General Terms and Conditions of Sale

Biogen Belgium N.V./S.A. 18 June, 2018

1) APPLICABILITY

1.1  These General Terms and Conditions of Sale (“Terms and Conditions”) apply to all sales by Biogen Belgium N.V./S.A. (“Biogen”) of any and all the medicinal product(s) over which Biogen exercises proprietary rights (including products manufactured by Biogen contract manufacturing partners or delivered from Biogen’s (including its distribution partners’) warehouses) as well as any related device(s)product (the “Products” and each a “Product”) to the customer. If for a specific sale of the Product it is unclear which set of terms and conditions apply, these Terms and Conditions will apply. By placing an order for the Product or accepting delivery the customer accepts without any reserve these Terms and Conditions.

1.2  These Terms and Conditions shall apply to the exclusion of all other terms and conditions. Biogen shall in particular not be bound by any terms and conditions, or reference thereto, contained in a customer’s general conditions of purchase, order form, confirmation or acceptance letter, or in any other correspondence. General terms and conditions, or reference thereto, from service providers and/or agents of Biogen will not be applicable either. No adaptations, deletions or changes to these Terms and Conditions shall be binding, unless separately and specifically approved in writing and signed by a duly authorized representative of Biogen.

1.3  Biogen shall have the right to amend these Terms and Conditions at all times. The amended terms and conditions shall enter into force upon a thirty (30) days notice to customer.

2) CONCLUSION OF CONTRACTS

2.1  Offers, quotations, prospectuses and other promotional documents of Biogen are always without obligation.

2.2  Received customer’s orders for the Product are irrevocable. A contract is concluded only upon Biogen’s written acceptance of an order. Staff of Biogen is not authorized to accept an order or conclude a contract orally. Acceptance of an order can be made conditional to advance payment if deemed necessary by Biogen. Accepted orders cannot be canceled by customer.

3) DELIVERY

Transport and transfer of title and risk

3.1  Products ordered by a customer shall be delivered DAP (Delivery at Place) at the place of destination agreed with the customer INCOTERMS® 2010 (“Delivery”). Legal title and risk in the Product shall pass to the customer upon Delivery.

3.2  Biogen is allowed to dispatch an order for the Product in parts. The terms of this section 3 shall apply to such partial deliveries as well.

Delivery dates

3.3  The date of delivery indicated by Biogen shall only be informative. Delivery is dependent on such factors as the availability of transporters, the order of presentation of the orders and the availability of stocks. Biogen shall make its best commercial efforts to (i) comply with the delivery date indicated upon acceptance of the order, and (ii) perform the accepted orders, subject to a force majeure case, as defined in section 11, subject to compliance by the customer with the payment conditions and more generally with its obligations under these Terms and Conditions.

3.4  Delays in the delivery of Product shall not justify the cancellation of the order nor give rise to any penalty or compensation.

Reception

3.5  Upon receiving the shipment of Product, the customer shall acknowledge receipt in the form required by Biogen, the customer shall also inspect the Products and report any shortage, damage, defects or non-conformance: (i) immediately to the transporter/service provider delivering the products; and (ii) within five (5) working days to Biogen by a registered letter with acknowledgement of receipt, setting out in full the alleged shortage, defect or non-conformance. The customer shall allow Biogen to take the necessary steps to ascertain the facts and find a remedy.

3.6  Unless the customer has made a report in conformity with the previous section 3.5, the Products shall be deemed accepted by the customer as having been delivered according to the contract and without any shortage, damage, defects or non-conformance.

3.7  The customer shall not return Products unless Biogen has given prior written approval. Biogen shall only pay return transport fees when an apparent defect in the Product is acknowledged by Biogen. The transporter/agent chosen by Biogen is the only person entitled to perform the return of the relevant Products.

3.8  Upon acknowledgement that an apparent defect in the Product exists by Biogen, and subject to verification by Biogen that it is responsible for the alleged defects, Biogen will provide replacement Product.

3.9  Any claim made by the customer under the terms and conditions described in this section does not entitle the customer to delay any payments.

