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GENERAL TERMS AND CONDITIONS for Small-Scale Manufacturing Services ("CONDITIONS")

1. Definitions and Interpretation

1.1 The following definitions apply in these Conditons:

Affiliate” means any person which, directly or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with a Party. For the purpose of this definition, “control” (including, with correlative meanings, “controlled by” and “under common control with”) means the possession, directly or indirectly, of (a) the power to direct or cause the direction of management or policies of such Party or (b) at least fifty percent (50%) of the issued share capital of such Party.

BioSpring” means BioSpring Gesellschaft für Biotechnologie mbH, Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany.

Contract” has the meaning given in clause 2.1.

Customer” means the person who purchases the Products and/or Services from BioSpring.

Order” means the Customer's order for the manufacture of Products and/or performance of other Services, in the form of the Customer's purchase order form or the Customer's written acceptance of the Quote, as the case may be.

Party” means BioSpring or Customer.

Price” means the amounts to be paid by Customer to BioSpring for the Services, including manufacturing of the Product, as agreed in the Contract.

Product” means the product to be manufactured by BioSpring under the Contract.

Quote” means BioSpring’s written quotation for the manufacturing of the Product or performance of other Services.

Services” means the services to be performed by BioSpring, including manufacturing of the Product and other services, as agreed in the Contract.

1.2 The following rules of interpretation apply in these Conditions.

1.2.1 A reference to legislation or a legislative provision is a reference to it as amended or re-enacted. A reference to legislation or a legislative provision includes all subordinate legislation made under that legislation or legislative provision.

1.2.2 Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms.

1.2.3 Unless expressly specified otherwise in these Conditions, the terms written and in writing shall be construed as including email.

2. Basis of the Contract

2.1 The Order constitutes an offer by Customer to purchase the manufacture of Products and/or other Services in accordance with these Conditions and the Quote (if any). The Order shall only be deemed to be accepted upon BioSpring’s written acceptance of the Order, at which point and on which date (“Commencement Date”) a contract between BioSpring and Customer for the supply of Products and/or other Services incorporating these Conditions and the Quote (if any) shall come into existence (“Contract”).

2.2 BioSpring’s Quote shall not constitute an offer, and, unless specified otherwise in the Quote, is only valid for a period of twenty (20) Business Days from its date of issue (where “Business Day” is defined as working day (i.e. Mondays to Fridays, excluding public holidays in Frankfurt am Main, Germany, and excluding 24 through 31 December)).

2.3 Customer’s general terms and conditions and any other terms introduced by Customer shall not apply to the manufacture of the Product or provision of other Services. Any references in an Order or other document introduced by Customer to such general terms and conditions or other terms, including to Customer’s purchasing conditions, shall be deemed non-written and without legal effect. This shall apply whether or not BioSpring has struck out any such reference before countersigning or otherwise agreeing to the Order or other document. Customer waives any right it might otherwise have to rely on any term endorsed upon, delivered with or contained in any documents of the Customer that is inconsistent with these Conditions.

3. Performance of Services

3.1 BioSpring will perform the Services in compliance with all laws, rules, regulations, ordinances, directives, and guidance applicable to the performance of the Services under the laws applicable at the place where the Services are performed by BioSpring.

3.2 The Parties agree that the manufacturing of Products and other Services are experimental in nature and therefore any specifications, amounts and other parameters, dates, and times for the Delivery (as defined in clause 5.1) of Deliverables (where “Deliverables” is defined as (i) any amount of the Product or (ii), in each case only if expressly agreed, any analytical data or certificate of analysis (CoA) or other work product, to be delivered by BioSpring under the Contract, but in each case excluding any rights in or to Improvements (as defined in clause 9.3) or BioSpring’s Background IP (as defined in clause 9.2) or BioSpring’s Confidential Information (as defined in clause 14.1)) or for the provision of other Services shall be non-binding. This shall apply whether or not the specifications, amounts and other parameters, dates, and times are expressly specified as being targeted or non-binding in the Contract. BioSpring disclaims any liability of whatsoever nature with respect to such specifications, amounts and other parameters, dates, and times. Without limiting the foregoing, if BioSpring, despite having exercised commercially reasonable efforts, cannot manufacture the Product, BioSpring will inform Customer accordingly and, provided that this is not due to any cause for which Customer is responsible, Customer shall only remain bound to pay the amounts due for the Services actually performed by BioSpring and any non-cancellable expenses, including cost for raw materials and consumables, incurred by BioSpring.

3.3 Without limiting the foregoing, BioSpring’s timely and proper performance of Services requires Customer to timely and properly provide or fulfill the following: (i) the receipt by BioSpring of any advance payment of Customer due in accordance with the Contract; (ii) the provision of any raw materials, including starting materials (such as amidites or solid support, as applicable) identified in the Contract as to be provided by or on behalf of Customer to BioSpring for the manufacturing of Product (“Customer Materials”); (iii) the final destination address of the Deliverables (to be) delivered by BioSpring in accordance with clause 5.1 (where applicable); and (iv) the provision of any information and documentation or any other cooperation by Customer necessary for BioSpring’s timely and proper provision of Services.

3.4 In case Customer does not fulfill its obligations set forth in clause 3.3 in due time, BioSpring is entitled to postpone the manufacturing of Product or performance of the Services (as applicable) accordingly up to the same quantity of days or, if necessary, to the next available manufacturing capacity. Customer shall bear and be liable for any further consequences resulting from such delay and BioSpring will not be liable for any damages and delays arising from or related thereto. Any other rights BioSpring may have due to Customer’s non-fulfillment of its obligations under clause 3.3 remain unaffected.

3.5 BioSpring may use third-party subcontractors, including through multiple tiers (together “Subcontractors”), to perform all or part of the Services under the Contract.

