Imprint

Otsuka Novel Products GmbH
Erika-Mann-Str. 21
80636 München (Munich), Germany
Tel.: + 49 89 2060205-00
Fax: + 49 89 2060205-55
Email: reception@otsuka-onpg.com

Managing Director: Masanori Kawasaki
Commercial register: HRB 190185, Munich Local Court
VAT identification number: DE 275782318

General Terms and Conditions of Sale

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We confirm your order subject to the exclusive application of our general terms and conditions of sale (“Terms and Conditions of Sale”).

§ 1 Application

(1) These Terms and Conditions of Sale shall apply exclusively. Differing or contrary terms of the purchaser shall not apply except if expressly agreed upon in writing.
(2) These Terms and Conditions of Sale shall also govern all future transactions between you and us, even if not expressly agreed, and shall also apply if we perform delivery despite our knowledge of differing or contrary terms.
(3) These Terms and Conditions of Sale shall only apply vis á vis entrepreneurs pursuant to Sec. 14 para. 1 German Civil Code (Bürgerliches Gesetzbuch, BGB), legal entities under public law, or special funds under public law within the meaning of sec. 310 para. 1 German Civil Code (Bürgerliches Gesetzbuch, BGB).
(4) The order can only be fulfilled if the ordering party can provide all documents necessary proving it is allowed to handle prescription medicines. The purchaser ensures and warrants in particular that he is eligible for the purchase of prescription medicines pursuant to § 47 German Drug Act (Arzneimittelgesetz, AMG).

§ 2 Offer, Acceptance

(1) Insofar as your order constitutes an offer within the meaning of § 145 BGB we are entitled to accept the offer within two weeks after receipt and in accordance with § 1 (4).
(2) Unless otherwise agreed, cost estimates from us shall be subject to change and non-binding. The purchaser may submit an offer based thereon, which we may accept in accordance with the aforementioned clause 2.1.
(3) In the event of an express offer by us, such shall only be binding for a period of two weeks from receipt or for the period specified in the offer.
(4) The documents submitted and information provided by us, such as drawings, plans, weights and measurements, shall only be binding insofar as we expressly list them in the order or order confirmation as an integral part of the contract and/or explicitly refer to them in the order or order confirmation.

§ 3 Prices, Payment

(1) Prices (payable in EUR) are CPT place of the consignee (Incoterms 2020), exclusive of the respective statutory VAT. In particular, costs for special packaging requested by the purchaser or packaging made necessary by purchaser’s requirements, for shipping as well as customs duties and levies and other taxes, are not included in the price, unless otherwise agreed.
(2) The purchase price is due and payable net within 30 days from the receipt of the invoice. In the case of non-payment interest shall accrue in accordance with statutory law. We reserve all rights to claim further damages for default. In all other respects, the statutory law shall apply.
(3) If purchaser’s financial situation significantly deteriorates after the conclusion of the contract which jeopardises our claim for payment, we are entitled to make performance conditional upon advance payment or the provision of a security by the purchaser. The purchaser may provide proof that we had been or should have been aware of this circumstance already before the conclusion of the contract.
(4) Payment for partial deliveries and services shall be due upon completion of the respective partial delivery or service and corresponding invoicing.
(5) We will adjust the prices accordingly if unforeseeable material cost increases or decreases occur between conclusion of the contract and delivery with regard to price-relevant components for which we are not responsible and which were part of the original price calculation. Such substantial cost increases or decreases may be based in particular on newly levied charges, additional or changed duties or taxes, changes in statutory provisions, changes in material or manufacturing costs, in particular energy costs, transport/freight costs including customs duties, import and export charges and changes resulting from exchange rate fluctuations. The prices shall be adjusted depending on the price change of the price-relevant component in accordance with the respective reference point and the share of the price-relevant component in the final product

§ 4 Offset, Retainer

The purchaser shall be entitled to offset only insofar as the purchaser’s counterclaim is undisputed, acknowledged, or assessed in a legally binding judgement. The purchaser is entitled to claim retention rights only to the extent such rights are based on the same transaction.

