GTC - Primed® Halberstadt

General Terms and Conditions of Primed® Halberstadt Medizintechnik GmbH

I. Scope of application
1. Sale and delivery of all products distributed by Primed Halberstadt Medizintechnik GmbH
(hereinafter referred to as „Primed“) in Germany and abroad shall be exclusively made on the
basis of these General Terms and Conditions. They shall be deemed to have been recognized
when an order is issued or a delivery is accepted by the ordering party or their agents.
2. This also holds true for future business transactions or deliveries between the same parties,
without the requirement of an express reference.
3. Our Terms and Conditions shall also apply if there are indications to the contrary in the terms
and conditions of the ordering party or the supplier. We hereby expressly object to these Terms
and Conditions, unless Primed has agreed to such deviating Terms and Conditions in writing.
4. Individual agreements reached between the parties shall remain unaffected by these Terms and
Conditions.
5. Should individual terms be or become inoperative, the remaining terms will not be affected.

II. Orders and Acknowledgement of orders

1. Our offers are non-binding. Orders shall only be binding for us if we acknowledge them in
writing or by fax/email or by sending the goods to you. Any verbal collateral agreements,
modifications, additions or assurances regarding offers or written agreements shall have no
effect until confirmed by us in writing.
2. We expressly reserve the right to modify the items ordered and delivered, particularly with
regard to material and workmanship, in the interest of technical development.
3. For transactions comprising several individual deliveries, each delivery shall be regarded as a
different transaction.

III. Prices

1. Our prices are quoted ex works without packaging
2. If the price has been agreed to be related to the weight of parts, the final price will be calculated
on the basis of the weight of the approved type samples.

IV. Terms of delivery, transfer of risk, packaging, dispatch

1. Delivery deadlines or periods shall only be binding if expressly agreed in writing. Primed‘s
compliance with the obligation to supply goods is dependent upon the prompt and proper fulfilment
of the ordering party‘s obligations. We reserve the right to defend against non-fulfilment.
2. In case of delays in delivery due to force majeure or other events which make it increasingly
difficult or even impossible for Primed to meet delivery commitments in time, Primed shall not
be answerable for the non-performance of any binding delivery dates.
3. The risk of damage, deterioration, destruction or loss of the goods shall be transferred to the
party ordering as soon as the consignment has been handed over to the person executing the
transport or has left Primed‘s warehouse or factory for the purpose of dispatch. If dispatch is
delayed at the request of the ordering party or through the fault of the ordering party, the risk
shall pass to the ordering party after the notification of readiness for dispatch.
4. Upon written request of the ordering party, the goods will be insured against storage damage,
breakage, transportation damage and fire damage at the latter‘s cost.
5. Unless otherwise agreed, Primed will choose packaging and dispatch at their own discretion.
6. Special packaging material (also pallets) that have not been invoiced, shall remain the property
of the supplier. The ordering party shall be obliged to store the packaging material with due
care and make sure that the packaging is returned free of charge.
7. Primed reserves the right to charge the shipping costs incurred for order-related short quantities.

V. Terms of payment

1. All payments shall be made in Euros to Primed only.
2. Unless otherwise agreed, the purchasing price:
a) for moulds and tools is to be paid 50% when the order is acknowledged, the other 50% of
the order price are to be paid within 30 days after submitting the type samples specified
in the contract. Once the ordering party has confirmed their change requests before the
moulds are produced, all costs incurred up to that time will be charged insofar as they
exceed the down-payment.
b) must be paid net (without any deductions) within 30 days after date of invoice.
3. In case any agreed payment dates are exceeded, interest amounting to 4% above the respective
discount rate of the Federal Bank of Germany will be charged, unless Primed can provide
evidence of higher debit interest.
4. Cheques and rediscountable bills of exchange will only be accepted by way of fulfilment; all
associated costs will be payable by the purchaser. The ordering party shall not be entitled to set
off and enforce retaining liens for any adverse claims not recognised by Primed.
5. If the terms of payment are not observed or circumstances become known justifying serious
doubts about the credit standing of the ordering party, all the claims held by Primed will
become payable immediately. In addition, Primed has the right to require advanced payments
for orders still outstanding and to rescind the contract after granting a reasonable period of
extension or to require compensation for non-performance; moreover, Primed can prohibit the
purchaser from reselling goods and repossess at the expense of the ordering party any goods
which have not been paid for.

