GTC – GENERAL TERMS AND CONDITIONS

GTC GENERAL TERMS AND CONDITIONS OF SALES, DELIVERY, CONTRACT AND PAYMENT OF BioPharmatec GMBH

1. SCOPE OF APPLICATION

We, the company BioPharmatec GmbH, are prepared to conclude a contract exclusively on the basis of these General Terms and Conditions, which are printed in German. We reject the applicability of other terms and conditions, in particular insofar as they conflict with or deviate from our terms and conditions. We, BioPharmatec GmbH, are not bound by such general terms and conditions. All deliveries, including those from future business transactions, shall be governed exclusively by our terms and conditions.

2. CONTRACT PRODUCTION / CONTRACT FILLING

The pure contract production offer does not include a legal examination of marketability. If this is required, it must be ordered separately by the customer. As the manufacturer, we assume no liability or warranty for marketability with regard to composition, dosage, label text etc.. Should statements have been made in this respect, these shall apply exclusively as an exchange of information. Should it become apparent in the course of production that implementation is technically impossible or only possible with unjustifiable additional expense, we shall be free to refuse implementation. In this case, all services received shall be refunded. Any further compensation shall be excluded. Our product calculation is based on the quantities specified in the recipes. Due to unavoidable production-related raw material losses, the delivery quantity may deviate from the order quantity by approx. 10%.

3. OFFER AND CONCLUSION OF CONTRACT

Our offers are always subject to change, unless they are limited in time. Orders shall be deemed to have been accepted if they have been confirmed by us in writing. Our written confirmation is exclusively authoritative for the content of the contractual relationship. Samples are deemed to be type samples; the properties of the sample are not guaranteed. The customer is obliged to indemnify and hold us harmless against all third-party claims. The customer shall be solely liable for the correctness – in particular but not exclusively safety, purity, marketability, identity, concentration etc. – of the raw materials provided by him (possibly via third parties).

4. DELIVERY

4.1

Deliveries are ex works.

4.2

Deadlines and dates for deliveries and services promised by us are always only approximate, unless a fixed deadline or a fixed date has been expressly promised or agreed. If shipment has been agreed, delivery periods and delivery dates refer to the time of handover to the forwarding agent, carrier or other third party commissioned with transportation.

4.3

We may – without prejudice to our rights arising from default on the part of the customer – demand that the customer extend delivery and performance deadlines or postpone delivery and performance dates by the period in which the customer fails to meet its contractual obligations to us.

4.4

BioPharmatec shall not be liable for impossibility of delivery or for delays in delivery insofar as these are caused by force majeure or other events unforeseeable at the time of conclusion of the contract (e.g. operational disruptions of any kind, difficulties in the procurement of materials or energy, transport delays, strikes, lawful lockouts, shortage of labor, energy or raw materials, difficulties in obtaining necessary official permits, official measures or the failure of suppliers to deliver or to deliver correctly or on time; late delivery of customer supplies such as raw materials, packaging materials, cans, lids, labels, package inserts, folding boxes, etc.) for which we are not responsible. If such events make delivery or performance significantly more difficult or impossible for us and the hindrance is not only of a temporary nature, we are entitled to withdraw from the contract.

4.5

However, in the event of non-delivery for which we are not responsible, the buyer shall have the right to withdraw from the contract at the earliest 8 weeks after the agreed delivery date. Further claims are waived. Excluded from this are claims for compensation for damages arising from injury to life, limb or health if we are responsible for the breach of duty and other damages based on an intentional or grossly negligent breach of duty. A breach of duty by BioPharmatec GmbH is equivalent to a breach of duty by a legal representative or vicarious agent. In the event that an order is canceled, the customer shall be obliged, subject to further claims, to compensate us for the damage incurred for the expenses and any loss of profit.

4.6

The risk shall pass to the customer at the latest when the goods are handed over to the forwarding agent, carrier or other third party designated to carry out the shipment. This shall also apply if partial deliveries are made. If dispatch or handover is delayed due to a circumstance for which the customer is responsible, the risk shall pass to the customer at the time at which the delivery item is ready for dispatch and we have notified the customer of this.