4) PRICE & PAYMENT TERMS

4.1  The customer shall purchase Products from Biogen at the price determined by Biogen and as set out by applicable laws and regulations or agreed with reimbursement authorities on a case-by-case basis (“Supply Price”).  Biogen reserves the right to change the Supply Price of the Product at any time without advance notice to or the consent of the customer.  Biogen shall provide the customer with prompt notice of any Supply Price change.

4.2  Biogen shall invoice customer for all amounts due for each order of Product. 

4.3  The Supply Price is exclusive of applicable value added, goods and services, local sales, use, excise or similar taxes applicable to the sale, shipment, delivery, ownership, possession or resale of Products or any other activities contemplated under this Agreement, and customer shall be liable for and pay all such taxes, whether or not listed on Biogen's invoices.  The customer shall reimburse Biogen in full for any and all taxes which are paid by Biogen for which the customer is responsible under this section. 

4.4  The customer shall not set off any amounts against, or delay payment of, any amounts due to Biogen under these Terms and Conditions without Biogen's prior written consent.

4.5  Invoices are payable by wire transfer (checks are not accepted) as per the payment terms described on our invoices.

4.6  If an invoice is disputed in any way, the customer will pay the undisputed portion of the invoice within the payment terms reffered to in section 4.5 above.

4.7  Any sum which has not been paid pursuant to the terms of section 4.5 shall trigger the payment of default interest at the legal rate. The assertion of a claim for further damages due to a default of payment shall remain unaffected.

4.8  Any default of payment will trigger immediate payment of all outstanding invoices even before the end of the payment terms referred to in section 4.5 above.

4.9  Notwithstanding all remedies legally available in the event of a default of payment, Biogen shall be entitled to suspend immediately with no prior notice the performance of the existing orders, set-off the outstanding unpaid amounts against any sum due to the customer, and request payment cash upon presentation of the order. The customer shall reimburse all fees in relation to the default of payment and all fees exposed by Biogen to recover the unpaid sums.

5) PRODUCTS USAGE AND HANDLING

5.1  Given the inherent complexity of the field of biotechnology, it cannot be guaranteed that Biogen’s Products function without defects in all applications, environments and/or combinations, nor that are they appropriate for the specific purpose intended by the customer.

5.2  Subject to the applicable regulations in force, Biogen may amend the Product whenever it considers the modification to be useful or necessary.

5.3  All recommendations made by Biogen in relation to the use and treatment of the Products are based on the information, methods and practices deemed adequate at the date of marketing. Biogen shall not be responsible for risks related to the development of the finished Product which may be revealed by later scientific or technological means. The recommendations made by Biogen do not exonerate the customer to observe the applicable legislation, regulations and third party rights.

5.4  Information provided in Biogen documentation, catalogues, prospectus, promotional documents or notices should be seen as for informative purposes only and can not be relied upon or seen as a guarantee.

5.5  The customer shall obtain specific written confirmation, signed by a duly authorized representative of Biogen, for any specification or any element related to the Product that the customer or final customer considers substantial.

5.6  The customer shall communicate to purchasers of the Product all required Biogen instructions and information.

5.7  The customer shall be the only responsible person for the management of the shelf life and expiry dates of the Product and shall in no event claim anything to Biogen in this respect.

5.8  Products cannot be returned to Biogen other than as set out in section 3.7.

6) OBLIGATIONS OF CUSTOMER – QUALITY CONTROL

6.1  The customer or its representative shall maintain the stocks of the Products under conditions compliant with relevant laws and regulations and with any instructions and recommendations of Biogen that may be provided from time to time. In particular, the customer shall comply with pharmaceutical laws and regulations, including the approved label for the Product, in the areas of hygiene, safety, environment for stocking, handling, use and treatment of the products.

6.2  The customer undertakes to answer to all quality-related questionnaires sent by Biogen from time to time within the deadline indicated by Biogen.

6.3  The customer undertakes to allow Biogen at all times with a twenty-four hour prior notice, to have access to its warehouse or any other warehouse or premises used by the customer in order to audit compliance of the stocks, handling, use and treatment of the Product with the instructions given by Biogen and regulations relating to hygiene and safety.

6.4  Biogen may conduct such an audit if there is any concern from Biogen with respect to the quality of the Product.

7) LIMITATION OF LIABILITY AND REMEDY

7.1  Biogen liability, on whatever ground, for damage suffered by customer or a third party as a result of or in connection with the Product, the contract and these Terms & Conditions shall be limited to liability for direct damage to goods, and shall furthermore be limited to the sole reimbursement or replacement of the Product, at the choice of Biogen.

