POLYPLUS TERMS & CONDITIONS OF SUPPLY AND PROVISIONS OF PRODUCTS & SERVICES (T & C)
ARTICLE 1. DEFINITIONS
For the purposes of these T & C, the following terms used herein with an initial capital letter shall have the following respective meanings, and shall be applicable both to the singular and plural forms:
“Affiliate(s)” means any legal entity which directly or indirectly controls or is controlled by or is under common control with Polyplus-transfection SA, for such period as such control exists. For purposes of this definition, “control” or “controlled” means (I) ownership directly or through one or more Affiliates, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interest in the case of any other type of legal entity, (II) status as a general partner in any partnership, or (III) any other arrangement whereby a Polyplus-transfection SA controls or has the right to control the board of directors or equivalent governing body of a corporation or other legal entity, or the ability to cause the direction of the management or policies of a corporation or other legal entity.
“Client” means any party that purchases/orders Product(s) and/or Service(s) from Polyplus.
“Client Materials” means any biological material, including macromolecules such as but not limited to nucleic acids, or samples provided by the Client to Polyplus for the performance of all or part of a Service.
“Client Specifications” has the meaning given to it in ARTICLE 3.1 (I) hereunder.
“Genetic Engineering Service(s)” means the service(s) specifically provided by Polyplus including consulting, computing assisted analysis, design, assembly and manufacture of Molecular Product(s), tests and assays for research use only.
“GMP” means the good manufacturing practice promulgated by the national or regional regulatory authorities, as detailed in EudraLex, Volume 4 of the “The Rules Governing Medicinal Products in the European Union”, “Good Manufacturing Practice (GMP) Guidelines” Part II and in the Commission Directive 2003/94/EC of October 8th, 2003, in the Commission Directive 2017/1572 of September 15, 2017, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and in the Commission Delegated Regulation 2017/1569 of May 23, 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use, and EU GMP Annex 1 (except for in vivo-jetPEI®-GMP Product), and ICH Q2(R1), Q7 and Q11 rules, as may be amended from time to time.
“Intellectual Property Rights” means all and any intellectual property rights or moral rights of any kind or nature throughout the world including, without limitation all improvements, ideas, algorithms, technical developments, data, works, material technical information, models, prototypes, specifications, methods, software (under source code and object code versions), files, plans, diagrams, patterns, as well as genetic and biological material, whether or not patentable or copyrightable, and all: (I) patents, patent applications, continuations, continuations-in-part, divisionals, reissues, re-examinations; (II) copyrights, copyright applications and copyrightable subject matters, registrations substitutions and extensions; (III) industrial designs, applications and registrations; (IV) trademarks and trade names, and their respective applications and registrations; (V) trade secrets and know-how and all other (vi) type proprietary information thereof.
“Molecular Product(s)” means any molecular products and/or (other) deliverables from the Genetic Engineering Service(s) (such as for example tailor made plasmid DNA, other nucleic acid molecule, sequencing or assay report) provided by Polyplus for research use only.
“NGS Services” means the nucleic acids sequencing services provided by Polyplus to a Client for research use only.
“Polyplus” means the French company Polyplus-transfection SA, (RCS Strasbourg n° 434 320 479) Vectura, 75 rue Marguerite Perey, 67400 Illkirch-Graffenstaden, France as well as any of its Affiliates, as the context requires.
“Predictive Sequence & Features” means predictive DNA sequence and features of the Molecular Product(s) to be assembled and supplied and/or assayed by Polyplus within the framework of a Genetic Engineering Service.
“Product(s)” means any product(s) supplied by Polyplus to a Client, including without being limited to transfection reagents, in vivo delivery technologies, Molecular Product(s) and/or Results.
“Purchase Order” has the meaning given to it in ARTICLE 2.1 hereunder.
“Purchase Order Approval” has the meaning given to it in ARTICLE 3.1 (V) hereunder.
“Purpose” has the meaning given to it in ARTICLE 5.1 hereunder.
“Results” means any report generated within the framework of the performance of a Service, including but not limited to NGS Services and Genetic Engineering Services
“Service(s)” means any service provided by Polyplus to a Client. Genetic Engineering Service(s) and NGS Service(s) are part of the Service(s) and provisions herein applying to Service(s) shall deem to apply to Genetic Engineering Service(s) as well as NGS Services, unless otherwise expressly mentioned in these T & C.
