General Terms of Delivery and Service for use in business transactions

- Version April 2020 -

A. Scope of Application

(1) In addition to the individual contractual agreements and the legal provisions, these General Terms of Delivery and Service (GTD) apply exclusively to the deliveries and services of Pharma Resources GmbH (hereinafter Pharma Resources) for all business transactions between Pharma Resources and the buyer, ordering party or client, hereinafter the Client. Pharma Resources shall not accept any deviating conditions of purchase or other deviating General Terms of Business of the Client, nor shall such conditions or terms become part of any contract as a result of acceptance of an order. Silence on the part of Pharma Resources shall not constitute acknowledgement. These GTD also apply if Pharma Resources accepts payments or renders services in the knowledge of conflicting or deviating conditions of the Client. The Client shall indicate his agreement with these Terms no later than by accepting the deliveries or services rendered by Pharma Resources.

 

(2) If, as a result of their inclusion pursuant to a legal act, these GTD form part of contracts with the Client, in the event of a continuing business relationship between Pharma Resources and the Client they shall also apply to all future contracts, without being included afresh, until such time as new GTD of Pharma Resources shall apply.

 

(3) All past and future agreements reached between Pharma Resources and the Client must always be recorded in writing, in order that they can more easily be proven.

 

B. Scope of Contract

(1) The nature and scope of the services due from Pharma Resources are determined by the agreements reached and, unless expressly agreed otherwise, shall be tailored to the regulations that apply at the time of conclusion of the contract.

 

(2) Where Pharma Resources renders services, unless expressly agreed otherwise in writing, Pharma Resources is obliged only to render services but not to achieve success.

 

(3) Where changes are made to the regulations, in particular the technical rules and regulations (e.g. cGMP (EU-GMP/AMWHV [Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients]) during the performance of the contract, this shall not cause any change to be made to the services due from Pharma Resources. However, for the duration of the performance of the contract, the contracting parties will inform each other of the planned or completed changes to the fullest extent possible and to the fullest extent of their knowledge. Any additions or changes to the services due from Pharma Resources that are thus necessitated will be agreed upon amicably between the contracting parties.

 

(4) The Client must promptly undertake all measures, give all declarations and supply all documents that are necessary for the proper performance of the contract by Pharma Resources.

 

C. Changes, Test Parameters

(1) Pharma Resources reserves the right to make appropriate changes to the content of its services in the event of missing or inaccurate information from the Client. Any prejudices arising as a result of this, in particular on account of costs or damages, shall be borne by the Client.

 

(2) Necessary changes may be made to the service rendered by Pharma Resources on the proviso that they are reasonable for the Client.

 

(3) For tests to which specific measurement or regulation values or other test parameters apply, the corresponding testing methods must be determined before commencement of delivery and acknowledged by both parties. If not determined in advance, the testing methods applied by Pharma Resources shall apply.

 

D. Information, Suitability, Ownership of Documents

(1) Any form of instruction given verbally or in writing shall be carried out by Pharma Resources to the best of its knowledge and conscience, based on our experience. Information about services or products of Pharma Resources, in particular in its brochures, catalogues, other documents and electronic media, e.g. on the internet, and in particular regarding the suitability and use of our services and products, do not, in themselves, constitute any assurance and are non-binding, unless they are expressly described as binding in our offer or an order confirmation. They do not exempt the Client from performing his own tests and trials. In particular, the Client is not exempt from personally checking the suitability of the services, products and recommendations of Pharma Resources for the intended purposes and all other uses. This applies in particular to compliance with legal and official requirements when using the services and products of Pharma Resources.

 

(2) Reports, opinions, analysis results and other documents, as well as models, specimens and all other objects made available by Pharma Resources for the execution of the order shall remain the property of Pharma Resources and must be returned on request. Pharma Resources reserves all rights to the foregoing, in particular copyrights. They may not be made available to third parties or used for any purpose other than that for which they were delivered to the Client. This applies in particular to documents designated as confidential. The Client must obtain the express, written permission of Pharma Resources before passing documents on to third parties.

 

E. Delivery Periods and Dates

(1) Delivery periods shall commence upon receipt of Pharma Resources’ order confirmation by the Client, but not before all the details of the order have been fully clarified and all information or documents required from the Client have been received; the same applies to delivery dates. The delivery period shall become invalid in the event of mutually agreed changes to the object of the order, and a new delivery period must be agreed.

 

(2) Commencement of the agreed delivery period is contingent upon the full clarification of all circumstances of material relevance to the performance of the contract. In particular, fulfilment of its contractual duties by Pharma Resources is contingent upon the timely and proper fulfilment of the Client’s duties. Failing this, the period will be extended by a reasonable length of time.

 

(3) The delivery periods stated by Pharma Resources are approximate, unless a firm delivery date has been expressly agreed.

 

F. Remuneration

(1) The prices are those stated in the offer. The current service rates of Pharma Resources apply to services rendered by it, and the Client may request the rates from Pharma Resources.

