AGB

General Terms and Conditions for the Supply of Goods and Services

These Terms and Conditions apply to all transactions carried out by Lohmann Pharma Herstellung GmbH (hereinafter referred to as “LPH”) with companies (individuals or legal entities or partnerships with legal capacity that engage in independent trade or commercial or freelancing activities). However, these General Terms and Conditions for the Supply of Goods and Services do not apply to legal transactions with consumers that are not engaged in any independent trade or commercial or freelancing activities. Agreements that deviate from these General Terms and Conditions (T&Cs), including any customer terms and conditions and side agreements that are in conflict with these T&Cs, shall only become part of these T&Cs on a case-by-case basis with LPH’s express prior consent.

 

1. Quote and contract conclusion

 

1.1 Verbal quotes and confirmations become binding for LPH only after and provided that LPH has confirmed them in writing. All LPH quotes, regardless of their form, are non-binding unless otherwise specified in writing. These General Terms and Conditions for the Supply of Goods and Services shall also apply to any deliveries based on a contract containing various on-call orders.

 

1.2 LPH quotes must be accepted within 14 business days as of the quote being sent. If LPH’s quote is only accepted upon the expiration of this period, the conclusion of a contract shall depend on whether LPH confirms acceptance of said quote as binding or not.

 

1.3 Contracts and contractual amendments are deemed to have been received or agreed (as the case may be), if and once LPH (i) has accepted the Customer’s order in writing; (ii) has accepted the addenda or amendments requested by the Customer in writing; (iii) has delivered the goods or provided the services ordered by the Customer.

 

1.4 Orders must be placed in writing. Unless explicitly agreed otherwise, contracts shall only be concluded once a written order has been issued, as stipulated in Section 1.1.

 

1.5 If services are provided, the contract shall include a description of the intended outcome of the ordered activities, e.g. written recommendation, report, model, research results, substance, semi-finished product, vaccine, cellular material, etc. (hereinafter referred to individually and collectively as the “Work”).

 

1.6 All figures and specifications of goods in catalogs, price lists, advertisements and similar media shall merely represent approximate values typical of the industry and shall be used to provide an approximate representation unless LPH has explicitly provided otherwise for a respective delivery in writing. LPH makes no assurances as to the accuracy and precision of weight information, dimensions, capacities and similar information regarding goods to be delivered or have been delivered, unless LPH has explicitly agreed otherwise for a specific delivery in writing. Measurements are provided without taking into account faults or environmental influences.

 

1.7 LPH is entitled to make changes to the goods to be delivered at any time in order to improve them or to comply with governmental regulations.

 

1.8 The Customer may only cancel an order with LPH’s written consent. This is without prejudice to LPH’s right to claim a processing fee and/or full remuneration. If LPH is still subject to its obligation to render services, Section 649 of the German Civil Code (Bürgerliches Gesetzbuch [BGB]) shall apply.

 

2. Pricing

 

2.1 Unless otherwise stipulated by law, LPH does not charge VAT, and all prices are listed without VAT. If LPH (or specific LPH services or products) is or becomes subject to VAT due to (future) legislation or jurisprudence, all prices shall be quoted ex-VAT and shall be billed with the applicable VAT rate added. In this case, LPH shall list VAT as a separate line item on the invoice.

 

2.2 LPH is entitled to separately invoice for the costs of special packaging, transport and insurance. If the packaging is (temporarily) loaned to the Customer, the Customer shall ensure that the packaging is promptly returned to LPH free from damage, and shall do so at its own expense and risk.

 

2.3 Prices are valid for a period of four (4) months as of the conclusion of the contract. If the period between the conclusion of the contract and the delivery date agreed by the Parties is more than four (4) months, or if delivery is delayed for reasons beyond LPH’s control, LPH shall be entitled to a reasonable price increase. The scope of the price increase may not exceed the increase in costs for the production of the good purchased in the period up to the delivery date. If the price increase caused by these factors is more than ten percent (10%) of the original price, the Customer is entitled to terminate the contract.

 

3. Delivery

 

3.1 Unless otherwise agreed, delivery is ex-works from the LPH site (Incoterms 2000). The Customer shall undertake to accept the delivery of goods upon request by LPH.

 

3.2 If LPH arranges the transport and/or export of goods for the Customer, LPH shall do this at the Customer’s expense. In this case, the risk for goods is transferred to the Customer at such time as LPH hands over the goods to be delivered to the shipper for shipping, even if ownership has not yet been transferred to the Customer.

 

3.3 If the Customer is responsible for the transport of the purchased goods or if shipping is delayed for reasons attributable to the Customer, punctual provision of the shipping notice by LPH shall constitute compliance with the delivery time. If shipping is postponed at the Customer’s request, the Customer shall be billed for all costs incurred for the storage of the goods one (1) month as of receiving notice of the provision of the goods for shipping. This shall not affect LPH’s right to withdraw from the contract and/or to assert claims for damages upon expiration of the contract following a reasonable grace period set by the Customer.

 

3.4 The delivery times specified by LPH shall never be considered deadlines unless otherwise expressly agreed in writing. In the event of overdue delivery, LPH must be sent notification of non-performance granting LPH a reasonable grace period to rectify the infringement. With respect to on-call orders, LPH must receive notification from the Customer in good time prior to the required delivery date. In the event that the Customer requests a contractual amendment, the delivery time shall be reasonably extended in proportion to the additional time required by LPH and/or in proportion to the delay in the provision of the delivery/service as a result of this amendment/addendum.

 

3.5 Where the Customer must provide LPH with data, substances, goods or samples (and the like) in connection with the delivery of goods and/or provision of services by LPH, the delivery period shall only commence upon receipt of said data, substances, goods or samples (and the like) by LPH. Agreed deadlines shall only commence once LPH has received all due and outstanding payments.

 

3.6 LPH is entitled to carry out partial deliveries of the purchased goods or to provide partial services and to invoice them separately.