“Quote” has the meaning given to it in ARTICLE 3.1 (II) hereunder.
ARTICLE 2. APPLICABILITY & ACCEPTANCE
2.1 These T & C shall govern all and any orders, for the purchase by a Client from Polyplus and supply and provision by Polyplus, of Product(s) and/or Service(s) (“Purchase Order”), and apply to any and all aspect thereof such as but not limited to: (I) any Quotes; (II) all acceptances, Purchase Orders, acknowledgements or confirmations by Client of a Quote; and (iii) the validation and confirmation of acceptance by the Client of the Predictive Sequences and Features and maps of Molecular Product(s) to be produced and delivered by Polyplus.
2.2. Client will be deemed to have agreed to all and any of these T & C when ordering Product(s) and/or Service(s)and these T & C shall prevail over any Client general terms and conditions.
2.3 In the event of a conflict of terms or difficulties of interpretation between a Quote, these T & C and/or any active confidentiality agreement (“CDA”) between Polyplus and Client, the related CDA shall take precedence over the Quote and these T & C for what regards confidentiality obligations.
Should a Supply Agreement relating to the supply of Product(s) and/or Service(s) be executed between Polyplus and the Client under a Quote, the provisions of the said Supply Agreement shall apply to the supply and/or provision by Polyplus to Client of Product(s) and/or Service(s) concerned and shall prevail over these T & C.
For any other subject matter, the Quote and these T & C shall prevail.
2.4 The signature of a supply agreement between Polyplus and Client for purchase of any in vivo-jetPEI® GMP Product(s) commercialized by Polyplus specifically for direct administration in humans is compulsory prior to such purchase and related Quote.
ARTICLE 3. ORDER PROCEDURE
3.1 The order procedure for the provision of Product(s) and/or Service(s) by Polyplus consists of the following steps which must be followed at all times:
(I) For the specific case of Genetic Engineering Service(s) and/or NGS Service(s), before Polyplus issuing a Quote as defined in (II) hereunder, Client will provide, in accordance with given instructions, Polyplus with:
– for NGS Services: a list of clearly labelled Client Materials to be sequenced as well as theoretical in silico sequences of these molecules, if available,
– for Genetic Engineering Services a specification of its requirements (hereafter ‘Client Specification’). Based on the said Client Specification, and after consultation with the Client, Polyplus will define the genetic characteristics, functions and components of the Molecular Product(s) to be supplied and/or assayed.
Based on the list mentioned in this paragraph for NGS Service(s) or on the defined characteristics, functions and components for Genetic Engineering Service(s), Polyplus will provide Client with a Quote for the provision of the corresponding NGS Service(s) or Genetic Engineering Service(s) and Molecular Product(s) as mentioned in (II) hereunder.
(II) Any and all purchases of Product(s) and/or Service(s) are subject to the issuance by Polyplus of a corresponding quote (herein “Quote”), being understood that Polyplus shall only provide documentation of confidential nature to the Client upon execution of an appropriate CDA;
(II) When placing a Purchase Order for a Product or a Service, the Client must provide Polyplus with the following information: Client corporate name and appropriate department within Client’s organization, invoice address and phone number, delivery address, contact name, email address and phone number, Quote reference and Purchase Order number, Product/Service’s part number when applicable, description, quantity, and, for any Purchase Order relating to Product(s), type of packaging and pack size of Product, as well as any other information that may be necessary for the provision, shipment and/or delivery of ordered Product(s)/Service(s) to Client or to any third party designated by the Client. It is Client’s responsibility to provide Polyplus with all and any relevant, complete and accurate information. In no event Polyplus shall be responsible or liable for any failure in the provision, shipment and/or the delivery of Product(s)/Service(s) due to an inaccurate, irrelevant and/or incomplete information and for the additional costs incurred as the result of such inaccurate, irrelevant and/or incomplete information, which shall be borne by the Client.
(IV) Purchase Orders shall be placed by mail at the following email address: firstname.lastname@example.org. No Purchase Order shall be considered when placed at another email address or when any other means is used.
(V) Only Polyplus’ formal acceptance of the Client’s Purchase Order (hereinafter “Purchase Order Approval”) shall be considered as a valid firm order for the Purchase Order concerned. Failure to confirm acceptance of a Purchase Order shall in no event be deemed as an acceptance of the corresponding Purchase Order by Polyplus.
