Standard Terms and Conditions
1. Scope of Application
These standard terms and conditions (“Standard Terms and Conditions”) apply to any and all sales of Rabipur® and/or Encepur® vaccines (“Products”) from Bavarian Nordic Switzerland AG, CHE-259.519.429, Grafenauweg 8, 6301 Zug, Switzerland (“BN”) to BN’s customers (“Customer”), if the sale of Products is not subject to a separate, written and signed sales contract between BN and Customer.
When Customer orders Products from BN, and the Purchase Order is accepted by BN, Customer expressly accepts that the ordering and sale will be subject to these Standard Terms and Conditions (each individual sales contract together with these Standard Terms and Conditions hereafter a “Sales Contract”). If the order is accepted by BN, the effective date of the Sales Contract is the date the order was made by Customer (“Effective Date”).
BN and Customer are hereinafter each referred to as a “Party” and jointly the “Parties”.
2. Purchase Orders
Customer shall issue to BN a formal purchase order for a quantity of Products (the “Purchase Order”). Each Purchase Order provided to BN by the Customer shall be in writing and shall specify product description, product code, quantity, order address and delivery and invoice address if they are different from order address.
BN is free to accept or reject any Purchase Order without giving reasons.
Each individual Sales Contract is only validly concluded upon approval of BN, i.e. in particular by explicit acceptance of the Purchase Order (or orders not qualifying as Purchase Orders) or by delivery of the ordered Products.
3. Price and Payments
Customer will pay the agreed dose prices for Products ordered from BN.
BN will invoice the Customer for the Products on the date of delivery of the Products to the Customer. Invoices will be payable within thirty (30) calendar days from the issuance date stated on the invoice.
All payments under the Sales Contract will be made by wire transfer and in CHF to such bank account as may be notified in writing by one Party to the other Party from time to time. All invoices delivered pursuant to the Sales Contract shall be in CHF.
If either Party fails to make any payment due to the other Party under the Sales Contract on the due date for payment and the payment is not in dispute between the Parties without prejudice to any other right or remedy available to the payee, the payee shall be entitled to charge the payor interest (both before and after judgement) on the amount unpaid at the annual rate of 5% on a daily basis until payment in full is made without prejudice to BN’s right to receive payment on the due date.
Customer shall not be entitled to offset any counterclaims against BN in payments to BN, nor shall the Customer have any right to withhold any portion of the payment because of counterclaims of any kind.
4. Taxes
Unless value added tax is specified separately, all payments to be made to BN under the terms of the Sales Contract are net, exclusive of value added tax. The payer shall pay to the payee in addition to those payments any value added tax or similar taxes legally due by the payee to the tax authorities on the services provided under the Sales Contract against issuance of an invoice with value added tax specified explicitly.
Any and all amounts to be paid to either Party under the Sales Contract will be made without deducting any withholding for taxes, duties or other amounts, unless otherwise required under applicable law. If the payee is required to withhold amounts from any payments payable to the payor, the Parties shall take all reasonable steps to do all such acts and things and to sign all such deeds and documents as will enable them to take advantage of any applicable double taxation agreements to reduce the rate of withholding or similar taxes with the object of paying the sums due under deduction of a reduced rate of withholding tax or on a gross basis.
5. Delivery
The Products will be delivered by BN to wholesalers delivered duty paid (DDP - Incoterms 2020) to the agreed delivery address. For medical professionals and legal entities employing medical professionals, delivery is not included in the price and BN will charge CHF 29 delivery fee for Purchase Orders with an order value below CHF 700.
Orders placed before noon will be delivered within 24 hours, while orders placed after noon will be delivered within 48 hours.
6. Product Packaging and Labelling
The Products will be packaged and labelled according to (i) the terms of the quality agreement (if any), (ii) the specifications and (iii) applicable laws and regulations in Customer’s country. The Products may only be offered, sold or delivered in the unaltered original packaging.
7. Sale of Products
Customer will sell the Products in its own name and for its own account and own risk. Customer shall determine the price at which it will sell the Products to customers at its discretion subject to compliance with the requirements of the relevant regulatory authorities and applicable laws.
