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General Purchasing Terms and Conditions of STADA Arzneimittel AG

(As of July 2022)

1. APPLICABILITY

1.1. These general purchasing terms and conditions (GTCs) shall apply to all business relationships with our suppliers, provided that the GTCs shall only apply if the supplier is an entrepreneur within the meaning of section 14 of the German Civil Code (BGB), a legal entity under public law or a special fund under public law.

1.2. These GTCs shall apply to STADA Arzneimittel AG (STADA) as well as to all entities which are affiliated companies pursuant to direct or indirect application of section 15 of the German Stock Cooperation Act (AktG), provided that such entities invoke these GTCs. To the extent the words “us” or “we” are used hereinafter, this shall be understood to refer to the company (STADA or the affiliated company pursuant to the previous sentence) which has entered into the agreement in question with the supplier and invoked these GTCs.

1.3. The parties agree that our GTCs shall apply exclusively. Divergent, contradictory or additional general terms and conditions of the supplier shall only and only to such extent become part of the agreement in question if we have agreed to their being applicable explicitly and in writing. The above consent requirement shall apply without exception, including for example also in such cases in which we have accepted deliveries by the supplier without reserving further rights despite having knowledge of the general terms and conditions used by the supplier.

1.4. Agreements which were individually negotiated with the supplier on a case-by-case basis (including ancillary agreements, additions and amendments) shall in any case have priority over these GTCs. As far as the content of such individual agreements is concerned, generally (unless proven otherwise) a written agreement or our written confirmation shall be required.

2. CONCLUSION OF AGREEMENT

An agreement shall come into effect if the supplier accepts our order by way of a corresponding written or electronic order confirmation within two (2) weeks after receipt of our order. If we have not received your corresponding order confirmation within 2 weeks, we shall no longer be bound to our offer. An acceptance of our order after the two (2) weeks period referred to above has expired shall be deemed to be a new offer and shall require our acceptance.

3. TERMS OF DELIVERY, TRANSFER OF RISK AND PRICES

3.1. The price which is set out in the order form is binding. The supplier shall make the delivery based on the conditions set out in the Incoterms 2010 “Delivered Duty Paid” (DDP) to the destination designated by us (Geliefert verzollt). The destination shall at the same time also be the place of performance (Erfüllungsort) for the delivery as well as for a potential supplementary performance (Nacherfüllung). The agreed purchase price shall include delivery “free of charge” (frei Haus) including packaging, transport insurance and statutory VAT. Packaging and insurance costs may not be charged separately. To the extent the parties have agreed upon delivery being provided “ex works” (EXW or Ab Werk) or as a debt collectible by the purchaser, then, if the parties nevertheless agree on the dispatch of the product, the cheapest method of delivery shall be used.

3.2. As regards the dispatch note, packaging and labelling of the goods, our at the time of order valid “General Terms and Conditions relating to the dispatch note, packaging and labelling of the goods for orders of STADA Arzneimittel AG” (also referred to as “Annex STADA Arzneimittel AG”) shall apply.

3.3. With each delivery, a delivery note specifying the date (of issuance and of shipment), contents of the delivery (item number and amount/volume) as well as our order reference (date and reference number) shall be enclosed. In cases in which the delivery note is missing or incomplete we cannot be held responsible for delays of processing or payment resulting from this.

3.4. The risk of accidental loss and accidental impairment of the goods shall be transferred to us upon delivery at the place of performance (Erfüllungsort), unless otherwise agreed in writing. To the extent the parties have agreed that an acceptance of the goods (Abnahme) is to take place, then the time of such acceptance shall be decisive for the risk transfer instead. In case an acceptance of the goods has been agreed upon, the applicable provisions of the German contract works law (Werkvertragsrecht as set out in sections 631 et seqq. German Civil Code (BGB)) shall also apply mutatis mutandis in all other respects. If we are in default of acceptance, delivery (Übergabe) and acceptance of the goods shall be deemed to have occurred.

