1. DEFINITIONS

“Buyer” means ALFRED E. TIEFENBACHER GmbH & Co. KG and/or any of its affiliates to which the Supplier is providing Products or Services under the Contract.

“Delivery Date” means the day on which the supply is or will be delivered in full on the agreed delivery address and according to the agreed delivery terms;

“Parties” means collectively the Buyer and the Supplier;

“Purchase Order” or “PO” means the document embodying the purchase, like but not limited to the Buyer’s order form; (including any ancillary documents provided by Buyer) and these Terms and Conditions. Unless otherwise provided herein, in the event of any conflict, the Terms and Conditions shall take precedence over other documents included in the PO.

“Products” means the equipment, parts, materials, supplies, and other goods Buyer has requested and the Supplier has agreed to supply to the Buyer under the PO.

“Supplier” means the entity providing the Products to and/or performing the Services and/or invoicing such for the Buyer under the PO.

“Services” means the services that the Buyer has requested, and the Supplier has agreed to perform for the Buyer under the PO.

“Terms and Conditions” means these General Terms and Conditions for the purchase of the Products or Services, together with any modifications or additional provisions specifically stated in the Buyer’s Purchase Order or specifically agreed upon by the Buyer in writing.

2. GENERAL

2.1          Scope of Application – These Terms and Conditions apply to all legal relationships of the Buyer, including requests for quotations, whereby the Buyer (or its affiliates) acts as a (potential) buyer of the Products or as a (potential) party ordering work, including each Purchase Order. Accordingly, the purchase of any Products or Services by Buyer is expressly limited to and governed by these Terms and Conditions; unless otherwise stated in a written commercial agreement between the Supplier and the Buyer. These Terms and Conditions are incorporated into and made a material part of any Purchase Order issued by Buyer. Any acceptance of Buyer’s offer is expressly limited to acceptance of these Terms and Conditions.

2.2          Prevalence of the Terms & Conditions – Unless otherwise explicitly agreed by the Buyer and the Supplier in writing, no terms or conditions shall become part of the Purchase Order or shall modify these Terms and Conditions, even if signed by a representative of the Parties, nor shall any course of performance, course of dealing, or usage of trade operate as a modification or waiver of these Terms and Conditions. By accepting any Purchase Order from the Buyer, issuing an order acknowledgement or confirmation, or commencing to perform under the Buyer’s Purchase Order, Supplier accepts and assents to these Terms and Conditions.

2.3          No Prejudice – Unless as explicitly otherwise agreed in any written agreement between the Buyer and Supplier, the Buyer’s other rights (whether conferred by law or agreement) shall not be prejudiced.

2.4          Separate Commercial Agreement – If the Buyer and the Supplier have entered into a separate written agreement with regard to the Products or Services supplied pursuant to the PO, the written agreement shall prevail over the Terms and Conditions of the said PO.

2.5          Quality Agreement – If the Buyer and Supplier have entered into a separate written quality agreement with regards to the goods or services supplied pursuant to the PO, such quality agreement shall be an integral part of the said PO.

3. PURCHASE ORDER ACCEPTANCE & CHANGES

3.1          Issuance of the POs – To purchase the Products or Services, the Buyer shall issue the Purchase Order which shall set out the type, quantity, price and required date of delivery of the Products and/or performance of Services, and other relevant information. The POs may be submitted manually or through any procurement system used by the Buyer to purchase the Products or Services.

3.2          PO Confirmation – The Supplier shall expressly/formally notify its acceptance or refusal of the PO within five (5) working days from order issuance (unless a different period is stated on the PO). POs not formally accepted or for which no explicit confirmation is received by the Supplier in accordance with the preceding sentence shall be deemed to be as fully accepted in all parts and the Terms and Conditions herein shall become binding and applicable to the said POs.

3.3          Binding Effect of the POs on the Buyer – The Buyer shall only be bound by written orders, offers and acceptances (including orders transmitted via email). This further applies to all additional and subsequent orders as well as to any modification of orders. Oral agreements (including agreements made in the course of telephone calls) require written confirmation (including such written confirmations transmitted via email). The Buyer shall not be obligated to purchase and pay for any Products and/or Services which have not been included in a PO. The Buyer shall not be obligated to purchase and pay for any Products and/or Services which have been included in a PO not approved by the duly authorized representative of Buyer. The Supplier may not claim compensation for any costs incurred from offers made, concepts, fee estimates or plans.