§ 5 Delivery and Resale

(1) Unless otherwise agreed in the contract, delivery is agreed [CPT place of the consignee (Incoterms 2020)].
(2) We shall be entitled to make partial deliveries and render partial services, if they are not unreasonable for the purchaser.
(3) Any statement of us regarding delivery and performance times is non-binding unless we have expressly confirmed the exact delivery or performance date in text form.
(4) Delivery is conditioned upon timely and proper performance of all duties of the purchaser. Defenses based on non-performance of the contract are reserved.
(5) Compliance with the delivery and performance times is subject to correct and timely self-delivery.
(6) In case of default in acceptance or other breach of duties to cooperate by the purchaser, we are entitled to exercise our statutory rights, in particular, to claim any resulting damage including but not limited to additional expenses, and to withdraw from the contract after setting and unsuccessful expiry of a reasonable deadline for remedy. Furthermore, we reserve the right, after the setting and unsuccessful expiry of a reasonable deadline for acceptance of the delivery or service, to otherwise dispose of the products and to deliver or perform to the purchaser with a reasonably extended deadline. Further damages are reserved. In this case, the risk of loss or damage to the products passes to the purchaser at the time of such default or breach of duty to cooperate.
(7) If the purchaser is holding a current and appropriate wholesale distribution authorization resale to a wholesaler is allowed.
(8) Only full packs in the designated released packaging size can be distributed. Blisters shall not be separated and sold.

§ 6 Returns

The following minimum criteria must be fulfilled:

(1) If the purchaser is holding a current and appropriate wholesale distribution authorization or manufacturing/import authorization, a maximum of 3 months holding time by the purchaser is acceptable, which is calculated from delivery to the purchaser until pickup of the products for return. If the purchaser does not possess any such license, a maximum of 5 days holding time by the purchaser is acceptable, which is calculated from delivery to the purchaser until pickup of the products for return.
(2) The medicinal product is in its unopened and undamaged secondary packaging and is in good condition.
(3) It has not expired and has not been recalled.
(4) The purchaser has demonstrated that the medicinal product has been transported, stored and handled in compliance with its specific storage requirements.
(5) The batch number of the product bearing the safety features is known, and there is no reason to believe that the product has been falsified.
(6) The purchaser is obliged to carry the transportation costs of the returns products.

§ 7 Retention of Title

(1) We reserve title to the delivered products until all claims which exist against the purchaser based on the business relationships at the time the contract is concluded have been fulfilled. This shall also apply to any future claims that we acquire from the ongoing business relationship with the purchaser.
(2) In case the purchaser culpably violates the contract, in particular in the event of default in payment, we are entitled to take back the products. Taking back the products does not constitute a withdrawal from the contract unless we explicitly declare a withdrawal in writing.
(3) The purchaser shall handle the products with due care and maintain suitable insurance.
(4) The purchaser may neither pledge the products nor assign them by way of security prior to the transfer of ownership and must clearly mark them as our property.
(5) The purchaser shall be entitled to resell the products in the ordinary course of business; however, he hereby assigns to us all claims in the amount of the final invoice amount of the claim accruing to him from the resale against his purchasers or third parties, irrespective of whether the products have been resold without or after processing. The purchaser shall remain authorized to collect this claim even after the assignment. Our authority to collect the claim ourselves shall remain unaffected. However, we undertake not to collect the claim as long as the purchaser meets his payment obligations from the proceeds collected, is not in default of payment and there is no significant deterioration of assets. If this is the case, we may demand that the purchaser inform us of the assigned claims and their debtors, provide all information required for collection, hand over the relevant documents and inform the debtors (third parties) of the assignment.
(6) The processing or transformation of the products by the customer is always carried out for us. If the products are processed with other items not belonging to us, we shall acquire co-ownership of the new item in the ratio of the value of the products (final invoice amount) to the other processed items at the time of processing. In all other respects, the same shall apply to the item created by processing as to the products delivered under retention of title.
(7) If the products manufactured by us are inseparably mixed with other items not belonging to us, we shall acquire co-ownership of the new item in the ratio of the value of the products subject to retention of title (purchase price plus VAT) to the other mixed items at the time of mixing. If the mixing takes place in such a way that the purchaser’s item is to be regarded as the main item, it shall be deemed agreed that the purchaser transfers co-ownership to us on a pro rata basis; the purchaser shall keep the sole ownership or the co-ownership for us.
(8) We undertake to release the securities we are entitled to upon the purchaser’s request if the realizable value of the securities exceeds the claims to be secured by more than 15%. The selection of the securities to be released shall be at our discretion.