3.5. The conditions pursuant to which our default of acceptance occurs shall be governed by the applicable laws, provided that the supplier shall be obligated to make us an explicit offer of his performance even if for a certain action or contribution owed by us (for example the provision of materials) a determined or determinable calendar date or period of time has been specified. In case we do enter into default of acceptance, the supplier shall be entitled to claim reimbursement for his extra expenses pursuant to applicable law (section 304 German Civil Code (BGB)). If the agreement in question relates to a product which is to be individually manufactured by the supplier and non-fungible (an individual construction / Einzelanfertigung), then the supplier shall only have additional rights if we have agreed to provide the contribution or assistance and we can be held responsible for our failure to provide the contribution or assistance.


4. INVOICES

Invoices shall be sent to us in duplicate promptly after the respective delivery. Conversely, invoices attached to the goods shall be deemed not to have been received by us. Each invoice must specify the responsible contact person referred to in the order form as well as our order number. In each invoice, excesses or shortfalls (if any) shall be identified. Invoices without the specifications made in sentences 3 and 4 can be sent back to the supplier in order to be completed. In case we receive an invoice which is incomplete pursuant to the requirements set out in this clause 4, then for the purposes of the payment term set out in clause 5, the date on which the completed invoice is received by us shall be decisive rather than the date the incomplete invoice was received.


5. PAYMENT TERM

Unless and to the extent not agreed differently by the parties, any payment owed under the agreement shall be due within sixty (60) calendar days of receipt of the correct invoice.

6. DELIVERY AND DELIVERY TERM

6.1. The delivery dates and delivery period specified in the order are binding. The delivery term shall begin on the order date.

6.2. The supplier shall without undue delay notify us of any delays in the delivery or supply, even if such delays are at the time only assumed or suspected. Such notifications shall not prevent or inhibit the supplier entering into default of delivery.

6.3. If the supplier in whole or in part defaults on his obligations to deliver or supply the product, we shall be entitled to rescind the agreement if a reasonable grace period set by us has lapsed without effect. If we rescind the agreement, we are entitled to at the supplier’s costs label the goods delivered by the supplier accordingly, store them separately from other products and ask the supplier to retrieve them. Potential further statutory or contractual claims arising from a default of the supplier shall remain unaffected.

6.4. If a contractual penalty relating to delays in delivery or performance has been agreed upon, this penalty shall remain unaffected as a minimum penalty in the sense of section 340 paragraph 2 German Civil Code (BGB). Such an agreed upon contractual penalty may be claimed at any time up to the due date of the final payment pursuant to the agreement in question and without a previous reservation of the right to claim the contractual penalty as described in section 341 paragraph 3 German Civil Code (BGB) being necessary.

6.5. Partial deliveries and partial performances require our prior written consent. To the extent incomplete deliveries or other performances are made towards us without our prior written consent, no (partial) fulfilment shall occur for such deliveries or performances, with the result that the applicable default provisions shall apply.

6.6. A performance shall not be deemed to have been completed before such time as all agreed upon documentations, in particular analysis certificates, have been handed over to us.


7. DELIVERED QUANTITIES

To the extent not agreed otherwise, the amounts specified in the order shall be deemed to be maximum volumes or amounts (as applicable) which may not be exceeded.


8. DEFECTS INVESTIGATION

8.1. As regards commercial obligations of examination and notification of defects, the relevant statutory provisions (sections 377, 381 German Commercial Code (HGB)) shall apply, provided that: Our obligation of examination shall be limited to defects which become apparent during our incoming goods inspection by way of an external visual examination including of the delivery papers (for example as regards transport damage, wrong delivery or short delivery) or during our quality control procedure using sampling. To the extent acceptance of the goods (Abnahme) has been agreed upon, no obligation of examination shall apply. In all other cases it shall be decisive to what extent an investigation obligation is feasible (tunlich), taking into account all circumstances of the individual case within the regular course of business operations. Our obligation of notification as regards any defects discovered at a later time shall remain unaffected. Notwithstanding our obligation of examination, our notification (notification of defect / Mängelanzeige) shall be deemed to have occurred without undue delay and on time if it reaches the supplier within fourteen (14) calendar days after discovery of the defect or for obvious defects within fourteen (14) calendar days after delivery of the defective good in question.

8.2. Acceptance of the goods and execution of payments, with or without a proviso, shall not be deemed to mean acceptance of the goods as fulfilment or a waiver of our rights regarding defects or any other rights.