3.4          PO Modification – The Buyer reserves the right to modify the Purchase Order with respect to quantities, delivery schedules and/or specifications as desired by Buyer by issuing one or more change orders to the Supplier. The Supplier shall not make any changes to Purchase Orders or affecting the Products or Services without the prior written consent of the Buyer.

(i)            If the Supplier’s costs are reduced because of changes, the Supplier shall reduce the Purchase Order price to reflect all such quantifiable cost savings, whether direct or indirect.

(ii)           If the Supplier’s costs are increased because of changes, the Buyer will consider the Supplier’s request for a reasonable adjustment to the Purchase Order price; provided, however, that if the Supplier does not notify the Buyer of a cost impact within ten (10) days of the issuance of the revision/release, then the Supplier shall be deemed to waive any claim for a price increase due to the revision/release; and provided further, that if the Supplier does provide notice of a cost impact and the Parties cannot agree upon a reasonable price adjustment within ten (10) days of such notice, the revision/release will not become effective, the Supplier shall not be entitled to any additional compensation or price changes, and the Buyer may terminate the PO without liability to the Supplier. Written or verbal acceptance of a revision or release and/or the provision of the Products or the Services to the Buyer after receipt of a revision to the purchase order constitutes the Supplier’s assent to such revision.

4. PRICING AND PAYMENT TERMS

4.1          Price in the PO – The price specified in the PO is binding and includes, unless agreed otherwise in writing, all agreed and usually expected services and ancillary services of the Supplier, including (but not limited to), as appropriate, costs for packaging, loading/unloading, transport, assembly, installation, testing and release, including all necessary accompanying documents, and all necessary information to judge the quality of the Products, insurance, material surcharges, any costs for exchanging or converting currency and any costs related to the payment other than a standard local money transfer. The Buyer does not acknowledge any written confirmation with pricing changes until a Purchase Order revision is completed and provided to the Supplier. The Buyer shall not be obligated to pay and shall not process payment for any invoice that does not match the price set forth on the corresponding PO or any additional costs which have not been explicitly accepted in writing by the Buyer prior to delivery.

4.2          Invoices by the Supplier – The Supplier shall invoice the Buyer on completed delivery of the Products or Services. Unless agreed otherwise, the purchase price for the ordered Products shall be due and payable within sixty (60) days from receipt of an accurate and complete invoice, payable in the currency as stated on the Purchase Order. Prices and rates are in Euros and are firm, unless agreed otherwise. All prices are exclusive of turnover tax (Value-Added Tax), but include any other taxes and levies, including yet not limited to environmental surcharges. If and insofar justified (i.e., in case of notified defects) the Buyer may hold back a respective portion of payments or withdraw from the transaction upon the lapse of a 10-working-day remedy period following notification thereof.

4.3          Set-offs – Any assignment or set-off with respect to the purchase price claimed by the Supplier requires prior written approval of the Buyer. The Buyer may balance without any further agreement or unilaterally set off any claims of supplier with its own claims or of its affiliates against the Supplier.

4.4          Price Guarantee – Supplier warrants that the prices and terms on which it supplies the Products and Services to the Buyer are no less favorable than those offered to other customers purchasing in similar quantities. The Supplier agrees to immediately reduce the price if it charges any customer purchasing in similar volume a lower price.

5. CONDITIONS OF DELIVERY

5.1          Transportation & Delivery – Unless expressly agreed otherwise, the Buyer may determine the mode of transportation as well as the carrier for all shipments and will inform the Supplier accordingly in writing. Delivery is at the expenses and risk of the Supplier. The Supplier shall be responsible for sufficient transport insurance at his own expenses and pay any customs duties. In addition, the Supplier shall pack the Products at its own expense as customary in business, and adequately protect them against transport damage.