4. Customer Materials and Customer Required Materials

4.1 Customer shall deliver the Customer Materials at the quantity, quality and times as required for manufacturing of Product, free of charge DDP BioSpring’s manufacturing site at Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany (or, if a different BioSpring facility is specified for Delivery in the Quote, if any, at such other facility) Incoterms® 2020.

4.2 For the purposes of export declaration, accounting, or tax purposes, as applicable, Customer shall provide BioSpring the value of the provided Customer Materials.

4.3 Customer shall provide or, in case of Customer Required Materials, ensure that the supplier of the Customer Required Materials provides BioSpring with certificates of analysis for the Customer Materials or Customer Required Materials (as applicable) and, for the duration of the Services, with sufficient and comprehensive data as may be reasonably required by BioSpring concerning the stability of the Customer Materials and Customer Required Materials, storage and safety requirements, including Material Safety Data Sheets (MSDS), and any available application instructions (where “Customer Required Materials” is defined as any materials which Customer requires, instructs, suggests, or indicates BioSpring to procure and use for manufacturing of Product (including any materials which Customer requires, instructs, suggests, or indicates BioSpring to procure from specific suppliers)).

4.4 BioSpring is not obligated to examine the incoming Customer Materials nor detect any defects or non-conformance of the Customer Materials to the agreed specifications. It is and shall remain in the sole responsibility of Customer that the Customer Materials are as required for them to be suitable for manufacturing of Product. BioSpring shall not be responsible or liable for the Product not being as agreed or for any delay of the performance of the Services, and Customer shall be liable for any such delay and damages, caused by the Customer Materials.

4.5 In the event the Parties have agreed on a return of Customer Materials by BioSpring to Customer, any such return shall be made EXW BioSpring’s manufacturing site at Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany (or, if a different BioSpring facility is specified for Delivery in the Quote, if any, at such other facility) Incoterms® 2020. Clauses 2 and 5.3 shall apply accordingly to such returns.

5. Delivery, Storage, Transport, and Customs

5.1 Regardless of whether BioSpring agrees to arrange onward shipment to Customer on behalf of Customer, any delivery of Deliverables shall be made EXW BioSpring’s manufacturing site at Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany (or, if a different BioSpring facility is specified for Delivery in the Quote, if any, at such other facility) Incoterms® 2020 (“Delivery”) on the condition that Delivery shall be deemed effected (i) in case of tangible Deliverables upon BioSpring notifying Customer that the Deliverables are available for pickup or upon the Deliverables leaving BioSpring’s facility for shipment, whichever is the earlier, and (ii) in case of intangible Deliverables, upon transmission to Customer by electronic means. Customer shall pick up the tangible Deliverables without undue delay, at the latest within one (1) week from Delivery. Any loading or loading assistance provided by BioSpring will be at Customer’s risk.

5.2 BioSpring will store any tangible Deliverables, at Customer’s risk, free of charge for up to one (1) week from Delivery, unless, in case of multiple Contracts, a longer free-of-charge storage period is expressly agreed with Customer in writing to allow for joint shipment of the material manufactured under such multiple Contracts. If shipment of the Deliverables is delayed, after such one (1) week or agreed longer free-of-charge storage period, without prejudice to any other rights BioSpring may have, BioSpring is entitled, in its sole discretion, to arrange onward shipment of the Deliverables to Customer at Customer’s cost, including costs for customs, taxes, fees, expenses, charges and other related costs, or to charge Customer for further storage; BioSpring is not obliged to insure the Deliverables for any such transport or storage. NOTWITHSTANDING THE FOREGOING AND WITHOUT PREJUDICE TO THE GENERAL LIMITATIONS OF LIABILITY AS SET FORTH IN CLAUSE 12, AFTER THE END OF THE ONE (1) WEEK OR THE AGREED LONGER FREE-OF-CHARGE STORAGE PERIOD, CUSTOMER IS DEEMED IN DELAY OF ACCEPTANCE AND, SUBJECT TO CLAUSE 12.1, BIOSPRING’S LIABILITY FOR ANY DAMAGE TO OR LOSS OF THE DELIVERABLES, INCLUDING UPON STORAGE AND TRANSPORT, IS LIMITED TO GROSS NEGLIGENCE AND INTENTIONAL MISCONDUCT.

5.3 BioSpring shall be entitled in its sole discretion to make customs clearings for the export of the Deliverables if deemed necessary by BioSpring according to the respective Delivery circumstances. For this purpose, Customer hereby authorizes BioSpring until revoked in writing to clear Customer’s export shipments through customs, to lodge the respective customs declarations and the valuation declarations, and to sign these documents legally binding. BioSpring shall not be liable for the correct clearing of customs and Customer shall hold harmless, defend and indemnify BioSpring from any claims, demands, liabilities, losses, costs, actions, suits, proceedings, damages, fines, penalties, government orders, taxes, costs and expenses arising from or related to customs or export of Deliverables.

6. Non-Conforming Deliverables

6.1 Customer shall without undue delay, but in no event later than ten (10) days from physical receipt of the respective tangible Deliverables or electronic receipt of the respective intangible Deliverable, as applicable, (i) examine the respective Deliverable for any shortage, damage or other defect, as applicable (such damage or other defect a “Non-Conformity” and the part of the Deliverable affected by the Non-Conformity “Non-Conforming Deliverable”) and (ii) notify BioSpring in writing of any Non-Conformity. If the Non-Conformity could not have reasonably been detected by Customer through examination upon physical or electronic receipt of the Deliverable, as applicable (“Latent Defect”), Customer shall notify BioSpring of such Latent Defect in writing without undue delay, but in no event later than three (3) days after discovery of such Latent Defect. Customer’s notice shall specify the concrete type of Non-Conformity and shall be sent to BioSpring together with a sample of the respective Non-Conforming Deliverable.

