GENERAL TERMS AND CONDITIONS for Analytical and Large-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 set out in the Quote, 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.

“Product” means the product to be manufactured by BioSpring under the Contract, as set out in the Quote.

“Quote” means BioSpring’s 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, under the Contract, as set out in the Quote.

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.

2. Basis of the Contract

2.1 The Order constitutes an offer by Customer to purchase the manufacture of Products and/or other Services set out in the applicable Quote in accordance with these Conditions. The Order shall only be deemed to be accepted when BioSpring issues 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 shall come into existence ("Contract"). Where applicable, the Contract shall also incorporate any separate document signed by both the Parties describing the tests, specifications and appropriate acceptance criteria that establish the set of criteria to which a Product or Service should conform to be considered acceptable under the Contract ("Signed Specifications").

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 a purchase 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 purchase 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 ("Applicable Laws"), including, where applicable to particular services as agreed in the Contract, cGMP (where "cGMP" is defined as (i) Directive 2003/94/EC and the current Good Manufacturing Practices guidance published by the European Commission in the “Guide to good manufacturing practice for medicinal products” (“The rules governing medicinal products for human use”), Volume IV and the relevant annexes; (ii) the applicable regulatory requirements for current good manufacturing practices promulgated by the U.S. Food Drug Administration (“FDA”) under 21 C.F.R. Parts 11, 210, 211, as applied to the manufacturing of API, (iii) the International Conference on Harmonization (ICH) Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; however each of the aforegoing only apply if and as explicitly agreed as mandatory in both the Contract and a separate quality agreement between the Parties on the allocation of responsibilities with regard to the quality assurance of Products or Services agreed in the Contract to be manufactured or provided under cGMP ("cGMP Products" and "cGMP Services", respectively), including the determination of issuing of the certificate of analysis (CoA) and other documents ("Quality Agreement"); in each case as in effect on the date of the performance of the respective Service).

3.2 The Parties agree that the manufacturing of Products and other Services are experimental in nature and therefore any milestones, specifications (except for Signed Specifications, if any), target amounts and other target parameters, dates, times, and timetables for the Delivery (as defined in clause 1) of Deliverables (where "Deliverables" is defined as any amount of the Product, data, reports, certificates, documents, results or any other work resulting from the Services to be delivered by BioSpring under the Contract, but excluding any rights in or to Improvements (as defined in clause 10.4) or BioSpring’s Background IP (as defined in clause 10.2) or BioSpring’s Confidential Information (as defined in clause 16.1)) or for the provision of other Services shall be non-binding. BioSpring disclaims any liability of whatsoever nature with respect to such milestones, specifications (except for Signed Specifications, if any), target amounts and other target parameters, dates, times, and timetables.

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 the first (1^st) 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 Quote as to be provided by or on behalf of Customer to BioSpring for the manufacturing of Product (“Customer Materials”) and the provision of any sample material identified in the Quote as to be provided by or on behalf of Customer for Analysis (as defined in clause 6) (“Customer Samples”); (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 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 unassigned slot. In case the delay requires BioSpring to postpone the performance of the Services to the next unassigned appropriate slot or in case the delay persists for two (2) weeks or more, (i) the cancellation fees (including any slot reservation fee) under clause 3.3 shall become due as minimum compensation to BioSpring for the delay and (ii) BioSpring shall be entitled to terminate the Contract with immediate effect for cause pursuant to clause 18.1; and, in each case, 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 Samples

4.1 Customer shall deliver the Customer Materials and Customer Samples at the quantity, quality and times as required or as set out in the Quote, free of charge DDP BioSpring’s facility specified in the Quote for Delivery (or, if no facility is specified, BioSpring’s manufacturing site at Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany) 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 and Customer Samples.

4.3 Customer shall provide BioSpring with certificates of analysis and TSE/BSE/non-animal certificates for the Customer Materials and (as applicable) Customer Samples 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 Samples, storage and safety requirements, including Material Safety Data Sheets (MSDS).

