General Terms and Conditions of Sale of INRESA Arzneimittel GmbH

§ 1 Scope of Applicability

1.1 In the absence of a separate agreement for the individual case, all quotations and orders for deliveries and performances of INRESA Arzneimittel GmbH (INRESA GmbH) shall be based upon and include by reference the present General Terms and Conditions of Sale of INRESA GmbH (hereinafter referred to as “the present General Terms and Conditions”). This shall apply also insofar as during ongoing business relations later on no explicit reference to the same should be made. No conflicting or deviating terms of the Customer shall apply unless explicitly acknowledged in writing by INRESA GmbH.

1.2 The present General Terms and Conditions shall apply only towards entrepreneurs within the meaning of § 14 of the German Civil Code, insofar as the contract belongs to the operations of the business, and legal entities under public law or special funds under public law pursuant to § 310 I of the German Civil Code.

§ 2 Quotations, Confirmation of Orders

2.1 All quotations by INRESA GmbH shall be without obligation or binding effect. Orders shall be deemed accepted only upon confirmation by INRESA GmbH by letter, fax or email, or when the order has been executed.

2.2 The respective order confirmation by INRESA GmbH shall be decisive for the scope and contents of the contract unless INRESA GmbH receives a written objection by the Customer within eight days after the order confirmation by INRESA GmbH. Oral ancillary agreements shall in any case require written confirmation by INRESA GmbH in order to become effective.

2.3 In the absence of explicit marking as such, the descriptive statements contained in descriptions of services and products, brochures, commercials and other informative and advertising materials left or made available to the Customer shall not constitute any guarantee of quality.

§ 3 Prices and Delivery

3.1 In the absence of special statements in the order confirmation, the prices according to the price list of INRESA GmbH as valid at the time of order placement shall apply. The prices listed shall apply solely to deliveries within Germany. They are exclusive of the statutory VAT.

3.2 The prices stated are exclusive of packaging, shipment / transport costs and transport insurance.

Supply pharmacies and dispensaries are supplied free domicile.

§ 4 Terms of Payment

4.1 Subject to a deviating order confirmation, invoices by INRESA GmbH shall be payable within 30 days net. For amounts of more than € 50 and payment within 10 days from the date of the invoice we allow 2 % discount. If the payment is effected more than 14 days after due date, we reserve the right to claim default interest to the amount of the customary bank interest rate.

The minimum order value is € 50.

4.2 The Customer shall be in default of payment in case of non-payment after a reminder sent after the due date. The Customer shall be in default at the latest, even without reminder, 30 days after due date and sending of the invoice. In case of default, INRESA GmbH shall have the right to claim default interest amounting to 8 % p.a. over the base interest rate as defined in § 247 of the German Civil Code, while reserving the right to assert a higher demonstrated damage due to delay in performance.

4.3 If the Customer is in default, INRESA GmbH shall be entitled, without prejudice to further rights, to exert, without previous notice, a right of retention to all still pending deliveries of goods and services – including those from other contracts – or to demand prepayment or provision of collaterals for the same. Furthermore, in such a case INRESA GmbH shall be entitled to demand payment in cash, regardless of the terms of accepted bills of exchange, against return of the bills of exchange. The same shall apply if any facts should come to the knowledge of INRESA GmbH after acceptance of an order which give rise to justified doubts about the ability of the Customer to pay.

4.4 Payment by cheque or bill of exchange shall be possible only on the basis of a previous agreement. Bills or cheques shall be accepted only on account of performance; the time of discharge or encashment, respectively, shall be deemed the time of payment; in the case of bill of exchange or check proceedings the time of release from liability. All costs and expenses for the discounting or discharge of the bills of exchange shall be borne by the Customer.

4.5 The Customer shall not be entitled to offset claims of INRESA GmbH with counterclaims unless such counterclaims are undisputed, ready to be decided, finally established or acknowledged by INRESA GmbH. The Customer shall be entitled to exercise a right to retention only insofar as the Customer’s counterclaim is undisputed, ready to be decided or finally established.

