A             Scope of application

• In addition to the individual contractual agreements and the statutory provisions, these General Terms and Conditions of Delivery and Service (GTC) shall apply exclusively to all business transactions between Dr. Haney Pharma GmbH and the buyer, purchaser or client, hereinafter referred to as the client. Dr. Haney Pharma GmbH does not accept any deviating terms and conditions of purchase and other deviating terms and conditions of the client. They also do not become part of the contract by acceptance of an order. Silence on the part of Dr. Haney Pharma GmbH is not regarded as recognition. These GTC also apply if Dr. Haney Pharma GmbH accepts payments or provides services in knowledge of conflicting or deviating conditions of the client. The client expresses his agreement with these conditions at the latest by accepting the deliveries or services provided by Dr. Haney Pharma GmbH.
• If these GTC are an integral part of contracts with the client through legal inclusion, in the event of an ongoing business relationship between Dr. Haney Pharma GmbH and the client, they shall also apply to all future contracts without renewed inclusion until the new GTC of Dr. Haney Pharma GmbH are valid.
• All agreements made or to be made between Dr. Haney Pharma GmbH and the client are to be recorded in writing for reasons of better traceability.

B     Scope of contract

• The type and scope of the services owed by Dr. Haney Pharma GmbH are based on the agreements made, whereby the regulations valid at the time of the conclusion of the contract must be applied, unless expressly agreed otherwise.
• Our offers are subject to change and non-binding. All transactions and contract conclusions only become binding for us when they are confirmed in writing or the services ordered are carried out. The same applies to additions, modifications or collateral agreements. The services and prices set out in the quotations are valid for 14 days after preparation of the quotation, unless expressly stated otherwise in the offer.
• If Dr. Haney Pharma GmbH provides services, it only owes services, but not success, unless expressly agreed otherwise in writing.
• If, during the provision of services, changes are made to the regulations, in particular to the technical regulations (e.g. cGMP (EU-GMP/AMWHV)) the services owed by Dr. Haney Pharma GmbH will not be changed. However, the contracting parties shall, as far as possible and known, inform each other of the intended or implemented changes during the period of performance of the service. Any necessary extension or amendment of the contractual obligation by Dr. Haney Pharma GmbH will be agreed by mutual consent.
• The client must take all measures, make declarations or provide all documents necessary for the contractual performance of services by Dr. Haney Pharma GmbH in good time.

C             Changes, Test parameters

• Haney Pharma GmbH reserves the right to make appropriate changes to the service content in the event of missing or incorrect information from the client. Any disadvantages arising from this, in particular costs or damage, shall be borne by the customer.
• Necessary changes to Dr. Haney Pharma GmbH’s services that are reasonable for the client are permissible. In the case of an order whose proper execution requires a deviation from the specifications in the corresponding offer in terms of scope and/or duration, the services may be adjusted in accordance with the valid prices to the extent which is required for the correct and proper execution of the order. The regulation under B (4) remains unaffected by this.
• For tests for which certain measurement or control values or other test parameters are to apply, the corresponding test methods must be specified and accepted by both parties before the start of delivery. If no specification is made, the test methods applied by Dr. Haney Pharma GmbH apply.

D             Exemption

• The client is responsible that he has acquired all rights to the documents and/or products handed over to Dr. Haney Pharma GmbH and that no rights of third parties, in particular copyrights, trademark rights and patent rights are violated or that he is not prevented from the utilisation of the aforementioned documents and/or products by other commitments or legal prohibitions.
• The client shall indemnify and hold Dr. Haney Pharma GmbH harmless if any claims are made by third parties, or official measures are taken in connection with the contractual use of the aforementioned items.

