Terms and Conditions of Purchase Boehringer Ingelheim, spol. s.r.o.

Boehringer Ingelheim, spol. s r.o. ("Boehringer Ingelheim ") places orders exclusively under the following Terms and Conditions of Purchase ("TCP"). The TCP in force at the time of contract conclusion is applicable. Boehringer Ingelheim is not bound by contradictory terms and conditions of business, sale, or delivery issued by the Supplier. The Supplier acknowledges the exclusive applicability of Boehringer Ingelheim ’s TCP upon acceptance but at the latest upon time of order fulfilment, even if Supplier makes reference to Supplier’s own terms and conditions. Acceptance and/or payment of the deliveries and services of the Supplier does not constitute Boehringer Ingelheim ’s agreement to the Supplier's terms and conditions. The above provisions also apply if offers or confirmation letters contain clauses that differ from, complement or modify Boehringer Ingelheim ’s TCP. Boehringer Ingelheim hereby expressly objects to such clauses. In instances where an agreement or framework agreement exists between Boehringer Ingelheim and the Supplier and/or Boehringer Ingelheim ’s order makes reference to an existing agreement or framework agreement, and such agreement or framework agreement does not regulate a specific legal issue, the respective clause in these TCP shall govern on this specific issue.

1. Offers / purchase orders / subcontractors

Samples, offers, cost estimates and price information from the Supplier are non-binding and free of charge for Boehringer Ingelheim . Purchase Orders (“PO” or “order”) are valid only if made in writing or confirmed by Boehringer Ingelheim in writing. Fax or electronic data exchange also constitutes the written form. Signature shall include electronic signature (e.g., DocuSign®). POs issued by Boehringer Ingelheim are considered accepted if the Supplier does not object by issuing a different order confirmation within five (5) business days following receipt of the written PO. If a deadline for delivery of less than five (5) business days is agreed to, the deadline for cancellation of the order by the Supplier is reduced to the deadline for delivery minus one (1) business day. The cancellation by the Supplier as well as the PO must be made in writing. The content of the PO cannot be assigned in whole or in part to third parties (subcontractors, etc.) without Boehringer Ingelheim ’s written consent.

2. Delivery / acceptance / REACH ordinance

The Supplier warrants timely compliance with the agreed delivery date. Partial or early deliveries require the express consent of Boehringer Ingelheim. If no deadline is agreed, delivery or service shall be provided immediately. The Supplier must notify Boehringer Ingelheim immediately of potential delivery delays, including its duration, its reason, and provide a new binding delivery date; the Supplier must obtain a approval in this regard from Boehringer Ingelheim.

Unless otherwise provided for in the PO, delivery is DAP (Delivered At Place) under INCOTERMS 2020 at the cost and risk of the Supplier. The Supplier undertakes to comply with all legal (in particular, export and customs and controlled goods and sanction party lists) and technical requirements for the respective shipment. The delivery to Boehringer Ingelheim must be marked so that the products (“products” shall mean merchandise and goods as well) under contract can be clearly identified and tracked. In particular, they must include a delivery note, PO number, PO items and recipient of the goods. The products ordered must also meet the EU's rules of origin; the Supplier must send the corresponding certificate of origin without further request to Boehringer Ingelheim.

Deliveries and services must be accepted in the presence of the Supplier or of the subcontractor acting on the Supplier's behalf, e.g., the shipper. If the delivery or service must be put into operation or use in order to be inspected for defects, acceptance will not take place until the testing operations have been completed successfully.

In the event of delayed or incomplete delivery, Boehringer Ingelheim is entitled to withdraw from the Supplier or to demand delivery after granting a grace period. In addition, in the event of delayed delivery, Boehringer Ingelheim has the right (without prejudice to further claims for compensation of damage) to demand a contractual penalty, not subject to the court's right of reduction or abatement, in the amount of 1% of the order value for each new week of delayed delivery, not to exceed 10% of the order value (gross price of the respective PO).

The Supplier confirms that all deliveries comply with regulations under EU law, in particular the REACH ordinance (EC) No. 1907/2006, RoHS directive 2011/65/EU and the WEEE directive 2012/19/EU as amended from time to time.

The Supplier is required under Article 7 or 8 of the REACH ordinance (EC) No. 1907/2006 Boehringer Ingelheim to submit its pre-registration, registration or approval to Boehringer Ingelheim without further request and before performance of service.