4.4 Qualification of Customer Materials and of the supplier of Customer Materials shall be the responsibility of Customer only and Customer shall be fully liable for any losses, damages and delays arising from or in connection with its failure of qualification of Customer Materials or of the supplier of Customer Materials.

4.5 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 and Customer Samples are as agreed or otherwise as required for the Customer Materials or Customer Samples to be suitable for the performance of the Services. BioSpring shall not be responsible or liable for the Product or other Services not being compliant with the Signed Specifications or otherwise not 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 or Customer Samples.

4.6 In the event the Parties have agreed on a return of Customer Materials or Customer Samples by BioSpring to Customer, any such return shall be made EXW BioSpring’s facility specified in the Quote for Delivery (or, if no facility is specified, BioSpring’s manufacturing site at Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany) Incoterms® 2020. Clauses 2 to 5.4 shall apply accordingly to such returns.

5. Delivery, Storage, Transport, Disposal and Customs

5.1 Any delivery of Deliverables shall be made EXW BioSpring’s facility specified in the Quote (or, if no facility is specified, BioSpring’s manufacturing site at Alt-Fechenheim 34, 60386 Frankfurt am Main, Germany) Incoterms® 2020 (“Delivery”). Delivery shall be deemed effected upon release of the Deliverables (such release including, in the case of cGMP Products, providing of the certificate of analysis (CoA) and the certification of compliance (CoC)), by BioSpring or, if no release is agreed or required, upon BioSpring notifying Customer that the Deliverables are available for pickup. Customer shall pick up the 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 the Deliverables at Customer’s risk free of charge for up to one (1) week from Delivery. If Customer fails to pick up the Deliverables within such one (1) week period, without prejudice to any other rights BioSpring may have, BioSpring is entitled, in its sole discretion, to have the Deliverables transported 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. NOTHWITHSTANDING THE FOREGOING AND WITHOUT PREJUDICE TO THE GENERAL LIMITATIONS OF LIABILITY AS SET FORTH IN CLAUSE 14, AFTER THE END OF THE ONE (1) WEEK FREE-OF-CHARGE STORAGE PERIOD, CUSTOMER IS DEEMED IN DELAY OF ACCEPTANCE AND, SUBJECT TO CLAUSE 1, BIOSPRING’S LIABILITY FOR ANY DAMAGE TO OR LOSS OF THE DELIVERABLES, INCLUDING UPON STORAGE AND TRANSPORT, IS LIMITED TO GROSS NEGLIGENCE AND WILLFUL MISCONDUCT.

5.3 If BioSpring has stored the Deliverables for two (2) months or more from Delivery and after having unsuccessfully set a final thirty (30) days deadline for pickup by Customer, BioSpring is entitled to dispose of the Deliverables at Customer’s cost. Such disposal shall not affect any other rights of BioSpring under the Contract, including the right to claim payment of the Price (where "Price" is defined as the amount to be paid for individual Services, including manufacturing of the Product, under the Contract, as set out in the Quote and not included in the "Price" are any taxes (in particular but not limited to value added tax (“VAT”)), 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), storage costs and any other payment due at the time of disposal.

5.4 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 Upon Delivery, Customer shall without undue delay examine the respective Deliverable for non-conformance to the Signed Specifications, shortage, non-conformity with cGMP (if applicable), any damage, or any other defect, including any incorrectness of documents (“Non-Conformity” and the part of the Deliverable affected by the Non-Conformity “Non-Conforming Deliverable”). If Customer discovers or has reasonable basis to discover any Non-Conformity, Customer shall notify BioSpring in writing without undue delay, but in no event later than the earlier of (i) ten (10) days from physical receipt of the respective Deliverable or (ii) fifteen (15) days from Delivery. If the Non-Conformity could not have reasonably been detected by Customer through examination upon Delivery (“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 1 SHALL BE DEEMED AN ACKNOWLEDGEMENT BY CUSTOMER THAT THE RESPECTIVE DELIVERABLES ARE NOT NON-CONFORMING DELIVERABLES AND ANY CLAIMS WITH RESPECT TO SUCH DELIVERABLES, WHETHER BASED ON THE CONTRACT OR THE APPLICABLE LAW, SHALL BE EXCLUDED.