6.2 FAILURE TO DULY NOTIFY BIOSPRING WITHIN THE PERIODS SET FORTH IN CLAUSE 6.1 SHALL BE DEEMED AN ACCEPTANCE BY CUSTOMER THAT THE RESPECTIVE DELIVERABLES ARE NOT NON-CONFORMING DELIVERABLES AND ANY CLAIMS WITH RESPECT TO ANY NON-CONFORMITY OF SUCH DELIVERABLES, WHETHER BASED ON THE CONTRACT OR OTHERWISE, SHALL BE EXCLUDED TO THE EXTENT PERMITTED UNDER ANY APPLICABLE LAWS.

6.3 In the event a Non-Conforming Deliverable has been established, and subject to clause 6.4, BioSpring shall, at its sole discretion, either: (i) undertake a subsequent fulfilment free of charge within a reasonable timeline and against Customer’s free-of-charge provision of the required Customer Materials, if any, and BioSpring shall have the right to decide, in its sole discretion, whether such subsequent fulfilment will be met by either rectification or by replacement of the Non-Conforming Deliverable); or (ii) reimburse Customer for any part of the Price already paid for such Non-Conforming Deliverable.

6.4 Notwithstanding the foregoing, Customer shall only have a right to reject any Non-Conforming Deliverable and shall only have any remedies with respect to any Non-Conformity if it is already existent upon Delivery and only provided that it is neither caused by nor due to any of the following: (i) Customer Materials or Customer Required Materials, (ii) Customer’s Background IP or any Confidential Information or other information or instructions provided or given by or on behalf of Customer in connection with the provision of the Services, (iii) deviations from specifications, amounts or other parameters, (iv) Force Majeure (as defined in clause 13.1), (v) previously unknown chemical reaction between the Product’s chemical components and packaging (“Compatibility Issues”), (vi) non-fulfillment or improper performance of Customer’s obligations as outlined in clause 3.3, or (vii) other reasons not directly attributable to BioSpring.

6.5 TO THE EXTENT PERMITTED BY ANY APPLICABLE LAWS THE FOREGOING SHALL CONSTITUTE CUSTOMER’S SOLE AND EXCLUSIVE REMEDIES FOR ANY NON-CONFORMING DELIVERABLE; THEY ARE EXCLUSIVE AND IN LIEU OF ALL OTHER REMEDIES OF CUSTOMER UNDER THE CONTRACT AND UNDER ANY APPLICABLE LAWS. TO THE EXTENT PERMITTED BY ANY APPLICABLE LAWS, ANY AND ALL CLAIMS OF CUSTOMER FOR ANY NON-CONFORMITY (INCLUDING RELATED TO LATENT DEFECTS) SHALL BE WAIVED AND BECOME TIME-BARRED ONE (1) YEAR AFTER DELIVERY OF THE RESPECTIVE DELIVERABLE. BIOSPRING SHALL HAVE NO LIABILITY FOR ANY NON-CONFORMITY (INCLUDING RELATING TO LATENT DEFECTS) AFTER ONE (1) YEAR FROM THE DATE OF DELIVERY OF THE RESPECTIVE DELIVERABLE.

7. Retention of Title and Withholding Right

7.1 BioSpring shall retain title to all Deliverables until Customer has made all payments due under the Contract and has cleared any open balance under any other contract between the Parties. For clarity, any passing of title to the Deliverables to Customer relates only to the tangible property in and to the Deliverables and not to any information, Know-How or Intellectual Property (each as defined in clause 9.1) incorporated, contained or embodied in the Deliverables or covering the Deliverables.

7.2 If Customer is in delay with any payments, whether under the Contract or any other contract between BioSpring and Customer, BioSpring has the right to withhold Delivery of the Deliverables and performance of any other Services or obligations under the Contract until Customer has made all payments due.

8. Price and Payments

8.1 The Price is exclusive of any taxes (in particular value added tax), customs, duties and bank transfer fees, charges, and other costs and expenses, if applicable, which have to be borne exclusively by Customer and may be invoiced in addition by BioSpring to Customer.

8.2 BioSpring will issue invoices for the Price in accordance with the due dates agreed in the Contract. Unless otherwise agreed in the Contract, all invoices shall be paid within sixteen (16) days from the invoice date. The payments shall be made in euros to a bank account indicated on BioSpring´s invoice at Customer’s own cost.

8.3 If Customer is in delay with any payment, BioSpring shall be entitled to charge interest in the amount of two percent (2%) per month. Such interest shall accrue on a monthly basis and shall be compounded monthly, not to exceed the maximum interest rate allowable under any applicable laws. Any other rights and remedies of BioSpring for delayed payment under the Contract and any applicable laws shall remain unaffected.

8.4 All amounts due under the Contract shall be paid as invoiced in full without any set-off, deduction or withholding.

9. Know-How and Intellectual Property

9.1 As used in these Conditions, (i) “Know-How” means any information or material, whether proprietary or not and whether patentable or copyrightable or not, which is not in the public domain, including inventions, data, formulae, specifications, data analysis, developments, techniques, materials, processes, procedures of manufacture, compositions of matter or methods of use and trade secrets, and (ii) “Intellectual Property” or “IP” means patents, rights to inventions, trade marks, trade names and domain names, rights in get up, goodwill and the right to sue for passing off or unfair competition, copyright and related rights, rights in designs, rights in computer software, database rights, rights in confidential information, rights in Know-How, and any other intellectual property, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals and extensions of, and the rights to claim priority from, such rights and all similar and equivalent rights and forms of protection in any part of the world.