Customer will, at Customer’s own cost and expense:
(i) Sell and handle the Products in accordance with the Sales Contract, any separate quality agreement, any quality procedures separately agreed between the Parties and in a manner that is consistent with GDP (EU-Guidelines 2013/C 343/01, if applicable to the customer type) and other applicable laws and regulations in the country/ies in which Customer sells and handles the Products (“Territory”);
(ii) receive and respond to all customer service enquiries, governmental enquiries and technical queries relating to the Products and forward to BN medical inquiries, Product complaints and Adverse Events in accordance with the adverse events reporting system set out in any separate pharmacovigilance agreement and/or in any procedures agreed between the Parties, including Section 21 and
(iii) not sell the Products under any trade names or trademarks other than those which are authorised by BN.
8. Compliance with Applicable Laws
Customer shall fulfil any and all of its obligations under the Sales Contract in accordance with all applicable laws and regulations in the Territory. In particular, but without limitation, those related to the registration, approval, marketing, distribution and sale of the Products, including GDP (if applicable to the customer type) and all applicable pharmaceutical industry marketing codes and guidelines as well as all anti-corruption laws.
9. Disputes with Customers
In the event of a serious dispute between the Customer and any proposed purchaser in relation to the sale or offer for sale of the Products, Customer shall forthwith inform BN of the details and circumstances of the dispute and BN shall be entitled (but not obliged) to participate in the resolution or defense of any such dispute at its own cost and the Customer shall comply with the reasonable directions and requirements of BN in relation thereto and shall not make any admissions without the prior written approval of BN.
10. Regulatory Approvals
Customer shall comply with all applicable legal requirements and regulatory requirements in relation to the Products in the Territory. BN shall be the holder of the marketing authorisation(s) for the sale and promotion of Products in the Territory to the extent permitted by the laws in the Territory. Customer will at its sole expense seek and obtain any regulatory approvals required to perform its obligations under the Sales Contract on or prior to the Effective Date and will maintain such regulatory approvals in force, except that any fees payable to the regulatory authorities associated with the obtaining, prolongation or variation of any marketing authorisations for the Products which are held by BN, will be at BN’s expense.
Prior to making any submission to any regulatory authority, Customer shall deliver to BN for approval all data, information, packaging, labelling and material in support of or relating to the submission. Customer shall, on request from BN, promptly provide to BN a copy of all registration documents, variation approvals and renewal licenses relating to the sale and distribution of the Products in the Territory.
11. Product Recall
Decisions to recall the Products shall be made by BN at its discretion and cost (subject to the third paragraph below, last sentence) and to the extent permitted under applicable laws.
Customer may make recall decisions regarding the Products in the Territory subject to BN’s prior written consent. However, such consent is not required for recall decisions imposed by regulatory authorities.
Customer shall comply with the procedures concerning recalls set out in any separate quality agreement and/or any quality procedures separately agreed between the Parties. If BN recalls any Products for whatever reason and whether voluntarily or otherwise, Customer shall comply fully with any separate quality agreement, any quality procedures separately agreed between the Parties, applicable laws, and with any reasonable instructions given by BN in relation to such recall. BN shall reimburse Customer the reasonable and documented costs of complying with this section (including the cost of replacing any defective Products) provided that the recall was not caused directly or indirectly as a result of the breach of the Sales Contract, any quality agreement, any quality procedures separately agreed between the Parties or any negligence or wilful act or omission on the part of the Customer.
12. Acceptance/Rejection
Customer must visually inspect, or will cause to be visually inspected, a fair and representative sample of each shipment of Products for damage upon receipt of delivery from BN to determine in particular if there are any defective products and/or delivery shortages (the “Defect”). Customer will notify BN in writing of any Defect which was detected by the Customer at the visual inspection as soon as possible following inspection and in any event within five (5) business days of the date of delivery of the Products to Customer. Hidden Defects that are not detectable on a visual inspection must be notified to BN within five (5) business days after discovery.
Customer will cooperate with BN in determining the cause for the alleged Defect. BN will notify Customer in writing as promptly as reasonably possible but no later than within ten (10) business days from the receipt of a notice of rejection whether it accepts Customer’s rejection.
The Products are temperature sensitive and must constantly be handled and stored on or between plus two (+2) and plus eight (+8) degrees Celsius by Customer. Products not handled or stored by Customer, Customer’s affiliates and/or subcontractors, under these temperature conditions cannot be considered a Defect or defective. In case of doubt, Customer has the obligation to prove that the Products have been handled and stored in accordance with the terms and conditions of the Sales Contract.