6.3 In the event Customer duly notifies BioSpring of any Non-Conforming Deliverable within the periods set forth in clause 1, BioSpring shall have the right to examine such reclamation and to test the respective Deliverable. BioSpring will notify Customer of the results of such examination and testing without undue delay.

6.4 In the event BioSpring does not agree with the results obtained by Customer, BioSpring will inform Customer about its differing opinion and findings. Should both Parties not come to a mutual agreement, the issue shall be submitted to an independent testing laboratory agreed upon by the Parties, whose decision shall be binding on both Parties. The costs of such tests shall be borne by the Party whose position has been found to be in error.

6.5 In the event a Non-Conforming Deliverable has been established by the Parties or by an independent laboratory testing as provided for above, and subject to clause 6, BioSpring shall, at its sole discretion, either: (i) undertake a subsequent fulfilment free of charge within a reasonable timeline and against Customer’s provision of the required Customer Materials or Customer Samples, if any, free of charge, and BioSpring shall have the right to decide, in its sole discretion, whether such subsequent fulfilment will be met by either rectification (reprocessing or, alternatively, rework) 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.

6.6 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-Conforming Deliverable if the Non-Conformity 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 Samples, (ii) Customer Background IP, Customer Improvements or any Confidential Information or other information or instructions, including the analytical methods and processes that are developed or used in the performance of the Contract for (a) the analysis (including release testing) of the pharmaceutical product containing the Product, the Product, Customer Materials, Customer Samples, or raw materials using certain analytical tests and methods, stability testing and releasing methods ("Analysis") or (b) other Services to the pharmaceutical product containing the Product, Customer Materials, Customer Samples, or raw materials (such methods and processes collectively, the "Analytical Methods"), provided or given by or on behalf of Customer in connection with the provision of the Services, (iii) deviations from specifications, except if agreed as part of the Signed Specifications, or deviations from target amounts or other target parameters, (iv) Force Majeure (as defined in clause 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.

6.7 TO THE EXTENT PERMITTED BY THE APPLICABLE LAW, 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 TO CUSTOMER UNDER THE CONTRACT AND UNDER THE APPLICABLE LAW. TO THE EXTENT PERMITTED BY THE APPLICABLE LAW, 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.

Documentation

Each Delivery of the Deliverables shall be accompanied by the documents set out in the Quote. For the avoidance of doubt, and subject to clauses 10 and 16, BioSpring’s Standard Operating Procedures (SOPs), batch records and campaign reports shall always remain the sole property and Confidential Information of BioSpring.

8. Retention of Title and Withholding Right

8.1 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 1) incorporated, contained or embodied in the Deliverables or covering the Deliverables.

8.2 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 or the Quality Agreement (as applicable) until Customer has made all payments due.

9. Prices and Payments

9.1 The Prices for the Products and other Services are as set out in the applicable Quote.

9.2 BioSpring will issue invoices in accordance with the due dates set forth in the Quote. The invoice for the first (1^st) payment set forth in the Quote shall be paid immediately upon receipt of the invoice. All other 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.

9.3 In the event that the achievement of a project timepoint or milestone (including start of manufacturing, start of other Services, completion of manufacturing, and completion of other Services, in each case as set forth in the Quote), is delayed or frustrated for any reason that lies outside of BioSpring’s responsibility, the corresponding milestone payment shall nonetheless be due at the date set forth in the Quote as if such delay had not occurred.

9.4 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 the applicable law. Any other rights and remedies of BioSpring for delayed payment under the Contract and the applicable law shall remain unaffected.