5.2          Lead Times – All Delivery Dates and periods are binding and are calculated from the date of the order.

5.3          Complete Deliveries – Deliveries are deemed fulfilled if the respective Products lawfully transfers into the Buyer’s possession at the agreed place and time of delivery together with any and all agreed upon, and reasonably expected documentation (including invoices, certificates of origin, shipment documents, certificates of analysis and any other documents which must be supplied under applicable rules regarding Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP ).The Supplier shall make no partial delivery or delivery before the date(s) stated on the Purchase Order unless otherwise agreed by the Buyer in written.

5.4          Late Deliveries – The delivery Dates specified in the PO are fixed dates and are calculated from the day the order is concluded. If the supplier cannot deliver the ordered Products within the agreed periods or on the agreed upon dates, or expects that this shall not be possible, the Supplier shall notify the Buyer in writing of the reasons and the expected duration of the delay. In case of a (total or partial) delay in delivery, the Buyer is entitled to:

(a)           withdraw from the delayed order in full or in part without setting a grace period and refuse acceptance of the Products;

(b)           accept the delayed order, granting the Supplier an appropriate grace period, and demand or withhold a contractual penalty in the amount of one percent (1%) of the agreed price per day of delay;

(c)           cover any urgent need for Products by entering into a respective contract with third parties (covering purchase), the Supplier shall bear any additional costs incurred.

5.5          Liability for Subcontractors – If part of the PO, or the PO in its entirety is performed by a third party, the Supplier shall be fully liable for defects or defaults on the part of its Suppliers or other vicarious agents, as it would for its own defects or default. The Buyer must grant its written consent prior to the appointment of any such third party.

6. TRANSFER OF TITLE & RISK

6.1          Transfer of Title – Ownership of the Products shall be transferred to the Buyer unconditionally and regardless of the payment of the price. In particular, this excludes all forms of simple, extended or prolonged retention of title. Any title which may be lawfully retained by the Supplier expires upon payment for the Products delivered to the Buyer and shall apply only to such Products.

6.2          Transfer of Risk – The risk of loss, for all Products sold to the Buyer shall pass to the Buyer only after the completion of unloading Products at the delivery location selected by the Buyer. Unless otherwise noted on the Purchase Order or if otherwise agreed by the Parties, the Products shall be shipped by Supplier to the destination specified on the Buyer’s PO, freight prepaid. Services shall be performed at the location identified in the applicable PO, if applicable.

6.3          Goods provided by the Buyer – If the Buyer provides the Supplier with goods for the performance of the PO, including raw materials, semi-finished products, materials and parts, models, tools, molds, specifications, drawings, data, software and information carriers, and any others as may be applicable.

(i)            these goods shall remain the property of the Buyer.

(ii)           The Supplier shall keep these goods, in its capacity of holder, clearly marked as being the property of the Buyer, in safe custody and in good condition, such for the account of the Supplier, and shall bear all risk of loss or destruction of these goods.

(iii)          The Supplier is obliged to carry insurance for these goods, for its own account, during the time that it has these goods in its possession.

(iv)          The Supplier shall ensure that these goods are used exclusively for the performance of the PO and is not authorized to sell, lease, pledge nor encumber or remove these goods from the Buyer’s control in any other way.

(v)           The Supplier shall return these goods to the Buyer forthwith and/or irreversibly delete any copies thereof, for its own account, after the PO has been executed, expired or terminated, unless agreed otherwise.

(vi)          The Supplier hereby grants its unconditional and irrevocable permission to the Buyer or a third party designated by the Buyer, to access all locations where the goods of the Buyer are or can be located and to take control of such goods.

(vii)         If the Supplier purchases or creates special tooling or molds on the request of and for the account of the Buyer these shall become the property of the Buyer as of their purchase/creation.

7. FORCE MAJEURE

7.1          Definition of Force Majeure – Force majeure shall mean an event beyond a Party’s control, which such Party could not reasonably have provided against before entering into the PO, and could not reasonably have avoided or overcome, and which is not substantially attributable to the other Party. Force majeure may include, but is not limited to, exceptional events or circumstances such as war, hostilities, terrorism, natural catastrophes such as earthquake, hurricane, typhoon or volcanic activity. The following events are examples of events that are not considered as Force Majeure: industrial dispute, labor lockout, labor shortage, sickness, shortage of raw materials, transport problems, non-performance of obligations by subcontractors.

