Rentschler Biopharma Nukleus Building Laupheim

General Terms and Conditions of Purchasing

1. Conclusion of Contracts

1.1. Unless otherwise agreed in writing, the following Terms and Conditions of Purchasing shall apply to all - including future - purchasing contracts. Unless otherwise agreed, the Conditions as amended at the time of our order, or at least when last communicated in text form, shall also apply as a framework contract for similar future contracts without the need for us to refer to them again in every case. We hereby expressly reject the validity of the Supplier's general terms and conditions. Any failure on our part to expressly reject them again shall not constitute acceptance.

1.2. These Terms and Conditions of Purchasing shall apply exclusively. All agreements or ancillary agreements must be in writing. Our employees are not authorised to make contractual alterations or ancillary agreements. Ancillary agreements and changes to the contract shall only become legally valid where we confirm them in writing.

1.3. Our orders are deemed valid on submission or confirmation, in writing, and not before. The Supplier shall notify us of any obvious mistakes such as typing errors, miscalculations or omissions. All orders must be confirmed by the Supplier in writing. If we do not receive such confirmation within 3 weeks of sending the order, we shall no longer be bound by our order.

1.4. Any drawings and other documents shall, by virtue of the order confirmation, become part of the contract and thus binding.

1.5. Legally relevant declarations and notifications made by the Supplier in relation to the contract (e.g. setting of deadlines, reminders, rescission) must be submitted in writing, i.e. in written or text form (e.g. letter, email or fax). This shall be without prejudice to formal statutory requirements or other evidence, in particular in case of doubt as to the legitimacy of the person making the declaration.

1.6. Our order number and date must be indicated on all correspondence, invoices and shipping documents.

1.7. Our Terms and Conditions of Purchasing only apply to the commercial and public-law sectors pursuant to Section 310 (1) German Civil Code (BGB).

1.8. References to the validity of statutory provisions are made solely for the purposes of clarification. The statutory provisions therefore apply even where no such reference is made, unless they are directly modified or expressly excluded by these Terms and Conditions of Purchasing.

1.9. Subject to compliance with the statutory requirements, we are entitled to store, process and use the Supplier's personal data to carry out pre-contractual tasks and for the purpose of implementing the contract.

1.10. In the course of initiating the contract and for the purpose of deciding on the formation, implementation (particularly against any partial advance payment or additional securities) and termination of the contractual relationship, we evaluate, possibly by way of commercial credit agencies, the risk of the Supplier failing to effect performance. This may involve the use of a credit score established by way of statistical processes. The corresponding data is generated using the Supplier's address data, company name and information contained in the Companies Register.

2. Prices

2.1. Any price indicated in our order shall be legally binding.

2.2. Unless otherwise agreed, the price includes all services and ancillary services provided by the Supplier (e.g. assembly and installation) as well as all ancillary costs (e.g. proper packaging, transport costs including any transport and indemnity insurance).

2.3. The prices specified in our order are deemed to be fixed prices exclusive of statutory value added tax.

3. Time to Delivery

3.1. The time to delivery specified in the purchase order is binding. Where the time to delivery is not specified in the order, or agreed elsewhere, it shall be 7 working days from conclusion of the contract. Agreed times to delivery shall commence on the date on which the purchase order is sent. As soon as the Supplier realises that it is unable to carry out the order on time, in whole or in part, - irrespective of the reasons - it shall notify us forthwith giving the reasons and likely period of the delay.

3.2. In the event of a delay in delivery our statutory rights apply. In particular, following the expiry of a reasonable extension of time without result, we are entitled to claim damages in lieu of performance or the reimbursement of expenses. This shall be without prejudice to Clause3.3.

3.3. Where the Supplier is in delay, we may - in addition to our statutory rights, particularly rescission and damages - claim lump sum compensation for our loss resulting from the delay, in the amount of 0.2% of the net price per full working day, but limited to a maximum of 5% of the net price for the late service. We retain the right to prove that our loss was higher. The Supplier retains the right to prove that there was no loss at all or that the loss was substantially lower.

4. Delivery

4.1. Where the delivery destination is unspecified, and unless otherwise agreed, delivery shall take place at our place of business in Laupheim. The relevant delivery destination also constitutes the place of performance as regards delivery and any subsequent performance (obligation to effect delivery to us).

4.2. Delivery shall take place carriage paid at the Supplier's risk. Shipments shall be prepaid. We do not pay freight in advance.

4.3. Transport insurance must be arranged by the Supplier. The Supplier shall be liable for any damage arising due to improper packaging, in particular the failure to comply with forwarding instructions.

4.4. The Supplier shall properly identify all deliveries that are subject to mandatory identification. Identification must also take place in the order confirmation and on all shipping documents. Where identification is incomplete, we shall not be held responsible for any delays in processing or payment arising as a result. The Supplier shall bear any costs and fees.

