PO, which records USP's duly authorized representatives may examine from time to time upon reasonable notice.
- Acknowledgment. The shipment of any goods or the furnishing of any services (or delivery of any deliverable arising therefrom), shall constitute acceptance by Supplier of the PO and each and all of the terms and conditions stated herein. If Supplier objects to any of the terms and conditions hereof, it shall notify USP in writing within ten days after issuance of the PO and withhold acceptance of the PO until such objection is settled by written agreement.
- Inspection. Applicable to Reference Standards Only: Supplier acknowledges the unique characteristics of USP Reference Standards. All goods and deliverables are subject to final review, inspection and acceptance by USP upon completion of collaborative testing, notwithstanding any payment or initial inspection. Applicable to All USP Purchases: Supplier acknowledges that all goods and deliverables are subject to final review, inspection and acceptance by USP.
- Quality. Suppliers that process or test USP materials shall (i) promptly communicate in writing any deviation from procedures with USP prior to execution; (ii) in case of non-conformance, deviation, or OOS result, promptly conduct an internal investigation at their own expense and, provide written notification to USP, including results; (iii) maintain calibration and preventive maintenance procedures and schedules for equipment/instruments used in the testing, processing and packaging of the product(s); (iv) document all required process and testing steps at the time such process or testing step is executed; (v) provide a complete Certificate of Conformance and/or Certificate of Analysis, as applicable, for the product with each shipment to USP.
- Rejections/Returns. USP reserves the right to refuse any goods or deliverables and to cancel all or any part of a PO for goods or deliverables not conforming to applicable specifications, drawings, samples or descriptions. Acceptance of any part of the PO shall not bind USP to accept future shipments of non-conforming goods or deliverables, nor deprive it of the right to return non-conforming goods or deliverables already accepted. Goods and deliverables, if rejected, may be returned to Supplier at Supplier's expense for transportation both ways, and no replacement or substitution shall be made unless so authorized by USP.
- Cancellation Due to Delay of Timely Delivery. The delivery of goods, services and deliverables shall strictly comply with the delivery date or delivery schedule, if any, specified by USP. If at any time it appears Supplier will not meet such delivery date or schedule, Supplier shall promptly notify USP in writing of reasons for, and the estimated duration of, the delay. If requested by USP, Supplier will ship delayed goods by means to avoid or minimize delay to the maximum extent possible, the added cost to be borne solely by Supplier. USP may exercise its other remedies, such as cancellation of the PO after 30 days for non-compliance and cover.
- Invoice. Unless otherwise specified by USP, a separate invoice shall be issued for each shipment and only after the goods are shipped or services and deliverables delivered. No payment will be made prior to receipt of goods, services or deliverables and current invoice (if such invoice is required by USP). Payment due dates, including discount periods, will be computed from date of invoice to date USP's check is mailed (or payment is otherwise transmitted by USP).
- Payments. Unless otherwise specified by USP, payment terms will be net 30 days. USP may withhold payment of any amounts to be paid to Supplier which are disputed in good faith by USP.
- Warranty. Applicable to Reference Standards Only: In accepting this PO, Supplier unconditionally represents and warrants, any other representation or agreement to the contrary notwithstanding, that the goods and deliverables supplied pursuant to this PO are of merchantable quality, conform to the specifications as stated on the PO and as otherwise provided by USP and are suitable for USP's purposes in the ordinary course of its business.
Applicable to All USP Purchases: In accepting this PO, Supplier unconditionally represents and warrants, any other representation or agreement to the contrary notwithstanding, that the goods and deliverables supplied pursuant to this PO are of merchantable quality, conform to the specifications as stated on the PO and as otherwise provided by USP and are suitable for USP's intended uses and purposes in the ordinary course of its business.