3.2 Polyplus may decide, at its sole discretion, not to confirm a given Purchase Order from a Client, in particular but not limited to, when Client does not provide all information mentioned in ARTICLE 3.1 (III) here above in a timely manner or, after several unsuccessful attempts by Polyplus to obtain all or part of the necessary information, it may reasonably be expected that the provision, shipment and/or delivery of the Product(s)/Service(s) to Client or to any third party designated by Client will be impossible or difficult to carry out under normal commercial conditions or will result in additional costs for Polyplus to be able to do so.
ARTICLE 4. PRICES & PAYMENT
4.1 Unless otherwise expressly mentioned, all prices are in Euros or in US dollars, as the case may be, exclusive of V.A.T. and any other statutory levies.
4.2 Polyplus is entitled to require payment from the Client of the entire amount of the Purchase Order in advance or upon delivery of the Product(s) or provision of the Service(s) concerned. Any payment due to Polyplus shall occur within thirty (30) days after the invoice date concerned, or as otherwise agreed in writing by Polyplus, without any discount, reduction, suspension or set off.
4.3 The Client shall be in default merely by the expiry of a deadline for payment without the need for any demand, notice of default or judicial intervention. Any payment not made by the Client on or before the due date shall accrue interest, without any prejudice of any other remedies that Polyplus may have. The Client shall be required to reimburse Polyplus for all the expenses incurred for collecting the amount due, including judicial and extrajudicial expenses, which shall, at any rate, include the actual costs incurred for legal assistance and advice thereof.
4.4 Should the Client cancel a Purchase Order for any reason whatsoever after Polyplus’ Purchase Order Approval as set out in ARTICLE 3.1 (V) here above, the Client shall bear cancellation and related costs.
ARTICLE 5. CLIENT OBLIGATIONS
5.1 In case any Client Materials are required by Polyplus for the performance of a Service (all hereafter the ‘Purpose’), Client shall promptly deliver or arrange for the prompt delivery to Polyplus of all the required Client Materials, free of charge for Polyplus, unless otherwise agreed in writing between Client and Polyplus prior to the beginning of the performance of the Service(s) concerned.
5.2 Client warrants that: (I) it is entitled to deliver all and any Client Materials to Polyplus for the Purpose; (II) the Client Materials and any parts thereof may and can be used by Polyplus for the Purpose; (III) that the use of the Client Materials or any parts thereof for the Purpose, either alone or in combination with any other product or materials, does not infringe upon or misappropriate any third party’s Intellectual Property Rights and (IV) it complies with provisions of ARTICLE 8.1 hereunder.
5.3 Client is sole responsible for (I) ensuring that the use by Client of the Product(s)/Services complies with all and any applicable laws, regulations and governmental policies (II) obtaining all and any related necessary approvals and permissions and (III) for following the instructions included in the Product(s)/Services protocols, non-hazardous product statement and/or any other relevant documents that accompany the Product(s) and/or the Services.
ARTICLE 6. DELIVERY AND TRANSFER OF RISK & TITLE
6.1 Delivery and shipment of Product(s) will be made according to the Incoterms® 2020 defined in the corresponding Quote.
6.2 The delivery date stated in the Quote or as otherwise agreed in writing by Polyplus is approximate and may never be regarded by the Client as a binding deadline.
6.3 Polyplus is entitled to make partial deliveries of the required amounts of Product(s)/Service(s), and to invoice any partial delivery separately.
6.4 Client assumes all responsibility for the importation of the Product(s), including but not limited to obtaining of all required permits, licenses or certificates or any other regulatory, legal or administrative authorizations (“Authorizations”). Polyplus shall in no event be liable for the failure of the Client to obtain such Authorization(s).
6.5 Title to the Product(s) shall pass from Polyplus to Client upon receipt by Polyplus of payment in full for all amounts due for Service(s) or units of Product(s) concerned by the related Purchase Order.
6.6 For the specific case of Results, Result(s) shall be communicated on the completion of the analysis by e-mail and/or post or by any other electronic means to the Client.
ARTICLE 7. AUTHORISED USE
To the exception of in vivo-jetPEI®-GMP Product commercialized by Polyplus specifically for direct administration to humans, all other Product(s) are not allowed to be and Client represents and warrants that Products will not be administered to humans.
Result(s) are provided and sold for laboratory research use only, and not for any diagnostic or therapeutic use or any other use not being laboratory research.