4.5. The delivery note must be attached to the shipment as an accompanying document. For the purposes of the incoming goods inspection, the delivery note shall indicate the number and date of our purchase order as well as item numbers and quantity. Invoices do not constitute delivery notes. The Supplier shall bear responsibility for all the consequences of any failure to comply with this obligation insofar as it is unable to prove that it was not responsible of the failure to comply. In the absence of the delivery note or where it is incomplete, we shall not be held responsible for any delays in processing or payment arising as a result.

4.6. Unless otherwise agreed in the individual case, partial delivery is not permitted. In any case, partial delivery which has already taken place shall not constitute an independent transaction.

4.7. The Supplier is obliged to provide proper packaging and where applicable detailed documentation in accordance with existing provisions.

4.8. The Supplier shall have a right of set-off or retention only in respect of counter-claims that have been upheld by a final court judgement or are undisputed.

4.9. The Supplier is not entitled to have its contractual performance carried out by third parties (e.g. subcontractors) without our prior written consent. Unless otherwise agreed in the individual case (e.g. where restricted to stock), the Supplier shall bear the procurement risk in relation to its services.

4.10. The risk of accidental destruction or accidental deterioration of the item shall pass to us on handover at the place of performance. Where an acceptance procedure has been agreed, this shall determine the transfer of risk. On acceptance, the statutory provisions of the law on contracts for work shall also apply in other respects.

4.11. In the event that we default on acceptance, the statutory provisions shall apply. However, the Supplier must also expressly offer us its work even where a specific or specifiable calendar period has been agreed for action or assistance on our part. Where we are in default, the Supplier can require compensation for its additional costs in accordance with the statutory provisions. Where the contract relates to the manufacture by the Supplier of a unique item (individual product), the Supplier shall only have additional rights where we have undertaken to provide assistance and are responsible for the failure to provide assistance.

4.12. The statutory provisions (Section 377 and 381 German Commercial Code (HGB)) shall apply to the commercial duty to examine goods and give notification of defects, subject to the following proviso: Our obligation to inspect is limited to defects that come to light during our incoming goods inspection by way of external examination including of the delivery documentation (e.g. transport damage, defective or short delivery) or that are detected in our quality control by random sampling. Where an acceptance procedure has been agreed there is no duty to inspect the goods. Otherwise, it depends on the extent to which an inspection is feasible considering the circumstances of the individual case according to the normal course of business. This shall be without prejudice to our obligation to give notification of defects discovered subsequently. Irrespective of our duty to examine the goods, our complaint (notification of defects) is deemed to be immediate and on time where it is sent within three working days from discovery or, in the case of obvious defects, from delivery.

5. Guarantee, Damages, Reimbursement of Costs

5.1. Unless otherwise specified, our rights in the case of material defects and defects in title (including incorrect and short delivery as well as improper assembly and defective instructions on assembly, operation or use) and in the case of other breaches of duty by the Supplier, shall be governed by the statutory provisions.

5.2. Under the statutory provisions, the Supplier is liable in particular for the fact that the goods have the agreed properties and condition when the risk passes to us. The product descriptions which - e.g. by way of identification or reference in our order - formed the subject matter of the respective contract or were incorporated into the contract in the same way as these General Terms and Conditions, are in any case deemed to be an agreement on properties and condition. It is irrelevant in this regard whether the product description comes from us, from the Supplier or from the manufacturer.

5.3. The failure to comply with specified performance and consumption figures as well as defects in the parts procured by the Supplier from its sub-suppliers are also deemed to be defects. The Supplier guarantees that the subject matter of delivery complies with the generally recognised technical rules and the rules on health and safety as well as with any accident prevention provisions binding upon us that are issued by the professional associations.

5.4. In the event of defective delivery, we can at our discretion demand that the defect be remedied or that a defect-free item be delivered within a reasonable deadline specified by us. Where the Supplier fails to comply with this, we can remedy the defect ourselves or engage a third party to do so and claim compensation for the expenses incurred, or a corresponding credit note, from the Supplier. Where subsequent performance by the Supplier is unsuccessful or unreasonable (e.g. due to particular urgency, danger to operational safety or the threat of disproportionate damage) there is no need to set a deadline; we will notify the Supplier of any such circumstances in advance where possible. In other respects, in the case of a material defect or a defect in title, we are entitled to a reduction in the purchase price, or to cancel the contract, in accordance with the statutory provisions. In addition, we have a right to claim compensation for damages and costs in accordance with the statutory provisions.

5.5. The Supplier shall be liable for replacement deliveries and repair work to the same extent as for the original subject matter of delivery.

5.6. The Supplier shall bear the costs which it incurs in respect of inspection and subsequent performance (including any removal and installation costs) even where it transpires that there was in fact no defect. This shall be without prejudice to our liability for damages in the case of an unauthorised request to remedy defects; in this case, however, we are only liable where we knew there was no defect or would have known but for our gross negligence.