Further, the Supplier undertakes to send Boehringer Ingelheim the current safety data sheets under Article 31, REACH ordinance, at the time of order placement and following all changes to the safety data sheet, c/o the following central e-mail address: GBSEHSSGlobalServices.MAN@boehringer-ingelheim.com.

The Supplier's violations of the duties under this Section entitle Boehringer Ingelheim to withdraw from the contract/the order.

3. Dispatch / prices / invoices

The figures determined by Boehringer Ingelheim upon initial inspection are definitive for the quantities, measurements, and weights of a delivery.

Boehringer Ingelheim will immediately inform the Supplier in writing of any defects in the delivery once they are identified/found during the course of ordinary business. This may not occur until further use. The Supplier waives any objection to delayed notification about defects under Section 377 UGB (Commercial Code). Undisclosed defects entitle Boehringer Ingelheim to submit warranty claims and/or claims for compensation of damage at any time. Any payments made do not constitute acknowledgement of proper delivery.

Final prices agreed are maximum prices. For shipments, they include all shipping and packaging costs. Unless otherwise provided for in the order, delivery is DAP (Delivered At Place) under INCOTERMS 2020. Sales tax will be listed separately.

Unless otherwise agreed, payments will be made (net) within 45 calendar days of delivery and receipt of the invoice.

Invoices must correspond to the applicable requirements under tax law and must include the relevant Boehringer Ingelheim tax number. Otherwise, they will be returned to the Supplier and will not be due for payment.

Exchange rate and currency fluctuations, along with bank fees, will be borne by the Supplier.

In the event of delay in payment, default interest shall be charged at the rate provided for in the statutory laws shall be charged. The date of the transfer order shall be deemed the date of payment.

Travel net costs shall only be reimbursable by Boehringer Ingelheim when they (i) were agreed to by Boehringer Ingelheim in writing and (ii) the Supplier submits the original receipts at actual costs. The currently valid version of the “Boehringer Ingelheim(BI ) Travel Expense Guideline for Contractors/Suppliers” is available online at Dokumente | Boehringer Ingelheim Österreich (boehringer-ingelheim.com) and shall apply mutatis mutandis.

4. Taxes

All payments stated shall be inclusive of any taxes and each party shall be responsible for and shall bear, pay, or set-off its own taxes assessed by a tax or other authority except as otherwise set forth in the contract. “Taxes” shall mean all forms of preliminary or finally imposed taxation, domestic and foreign taxes, fees, levies, duties and other assessments or charges of whatever kind (including but not limited to sales, use, excise, stamp, transfer, property, value added, goods and services, withholding and franchise taxes) together with any interest, penalties or additions payable in connection therewith.

The price is understood to be exclusive of value added tax (VAT) or comparable indirect taxes (e.g. goods and service tax, etc.). VAT and comparable indirect taxes must be paid additionally as required by law.

As far as expenses are reimbursed the VAT on any reimbursed expenses may only be reimbursed by Boehringer Ingelheim provided the Supplier cannot deduct VAT and such inability is not due to default (e.g., delay) on the part of the Supplier.

If applicable laws or regulations require withholding by Boehringer Ingelheim of any taxes imposed upon Supplier on account of any royalties and other payments made under this contract to benefit of Supplier, such taxes have to be retained by the proper tax authorities on account of the Supplier. Official receipts of payment of any retained local withholding tax shall be secured and sent by Boehringer Ingelheim to the Supplier as evidence of such payment only upon the Supplier´s request. The parties shall cooperate and exercise their best efforts to ensure that any withholding taxes imposed on Supplier are reduced as far as possible under the provisions of any relevant double tax treaty. Witholding taxes retained by Boehringer Ingelheim and paid to the proper local tax authorities as well as a possible refund of retained and paid local withholding taxes from the local tax authorities in favor of Contractor are paid in local/Czech currency. Any effect by currency conversion is benefit or burden of Supplier as tax-payer and are not refundable or taken by Boehringer Ingelheim.

5. Warranty / liability / insurance

The Supplier warrants the use of the best suitable material, along with correct and proper execution, taking account of the latest state of the art. Supplier warrants full compliance of the merchandise sold with the samples, models and descriptions delivered by it. The information provided by the Supplier in relation to the sales negotiations, but especially in catalogues, advertising materials, public statements, data sheets and/or other product descriptions including product surveys by Boehringer Ingelheim , are considered to be the contractually agreed product characteristics. In this regard, the Supplier further warrants that the products will have the agreed contractual characteristics; at a minimum, however, the products will be available for use as required under the contract or will have the characteristics that are typical for (or expected of) goods of the same type and quality.

