Last Updated: February 2024
“Buyer” or “PTC” (without distinction) shall be understood as being PTC Therapeutics, Inc. or any of its affiliates, as the company making the purchase of goods and/or services from Supplier.
“Supplier” shall be understood as being the entity (supplier/vendor/service provider) to which the Purchase Order is sent for the supply of products and/or services, as referred to therein.
PTC and Supplier are also referred to herein individually as a “Party,” and collectively, as the “Parties”.
- APPLICABILITY OF PTC TERMS AND CONDITIONS: The PTC Terms and Conditions are applicable worldwide for projects quoted under Twenty-Five Thousand US Dollars or Euros (USD 25 000 or EUR 25 000) or for Latin America under Twenty-Five Thousand local currency.
The PTC Terms and Conditions are not applicable to:- Healthcare Professionals’ agreements, including consulting, speaker and sponsorship agreements
- Patient Advocacy Groups’ agreements
- Event Sponsorships and grants
- Investigator Initiated Studies
- Full-time consulting arrangements with any individual person
- Material transfer, licensing, distribution, manufacturing, quality, clinical trial and intercompany agreements
- HR Employment agreements
- Projects where the primary purpose is the processing of PTC employees’ personal data by Supplier
- Projects where the primary purpose is the processing of patients and/or healthcare professional’s personal data by Supplier
- Projects involving IP creation, or services/products to be owned by PTC after delivery or license to PTC.
- ACCEPTANCE OF PTC TERMS AND CONDITIONS: The proposal or quote which has been issued by Supplier in connection with any provision of goods and/or services to PTC, is deemed accepted by PTC, only if sent together by PTC with a Purchase Order. Supplier’s action in either (a) accepting a Purchase Order in writing, (b) delivering any or all products described in the Purchase Order, and/or (c) performing the services described in the Purchase Order will constitute Supplier’s unqualified acceptance of PTC Terms and Conditions (the “Agreement”). PTC Terms and Conditions will not apply if (i) the Parties have signed a contract or agreement which governs a transaction between PTC and Supplier, or (ii) in case the proposal or quote which has been issued by Supplier is subject to an existing agreement between PTC and Supplier.
All the terms, conditions and specifications to which no specific reference is made in the accepted Purchase Order, shall be understood as being rejected by PTC and shall be ineffective. Any and all Supplier’s Terms and Conditions of Sale, unless expressly accepted by PTC in writing are waived by virtue of the receipt of the Purchase Order and also rendered null and void. - WARRANTY: Supplier warrants that all goods and services (including, without limitation, packaging and labeling) shall be of merchantable quality, free from defects in material, design and workmanship, shall conform to specifications, samples, drawings and plans, if any, provided to or by PTC (excluding any limitations or disclaimers unless approved in writing by PTC), shall be performed in a sound, professional and competent manner, and shall be fit for PTC’s intended particular purposes.
- TERMS OF PAYMENT AND INVOICE: Supplier accepts the term of payment as indicated in the Purchase Order. In case the payment term is not indicated, it will be 30 days. All invoices must include the requisites provided in current applicable legislation and Supplier is under the obligation to include the Purchase Order number on the invoice. PTC will not pay any invoice unless the Supplier has submitted the invoice electronically as indicated in the Purchase Order.
- PRODUCT UNIFORMITY: Without the written consent of an authorized representative of PTC, Supplier must not make any changes in the goods or services to be provided including, without limitation in the case of goods, those that may alter properties, impurities, specifications, dimensions, or any other characteristic of the goods.
- INDEMNITY: Each Party agrees to protect, indemnify, defend, reimburse and save harmless the other Party and its affiliates from any and all loss, cost, damage, expense, fine and penalty (including, without limitation, reasonable attorneys’ fees, court costs and expert fees), of any nature, including, but not limited to any claim of death or injury to persons or damage to property, in any way arising out of, or attributable to, the negligence, willful misconduct or breach of the Agreement by the indemnifying Party or its agents, except to the extent any such loss, cost, damage or expense was caused by the negligence, willful misconduct or breach of the Agreement by the indemnified Party or its agents.
- INFRINGEMENT: Supplier warrants that the use or sale of the goods and services will not infringe any patents, trademarks, or other intellectual property rights. Supplier will indemnify, defend, reimburse, and hold harmless PTC from all expenses, including, without limitation, attorneys’ fees, court costs, expert fees, claims and liabilities arising out of a breach of this warranty.
- DEFECTIVE OR NON-CONFORMING GOODS. If any goods do not conform to all the terms of the Agreement or any warranties, are defective or are unsuitable, PTC may, at Supplier’s expense, return the goods for, at PTC’s option, full credit, or refund of the purchase price. PTC is under no duty to inspect any goods before use or resale thereof and use, repackaging or resale or PTC’s payment to Supplier does not constitute a waiver of or in any way limit PTC’s rights or remedies.