7.2          Suspension of Obligations – Neither Party shall be considered in breach or under any liability whatsoever for non-performance, part performance, defective performance or delay in performance of any obligation to the extent that such a performance is prevented by any cause of Force Majeure. If a circumstance of force majeure should arise, the Parties shall endeavor to comply with their obligations under the PO as much as possible.

7.3          Termination due to Force Majeure – Upon the occurrence of an event of Force Majeure, the obligation(s) of the Parties that cannot be fulfilled as a result of such an event shall be automatically postponed for a maximum period of two (2) weeks after the force majeure occurs If the Supplier is unable to honor its obligations under the PO after the end of the said four (4) weeks, the Buyer shall be entitled to terminate the PO, without any obligation of compensation of any kind whatsoever or payment of costs. If the PO is terminated for Force Majeure accordingly, the Supplier shall return to the Buyer the payments it received from the Buyer for the non-delivered Products.

8. WARRANTIES &LIABILITIES OF THE SUPPLIER

8.1          Supplier Warranties – In addition to all warranties provided under applicable laws, the Supplier represents and warrants that all delivered Products:

(a)     have been manufactured in accordance with all applicable provisions (including GMP and/or GDP, if applicable), statutory regulations and requirements outlined by authorities and professional associations, as well as Buyer’s standards and comply with all applicable laws, codes, regulations and standards,

(b)     are new, merchantable, of good workmanship and quality and fit for the ordinary purposes for which they are being used;

(c)     are free from defects; liens and encumbrances and

(d)     comply with all specifications and all standards that have been explicitly laid down in offers, invoices or individual agreements with Buyer, or that – if not agreed – conform with the typical market standards.

8.2          Buyer’s rights – In addition to all rights and remedies available under the applicable laws, if the Supplier breaches any warranty, and/or deliver defective Products, Buyer may, at its own discretion and in addition to any rights or remedies it may have: (i) return such items to the Supplier at the Supplier’s risk and expense; (ii) require the Supplier, at its expense to promptly replace the defective Products or repair them as soon as technically possible; (iii) , at the latest within ten (10) working days from the defect notice, require Supplier to restore the agreed state free from defects or refund all payments made with respect to the delivery of such Products immediately and without deduction. The Buyer may also cancel the PO immediately (redhibition). In cases of urgency the Buyer retains the right to have such Products revised by itself or by third parties or to have replacements shipped by third parties at the expense of supplier.

8.3          Defects – Apparent defects of the delivered Products shall be notified by the Buyer within sixty (60) calendar days of receipt of the Products, all other latent defects within ninety (90) calendar days of their discovery. The payment of invoices by Buyer shall not be qualified as unconditional acceptance of the Products. Failure to give notice of any defect or non-conformity shall not affect any remedies available to the Buyer or operate as acceptance of any Product or Service with a latent defect.

9. INSPECTIONS

9.1          Inspection and Acceptance – Notwithstanding payment, transfer of title or prior inspection, all Products and Services are subject to final acceptance or rejection by the Buyer at the delivery destination. The Buyer is not bound to examine the Products at the time of delivery and not examining upon delivery shall not deprive (by way of expiration, extinguishment or otherwise) the Buyer of any rights whatsoever.

9.2          Outgoing inspection – The Supplier shall conduct an outgoing Products inspection to make sure that the Supply is in accordance with the agreed requirements of the Buyer. If needed, the Supplier will accompany the delivery with a testing and/or measuring report, at no costs.

9.3          Audits, Testing & Inspections – Testing, inspections & audits of the facility, the Products, materials and any property of the Buyer covered by the PO may be carried out by or on behalf of the Buyer or by Buyer’s customers at any time, at the Buyer’s request. The Supplier shall cooperate in the testing, audit or inspection, without further costs for the Buyer. Such inspection, audit or testing, whether during manufacture prior to delivery or within a reasonable time after delivery, shall not constitute acceptance of any work-in-progress or finished Products, whether or not a breach of warranty or other defect had become evident at the time.