 

3.7 Where LPH stores goods for the Customer and/or goods have already been manufactured for the Customer in connection with an on-call order and have been set aside for the Customer, the Customer shall bear the full risk for these goods and must insure them.

 

3.8 The Customer shall bear the risk for the goods that LPH has delivered and that the Customer – or the organization under which the Customer carries out its activities – retains as consignment goods. The Customer shall insure these goods during the consignment period at its own expense and shall maintain said insurance coverage.

 

3.9 Force majeure or other circumstances beyond LPH’s control, including, but not limited to, labor disputes, governmental actions or failure to act, traffic disruptions, regardless of whether they have an impact on LPH or LPH’s subcontractors, shall release LPH from its obligation to deliver the goods or provide the services to the Customer for the duration of the aforementioned events. If such an event makes the delivery of goods or provision of services by LPH completely impossible, LPH is fully released from its obligation to deliver the goods or provide the services.

 

4. Payment/assignment/offsetting/right of retention

 

4.1 The Customer shall pay the entire amount agreed or, in the event of prepayment, the outstanding balance in the currency specified to an account specified by LPH without deductions, discounts or offsetting, and shall do so within ten (10) days as of receiving the invoice. Where payment is made by check or bills of exchange, the Customer shall bear any and all collection fees associated with this.

 

4.2 Any and all amounts to be paid to third parties as part of the performance of a contract (including, but not limited to, customs duties, taxes, transport costs, fees and charges payable to authorities or associations/committees in relation to obtaining approvals, declarations or permits) shall be borne by the Customer.

 

4.3 If the Customer fails to pay the amount due within ten (10) days as of the invoice date pursuant to Section 4.1 above, the Customer shall be deemed to be in default of payment without receiving any additional notifications. In this case, LPH is entitled to the legally stipulated interest.

 

4.4 The Customer is not entitled to assign LPH-related receivables and rights that it might hold to third parties without LPH’s prior written consent.

 

4.5 The Customer may only offset payables to LPH with receivables from LPH that are not under dispute, cannot be appealed or are (proven to be) ready to be decided.

 

4.6 The Customer is only entitled to a right of retention if and insofar as its counterclaim is based on the same contract. Otherwise, Section 4.4 above shall apply.

 

5. Obligations of the Customer

 

5.1 The Customer shall undertake to comply with all applicable laws and regulations. The Customer shall ensure that it has obtained any and all required permits and authorizations and shall undertake to provide verification of this upon request by LPH. The Customer shall indemnify LPH from all third-party claims in connection with non-compliance with the aforementioned laws and regulations and/or failure to hold the required permits and authorizations. The Customer shall not infringe upon any intellectual and industrial property rights (including patent claims or patent registrations) of LPH. Otherwise, the Customer shall be subject to a fine in the amount of €15,000 per violation and for each day this violation persists, payable immediately. The fine is without prejudice to LPH’s right to demand cessation of the infringement or additional claims for damages. The latter shall only apply if and insofar as the scope of the damage exceeds the sum of the fine.

 

5.2 The Customer shall promptly provide LPH with all information, data, specifications and materials, the provision of which by the Customer to LPH the Parties have agreed to. Unless otherwise agreed in writing, LPH is not required to review this data for accuracy. Any and all specifications and materials provided by the Customer must be fully suitable for the purpose for which LPH uses them in connection with the assignment.

 

5.3 Where Customer or third-party employees to be specified or involved by the Customer must enter LPH premises in connection with the performance of the contract, the Customer must ensure – and guarantee – that all such persons comply with and fulfill any and all regulations LPH has specified in this respect.

 

5.4 The Customer shall indemnify LPH from all third-party claims – with the term “third party” including the Customer’s employees – asserted by third parties for incurred injuries or other damage in connection with or resulting from the presence of said third parties on LPH’s premises, regardless of whether such claims are related to compliance by said third parties with the responsibilities specified in the previous Section.

 

5.5 The Customer shall ensure that data, information, documents, records (in the broadest sense of this term), computer software, expertise and the like that LPH has provided to the Customer or the use of the same by LPH is not in violation of third-party rights. The Customer shall assist LPH in mounting a defense against any claims, and shall indemnify LPH from any related third-party claims.
5.6 If the contract (also) concerns sample research, the Customer is responsible for selecting suitable samples, their representativeness, and specifying the code, brand and product designations.

 

6. Confidentiality and disclosure

 

6.1 LPH shall only undertake to maintain confidentiality with respect to the name of the Customer and/or the research findings where this has been expressly agreed in writing. This duty of confidentiality shall apply during the agreed period or, if none was agreed, for up to two (2) years as of the date of the most recent invoice.

 

6.2 LPH’s duty of confidentiality shall not extend to arithmetic methods, software and experimental processes used by LPH whose development was not specifically intended when the assignment was granted. With respect to reviews, analyses, measurements or research, the scope of LPH’s duty of confidentiality is limited to the findings of the review, analysis, measurement or research carried out.

 

6.3 If and insofar as the Customer provides LPH with data that the Customer specifies as “confidential,” LPH shall treat this data confidentially, without prejudice to the above provisions, and shall not disclose this data to third parties for review or use without receiving the Customer’s explicit consent. This shall not apply if LPH was already aware of the data specified as “confidential” for another reason or if said data had legally come into LPH’s possession in another way, or if said data was already part of the public domain or became part of the public domain without this being attributable to LPH. LPH shall not be subject to an agreed duty of confidentiality if LPH is required to disclose such data due to statutory obligations and/or if LPH determines an apparent risk for people or goods that makes disclosure necessary at LPH’s reasonable discretion.

 

6.4 LPH reserves the right to disclose to third parties at any time how LPH interprets data or research findings in those cases where the Customer discloses research results, methods, etc. in a manner that appears to be incorrect in LPH’s view.

 

6.5 If the Customer releases publications or distributes information in connection with delivered goods, Work, research methods or other matters, the Customer must also mention LPH’s role in connection with said goods, Work, research methods or other matters and, if and insofar such publications or distributions involve publications or partial publications of Work, the name of the respective author.