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

10. Know-How and Intellecual Property

10.1 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.

10.2 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”).

10.3 BioSpring’s Background IP relevant for the Services includes certain inventions, analytical methods, manufacturing processes, methods, methodologies, technologies, data, improvements, pre-existing products, materials, tools and other Know-How and Intellectual Property relating to the manufacture and analysis of oligonucleotides, including the development, characterization and validation of analytical methods and manufacturing processes relating to oligonucleotides.

10.4 All Know-How, improvements, enhancements and modifications developed by or on behalf of either Party or jointly by both Parties under the Contract (“Improvements”), which solely and specifically cover the molecular, chemical or compositional structure of the Product but of no other oligonucleotide product (“Customer Improvements”) shall be, as between the Parties, the sole property of Customer. Subject to clause 11, BioSpring hereby assigns and agrees to assign to Customer all of its rights, title and interest in any Customer Improvements, and Customer hereby accepts such assignment, provided that for any employee inventions constituting Customer Improvements, the provisions of clause 10.6 shall prevail. Customer Improvements shall be the Confidential Information of Customer.

10.5 All Improvements which do not constitute Customer Improvements (“BioSpring Improvements”) shall be the sole and exclusive property of BioSpring. For clarity, BioSpring Improvements include (i) any and all Improvements relating to the manufacturing process (including process characterization and process validation data), Analytical Methods and characterization or validation methods used in connection with the manufacture or Analysis under the Contract, and (ii) any and all Improvements to BioSpring's Background IP, including any Know-How relating to the manufacture or analysis of oligonucleotides or the characterization or validation of manufacturing processes or analytical methods in general, and in particular any and all Improvements relating to the manufacturing process, Analytical Methods or characterization or validation methods or to BioSpring's Background IP that are incorporated, contained or embodied in BioSpring’s SOPs, any batch records, campaign reports, process control strategy (PCS) documents, presentations, email correspondence or other documents disclosed or otherwise made accessible to Customer in connection with the Services. All rights, title and interest in and to BioSpring Improvements shall be vested in BioSpring. With respect to any BioSpring Improvements co-developed by Customer and BioSpring, Customer hereby assigns and agrees to assign to BioSpring all of its rights, title and interest in and to such BioSpring Improvements, and BioSpring hereby accepts such assignment. BioSpring Improvements shall be the Confidential Information of BioSpring.

10.6 Inventions made by BioSpring’s personnel are subject to the mandatory statutory provisions of the German Act on Employees’ Inventions (ArbnErfG). BioSpring shall notify Customer of any employee inventions constituting Customer Improvements together with such information as is available to BioSpring and reasonably necessary to understand the invention. Both Parties shall treat the invention and supporting information as Confidential Information in accordance with clause 16 in order to safeguard patentability. If Customer expresses its interest in the employee invention within six (6) weeks from receipt of such notice, BioSpring shall claim the employee invention within the legal period according to Art. 6 para. 1 and para. 2 ArbnErfG without any limitation and assign all rights thereto to Customer. Customer shall reimburse BioSpring for all payments to be made by BioSpring to BioSpring’s personnel in accordance with Applicable Laws requiring remuneration for inventions including ArbnErfG, for any Customer Improvements assigned to Customer in accordance with this clause 6.

10.7 Where applicable and as required or permitted by the applicable law, the directors or employees of BioSpring shall be named as (co)-inventors in any applications for patents resulting from Customer Improvements submitted by Customer. If any rights, title or interest in any BioSpring Improvements are assigned by Customer to BioSpring in accordance with clause 5, Customer shall render necessary assistance reasonably requested by BioSpring in preparing, applying for and prosecuting applications for patents resulting from BioSpring’s Improvements, at BioSpring's cost. Customer shall towards this end sign and execute and cause its employees, within the scope of the employer's right to issue instructions, to execute such assignment forms and other documents as are necessary to protect patents resulting from BioSpring Improvements. Where applicable and as required or permitted by the applicable law, the directors or employees of Customer shall be named as (co)-inventors in such applications submitted by BioSpring.