If the products ordered by Boehringer Ingelheim are used to manufacture pharmaceutical and/or medical products and/or cosmetics and/or food, the World Health Organisation's good distribution practices for the pharmaceuticals industry as amended from time to time shall apply.
The Supplier shall hand over the goods or services under the contract, with all work products, to Boehringer Ingelheim ; the right to use and dispose of the goods or services to be provided by the Supplier along with the work products, including know-how (regardless of manner) is assigned exclusively, irrevocably and without limitation to Boehringer Ingelheim.

On the basis of the transferred rights, Boehringer Ingelheim is entitled to apply worldwide for intellectual property rights in its own name and at Boehringer Ingelheim ’s own expense and to use the invention while naming the inventors. If necessary, the Supplier shall assist with the issuance and maintenance of these intellectual property rights using any declarations required by Boehringer Ingelheim.

The Supplier must indemnify Boehringer Ingelheim and hold Boehringer Ingelheim harmless from disputes arising from intellectual property or industrial property rights and warrants unrestricted use of the goods delivered.

In the event of defective delivery, Boehringer Ingelheim is entitled to demand improvement and/or replacement delivery at no cost to Boehringer Ingelheim , a reasonable price discount, or complete or partial cancellation of the order. Any expenses Boehringer Ingelheim incurs as a result, such as for transport, travel, labour, materials or the costs of any work in excess of the ordinary inspection of incoming goods will be borne by the Supplier. If the Supplier does not comply with Boehringer Ingelheim ’s written request to remedy the defect within a reasonable deadline set by Boehringer Ingelheim , Boehringer Ingelheim can perform the required activities itself, or have the activities performed by a third party, at the Supplier's cost. Boehringer Ingelheim can remedy minor defects, or have them remedied, immediately and at the Supplier's cost. If Boehringer Ingelheim exercises its legal right to withdraw from the contract, the goods will be returned to the Supplier at their place of origin at the Supplier's risk and cost. Boehringer Ingelheim is also entitled by law to file claims for compensation of damage due to non-performance and damage that is not caused to the subject of delivery itself.

The period of limitation to report defects is 24 months. For the delivery of goods, it begins upon handover; for contracts for work and services, it begins upon acceptance, i.e. at the time the risk is transferred. Once the defects are remedied in full, the warranty period will recommence.

The Supplier is liable to Boehringer Ingelheim for all types of fault, in particular for all types of negligence of its employees or other agents. The Supplier shall be liable for the fault of its vendors and Suppliers as it would be for its own fault.

The Supplier will indemnify Boehringer Ingelheim from claims, regardless of legal reason, that are made by Boehringer Ingelheim ’s contract partners and other third parties for any violation or contractual or collateral contractual duties (whether due to negligence or intent) or for non-contractual duties of care of the Supplier. This applies in particular to product liability claims that result from a faulty product of the Supplier, regardless of who is considered the manufacturer of the final product under liability laws. In this regard, the Supplier must prove that the goods delivered to Boehringer Ingelheim were not defective. It will cover any resulting costs and expenses (including the costs of any legal disputes or required retrofit or recall campaigns).

At Boehringer Ingelheim ’s request, the Supplier must document employers' liability and product liability insurance that is customary in the market and adequate for the risk by presenting a valid insurance certificate to Boehringer Ingelheim.

6. Additional provisions for services

The type, scope and costs of services are described in detail in a confirmation of services rendered or in the order. In the event of changes, an order change must be agreed by the parties. Otherwise, the Supplier cannot demand payment for these changes. The Supplier must inform Boehringer Ingelheim immediately in writing about any changes once it obtains knowledge of them. Services will be billed either as fixed prices, based on time and materials, or as hourly rates; in the latter case, a maximum amount of billable hours will be agreed. For services billed hourly, only the actual hours worked can be billed. Payment will be made based on itemised bills to be approved by Boehringer Ingelheim . The Supplier warrants that it will perform the services to the best of its knowledge and belief and according to the state of the art. The warranty provisions under Section 5 will apply accordingly. The Supplier warrants that it will use only qualified personnel to perform the services. These employees will be listed on the itemised bills. The Supplier will not replace employees without a legitimate reason. In each case, prior written consent must be obtained from Boehringer Ingelheim . The Supplier undertakes to immediately oblige its employees, contractors, etc. involved in the project (commissioned services) to follow the same duties of confidentiality that it is bound by under these TCP.