- CHANGES: PTC may direct Supplier to make changes in the goods or services ordered or in the requirements of the drawings, specifications, or instructions. Supplier shall promptly review such changes and within five (5) days inform PTC of any change in Supplier’s cost of performance or delay in delivery. Any change in price or delivery shall be conditioned upon the written consent of an authorized representative of PTC. If Supplier shall fail to comply with this procedure, Supplier shall be deemed to have waived all claims for increased cost or extension of time of performance.
- DELIVERY; PERMITS, ETC.; TIME IS OF THE ESSENCE: Supplier’s performance shall be in strict conformance with the delivery and other time provisions specified in the Agreement. Supplier shall, at its sole expense, obtain, keep in force, and comply with, any and all permits, licenses, qualifications, and approvals required under any applicable laws and regulations with respect to the goods and services provided hereunder and shall comply at all times with Buyer’s site rules and regulations when on or in Buyer’s premises.
Time is of the essence. If Supplier fails to perform according to the terms of PTC’s order within the required time, PTC may cancel the Agreement in written and purchase the goods and services elsewhere and hold Supplier liable for any and all costs and damages incurred. - AUDIT: PTC and its authorized representatives may inspect the products and/or the development of the services during the manufacturing process or the provision of the services, respectively, and if applicable on Supplier’s premises, where Supplier shall do everything necessary for said inspections. The inspection and acceptance of the products and/or services shall not release Supplier from its responsibilities for supplying the product and/or providing the services in accordance with specifications given by PTC.
- TAXES: Any applicable sales, use or transportation taxes and any other present or future tax that may apply to the manufacture, sale or transportation of goods and provision of services is included in the price and shall be paid by Supplier.
- INDEPENDENT CONTRACTOR: Supplier shall perform all obligations under this Agreement as an independent contractor and not an employee or agent of PTC. All members of staff assigned by Supplier to the duties related to this Agreement shall depend, for work and functional matters, on Supplier, who hereby assumes all the corresponding obligations as the employer and undertakes to pay the salaries and social security contributions in accordance with current applicable legal provisions and to strictly comply with health and safety legislation on the activities that are to be carried out.
- COMBATING TRAFFICKING IN-PERSONS: PTC has a zero-tolerance stance regarding the violation of human rights and an obligation to inform its Suppliers of PTC’s strict adherence to combating human trafficking and the serious adverse consequences which may be imposed on individuals who violate these requirements. All labor must be voluntary, Suppliers shall not engage in or support any form of human trafficking, trafficking in persons, discrimination, modern slavery, or child labor. Without fear of retaliation, Suppliers may report any credible information of any actual or potential violation of human trafficking law to the Global Human Trafficking hotline at 1–844–888–FREE or email address at help@befree.org. FAR § 52.222-50(b). (see FAR references at http://www.acquisition.gov/far/) (United States 48 CFR)
- SMALL BUSINESS SUBCONTRACTING PROGRAM: PTC is a registered United States federal government contractor, and in that capacity, PTC is required to develop and maintain a small business subcontracting program to assure that small business, veteran-owned, service-disabled veteran owned, HUBZone small business, small-disadvantaged business and women-owned business have an equitable opportunity to compete for subcontracts between PTC and Suppliers. To the extent a Supplier’s Agreement with PTC is a subcontract under any prime contract between PTC and the U.S. federal government, the Supplier must provide PTC with a formal subcontracting plan under the flowdown provision set forth in FAR 21 52.219-9(d)(9). (see FAR references at http://www.acquisition.gov/far/) (United States 48 CFR)
- FORCE MAJEURE: Neither of the Parties may lodge any claims for responsibility or liability against the other Party for full or partial breach of the obligations assumed when said breach is due to Force Majeure. The Party affected by the cause of Force Majeure shall notify the other Party of the event as soon as possible and shall make every effort to take all measures in its power to reduce the negative or damaging effects thereof in fulfilment of its obligations. Furthermore, no liability shall result from PTC’s delay in performance or non-performance, caused by circumstances beyond PTC’s control, including but not limited to fire, flood, war, Government action, accident, or inability to obtain transportation.
Should Supplier’s fulfilment of its obligations be delayed or rendered impossible by causes of Force Majeure, Supplier shall notify PTC in writing as soon as possible, and, in whatsoever case, in a term of no more than 48 hours after the cause of Force Majeure has occurred or as from the moment when Supplier becomes aware thereof, as applicable, providing details of the causes of said Force Majeure in writing, together with the time it is expected to last and indicating the obligations pending execution that have been or may be delayed or rendered impossible. At PTC’s option, quantities so affected may be eliminated without liability, but the Agreement, at the option of PTC, shall remain otherwise unaffected. - CONFIDENTIALITY: All drawings, plans, specifications and other documents, data and information furnished by PTC to Supplier, orally or in writing, shall be treated as confidential by Supplier, even though said information does not bear whatsoever seal or sign that identifies it as confidential. Supplier shall not make any use thereof except in performance of the Agreement. Supplier shall not disclose same to anyone before or after performance of the services without having obtained the prior written consent of an authorized representative of PTC. All such drawings, plans, specifications and other documents, data and information shall be returned to PTC upon request.