10.8 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 BioSpring Improvements. Nothing in the Contract shall be deemed to convey (i) to Customer any right, title or interest in or license to BioSpring’s Confidential Information or BioSpring's Background IP or BioSpring Improvements or (ii) to BioSpring any right, title or interest in or license to Customer’s Confidential Information or Customer's Background IP or Customer Improvements, except in each case as explicitly provided for in this clause 10.

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

10.10 For clarification, nothing in this clause 10 shall prevent BioSpring or its Affiliates from using raw data resulting from the Analysis of the Product or any pharmaceutical product containing the Product that solely and specifically cover the chemical characteristics of the Product (including in particular quantity, purity, stability values, water content and identity of oligonucleotides) in anonymized and aggregated form to further develop BioSpring's Background IP and to make, use and sell compounds and provide analytical services as part of its business as contract manufacturer of oligonucleotides.

10.11 The assignment of Customer Improvements to Customer under clause 4 shall become effective upon payment in full of the Total Remuneration (as defined in clause 17.1).

11. cGMP and API Production

11.1 With respect to the manufacture of cGMP Products and the provision of other cGMP Services under the Contract, the Parties shall enter into a separate Quality Agreement.

11.2 In the event the cGMP Product shall be used as an active pharmaceutical ingredient (API) of a pharmaceutical product, the Parties, in addition, shall agree on the allocation of responsibility for compliance with the regulatory requirements within a separate Quality Agreement. The same applies for the use of other cGMP Services for pharmaceutical products. Until and unless such agreement on the allocation of responsibility is reached, BioSpring is not obliged to release any cGMP Product or other cGMP Services. Notwithstanding the foregoing and anything to the contrary in these Conditions, Customer shall in any event be solely responsible for the use, development, pre-clinical and clinical testing or trial, production and marketing of any pharmaceutical products made from, containing or using any cGMP Products or other cGMP Services.

12. Representations and Warranties

12.1 Customer makes the following representations and warranties:

12.1.1 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 but not limited to any applicable import/export restrictions or sanctions regimes.

12.1.2 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.

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

12.1.4 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.

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

12.1.6 There are no special or unusual hazards involved in (the handling of) Customer Materials, Customer Samples 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.

12.1.7 Neither the sequence of any product or material (including, for the purposes of this clause 1.7 the Product, Customer Materials and Customer Samples) 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, Customer Background IP or Customer Improvements 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.

12.2 EXCEPT FOR CUSTOMER'S REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS CLAUSE 12, 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.

13. Indemnification

13.1 Customer shall be liable to BioSpring and BioSpring’s Representatives (as defined in clause 4) 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, pre-clinical and clinical testing, production and marketing of any pharmaceutical products made from, containing or using any Product or other Deliverable, (iv) the use, application, possession, import, export, or supply of Customer Materials, Customer Samples, Customer’s Confidential Information, other information provided by or on behalf of Customer, sequences, Product, Design, Customer Background IP, or Customer Improvements 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 12.1, or (viii) Customer’s negligence or willful misconduct; except to the extent such Claims are caused by BioSpring´s gross negligence or willful misconduct.

14. Limitation of Liability

14.1 THE LIMITATION OF LIABILITY SET OUT BELOW IN THIS CLAUSE 14 SHALL APPLY NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THESE CONDITIONS OR THE APPLICABLE QUOTE, TO THE EXTENT PERMITTED UNDER THE APPLICABLE LAW.

14.2 SUBJECT TO CLAUSE 1, BIOSPRING’S LIABILITY FOR NON-CONFORMING DELIVERABLES SHALL BE LIMITED TO THE REMEDIES SET FORTH IN CLAUSE 6.