5.7. A claim by us for damages in lieu of performance only results in the loss of our right to claim delivery once the damages claim has been fulfilled.

5.8. In addition to claims under warranty, we are also entitled to the supplier's statutory recourse within the supply chain (supplier's recourse pursuant to Sections 445a, 445b, 478 BGB) even where the defective goods have been processed by us or another company, e.g. by installation into, combination with or mixing with another product.

5.9. Our claims for subsequent delivery, repair and damages or compensation for costs, arising from material defects or defects in title, delivery of goods or services other than those agreed or delivery of an insufficient quantity ("defective delivery"), shall expire no earlier than 36 months after delivery of the goods. Insofar as an acceptance procedure has been agreed, the limitation period shall commence on acceptance. This shall be without prejudice to longer statutory or contractually agreed limitation periods, particularly in the case of fraud on the part of the Supplier. The aforementioned limitation period also applies mutatis mutandis to claims arising from defects in title, although the statutory limitation period for third-party rights in rem to the restitution of property remain unaffected; claims arising from defects in title shall not expire under any circumstances insofar as the third party still has the right to bring a claim against us - particularly in the absence of limitation.

5.10. The limitation period under the sale of goods law including the foregoing extension shall apply - in accordance with statute - to all contractual claims under warranty. Insofar as we are also entitled to non-contractual claims for damages due to a defect, the regular statutory limitation period (Sections 195 and 199 BGB) shall apply in this respect unless the limitation period applicable under sale of goods law results in a longer limitation period in the individual case.

6. Indemnification, Insurance

6.1. Where an action is brought against us under producer's liability owing to a defective delivery by the Supplier, and the Supplier is responsible for product damage, the Supplier shall indemnify us in this regard against third-party claims to the extent that the cause lies within the Supplier's managerial and organisational sphere of control and the Supplier itself is liable vis à vis third parties.

6.2. In accordance with its obligation to indemnify, the Supplier shall reimburse expenses pursuant to Sections 683 and 670 BGB resulting from or in connection with a third-party claim including product recalls undertaken by us. Insofar as it is possible and reasonable to do so, we will inform the Supplier of the content and extent of recall measures and allow it the chance to comment. This shall be without prejudice to additional statutory rights.

6.3. The Supplier shall conclude and maintain business liability insurance, including cover for instances of product liability, with lump-sum coverage of at least € 5 million per claim for personal injury/material damage. At our request, the Supplier shall provide appropriate documentary evidence of the existence of the aforementioned insurance policies.

7. Invoice and Payment

7.1. Invoices shall be sent to us for each delivery indicating order number, order date and item number. Payment periods start to run on the date of receipt of the invoice. Where the ordered item or the documents belonging to the order are not received until after invoicing, the payment period shall not commence until the last item is received. Costs that have to be proven by way of data sheets, time sheets etc. will only be recognised, subject to further examination, where this documentation has been confirmed by us.

7.2. The Supplier may only assign its right to receive the purchase price with our prior consent. Such consent may not be refused without good cause.

7.3. We shall be entitled to rights of set-off and retention as well as the plea of non-performance in accordance with the law. We are entitled to withhold outstanding payments, in particular, for as long as we have claims against the Supplier for inadequate or defective performance.

7.4. Unless otherwise agreed, we will settle invoices as from delivery following submission of an auditable invoice, by bank transfer or crossed cheque and, at our discretion, either within 14 days subject to 2% discount or within 60 days net.

7.5. We are not subject to interest on late payments. In the event of default on payment, the statutory provisions apply.

7.6. The place of performance for payments is Laupheim.

8. Third-Party Claims

8.1. The Supplier shall be liable for ensuring that the delivery, and the correct use and correct operation thereof, does not constitute an infringement of patents or other third-party intellectual property rights including copyright.

8.2. The Supplier undertakes to indemnify us against any third-party claims brought against us for infringements of such intellectual property rights effected by or attributable to the Supplier. Indemnification shall be provided upon first written request.

8.3. The Supplier shall notify us of the existence of related intellectual property rights which, in view of the purpose of the contract, could pose a problem.

9. Order Documentation

9.1. Drawings and documents, particularly those which we require for the setting up, operation and maintenance or repair of the delivery item, shall be provided free of charge by the Supplier, in good time and without the need for a request.

9.2. All information, drawings, designs, films, originals, analysis methods, instructions and other documents on the manufacture and/or testing of the delivery item, that are made available to the Supplier, must be returned to us on request for our own continued exclusive cost-free use and must not be utilised for other purposes, copied or made available to third parties.