 

6.6 The Customer is not permitted to use the LPH’s Work and/or name in connection with the assertion of claims or initiation of (court or arbitration) proceedings or for marketing or hiring purposes.

 

6.7 LPH is entitled to independently publish the Work or parts thereof at any time without being required to compensate the Customer, even in cases where the rights to the intellectual or industrial property for the (parts of the) Work are or will be transferred to the Customer. Publications shall be sent to the Customer in advance for comment. Under no circumstances shall the Customer be able to derive any related rights as a result of this, nor shall LPH be required to include the Customer’s comments in the publication.

 

7. Retention of title

 

7.1 All deliveries are subject to retention of title. Ownership is transferred to the Customer only after the Customer has fulfilled all its obligations resulting from or in connection with delivery contracts with LPH by the payment deadline. In the event of a running account, the retention of title is considered collateral for the outstanding amount payable to LPH.

 

7.2 If the purchased good, which was delivered with retention of title, is mixed or combined with a product that is the property of the Customer or a third party, LPH shall obtain proportional joint ownership of the new product instead of the Customer, commensurate with the purchase price of the mixed or combined good at the value of the new product. If the purchased products that were delivered with retention of title are treated or processed, LPH is legally deemed to be the manufacturer as defined by Section 950 BGB, without, however, assuming the obligations or liabilities of a manufacturer.

 

7.3 The Customer is entitled to sell the goods that were delivered with retention of title of which LPH has acquired joint ownership or ownership pursuant to Section 7.2. The Customer hereby assigns the first part of its receivables resulting from authorized and unauthorized resale to LPH in advance, corresponding to the invoice price of the purchased goods that were delivered by LPH. By way of collateral, the Customer shall assign to LPH any receivables from and ancillary rights that it holds against third parties in connection with the resale of goods subject to retention of title, and any claims against its insurers in this respect in advance. In such cases where goods are exported, the Customer shall also assign to LPH all receivables that it currently holds or will hold in future from domestic and international financial institutions relating to the export of the goods, including, but not limited to, all receivables from collection orders, letters of credit and their confirmations as well as sureties and guarantee agreements. If the goods under retention of title are sold by the Customer together with other goods which are not owned by LPH, whether with or after processing, the aforementioned receivables shall be pro rated at the net amount at which LPH has invoiced the Customer for these goods and are deemed assigned to LPH. The aforementioned assignments are not considered a deferred payment claim by LPH against the Customer. Upon request, the Customer shall provide LPH with the names and addresses of customers and the amount of the respective receivables.

 

7.4 The Customer is entitled recover the receivables assigned to LPH as soon as it meets its payment obligations, and if LPH does not revoke its consent for another reason. However, this shall not affect LPH’s power to recover such receivables itself. Nevertheless, we affirm that we shall refrain from recovering such receivables unless the Customer fails to make payments to LPH, insolvency proceedings regarding the Customer’s assets fail, or such insolvency proceedings are rejected due to lack of assets. If one of the above cases occurs, the Customer shall provide LPH with all information and records required to recover the receivables assigned to LPH and shall inform its creditors of said assignment. If the Customer has a running account with its customer that includes its receivables, the assignment refers to the balance of said running account. LPH hereby accepts the assignment specified in this provision.

 

7.5 If the value of the collateral created for LPH’s benefit exceeds LPH’s receivables from the Customer by more than ten percent (10%), LPH shall release the collateral up to the specified limit upon request by the Customer or a third party negatively affected by this excessive collateral. LPH is entitled to designate the collateral to be released.

 

7.6 Until such time as the goods or products delivered subject to retention of title resulting from their mixing, combination, handling or processing are in use, the Customer shall store such goods or products under appropriate conditions and separately from other products and shall label such goods as under LPH ownership. Any and all costs and expenses required to maintain the goods during this time shall be borne by the Customer, and the Customer shall further be liable to LPH for any depreciation in value.

 

7.7 No pledging or transfer of title is permitted with regard to the goods purchased subject to retention of title or the goods specified in Section 7.2. The Customer shall immediately inform LPH of any seizure of the goods or any other encroachments on property rights caused by third parties, and shall prevent such third parties from taking the respective measures. The Customer shall assign to LPH any and all claims against third parties caused by damage or loss of the goods in question. LPH hereby accepts this assignment. If the Customer violates the contract, particularly in the case of default, LPH is entitled to terminate the contract and take back the goods delivered with retention of title.

 

8. Circumstances beyond the control of either Party

 

8.1 LPH is entitled to withdraw from contracts concluded with the Customer if LPH’s supplier fails to deliver or delivers too late for reasons beyond LPH’s control resulting in LPH being unable to fulfill its obligations to the Customer or being unable to fulfill them on time.

 

8.2 Force majeure or other extraordinary circumstances, including, but not limited to, labor disputes, governmental actions or failure to act or traffic disruptions, regardless of whether they have an impact on LPH or LPH’s subcontractors, shall release LPH from its obligation to deliver the goods or provide the services to the Customer for the duration of said events. If such an event makes the delivery of goods or provision of services by LPH completely impossible, LPH is fully released from its obligation to deliver the goods or provide the services.

 

8.3 A potential contractual penalty agreed with the Customer is not deemed to be incurred in any of the cases described in Sections 8.1 and 8.2.

 

8.4 If LPH has already partially fulfilled its obligations or is only able to partially fulfill its obligations when the circumstances beyond its control begin, LPH may separately invoice the already delivered or deliverable part, and the Customer shall undertake to pay the invoice as if it relates to a separate contract.