ARTICLE 8. WARRANTIES & DISCLAIMER
8.1 Client represents and warrants that the Client Specifications and any and all Client Materials are correct and without any error, complete, of a good and adequate quality and fit for Purpose, have been manufactured and tested in accordance with GMP or ISO guidelines, as applicable, and can be used safely and in a harmless manner for the Service concerned, Polyplus disclaiming any representations, responsibilities or warranties of any kind in this regard, in particular but not limited to, for not being able to perform the Service due to Client Specifications and/or Clients Material(s). Client shall compensate Polyplus in full for all costs made and extra work to be performed by Polyplus as a result of Client Specifications and/or Client Materials not being correct, complete, of a good quality or fit for Purpose
8.2 Client acknowledges and agrees that Polyplus relies and will rely on the Client Specifications and the Client Materials as received by Polyplus. Accordingly, and considering Client’s validation and agreement with the Predictive Sequence & Features of Molecular Product(s) to be supplied by Polyplus, Polyplus is relieved from any responsibility or liability for the quality of the Molecular Product(s) supplied, or any defects in the design or in the Molecular Product(s) or the Service(s)provided.
8.3 All Molecular Product(s), Results and Service(s) are provided, performed and sold “as is”, without representation, warranty or condition of any kind, express or implied statutory or otherwise, however arising (whether by contract, tort, negligence, principles of manufacturer’s liability, operation of law, conduct, statement or otherwise), including, without restriction, any implied warranty or condition of quality, merchantability, merchantable quality, durability, title, non-infringement or fitness for a particular purpose. Results and any related analyses, interpretations, estimates, consultancy services and inferences cannot be fully accurate and/or relevant in all cases.
8.4 For other Product(s) which are neither Molecular Product(s) nor Results, Polyplus warrants that the Product(s) sold by Polyplus to the Client shall, at the date of its/their delivery, be free from defective material and workmanship, conform to its/their related specifications, GMP when applicable, and contain no latent defect. NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, and, in particular but not limited to, warranty regarding the effectiveness of the other Product(s) once it/they has/have been incorporated to another product or mixed to constitute a compound or warranties of merchantability or fitness for a particular purpose, are provided by Polyplus on such other Product(s).
8.5 Neither Polyplus nor Client, under or in connection with these T & C, shall be liable towards each other for any loss of actual or anticipated profits, losses caused by business interruption, loss of goodwill or reputation, or any indirect, incidental, punitive, special, exemplary or consequential loss or damages (“Indirect Loss”) whether such Indirect Loss are based on tort, (including negligence) warranty, contract or any other legal theory.
ARTICLE 9. INDEMNIFICATION
Client shall, at its own expense, indemnify, defend and hold Polyplus, its directors, officers, employees, agents, sub-contractors, successors and assignees (any such directors, officers, employees, agents, successors and assignees, hereafter ‘Indemnitees’) harmless from and against any and all claims, demands, losses, liabilities, settlement, amounts, costs, damage and expenses whatsoever (including, reasonable attorneys’ fees and other costs of defending any action), that Polyplus or any Indemnitees incur in any way, arising out of or relating to:
(a) any breach by Client of Client’s obligations under these T & C; (b) any use of the Product(s) and/or Services; (c) any failure of Client to comply with good laboratory practice, laws, regulations, guidelines or decisions in the handling or use of the Product(s) and/or Services (d) any violation or infringement by Client of any third party’s Intellectual Property Rights in the handling, storage or use of the Product(s) and/or the Services; (e) any claim (from a third party) that the use by Polyplus of any Client Materials or Client Specifications or parts thereof violates or infringes any third party’s Intellectual Property Rights or (f) any damage caused by the use of the Product or by a defect of the product with which the Product has been incorporated, mixed or associated, except a damage due to a defect caused, in whole or in part, by the manufacture of the Product concerned or the nonconformity of the Product concerned to its related specifications.
ARTICLE 10. INSURANCE
The Client shall maintain adequate insurance to cover its civil and commercial liability against all and any of its activities and obligations associated with these T &C and purchase, storage, handling and use of Product(s) and/or Services.