9.3. The same applies to the documents/items referred to under 9.2, which the Supplier has manufactured according to our information and/or on our behalf, or which are to be acquired by us. In the case of copyrighted work, we shall be entitled to the exclusive right of use.

9.4. The Supplier shall regard the order, and the work based thereon, as a trade secret and treat it confidentially. The Supplier shall be liable for all damages which we incur as a result of the breach of this duty.

10. Audits

10.1 In the case of GMP suppliers, we shall be entitled to carry out GMP-compliant audits at the Supplier's premises every 2 years. The audit shall take place during normal working hours and may last up to 2 days. It shall take place at times to be agreed between ourselves and the Supplier. We shall give at least 3 months' prior notice of such audits. The audit right includes the right to inspect any facility used by the Supplier or an approved subcontractor for the manufacture and/or delivery of products and to test all scientific processes and records relating to the manufacture and/or delivery of products insofar as such tests are not incompatible with the aforementioned valid laws and conditions.

10.2 Compliance with the human rights strategy at our direct suppliers is checked by means of appropriate control mechanisms and their risk-based implementation. To this end, the supplier grants us the right, in the event of a risk identified by us, to carry out controls with regard to compliance with the prohibitions relating to this risk, (i) through our own on-site control, (ii) through third parties mandated with audits and, (iii) through the use of approved certification or audit systems, insofar as these guarantee the implementation of independent and appropriate controls.

11. Compliance and Combating Corruption

11.1. The Supplier shall ensure strict compliance with the applicable statutory prohibitions relating to bribery of public officials and private persons, in particular (but not exclusively) in the health sector, to the exertion of undue influence and to money laundering. This includes inter alia the German Criminal Code, the German Law on Minor Offences (OWiG), the US Foreign Corrupt Practices Act of 1977 and the UK Bribery Act of 2010.

11.2. The Supplier undertakes to implement and transpose all the necessary directives and measures for the prevention and avoidance of corruption. The Supplier declares that, to its knowledge, its legal representatives, managing directors, employees and agents, do not, either directly or indirectly, offer, take, approve, authorise, request or accept money or other items of value, or any advantage or gift, vis à vis persons, companies or organisations of any sort, including government representatives or government employees, for the purpose of exerting influence over such persons in their public capacity or for the purpose of rewarding or bringing about the improper execution of the duties or work of such persons in order to gain or keep business for the Corporation or to bring about advantages for the business activities of the Corporation.

11.3. The Supplier undertakes and guarantees that it will observe the relevant prohibitions under competition and cartel law and, in particular, that it has not entered into anticompetitive practices with other market players, suppliers or customers, nor will it do so.

11.4. The Supplier undertakes and guarantees that it will observe the relevant prohibitions under competition and cartel law and, in particular, that it has not entered into anticompetitive practices with other market players, suppliers or customers, nor will it do so.

11.5. Supplier hereby agrees that the Rentschler’s Supplier Code of Conduct, available at https://rentschler-biopharma.com/supplier-code-of-conduct/, is incorporated into the respective legal transaction by this reference and is complied with by Supplier. The supplier shall address the Code of Conduct appropriately along the supply chain.

11.6. We can require proof of compliance with the aforesaid standards, by way of appropriate documentary evidence or declarations from the Supplier, at any time. The Supplier further undertakes to precisely document compliance with this contractual clause for a reasonable period of time following termination of this contract.

11.7. The Supplier shall inform us forthwith and in writing of the breach of any clause of this contract.

11.8. Where, in our view, there are sufficient grounds for believing that the Supplier has breached one of the foregoing clauses, we shall be entitled to suspend implementation of this contract without notice for as long as we consider it necessary to investigate the relevant conduct. The Supplier shall have no right to claim compensation for the suspension of implementation.

11.9. Where the Supplier is in breach of one of the said contractual clauses, (i) we are entitled to terminate this contract with immediate effect and (ii) the Supplier is obliged to indemnify us for any loss, damage and all reasonably incurred expenses arising as a result of the breach.

12. Place of Performance, Choice of Law

12.1. Where the Supplier is a trader within the meaning of the German Commercial Code, a legal person under public law or a special fund under public law, the exclusive (and international) place of jurisdiction in respect of all disputes arising from the order shall be that of our registered office in Laupheim. We are however also entitled to bring a claim at the place of performance under these conditions or under a prior-ranking individual agreement, or in the court with general jurisdiction over the Supplier.

12.2. These General Terms and Conditions, and the entire legal relationship between ourselves and the Supplier, shall be exclusively subject to the law of the Federal Republic of Germany, to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods.

As of: June 2024

General Terms and Conditions for Work and Services

1. Conclusion of Contracts

1.1. Unless otherwise agreed in writing, the following General Terms and Conditions shall apply to all - including future - contracts for work and services. Unless otherwise agreed, the Conditions as amended at the time of our order, or at least when last communicated in text form, shall also apply as a framework contract for similar future contracts without the need for us to refer to them again in every case. We hereby expressly reject the validity of the Contractor's general terms and conditions. Any failure on our part to expressly reject them again shall not constitute acceptance.