The Price shall include all costs and expenses of the Supplier [including all service fees (such comprising all internal costs) and out-of-pocket expenses (such as deliveries, accommodation, production, and travel “pass-through costs”)] incurred by the Supplier in connection with the Services, except for such costs and expenses that are explicitly excluded from the Price in the PO.

Boehringer Ingelheim shall only pay invoices for pass-through costs if (i) they are defined in the respective PO or are otherwise approved by Boehringer Ingelheim and (ii) the Supplier provides the original receipts or invoices to Boehringer Ingelheim . Supplier shall not make a profit on these pass-through items, other than by means of the time/service charges payable to it under the terms of the Agreement or a PO pursuant hereto. All pass-through costs shall be billed to Boehringer Ingelheim at actual cost, without any profit, overhead, or general administration charges or markup applied to such expenses by the Supplier Any and all discounts, rebates and allowances received by the Supplier on pass-through costs shall be passed on to Boehringer Ingelheim.

Boehringer Ingelheim shall be entitled to terminate its placed order at any time and with immediate effect. In such case, however, Boehringer Ingelheim shall be obliged to compensate the Supplier for all Services it has hitherto rendered pursuant to the specification of services. Costs the Supplier incurs for obligations the Supplier has already entered into at the time it received notice of termination shall likewise be refunded, provided those obligations comply with the specification of services and the Supplier is unable to terminate them. The right of both parties to terminate the contract without notice for cause shall remain unaffected.

Unless otherwise agreed in writing, Supplier shall irrevocably and exclusively assign all registrable and non-registrable intellectual property rights (hereinafter "IP Rights") created within the scope of its work and its work results for Boehringer Ingelheim (hereinafter “Results”) to Boehringer Ingelheim so that Boehringer Ingelheim then acquires ownership of them. If assignment of the IP Rights, such as the case with copyrights, is not legally possible, then Supplier shall grant Boehringer Ingelheim an exclusive right that is unrestricted in time, location, or content (including reproduction, revision and translation rights) to use the Results for all purposes and in all known and as yet unknown ways by Boehringer Ingelheim itself or by third parties and to assign these rights in whole or in part to third parties. The assignment of IP Rights shall be effective at the time the services are performed.

Upon Boehringer Ingelheim ’s request all agreed upon deliverables, including the Results, prepared by the Supplier shall be made available to Boehringer Ingelheim in compatible electronic formats appropriate for the Results and stipulated by Boehringer Ingelheim , such as office software file formats (.docx, .xlsx, .pptx, .pdf); video, animation, audio or virtual reality file formats; or web code. In addition, the source files generated in the design and creation of the final Results shall be provided and packaged according to Boehringer Ingelheim guidelines, such as files created by Adobe InDesign, Adobe Photoshop, Adobe Illustrator, Adobe Premier, etc. The Results in final format and source files shall be uploaded free of charge to Boehringer Ingelheim’s Digital Asset Management (DAM) system upon completion of work and any relevant approvals, such as Medical Legal Review (MLR) Approval, including the assignment of corresponding metadata. In addition, upon Boehringer Ingelheim ’s request, the Supplier shall provide (if any) any and all stock creative components (such as stock photos, stock video, stock audio, logos, icons, etc.) provided by the Supplier or purchased or created on behalf of Boehringer Ingelheim for use in the Results, including all licensing information with respect to any such material, design or any other information, according to Boehringer Ingelheim provision guidelines for the DAM provided by Customer.

7. Transfer of ownership

It is agreed with the Supplier that ownership of the ordered goods will be transferred to Boehringer Ingelheim upon payment. The Supplier warrants that there are no third party rights to the delivered goods. Retention of title will not be extended or passed on to the Supplier.

8. Quality

The Supplier must produce the products under the contract for delivery, taking account of the environmental, safety and legal requirements applicable to the relevant products under the contract, of the ISO standards, etc., the generally accepted rules of engineering and of standard market quality requirements; it must also perform inspections on these products. The Supplier will maintain a standard market quality management system; it will maintain and further develop this for the time of collaboration in line with the relevant standards. Furthermore, an escalation process and deviation process shall be established by the Supplier, which ensures that the information on the deviation is passed on to their customers. “Deviation” is understood as deviation from agreements, work procedures, specifications or established standards.