 

8.5 Circumstances beyond LPH’s control as defined by Section 8 shall be deemed to exist in particular in the event of a raw materials shortage, stagnation, transport problems, war or the threat of war, full or partial mobilization, insurrection, sabotage, flooding, fire or any other destructive event at LPH. Circumstances beyond LPH’s control are also deemed to exist if one or more of the aforementioned circumstances occurs at LPH’s supplier companies and, as a result, LPH is unable to fulfill its obligations or is or was not able to fulfill them in a timely manner. Circumstances beyond LPH’s control are also deemed to exist if LPH must utilize its own production capacities as a result of a decision by a national or international authority or (advisory) organization (e.g. the WHO or the German Council of the Federal Board of Health) to prevent or combat the spread of disease, disorder or epidemics, if – with the exception of a willful act or failure to act or deliberate gross negligence by executive employees who are part of its management – a license or permit required for fulfilling the contract is denied or rescinded, or if LPH is ordered to cease fulfilling the contract as a result of a court or governmental decision.

 

9. Defects

 

9.1 Upon delivery, the Customer must inspect the delivered goods to check the delivery quantity is correct and check for visible defects. Alternatively, such an inspection must be carried on behalf of the Customer. LPH must be informed of any discrepancies in quantities and any visible defects immediately upon delivery. The Customer shall report any defects that are not obvious which are detected after delivery within two (2) calendar days as of being noticed, but in any case within two (2) calendar days after the Customer should have reasonably detected these defects. Upon delivery of semi-finished products, goods in large containers and other goods the Customer will process to produce a final product, the Customer shall inspect said goods within a period of 30 days as of their receipt at the processing location for defects that are not immediately apparent. No processing may occur without prior inspection by the Customer. Upon request by LPH, the Customer shall provide documentation confirming the (incoming goods) inspection. The right to lodge a complaint shall be null and void if defects are not reported in due time, if the goods are processed without prior inspection, if the inspection is performed after expiration of the aforementioned period and/or if the defect was caused by the Customer.

 

9.2 All information provided must be verified for accuracy within 72 as of receipt of the report.

 

9.3 With regard to visible defects, the Customer shall undertake to carefully carry out their inspection or have the inspection carried out carefully regardless of whether the shipper is involved or not. The Customer shall bear the risk involved in sample inspection and may not claim by way of defense that it had not confirmed a visible defect that could have been noticeable upon delivery because it failed to inspect the entire shipment or had not arranged for the same to be inspected. In particular, the Customer must check the goods delivered for the following: i) shelf life; ii) pharmaceutical form; iii) readability of the labels affixed to the goods; iv) whether the content of the boxes matches the information on the packaging; and v) whether the labels on the various goods correspond to the agreed specifications (with regard to composition) or comply with statutory regulations with regard to the goods sold. Otherwise, the Customer shall forfeit any rights acquired in this regard.

 

9.4 With respect to visible defects, the Customer shall undertake to carefully carry out the inspection or have it carefully carried out. The Customer shall bear the risk involved in sample inspection and may not claim by way of defense that it had not confirmed a defect because it had not inspected the entire shipment or had not arranged for the same to be inspected. In particular, the Customer must check the goods delivered for the following: (i) whether the goods correspond to the agreed specifications (with regard to composition) or comply with statutory regulations; and (ii) whether the goods are damaged, soiled or in any other way defective as a result of transport. Otherwise, the Customer shall forfeit any rights acquired in this regard. Once LPH has fulfilled its release obligations upon provision of the delivered goods or has carried out similar inspections, the Customer shall bear the burden of proof that the aforementioned defects are not the result of transport, and shall be responsible for subsequent storage of said goods.

 

9.5 In the event of a justified complaint, LPH shall undertake to merely rectify the defect (this also includes inaccuracies or gaps in the information provided) or exchange the respective goods at its discretion.

 

9.6 If it is not possible to rectify the defect, or if such rectification by LPH or its acceptance by the Customer is unreasonable to expect, or if the rectification would result in excessive costs, the Customer is entitled to withdraw from the contract or to a reduction in price, without prejudice to any claims for damages the Customer might otherwise be entitled to.

 

9.7 The Customer’s claim against LPH for reimbursement of the costs incurred by rectification, including, but not limited to, shipping and transport costs and labor and material costs, is excluded in such cases in which said costs and expenditures are higher because the delivery of goods or provision of services was directed to another site and not the Customer’s premises, unless said transport to another site was for the intended use of the item involved in this delivery/provision of services.

 

9.8 The Customer is only entitled to recourse against LPH provided that it has not concluded any agreements exceeding statutory warranty rights with its customers. The provisions stipulated in Section 9.7 above shall also apply with regard to the Customer’s scope of recourse against LPH.

 

9.9 In the event of complaints due to defects, the Customer may only withhold payments in the amount of the defects that arose.

 

9.10 The legal statute of limitations for quality and legal defects is one (1) year as of the transfer of risk unless (i) a longer period applies pursuant to Sections 438(1)(2), 479(1), 634(a)(1)(2), 651 BGB; or (ii) the defect was maliciously kept secret; or (iii) one of the liability cases specified in Section 10.1 below has occurred.

 

9.11 Our liability of compensation is subject to Section 10.1 of these Terms and Conditions.

 

9.12 The above provisions do not imply a reversal of the burden of proof to the disadvantage of the Customer.

 

10. Liability

 

10.1 Claims for damages and reimbursements for costs (hereinafter referred to as “Claims for Damages”) by the Customer shall be excluded, regardless of their legal basis, unless these Claims for Damages are based on (i) the provisions set forth in the German Product Liability Act (Produkthaftungsgesetz); (ii) LPH’s willful or grossly negligent violation of contractual or statutory obligations; (iii) impairment of the Customer’s health or bodily injury to the same as a result of a violation of an obligation for which we are liable; (iv) LPH’s warranty regarding the existence of a specific feature; or (v) LPH violating material contractual obligations.

 

10.2 In the event that LPH violates material contractual obligations, the Claims for Damages asserted by the Customer against LPH shall be limited to the foreseeable damages typical of such a contract, unless we can be made liable for a willful or grossly negligent violation of an obligation or based on impairment of the Customer’s health or bodily injury to the same or LPH’s warranty regarding of the existence of a specific feature.