All warranties herein stated shall run to USP, its customers and the users of the goods or deliverables or products into which such goods or deliverables may be incorporated. If this PO is for services then by in accepting this PO, Supplier also unconditionally represents and warrants, any other representation or agreement to the contrary notwithstanding, that: (i) its performance of the services and the deliverables arising therefrom, or any portion or function thereof, or the use of the deliverables or any portion thereof, will not violate or infringe any third-party patent, trademark, copyright, trade secret or similar rights; (ii) the services will be provided by qualified personnel reasonably skilled and trained in the performance of the services and in a workmanlike and professional manner in accordance with general industry standards; (iii) it is currently under no obligation to any third party, nor will it enter into any obligation to a third party, that could interfere with its rendering to USP the services or deliverables; (iv) any documentation provided to USP shall meet reasonable standards of clarity and detail; and (v) all deliverables will be warranted to perform according to their specifications.
- Indemnification. Supplier agrees to indemnify and hold harmless USP, its subsidiaries and affiliates (and its and their respective directors, employees and agents) from any losses, liabilities, damages and expenses (including without limitation reasonable attorneys' fees) arising, directly or indirectly, from: (i) Supplier's breach of any provision hereof, including without limitation the confidentiality obligations and the warranties made herein; (ii) any negligent or wrongful act or omission of Supplier, its employees, consultants or subcontractors; (iii) Supplier's failure to comply with applicable laws and regulations in filling the PO; (iv) any claim charging that USP's purchase of goods, services or deliverables under the PO constitutes misappropriation of trade secrets, breach of a confidential relationship, or trademark, trade secret or copyright infringement; and/or (v) any claim charging that any goods or deliverables acquired under the PO, or the use of such goods or deliverables, infringe a third-party's patent anywhere in the world. If the goods or deliverables, or the use of such goods or deliverables, are held to constitute an infringement and their sale or use is enjoined, Supplier shall, at its expense and option, either procure for USP and its affiliates the right to continue to use such goods or deliverables, or replace same with an equivalent non-infringing product, or modify same so it becomes an equivalent non-infringing product. This Section will not be construed to limit or exclude any other claims or remedies that USP or its affiliates (and its and their respective directors, employees and agents) may assert.
- Limitation of Liability. UNDER NO CIRCUMSTANCES WILL USP OR ITS SUBSIDIARIES OR AFFILIATES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, SPECIAL, PUNITIVE, OR INCIDENTAL DAMAGES OR LOST PROFITS, WHETHER FORESEEABLE OR UNFORESEEABLE, BASED ON CLAIMS OF SUPPLIER OR ANY OTHER PARTY ARISING OUT OF BREACH OR FAILURE OF EXPRESS OR IMPLIED WARRANTY, BREACH OF CONTRACT, MISREPRESENTATION, NEGLIGENCE, STRICT LIABILITY IN TORT, FAILURE OF ANY REMEDY TO ACHIEVE ITS ESSENTIAL PURPOSE, OR OTHERWISE. NOTWITHSTANDING THE FORM (CONTRACT, TORT OR OTHERWISE) IN WHICH ANY LEGAL OR EQUITABLE ACTION MAY BE BROUGHT. IN NO EVENT WILL USP OR ITS SUBSIDIARIES OR AFFILIATES BE LIABLE FOR DAMAGES OR LOSSES THAT EXCEED THE AMOUNT OF FEES PAID BY USP FOR THE GOODS OR SERVICES THAT GAVE RISE TO SUCH DAMAGES OR LOSSES FOR EACH RESPECTIVE BREACH OR SERIES OF RELATED BREACHES. THIS SECTION WILL NOT APPLY ONLY WHEN AND TO THE EXTENT THAT APPLICABLE LAW SPECIFICALLY REQUIRES LIABILITY DESPITE THE FOREGOING DISCLAIMER, EXCLUSION AND LIMITATION.