E             Information, Suitability, Ownership of documents

• All verbal and written advice is provided by Dr. Haney Pharma GmbH to the best of its knowledge and belief based on its experience. Information on services or products of Dr. Haney Pharma GmbH, in particular in its brochures, catalogues, other documents and electronically presented media, e.g. on the Internet, in particular on the suitability and use of our services and products, do not contain any assurances per se and are non-binding unless expressly described as binding in our quotation or an order confirmation. They do not exempt the client from carrying out his own tests. In particular, the client is not exempt from checking the suitability of Dr. Haney Pharma GmbH’s services, products and recommendations for the intended and all other uses. This applies in particular to the observance of legal and official regulations when using the services and products of Dr. Haney Pharma GmbH.
• Reports, expert opinions, analysis results and other documents as well as models, samples and all other items provided by Dr. Haney Pharma GmbH for the execution of the order remain the property of Dr. Haney Pharma GmbH and must be returned on request. Dr. Haney Pharma GmbH reserves all rights thereto, in particular copyrights. The aforementioned documents and items shall not be made accessible to third parties or used outside the purpose for which they were handed over to the client. This applies in particular to such documents which are marked as confidential. Before passing on documents to third parties, the client must obtain the express written consent of Dr. Haney Pharma GmbH.

F             Delivery periods and dates

• Delivery periods begin upon receipt of the order confirmation from Dr. Haney Pharma GmbH by the client, but not before complete clarification of all details of the order and receipt of all information or documents to be supplied by the client; the same applies to delivery dates. In the event of amicable changes to the subject matter of the order, the delivery date shall lapse and must be agreed upon anew.

• The start of the agreed delivery period requires the complete clarification of all circumstances essential for the provision of the service. Compliance with Dr. Haney Pharma GmbH’s performance obligations requires in particular the timely and proper fulfilment of the client’s obligations. Otherwise the period will be extended appropriately.

• The delivery periods stated by Dr. Haney Pharma GmbH are approximate unless the delivery date has been expressly agreed as binding.

• f Dr. Haney Pharma GmbH is responsible for the delayed delivery and Dr. Haney Pharma GmbH has been granted a reasonable grace period without success, the client may withdraw from the contract. Unforeseen events (regulated in more detail under point K) extend the delivery time accordingly. Dr. Haney Pharma GmbH reserves the right to make partial and subsequent deliveries within the scope of what is reasonable for the client. If Dr. Haney Pharma GmbH is still unable to perform after a reasonable extension, both the client and Dr. Haney Pharma GmbH are entitled to withdraw from the contract. The regulation under K applies to claims for damages on the part of the customer due to delayed delivery.

G            Payment

• The prices depend on the quotation. The services provided by Dr. Haney Pharma GmbH are subject to their current service rates, the rates of which can be requested from Dr. Haney Pharma GmbH by the client.
• In addition to the agreed prices, the customer must also bear the incidental costs associated with the service (e.g. official documents, travel costs, expenses for postage or telecommunications services, translations) and the statutory value added tax at the time of the service provision.
• Haney Pharma GmbH is entitled to change the agreed price appropriately if changes occur before or during the execution of the order because the information and documents provided by the client were incorrect or if the customer wishes other changes.
• Haney Pharma GmbH is entitled to demand an appropriate advance payment upon conclusion of the contract. Interest will not be reimbursed for this.
• Invoices are due 10 days after the invoice date, at the latest 14 days after receipt by the customer. They are payable without deductions. In the event of non-payment, the customer shall be in default after the due date without further reminder. Discounts and rebates are not granted.
• The prices shown in our offers are exclusively performance-related and expressly do not include:

1. Expenses for the use of third parties necessary for the provision of services. This includes fees of involved authorities, certification and translation costs, as well as shipping costs.
2. Costs and expenses for necessary legal advice and/or representation.
3. travel expenses, as well as costs and expenses for presentations on site.
4. Set-off, Rights of retention

• The customer may only offset undisputed, recognised or legally established claims.
• The assignment of claims against Dr. Haney Pharma GmbH requires the consent of Dr. Haney Pharma GmbH.
• The client has a right of retention only if the counterclaim is based on the same contractual relationship and is acknowledged, undisputed, ready for decision or legally binding or if Dr. Haney Pharma GmbH has substantially violated obligations from the same contractual relationship despite a written warning and no adequate security has been offered. If Dr. Haney Pharma GmbH’s performance is undisputedly defective, the client is only entitled to withhold payment to the extent that the amount withheld is in reasonable proportion to the defects and the probable costs of remedying the defect.