 

10.3 A violation of an obligation during the fulfillment of obligations by duly authorized LPH representatives or persons employed by LPH shall be deemed to be a violation of an obligation by LPH itself.

 

10.4 If and insofar as LPH’s liability is excluded or limited, such limitation shall also apply to the personal liability of LPH employees, employee representatives or other LPH representatives.

 

10.5 Section 9.12 of these Terms and Conditions shall apply mutatis mutandis.

 

11. Instructions for storage and use

 

11.1 Unless otherwise specified by LPH in writing, the goods delivered by LPH must be stored and used in accordance with LPH’s instructions.

 

11.2 The Customer shall verify that goods provided to third parties are used and stored in accordance with LPH’s instructions the shelf life indicated on the relevant product.

 

11.3 The Customer shall ensure strict compliance with the instructions stipulated in this Section by its employees. In the event that goods are resold, the Customer shall ensure any contractual partners or other third parties that use and process said goods comply with these instructions.

 

11.4 If LPH is held liable by third parties in connection with defects in the products manufactured or sold by LPH, whether alleged or not, and such claims are associated with the Customer’s failure to fulfill one or more obligations pursuant to this Section or with a third party’s failure to fulfill these obligations, the Customer shall indemnify LPH from any and all costs and damages relating to said non-compliance.

 

11.5 If the Customer resells goods purchased from LPH to third parties, the Customer shall ensure that the goods comply with all requirements and provisions set forth for the goods in accordance with the applicable laws and regulations in the country of destination. The Customer shall indemnify LPH from any and all claims by third parties relating to the Customer’s non-compliance with the provisions set forth in this Section.

 

11.6 In the event it becomes necessary to destroy products, irrespective of the reasons for said destruction, the Customer shall ensure that such destruction is undertaken with the highest degree of care and appropriately taking all applicable regulations into account. The above provision shall apply regardless of the Customer’s obligation to return products to LPH upon request by LPH if the shipment has yet to be destroyed.

 

12. Recall

 

12.1 The Customer shall immediately inform LPH of any incidents with adverse reactions or suspected adverse reactions (as defined in Directive 2001/82/EG to the goods delivered by LPH and shall provide comprehensive support to LPH in the provision of information regarding said incidents or adverse reactions.

 

12.2 Should LPH decides for its own reasons to execute a recall of the goods delivered by LPH – a term that, among other things, includes the publication of warnings to the target group for which the goods are intended as well as the recall of products from the market – the Customer shall fully support this measure.

 

12.3 If this occurs, the Customer shall, among other things, request the return of all products and deliveries of products (goods) that fall under the scope of the recall to LPH upon request by LPH, and shall inform LPH of the parties to which the Customer has provided such products and take any measures requested by LPH within a reasonable period of time in order to assist LPH as efficiently as possible during the recall.

 

12.4 The Customer shall conclude contracts with its customers such that its contractual partners (and the customers of its customers) are also required to immediately respond to request by the Customer or LPH regarding a recall as described above.

 

12.5 If the Customer is required to provide information that may be relevant to a recall to a party other than LPH, the Customer shall immediately inform LPH accordingly in writing, including the content of said information.

 

13. Data protection

 

LPH is entitled to store data regarding its customers and to process and use said data for business purposes as permitted by law.

 

14. Language/applicable law and settlement of disputes

 

14.1 German law exclusively applies to the contractual relationship between the Parties. The applicability of the United Nations Convention on Contracts of the International Sale of Goods is hereby excluded.

 

14.2 All disputes shall be settled by the competent court in Cuxhaven if the other Party has its registered office in a Member State of the European Union or in Norway, Switzerland or Iceland at such time as proceedings are initiated. The foregoing shall not affect LPH’s authority [to present this dispute to a competent arbitrator in accordance with this provision].

 

14.3 All disputes shall be settled by arbitration proceedings pursuant to German Arbitration Institute (DIS) rules if the other Party does not have its registered office in a Member State of the European Union or in Norway, Switzerland or Iceland at such time as proceedings are initiated. These arbitration proceedings shall take place in Hamburg and shall be conducted by three (3) arbitrators. The language of arbitration shall be German.

 

Terms and Conditions

 

General Terms and Conditions of Purchase of Lohmann Pharma Herstellung GmbH

All deliveries, services and offerings by our suppliers (hereinafter jointly referred to as the “Supplier”) shall exclusively be undertaken on the basis of these General Terms and Conditions of Purchase of Lohmann Pharma Herstellung GmbH (hereinafter referred to as the “Purchase T&Cs”). These Purchase T&Cs are an integral part of all contracts Lohmann Pharma Herstellung GmbH (hereinafter referred to as “LPH”) concludes with its Supplier regarding services rendered and deliveries made by the latter, both in current or future business relationships, even if they are not separately agreed upon again. Derogating agreements, in particular confliction terms and conditions of our Supplier or third parties and any side agreements shall require our express written consent in each case in order for them to become part of any contract. Even if we offer no separate objection to their applicability, such terms and conditions shall not apply. Even if we refer to any correspondence that contains or refers to the general terms and conditions of the Supplier or a third party, this shall not be construed as our consent to the applicability of such terms and conditions.
The Supplier agrees to the exclusive binding nature of these General Terms and Conditions of Purchase at the latest upon delivery of the goods ordered or upon provision of the services ordered.
These Purchase T&Cs shall not apply to consumers.

 

1. Quotes, orders, contract conclusion

 

1.1 The Supplier shall submit quotes to LPH free of charge. With respect to quantities, composition and performance, the Supplier’s quote shall adhere to LPH’s request and any deviations shall be specifically indicated in writing. The above sentence shall apply mutatis mutandis to the Supplier’s order confirmation.

 

1.2 LPH’s orders are only considered binding for LPH if LPH has submitted or confirmed the same in writing (by fax or letter). The same shall apply mutatis mutandis to amendments or addenda to orders.