- Insurance. Supplier shall, at its own expense, maintain with a reputable insurer (and provide written certificate(s) of insurance to USP if and when requested) for a period of at least 3 years after the fulfillment of the PO reasonable and customary insurance coverage, including, but not limited to, (i) worker's compensation statutory coverage as required by the laws of the applicable jurisdiction, and (ii) commercial general liability insurance including coverage for product liability in the minimum amount of $2 million in respect of claims for any losses, costs and expenses arising out of or relating to Supplier furnishing the goods, deliverables and/or services under the PO. The certificate(s) of insurance will, if requested by USP, designate USP as "additional insured" under the commercial general liability policy and will include the agreement for the insurer to give USP written notice at least 30 days prior to the effective date of any cancellation, lapse or material change in the policy, and will contain a waiver of subrogation in favor of USP.
- Copyrights; Rights to Inventions. USP will be the exclusive owner of all deliverables created by Supplier in connection with or during the performance of services provided pursuant to a PO, any works based on or derived from such deliverables ("Derivatives"), and any ideas, concepts, inventions or techniques that Supplier may conceive or first reduce to practice in connection with developing the Deliverables ("Deliverable Concepts") (the deliverables, Derivatives, and Deliverable Concepts are collectively referred to as, "USP Materials") and all intellectual property rights therein, including patents, copyrights, trade secrets, trademarks, moral rights, and similar rights of any type under the laws of any governmental authority (collectively, "Intellectual Property Rights"). All copyrightable USP Materials shall be prepared by Supplier as a "work made for hire" for USP, and USP shall be considered the author of the USP Materials for purposes of copyright. To the extent that the USP does not acquire ownership of such copyrights as a work made for hire, and with respect to all other rights, Supplier hereby assigns and agrees to assign upon creation to USP all right, title and interest in and to the USP Materials and all Intellectual Property Rights therein. To the extent such assignment of rights and ownership is invalid or any of the foregoing rights, including so-called "moral rights" or rights of "droit moral," may be inalienable, Supplier agrees to waive and agrees not to exercise such rights, and if such waiver and agreement are deemed invalid, to grant to USP and its designees the exclusive, transferable, perpetual, irrevocable, worldwide and royalty free right to make, use, market, modify, distribute, transmit, copy, sell, practice, and offer for sale and import the USP Materials and any process, technology, software, article, equipment, system, unit, product or component part covered by the Deliverable Concepts or a claim of any patent in any part of the Deliverable Concepts. At USP's request, Supplier will obtain the execution of any instrument, including from any employee or contractor, that may be appropriate to assign these rights under this paragraph to USP or perfect these rights in USP's name. Supplier agrees that any copyrightable material prepared for USP shall carry on the face thereof in legible form a copyright notice identifying USP and the year of publication.
- Force Majeure. Supplier and USP, as the case may be, shall be excused for delays in performance or failure of performance to the extent arising from causes beyond such party's reasonable control, including without limitation strikes, wars, fires, floods, earthquakes, acts of terror or other acts of God. In the event of any such event or condition, the party whose performance is excused hereunder shall notify the other promptly thereof and shall make diligent efforts to perform at its earliest opportunity and the other party shall be permitted to suspend its performance under the PO. If Supplier's performance is excused hereunder, USP shall have the right, and Supplier agrees to provide to USP the assistance and information necessary for USP, to make, have made, or otherwise procure replacement goods and services.
- Shipping Terms. Unless otherwise specified by USP, delivery of goods is to be F.O.B. USP's plant. If goods are to be shipped F.O.B. shipping point, and USP has not designated routing, Supplier is required to ship via the most economical method that will meet delivery date. Supplier shall provide a packing list to USP for all shipments referencing the appropriate order number. Bills of lading, if any, shall also reference the appropriate order number.
- Transportation Liability. Supplier agrees that in any case where freight regulations covering goods transported by common carrier establish a maximum limit on the carrier's liability for loss or damage suffered in transit, Supplier will be liable to USP for any loss or damage in excess of such maximum limit up to the full replacement cost of the goods.