9.2 Each Party retains all rights, title and interest in and to all Know-How and Intellectual Property owned by or licensed to such Party prior to the Commencement Date or created or acquired by, or licensed to, such Party on or after the Commencement Date independently from the Contract (“Background IP”).

9.3 All Know-How, improvements, enhancements and modifications and any Intellectual Property related thereto developed by or on behalf of either Party or jointly by both Parties under the Contract (“Improvements”), including any further development of the manufacturing technology shall be, as between the Parties, the exclusive property of BioSpring. Customer hereby assigns and agrees to assign to BioSpring all of its rights, title and interest in and to Improvements, and BioSpring hereby accepts such assignment. Improvements shall be the Confidential Information of BioSpring.

9.4 If any rights, title or interest in any Improvements are assigned by Customer to BioSpring in accordance with clause 9.3, Customer shall render all necessary assistance reasonably requested by BioSpring to give full effect to the assignment and to prepare, apply for and prosecute applications for patents or other Intellectual Property resulting from such Improvements, at BioSpring's cost. Customer shall towards this end sign and execute and cause its employees and any other personnel working under the Contract on behalf of Customer to execute such assignment forms and other documents as necessary for such purposes. Where applicable and as required by any applicable laws, the directors or employees of Customer or other personnel working under the Contract on behalf of Customer shall be named as (co)-inventors in any such patent applications submitted by BioSpring.

9.5 In no case may Customer file any patent application or application for other Intellectual Property that incorporates BioSpring’s Confidential Information or BioSpring's Background IP or any Improvements. Nothing in the Contract shall be deemed to convey to Customer any right, title or interest in or license to BioSpring’s Confidential Information or BioSpring's Background IP or any Improvements.

9.6 Customer hereby grants to BioSpring a non-exclusive, worldwide, transferable, fully paid up, royalty-free license with the right to sublicense to BioSpring’s Subcontractors and Affiliates, to use Customer’s Background IP as necessary to perform the Services or as necessary for BioSpring to exercise or perform BioSpring’s other rights and obligations under the Contract.

10. Representations and Warranties

10.1 Customer makes the following representations and warranties:

10.1.1 Customer will comply with all laws applicable to its operations or applicable to the Customer’s ordering, handling or use of the Product or other Services, in particular any applicable import/export restrictions or sanctions regimes.

10.1.2 Customer (i) has the rights and authorization to disclose the Confidential Information and other information for the purpose of the Contract, and (ii) has no obligation toward any third party that would prevent it from disclosing the disclosed information to BioSpring.

10.1.3 Customer is the owner of or has the right to use, and to allow BioSpring to use and have used, Customer Materials, Customer’s Confidential Information and Customer’s Background IP, and there are no third party rights that may prevent or would be infringed by the supply or use of Customer Materials, Customer Required Materials, Customer’s Confidential Information or Customer’s Background IP to and by BioSpring or any of its Subcontractors in accordance with and for the purposes of the Contract.

10.1.4 Customer has provided and will continue to provide to BioSpring without delay all necessary materials, information, rights and support as required by BioSpring in order for BioSpring to perform its obligations under the Contract.

10.1.5 Any information and Confidential Information provided by Customer to BioSpring is correct, up to date and comprehensive.

10.1.6 There are no special or unusual hazards involved in (the handling of) Customer Materials, Customer Required Materials, or the Product other than those (if any) already communicated in writing to BioSpring prior to the Commencement Date, and Customer will immediately give notice to BioSpring in writing upon knowledge of such hazards after the Commencement Date.

10.1.7 Neither the sequence of any product or material (including, for the purposes of this clause 10.1.7 the Product, Customer Materials and Customer Required Materials) to be manufactured, used or analyzed by BioSpring as part of the Services nor the molecular, chemical or compositional structure of such product or material nor the Design (where “Design” is defined as the sequence of an oligonucleotide including the pattern and nucleotide modifications and other modifications introduced within that sequence), application or use of such product or material do infringe or will infringe, during the term of the Contract and any time thereafter, the Intellectual Property of any third party. BioSpring does not assume any obligations or liability in this respect. Should the manufacture, analysis, use, import or export of a product or material by BioSpring or its Subcontractors require a license under any Intellectual Property of any third party due to the sequence or the molecular, chemical or compositional structure of such product or material or the Design, application or use of such product or material, Customer will obtain the necessary license(s) and rights from the relevant third party for use by BioSpring or its Subcontractors, at no cost to BioSpring. The use by BioSpring of any product or material or any sequence or Design of any product or material provided by Customer or to be manufactured, used or analyzed for Customer, Customer’s Confidential Information, other information provided by Customer or Customer’s Background IP, and the compliance by BioSpring with any requirements or instructions of Customer in connection with the performance of its obligations under the Contract, in particular the manufacture, analysis, use, export, import and supply of products and materials and Deliverables, does not infringe any third party’s Intellectual Property or other rights.

10.2 EXCEPT FOR CUSTOMER'S REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS CLAUSE 10, THE PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, UNDER OR IN CONNECTION WITH THE SERVICES OR THE CONTRACT. ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES UNDER STATUTORY LAW AND THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT, ARE HEREBY DISCLAIMED BY BOTH PARTIES.