 

1.3 The Supplier shall accept every order in writing within ten (10) days by providing the price, quantity and delivery/performance period. If LPH does not receive the Supplier’s acceptance within ten (10) days, LPH is entitled to revoke its order.

 

2. Pricing

 

2.1 The prices quoted by the Supplier and/or agreed with us are fixed prices that do not include VAT at the respectively applicable statutory rate.

 

2.2 The agreed prices include the remuneration for all deliveries and services sent to the Supplier (including any required certificates, drawings, assessments, etc., as well as their translation into German and/or English requested by LPH) and any incidental costs. Unless otherwise agreed between the Supplier and LPH in writing, the prices agreed include delivery duty paid (DDP according to Incoterms, as amended from time to time).

 

2.3 LPH shall only undertake to pay for deliveries/services not included in a contract if LPH has ordered the same in writing from the Supplier before the delivery/service was carried out.

 

2.4 For billing by quantity, dimensions and weights, the values determined by LPH on the day of the receiving inspection shall apply.

 

3. Deadlines

 

3.1 The deadlines for deliveries/services specified in the order are binding. The relevant date for meeting the deadline is the date on which we receive the goods or services.

 

3.2 The Supplier shall undertake to immediately notify LPH in writing if it determines that the agreed date or deadline cannot be adhered to or that difficulties may arise with respect to meeting the deadline. Such notification must include the reason for and likely duration of the delay. The statutory provisions shall apply if the agreed deadlines are not adhered to. In particular, LPH is entitled to demand compensation for damages in lieu of performance upon unsuccessful expiration of a reasonable grace period. In any case, partial deliveries/services that have already been performed are not considered independent performance and unconditional acceptance of late delivery/service by LPH shall not be construed as a waiver of the claims to which LPH is entitled as a result of said delay. This shall apply until such time as final payment of the remuneration is made for the respective delivery or service. Any further Claims for Damages shall remain unaffected by this.

 

4. Quality

 

The Supplier’s deliveries must comply with the order and specifications and/or the samples provided or specified to the Supplier by LPH and all applicable regulations and standards in every respect.

 

5. Delivery, transfer of risk and insurance

 

5.1 The place of performance is the place of use specified by LPH. Provided no other agreement has been concluded, the risk of accidental loss or deterioration of the delivery shall transfer to LPH upon acceptance and unloading of the delivery at the place of performance. Unless otherwise agreed in writing, LPH shall only undertake to accept delivery items during its usual business hours. The delivery items shall be delivered carriage paid to the place of use specified by LPH.

 

5.2 The Supplier shall insure all delivery items against loss (particularly fire and theft) and any deterioration up to the replacement value for the period until such time as the delivery items are handed over to LPH, and shall do so at its own expense.

 

5.3 Partial deliveries or services are generally not permitted unless LPH has explicitly accepted the same in writing or if they are considered reasonable for LPH. If and insofar as LPH has accepted partial deliveries or partial services, the contract shall be interpreted as an individual contract with respect to each partial delivery or partial service. However, any failure to make a partial delivery or provide a partial service shall entitle LPH to withdraw from the entire contract at its discretion. In the case of partial deliveries or services where no agreement has been concluded or where the same cannot be considered reasonable, LPH is entitled to reject the acceptance of such partial deliveries or services. If a partial delivery or partial service is rejected, LPH is not required to pay for it. The Supplier shall bear the risk in this respect and shall return them at its own expense and risk. This shall apply mutatis mutandis to excess or short deliveries or excess or short services.

 

5.4 LPH may reject the acceptance of a delivery or service for as long as a force majeure event, no-fault disruption, rioting, governmental measure or any other unavoidable circumstance beyond our control (including labor disputes) makes it impossible or unreasonable for LPH to accept such delivery or service. In such an event, the Supplier shall store and insure the respective delivery at its own expense and risk until such time as LPH is able to accept delivery. During such events and within two (2) weeks after they end, LPH is entitled – without prejudice to any other rights to which LPH is entitled – to withdraw from the contract, in whole or in part, unless the duration of the event is immaterial and demand for the goods or services ordered by LPH does not decrease significantly.

 

5.5 If LPH has agreed with the Supplier that delivery should be made to a third party instead of LPH, the Supplier shall provide LPH with proof of shipment to said third party in the form of a confirmation of receipt by said third party.

 

5.6 Two copies of the delivery note(s) and packing slip(s) must be included with the goods in a sealed envelope. At a minimum, the delivery note must contain the order number, order date, the number of packages and their contents and, for partial deliveries, the outstanding quantity still to be delivered.

 

5.7 If the Supplier requests the packaging material be returned from LPH, the Supplier shall explicitly note this on the respective delivery note. Packaging material shall be returned at the Supplier’s expense and risk.

 

6. Supplies, documents and accident prevention

 

6.1 The Supplier shall request any documents or items (materials, substances, etc.) to be provided by LPH for the fulfillment of the order in a timely manner.

 

6.2 The Supplier is liable for any loss or damage of items (materials, substances, etc.) supplied to it by us. In the event of a loss, damage or flaws in the items supplied by LPH, the Supplier shall immediately halt processing and notify LPH accordingly in writing.

 

6.3 The items supplied by LPH shall be treated and processed on our behalf and shall remain under LPH’s ownership throughout all treatment and processing stages. Where items are processed together with other items not owned by LPH, LPH is entitled to co-ownership in any newly produced item proportionate to the value of the materials supplied by LPH compared with the value of all materials used during manufacturing as well as the Supplier’s expenses for their processing. In this respect, the Supplier shall store such items for LPH free of charge. This shall apply mutatis mutandis should we lose ownership of items supplied by us due to combination or mixing.

 

6.4 LPH reserves the right to all property rights, copyrights and design rights and any other intellectual property rights with respect to images, drawings, calculations, samples, models, matrices, equipment and other documents, regardless of whether such documents are hard copies or electronic documents, as well as with respect to items specifically used by the Supplier to deliver the goods or provide the services, whether or not such items are provided by LPH. These may not be disclosed to third parties without LPH’s prior written consent. They shall be used exclusively for the purpose specified in the order and must be safely stored by the Supplier at the Supplier’s own risk until such time as they are to be returned to LPH without delay once the order has been processed, including any duplicates or copies made. The Supplier is not entitled to a right of retention/right to refuse performance.