Supplier may not use the logos, distinguishing signs and marks owned by PTC and may not refer to PTC as a customer unless it has obtained the prior and express consent thereof. - SUBCONTRACTING, TRANSFER AND ASSIGNMENT: Supplier must not partially or fully subcontract the execution of the Agreement without prior approval in writing from PTC. Should subcontracting be expressly authorized, Supplier must be fully responsible for the supply or provision of the service and shall respond before PTC for whatsoever breach. Supplier must not transfer the Agreement or any of the rights and obligations arising from PTC Terms and Conditions, without prior approval in writing from PTC. Furthermore, the Agreement must not be assigned by Supplier without PTC’s prior written consent.
- APPLICABLE LAW; NON-DEBARMENT: Supplier shall comply with all applicable laws and regulations when providing goods or services to PTC under the Agreement. Supplier warrants that the goods and services shall comply with all applicable laws, standards, and regulations, whether governmental or industrial, in effect on the date of delivery or known in the industry to become effective after such date. The validity, interpretation and performance of the Agreement shall be governed by the laws of Supplier’s country of residence. Supplier warrants that it will not utilize any debarred, excluded or disqualified personnel to provide any goods or services to PTC.
- PERSONAL DATA: Supplier shall be responsible for complying with its respective obligations under applicable data protection laws and regulations to the processing (e.g., collection, modification, transfer, retention, and/or deletion) of data relating to individuals (“Personal Data”) pursuant to services provided under this Agreement.
- INFORMATION SECURITY: Each Party certifies that it adheres to and maintains up-to-date best practices for information security as are known in its industry. In the event of a security breach that may affect the disclosing party’s information or that results in the degradation of activities performed hereunder, the receiving party will notify the disclosing party immediately (for notices to PTC, with an email copy to: DataPrivacy@PTCBio.com) after becoming aware of the breach, and provide daily updates in regards thereto until the disclosing party determines that it is satisfied with the response. In addition, the receiving party shall be open to a security audit and provide appropriate remedies, in the event of such a breach.
- PHARMACOVIGILANCE: Under this Agreement, the following definitions shall apply:
- “Adverse Events” or “AE” shall mean any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with the treatment.
- “Other Safety Information” shall include information regarding exposure to drug during pregnancy / breastfeeding; overdose; drug abuse; drug misuse; medication errors; suspected transmission of infectious agents; reports of lack of efficacy; possible drug interactions; off-label use; occupational exposure.
Supplier agrees to notify PTC of any information concerning any Adverse Event or Other Safety Information relating to a PTC medicinal product(s), within one (1) day, but no later than three (3) calendar days of the date of Supplier first becoming aware of such Adverse Event or Other Safety Information, via e-mail to: pharmacovigilance@ptcbio.com.
- SUSPENSION OR TERMINATION: PTC, for its convenience, shall have the right to suspend or terminate Supplier’s work hereunder or any part thereof, including, without limitation, delivery, upon written notice to Supplier. Upon receipt of said notice, Supplier shall stop all work and promptly comply with PTC’s instructions to minimize the cost to PTC. In the event of termination for convenience, Supplier shall issue an invoice for the services and/or products effectively provided and/or delivered to PTC. Any cost claimed by Supplier under this Section shall be subject to the audit and approval of PTC. Upon termination, in respect of the provision of goods, such goods shall become the property of PTC in their then state of completion at the option of PTC.
- WAIVER: Either Party’s waiver of any breach any of the provisions of the Agreement shall not constitute a waiver of any other breach of the same or any other provision.
- LOST PROFIT: Neither Party shall be responsible for any incidental, indirect or consequential damages including loss of profits except those arising out of fraud or negligence.
- SEVERABILITY AND REMEDIES: In the event that any provision contained herein is held to be invalid or unlawful, such provision shall be severable from the remaining provisions of the Agreement which shall remain in full force and effect. All rights and remedies granted to either Party hereunder are in addition to and not in lieu or limitation of any of PTC’s rights or remedies at law or equity.
- NOTICES: All communications to be made by either Party shall be made in writing and sent to the contact email address provided on the Purchase Order. Supplier must include the Purchase Order number provided by PTC in all cases and for reference. Notices under this Agreement must also be emailed to legal@ptcbio.com.