4.7

Storage costs after the transfer of risk shall be borne by the customer. In the case of storage by BioPharmatec GmbH, the storage costs shall amount to 0.25 % of the invoice amount of the delivery items to be stored per expired week. We reserve the right to claim demonstrably higher or lower storage costs.

5. PACKAGING

If packaging is carried out in containers supplied by the customer, no guarantee is given for the suitability of the packaging. We are entitled, but not obliged, to give notice of unsuitable packaging material. If no subsequent delivery of the rejected packaging material is made within two weeks, we shall be entitled to use suitable material at the customer’s expense. Transport damage must be reported to us immediately. If a forwarding agent is commissioned with the shipment, the damage incurred must be noted on the consignment note. In any case, the respective conditions of the forwarding agent must be observed in the event of transport damage and the damage must also be claimed from the forwarding agent. We are entitled to make partial deliveries or render partial services at any time. Excess or short deliveries of a maximum of 10% of the contractual quantity are permissible.

6. DEFICIENCY CLAIMS

Compliance with our delivery and performance obligations presupposes the proper and timely fulfillment of the customer’s obligations.

6.1

The customer is obliged to inspect the goods within three working days of receipt. Defects recognizable during this inspection with due care must be reported to us in writing or by e-mail within this period, other defects immediately after discovery. Complaints made at a later date will not be recognized. Rejected goods must be kept by the customer until our final decision on the rejection or recognition of warranty obligations and may only be returned with our consent. The customer must in any case allow us to inspect the goods, if necessary by a third party commissioned by us.

6.2

Deviations from the actual filling weight are possible due to deviating specific weights of individual batches and are not a defect within the scope of the pre-packaging regulations.

6.3

Any complaints are only to be treated as price-reducing if they are documented at the same time by a DAkkS (Deutsche Akkreditierungsstelle GmbH) accredited laboratory and must be reported immediately after receipt of the laboratory documents, without prejudice to the complaint period in No. 6.1).

6.4

In the case of contract manufacturing, we do not assume any warranty with regard to the chemical, physical and microbial reactions of the finished product due to the recipe. We also exclude all claims for damages subject to Section 7 “Statute of limitations, limitation of liability” below. The customer is responsible for analyzing the finished products. The customer may commission us to analyze the finished products separately and at his own expense.

6.5

Warranty for the chemical stability, technical shelf life, microbiological development and reaction of the end product with the primary packaging is only assumed after a 6-9 week stress test has been carried out, whereby this is only carried out after a separate order has been placed. The costs of any analyses commissioned by the customer are not covered by us. The correct designation under food law when selling the goods is independent of our product designation and is the responsibility of the customer.

6.6

We accept raw materials provided by the customer by arrangement. The goods can be sent to us after the order confirmation has been received, but not before. Storage costs for raw materials received before order confirmation shall be borne by the customer. In the case of storage by BioPharmatec GmbH, the storage costs shall amount to 0.25% of the invoice amount of the delivery items to be stored per week. We reserve the right to claim demonstrably higher or lower storage costs. The goods will only be accepted, released and processed with a corresponding certificate of analysis, delivery bill and details of the best-before date and batch number. Otherwise the raw goods cannot be processed.

6.7

BioPharmatec GmbH shall not be liable if third parties tamper with the goods or if the delivered goods are not used, stored or treated etc. as intended, unless it can be proven that existing defects would have occurred even without such tampering or improper use.

7. STATUTE OF LIMITATIONS, LIMITATION OF LIABILITY

7.1

Claims for defects shall become time-barred 12 months after delivery of the goods to the customer, but at the earliest after expiry of a specified best-before date. Notwithstanding the above, § 479 BGB shall apply to the limitation period for recourse claims.

7.2

If, despite all due care, the delivered goods have a defect that already existed at the time of the transfer of risk, we shall, subject to proper and timely notification of defects, either repair the goods or deliver replacement goods at our discretion (subsequent performance). We must always be given the opportunity for subsequent performance within a reasonable period of time. Any rights of recourse shall remain unaffected by the above provision without restriction. If the subsequent performance fails twice, the customer may – without prejudice to any claims for damages – withdraw from the contract or reduce the remuneration.