11. Indemnification

11.1 Customer shall be liable to BioSpring and BioSpring’s Representatives (as defined in clause 14.3) for and agrees to defend, indemnify and hold harmless BioSpring and BioSpring’s Representatives against and from any and all claims, demands, liabilities, losses, actions, suits, proceedings, damages, fines, penalties, government orders, taxes, costs, and expenses (including reasonable attorneys’ fees) (each, a “Claim”) arising from or related to (i) the materials or the processes or steps which Customer requires BioSpring to use or apply, or any other instructions given by Customer in connection with the performance by BioSpring of the Services or any other obligations under the Contract, (ii) the performance by BioSpring of its obligations under the Contract, (iii) the use, application, possession or sale of the Product or other Deliverables by Customer or any third party, in particular the use, development, testing, production and marketing of any products made from, containing or using any Product or other Deliverable, (iv) the use, application, possession, import, export, or supply of Customer Materials, Customer Required Materials, Customer’s Confidential Information, other information provided by or on behalf of Customer, sequences, Product, Design or Customer’s Background IP by BioSpring in accordance with the Contract, (v) the Products or Deliverables themselves, (vi) Customer’s breach of the Contract, (vii) Customer’s breach of a representation or warranty given in clause 10.1, or (viii) Customer’s negligence or intentional misconduct; except to the extent such Claims are caused by BioSpring’s grossly negligent or intentional breach of the Contract.

12. Limitation of Liability

12.1 THE LIMITATION OF LIABILITY SET OUT BELOW IN THIS CLAUSE 12 SHALL APPLY NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THESE CONDITIONS OR THE CONTRACT, TO THE EXTENT PERMITTED UNDER ANY APPLICABLE LAWS.

12.2 SUBJECT TO CLAUSE 12.1, BIOSPRING’S LIABILITY FOR NON-CONFORMING DELIVERABLES SHALL BE LIMITED TO THE REMEDIES SET FORTH IN CLAUSE 6.

12.3 SUBJECT TO CLAUSE 12.1, UNDER NO CIRCUMSTANCES SHALL BIOSPRING BE LIABLE FOR THE PRODUCT OR OTHER DELIVERABLES BEING FIT FOR A PARTICULAR PURPOSE TO WHICH CUSTOMER INTENDS TO PUT IT AND CUSTOMER SHALL BE SOLELY RESPONSIBLE FOR THE USE, DEVELOPMENT, TESTING, PRODUCTION AND MARKETING OF ANY PRODUCTS MADE FROM, CONTAINING OR USING ANY PRODUCT OR OTHER DELIVERABLE. CUSTOMER SHALL BE SOLELY RESPONSIBLE AND LIABLE FOR ENSURING THAT ANY PRODUCTS MADE FROM, CONTAINING OR USING ANY PRODUCT OR OTHER DELIVERABLE COMPLIES WITH ANY APPLICABLE LAWS, INCLUDING THE SAFETY OF SUCH PRODUCTS.

12.4 SUBJECT TO CLAUSE 12.1, BIOSPRING SHALL NOT BE LIABLE FOR ANY DELAY OR DAMAGES ARISING FROM OR RELATED TO CUSTOMER MATERIALS, CUSTOMER REQUIRED MATERIALS, CUSTOMER’S CONFIDENTIAL INFORMATION, ANY OTHER MATERIALS OR INFORMATION PROVIDED BY OR ON BEHALF OF CUSTOMER, ANY INSTRUCTIONS OR DECISIONS OF CUSTOMER, THE NON-FULFILLMENT OR IMPROPER PERFORMANCE OF CUSTOMER’S OBLIGATIONS TO PROVIDE INFORMATION AND DOCUMENTATION NECESSARY FOR BIOSPRING’S PROVISION OF SERVICES, THE NON-PERFORMANCE OR IMPROPER PERFORMANCE OF ANY OTHER COOPERATION BY CUSTOMER NECESSARY FOR BIOSPRING’S PROVISION OF SERVICES (IN PARTICULAR REPLIES, FEED-BACK, DECISIONS, APPROVALS, AND SIGNATURES, AS APPLICABLE), COMPATIBILITY ISSUES, OR OTHER CAUSES NOT ATTRIBUTABLE TO BIOSPRING.

12.5 SUBJECT TO CLAUSE 12.1, BIOSPRING SHALL NOT BE LIABLE FOR ANY DAMAGES OR DELAYS ARISING FROM OR RELATED TO ANY (I) NON- OR MAL-FUNCTIONALITY OF EQUIPMENT OR MACHINERY OR (II) NON-AVAILABILITY (INCLUDING SHORTAGE) OF RAW MATERIALS, EQUIPMENT OR MACHINERY, SUPPLIERS, EXTERNAL LABORATORIES OR OTHER MEANS OF PRODUCTION ESSENTIAL FOR THE PROVISION OF THE SERVICES AT COMMERCIALLY REASONABLE TERMS.

12.6 SUBJECT TO CLAUSE 12.1, BIOSPRING SHALL NOT BE LIABLE IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND BREACH OF STATUTORY DUTY), OR OTHERWISE, FOR ANY (I) LOSS OF PROFIT, (II) INCURRED USELESS EXPENDITURES, (III) PENALTIES, (IV) STANDSTILL OF OPERATIONS, (V) LOSSES, COSTS OR EXPENSES ARISING FROM A PRODUCT RECALL OR (VI) ANY FORM OF CONSEQUENTIAL, INDIRECT, PUNITIVE OR REMOTE DAMAGE; IN EACH CASE ARISING OUT OF OR IN CONNECTION WITH THE CONTRACT (INCLUDING UNDER ANY INDEMNITY OBLIGATIONS).

12.7 SUBJECT TO CLAUSE 12.1, BIOSPRING’S TOTAL AGGREGATE LIABILITY WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND BREACH OF STATUTORY DUTY), OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THE CONTRACT (INCLUDING UNDER ANY INDEMNITY OBLIGATIONS) FOR ANY DAMAGE TO OR LOSS OF CUSTOMER MATERIALS OR DELIVERABLES (AS SET FORTH IN CLAUSE 5.2) SHALL BE LIMITED TO A MAXIMUM AMOUNT OF FIVE THOUSAND EUROS (EUR 5,000).