14.3 SUBJECT TO CLAUSE 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, PRE-CLINICAL AND CLINICAL TEST, PRODUCTION AND MARKETING OF ANY PHARMACEUTICAL PRODUCTS MADE FROM, CONTAINING OR USING ANY PRODUCT OR OTHER DELIVERABLE. CUSTOMER SHALL BE SOLELY RESPONSIBLE AND LIABLE FOR ENSURING THAT ANY PHARMACEUTICAL PRODUCTS MADE FROM, CONTAINING OR USING ANY PRODUCT OR OTHER DELIVERABLE COMPLIES WITH THE APPLICABLE LAW, INCLUDING THE SAFETY OF SUCH PRODUCTS.

14.4 SUBJECT TO CLAUSE 1, BIOSPRING SHALL NOT BE LIABLE FOR ANY DELAY OR DAMAGES ARISING FROM OR RELATED TO CUSTOMER MATERIALS, CUSTOMER SAMPLES, 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 PARTICULARLY BUT NOT LIMITED TO REPLIES, FEED-BACK, DECISIONS, APPROVALS, SIGNATURES AND THE RETURN OF THE SIGNED SPECIFICATIONS COUNTER-SIGNED BY CUSTOMER, AS APPLICABLE), COMPATIBILITY ISSUES, OR OTHER CAUSES NOT ATTRIBUTABLE TO BIOSPRING.

14.5 SUBJECT TO CLAUSE 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.

14.6 SUBJECT TO CLAUSE 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).

14.7 SUBJECT TO CLAUSE 1, (I) 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 TWENTY-FIVE THOUSAND EUROS (EUR 25,000) AND (II) BIOSPRING SHALL NOT BE LIABLE IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND BREACH OF STATUTORY DUTY), OR OTHERWISE FOR ANY DAMAGE TO OR LOSS OF CUSTOMER SAMPLES ARISING OUT OF OR IN CONNECTION WITH THE CONTRACT (INCLUDING UNDER ANY INDEMNITY OBLIGATIONS).

14.8 SUBJECT TO CLAUSE 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), HOWEVER CAUSED AND ON ANY THEORY OF LAW, SHALL BE LIMITED TO A MAXIMUM AMOUNT EQUAL TO THE LESSER OF (A) THE AMOUNT OF THE PRICE(S) PAID UNDER THE CONTRACT OR (B) TWO HUNDRED AND FIFTY THOUSAND EUROS (EUR 250,000).

14.9 SUBJECT TO CLAUSE 1 AND WITHOUT PREJUDICE TO CLAUSE 14.8, 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 TWO HUNDRED AND FIFTY THOUSAND EUROS (EUR 250,000).

14.10 SUBJECT TO CLAUSE 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 19.11 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).

14.11 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.

14.12 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 THIS AGREEMENT.

15. Force Majeure

15.1 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”).

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

16. Confidentiality

16.1 “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, whether or not identified as confidential (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 Contract, any Services, and any other Know-How, trade secrets and information in connection therewith. 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 batch records, campaign reports, process control strategy (PCS) documents, SOPs, 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 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, in whichever form.

16.2 The Receiving Party agrees not to disclose to any third party (except as permitted in accordance with clause 4) the Disclosing Party’s Confidential Information and not to use the Confidential Information of the Disclosing Party for any purposes other than for the performance of or any other use explicitly permitted under the Contract and not to exploit such Confidential Information commercially or otherwise without prior written consent of the Disclosing Party.

16.3 The Receiving Party further agrees to (i) treat the Disclosing Party’s Confidential Information with the same degree of care as the Receiving Party uses to protect the Receiving Party’s own Confidential Information, but in no event with less than a reasonable degree of care, (ii) treat the existence of the Contract, its contents and all information regarding the Disclosing Party’s business as confidential, and (iii) give and allow access to the Disclosing Party’s Confidential Information only to such third parties who comply with the requirements of clause 4. below. The Receiving Party is not permitted to obtain Confidential Information through reverse engineering. “Reverse Engineering” within this meaning is any action, including observation, testing, examination, mapping-back, disassembly or reassembly, with the purpose of reconstructing or obtaining Confidential Information.