 

7. Invoices and payments

 

7.1 Invoice amounts shall be paid within the periods specified in the order. Unless any special agreements have been concluded, the invoice shall be settled within 30 days as of the date the invoice is due and receipt of both a correct invoice and delivery or performance. Payment shall be made subject to invoice verification.

 

7.2 A correct invoice must be sent to LPH separately from the goods for every order, specifying the order date and order number. The invoice must list VAT separately at the respective statutory rate and include the Supplier’s VAT ID number.

 

8. Offset and retention

 

8.1 The Supplier may only effectively offset counterclaims against claims by LPH if and insofar as such counterclaims are undisputed or have been legally established.

 

8.2 The Supplier is not entitled to retain delivery items or withhold services as a result of potential Supplier counterclaims against LPH on the basis of earlier transactions or other transactions as part of an ongoing business relationship with LPH.

 

8.3 LPH is entitled to set-off and retention rights to the extent legally permitted.

 

9. Defects

 

9.1 Goods are accepted subject to an inspection to ensure said goods have no defects, and in particular, are inspected for accuracy and completeness if and when this is feasible in the normal course of business. Section 377 of the German Commercial Code (Handelsgesetzbuch [HGB]) notwithstanding, goods shall be deemed to have been approved if LPH does not notify the Supplier of any excess or short delivery or identifiable defects upon acceptance within a period of two (2) weeks as of receipt of the delivery. Notification in writing is equivalent to notification by telephone or email within the specified period with subsequent written confirmation. In this respect, the Supplier shall waive its right to lodge an objection due to delayed notification of defects. In the event of defects occurring or becoming apparent later, the above provision regarding notification of defects shall apply mutatis mutandis. The two-week (2-week) notification period in this case shall commence upon discovery of the short/excess delivery or the defects.

 

9.2 The statutory provisions regarding defects in quality and title shall apply unless otherwise agreed below.

 

9.3 LPH is entitled to demand replacement delivery free of charge, rectification of defects free of charge or a reasonable discount to compensate for shortfalls or defects at its discretion The Supplier may reject the manner of rectification chosen by LPH if performance of such choice of rectification would entail disproportionate costs. If the Supplier does not immediately make efforts to rectify the situation upon request by us, we are entitled in urgent cases to have a replacement delivery or rectification of defects carried out at the Supplier’s expense or have third parties do so, in particular to avert acute danger or greater damage (e.g. as a result of production interruptions). Additional guarantee claims shall remain unaffected by this.

 

9.4 In the event of defects of title, the Supplier shall further indemnify LPH from any existing third-party claims unless the defect of title is not attributable to the Supplier.

 

9.5 Claims for defects shall expire after three (3) years unless the mandatory provisions of stipulated in Sections 478 and 479 of the German Civil Code (Bürgerliches Gesetzbuch [BGB]) apply. Also excluded are cases in which the delivery was used in accordance with its usual purpose for construction and has caused the building to be unsound.

 

9.6 The limitation period shall commence upon delivery of the goods or provision of the services (transfer of risk).

 

9.7 If the Supplier fulfills its rectification obligations by way of replacement delivery, the limitation period for the goods delivered in replacement shall re-commence upon their delivery to the place of performance unless the Supplier has expressly and appropriately reserved the right to make the replacement delivery as a gesture of goodwill, to avoid a dispute, or in the interest of continuing the contractual relationship with LPH.

 

9.8 The limitation period shall also be suspended until the Supplier has finally rejected any claims in writing after a complaint has been asserted.

 

10. Liability

 

10.1 Claims for Damages and reimbursement of expenses (hereinafter jointly referred to as “Claims for Damages”) by the Supplier against LPH shall be excluded, regardless of their legal basis, unless such Claims for Damages are based on provisions set forth in the German Product Liability Act (Produkthaftungsgesetz), LPH’s willful or grossly negligent violation of contractual or statutory obligations, impairment of the Supplier’s health or bodily injury to the same as a result of a violation of an obligation by LPH, the assumption of a warranty regarding the existence of a specific feature, or the violation of material contractual obligations by LPH. Material contractual obligations are those that typically make the performance of the contract in question possible in the first place. In the event of a violation of material contractual obligations, the Supplier’s right to assert Claims for Damages against LPH is limited to the foreseeable damages typical of such a contract, unless LPH is liable for a willful or grossly negligent violation of obligations, impairment of the Supplier’s health or bodily injury to the same, or the assumption of a warranty for the existence of a specific feature. Violations of obligations by our legal representatives or vicarious agents shall be considered equivalent to a violation of obligations by LPH itself. The foregoing provisions shall not imply a reversal of the burden of proof to the disadvantage of the Supplier.

 

10.2 The Supplier shall warrant that, during the development and/or manufacturing of the delivery goods or the provision of services, the state-of-the-art in science and technology was applied and all applicable statutory regulations and standards were complied with; that comprehensive quality control measures were carried out prior to delivery; that all measures to fulfill these obligations were sufficiently documented; that this documentation shall be kept on record for 11 years; and that we or a third party appointed by us shall be given access to said documentation at any time upon request. A right of retention/right to refuse performance is excluded in this respect. This shall not affect the provisions stipulated in Section 12 of these Purchase T&Cs.

 

10.3 If product liability claims are asserted against LPH based on other statutory provisions, the Supplier shall indemnify us from said claims upon our first request if and insofar as the damage was caused by goods delivered or services provided by the Supplier. However, in the case of strict liability, this shall only apply if the Supplier is at fault. If the cause of the damage falls under the Supplier’s scope of responsibility, the Supplier shall bear the burden of proof to demonstrate that it is not at fault.