8.3. In case of defects, we are entitled to retain a percentage of the purchase price which is proportional considering the defect in question.


9. LIABILITY FOR DEFECTS

9.1. As regards our rights in connection with material defects or defects of title relating to the goods (such defects including wrong delivery; short delivery; improper installation; or insufficient installation, operating instruction or instruction manual) and further violations of obligations of the supplier, the statutory provisions shall apply to the extent not specified otherwise hereafter.

9.2. Pursuant to applicable statutory law, the supplier shall in particular be held responsible that the goods at the time of the risk transfer have the agreed properties and are suitable for the contractually agreed use, or in case no use was agreed upon, the customary use. In particular, the goods must meet the quality standards and specifications set out by us. In addition, the supplier shall also be held responsible for the deliverable goods having been manufactured in compliance with applicable European Union statutory provisions as well as the applicable national laws of the EU member states or states of the European Economic Area (as applicable) and the goods’ fulfilling all requirements necessary for them to be imported into and marketed as well as sold in the EU or the EEA (as applicable). In particular, the environmental protection provisions and – to the extent drugs, medical products, nutritional supplements and/or cosmetics or products which are used in connection with the manufacture of the aforementioned product categories are to be supplied – the Good Manufacturing Practice (GMP) requirements shall also be upheld. The supplier shall also be held responsible for the sold goods being free of rights of third parties that are in conflict to the agreement entered into between the supplier and us.

9.3. In case of defects, the supplier shall initially be obliged to rectify defects by way of either (as decided by us) eliminating the defect (Nachbesserung) or effecting a substitute delivery (Nachlieferung) within an appropriate time period set by us. If the supplier does not fulfil his rectification obligation within the reasonable time period specified by us, then we shall be entitled to rectify the defect ourselves and to claim compensation for the expenses necessary for this or an appropriate advance payment. If the supplier has failed to rectify the defect pursuant to the above or such rectification is unreasonable to us (for example due to particular urgency, due to the operational safety being endangered or due to disproportionate damages being imminent), we shall not be obligated to set a time period for rectification; we will inform the supplier of any such circumstances without undue delay and, to the extent this is possible, ahead of time.

9.3. Rectification pursuant to the above shall also include removing the defective goods and subsequently re-installing, if the goods have in accordance with their type and intended purpose been installed into another object or attached to another object; our statutory claims relating to reimbursement of corresponding expenses shall remain unaffected. The expenses which are necessary for the inspection and rectification shall be borne by the supplier even if it turns out that there was not a defect after all. Our liability for damages resulting from unjustified requests to remedy a defect shall remain unaffected, provided that we shall only be liable if and to the extent we either intentionally or grossly negligently did not recognize that the goods were after all not defective.

9.4. In order to allow for a smooth production process, we are entitled to rectify smaller defects ourselves with the prior consent of the supplier. Any costs resulting from this may be invoiced to the supplier. Any further liability rights for defects shall remain unaffected by this.

9.5. In addition, we shall in cases of material defects or defects of title relating to the goods be entitled to reduce the purchase price (Minderung) or rescind the agreement (Rücktritt) pursuant to applicable statutory law. Furthermore, we shall also be entitled to claim damages or reimbursement of expenses pursuant to applicable statutory law.


10. RECOURSE AGAINST SUPPLIERS

10.1. In addition to our other claims for defects, we shall be fully entitled to all recourse claims within a supply chain granted pursuant to statutory law (recourse against suppliers pursuant to sections 445a, 445b, 478 German Civil Code (BGB)). In particular, we shall be entitled to request from the supplier the exact type of rectification (eliminating the defect or effecting the substitute delivery) which we owe our own customer in the specific case at hand (where applicable). Our right to choose pursuant to statutory law (section 439 paragraph 1 German Civil Code (BGB)) shall remain unaffected by this.

10.2. Prior to acknowledging or fulfilling a rectification claim (including a claim for reimbursement of expenses pursuant to sections 445a paragraph 1, 439 paragraphs 2 and 3 German Civil Code (BGB)) asserted by one of our customers, we shall inform the supplier accordingly and, after having provided him with a brief description of the factual circumstances, request a written statement. If and to the extent the supplier does not within a reasonable time period provide the substantiated statement, then any rectification claim actually fulfilled by us shall for the purposes of the agreement with the supplier be deemed to have been owed to our customer.