12.8 SUBJECT TO CLAUSE 12.1, BIOSPRING’S TOTAL AGGREGATE LIABILITY WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND BREACH OF STATUTORY DUTY), OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THE CONTRACT (INCLUDING UNDER ANY INDEMNITY OBLIGATIONS) SHALL BE LIMITED TO A MAXIMUM AMOUNT EQUAL TO THE LESSER OF (A) THE AMOUNT OF THE PRICE PAID UNDER THE CONTRACT OR (B) TWENTY-FIVE THOUSAND EUROS (EUR 25,000).

12.9 SUBJECT TO CLAUSE 12.1 AND WITHOUT PREJUDICE TO CLAUSE 12.8, BIOSPRING’S TOTAL AGGREGATE LIABILITY WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND BREACH OF STATUTORY DUTY), OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH ANY CONTRACT BETWEEN THE PARTIES ENTERED INTO UNDER THESE CONDITIONS (AS AMENDED FROM TIME TO TIME) (INCLUDING UNDER ANY INDEMNITY OBLIGATIONS) SHALL BE LIMITED TO A MAXIMUM AMOUNT OF TWENTY-FIVE THOUSAND EUROS (EUR 25,000).

12.10 SUBJECT TO CLAUSE 12.1, NO ACTION OR PROCEEDINGS UNDER OR IN RELATION TO THE CONTRACT IN RESPECT OF ANY EVENT (OR SERIES OF CONNECTED EVENTS) MAY BE BROUGHT OR COMMENCED BY CUSTOMER (WHETHER IN ACCORDANCE WITH CLAUSE 16.11 OR OTHERWISE) AT ANY TIME AFTER THE DATE TWO YEARS AFTER THE RELEVANT EVENT (OR THE FIRST EVENT IN THE RELEVANT SERIES OF CONNECTED EVENTS).

12.11 ANY EXCLUSION OR LIMITATION OF LIABILITY OF BIOSPRING SHALL ALSO APPLY TO THE LIABILITY OF ITS AFFILIATES AND SUBCONTRACTORS AND TO THE PERSONAL LIABILITY OF BIOSPRING’S AND ITS AFFILIATES’ DIRECTORS, OFFICERS AND EMPLOYEES, AND BIOSPRING’S OTHER REPRESENTATIVES.

12.12 THE TERMS IMPLIED BY SECTIONS 13 TO 15 OF THE SALE OF GOODS ACT 1979 AND SECTIONS 3 TO 5 OF THE SUPPLY OF GOODS AND SERVICES ACT 1982 ARE, TO THE FULLEST EXTENT PERMITTED BY LAW, EXCLUDED FROM THE CONTRACT.

13. Force Majeure

13.1 Notwithstanding anything to the contrary in the Contract, BioSpring shall neither be responsible nor liable in any way nor be deemed to be in default under, or in breach of any provision of the Contract for failure or delay in performing any obligation under the Contract resulting from any cause or circumstance beyond its reasonable control, in each case at BioSpring or within its supply chain (including suppliers of raw materials, consumables and equipment required for performing the Services and external laboratories) (each such cause “Force Majeure”).

13.2 BioSpring shall moreover be entitled to such additional time as may be reasonably necessary to perform its obligations hereunder.

14. Confidentiality

14.1 “Confidential Information” means any and all data and information that is or was disclosed or otherwise made accessible by or on behalf of a Party (the “Disclosing Party”) or its Representatives to the other Party (the “Receiving Party”) or its Representatives, before or after the Commencement Date, (a) in written or other tangible form or (b) electronically, orally, visually or otherwise such as, without limiting the generality of the foregoing, all trade secrets, Know-How, proprietary or non-public information or data, business or personal data, including (i) scientific and technical information regarding any of the products or services, equipment, materials or facilities of Disclosing Party or any of its Affiliates, (ii) business and financial information regarding the products or services of Disclosing Party or any of its Affiliates, (iii) information regarding Disclosing Party and its Affiliates, and their respective customers or suppliers, and (iv) the existence and content of the Contract and all related discussions and negotiations, any Services, and any other Know-How, trade secrets and information in connection therewith, when such data and information:

(1) is clearly marked as Confidential Information, is described as such or is otherwise reasonably recognisable as such; or

(2) is reasonably to be regarded as confidential because of its contents; or

(3) is derived from Confidential Information which has been provided by or on behalf of the Disclosing Party or its Representatives;

irrespective of whether the information is additionally protected as a trade secret under any applicable laws.

For clarity, Confidential Information of BioSpring includes: (a) its proprietary or confidential scientific, technological and business information relating to the manufacturing, quality control and characterization of oligonucleotides (including presentations, email correspondence and other documents disclosed or otherwise made accessible to Customer in connection with the Services), to the analysis of oligonucleotide raw materials, the characterization and validation of manufacturing processes and analytical methods, and to services regarding the aforementioned activities (including Quotes), as well as its manufacturing, analytical characterization and validation technologies and Know-How (including raw data) and any improvements thereof; and (b) all the information, in whichever form, observed or otherwise acquired by Customer or its Representatives during meetings, tours, visits, audits or presence of any form taking place on BioSpring’s premises.

14.2 The Receiving Party shall (i) not disclose to any third party (except as permitted in accordance with clause 14.3) the Disclosing Party’s Confidential Information, (ii) not use the Disclosing Party’s Confidential Information for any purposes other than for the performance of or any other use explicitly permitted under the Contract, (iii) not exploit such Confidential Information commercially or otherwise, without the Disclosing Party’s prior written consent, (iv) treat the Disclosing Party’s Confidential Information with the same degree of care as the Receiving Party uses to protect its own Confidential Information, but in no event with less than a reasonable degree of care, (v) keep the Disclosing Party’s Confidential Information separately from all other documents, materials and notes relating to other companies, (vi) keep the Disclosing Party’s Confidential Information in a safe place in order to protect it from theft or unauthorised access, and (vii) only make copies of such Confidential Information to the extent necessary for the performance of the Contract. The Receiving Party is not permitted to obtain Confidential Information through “Reverse Engineering” (meaning any action, including observation, testing, examination, mapping-back, disassembly or reassembly, with the purpose of reconstructing or obtaining Confidential Information).