7.3

Claims for defects shall not exist in the event of only insignificant deviations from the agreed quality, only insignificant impairment of usability, natural wear and tear or damage arising after the transfer of risk as a result of incorrect or negligent handling, excessive use or due to special external influences which are not provided for in the contract. If the customer or third parties carry out improper modifications or other processing, there shall also be no claims for defects for these and the resulting consequences.

7.4

Claims of the customer for the expenses necessary for the purpose of subsequent performance, in particular transport, travel, labor and material costs, are excluded if the expenses increase because the goods delivered by us have subsequently been taken to a place other than the customer’s branch office or to a place other than the place of delivery expressly agreed in the individual case, unless the transfer corresponds to their intended use.

7.5

The customer’s right of recourse against us shall only exist insofar as the customer has not made any agreements with his buyer that go beyond the legally mandatory claims for defects. Paragraph 7.4 also applies accordingly to the scope of the customer’s right of recourse against the supplier.

7.6

The above limitations of liability do not apply to the fulfillment of essential contractual obligations or in the case of guaranteed characteristics. However, our liability for damages is generally limited to such damages that were foreseeable at the time of conclusion of the contract, taking into account all known or recognizable circumstances with due diligence. In addition, we shall only be liable for indirect damage and consequential damage resulting from defects in the goods if such damage is typically to be expected when the goods are used as intended.

7.7

The above restrictions and limitations do not apply: For damages resulting from injury to life, body or health that are based on a negligent breach of duty on our part or an intentional or grossly negligent breach of duty by one of our legal representatives or vicarious agents; For other damages that are based on our grossly negligent breach of duty or on an intentional or grossly negligent breach of duty by one of our legal representatives or vicarious agents; For liability under the Product Liability Act. All of the above liability rules also apply equally to the personal liability of our legal representatives, executive bodies, employees and other vicarious agents.

8. PRICES, TERMS OF PAYMENT, OBLIGATIONS OF THE BUYER TO COOPERATE

All prices are strictly net ex works, unless otherwise agreed. The invoice amounts are due in euros without deduction within the payment period stated on the invoice. Any shipping costs will be charged additionally. The customer shall be solely responsible for any customs formalities, the handling of imports and customs clearance; the customer shall also bear customs duties, levies, taxes, costs and fees. At no time shall we be deemed to be the distributor. All border traffic is carried out on behalf of the customer.

8.1

Subsequent price changes by our suppliers remain reserved in any case and can be passed on to the customer. Only the quantities, masses and weights determined by our factories or distribution centers at the time of dispatch shall be decisive for invoicing. Our invoices are payable net immediately upon receipt, unless otherwise agreed in writing. If the payment deadline is exceeded, we shall be entitled to charge interest on the purchase price at a rate of 9% above the respective base interest rate of the European Central Bank from the due date. We expressly reserve the right to claim further damages for default. We are also entitled to withhold further deliveries until the buyer has settled all overdue claims in full. We reserve the right to assign the claim to third parties.

8.2

The customer shall support us in the fulfillment of the contractually owed services. The customer is obliged to provide the services to be rendered by him (e.g. notification of the delivery address, delivery of labels, delivery of suitable packaging, delivery of the raw materials provided) in good time. In the event of a delay on the part of the customer, we shall be entitled to invoice our production costs incurred up to that point. In this case, the customer shall be in default no later than 14 days after receipt of a written request from us. The customer’s right to refuse performance is excluded. Offsetting by the customer is only permitted if his counterclaim is recognized by us in writing or has been legally established. If the invoice is not paid, we shall be entitled to charge the interest rate agreed under clause 8.1. of these terms and conditions. We are entitled, despite any provisions of the customer to the contrary, to initially offset payments against the customer’s older debts. In this case, we shall inform the customer immediately of the type and amount of the set-off. A payment shall only be deemed to have been made when we can dispose of the amount. Checks and bills of exchange are only accepted on account of performance.