10.3. Recourse claims within a supply chain shall also be deemed applicable if the defective good has been processed further (weiterverarbeitet) by us or by another entrepreneur, for example via installation into another object.


11. PRODUCT LIABILITY

11.1. If and to the extent a third party has based on the German Product Liability Act (ProdHaftG), Medicines Act (AMG), Environmental Liability Act (UmwelthaftungsG), applicable torts law provisions or comparable domestic or foreign statutory laws asserts a claim against us, then the supplier shall be obligated to indemnify us against all costs and damages of third parties if the reason which the claims in question are based on is a faulty delivery attributed to the supplier or such reason lies within his range of command and organization and the supplier would himself be liable in relation to third parties pursuant to the aforementioned laws.

11.2. The aforementioned indemnification and damages obligation shall also apply in such cases in which we due to a defect attributable to the supplier issue a recall action or a comparable commercial action or in which we are exposed to or forced to ward off market surveillance measures issued by the relevant market surveillance authorities. We will – to the extent possible and reasonable - inform the supplier about the content and extent of recall actions and give him an opportunity to make a statement. Further claims pursuant to statutory law shall remain unaffected.

11.3. For the duration of the agreement, the supplier shall at its own cost for damages caused by him, his personnel or other vicarious agents (Erfüllungsgehilfen) or other representatives through or in connection with services provided, goods or property delivered enter into a business liability, product liability and recall cost insurance with a sum insured that is market standard and risk commensurate, which shall, however, under no circumstances be for less than five million (5.000.000) EUR lump sum per insured event for damage to persons, property and/or financial losses. The supplier shall upon our request provide to us a relevant insurance cover note.


12. RETENTION OF TITLE

12.1 To the extent we contribute materials, parts or products to the supplier (hereinafter Contributions), we shall retain the title to such materials, parts or products. Any processing (Verarbeitung) or conversion (Umbildung) of such Contributions shall be deemed to have been performed for us. In case processing or mixing (Vermischung) occurs, we shall acquire ownership or co-ownership of the new goods proportional to the extent of the value of our Contributions relative to the value of any other processed objects at the time of processing. The same shall apply in case a delivered product is processed further by us, in which case we shall be considered its manufacturer (Hersteller) and shall pursuant to the applicable law acquire (co-)ownership of the finished product at the latest at the time of processing.

12.2. Contributions shall be labelled as “Owned by STADA”, be stored appropriately and separately and insured against all the usual risks, in particular against theft, fire and water damage. Pledging or security transfers to third parties of Contributions or of goods (co-)owned by us are not permitted. If third parties attempt to access Contributions or goods (co-)owned by us, the supplier shall inform them of our (co-)ownership and shall immediately inform us of the third party’s attempt.


13. CONSTRUCTION PROTECTION AND TOOLS

13.1. Documents and resources provided by us, such as for example final artworks, samples, plans, films, tools and models, shall remain our property and shall be treated confidentially. In particular, these shall not be used for other purposes, copied nor provided to third parties. The supplier is obligated to store these in an appropriate manner and without further cost to us. After completion of the order, these objects shall, to the extent not agreed differently, upon our request be returned to us which request we may make at any given time. Final artworks shall in any case be returned to us after completion of the order without undue delay.

13.2. In case it has been agreed that we will pay for the costs of the tools, then we shall acquire unrestricted ownership of the tools in question immediately after having paid such costs. In case not agreed otherwise, the tools shall remain with the supplier by way of loan until the respective order or orders have been completed. The same shall also apply for tools regarding which the parties mutually agree that the relevant costs are included in the price of the purchased goods. The supplier is obligated to keep tools and attachments in operational condition without additional costs to us and to return them to us after fulfilment of the order. Such tools may only be used for purposes other than the manufacture of articles ordered by us with our prior written consent. The supplier shall only have a right of retention if his counter claim is undisputed or has been finally determined by a court.


14. STATUTE OF LIMITATION

14.1. The parties’ mutual claims against one another shall become time-barred pursuant to the applicable legal provisions, to the extent not provided otherwise below.