- Confidentiality; No Publicity. Supplier shall keep in confidence and shall not, without securing the prior written consent of USP, originate any publicity (including any news release or public announcement) or disclose to any third party information relating to: the existence of the relationship with USP; USP's purchasing systems or practices (including, without limitation, descriptions of purchased items, quantities purchased and prices paid); the nature of the services performed and deliverables and goods delivered under the PO; and any proprietary or confidential data, designs, or other information supplied by, or on behalf of, USP. Notwithstanding the foregoing, Supplier may disclose such confidential information (i) to Supplier's employees having a need to know such information to process the PO or improve the services provided by Supplier to USP or (ii) to comply with applicable laws, court orders, or government regulations. If disclosure is permitted under clause (ii) above, Supplier shall consult with USP in connection with any publicity in a reasonable time prior to its release to allow USP to comment thereon, and to prevent its release if so permitted by law. Supplier agrees that it will take appropriate action by instruction, agreement, or otherwise with its employees and subcontractors who are permitted access to the aforementioned information to notify them of Supplier's obligations hereunder. Upon USP's request any data, designs, or other information furnished to Supplier (and copies thereof) shall be returned to USP.
- USP's Property. All tools, equipment and materials of every description furnished to Supplier by, or specifically paid for by, USP, and any replacement thereof, and any materials affixed or attached thereto, shall be and remain the personal property of USP, and shall be safely stored separate and apart from Supplier's property. Supplier shall not substitute any property for USP's property and shall not use such property except in filling USP's purchase orders. Such property while in Supplier's custody or control shall be held at Supplier's risk, shall be kept insured by Supplier at Supplier's expense in an amount equal to the replacement cost with loss payable to USP and shall be subject to removal at USP's written request, in which event Supplier shall prepare such property for shipment and shall redeliver to USP in the same condition as originally received by Supplier, reasonable wear and tear excepted.
- Material Safety Data Sheets. An appropriate material safety data sheet ("MSDS") and labeling, as and if required by law, will precede or accompany each shipment of Supplier. Further, Supplier shall send to USP updated MSDS's and labeling as required by law.
- Compliance with Laws. Supplier agrees to comply with the applicable provisions of any federal, national, state or local law, and all orders, rules and regulations issued thereunder, whether now or hereafter in force, and any provisions, representations or agreements required thereby to be included in the contract resulting from acceptance of the PO are hereby incorporated by reference, including, but not limited to, those prohibiting discrimination against any employee or applicant for employment because of race, color, religion, sex or national origin, or physical or mental handicap and those providing for the employment of disabled veterans and veterans of the Vietnam era.
- Choice of Law. The laws of the State of Maryland, without regard to principles of conflict of laws, will govern these terms and conditions and the PO.
- Complete Agreement. These terms and conditions and the other agreements (e.g., supply agreements, service agreements, statements of work) if any, pursuant to which this PO was issued contain the entire understanding of the parties with respect to the subject matter of the PO. In the event of any conflict between the terms and conditions contained herein and those in any other applicable written agreement relating to the subject matter of the PO and governing the relationship between USP and Supplier, the conflicting terms and conditions in the other agreement will govern. No modification, amendment or waiver of any term or condition hereof shall be effective unless set forth in writing signed by USP and Supplier. Unless agreed to by USP in a writing, USP will not be bound to any additional or different terms or conditions hereafter transmitted by Supplier and USP will not be bound by its silence, course of dealing, usage of the trade or its acceptance of the goods or services.
- Assignment. The PO and Supplier's rights and duties hereunder shall not be assignable by Supplier without the prior written consent of USP, which consent may be withheld in its sole discretion. USP may assign its rights and obligations hereunder to any one or more of its affiliates. The PO and these terms and conditions shall inure to the benefit of and be binding upon USP and Supplier and their respective successors and permitted assigns; nothing contained herein shall give to any other person any benefit or any legal or equitable right, remedy or claim.
- Miscellaneous. Headings used herein are for convenience only and shall not be used for interpretive purpose. A party's failure to act with respect to another party's breach of any provision contained herein does not constitute a waiver. If any provision herein is held to be invalid or unenforceable, such provision shall be narrowly construed, if possible, or otherwise deemed ineffective and the remaining provisions shall not be affected. These terms and conditions will survive the fulfillment of the PO.