10. INDEMNIFICATION & INSURANCE

10.1       Indemnification by Supplier – The Supplier shall release, defend, indemnify and hold the Buyer, its shareholders, officers, directors, employees, agents and representatives harmless from and against any claims, demands, causes of action, judgements, proceedings, awards, damages, losses, fines, penalties, costs, expenses and liabilities (collectively, “Losses”) caused by, arising out of or relating to the Products, Services, or any act or omission of the Supplier, its shareholders, officers, directors, employees, agents or representatives, including, without limitation, Losses arising from or related to personal injury, death, property damage, economic loss, or intellectual property infringement. In the event third parties raise claims against the Buyer that are based on the Supplier’s breach of its statutory or contractual obligations, the supplier shall fully indemnify and hold the Buyer harmless.

10.2       Buyer´s Liability – The Buyer’s liability vis-à-vis supplier shall, as far as legally permissible, be excluded.

10.3       Insurance – The Supplier shall maintain commercial general liability insurance, including products liability and completed operations coverage, in amounts not less than the equivalent of EUR five (5) million per occurrence and the equivalent of EUR. 10 million aggregate. The Supplier shall name the Buyer as an additional insured under such policy (broad form vendor endorsement, if applicable), waive subrogation against the Buyer, and provide the Buyer with a certificate of insurance evidencing the same upon request. These insurance requirements do not in any way limit the Supplier’s indemnification obligations.

11. SUSPENSION & CANCELLATION OF THE PO(s)

11.1       Insolvency of the Supplier – The Buyer shall have the right to immediately  suspend its obligations and/or cancel the Purchase Order, either in whole or in part, without any further notice of default, without any obligation for compensation of any kind whatsoever and without prejudice to all other rights and remedies of the Buyer, in the event of any of the following or any other similar occurrences: (i) insolvency of the Supplier; (ii) filing of a voluntary petition in bankruptcy by the Supplier; (iii) filing of any involuntary petition in bankruptcy against the Supplier; (iv) appointment of a receiver or trustee for the  Supplier; (v) temporary suspension of payments, or liquidation of the Supplier’s business, or the stoppage or hindrance of work caused by industrial dispute, or (vi) the Supplier making an assignment for the benefit of creditors.

11.2       Material Breach – The Buyer shall have the right to immediately suspend its obligations and/or cancel all or any part of the Purchase Order, without any further notice of default, without any obligation for compensation of any kind whatsoever and without prejudice to all other rights and remedies of the Buyer, in the event that the Supplier: (i) repudiates or breaches any of the terms of the Purchase Order or these Terms and Conditions; (ii) fails to perform the Services or deliver the Products as specified by the Buyer under the PO; or (iii) fails to make progress so as to endanger timely and proper completion of the Services or delivery of the Products, and the Supplier does not correct such failure within three (3) days (or such shorter period of time if commercially reasonable under the circumstances) after receipt of notice from the Buyer specifying such failure or breach.

11.3       Convenience – Without prejudice to any other provisions, the Buyer is entitled to terminate all or any part of the Purchase Order at any time for its own convenience. In such case the Supplier shall be entitled to, but only to, an equitable amount not in excess of its verified direct costs reasonably and necessarily incurred prior to the cancellation of the PO, expended or committed to third parties in accordance with lead times for materials and labour as appropriate for corresponding Delivery Dates prior to the notice of termination (less salvage value and any other amounts recoverable by the Supplier). The payment required by the foregoing sentence shall constitute the Buyer’s sole and exclusive liability and obligation with respect to cancellation of any PO.

12 MISCELLANEOUS

12.1       Severability – Any provision contained herein determined to be unenforceable, illegal or invalid shall be automatically voided and shall not affect the enforceability, legality or validity of the remaining provisions herein.

12.2        Assignment – The Supplier shall not assign, delegate, or subcontract its performance under any Purchase Order of the Buyer or these Terms and Conditions without the prior written consent of the Buyer.

12.3       Confidentiality – All documents and information submitted by the Buyer shall be used exclusively for the purpose of the respective transaction and by the personnel of the supplier necessary on a need-to-know basis and shall in any event be treated by the Supplier as confidential information and shall be returned upon completion of the transaction, as well as immediately upon demand of the Buyer. Copies, if any, shall be deleted immediately and irretrievably. In the event that the Supplier engages a third party for the performance of its contractual obligations, it shall make sure that such third party contractually commits itself to at least the same degree of confidentiality.