16.4 The Receiving Party shall make Confidential Information of the Disclosing Party available only to those of its Affiliates, and those of 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 16. 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) (i) shall perform in a manner consistent with the Contract, and (ii) shall act in the responsibility of Customer and Customer remains liable for the performance of its Representatives as for its own performance under the Contract. 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, auditor or advisor (except for accountants, tax or legal advisors who are bound by law to a professional obligation to maintain confidentiality), (a) such Representative must under no circumstances be reasonably considered to be, or work on behalf of, an actual or potential competitor of BioSpring, (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, once notified by BioSpring, disclose or allow disclosure of any of BioSpring’s Confidential Information to such Representative.

16.5 Without limiting each Party’s right to make available Confidential Information of the respective other Party to its Representatives in accordance with the preceding paragraph, 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 above in this clause 16.

16.6 The foregoing confidentiality and non-use obligations shall however not apply to such Confidential Information which the Receiving Party proves by written records (i) was demonstrably in the possession of Receiving Party at the time it was received from the Disclosing 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. 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.

16.7 If Confidential Information of the Disclosing Party must be disclosed to courts, governmental or regulatory agencies or other authorities or 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 give, to the extent possible, the Disclosing Party reasonable advance notice in writing of such disclosure and shall use reasonable efforts to 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 16 in relation to the disclosed information.

16.8 For the avoidance of doubt, notwithstanding anything to the contrary in this clause 16, batch records, campaign reports, process control strategy (PCS) documents and SOPs are part of BioSpring’s Confidential Information and there is no need or right for Customer to allow access to or disclose to any Representative (except for such of its or its Affiliates’ officers, directors, employees who each (i) fulfill the conditions defined in clause 4 and (ii) are performing the QP release of the Product manufactured hereunder for the sole purpose of the QP release of the Product) or to any other third party any batch records, campaign records, process control strategy (PCS) documents or SOPs. Other than as described in the immediately preceding sentence, Customer will need a special prior written approval by BioSpring to make other disclosures of batch records, campaign reports, process control strategy (PCS) documents or SOPs.

16.9 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 applicable law or, in the case of BioSpring, its document retention obligations under the Quality Agreement or BioSpring`s cGMP standards, 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 16 in respect of such Confidential Information.

16.10 The Parties hereby agree that any non-compliance or breach, or threatened non-compliance or breach, of the obligations under this clause 16 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.

16.11 The Parties’ respective obligations under this clause 16 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 Improvements, (iii) reveals the properties of any Background IP or Improvements of the Disclosing Party, or (iv) allows to determine the properties of any Background IP or Improvements of the Disclosing Party (by Reverse Engineering or otherwise), such Confidential Information shall remain subject to the obligations set forth in this clause 16 until such obligations no longer apply as provided for under clause 6.

17. Cancellation and Termination by Customer

17.1 Customer shall be entitled to cancel (i.e. until start of manufacturing) a Contract that includes manufacturing Services without cause with five (5) Business Days’ notice by notifying the cancellation to BioSpring by registered letter with acknowledgement of receipt, provided that BioSpring shall be entitled to the slot reservation fee specified in the Quote and, in addition to compensation in accordance with the following schedule:

Notwithstanding the above schedule, if Customer cancels a Contract that includes manufacturing Services (i) after the ordering of raw materials by BioSpring or (ii) at or less than three (3) months prior to the start of manufacturing as set out in the Quote, Customer shall pay BioSpring ninety-two point five percent (92.5%) of the Total Remuneration under the Contract. If BioSpring, based on its own judgment and discretion, can use part of the raw materials for other projects or products, BioSpring will inform Customer and offer a credit for that part of the raw materials which can be used for other products or projects.