7.2  In no event shall Biogen be liable for any indirect, incidental, special, consequential or exemplary damages, including without limitation property damage, lost profits or other economic loss resulting from the delivery, sale, use or inability to make use of the Product.

7.3  The limitation of liability in sections 7.1 and 7.2 shall not apply to damage resulting from the intentional or grossly negligent conduct of the management of Biogen, to damage resulting from death or injury, nor to liability based upon product liability, except when the damage is jointly caused by the Products’ defect and the victim’s fault or negligence.

7.4  The customer shall defend, indemnify and hold harmless Biogen from and against all loses, costs and expenses, including attorney’s fees, in any way arising out of or relating to an abnormal, improper or non conform use of the Products from the negligence of the customer; from the violation of these Terms and Conditions; or from any other misconduct of the customer.

8) INTELLECTUAL PROPERTY

8.1  Biogen and/or its third party licensors and/or its Affiliates shall remain and be the owner of all Biogen Commercial Data and the intellectual property rights in and relating to the Biogen Commercial Data, and the Customer shall not acquire any rights in any Biogen Intellectual Property. No license, either expressed or implied, is granted to the Customer under any Biogen Intellectual Property or intellectual property controlled by Biogen for any of the Products, except that the Customer may use the trademarks for the Products only for the purposes of performing its obligations under this Agreement.

8.2  The Customer shall not take steps and shall not assist others to take steps, directly or indirectly, to attempt to secure any rights (including the filing of any applications for registration or obtaining any registrations) in any of the trademarks or intellectual property used on or in connection with the Products.

8.3  The Customer shall not during the Term or thereafter, market, directly or indirectly, any product under any trademark which is the same as or similar to that used on any of the Products, or which so closely resembles the same that it would be likely to lead to confusion or uncertainty or to otherwise deceive or mislead the public.

8.4  Upon termination or expiration of this Agreement for any reason whatsoever, the Customer shall not, directly or indirectly, thereafter use or attempt to register any trademark which is the same as or similar to any trademark used on any of the Products, or which so closely resembles the same that it would be likely to lead to confusion or uncertainty or to otherwise deceive or mislead the public.

8.5  The Customer shall immediately inform Biogen of any improper or wrongful use of the trademarks for the Products or any Biogen Intellectual Property of which the Customer becomes aware in the jurisdictions in which the Products are distributed.

9) FORCE MAJEURE

9.1  Biogen shall not be liable for any delay in delivery or modification, suspension or cancellation of performance or other failure of performance hereunder in whole or in part caused by events beyond its influence and control and for which Biogen bears no responsibility, including, but not limited to acts of God, war, orders of government or unforeseeable, unavoidable labor disputes at Biogen or its suppliers. If the end of the delay is not foreseeable or if it lasts for more than one (1) month each party shall be entitled to rescind the contract.

10) MISCELLANEOUS

Choice of Law; place of jurisdiction

10.1  These Terms and Conditions shall be governed by and subject to the laws of Belgium, excluding any conflict of laws provisions. The UN Convention on the International Sale of Goods (GISG) shall not apply.

10.2  The exclusive jurisdiction for any dispute in relation to the application of these Terms and Conditions, their interpretation, their implementation and the sale agreements concluded by Biogen, or the payment of the price shall be the courts of Brussels. Biogen, however, shall be entitled to sue the customer at any other place having jurisdiction.

No Waiver

10.3  Neither party’s waiver of a breach or default under any of the provisions of these Terms and Conditions or failure to enforce any of the provisions hereof or to exercise any right or privilege hereunder shall thereafter be construed as a waiver of any subsequent breach or default, or as a waiver of any such provisions, rights or privileges hereunder.

Amendments

10.4  These Terms and Conditions can be modified, amended or rescinded only in a written document duly signed by the authorized representatives of the parties hereto.

Severability

10.5  If any one or more provisions of these Terms and Conditions shall be found to be illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby and shall remain in full force and effect, provided the surviving terms reflect the original intent.

Biogen-248272 | Version 09/2024