If BN accepts Customer’s rejection, BN will, at BN’s election, either (i) replace such rejected Products free of charge as soon as possible but in any event within twenty (20) business days after acceptance by BN, (ii) refund the Customer the price of the rejected Products or (iii) repair/rectify the Defect or defective Products (if possible). Any other rights or remedies of Customer are explicitly excluded.
If BN accepts Customer’s rejection, at BN’s election and upon authorisation from BN to do so, Customer will either:
(A) destroy the rejected Products promptly and will provide BN with certification of such destruction; or
(B) return such rejected Products to BN at the BN’s cost, provided that such return is permissible by applicable law or regulations.
In no event must Customer return Products to BN without prior approval from BN.
If BN has not received notice from Customer that a Product is defective within 12 months from the delivery date, the Product is deemed accepted by Customer and BN shall not have no obligation to return, refund or repair/rectify any Products if the defect is first discovered by Customer after this date.
Other aspects on return handling are regulated in the BN return policy, available under www.bavarian-nordic.com/return-policy/europe.aspx
13. Subcontracting
Customer shall not be entitled to sub-contract its rights and obligations under the Sales Contract without the prior written consent of BN.
14. Liability
The maximum aggregate liability of each Party (and its affiliates) to the other Party (and its affiliates) cannot exceed the sum of the net Price of the Products ordered by the Customer in the last twelve (12) months preceding the liability event.
In no event will a Party be liable to the other party for any indirect or consequential damages of any kind (including, but not limited to loss of profits, loss of data or loss of use) even if the other Party has been advised of the possibility of such damages or losses save in the case of breaches of Clauses 7(iii) (Sale of Products), 20 (Confidentiality) and/or 30 (Data Protection).
The above limitations of liability shall not apply in case of (i) gross negligence or willful intent, (ii) fraudulent misrepresentation, (iii) bodily injury or (iv) inadmissibility of a limitation of liability due to mandatory legal provisions.
15. Indemnification
Customer hereby agrees to indemnify and hold BN and all officers, directors, employees and agents thereof harmless from any and all third party claims arising from (i) a material breach by Customer of the Sales Contract, any quality agreement or any quality procedures separately agreed between the Parties and/or (ii) the negligence or wilful misconduct of Customer; and which, in any case, is not otherwise attributable to (i) any breach by BN of the Sales Contract, any quality agreement or any quality procedures separately agreed between the Parties, or (ii) any negligent act or omission or wilful misconduct on the part of BN.
BN hereby agrees to indemnify and hold Customer and all officers, directors, employees and agents thereof harmless from all damages related to third party claims arising from (i) a material breach by BN of the Sales Contract, any quality agreement or any quality procedures separately agreed between the Parties, (ii) the manufacture of the Products; (iii) or the negligence or wilful misconduct of BN and which, in any case, are not otherwise attributable to (i) any breach by Customer of the Sales Contract, any quality agreement or any quality procedures separately agreed between the Parties, or (ii) any negligent act or omission or wilful misconduct on the part of Customer.
16. Insurance
Each Party shall from the Effective Date and six years thereafter maintain comprehensive general liability insurance coverage in line with its obligations under the Sales Contract and any obligations imposed by local laws, with a minimum limit of at least €5 million per claim or series of claims. Each Party shall provide the other with evidence of such insurance at the other Party’s request. A Party’s liability under the Sales Contract shall not be limited to the amount of any insurance coverage maintained by it.
17. Force Majeure
Failure of either Party to perform its obligations under the Sales Contract (other than of the obligations to make any payments or of confidentiality) shall not subject such Party to any liability or place them in breach of any term or condition of the Sales Contract to the other Party if such failure is caused by means of an event beyond the control of a Party (or any person acting on its behalf, like BN’s warehouse provider, Movianto), which by its nature could not have been foreseen by such Party (or such person), or, if it could have been foreseen, was unavoidable, and includes, without limitation, acts of God, storms, floods, riots, fires, sabotage, epidemics, pandemics, civil commotion or civil unrest, interference by civil or military authorities, acts of war (declared or undeclared) or armed hostilities or other national or international calamity or one or more acts of terrorism or failure of energy sources (“Force Majeure Event”). The corresponding obligations of the other Party will be suspended to the same extent. Any obligations of the affected Party will be extended for a period of time equal to the number of days of the delay, provided however, that in the event that such Party is unable to fulfil its obligations under the Sales Contract within sixty (60) days, either Party may terminate the Sales Contract on written notice.