17.2 If Customer terminates a Contract that includes manufacturing Services after the agreed start of manufacturing, Customer shall pay BioSpring one hundred percent (100%) of the Total Remuneration. BioSpring will provide to Customer all Products already manufactured at the time of such termination upon Customer meeting its payment obligations.

17.3 In addition to the cancellation fee (including the slot reservation fee) set forth above, to the extent that BioSpring has already performed any Services under the Contract up to the effective date of the cancellation, Customer shall pay the Price(s) agreed for such Services and such amounts shall not be included in the Total Remuneration used as basis for the calculation of the cancellation fee. BioSpring will provide to Customer all Deliverables resulting from such Services already performed at the time of cancellation upon Customer meeting its payment obligations.

17.4 BioSpring’s independent and confidential assessment of the projects shall form the exclusive basis for the suitability of usage of raw materials for other projects or products for the purpose of clause 1. BioSpring shall not be obliged to disclose details of any other projects or products, but will make general statements in such respect in good faith after an internal confidential assessment in its sole discretion.

17.5 Unless otherwise set out in the Quote, Customer shall have the right to cancel or terminate a Contract that does not include any manufacturing Services with four (4) months' written notice to BioSpring, provided that in the event of such cancellation or termination, Customer shall pay a cancellation fee of twenty percent (20%) of the Total Remuneration. In addition, Customer shall (i) pay to BioSpring all amounts due under the Contract for any Services already performed by BioSpring up to the effective date of the cancellation or termination and (ii) reimburse BioSpring for any non-cancellable and non-refundable expenses and costs incurred by BioSpring in connection with the cancelled or terminated Contract up to the effective date of cancellation or termination, including costs for raw materials and consumables incurred by BioSpring. BioSpring will provide to Customer all Deliverables resulting from Services already performed at the time of cancellation upon Customer meeting its payment obligations.

17.6 Notwithstanding the foregoing provisions, the total amounts due from the Customer under this clause 17 in respect of the Contract shall not exceed one hundred percent (100%) of the Total Remuneration.

17.7 All payments under this clause 17 are exclusive of any taxes (in particular but not limited to VAT), customs, duties, bank transfer fees, charges, and other costs and expenses, if applicable. Such taxes, customs, duties, bank transfer fees, charges and other costs and expenses shall be borne exclusively by Customer and will be additionally invoiced by BioSpring to Customer.

17.8 Nothing in this clause 17 shall affect the right of either Party to terminate the Contract for cause; such termination shall be exclusively governed by clause 1.

Termination for Cause, Survival

18.1 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 law, 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 occurs in relation to Customer, so that a third party not reasonably acceptable to BioSpring (in particular but not limited to a competitor of BioSpring), gains control over 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 18.1, 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 18.1, Customer shall remain bound to pay the Total Remuneration under the Contract.

18.2 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 10), Representations and Warranties (clause 12), Indemnification (clause 13), Limitation of Liability (clause 14), Force Majeure (clause 15), Confidentiality (clause 16), General (clause 19). The provisions of the Quality Agreement (if applicable) will survive any cancellation, termination or expiration of the Contract as provided for in the Quality Agreement.

19. General

19.1 Entire Agreement. With regard to the subject matter of the Contract and subject to clause 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.

19.2 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). In the event of any conflict between the Quality Agreement and these Conditions, these Conditions shall prevail, govern and control; provided, however, that the Quality Agreement shall prevail in respect of quality, cGMP and regulatory requirements.

19.3 Third Party Rights. The Contract shall be binding upon and inure to the benefit of the Parties only and 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 this 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).

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

19.5 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.

19.6 Variation. Amendments and additions to the Contract may only be made by a written document signed by authorized representatives of both Parties; this also applies to any waiver of the requirement of written form.

19.7 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.

19.8 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.

19.9 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 (which includes email) 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.

19.10 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.

19.11 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 19.11 shall not prohibit either Party from seeking preliminary and injunctive relief from a court of competent jurisdiction as expressly set forth in clause 16 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: June 2022