1. Statute of limitations, Suspension of limitation

• The limitation period for claims and rights due to defects in products, services and work performances of Dr. Haney Pharma GmbH and the resulting damages is 1 year. Mandatory statutory limitation periods remain unaffected by this.
• The limitation period according to para.1 sentence 1 does not apply in case of intent, if Dr. Haney Pharma GmbH maliciously concealed the defect or assumed a guarantee for the condition of the item, in case of claims for damages due to injury to life, body or health or freedom of a person, in case of claims under the German Product Liability Law (Gesetz über die Haftung für fehlerhafte Produkte), in case of a grossly negligent breach of duty or in case of culpable breach of essential contractual obligations as well as in case of relevance of the statutory provisions on consumer goods purchase regulation in the German Civil Code (§ 474 BGB – Verbrauchsgüterkauf).
• Subsequent performance measures, i.e. the delivery of a defect-free item or the removal of the defect, do not allow the period of limitation to begin anew, but only suspend the period of limitation applicable to the original delivery item for the duration of the subsequent performance measure carried out. In case of doubt, the performance of subsequent performance by Dr. Haney Pharma GmbH does not constitute an acknowledgement within the meaning of § 212 No. 1 BGB.
• A change of the burden of proof to the disadvantage of the client is not connected with the above regulations.
• Unless expressly provided otherwise, the statutory provisions on the commencement of the limitation period, the suspension of expiry, the suspension and the recommencement of periods shall remain unaffected.

J              Termination

• The contract shall enter into force upon signature by both contracting parties and shall remain valid until terminated by one of the contracting parties.
• Ordinary termination must be made in writing by registered letter with acknowledgement of receipt in accordance with the contractually agreed period. The right to extraordinarily terminate the contract for good cause remains unaffected by this.
• Amendments and supplements to the contract and its annexes shall be made by mutual agreement and must be made in writing.

K             Force Majeure

Events of force majeure as well as significant, unforeseeable obstacles outside Dr. Haney Pharma GmbH’s sphere of influence, such as strikes, lockouts, exceeding of delivery deadlines or delivery failures of sub-suppliers, operational, sales or supply disruptions due to a shortage of energy, raw materials or labour, difficulties in procuring means of transport, traffic disruptions, orders from public authorities, from us or our suppliers, release Dr. Haney Pharma GmbH from the respective contractual obligations according to the duration of such measures and obstacles. Dr. Haney Pharma GmbH is not responsible for the aforementioned circumstances even if they occur during an already existing delay. The beginning and end of such measures and obstacles or the unavailability of the delivery item shall be notified to the customer without delay. If delivery is delayed by more than 4 weeks due to such measures and obstacles, the contracting parties are entitled to withdraw from the contract. In the event of withdrawal, payments already made will be refunded. Further claims are excluded.