4.6 The Customer shall have no right to retention for partial deliveries pursuant to § 320 II of the German Civil Code.

4.7 INRESA GmbH shall be entitled to offset against claims of the Customer, including claims from other invoices, at any time.

§ 5 Transfer of Risk, Terms of Delivery and Performance

5.1 Upon delivery, the risk passes to the Customer as soon as the goods leave the warehouse of INRESA GmbH; in case of picking up by the Customer, upon notification of their readiness to be collected. Shipping shall always be at the Customer’s risk. Unless agreed otherwise, INRESA GmbH shall determine the mode of shipment. Transport insurance shall be taken out only upon the Customer’s explicit request and at the Customer’s expense. If the shipping should be delayed as a consequence of circumstances which the Customer is responsible for, the risk shall devolve to the Customer upon notification of the readiness to be collected. However, in such a case INRESA GmbH is ready to take out, at the Customer’s expense, the insurances which the Customer requests.

5.2 In the absence of any explicit written agreements, the statement of dates for the provision of goods and services is non-committal. Agreed and binding terms of delivery and performance shall begin no earlier than upon receipt of the order conformation by INRESA GmbH, but not before the timely and proper discharge of the Customer’s obligations to cooperate and not before receipt of any down-payment agreed upon. Terms of delivery shall be deemed kept if the delivery item has left the distributing warehouse or the readiness for collection or shipping has been notified by expiry of the term.

5.3 INRESA GmbH strives to comply with agreed terms of delivery and performance. If INRESA GmbH should be in default with a delivery or other performance, the Customer – if it can demonstrate having incurred damage thereby – shall be entitled to demand a flat compensation amounting to 0.5 % of the order value per week, but no more than 5 % of the total order value. Further claims of the Customer for damages based on the delay of the delivery or performance are disclaimed. This shall not apply if and insofar as the delay is due to violation of an essential contractual obligation, or if and insofar the liability is statutory in cases of intent, gross negligence or for injury to health, life or limb; this shall not be deemed to reverse the onus of proof to the Customer’s disadvantage.

5.4 INRESA GmbH’s obligation to deliver shall be subject to timely and proper supply of raw materials from its contractors. INRESA GmbH shall inform the Customer immediately in case of unavailability of the item to be delivered, and shall in case of withdrawal immediately refund the appropriate consideration to the Customer.

5.5 The Customer’s statutory right of withdrawal in case of delayed delivery or performance shall remain unaffected but premises that INRESA GmbH is responsible for the delay. Upon request by INRESA GmbH the Customer shall state within a reasonable term whether it withdraws from the contract after expiry of the term due to delay of the delivery or performance, or insists upon the delivery or performance.

5.6 Operational disturbances outside its control (lack of materials, strikes) and other events of force majeure shall release INRESA GmbH for the time of the disturbance from the obligation to perform.

5.7 Partial deliveries and performances shall be permissible to a reasonable extent.

5.8 Unless agreed otherwise in the individual case, INRESA GmbH shall not be obliged to provide a performance guarantee.

§ 6 Retention of Title

6.1 In case of the delivery of goods, the delivered goods shall remain the property of INRESA GmbH until complete fulfilment of all claims from the business relationship with the customer, regardless of the legal bases. In case of account current, the retained property shall be deemed collateral for the respective outstanding balance claim of INRESA GmbH.

6.2 In case of behaviour of the Customer that is contrary to the contract, in particular in case of payment default, imminent cessation of payments, unsatisfactory information about the ability to meet financial obligations or about the financial situation of the Customer,          compulsory execution against the Customer’s assets or bill protests, as well as in case of a petition for the opening of insolvency proceedings into the assets of the Customer having been filed, INRESA GmbH shall be entitled to withdraw the shipped goods, which the Customer shall be obliged to surrender. Withdrawal of the goods or assertion of the retention of title shall not require withdrawal from the contract on the part of INRESA GmbH. These actions or seizure of the shipped goods by INRESA GmbH shall not constitute a withdrawal from the contract unless INRESA GmbH should explicitly have withdrawn in writing. Having taken back the delivered goods, INRESA GmbH shall be entitled to turn the same to account. The proceeds from the sale shall be credited against the liabilities of the customer – minus reasonable costs for the utilization.

