1.1

These General Terms and Conditions of Delivery (‘GTC’) apply to all deliveries of pharmaceutical products (collectively ‘Products’) by G.L. Pharma GmbH (‘GL PHARMA’) to companies within the meaning of the applicable laws. Conflicting or deviating terms and conditions of the buyer shall not be recognised unless their validity is expressly agreed to in writing.

1.2

In addition, where relevant, the guidelines on good distribution practice (GDP, 2013/C 343/01), the EU GMP rules, Directive 2011/62/EU (anti-counterfeiting) including Delegated Regulation (EU) 2016/161 on safety features, the Medicines Act and other mandatory public law provisions shall also apply.

2.1

Offers made by GL PHARMA shall be subject to change. A contract shall only concluded upon written order confirmation or dispatch of the goods.

2.2

GL PHARMA documents (e.g. specifications, CoA samples, label designs) may not be reproduced or made available to third parties without the supplier’s consent.

3.1

Incoterms: Unless otherwise agreed, deliveries shall be made EXW in accordance with INCOTERMS® 2020 from the warehouse of GL PHARMA. Other delivery terms may be specified in the order confirmation.

3.2

Temperature-controlled products shall be delivered exclusively in validated, GDP-compliant transport packaging and processes. The buyer shall ensure that further storage/distribution is carried out in compliance with GDP.

3.3

GL PHARMA shall be entitled to partial and advance deliveries.

3.5

Force majeure/extraordinary circumstances (e.g. pandemics, official measures, supply bottlenecks, energy/raw material shortages, labour disputes, transport disruptions, failure of critical suppliers) shall extend the delivery periods by the duration of the disruption plus a reasonable restart period. Claims for damages due to delay shall be limited within the scope of Section 15.

4.1

Risk shall pass in accordance with the agreed INCOTERMS clause; in the absence of an agreement, risk shall pass upon delivery of the goods to the place of performance (EXW).

4.2

Notwithstanding delivery and transfer of risk, the goods remain the property of GL PHARMA until full payment has been made or all claims to which GL PHARMA shall be entitled from the business relationship with the buyer have been satisfied (retention of title). The buyer hereby assigns to GL PHARMA, as security, any claims arising from the resale of the goods subject to retention of title, and GL PHARMA accepts this assignment. The buyer shall only authorised to dispose of the goods subject to retention of title in the event of resale with deferral of the purchase price under the conditions that he (i) informs the second buyer of the assignment of security at the same time as the resale or notes the assignment in his business records, and (ii) again agrees a retention of title with his customer. Upon request, the buyer shall disclose to GL PHARMA the assigned claim along with its debtor, provide all information and documents required for its collection of the claim, and notify the third-party debtor of the assignment. In the event of seizure or other claims, the buyer is obliged to disclose GL PHARMA’s right of ownership and to notify GL PHARMA immediately. GL PHARMA shall be entitled to conduct a third-party debtor notification itself. The buyer shall not be entitled to further assign the claims, in particular not to factoring. The buyer shall grant GL PHARMA access to its premises at any time to inspect and take inventory of the goods subject to retention of title.

5.1

Prices shall be net plus statutory taxes, duties, fees, customs duties, disposal and compliance costs, where applicable.

5.2

Unless otherwise agreed, invoices shall become due net 30 days from the invoice date without deduction. In case of late payment, statutory default interest will apply; further rights remain unaffected.

5.3

The buyer’s rights of set-off and retention shall be excluded unless the counterclaim is undisputed or has been legally established.

5.4

All price reductions shall be granted only on condition of full and timely payment. If the buyer defaults on their payment obligations or if insolvency proceedings are opened against the buyer’s assets, GL PHARMA shall be entitled to demand the valid list price (selling price ex-works, pharmacy purchase prices) of the unpaid goods from the buyer.

5.5

Credit notes issued by GL PHARMA may only be used to offset future deliveries or services. Cash payments or other financial compensation shall be excluded.

6.1

The buyer shall immediately upon delivery carry out a GDP-compliant incoming goods and temperature inspection as well as a visual inspection for transport damage, conformity with the order (quantity, item, batch, expiry dates) and security features (serialization/tamper protection).