14.3 The Receiving Party shall make Confidential Information of the Disclosing Party available only to those of its Affiliates, and those of its and their respective officers, directors, employees, agents, consultants, auditors, accountants and legal advisors (each a “Representative”) who need to have access to it for the purpose of performance of the Contract and who are bound by confidentiality and non-use obligations no less stringent than the obligations defined above in this clause 14. Customer shall procure that any Representative which Customer may use in the scope of the Contract (other than accountants or tax or legal advisors who are bound by law to a professional obligation to maintain confidentiality) shall perform in a manner consistent with the Contract, including clause 14.2. Customer shall be responsible for any acts or omissions of its Representatives as though they were Customer's own and Customer shall be liable for the performance of its Representatives as for its own performance under the Contract. Further, Customer shall ensure that, to the extent permitted by law, if the Representative to whom Confidential Information is (to be) disclosed is an agent, consultant or auditor, (a) such Representative must under no circumstances be reasonably considered to be, or work on behalf of, an actual or potential competitor of BioSpring and (b) before such a Representative is used in the scope of the Contract, Customer shall inform BioSpring of the identity of such Representative and such Representative shall on demand of BioSpring accept to be bound by an appropriate confidentiality agreement directly enforceable by BioSpring. If the conditions under (a) above are not fulfilled, BioSpring may refuse such Representative’s access to BioSpring’s Confidential Information and Customer shall not, unless and until notified by BioSpring, disclose or allow disclosure of any of BioSpring’s Confidential Information to such Representative.

14.4 Without limiting each Party’s right to make available Confidential Information of the respective other Party to its Representatives in accordance with clause 14.3, BioSpring has the right to make available Confidential Information of Customer to Subcontractors who need to have access to it for the purpose of performance of the Contract and who are bound by confidentiality and non-use obligations no less stringent than the obligations defined in this clause 14.

14.5 Confidential Information shall not include any data, information or material which the Receiving Party can demonstrate with competent written evidence that it: (i) was demonstrably and rightfully in the possession of Receiving Party at the time it was received from the Disclosing Party, without any confidentiality obligation towards Disclosing Party or any third party; (ii) was known to the public or generally available to the public at the time it was received; (iii) becomes known to the public or generally available to the public (subsequent to the date it was received) other than by a breach of the Contract, or (iv) is received by the Receiving Party in good faith from any third party who is not in violation of a confidentiality obligation towards Disclosing Party. The Parties acknowledge and agree that the mandatory statutory provisions governing trade secrets under the applicable law shall remain unaffected by the terms of the Contract. Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party or any of its Representatives unless the specific combination itself is published or available to the general public or in the rightful possession of the Receiving Party or such Representative.

14.6 If Confidential Information of the Disclosing Party must be disclosed to courts, governmental or regulatory agencies or other authorities or disclosure of Confidential Information of the Disclosing Party is otherwise required by law, the Receiving Party and its Representatives shall be entitled to do so to the extent required by law provided, however, that the Receiving Party or its relevant Representative shall (i) give, to the extent possible, the Disclosing Party reasonable advance notice in writing of such disclosure and (ii) use reasonable efforts to limit disclosure and secure confidential treatment of such Confidential Information (whether through protective order or otherwise). Such permitted disclosure shall, however, not relieve the Receiving Party or its Representatives of their obligations under this clause 14 in relation to the disclosed information.

14.7 At the Disclosing Party’s request, and in any case upon expiry or termination of the Contract, the Receiving Party shall promptly destroy or return, as elected by the Disclosing Party in its sole discretion, all of the Disclosing Party’s Confidential Information, and all copies thereof in the Receiving Party’s or its Representatives’ possession or control. Notwithstanding the foregoing, (i) copies of Confidential Information may be retained by the Receiving Party in a secured location or access-controlled files solely to allow the Receiving Party to ensure its continued compliance with the Contract or any applicable laws or, in the case of BioSpring, any documents retained under its quality guidelines, and for no other purpose, and (ii) the Receiving Party shall not be required to destroy or alter any computer back-up tapes or similar storage made of Confidential Information in the ordinary course of the Receiving Party’s business, provided that the Receiving Party shall continue to comply with its obligations under this clause 14 in respect of such Confidential Information.

14.8 The Parties hereby agree that any non-compliance or breach, or threatened non-compliance or breach, of the obligations under this clause 14 by the Receiving Party itself or by any of Receiving Party’s Representatives may cause immediate and irreparable harm to the Disclosing Party which may not be adequately compensated by monetary damages and that in the event of such non-compliance or breach or threatened non-compliance or breach, the Disclosing Party shall have, in addition to any and all remedies of agreement, law and equity, the right to seek preliminary and injunctive relief before any court of competent jurisdiction in order to ensure compliance and prevent violation of the obligations hereunder.

14.9 The Parties’ respective obligations under this clause 14 shall apply during the term of the Contract and survive termination or expiration of the Contract for a period of fifteen (15) years; provided that to the extent that the Disclosing Party’s Confidential Information (i) constitutes a trade or company secret, (ii) constitutes the Disclosing Party’s Background IP or, in the case of BioSpring, Improvements, (iii) reveals the properties of any of the Disclosing Party’s Background IP or, in the case of BioSpring, Improvements, or (iv) allows the determination of the properties of any of the Disclosing Party’s Background IP or, in the case of BioSpring, Improvements (by Reverse Engineering or otherwise), such Confidential Information shall remain subject to the obligations set forth in this clause 14 until such obligations no longer apply as provided for under clause 14.5.