18. Term and Termination Rights
Each of the Parties shall have the right to terminate the Sales Contract for cause with immediate effect upon giving written notice of termination to the other (the “Defaulting Party”) if the Defaulting Party commits a material breach of the Sales Contract which is incapable of remedy or which in the case of a breach capable of remedy shall not have been remedied within thirty (30) calendar days of the receipt by the Defaulting Party of a written notice from the other Party identifying the breach and requiring its remedy.
Either Party may also terminate the Sales Contract with immediate effect upon giving written notice if the other Party ceases to carry on business or goes into liquidation or becomes insolvent or if an encumbrancer takes possession of or a receiver is appointed with respect to any of the other Party’s assets or any other similar or equivalent action is taken against or by the other Party under any jurisdiction by reason of its insolvency or in consequence of debt.
Without prejudice to its other rights, BN has the right to terminate the Sales Contract by written notice to the Customer with immediate effect in the event that the Customer fails to make payment with respect to any Products supplied under or pursuant to the Sales Contract when such payment is due.
When an order has been accepted by BN, Customer cannot cancel this order. A party cannot terminate the Sales Contract except as set forth above in this Clause 18.
19. Effects of Termination
Upon the termination of the Sales Contract for any reason, unless otherwise instructed by BN:
(i) If BN so directs, the Customer shall return to BN all documents shared by BN relating to the Products, together with all copies of or extracts from that material in the possession or power of the Customer or, destroy or otherwise dispose of such documents in accordance with BN’s directions and at the expense of the Customer;
(ii) all outstanding invoices rendered by BN in respect of the Products shall become due and payable in accordance with the payment terms of the Sales Contract; and
(iii) the Customer shall cease to make any further use of any of BN’s intellectual property or any material relating to the Products.
The Customer shall have no claim against BN or any affiliate of BN for compensation for loss of distribution rights, loss of goodwill or similar loss.
The termination of the Sales Contract shall not relieve the Parties of any obligation accruing prior to such termination. Without limiting the foregoing, the obligations pursuant to Sections 9 (Disputes with Customers), 13 (Subcontracting), 14 (Liability), 15 (Indemnification), 16 (Insurance), 19 (Effects of Termination), 20 (Confidentiality), 23 (Assignment), 24 (Severability), 25 (Governing Law and Jurisdiction) as well as any other sections which according to its explicit wording or nature intends to survive termination of the Sales Contract, shall survive termination of the Sales Contract.
20. Confidentiality
Neither Party shall use for any other purpose than the performance of the Sales Contract or disclose to a third party any confidential and/or proprietary information received by it from the other Party pursuant to the Sales Contract, including without limitation information related to the Products, prices, their distribution, technology, research plans, business affairs and/or finances, including, any Know-How (the “Confidential Information”), without the prior written consent of the disclosing Party, from the Effective Date and for five years after termination. On termination of the Sales Contract for any reason, each Party shall return to the other Party any Confidential Information of the other Party held by it, or, at the other’s request, destroy such Confidential Information.
Nothing contained in this Section shall be construed to restrict the Parties from disclosing Confidential Information as required:
(i) for regulatory, tax, securities or customs reasons;
(ii) by law or court or other government order;
(iii) for confidential audit purposes; or
(iv) from using such Confidential Information as is reasonably necessary to perform acts permitted by the Sales Contract, including the registration or sale of the Products.
Notwithstanding anything contained in the Sales Contract to the contrary, the Parties shall not be liable for a disclosure of Confidential Information, if the information so disclosed:
(i) was in the public domain at the time of disclosure without breach of the Sales Contract; or
(ii) was known to or contained in the records of the recipient from a source other than the discloser at the time of disclosure, without breach of any confidentiality obligations, and can be so demonstrated; or
(iii) was independently developed by the recipient; or
(iv) becomes known to the recipient from a source other than the other party without breach of any confidentiality obligations by recipient and can be so demonstrated.