L              Limitations of liability

• The liability of Dr. Haney Pharma GmbH in cases of intent or gross negligence is governed by the statutory provisions. Furthermore, Dr. Haney Pharma GmbH is only liable in accordance with the Product Liability Act, for injury to a person’s life, body or health or for culpable breach of material contractual obligations, i.e. a breach of those obligations the performance of which is essential for the proper performance of the contract and on whose compliance the contractual partner may regularly rely. Claims for damages due to a slightly negligent breach of essential contractual obligations are limited to the foreseeable damage typical for the contract. Dr. Haney Pharma GmbH’s liability is also limited in cases of gross negligence to contract-typical, foreseeable damage if none of the exceptional cases listed in sentence 2 of this paragraph 1 applies.
• As far as Dr. Haney Pharma GmbH is not liable due to intent, gross negligence, culpable violation of essential contractual obligations, injury to life, body or health of a person or according to the Product Liability Act, Dr. Haney Pharma GmbH’s liability for damages to the client’s legal assets, e.g. to other items, lost profit or other financial losses, is excluded.
• The provisions of the above paragraphs 1 and 2 extend to damages in addition to performance and damages instead of performance, for whatever legal reason, in particular due to defects, the breach of obligations arising from the contractual obligation or from tort. They also apply to the claim for reimbursement of wasted expenses and to liability for impossibility and delay.
• Claims for damages against Dr. Haney Pharma GmbH for damage to property and product assets are limited to the amount of the sum insured under the business and product liability insurance taken out by Dr. Haney Pharma GmbH. This limitation of liability does not apply if Dr. Haney Pharma GmbH is liable due to intent, gross negligence, culpable violation of essential contractual obligations or under the Product Liability Act or in cases in which the client asserts claims for damages on the basis of a guarantee or assurance given by Dr. Haney Pharma GmbH for the presence of a property, unless the purpose of the quality guarantee only extends to the contractual conformity of the underlying delivery, but not to the risk of consequential damage caused by a defect.
• The obligation to pay compensation is also excluded if the customer has effectively limited his liability towards his customer. The client will endeavour to agree the limitations of liability to the legally permissible extent also in Dr. Haney Pharma GmbH’s favour.
• Insofar as Dr. Haney Pharma GmbH’s liability for damages is excluded or limited, this also applies to all claims of the client due to culpa in contrahendo, breach of ancillary obligations, claims according to § 823 BGB as well as claims due to impossibility and delay. As far as the liability of Dr. Haney Pharma GmbH is excluded or limited, this also applies to the personal liability of our employees, workers, staff, representatives, subcontractors and vicarious agents.
• The customer’s rights in respect of defects as well as all contractual claims for damages due to defective deliveries presuppose that the customer has properly complied with the obligations to examine and give notice of defects in accordance with § 377 HGB (German Commercial Code) and comparable foreign national regulations. Otherwise the defect shall be deemed to have been approved. In particular, the customer must inspect the goods with reasonable thoroughness immediately after delivery or collection. Notice of any defects ascertained must be given in writing without delay. Defects which cannot be detected even with the most careful inspection must be notified in writing immediately after discovery, with immediate cessation of any treatment and processing. Otherwise the defect shall be deemed to have been approved. The burden of proof that there is a hidden defect is borne by the client.
• The provisions of § 377 HGB apply accordingly to services and work performances. The notice of defects does not release the customer from his payment obligations.
• Haney Pharma GmbH assumes no liability for quality defects or legal deficiencies for the manufactured finished or semi-finished product in therapeutic or pharmacological regard and is not obliged to test formulations handed over to it for their pharmacological correctness and expediency, their effectiveness or harmlessness. This also applies if the raw materials are purchased or supplied by Dr. Haney Pharma GmbH. The client is solely liable for the permissibility of production and distribution according to pharmaceutical law, trade police law, patent law, trademark law or other regulations and must immediately indemnify Dr. Haney Pharma GmbH from all claims of third parties which may be raised against Dr. Haney Pharma GmbH due to the permissibility of production or distribution.
• Furthermore, Dr. Haney Pharma GmbH’s pre-contractual, contractual and non-contractual liability is limited to intent and gross negligence. The limitation of liability also applies in the event of the fault of a subcontractor of Dr. Haney Pharma GmbH.

1. Place of jurisdiction, Applicable law, Place of performance, Invalidity, Data protection

• For all disputes arising from the contractual relationship between the parties, the exclusive local and international jurisdiction of the court responsible for the registered office of Dr. Haney Pharma GmbH, in this case Rostock, is agreed. This also applies to disputes in lawsuits with regard to documents, bills of exchange or cheques. Dr. Haney Pharma GmbH is also entitled to sue the client at his registered office.
• The contractual relationship with the customer shall be governed exclusively by the law of the Federal Republic of Germany.
• Unless otherwise agreed, the place of performance is the registered office of Dr. Haney Pharma GmbH in Wackerow.
• Should any provision of these General Terms and Conditions and the further agreements made be or become invalid, this shall not affect the validity of the remainder of the contract. The contracting parties shall endeavour to replace the invalid clause with another clause which comes as close as possible to the economic purpose and legal meaning of the original wording, taking into account the legal provisions applicable in this case.
• We store the customer’s personal data within the scope of the business relationship by means of electronic data processing in accordance with the Federal Data Protection Act and the General Data Protection Regulation.

Dr. Haney Pharma GmbH

Dreizehnhausener Str. 1A

17498 Wackerow

Germany

Phone:+49 3834-51 77 877

Fax: +49 3834-51 47 187

E-mail: contact@haney-pharma.de

Web: www.haney-pharma.de

Legal form: Gesellschaft mit beschränkter Haftung (Limited liability company)

Managing Director: Dr. Jeanette Haney

VAT ID No.: DE3164900022