The Supplier must inform Boehringer Ingelheim in advance and in good time about any changes to the products under the contract and the processes in its company. This also applies to products that the Supplier obtains from third parties. In the event of planned changes to the manufacturing or inspection process or a change in manufacturing location, the Supplier must inform Boehringer Ingelheim immediately in writing. Boehringer Ingelheim retains the right in all cases to inspect the products again following the aforementioned changes in line with the rules of Boehringer Ingelheim ’s product qualification process and/or to subject these products to a technical approval procedure; Boehringer Ingelheim can reject the changes if these changes prevent the product from passing Boehringer Ingelheim ’s product qualification process. Those changes include changes that deviate from the agreed "specification", manufacturing process, batch number, manufacturing location (also applies to sub-contractors), discontinuation of service, material durability, primary packaging materials, materials of animal origin, as well as a change of company name and address. Boehringer Ingelheim reserves the right to audit the Supplier or its affiliated companies upon request.

9. Intellectual property rights / confidentiality / materials

Drawings, models, samples, tools and documents of all kinds that are produced by Boehringer Ingelheim or based on Boehringer Ingelheim specifications are Boehringer Ingelheim property and cannot be used for third parties or otherwise made accessible to them.

The Supplier shall be liable for ensuring that the samples, brands, models, drawings, descriptions and documentation it provides are free of third party rights and that, in particular, intellectual property rights of third parties are not violated. The goods delivered must correspond to legal regulations and official requirements. In all cases, the Supplier will indemnify Boehringer Ingelheim from violations of these rights and regulations in the event of third-party claims for compensation of damage.

The Supplier undertakes not to disclose any confidential information provided to it, along with knowledge that it obtains during order fulfilment. This obligation shall apply even after order fulfilment. The Supplier also agrees not to use this information for itself or have it used by third parties on its behalf. The documents generated within the scope of the work shall be retained by the Supplier at least for the statutorily defined periods. On the request of Boehringer Ingelheim , after order fulfilment or notification that the order will not be placed / will be cancelled, all confidential information, including all copies made (except for a copy to document compliance with the confidentiality agreement), must be returned to Boehringer Ingelheim.

Without the prior consent of Boehringer Ingelheim, the Supplier cannot make direct or indirect reference to its work for Boehringer Ingelheim , i.e. in particular it cannot name Boehringer Ingelheim as a reference client or use brands, logos, etc. of Boehringer Ingelheim. This also applies with regard to other Boehringer Ingelheim group companies.

Materials/parts provided remain Boehringer Ingelheim property, must be stored separately by the Supplier, and are to be used only for the Boehringer Ingelheim order. Upon processing, Boehringer Ingelheim becomes the direct owner of the new or converted items. The Supplier shall be liable for damage or loss, even if it was not at fault.

10. Applicable law / place of performance / venue

All disputes arising from or in regard to the contract are subject exclusively to Czech law, with the exclusion of the UN Convention on the International Sale of Goods and international conflict of laws rules. The location of fulfilment for delivery is the relevant named place of destination. All disputes will be handled by the court with local and material responsibility for commercial matters in Prague, Czech Republic.

11. Force majeure

Force majeure, labour disputes, business disruptions without fault, unrest, official measures and other unavoidable incidents will indemnify Boehringer Ingelheim for their duration from the obligation to accept the subject matter of the contract by a deadline. During such incidents and for two (2) weeks after their conclusion, without prejudice to Boehringer Ingelheim ’s other rights, Boehringer Ingelheim is entitled to withdraw in whole or in part from the contract if these incidents are of a considerable duration.

12. Software

Unless otherwise agreed in an individual contract, the Supplier shall grant Boehringer Ingelheim at a minimum an exclusive, non-transferable and perpetual right of use to software and hardware products and the related documentation. For the purposes of data backup, Boehringer Ingelheim is entitled to make copies. Boehringer Ingelheim is also entitled, with reference to any copyright notices by the author, to provide these to Boehringer Ingelheim customers for the purposes of contractual fulfilment. The Supplier warrants that the software and its data structure are without errors and that it has made proper copies.

13. Compliance / Anti-Bribery/Anti-Corruption / Data Protection / Trade Compliance/Export Control/ Pharmacovigilance/ ESG (Environment, Social and Governance) & Sustainability

Supplier Code of Conduct/UN Global Compact:

The Supplier warrants that it will perform the Services in strict compliance with all applicable Laws, including labour Laws and Laws relating to environment, health and safety. Boehringer Ingelheim is committed to the fundamental principles of corporate responsibility and integrity, human rights, working standards and anti-corruption laws as set forth in the "Supplier Code of Conduct" available online Dokumente | Boehringer Ingelheim Österreich (boehringer-ingelheim.com). The Supplier acknowledges these fundamental principles. Where a provision of a agreement or a PO is more stringent than a provision of the Supplier Code of Conduct, the provision of the respective agreement or the PO shall prevail.