9. RESERVATION OF TITLE

9.1

All delivered goods shall remain our property until the customer has settled all claims, in particular claims from current bills of exchange and checks, as well as the claims from the respective balance of the business relationship with us.

9.2

Handling and processing of the goods delivered subject to retention of title shall be carried out for us as manufacturer within the meaning of § 950 BGBB, without this placing us under any obligation. In the event of processing by the customer with other goods not belonging to us or supplied by us, we shall be entitled to co-ownership of the new item in the ratio of the invoice value of the goods delivered subject to retention of title to the invoice value of the processed goods. The same shall apply in the event of mixing.

9.3

Should the retention of title expire due to combination, processing or mixing, the customer hereby assigns to us the rights to which he is entitled to the new stock or the new item in the amount of the respective invoice value of the goods delivered under retention of title. The customer shall store the new stock or the new item for us free of charge. The resulting co-ownership rights shall also be deemed to be our reserved property.

9.4

The customer is entitled to resell the reserved goods in the ordinary course of business as long as he is not in arrears with his payments to us. The customer is obliged to agree a retention of title with his customers. The customer’s claim from the resale shall already now be deemed assigned to us in the amount of the purchase price attributable to the goods subject to retention of title. We already accept this assignment today. The retention of title shall expire in the event of resale or upon payment of the full purchase price to us. Should the customer enter into or have entered into a current account agreement with his customers which results in the claim from the resale not being transferred directly to us, the claim from the current account relationship against the customer’s buyer shall be deemed to have been assigned to us already now. We in turn hereby accept this assignment. All claims of the customer from the resale of the reserved goods, which have been assigned to us on the basis of this condition, shall serve as security for the claim to the same extent as the reserved goods themselves.

9.5

The customer must inform us immediately if enforcement measures are taken against the reserved property. Should the customer acquire claims against an insurer or other third parties as a result of damage, reduction, loss or other destruction of the goods subject to retention of title, these claims, together with all ancillary rights, are hereby assigned to us to the extent of the value of the goods subject to retention of title at the time of delivery, whereby we hereby accept the assignment. The retention of title is conditional in such a way that it expires immediately upon full payment of all claims arising from the business relationship. In this case, ownership of the reserved goods shall be transferred to the customer and the customer shall also be entitled to the assigned claims. If the value of the securities exceeds our claims by more than 20%, we shall release securities of our choice at the customer’s request.

10. LIABILITY OF THE CUSTOMER

The customer shall bear sole responsibility for all textual and advertising statements on the packaging and in the context of marketing. Insofar as liability should nevertheless arise for us from the respective legal situation, the customer shall indemnify us internally from any claims and shall pay a corresponding compensation for damages including all costs for the defense against such claims. This also applies in particular to any legal fees and court costs incurred. This provision shall also apply if the rights of third parties are impaired by the marketing of the respective product (e.g. patent rights or similar). This applies in particular in the event that our goods are exported by the customer to territories outside the Federal Republic of Germany, especially if our products infringe third-party property rights. The same applies if physical injury or damage to health or property occurs due to improper use.

11. PLACE OF PERFORMANCE

Unless otherwise stated in the order confirmation, the place of performance shall be the registered office of BioPharmatec GmbH.

12. PLACE OF JURISDICTION / CHOICE OF LAW

The place of jurisdiction shall be the competent court at the registered office of BioPharmatec GmbH. However, we shall also be entitled to assert claims against the customer at his general place of jurisdiction or at another place of jurisdiction provided for by law, EU law or international law. The implementation, application and interpretation of these General Terms and Conditions, the contracts concluded on their basis and the business relationship with the customer as a whole shall always be governed exclusively by German law, to the exclusion of the provisions of the UN Convention on Contracts for the International Sale of Goods.

13. SEVERABILITY CLAUSE

Should individual provisions of these General Terms and Conditions and/or the respective supplementary individual contractual provisions with the customer, including this provision itself, be or become invalid in whole or in part, the validity of the remaining provisions or parts of such provisions shall remain unaffected. The invalid provision shall be replaced by valid provisions that come as close as possible to the economic intent of the invalid provision. In case of doubt, the respective statutory provisions shall apply instead.