VI. Moulds and tools

1. The mould and tool price also includes the sampling costs but not the costs for testing and
processing equipment and modifications requested by the ordering party.
2. Unless otherwise agreed, Primed is and remains the owner of the moulds and tools produced
for the ordering party by Primed themselves or by a third party assigned by Primed. These
moulds and tools shall be exclusively used for the orders of the ordering party, as long as the
ordering party honours their payment and purchasing obligations. Primed‘s obligation to store
the moulds will expire two years after the last delivery of parts.
3. If in accordance with the terms of this agreement the ordering party is to become the owner
of the moulds and tools, the ownership shall be transferred to the ordering party after paying
the purchasing price for the moulds and tools. The handing over of the moulds and tools to the
ordering party shall be replaced by Primed‘s obligation to store them. Regardless of the ordering
party‘s legal claim for restitution of property and the service life of the moulds, Primed
shall be entitled to be the exclusive owner of the moulds, until a minimum quantity to be
agreed upon has been purchased and/or until a certain period of time has elapsed.
4. For moulds and tools owned by the ordering party pursuant to item 3 and/or moulds and tools
loaned out by the ordering party, Primed‘s liability regarding storage and maintenance is
restricted to the care expended on their own property. Maintenance and insurance costs shall
be borne by the ordering party. Primed‘s obligations shall expire if the ordering party- on completion
of the order and after respective demand- fails to collect the moulds within the adequate
period. As long as the ordering party has not fulfilled their contractual obligations in full, Primed
has a right of retention to the moulds.

VII. Material provision

1. Whenever materials are provided by the ordering party, these materials shall be supplied in due
time and perfect condition at the cost and risk of the ordering party and must include reasonable
excess quantities of no less than 5%.
2. If these requirements are not met, the supply period will be extended by a reasonable period of
time. Except in cases of force majeure, the ordering party shall pay the additional costs thus
incurred, including those of interruption of production.

VIII. Reservation of title

1. The goods supplied will remain Primed‘s property until all claims held by Primed against the
ordering party have been settled. The ordering party is not authorised to dispose of the conditional
goods in other ways, in particular by pledging or assignment as security. In cases of breach
of contract on the part of the ordering party, especially default of payment, Primed shall be
entitled to reclaim and take back the goods.
2. The ordering party shall be entitled to resell the goods as part of ordinary business transactions.
The ordering party assigns to us claims to the goods held against a third party in the course
of resale, up to the corresponding invoiced amount. We accept this assign-ment. Following the
transfer, the customer shall be authorized to collect the amounts receivable. However, we
undertake not to collect said amount receivable for as long as the customer meets their
financial obligations out of the proceeds collected, does not default on payment and has not
applied for composition or bankruptcy proceedings or has suspended payments. But should
such situation arise, we may demand that the customer disclose the claims assigned and the
related debtors, that they provide all information necessary for collection, that they hand over
all pertinent documentation and that they inform the debtor of the assignment.
3. Processing or compounding by the ordering party shall exclude the acquisition of owner-ship;
Primed shall remain the owner of the new product. In case of processing, connecting or mixing
according to the intended use, the assignment shall correspond to the invoiced amount of the
goods used.
4. If Primed exercises their reservation of ownership in compliance with the above provisions by
repossessing conditional goods, they shall be entitled to sell the goods on the open market or
have them auctioned. The goods will be repossessed at the amount of the proceeds obtained
but at no more than the agreed supply prices. The right to make further claims for damages, in
particular loss of profits, is reserved.