1.2. These Terms and Conditions of Work and Services shall apply exclusively. All agreements or ancillary agreements must be in writing. Our employees are not authorised to make contractual alterations or ancillary agreements. Ancillary agreements and changes to the contract shall only become legally valid where we confirm them in writing.

1.3. Our orders are deemed valid on submission or confirmation, in writing, and not before. The Contractor shall notify us of any obvious mistakes such as typing errors, miscalculations or omissions. All orders must be confirmed by the Contractor in writing. If we do not receive such confirmation within 3 weeks of sending the order, we shall no longer be bound by our order.

1.4. Any drawings and other documents shall, by virtue of the order confirmation, become part of the contract and thus binding.

1.5. Legally relevant declarations and notifications made by the Contractor in relation to the contract (e.g. setting of deadlines, reminders, rescission) must be submitted in writing, i.e. in written or text form (e.g. letter, email or fax). This shall be without prejudice to formal statutory requirements or other evidence, in particular in case of doubt as to the legitimacy of the person making the declaration.

1.6. Our order number and date must be indicated on all correspondence, invoices and shipping documents.

1.7. Our Terms and Conditions of Work and Services only apply to the commercial and public-law sectors pursuant to Section 310 (1) German Civil Code (BGB).

1.9. Subject to compliance with the statutory requirements, we are entitled to store, process and use the Contractor's personal data to carry out pre-contractual tasks and for the purpose of implementing the contract.

1.10. In the course of initiating the contract and for the purpose of deciding on the formation, implementation (particularly against any partial advance payment or additional securities) and termination of the contractual relationship, we evaluate, possibly by way of commercial credit agencies, the risk of the Contractor failing to effect performance. This may involve the use of a credit score established by way of statistical processes. The corresponding data is generated using the Contractor's address data, company name and information contained in the Companies Register.

1.11. Changes to the nature and scope of performance and other subsequent contractual changes are only deemed to have been agreed where have given our prior express written confirmation. Where the basis of the price calculation changes as a result of such approved changes in performance, new prices must be agreed before continuing.

2. Prices

2.1. Any price indicated in our order shall be legally binding.

2.2. Unless otherwise agreed, the price includes all services and ancillary services provided by the Contractor (e.g. assembly and installation) as well as all ancillary costs (e.g. proper packaging, transport costs including any transport and indemnity insurance).

2.3. The prices specified in our order are deemed to be fixed prices exclusive of statutory value added tax.

2.4. Where contractual performance consists of the regular provision of work and/or services, the Contractor shall take account of any price reductions which occur during the contractual period, including those which are in our favour. This shall apply in particular where the Contractor reduces the prices for services in general or for individual third parties.

2.5. Where we engage the Contractor based on previous orders or pursuant to a permanent agreement on the provision of services, the Contractor shall be obliged to inform us of any changes in specifications, the composition and contents of the materials used and in manufacturing and working procedures, prior to provision of the service and/or manufacture. The foregoing also applies in the case of a change of supplier.

3. Performance Period

3.1. As an essential component of the contract, the performance period(s) specified in the order shall be binding. Where the performance period is not specified in the order, or agreed elsewhere, it shall be 7 working days from conclusion of the contract. Agreed performance periods shall commence on the date on which the order/assignment or letter of confirmation is sent. As soon as the Contractor realises that it is unable to carry out the order on time, in whole or in part, - irrespective of the reasons - it shall notify us forthwith giving the reasons and likely period of the delay.

3.2. The services/work is deemed to have been performed on time where it can be accepted by us on time. In the event of a delay in performance our statutory rights apply. In particular, following the expiry of a reasonable extension of time without result, we are entitled to claim damages in lieu of performance or the reimbursement of expenses. This shall be without prejudice to Clause 3.3.

3.3. Where the Contractor is in delay, we may - in addition to our statutory rights, particularly rescission and damages - claim lump sum compensation for our loss resulting from the delay, in the amount of 0.2% of the net price per full working day, but limited to a maximum of 5% of the net price for the late service. We retain the right to prove that our loss was higher. The Contractor retains the right to prove that there was no loss at all or that the loss was substantially lower.

3.4. Where the Contractor is in delay, we may, following a reminder and expiry of the deadline without result, engage a third party to effect performance of the service. Any additional costs arising as a result shall be reimbursed by the Contractor. This shall be without prejudice to Clause3.3.

4. Performance and Acceptance

4.1. Where the place of performance is unspecified and unless otherwise agreed, performance shall take place at our place of business in Laupheim. The relevant place of performance also constitutes the place of performance as regards the service and any subsequent performance (obligation to effect delivery to us).