14.2. In deviation from section 438 paragraph 1 no. 3 German Civil Code (BGB), the general limitation period for claims for defects shall be three (3) years starting at the transfer of risk to us. To the extent an acceptance (Abnahme) is agreed upon, the limitation period shall begin with the acceptance. The three (3) years long limitation period shall also apply to claims arising out of defects in title, provided that the statutory limitation term for third parties’ in rem claims to return (section 438 paragraph 1 no. 3 German Civil Code (BGB)) shall remain unaffected; in addition, claims for defects in title shall under no circumstances lapse as long as the third party in question – in particular due to a lack of his claim having lapsed – can still raise its corresponding claim towards us.

14.3. The limitation periods of German law of purchase (Kaufrecht) taking into account also the extensions set out above shall – to the extent legally permissible – apply to all claims resulting from contractual liability claims for defects. To the extent we are also entitled to non-contractual damages claims resulting from a defect, the regular limitation term (sections 195, 199 BGB) shall apply to such claims, provided that the application of the limitation terms resulting from the German law of purchase (Kaufrecht) does not lead to a longer limitation term in the specific case at hand.


15. DUTY OF CARE AND CONFIDENTIALITY OBLIGATION

15.1. The supplier is obligated to treat all documents which he has received in the context of the business relationship with us as well as all information received from us that by its nature is to be viewed as our trade secrets or internal information as confidential information, treat them with the strictest confidentiality towards third parties and only provide them to employees on a “need to know”-basis. Disclosure or reproduction of such information shall only be permitted if and to the extent it is necessary for fulfilment of the supply agreement or has been previously permitted by us in writing. Upon our request, the supplier shall return the documents to us. Our ownership rights to the confidential information shall in any case remain unaffected.

15.2. In addition, the supplier is obligated to treat the business relation with us with the strictest confidentiality towards third parties if and to the extent we have not previously permitted such a disclosure in writing.

15.3. Products which were tailor-made for us may not be referred to, pictured or described in any of the supplier’s advertisements without our prior written consent.

15.4. The supplier is obligated to return all documents or information to us as soon as he no longer requires them to fulfil his contractual obligations, but at the latest at the end of the business relationship with us. In cases in which a return is not possible, he shall be obligated to irretrievably destroy or delete them. Statutory retention requirements shall remain unaffected.


16. SAFETY REGULATIONS

If and to the extent the supplier has works performed on our premises, he is obligated to at his own costs take out voluntary insurances which cover all damages that might arise for us in connection with these works by the supplier and/or his vicarious agents (Erfüllungsgehilfen), respectively. In addition, the supplier shall also be obligated to abide by the STADA factory regulations and safety standards and accident prevention regulations during his presence on our premises, comply with any instructions of our local security officers without undue delay and ensure that also his vicarious agents (if any) shall abide by and comply with these.


17. DATA PROTECTION LAW

If and to the extent we collect and/or process data of the supplier in order to enter into, execute and/or end the contractual relationship with the supplier, such collecting and/or processing shall be carried out pursuant to the applicable statutory specifications relating to data protection, in particular the GDPR. Further information regarding this can be found in our data privacy policy pursuant to Articles 13 and 14 GDPR under Compliance.


18. MISCELLANEOUS

18.1. Assignments of claims against us shall only be effective with our prior written consent. This shall leave section 354a German Commercial Code (HGB) unaffected.

18.2. These GTCs and the contractual relationship between us and the supplier shall be governed by the laws of the Federal Republic of Germany under exclusion of the UN Sales Convention.

18,3, Subject to section 3.1 or unless otherwise agreed, the place of performance (Erfüllungsort) shall be Bad Vilbel.

18.4. If the supplier is a merchant pursuant to the meaning of the German Commercial Code (HGB), a legal entity under public law or a special fund under public law, then the exclusive venue for all disputes resulting from the contractual relationship, including disputes in relation to promissory notes or cheques, shall be Frankfurt/Main, Germany. For proceedings initiated by us, we shall also have the right to instead elect to have the general place of jurisdiction of the supplier be deemed the agreed place of jurisdiction. Applicable overriding statutory legislation, in particular as may relate to exclusive venues, shall remain unaffected.