ARTICLE 11. CONFIDENTIALITY
11.1 The Quote as well as any documentation provided with the Product(s) and/or Service(s), if any, are confidential. The Client shall use the same degree of care that it uses in safeguarding its own similar confidential information and, in any event, no less than a reasonable degree of care. In particular, Polyplus shall not disclose any information linked to the Client Materials or to confidential technical information provided by Client under a Purchase Order, unless otherwise agreed with prior consent. This undertaking shall remain effective for five (5) years as from the date of receipt by Polyplus of the Purchase Order concerned, notwithstanding the latter’s termination or expiry. If Polyplus and Client have signed a CDA in relation with the subject matter of the said Quote, which is in force during the term of the said Quote, provisions of the said CDA shall apply to the Quote concerned.
11.2 Polyplus may use and exploit residuals for any purpose after the return or destruction of Client’s confidential information without breach of its confidentiality obligations hereunder. As used herein, residuals shall mean ideas, information and understandings retained in the unaided memory of Polyplus’ employees as a result of their review, evaluation and testing of the Client’s confidential information after the return thereof.
11.3 Notwithstanding provisions of ARTICLE 11.1 here above, either party may disclose such terms, conditions or pricing to legal, accounting and professional advisors bound by formal ethical or fiduciary duties requiring such advisors to treat, hold and maintain such information confidential in accordance with these T & C.
11.4 Neither party shall use the name of the other party in publicity, advertising, or similar activity, without the prior written consent of the said other party.
ARTICLE 12. INTELLECTUAL PROPERTY RIGHTS
12.1 The provision and sale of Product(s) and/or Service(s) under these T & C shall not, by implication or otherwise, convey or be construed as conferring or granting, in any way whatsoever, any license or rights of any kind under any Polyplus Intellectual Property Rights and Client expressly assumes all risks of any infringement of third party’s Intellectual Property in the handling, storage or use of the Product(s) and/or the Services.
In particular, Polyplus will own and expressly retains the ownership of all tools and technologies, including any Polyplus Intellectual Property Rights in relation thereto, that have been or will be used or applied by Polyplus for the design, development, manufacture and/or production of the Product(s) and/or the provision of the Service(s).
12.2 Client will own and remains the owner of the Client Materials and/or Client Specifications including any Client Intellectual Property Rights in relation thereto, and Client hereby grants Polyplus a non-exclusive royalty free right and license under any Client Intellectual Property Rights to use and have used any such Client Materials and/or Client Specifications for the Purpose.
ARTICLE 13 ENTIRE AGREEMENT
13.1 These T & C and any related Quote, statement of work, or the like (if any) issued by Polyplus that includes these T & C, together with any active CDA and Supply agreement, if applicable, constitute the complete and entire statement of all terms, conditions and representations of the agreement between Polyplus and Client with respect to its subject matter, and Client acknowledges that it has not relied on any statement, oral or written, made prior to these T & C.
13.2 Each provision in these T & C is independent and severable from the others, and no provision will be rendered unenforceable because any other provision is found by a proper authority to be invalid or unenforceable in whole or in part. If any provision of these T & C is found by such an authority to be invalid or unenforceable in whole or in part, such provision shall be changed and interpreted so as to best accomplish the objectives of such unenforceable or invalid provision and the intent of the parties, within the limits of applicable law.
ARTICLE 14. FORCE MAJEURE
Polyplus shall not lose any rights hereunder or be liable to the Client for damage or losses on account of failure, full or partial non-fulfilment or delay of performance if the failure, full or partial non-fulfilment or delay is occasioned by government action, war or danger of war, civil war, riot, explosion, strike, lockout, embargo, act of God or natural disaster such as fire, hurricane, earthquake, flood, pandemic, epidemic, failures by suppliers and/or carriers or any other similar cause beyond the control of Polyplus (each a “Force Majeure Event”), provided that Polyplus has exerted all reasonable efforts to avoid or remedy such Force Majeure Event. Should the Force Majeure Event last for more than one (1) month, either party shall be entitled to terminate the Quote and related Purchase Order concerned with immediate effect, by written notice to the other party, without compensation.
ARTICLE 15. APPLICABLE LAW & DISPUTES
15.1 These T & C and related Quote shall be governed by and be construed in accordance with the Laws of France without regard to conflicts of law rules and provisions of The United Nations Convention on Contracts for the International Sale of Goods which are expressly excluded.
15.2. In the event of any dispute between the parties as to the interpretation, the validity, the termination or the performance of these T & C and related Quotes, the courts located in Paris (France) shall have exclusive jurisdiction.