§ 8 Warranty

(1) Precondition for any warranty claim of the purchaser is the purchaser’s full compliance with all requirements regarding inspection and objection established by sec. 377 HGB (German Commercial Code).
(2) Warranty claims shall be time-barred after 12 months of the passage of risk.
(3) In case of defects in the products, the purchaser is entitled to subsequent performance, at our discretion, in the form of repair or delivery of conforming products. If such subsequent performance has failed, the purchaser is entitled to reduce the purchase price or to withdraw from the contract.
(4) A deadline to be set by the purchaser for subsequent performance must be reasonable and must be in writing. Subsequent performance shall only be deemed to have failed if three attempts have been unsuccessful. We may refuse subsequent performance if it is only possible at disproportionate cost.
(5) The above limitations of warranty do not apply to damages according to the 16th section of the AMG.

§ 9 Liability

(1) The purchaser is liable according to statutory law.
(2) In case of intent or gross negligence, our liability is unlimited. In case of slight negligence, we are only liable for a breach of fundamental contract obligations (an obligation which must be fulfilled to enable due performance of the contract and on whose fulfilment the purchaser generally relies and may rely) and our liability shall be limited to the foreseeable damage which is typical for this kind of contract.
(3) The above exclusions and limitations of liability shall not apply in the event of fraudulent concealment of a defect, from the assumption of a guarantee and for claims under the Product Liability Act, for damages arising from injury to life, limb or health and for damage to medicinal products within the meaning of section 16 of the German Drug Act (Arzneimittelgesetz, AMG).
(4) Insofar as our liability is excluded or limited, this shall also apply to the personal liability of our employees, representatives and vicarious agents.

§ 10 Confidentiality

(1) “Confidential Information” means business, marketing, technical, scientific, financial and other information, specifications, designs, plans, drawings, software, prototypes or process techniques of us or purchaser which, at the time of disclosure by us or purchaser, is marked confidential (or similarly marked), is communicated under confidential circumstances, or would be considered confidential by the parties using reasonable business judgment.
(2) We will and the purchaser will keep all Confidential Information strictly confidential, will not disclose such information nor to use it for any purpose other than the contract. This applies to all third parties, including unauthorized employees or freelancers, if the disclosure is not necessary for the fulfilment of the obligations under this contract.
(3) Confidential Information does not include such information which (i) was generally known or publicly available or became so without the receiving party’s action, (ii) was already in the receiving party’s possession prior to the receiving party’s receipt of the information from the disclosing party, (iii) was lawfully obtained from a third party who had the right to disclose such information, or (iv) was independently developed by a party without access to the disclosing party’s Confidential Information.

§ 11 Applicable law, Jurisdiction

(1) This contract shall be governed by the laws of the Federal Republic of Germany (excluding the Convention on Contracts for the International Sale of Goods).
(2) Place of performance and exclusive place of jurisdiction for all disputes arising out of or in connection with this contract shall be Munich, Germany.

§ 12 Language Version

In case of deviations between the German and the English version of these Terms and Conditions of Sale, the German version shall prevail.

Copyright

Rights for all content contained in this website—information including but not limited to text, trademarks, logos, and graphics, features including but not limited to software and icons, and editing and placement of the content—belong to Otsuka Novel Products GmbH or are used with legitimate rights. Under copyright laws, it is strictly forbidden for you to use or duplicate the contents of this website, without the company’s permission, for anything other than your own personal, non-commercial use.

Disclaimer

As a content provider pursuant to Sec. 7 para. 1 of the German Telemedia Act (Telemediengesetz, TMG) Otsuka Novel Products GmbH (“ONPG”) is, in accordance with statutory laws, responsible for its “own content” provided at www.otsuka-onpg.com.

A distinction must be made between this own content and cross-references (“links”) to content from other providers. In this respect, ONPG provides “third-party contents” which are available for use through these cross-references and are respectively marked as “[external]” or available over a new browser window.

When the links were first inserted the third party contents were checked to see whether they might cause a liability under civil or criminal law. However, it cannot be ruled out that contents are subsequently changed by the respective providers. ONPG does not continuously check the contents for changes (to which the links refer) that could constitute a new liability. If, in your opinion, the linked external pages are in breach of applicable law or contain otherwise inappropriate content, please inform us via reception@otsuka-onpg.com.

Our Internet pages contain general information about ONPG, our products and our services. They are not intended to give medical or other advice or instructions regarding the products and services offered by ONPG. For specific inquiries concerning our products and services, please contact ONPG directly.