6.3 The customer shall treat the delivered goods with due care and upon request of INRESA GmbH appropriately insure them for the duration of the retention of title. The Customer herewith assigns any claims against the insurance to INRESA GmbH, which accepts the assignment. In case of seizure or other interference by third parties the Customer shall inform INRESA GmbH immediately in writing to enable INRESA GmbH to assert its rights of ownership. Insofar as the third party is not able to refund to INRESA GmbH the judicial and extrajudicial costs for assertion of the rights of ownership of INRESA GmbH, the Customer shall be liable for the losses incurred by INRESA GmbH thereby.

6.4 The customer may sell goods owned by INRESA GmbH only in the regular course of business under its regular terms and conditions; this, however, shall apply only as long as the Customer is not in default. For the case of resale, the Customer hereby assigns the claims against its customers or third parties arising therefrom to the amount of the invoice value (inclusive of VAT) plus a security surcharge of 10 % to INRESA GmbH, which hereby accepts the assignment.

6.5 The customer shall be entitled to collect the claims assigned to item 6.4 above to INRESA GmbH until revocation by INRESA GmbH, which shall be permissible at any time. INRESA GmbH shall exercise this right of revocation only for cause. Upon request, the Customer shall inform the third party debtors about the assignment to INRESA GmbH and provide INRESA GmbH with the information and documents required for collection.

6.6 The customer may not assign or pledge retained goods owned by INRESA GmbH to third parties, assign the claims from resale of the same to third parties or use them to offset, nor agree upon a prohibition of assignment with its customers with regard to these claims. In case of a blanket assignment by the customer, the claims assigned to INRESA GmbH shall be explicitly exempt therefrom.

6.7 If the value of the collaterals existing for INRESA GmbH should exceed the claims of INRESA GmbH against the Customer by more than 10 %, upon request INRESA GmbH shall release the collaterals exceeding this limit, whereby the selection of the items to be released shall be at the discretion of INRESA GmbH.

§ 7 No Return or Replacement

7.1 For reasons of drug safety, goods delivered in accordance with a contract will not be taken back or replaced.

7.2 If the Customer should return goods to INRESA GmbH unprompted, INRESA GmbH reserves the right to destroy these goods without notice or compensation.

§ 8 Defects

8.1 In case of defects externally visible on the packaging of a shipment, prior to acceptance of the delivery the Customer shall initiate written confirmation of the detectable deficiencies by the postal service or the transportation company in charge. In case of damage to the goods which are not externally detectably upon delivery yet but may have been caused by transport, immediately after detection of the same, but no later than three working days after detection, the Customer shall notify the postal service or the transportation company in charge and demand written recording of the facts in the case.

Here working days for the purposes of the present General Terms and Conditions shall be all days with the exception of Sundays and public holidays. If the Customer should fail to meet these obligations, any claims on his part against INRESA GmbH for damages or replacement of expenses based on defects on the goods delivered shall be disclaimed, unless said defects should be due to intention or gross negligence or INRESA GmbH should have culpably breached any essential contractual obligation, or in cases of damage to health, life or limb.

8.2 The Customer shall inspect deliveries immediately upon receipt and notify any claims for defects immediately upon receipt, in the case of concealed defects immediately after their having become detectable, in writing to INRESA GmbH.

8.3 In the case of defects of the delivery item notified in due time, the Customer shall first be entitled to rectification or compensation delivery at INRESA GmbH’s choice. The expenses incurred thereby, such as labour, material, transport and travel costs, shall be borne by INRESA GmbH only insofar as the same are not increased by the delivery item having been brought later to a place different from the agreed place of delivery, unless this relocation should correspond to the intended use. Replaced goods shall become the property of INRESA GmbH and are to be returned to INRESA GmbH.