15. Termination for Cause, Survival

15.1 Either Party may terminate the Contract with immediate effect for cause by written notice to the other Party:

(i) in the event of a material breach of the other Party of its obligations if such defaulting Party fails to cure such breach within thirty (30) Business Days upon receipt of a written notice by the non-defaulting Party specifying the nature of the default and requiring the defaulting Party to cure such default;

(ii) to the extent permitted under the applicable insolvency or bankruptcy laws, upon the institution by or against the other Party of insolvency, receivership or bankruptcy proceedings, or upon the other Party’s dissolution or cessation of business at any time for thirty (30) consecutive days; or

(iii) in the case of BioSpring only, if a change of control (as defined in clause 1.1) occurs in relation to Customer, such termination to be notified to Customer within thirty (30) Business Days after BioSpring becomes aware of the change of control.

If Customer terminates the Contract for cause pursuant to this clause 15.1, Customer shall remain bound to pay all amounts due for the Services performed by BioSpring until the effective date of the termination and any non-cancellable expenses incurred by BioSpring until the effective date of termination, including cost for raw materials and consumables incurred by BioSpring.

If BioSpring terminates the Contract for cause pursuant to this clause 15.1, Customer shall remain bound to pay the total Price to be paid under the Contract.

15.2 Unless expressly stated otherwise in these Conditions, cancellation, termination or expiry of the Contract shall not affect any of the Parties’ rights and remedies that have accrued as at termination. Any provision of these Conditions that expressly or by implication is intended to come into or continue in force on or after cancellation, termination or expiry shall remain in full force and effect, including: Know-How and Intellectual Property (clause 9), Representations and Warranties (clause 10), Indemnification (clause 11), Limitation of Liability (clause 12), Force Majeure (clause 13), Confidentiality (clause 14), General (clause 16).

16. General

16.1 Entire Agreement. With regard to the subject matter of the Contract and subject to clause 16.2, the Contract constitutes the entire understanding between the Parties and supersedes and replaces all prior arrangements, understandings and agreements between the Parties thereto whether written or oral.

16.2 Conflicting Provisions. Any information disclosed under a separate confidentiality agreement between the Parties entered into before conclusion of the Contract shall be deemed disclosed under the Contract to the extent that it constitutes Confidential Information. In the event of a conflict between any provision of such confidentiality agreement and these Conditions in relation to Confidential Information relevant for the performance of the Contract, these Conditions shall prevail, govern and control. In the event of any conflict between the Quote and these Conditions, these Conditions shall prevail, govern and control unless expressly and specifically stated in the Quote to deviate from and supersede a specific provision of these Conditions on a specific matter (such provision and matter being clearly specified).

16.3 Third Party Rights. The Contract shall be binding upon and inure to the benefit of the Parties only. Representatives of either Party and other third parties are not and will not become a Party to the Contract and, save as expressly stated in these Conditions, they are not entitled to any rights under the Contract as third party beneficiaries (whether under the Contracts (Right of Third Parties) Act 1999 or otherwise).

16.4 Assignment. Customer shall not assign or transfer the Contract or any rights or obligations hereunder without the prior written consent of BioSpring.

16.5 No Partnership or Agency. The Contract does not and shall not be construed to create any partnership, joint venture, agency or employment relationship between the Parties and neither Party shall, by reason of any provision hereof, be deemed to be a partner, joint venturer, agent, employee or legal representative of the other Party nor shall either Party have the ability, right or authority to act, or assume or create any obligation of any kind, express or implied, in the name of or on behalf of the other Party.

16.6 Variation. Amendments and additions to the Contract may only be made by express written agreement between the Parties; this also applies to any waiver of the requirement of written form.

16.7 Waiver. The failure to enforce the Contract over a non-compliance or breach, or threatened non-compliance or breach, shall not be construed as a waiver of rights to enforce.

16.8 Severance. The provisions of these Conditions shall be severable. Invalidity or unenforceability of any provision shall not affect any other provision of these Conditions. In lieu of the invalid or unenforceable provision a reasonable provision shall be deemed to be effective which shall achieve as nearly as possible the original intention of the invalid or unenforceable provision.

16.9 Notices. To be effective, any notice or other communication required or permitted by either Party to the other Party under the Contract shall be in writing and sent (i) to the registered office of the other Party or (ii) by email to the address as may from time to time be specified in writing by one Party to the other for the purposes of this clause. Any notice and other communication will be effective when received by the Party to which it is addressed. This clause does not apply to the service of any proceedings or other documents in any legal action or, where applicable, any arbitration or other method of dispute resolution.

16.10 Governing Law. The Contract and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed exclusively in accordance with the law of England and Wales with the exclusion of its rules of conflict-of-laws. The UN Convention on Contracts for the International Sale of Goods (CISG) shall not apply.

16.11 Arbitration. All disputes arising out of or in connection with the Contract (including non-contractual disputes) shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said rules. The arbitration proceedings shall take place in Frankfurt am Main, Germany. The language of the arbitration proceedings shall be English and all documents not in English submitted by any Party must be accompanied by an English translation. This clause 16.11 shall not prohibit either Party from seeking preliminary and injunctive relief from a court of competent jurisdiction as expressly set forth in clause 14 or in the event of a breach or prospective breach of the Contract by the other Party which would cause irreparable harm to the first Party. The costs of the arbitration (including reasonable attorney’s fees and associated costs and expenses) shall be borne by the Parties in proportion to the outcome of the arbitration (taking into account the relative success of the claims and defenses of the Parties), as ordered by the arbitrators.

Last updated: April 2024