6.2

Obvious defects, transport damage and temperature deviations (excursions) shall be reported in writing within 5 working days of delivery, hidden defects within 10 working days of discovery, and evidence shall be provided (e.g. logger data, photos).

6.3

Until clarification, the goods concerned shall be blocked (quarantined) and not placed on the market. GL PHARMA shall give instructions on how to proceed (e.g. return, destruction, replacement delivery).

7.1

GL PHARMA warrants that the products comply with the agreed specifications and are free from material defects and defects of title at the time of transfer of risk. No additional guarantees shall arise from public statements, brochures or samples.

7.2

The statutory warranty period begins with the transfer of risk. Upon proper notification of defects, GL PHARMA will, at its discretion, remedy the defect by replacement, repair, or credit note. Further claims are governed by clause 15.

7.3

Warranty shall be voided in cases of improper storage/transport by the buyer, failure to comply with GDP/operating instructions, normal wear and tear, Force Majeure, or modifications/interventions without GL PHARMA’s consent.

8.1

The buyer undertakes to report suspected cases of side effects/adverse events, product complaints and complaints about suspected counterfeiting, quality defects or lack of efficacy immediately, at the latest within 1 (one) working day of becoming aware of them, to pv@gl-pharma.at.

8.2

The buyer supports GL PHARMA in identifying, documenting and evaluating the reports (e.g. forwarding minimum data sets, returning sample packs, photos, logger data) and shall comply with data protection requirements according to Art. 6, 9 GDPR.

9.1

GL PHARMA shall be entitled and, where necessary, obliged to recall or return products or to implement corrective safety actions if this is necessary for quality, safety, regulatory or official reasons. The buyer shall support GL PHARMA in this matter free of charge and without delay (e.g., customer information, blocking, recall).

9.2

The buyer shall not initiate any unauthorized recalls unless imminent danger requires immediate action. In this case, GL PHARMA must be informed immediately.

10.1

Serialised products are delivered with a 2D data matrix code and tamper-evident packaging. The buyer shall check the integrity and, where legally required, decommissions/verifies the security features in the national system (e.g. National Medicines Verification System).

10.2

The buyer shall refrain from any manipulation of security features and reports suspected counterfeiting immediately to GL PHARMA.

11.1

Both parties shall comply with all relevant pharmaceutical, narcotics, sanctions and export control regulations, as well as competition and anti-corruption regulations (including EU/national medicinal products act, GDP/GMP, (EU) 2016/161).

12.1

Business and trade secrets, specifications, prices, QA documents and similar information shall be treated as confidential.

12.2

Personal data, particularly in the context of pharmacovigilance, will only be processed to the extent permitted by law.

13.1

In the event of a delay, the buyer must set GL PHARMA a reasonable grace period in writing. Contractual penalties shall only be valid if expressly agreed upon.

14.1

Neither party shall be liable for any failure to perform its contractual obligations if this failure is due to Force Majeure. The affected party shall inform the other party immediately and take appropriate measures to mitigate the damage.

15.1

GL PHARMA shall be liable for damages resulting from injury to life, body, or health, as well as under the Product Liability Act, in accordance with statutory provisions.

15.2

GL PHARMA shall be liable only for other damages in cases of intent and gross negligence. In this case, liability shall be limited to the foreseeable damage typical for this type of contract and to the net order value per claim to the extent legally permissible.

15.3

Liability for slight negligence, lost profits, loss of production, pure financial losses and indirect damages shall be excluded to the extent permitted by law.

16.1

These general terms and conditions apply to the respective order. Ongoing delivery relationships may be terminated for good cause, in particular in the event of default in payment, serious violations of GMP/GDP or official prohibitions.

17.1

Should individual provisions be invalid, the validity of the remaining provisions shall remain unaffected. The invalid provision shall be replaced by a provision that comes closest to the economic purpose of the invalid provision.

17.2

Written form: Amendments and supplements must be made in writing; this also applies to the waiver of this formal requirement, insofar as this is legally permissible.

17.3

Law and place of jurisdiction: Austrian substantive law shall apply, excluding conflict of laws provisions and the UN Convention on Contracts for the International Sale of Goods (CISG). The exclusive place of jurisdiction shall be, insofar as permissible, the registered office of GL PHARMA.