 

(2) In addition to the agreed prices, the Client shall also pay the incidental costs associated with the service(s) provided (e.g. travel expenses, disbursements for postage or telecommunications, translations) and the statutory VAT in force at the time of performance of the contract.

 

(3) Pharma Resources is entitled to make reasonable changes to the agreed price if, prior to or during the performance of the contract, changes occur because the instructions given and documents made available by the Client were inaccurate or other changes are required by the customer.

 

(4) Pharma Resources is entitled to demand an appropriate advance payment at the time of conclusion of the contract. No interest will be reimbursed on such payments.

 

(5) Invoices are payable 14 days after the invoice date and at the latest 14 days after their receipt by the Client. They must be paid without deductions. In the event of non-payment, the Client shall be in default after the due date, without further reminder. No trade or other discounts will be granted.

 

G. Setoff, Rights of Retention

(1) The Client may only undertake setoff against undisputed, acknowledged or legally established claims.

 

(2) The assignment of claims against Pharma Resources requires the latter's consent.

 

(3) The Client shall only have a right of retention where the counterclaim is based on the same contractual relationship and is acknowledged, undisputed, ready to be decided or legally established or where Pharma Resources is in material breach of duties under the same contractual relationship despite having received a written warning, and no appropriate assurances have been offered. If the performance of the contract by Pharma Resources is indisputably defective, the Client shall only have the right of retention to the extent that the amount retained is commensurate with the defects and the likely costs of remedying the defects.

 

H. Statute of Limitations, Suspension of Statute of Limitations

(1) The statute of limitations for claims and rights on account of defects in products, services and work performances of Pharma Resources and the resulting damages is 1 year. The preceding statute of limitations does not apply if and insofar as, in the instances provided for in §§ 438 (1) no. 2, 479 and 634 a (1) no. 2 BGB [German Civil Code], the law prescribes longer periods. The statute of limitations pursuant to sentence 1 also applies to all compensation claims against us, irrespective of whether they are connected with a defect and irrespective of the legal basis for the claim.

 

(2) The statute of limitations pursuant to paragraph 1, sentence 1 does not apply in the event of intent, where Pharma Resources has fraudulently concealed the defect or has assumed a guarantee for the quality of the object, in the event of compensation claims on account of injury to the life, body or health or freedom of a person, in the event of claims under the German Product Liability Act, in the event of a grossly negligent breach of duty or in the event of a culpable breach of contractual duty, as well as in the event that the legal provisions on sales of consumer goods apply.

 

(3) Supplementary performance measures, i.e. the delivery of an object that is free from defects or the rectification of the defects, shall not cause the statute of limitations to begin afresh but rather shall only suspend the statute of limitations that applied to the original delivery object, by the duration of the supplementary performance measure carried out. In case of doubt, there shall be no acknowledgement pursuant to § 212, no. 1 BGB with regard to the performance of supplementary measures by Pharma Resources.

 

(4) The preceding provisions do not entail a change in the burden of proof to the detriment of the Client.

 

(5) Unless expressly agreed otherwise, the legal provisions with regard to the commencement of the statute of limitations, the suspension of expiry and the suspension and recommencement of limitation periods shall remain unaffected.

 

I. Force Majeure

Incidences of force majeure and substantial, unforeseeable impediments that are beyond the sphere of influence of Pharma Resources, such as strikes, lock-outs, the exceeding of delivery periods or non-delivery by subcontractors, disruptions to business, distribution or supply due to a lack of energy, raw materials or manpower, difficulties arranging transport, traffic congestion and orders of higher authority, affecting us or our suppliers, shall release Pharma Resources from the respective contractual duties for the duration of such measures and impediments. Pharma Resources may likewise not be held responsible for the aforementioned circumstances if they occur during a delay that has already arisen. The commencement and end of such measures and impediments and/or the non-availability of the object of delivery will be notified to the Client without delay. If delivery is delayed by more than 4 weeks due to such measures and impediments, the contracting parties shall be entitled to cancel the contract. In the event of such cancellation, restitution will be made for reciprocal services already rendered. Further claims are excluded.

 

J. Limitations of Liability

 

(1) In instances of intent or gross negligence, the liability of Pharma Resources shall be determined by the provisions of law. In general, Pharma Resources is only liable in accordance with the German Product Liability Act, on account of injury to the life, body or health of a person or on account of the culpable breach of contractual duty, i.e. a breach of those duties the fulfilment of which is essential for the proper performance of the contract and which the contractual partner may routinely trust to be honoured.

Compensation claims on account of a slightly negligent breach of contractual duty are restricted to the predictable damages common to the contract.

In instances of gross negligence, the liability of Pharma Resources is also restricted to the predictable damages common to the contract if none of the exceptions listed in sentence 2 of the present paragraph 1 apply.

 

(2) If and insofar as Pharma resources is not liable on account of intent, gross negligence, culpable breach of contractual duty, injury to the life, body or health of a person or under the German Product Liability Act, the liability of Pharma Resources for damages to legal assets of the Client, e.g. to other objects, lost profit or other pecuniary loss, as a result of the performance or the object of the delivery or performance, shall be excluded.