Anti-Bribery/Anti-Corruption (ABAC):

The Supplier represents that it, its owners, its members of the board and the supervisory board, directors, employees, sub-Suppliers and agents will act in compliance with any applicable anti-bribery/anti-corruption (ABAC) laws and regulations in connection with Boehringer Ingelheim’s business operations or this contract and will not, directly or indirectly, (i) offer, promise or give a bribe, any benefit or advantage to any Public Official or any other third party including legal entities in exchange for an improper advantage, in particluar (a) to comply with regulatory requirements, (b) to enter into transactions of any kind, including business transactions in which Boehringer Ingelheim is involved, (c) to obtain any other improper advantage; (ii) except where there is a legal obligation, give anything of value to any Public Official without the prior written approval by Boehringer Ingelheim , regardless of whether or not such benefit might constitute a bribe; (iii) give anything of value to any third party for the purpose of offering, promising or giving a bribe or any other improper advantage to a Public Official or to reimburse a sub-supplier, agent or any other third party for such bribe or any other improper advantage; (iv) request, accept a promise of or receive any payment, benefit or other advantage from any third party for oneself or for a third party in exchange for an improper advantage in the procurement of goods or services in connection with this contract.

For the purpose of this contract, “Public Official” means any officer, employee or representative of a national or foreign government international organization and of any respective associated department, agency, institution and organization, including public companies and political parties as well as any person acting in an official capacity for any such government, international organization, department, agency, institution and organization as well healthcare professionals, working in healthcare institutions, in which the national, regional or local government owns an interest or which are financed partly or as a whole by the respective government.

The Supplier shall report violations of this ABAC clause to Boehringer Ingelheim.

The Supplier shall ensure that its owners, its members of the board of directors and the supervisory board, directors, employees, sub-suppliers, and agents receive, if necessary, appropriate ABAC training and are informed of the obligations under this ABAC clause.

Boehringer Ingelheim shall have the right to audit Supplier’s records at its own costs and in case of reasonable suspicion of any violation of this ABAC clause upon reasonable prior notice, to ensure Supplier’s compliance with this ABAC clause, applicable laws and regulations. Boehringer Ingelheim shall ensure confidentiality concerning the audit. In addition, upon Boehringer Ingelheim ‘s request, the Supplier shall certify compliance with the foregoing in a form suitable for Boehringer Ingelheim . In case of suspicion of a material breach of this ABAC clause, Boehringer Ingelheim shall have the right to request confirmation by an external auditor as well.

Any violation of this ABAC clause constitutes a material breach of this contract. Therefore, Boehringer Ingelheim shall have the right, without prejudice to any further rights, to terminate this contract for cause and with immediate effect in case of a violation of this ABAC clause by the Supplier.

The Supplier is aware of and acknowledges that Boehringer Ingelheim has the right to exclude any potential contractual partner that engage in bribery, collusive practices or any other form of corruption or fraud from bids for tenders and future business relations.

The Supplier shall indemnify and hold Boehringer Ingelheim harmless for any loss or damage resulting from any violation of the applicable ABAC laws and regulations by the Supplier’s owners, members of the board of directors and the supervisory board or the Supplier’s own negligent conduct that made it possible for its employees, sub-suppliers or agents to violate such laws and regulations in connection with Boehringer Ingelheim ’s business operations or this contract.

Data protection:

In compliance with applicable data protection law (DSG), the Supplier has, to the extent that the Supplier collects, processes or uses personal data on behalf of Boehringer Ingelheim when rendering Services (“Processing”), according to the European General Data Protection Regulation 2016/679 (GDPR) enter into contractual arrangement with Boehringer Ingelheim . Henceforth, due to the GDPR, additional contractual arrangements between Boehringer Ingelheim and the Supplier will be required in order to comply with the GDPR.

In case of abroad transfer of personal data to recipients seated outside the European Union/European Economic Area, which do not provide for an adequate data protection level, such contractual arrangements may include (i) Boehringer Ingelheim’s standard contract for Processing, and/or (ii) the European Union’s Standard Contractual Clauses/Standard Data Protection Clauses for the transfer of personal data to processors and/or (iii) any other agreement that competent data protection authorities have declared to be compulsory or acceptable to comply with data protection law obligations.