4.2. Travel and transport costs as well as travelling time will not be charged to us as part of the performance of services.

4.3. The Contractor's staff shall observe all of the Client's guidelines, including the stipulations contained therein regarding access, safety and conduct and, in certain circumstances (particularly in the case of services in GMP-relevant areas), they shall receive training in this regard, in good time prior to performance, at the Client's request. The Contractor shall ensure that the same is true of the approved sub-contractors.

4.4. The Contractor is not entitled to effect part performance without express approval. Insofar as services take place on our business premises or otherwise with reliance on our business resources, the Contractor shall effect performance during our normal business hours.

4.5. Where remuneration is based on time spent, the Contractor shall prepare a written activity report which must be validated by us. Unless otherwise agreed, the activity reports shall be based on time intervals of 1/10 of an hour (6 min.). The Contractor's remuneration based on time spent shall be due no earlier than submission to us of complete and verifiable activity reports.

4.6. We are only obliged to assist with contractual performance insofar as this has been contractually agreed in line with the statement of work.

4.7. Unless otherwise agreed in the individual case, part performance is not permitted. In any case, part performance which has already taken place shall not constitute an independent transaction.

4.8. The Contractor is obliged to provide detailed documentation in accordance with existing provisions.

4.9. The Contractor shall have a right of set-off or retention only in respect of counter-claims that have been upheld by a final court judgement or are undisputed.

4.10. The Contractor is not entitled to have its contractual performance carried out by third parties (e.g. subcontractors) without our prior written consent. Unless otherwise agreed in the individual case (e.g. where restricted to stock), the Contractor shall bear the procurement risk in relation to its services.

4.11. The risk of accidental destruction or accidental deterioration of the item shall pass to us on handover at the place of performance. Where an acceptance procedure has been agreed, this shall determine the transfer of risk. On acceptance, the statutory provisions of the law on contracts for work shall also apply in other respects.

4.12. In the event that we default on acceptance, the statutory provisions shall apply. However, the Contractor must also expressly offer us its work even where a specific or specifiable calendar period has been agreed for action or assistance on our part. Where we are in default, the Contractor can require compensation for its additional costs in accordance with the statutory provisions. Where the contract relates to the manufacture by the Contractor of a unique item (individual product), the Contractor shall only have additional rights where we have undertaken to provide assistance and are responsible for the failure to provide assistance.

4.13. Unless otherwise agreed in an individual contract, formal acceptance must take place in the case of a contract to produce a work. Where acceptance or pre-acceptance takes place at the Contractor's registered office, the Contractor must notify us of this in writing at least two weeks prior to the envisaged acceptance date. Together with the Contractor, we will prepare an acceptance report relating to the acceptance procedure. During every acceptance or pre-acceptance procedure, the Contractor shall submit the appropriate safety data sheets and test certificates relating to the materials used.

4.14. Where contractual performance consists of the regular provision of work and/or services, there will be a monthly statement of account. This shall be without prejudice to Clauses 4.5 and paras. 7.

5. Guarantee, Damages, Reimbursement of Costs

5.1. Unless otherwise specified, our rights in the case of material defects, defects in title and defects in the quality of services (including incorrect and short delivery, improper assembly, defective instructions on assembly, operation or use or non-compliant or defective provision of services) and in the case of other breaches of duty by the Contractor, shall be governed by the statutory provisions.

5.2. Under the statutory provisions, the Contractor shall be liable, in particular, for ensuring that the agreed work or services provided correspond to the agreed scope of performance and/or have the agreed properties and condition. The descriptions of the content, quality and scope of services which - e.g. by way of an identification or reference in our order - formed the subject matter of the respective contract or were incorporated into the contract in the same way as these General Terms and Conditions, are in any case deemed to be an agreement on properties and condition. In this regard, it is irrelevant whether the statement of work originates from us, from the Contractor or from a third party, particularly the manufacturer of any materials used by the Contractor.

5.3. The failure to comply with specified performance and consumption figures as well as defects in the parts procured by the Contractor from its sub-contractors/sub-suppliers are also deemed to be defects. The Contractor guarantees that the work and/or services delivered comply with the generally recognised technical rules and, where applicable, the rules on health and safety as well as with any accident prevention provisions binding upon us that are issued by the professional associations. Services must be provided in accordance with the standards of quality and care customary in the field.

5.4. In the event of defective performance, we can at our discretion demand that the defect be remedied or that the service be repeated without defects e.g. by delivering a defect-free item or repeating a service within a reasonable deadline specified by us. Where the Contractor fails to comply with this, we can remedy the defect ourselves or engage a third party to do so and claim compensation for the expenses incurred, or a corresponding credit note, from the Contractor. Where subsequent performance by the Contractor is unsuccessful or unreasonable (e.g. due to particular urgency, danger to operational safety or the threat of disproportionate damage) there is no need to set a deadline; we will notify the Contractor of any such circumstances in advance where possible. In other respects, in the case of a material defect or a defect in title, we are entitled to a reduction in price, or to cancel the contract, in accordance with the statutory provisions. In addition, we have a right to claim compensation for damages and costs in accordance with the statutory provisions.