IX. Liability for defects

1. The ordering party shall be obliged to inspect the goods received from Primed immediately
after delivery and to report any defects or delivery errors immediately, at the latest within one
week after receipt of the goods. Any defects that cannot be detected even by careful scrutiny
of the goods within one week after receipt of the goods shall be notified in writing immediately
after discovery, but at the latest six months after receipt of the goods enclosing certificate of
the consignment in question.
2. Failure to comply with the instructions for use or the indications on the packaging of the goods,
or to use or store the goods according to the intended use, will result in the lapse of all warranties,
unless it conflicts with any legal requirements.
3. If Primed has provided advice to the ordering party, Primed shall be liable for functionality and
suitability of the consignment only upon prior express written approval.
4. In case of a justified notice of defects- for which quality and workmanship of the samples
approved by the ordering party in writing shall prevail- Primed shall be entitled at its own
discretion to either remedy the situation or substitute the product free of charge. Replaced
goods are to be returned to Primed at their request.
5. Unauthorised re-working and improper handling shall result in the loss of any right to claim
compensation due to defective parts. After giving Primed prior notification, the ordering party
is authorised to rework items and to require compensation for reasonable costs only if this is
being done to advert unreasonable losses or if Primed is in default with the remedying of defects.
6. In particular, our liability for all breaches of obligations relating to the implementation of a
contract, irrespective of the legal reason, shall be limited to the compensation for the direct
damage which is reasonably foreseeable for us, but no more than 7,5% of the net value of the
goods ordered. Under no circumstances we will accept liability for damage arising from business
interruption or loss of production, in particular loss of profit and increased production costs.
7. The aforementioned limitation of liability shall not apply if the damage is attribute to a wilful or
grossly negligent breach of duty. Liability in accordance with the German Product Liability Act
shall not be affected.

X. Return of goods

1. Primed will accept the return of goods only in justified exceptional cases. The goods can only
be returned with express written approval; without this approval no credit note will be issued
for the returned goods.
2. The amount to be refunded for the returned goods depends on their age and their suitability
for resale. Non re-saleable goods and individually manufactured products are excluded from return.
3. The customer shall bear the risk for the transport of returned goods.

XI. Intellectual and industrial property rights

1. We reserve the ownership rights and copyrights to illustrations, plans, drawings, drafts, design
proposals, calculations and any other documents enclosed with Primed‘s offers or which have
been disclosed to the ordering party within the framework of the cooperation. The ordering
party shall require Primed‘s written approval for their distribution to third parties.
2. Whenever Primed supplies drawings, models or samples to the ordering party, the latter
warrants that no property rights of third parties are breached thereby. The ordering party shall
hold Primed harmless in relation to claims from third parties and reimburse any damages
incurred. If a third party forbids production or supply by invoking a property right which they
hold, Primed is entitled to discontinue work without reviewing the legal situation.

XII. Export and Domestic Distribution

1. Prior written consent is required for the sale, shipment, and export of our goods to Canada, the
USA, Japan, Brazil, and China. We reserve the right to assess a contractual penalty in the event
that goods are traded on these markets without our written consent.
2. Each reseller shall be obliged to guarantee traceability of their final customers, so that in case
of a recall according to MDR 2017/745, their final customers can be reached and the medical
device can be withdrawn from the market. This obligation also applies for the period after the
business relations have ended.
3. Deliveries and services are subject to the condition that performance is not opposed by national
or international regulations, in particular, but not limited to, export control regulations, embargos,
or other sanctions. The contracting parties covenant to provide any and all information and
documentation required for the export/shipment/import. Delays resulting from export assessments
or approval procedures render deadlines and delivery periods ineffective. If the required
permits are not issued, the contract shall be deemed as not concluded with regard to the ordered
goods; damage compensation claims related to these delays and overruns of the aforementioned
deadlines are precluded.

XIII. General Obligations of the Dealer and the Customer (Art. 14 MDR 2017/745)

All dealers and customers who procure products from Primed and in turn offer these products
on the market or distribute them commercially are subject to the general obligations of Art. 14
MDR 2017/745.

XIV. Place of fulfilment, place of jurisdiction and applicable law

1. The place of fulfilment for any obligations arising from the contractual relations between Primed
and the ordering party is the head office of our company.
2. The place of jurisdiction is- at Primed‘s discretion- Primed‘s head office or the head office of the
ordering party. This shall also apply to documentary, bills of exchange and cheque proceedings.
3. These Terms and Conditions and all contractual relations between the parties shall be governed
by the law of the Federal Republic of Germany. Applicability of the UN Convention on Contracts
for the International Sale of Goods shall be expressly excluded.

General Terms and Conditions of Primed Halberstadt Medizintechnik GmbH
Date of revision of the text: 24.06.2022