12.4        Relationship between the Parties – The relationship between the Buyer and the Supplier is solely that of independent contracting parties, and nothing in these Terms and Conditions or any purchase order of Buyer shall be construed to create an employment, joint venture, partnership, or agency relationship between the Buyer and the Supplier.

12.5       Notices – All notices, requests, consents, claims, demands, waivers and other communications hereunder (each, a “Notice”) shall be in writing and addressed to the Parties at the addresses set forth on the face of the Contract or to such other address that may be designated by the receiving party in writing. All Notices shall be delivered by personal delivery, nationally recognized overnight courier (with all fees pre-paid), facsimile (with confirmation of transmission), electronic mail or certified or registered mail (in each case, return receipt requested, postage prepaid). Except as otherwise provided in this Contract, a Notice is effective only (a) upon receipt of the receiving party, and (b) if the party giving the Notice has complied with the requirements of this Section.

12.6       Buyer´s right to set-off – The Buyer may withhold out of amounts otherwise due to the Supplier under the PO or any other agreement with the Supplier such sums sufficient to compensate itself for any amount at any time that may be owed from the Supplier to the Buyer in connection with the purchase order or such other agreement, with reserving all additional rights and remedies provided by law or equity.

12.7       Data Protection – The Supplier shall ensure that all employees and contractors engaged for the performance of the contract shall comply with the statutory data protection provisions.

(i)            The Supplier shall deploy, for the performance of its services, only such personnel who have been committed in writing to maintain confidentiality of any personal data. The Supplier shall provide evidence of this upon the Buyer’s request.

(ii)           The Supplier shall ensure that the Buyer is informed about all circumstances which the Buyer must be aware of for data protection or confidentiality reasons. In particular, the Supplier shall inform the Buyer immediately of any data security and data privacy breach in writing. Further the Supplier shall inform the Buyer immediately of any request of regarding access, rectify or erasure of its personal data. In case the Supplier is obliged to disclose the personal data by virtue of an order of a competent authority or a court, it shall, where permissible, inform the Buyer in writing as soon as possible about any such disclosure order. The Buyer shall be entitled to cancel the PO for good cause and with immediate effect partially or in its entirety, in the event that the Supplier does not fulfil its data protection obligations within a reasonable period of time set by the Buyer, or in the event of the Supplier’s grossly negligent or willful breach of its data protection obligations.

(iii)          The Supplier undertakes to keep all information and documents provided to them by the Buyer confidential. Excluded from this is information and documents that are publicly known or made public without the Supplier’s assistance.

12.8       Compliance with Law – The Supplier warrants that it shall: (a) not promise, offer, pay, cause to pay, accept payment or induce payment or take any action that could be considered a bribe; (b) comply with all applicable laws and regulations, including those related to bribery and corruption (such as, but not limited to, the US Foreign Corrupt Practices Act, UK Bribery Act, OECD Convention dated 17th December 1997, the Treaty on the Functioning of the European Union (TFEU), the 1997 Convention on fighting corruption involving officials of the EU or officials of EU countries, the 2003 Council Framework Decision on combating corruption in the private sector, which criminalizes both active and passive bribery); (c) comply with industry standards; and (d) perform its obligations under this agreement with high ethical and moral business and personal integrity standards; (d) comply with the Buyer’s Code of Conduct (and any published updates) which can be viewed and downloaded from the following website: https://tiefenbacher-pharmaceuticals.com/wp-content/uploads/2022/03/Code_of_Conduct_11-2020.pdf.

12.9       Survival – Provisions of these Terms and Conditions which by their nature should apply beyond their terms will remain in force after any termination or expiration of these Terms and Conditions including, without limitation, the following provisions: Section 8 (Warranties & Liabilities of the Supplier), Section 10 (Indemnification & Insurance); Section 12.6 (Buyer’s right to set-off); Section 12.8 (Compliance with Law) and Section 13 (Governing Law and Dispute Resolution).

13. GOVERNING LAW AND JURISDICTION

These Terms and Conditions shall be governed by and construed in accordance with the laws of Germany without regard to The United Nations Convention on International Sale of Goods and its conflict of law provisions. Any disputes arising out of or in connection with these Terms shall be subject to the exclusive jurisdiction of the courts of Hamburg, Germany.