8.4 Insofar as INRESA GmbH should fail to rectify the defect within a reasonable term to be set by the Customer, the Customer may, without prejudice to any claims for damages or replacement of expenses under § 9, opt to either demand reduction of the purchase price or – provided that the breach of obligations on the part of INRESA GmbH is not insignificant – withdraw from the contract.

8.5 The responsibility of INRESA GmbH for material defects shall be deemed voided if the delivery item has been modified by the Customer without authorization. Only in urgent cases of danger to operational safety or for protection against disproportionally high damage, the Customer shall have the right to eliminate a defect independently or have it eliminated by third parties and demand compensation for the expenses incurred thereby from INRESA GmbH. The same shall apply if INRESA GmbH is in default concerning the elimination of a defect. In all these cases INRESA GmbH must be notified immediately.

8.6 Claims for defects – including claims for damages and for compensation of expenses based on defects, insofar as these are not due to intent or gross negligence of INRESA GmbH and do not result in damage to health, life or limb – shall lapse within twelve months from delivery. This shall not apply if and insofar as a longer limitation period is statutory under applicable law. For replacement parts or rectification, respectively, INRESA GmbH shall be liable until expiry of the limitation period for the original delivery item.

8.7 In case of claims for defects, payments by the Customer may be withheld only to an extent in a reasonable relation to the defects occurred and only if the Customer’s claims are undisputed, ready to be decided, finally established or acknowledged. If the claim for defects should have been notified without justification, INRESA GmbH shall be entitled to demand compensation of its expenses incurred thereby by the Customer.

§ 9 Liability

9.1 Subject to the provisions of 9.2, INRESA GmbH shall be liable according to the statutory provisions if the Customer asserts claims for damages or compensation of expenses which are based on intent or gross negligence, or if INRESA GmbH has culpably violated an essential contractual obligation, as well as in cases of damage to health, life or limb.

9.2 Insofar as no intentional or grossly negligent breach of obligations and no damage to health, life or limb have been imputed to INRESA GmbH, claims for damages or compensation of expenses shall lapse within twelve months, and the amount of the liability shall be limited to the predictable typical damage, but no more than the order value. In addition, the Customer’s claims for compensation of expenses shall in all cases be maximally limited to the interest which the Customer may have in the fulfilment of the contract.

9.3 Any further liability for compensation of damages or expenses beyond the provisions of the present General Terms and Conditions is disclaimed regardless of the legal nature of the asserted claim. In particular, INRESA GmbH shall not be held liable for any damage that has not occurred to the delivery item or performance itself, e.g. lost profits or property damage of the Customer. The mandatory provisions of the German Product Liability shall remain unaffected thereby.

9.4 Insofar as liability of INRESA GmbH is excluded under the present General Terms and Conditions, the same shall also apply to liability of the organs of INRESA GmbH and of assistants and vicarious agents, in particular of employees.

§ 10 Resale

10.1 Resale of delivered drugs shall be permissible only in the original package and including the original package insert by INRESA GmbH.

10.2 Resale of delivered drugs abroad, including free-port areas, shall not be permissible unless permitted by mandatory legal provisions.

§ 11 Concluding Provisions, Place of Performance, Legal Venue and Invalidity of Individual Provisions

11.1 The contractual relationships with the customers of INRESA GmbH shall be exclusively subject to and governed by German law, excluding and waiving application of the CISG.

11.2 The exclusive place of performance for both parties to the contract shall be Freiburg im Breisgau. The legal venue shall be Freiburg im Breisgau; any exclusive legal venues shall remain unaffected thereby.

11.3 If any provision of the contract concluded between INRESA GmbH and the Customer, including the present General Terms and Conditions, should be or become invalid, the other provisions of the contract including the present General Terms and Conditions shall remain unaffected thereby and continue to be effective and binding.