21. Pharmacovigilance
In the unlikely event Customer is informed of any safety information (defined as: any suspected adverse drug reactions (ADRs) and adverse events, suspected transmission of an infectious agent, lack of effect, abuse, misuse, medication error, overdose, off-label use, all the latter special scenarios refer to whether or not associated with adverse event, same for use of product during pregnancy or breastfeeding with or without any associated adverse event, product quality complaints (PQCs) (associated with potentially safety relevant information), any suspected counterfeit product, unexpected positive effects, occupational exposure), Customer is requested to forward the information as received via email to BN drug.safety@bavarian-nordic.com immediately and will advise the end user to report also all current and any further information to BN or the local health authority directly, as applicable. BN is responsible for the further follow-up of the obligations arising from the regulations on the reporting of adverse reactions and other safety information to the extent permitted by the laws in the Territory.
22. Entire Agreement and Inconsistency
The Sales Contract supersedes all prior and conflicting agreements or understandings, whether verbal or written, concerning the procurement of the Products. In particular, shall no Customer standard terms and conditions for purchase or supply or any such terms or conditions contained in Customer’s purchase order, acknowledgment or other form or correspondence be of any force or effect.
Notwithstanding the foregoing, any prior nondisclosure agreement or similar agreement shall remain in effect in accordance with its terms and applicable to information provided by the Parties prior to the Effective Date of the Sales Contract. Further, and not notwithstanding the foregoing, any quality agreement entered into between the Parties shall supersede over the Sales Contract with respect to technical and quality matters, but not on other matters. Further, and notwithstanding the foregoing, any pharmacovigilance agreement entered into between the Parties shall supersede over the Sales Contract with respect to pharmacovigilance matters, but not on other matters.
In case of conflicts or discrepancies between the English and German language versions of the Standard Terms and Conditions, the English language version prevails. In case of conflicts or discrepancies between the Standard Terms and Conditions and BN’s return policy, the Standard Terms and Conditions shall prevail.
23. Assignment
The Customer may not assign the Sales Contract nor any right or obligation hereunder, in whole or part, without the prior express written consent of BN. BN may assign the Sales Contract to (i) any affiliate or (ii) any successor by merger, de-merger or sale of substantially all of its assets.
24. Severability
If one or more of the provisions of the Sales Contract become void or unenforceable as a matter of law, then the Sales Contract shall be construed as if such provision were not contained herein and the remainder of the Sales Contract shall be in full force and effect, and the Parties will use their best efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.
25. Governing Law and Jurisdiction
The Sales Contract shall be governed by and construed under the substantive laws of Switzerland, to the exclusion of the UN Convention on Contracts for International Sale of Goods (CISG). Any disputes arising out of or relating to the Sales Contract shall be subject to the exclusive jurisdiction of the courts of Zug, Switzerland.
26. Relationship between the Parties
Customer is an independent buyer with respect to BN and nothing in the Sales Contract will be construed to create a partnership, joint venture or employment relationship between the Parties. Neither Party has the authority to bind the other to any commitment whatsoever, and the Parties agree they will not hold themselves out to third parties as having authority to do so. Particularly, Customer shall not represent itself as an agent of BN for any purpose, nor pledge BN’s credit or give any condition or warranty or make any representation on the BN’s behalf or commit BN to any contract, agreement or obligation.
27. Waivers and Amendments
The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of the Sales Contract shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver.
BN may amend these Standard Terms and Conditions at any time. BN shall communicate such modifications in advance in an appropriate manner. In case of ongoing contractual relationships, e.g. call orders, the amendments shall be deemed to have been accepted by the Customer if no objection is raised in writing within one month of notification.
In addition, provisions of these Standard Terms and Conditions may be amended regarding a specific Purchase Order, but only, if the Purchase Order and order confirmation (or a written document signed by authorized representatives of each Party) explicitly state (i) which provision of the Standard Terms and Conditions shall be amended and (ii) the new amended wording.
28. Publicity
The Customer shall not make any statement to the public regarding the execution or the subject matter of the Sales Contract without the prior written consent of BN except to the extent required by any applicable law, including disclosures required by any securities exchange regulation.
29. Notifications
Where the Sales Contract provides for a notification to be made in writing, such form shall be deemed to be complied with in case of a communication in text form in a letter, e-mail or another customary form of electronic transmission, unless the signature of one or more Parties is explicitly required.
30. Data Protection
Each Party shall be considered an independent controller according to data protection law of the personal data it may process under the Sales Contract, which include personal data a Party may receive from or have access to at the other Party (like work contact details of the BN contact person). Neither Party shall be considered data processor of the other. Each Party shall process such personal data in accordance with applicable data protection regulations.