5.5. The Contractor shall be liable for replacement deliveries and repair work to the same extent as for the original subject matter of performance.

5.6. The Contractor shall bear the costs which it incurs in respect of inspection and subsequent performance (including any removal and installation costs) even where it transpires that there was in fact no defect. This shall be without prejudice to our liability for damages in the case of an unauthorised request to remedy defects; in this case, however, we are only liable where we knew there was no defect or would have known but for our gross negligence.

5.7. A claim by us for damages in lieu of performance only results in the loss of our right to claim delivery once the damages claim has been fulfilled.

5.8. Our claims for subsequent delivery, repair and damages or compensation for costs, arising from material defects or defects in title, delivery of goods or services other than those agreed or delivery of an insufficient quantity ("defective delivery"), shall expire no earlier than 36 months after delivery of the goods or services. Insofar as an acceptance procedure has been agreed, the limitation period shall commence on acceptance. This shall be without prejudice to longer statutory or contractually agreed limitation periods, particularly in the case of fraud on the part of the Contractor. The aforementioned limitation period also applies mutatis mutandis to claims arising from defects in title, although the statutory limitation period for third-party rights in rem to the restitution of property remain unaffected; claims arising from defects in title shall not expire under any circumstances insofar as the third party still has the right to bring a claim against us - particularly in the absence of limitation.

5.9. The limitation period under the German Civil Code (BGB) including the foregoing extension shall apply - in accordance with statute - to all contractual claims under warranty or claims due to a breach of contractual duty. Insofar as we are also entitled to non-contractual claims for damages, the regular statutory limitation period (Sections 195 and 199 BGB) shall apply in this respect unless the applicable limitation period under contract law results in a longer limitation period in the individual case.

6. Indemnification, Insurance

6.1. Where an action is brought against us under producer's liability owing to defective performance on the part of the Contractor, and the Contractor is responsible for product damage, the Contractor shall indemnify us in this regard against third-party claims to the extent that the cause lies within the Contractor's managerial and organisational sphere of control and the Contractor itself is liable vis à vis third parties.

6.2. In accordance with its obligation to indemnify, the Contractor shall reimburse expenses pursuant to Sections 683 and 670 BGB resulting from or in connection with a third-party claim including product recalls undertaken by us. Insofar as it is possible and reasonable to do so, we will inform the Contractor of the content and extent of recall measures and allow it the chance to comment. This shall be without prejudice to additional statutory rights.

6.3. The Contractor shall conclude and maintain business and environmental liability insurance, including cover for instances of product liability, with lump-sum coverage of at least € 5 million per claim for personal injury/material damage. The Contractor shall also conclude and maintain pecuniary loss liability insurance for purely pecuniary loss which is not covered by the business and environmental liability insurance, with lump-sum coverage of at least € 5 million per claim. At our request, the Contractor shall provide appropriate documentary evidence of the existence of the aforementioned insurance policies.

7. Invoice and Payment

7.1. Invoices shall be sent to us for each service indicating order number, order date and item number. Payment periods start to run on the date of receipt of the invoice. Where the ordered service is not performed until after invoicing, the payment period will not commence until complete performance of the service and, where applicable, successful acceptance. Costs that have to be proven by way of data sheets, time sheets etc. will only be recognised, subject to further examination, where this documentation has been confirmed by us.

7.2. The Contractor may only assign its right to receive payment with our prior consent. Such consent may not be refused without good cause.

7.4. Unless otherwise agreed, we will settle invoices following performance or, where agreed, following successful acceptance and submission of an auditable invoice, by bank transfer or crossed cheque and, at our discretion, either within 14 days subject to 2% discount or within 60 days net.

7.5. We are not subject to interest on late payments. In the event of default on payment, the statutory provisions apply.

7.6. The place of performance for payments is Laupheim.

8. Third-Party Claims

8.1. The Contractor shall be liable for ensuring that its work, and the correct use thereof by us, does not constitute an infringement of patents or other third-party intellectual property rights including copyright.

8.2. The Contractor undertakes to indemnify us against any third-party claims brought against us for infringements of such intellectual property rights effected by or attributable to the Contractor. Indemnification shall be provided upon first written request.

8.3. The Contractor shall notify us of the existence of related intellectual property rights which, in view of the purpose of the contract, could pose a problem.

9. Order Documentation

9.1. Drawings and documents, particularly those which we require for operation, maintenance or repair of the item installed by the Contractor or in order to use the work provided by the Contractor, shall be provided free of charge by the Contractor, in good time and without the need for a request.