 

The Supplier shall further undertake to compensate LPH for any expenses and damages that arise from or in connection with a recall action carried out by us or any other necessary measures that may arise in connection with a defect in the goods delivered or services provided by the Supplier or are the result of such a defect. Where possible and reasonable, LPH shall inform the Supplier of the content and scope of the recall measure or any other measures to be carried out, and shall provide the Supplier with the opportunity to comment. The Supplier’s liability according to the statutory or other contractual provisions shall remain unaffected by this.

 

10.4 The Supplier shall undertake to carry product liability insurance with a minimum coverage of EUR ten (10) million per damage case – excluding a serial damage – for the duration of the concluded contract. LPH is entitled to request confirmation of the insurance coverage in question from the Supplier.
10.5 Anyone performing work within LPH’s facilities or on LPH’s premises in service of performance of the contract shall be subject to the provisions of the applicable work regulations. The Supplier shall ensure that such persons comply with the regulations applicable for entering the company premises. LPH accepts no liability for accidents involving such persons on company premises or in the company’s facilities unless this is caused by a willful or grossly negligent breach of duty by LPH’s legal representatives or vicarious agents.

 

11. Third-party property rights

 

11.1 The Supplier shall be liable for ensuring no patents or other third-party property rights are infringed upon by the delivery, use and operation of the goods delivered or services provided.

 

11.2 If claims are asserted against LPH by a third party due to the patent infringement or a violation of other third-party property rights, the Supplier shall undertake to indemnify LPH from these claims at LPH’s first written request. Without the Supplier’s consent, LPH shall not conclude any agreements and, in particular, not agree to any settlements.

 

11.3 The Supplier’s duty to indemnify relates to all expenses that LPH necessarily incurs as a result of or in connection with a third-party claim.

 

11.4 LPH shall be entitled to a right of recourse against the Supplier regardless of whether the Supplier is at fault.

 

12. Pharmaceuticals manufacturing

 

12.1 If and insofar as the products ordered by LPH are used to manufacture medical products, the Supplier must independently comply with the Requirements for the quality, packaging and transport of active ingredients and excipients for the pharmaceutical industry compiled by the World Health Organization, as amended from time to time.

 

12.2 In this case, the Supplier shall immediately and specifically inform LPH in writing of manufacturing changes that may have an impact on quality.

 

12.3 Where possible, each delivery should be from a single batch and represent a homogeneous unit. The batch number must be clearly and permanently indicated on every package and every delivery note. If a delivery consists of several batches of the same product, all batch numbers must be indicated on the packages and the delivery note.

 

12.4 For any continuous production processes where it is not possible to record batches, the Supplier must ensure that the quality meets with the specifications. The Supplier shall clearly and permanently indicate the product designation, net weight, tare weight, batch number and storage information and warnings that need to be complied with, if any, on each package.

 

13. Data protection

LPH is entitled to electronically store, process and use the Supplier’s data required as part of the business relationship and the individual contracts for LPH’s business purposes as permitted by law.

 

14. Confidentiality

 

14.1 The Supplier shall undertake to treat the terms and conditions of ordering and any information and documents provided for this purpose confidentially and maintain secrecy for the entire contractual term and for 11 years as of conclusion of the contract, and shall only use such information to execute the order. This shall not apply to information in the public domain. The Supplier shall limit disclosure of such confidential information to those employees, representatives and/or subcontractors who require access to said information in order to fulfill the Supplier’s obligations to LPH. The Supplier shall ensure that such employees, representatives and/or subcontractors are subject to the same duties of confidentiality and secrecy as the Supplier itself.

 

14.2 The Supplier is not entitled to refer to LPH in its advertising materials, brochures or online without prior written consent, nor may it display deliveries that were produced for us.

 

15. Assignment

 

The Supplier is not entitled to assign its claims from the contractual relationship to third parties. However, this shall not apply to monetary claims.

 

16. Jurisdiction and applicable law

 

16.1 The exclusive place of jurisdiction for any disputes arising directly or indirectly from the contractual relationship with the Supplier, including from deeds, bills of exchange or checks, is the Local or District Court with jurisdiction for Cuxhaven. However, we retain the right to initiate court proceedings against the Supplier at our discretion at a court with jurisdiction over the Supplier’s registered office.

 

16.2 The law of the Federal Republic of Germany shall apply to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods. Customary terms shall to be interpreted according to the applicable Incoterms, as amended from time to time.

 

17. EU regulations to combat terrorism

 

17.1 Regulations (EC) 881/2002 and (EC) 2580/2001 of the Council of the European Union, which directly apply to every Member State of the European Community, have forbidden the direct or indirect provision of money or economic resources to certain individuals or legal entities, groups or organizations for the purposes of combating terrorism. The Supplier shall undertake to comply with this prohibition and to have its business partners and employees verify whether a firm’s name identity is connected to any individuals or legal entities, groups or organizations listed in the annexes published in connection with these regulations. In the event that a firm is listed, the Supplier shall refrain from engaging in any business transactions with these persons, groups or organizations.

 

17.2 In the event of a violation of the provisions of Section 17.1 above, LPH is entitled to cancel all existing orders for good cause as well as to assert Claims for Damages.

 

18. Granting of benefits

 

All orders are made under the express condition that the Supplier does not promise or grant any benefits to LPH’s employees or workers when or on the occasion of placing an order that might jeopardize LPH’s interests or are in breach of moral standards. In the event of a violation of this provision, LPH is entitled to cancel all existing orders for good cause as well as to assert Claims for Damages.

 

19. Severability Clause

 

Should one or more provisions of this agreement be or become invalid or unenforceable, this shall not affect the validity of the remaining contractual provisions. The Parties shall undertake to replace said invalid or unenforceable provision with the provision most closely approximating the original economic intent of the invalid or unenforceable provision. The same shall apply to any lacunae.

Contact

Any Questions left?

Lohmann Pharma Herstellung GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven, Germany

 +49 (0)4721 5903-0

 +49 (0)4721 5903-167

  info@lohmann-pharma.de