 

(3) The provisions of the preceding paragraphs 1 and 2 extend to compensation in addition to performance and compensation in lieu of performance, irrespective of the legal basis, in particular on account of defects, the breach of duties under the contractual relationship or unauthorised actions. They also apply to claims to restitution for wasted expenditure and to liability on account of impossibility and delay.

 

(4) Compensation claims made against Pharma Resources on account of damage to tangible assets and products are restricted to the amount of the insured sum under the business and product liability insurance concluded by Pharma Resources. This limitation of liability does not apply if and insofar as Pharma Resources is liable on account of intent, gross negligence, culpable breach of contractual duty or under the German Product Liability Act, and in the instances in which the Client asserts compensation claims on the basis of a guarantee or assurance given by Pharma Resources for the existence of a particular property, unless that guarantee extends solely to the contractual conformity of the underlying delivery, but not to the risk of consequential harm caused by a defect.

 

(5) The liability to pay damages is also excluded if and insofar as the Client has effectively restricted his liability vis-à-vis his customer. In such event, the Client will endeavour to also agree the limitations on liability in favour of Pharma Resources, to the legally permitted extent.

 

(6) If and insofar as the liability of Pharma Resources to pay compensation is excluded or restricted, this shall also apply to all claims of the Client on account of negligence in contracting, breach of accessory duties, claims pursuant to § 823 BGB and claims on account of impossibility and delay. If and insofar as the liability of Pharma Resources is excluded or restricted, this shall also apply to the personal liability of our appointees, employees, co-workers, representatives, vicarious agents and assistants.

 

(7) The Client’s claims arising from defects and all contractual compensation claims on account of defective deliveries are contingent upon the Client having properly complied with the duties of inspection and objection pursuant to § 377 HGB [German Commercial Code] and similar rules under foreign law. Failing this, the defect shall be deemed to have been approved. In particular, the Client must inspect the goods immediately after their delivery or at the time of collection, with all reasonable thoroughness. The defects identified during that inspection must be notified immediately, in writing.

Defects that cannot be detected even by the most careful inspection must be notified in writing immediately after they are detected, and all and any processing of the items concerned must immediately cease. Failing this, the defect shall be deemed to have been approved.

The burden of proving the existence of a hidden defect shall lie with the Client.

 

(8) The provisions of § 377 HGB apply by analogy to services and work performances. A complaint about a defect shall not discharge the Client from honouring his payment duties.

 

(9) Pharma Resources accepts no liability for material defects or deficiencies in title in respect of the manufactured finished product or semi-finished product in a therapeutic or pharmacological respect and is not obliged to check the formulas delivered to it for execution for their pharmacological accuracy and suitability, their effectiveness or their safety. The same applies if the base materials are purchased or supplied by Pharma Resources. Only the Client is liable for the permissibility of manufacture and distribution in accordance with the provisions and rules of drugs legislation, factory inspectorates, patent law, trademark law or other provisions and must immediately indemnify Pharma Resources against all claims of third parties that may be made against Pharma Resources on account of the permissibility of manufacture or distribution.

 

(10) In general, the pre-contractual, contractual and non-contractual liability of Pharma Resources is restricted to intent and gross negligence, and this restriction of liability also applies to faults of a vicarious agent of Pharma Resources.

 

K. Jurisdiction, Applicable Law, Place of Performance, Invalidity, Data Protection

(1) The sole local and international competence of the court with jurisdiction over the seat of business of Pharma Resources, in this case Hamelin or Hanover, is agreed for all disputes arising from the contractual relationship between the parties. This also applies to disputes in proceedings restricted to documentary evidence, summary bill enforcement proceedings or cheque payment enforcement proceedings. However, Pharma Resources is also entitled to bring action against the Client at his place of business.

 

(2) The contractual relationship with the Client is subject exclusively to the law of the Federal Republic of Germany.

 

(3) Unless otherwise agreed, the place of performance is the seat of business of Pharma Resources in Hamelin.

 

(4) Should any provision of these GTD and the additional agreements reached be or become invalid, this shall not affect the validity of the remainder of the contract. Having due regard for the relevant legal provisions in each case, the contracting parties shall endeavour to replace the invalid clause with another clause with economic purpose and legal tenor corresponding as closely as possible to the original wording.

 

(5) We use electronic data processing to store personal data of the Client in connection with the business relationship, in accordance with the Federal Data Protection Act.

 

 

 

 

Pharma Resources GmbH

Domeierstraße 29/31

31785 Hameln / Deutschland

 

Telefon: +49 5151 609 96-0

Telefax: +49 5151 609 96-30

 

E-Mail: info@pha-res.com

Web: www.pha-res.com

 

Rechtsform: GmbH

Geschäftsführer: Heidi Lürig, Dipl. Ing. Detlef Lürig MBA

Juliana Dodillet Wirtschaftsjuristin LL.B., MBA, Jens Huter, MBA

 

Handelsregister: Amtsgericht Hannover HRB 20496

Ust-ID-Nr.: DE274991099