9.2. All information, drawings, designs, films, originals, analysis methods, instructions and other documents on the manufacture and/or testing of the delivery item, that are made available to the Contractor, must be returned to us on request for our own continued exclusive cost-free use and must not be utilised for other purposes, copied or made available to third parties.

9.3. The same applies to the documents/items referred to under9.2, which the Contractor has manufactured according to our information and/or on our behalf, or which are to be acquired by us. In the case of copyrighted work, we shall be entitled to the exclusive right of use.

9.4. The Contractor shall regard the order, and the work based thereon, as a trade secret and treat it confidentially. The Contractor shall be liable for all damages which we incur as a result of the breach of this duty.

10. Audits

10.1 Where, in the case of GMP services, the quality of the work cannot be measured solely by way of work carried out on site at our premises and by us (e.g. in the case of calibration work using reference standards provided by the Contractor), we shall be entitled to carry out annual GMP-compliant audits at the Contractor's premises, where required. We will carry out the auditing during normal working hours and at times agreed well in advance with the Contractor. We shall give at least 3 months' prior notice of such audits.

10.2 Compliance with the human rights strategy by our (direct) contractors is checked by means of appropriate control mechanisms and their risk-based implementation. To this end, the contractor grants us the right, in the event of a risk identified by us, to carry out controls with regard to compliance with the prohibitions relating to this risk, (i) through our own on-site control, (ii) through third parties mandated with audits and, (iii) through the use of approved certification or audit systems, insofar as these guarantee the implementation of independent and appropriate controls.

11. Compliance and Combating Corruption

11.1. The Contractor shall ensure strict compliance with the applicable statutory prohibitions relating to bribery of public officials and private persons, in particular (but not exclusively) in the health sector, to the exertion of undue influence and to money laundering. This includes inter alia the German Criminal Code, the German Law on Minor Offences (OWiG), the US Foreign Corrupt Practices Act of 1977 and the UK Bribery Act of 2010.

11.2. The Contractor undertakes to implement and transpose all the necessary directives and measures for the prevention and avoidance of corruption. The Contractor declares that, to its knowledge, its legal representatives, managing directors, employees and agents, do not, either directly or indirectly, offer, take, approve, authorise, request or accept money or other items of value, or any advantage or gift, vis à vis persons, companies or organisations of any sort, including government representatives or government employees, for the purpose of exerting influence over such persons in their public capacity or for the purpose of rewarding or bringing about the improper execution of the duties or work of such persons in order to gain or keep business for the Corporation or to bring about advantages for the business activities of the Corporation.

11.3. The Contractor undertakes and guarantees that it will observe the relevant prohibitions under competition and cartel law and, in particular, that it has not entered into anticompetitive practices with other market players, suppliers or customers, nor will it do so.

11.4. The Contractor shall observe the relevant export controls. Where, following conclusion of the contract, it transpires that its implementation would be in breach of valid export control provisions, the Contractor hereby declares that it is willing to adapt or cancel the contract, taking account of its own interests.

11.5. Contractor hereby agrees that Rentschler`s Supplier Code of Conduct, available at https://rentschler-biopharma.com/supplier-code-of-conduct/, is incorporated into the respective legal transaction by this reference and is complied with by Contractor. The Contractor shall address the Code of Conduct appropriately along the supply chain.

11.6. We can require proof of compliance with the aforesaid standards, by way of appropriate documentary evidence or declarations from the Contractor, at any time. The Contractor further undertakes to precisely document compliance with this contractual clause for a reasonable period of time following termination of this contract.

11.7. The Contractor shall inform us forthwith and in writing of the breach of any clause of this contract.

11.8. Where, in our view, there are sufficient grounds for believing that the Contractor has breached one of the foregoing clauses, we shall be entitled to suspend implementation of this contract without notice for as long as we consider it necessary to investigate the relevant conduct. The Contractor shall have no right to claim compensation for the suspension of implementation.

11.9. Where the Contractor is in breach of one of the said contractual clauses, (i) we are entitled to terminate this contract with immediate effect and (ii) the Contractor is obliged to indemnify us for any loss, damage and all reasonably incurred expenses arising as a result of the breach.

12. Place of Performance, Choice of Law

12.1. Where the Contractor is a trader within the meaning of the German Commercial Code, a legal person under public law or a special fund under public law, the exclusive (and international) place of jurisdiction in respect of all disputes arising from the order/assignment shall be that of our registered office in Laupheim. We are however also entitled to bring a claim at the place of performance under these conditions or under a prior-ranking individual agreement, or in the court with general jurisdiction over the Contractor.

12.2. These General Terms and Conditions, and the entire legal relationship between ourselves and the Contractor, shall be exclusively subject to the law of the Federal Republic of Germany, to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods.

As of: June 2024