Trade Compliance/Export Control:

The Supplier acknowledges that any products, goods, software, technology (specific technical information necessary for the development, production, or use of a product) and technical services provided to Boehringer Ingelheim under this contract (hereinafter “Items”) may be subject to international, EU, U.S. or other applicable trade compliance and/or export control laws and regulations (hereinafter “Laws”) restricting exports, re-exports, transfers or disclosures, regardless of the mode of provision. The Supplier shall comply with all such Laws.

If the Item is subject to any restrictions or license requirements under the Laws, the Contractor shall notify Boehringer Ingelheim about these restrictions accordingly. Upon request, the Supplier shall provide information and other assistance necessary for the classification, export documentation, license determination, export licensing, etc. of Items provided to Boehringer Ingelheim under this contract.

The Supplier confirms that it is neither a Sanctioned Party om terms of UN, U.S., EU or any national Sanctioned Party List nor controlled by a Sanctioned Party to 50% or more. The Supplier shall notify Boehringer Ingelheim without undue delay in case of any changes of this status.

Obligations of the Supplier regarding Pharmacovigilance relating to services:

As used herein an “Adverse Event” or “AE”

means any undesirable and/or unfavorable and unintended medical occurrence in a patient (human or animal) or participant in a clinical study to whom a Boehringer Ingelheim (animal) medicinal product (Boehringer Ingelheim Product) for humans or animals has been administered which is not necessarily related to the respective treatment.

In order to enable Boehringer Ingelheim to comply with its worldwide regulatory reporting responsibility, the Supplier/contractual partner shall forward to Boehringer Ingelheim – in line with applicable law (i.e., data protection law, professional and medical confidentiality obligations) – all information received on an AE and asymptomatic human exposure within one (1) business day after the Supplier became aware of without screening, selection or further processing by email:

For Boehringer Ingelheim product for veterinary use:

Any AE that occurs after any use of a proprietary veterinary product (off-label and on-label uses and misuse). Included are events related to a suspected lack of expected efficacy, noxious reactions in humans after being exposed to the product, a suspected violation of the approved maximum residues limits or a insufficient withdrawal period, a potential environmental problem or a suspected transmission of an infectious agent. A human exposure to a proprietary veterinary product that is not associated with an adverse event, will be defined as asymptomatic human exposure.

For Boehringer Ingelheim product for human use:

i) AEs, including abnormal laboratory values and AEs occurring from drug withdrawal or drug interactions, or associated with a
product complaint or with a falsified BI Product; Boehringer Ingelheim Product information, e.g. interacting drug, product complaint and falsified product information should be included in the report;
ii) reports with or without AE of: drug abuse, misuse, overdose (intentionally or accidentally), errors in drug treatment process
(i.e. medication errors), off-label use of a Boehringer Ingelheim Product (i.e. used in a non-registered indication), lack of efficacy, occupational exposure, suspected transmission of an infectious agent via a BI Product or unexpected benefit;
iii) reports of: embryo or foetus potentially exposed to the BI Product (via mother or semen with/without AE), AEs occurring in breastfed infants.

Unless the Supplier/contractual partner receives different information from Boehringer Ingelheim in writing, the Supplier shall forward all information in English translation on AEs (human and animal use), including on the aforementioned items i) through iii), as it has been received, without screening, selection or further processing, by secure e-mail to the following respective Boehringer Ingelheim PV e-mail address indicating the date of receipt:

For Boehringer Ingelheim product for veterinary use:

E-Mail: AHPV.CZ@boehringer-ingelheim.com

For Boehringer Ingelheim product for human use:

E-mail: PV_local_Czech_Republic@boehringer-ingelheim.com

Boehringer Ingelheim shall confirm receipt of PV Data sent by Supplier/contractual partner in writing, preferably by email. If Supplier/contractual partner does not receive confirmation within on (1) business day, Supplier/contractual partner must contact Boehringer Ingelheim for clarification.
Upon Boehringer Ingelheim ’s request, the Supplier/contractual partner shall provide Boehringer Ingelheim with further information on the respective
AE report.

Depending on the scope of Services under this contract, Boehringer Ingelheim may request the Supplier/contractual partner to comply with additional PV requirements, including but not limited to PV training for the Supplier’s/contractual partner’s personnel engaged in the provision of the
Services. The Supplier/contractual partner agrees to comply with all PV provisions required by applicable law or Boehringer Ingelheim policies (e.g., SOPs) which shall be specified in writing for each Order, as required.

The Supplier/contractual partner shall apply with all archiving and record-keeping requirements according to respective industry standards and applicable law. With regard to records retention the Supplier/contractual partner shall apply its internal processes and systems on records retention.

For projects with Suppliers/contractual partners screening websites and Social Media channels, accounts and handles owned, controlled, or sponsored by Boehringer Ingelheim’s Animal Health Business, the Supplier/contractual partner shall ensure active screening of all incoming information. on a daily basis and perform AE reporting to Boehringer Ingelheim as defined above. For potential AE identified through digital media screening the Supplier must confirm the existence of a valid reporter prior to forwarding to Boehringer Ingelheim. If the reporter directly contacts the Supplier via direct message or email, this reporter is considered valid and the AE report must be forwarded to BI. When a potential AE is identified via means other than direct message or email, the Supplier must attempt to contact the reporter if the Contractor has a means to do so (e.g., account on the platform/site from which to send a message). If the Supplier does not have a means to contact the reporter or if no response is received this is not considered a valid reporter and the event information shall not be forwarded to Boehringer Ingelheim. Records of any contact attempts shall be archived by Supplier and shall be provided at Boehringer Ingelheim’s request.

The Supplier is responsible for ensuring that its staff is adequately informed and trained to comply with the obligations described in this Section and for documenting this training.

ESG (Environment, Social and Governance) & Sustainability

A. Commitment to Sustainability Principles

Supplier hereby acknowledges and commits to Boehringer Ingelheim’s sustainability principles in the fields of ethical business management, environment & climate protection, social standards & human rights as well as implementation of sustainability in supply chain management. Supplier in particular shall apply the detailed principles set forth hereinbelow:

1. Social Standards and Human rights

Supplier complies with applicable laws and regulations in the field of occupational health and safety, protection of workforce, and human rights in Supplier’s (and Supplier’s affiliates’) own operations; Supplier ensures that these standards are respected along its whole value chain including its own suppliers and service providers. As part of its commitment to respect these standards, Supplier establishes adequate due diligence procedures and participates in an appropriate grievance mechanism, including effective investigation and corrective & preventive action mechanism for any identified issues.

2. Environmental Protection and Sustainability

Supplier complies with applicable laws and regulations in the field of environmental protection. Supplier ensures that its processes are designed to limit and reduce its environmental footprint through the life cycle of the products and services it supplies.

3. Governance, Risk Management and Continuous Improvement

Supplier establishes management control and risk management systems that (1) ensure compliance with its contractual commitments and with applicable laws and regulations, (2) provide an understanding of the impact of Supplier’s operations on environment and potentially affected people as well as recognition, effective prevention and prioritization of risks and opportunities arising from its operations and (3) integrate continuous improvement of the systems. As part of such systems, written policies and standards are established and good documentation practices are applied.

B. Reporting and Access to Information

Supplier shall comply with any financial and non-financial reporting obligations applicable to its operations, in particular regarding sustainability and supply chain due diligence. Supplier shall make accessible any related data and information required for Boehringer to comply with Boehringer Ingelheim’s own reporting and due diligence obligations. Within reasonable intervals, Supplier shall also grant Boehringer Ingelheim the right to audit Supplier’s documentation and actual practices to ensure compliance with Supplier’s commitments and obligations under this Agreement.

14. Closing provisions

If any part of these TCP is or becomes void, this shall not affect the remaining terms and conditions or the contract. The relevant provision must be replaced with one that comes closest to the original economic and legal intent.

Statements on behalf of Boehringer Ingelheim are legally binding only if they are made by the required number of authorised representatives, i.e. members of executive management, holders of Prokura (power of attorney) or authorised agents.

The Supplier cannot rescind the contract due to error and/or laesio enormis.

Claims cannot be set off against claims of Boehringer Ingelheim. The Supplier does not have any rights of retention.

There are no verbal or written collateral agreements to this contract. Amendments and addenda must be made in writing; this also applies to a waiver of the written form requirement. Signature shall include electronic signature (e.g., DocuSign®).

A failure by Boehringer Ingelheim to exercise or assert its rights under these TCP does not constitute a waiver of these rights; it expressly reserves the right to later exercise or assertion of these rights.

July 2024