- Objectives
- These terms and conditions (the “Terms and Conditions”) will apply to any sale of Products and/or services by Neovii Pharmaceuticals AG, a Swiss limited liability company (AG), having its head offices at Zürcherstrasse 19, 8640 Rapperswil SG, Switzerland (“Neovii”) to a purchaser (the “Client”), subject to any variations agreed in writing between the Parties.
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Definitions
- “Adverse Event”: Any undesirable event experienced by a patient whilst taking the Products, regardless of whether or not the Products is suspected to be related to the event. For purposes hereof Adverse Events include medication errors, administration overdose, and Products misuse/abuse.
- “Complaints” means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the Products after it is released for distribution, including information relating to potential tampering, adulteration and counterfeiting.
- “Losses” means all losses, claims, charges, fines, liabilities, costs (including but not limited to attorney and experts’ fees and legal costs), settlements, judgements, fees, expenses and damages of any nature whatsoever and whether or not reasonably foreseeable or avoidable;
- “Products and Services Tax” means any tax, customs, levies, duties, fees, deductions, withholdings and charges including any additional tax imposed on the supply of, or payment for, Products or services, imposed or assessed under any applicable law and its related legislation;
- “Product Information” means any information relating to:
- the death, serious injury or illness of a person that may have been caused by the use or misuse of Products (a serious injury or illness includes any acute physical injury or illness requiring medical or surgical treatment by, or under the supervision of, a doctor or nurse); or
- human health and/or wellbeing arising following exposure of humans to Products. Examples include, but are not limited to, Adverse Event information, reports of patients taking Products whilst pregnant, reports of drug abuse or overdose, reports of drug interaction, information received as part of Products complaints, as well as information regarding unexpected therapeutic benefits (i.e. an unexpected improvement in a concurrent condition other than the one being treated);
- Neovii and the Client are each referred to individually as a “Party” and collectivity as the “Parties”.
- “Products” means Neovii’s product listed on Appendix 1 hereto.
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Acceptance of Orders
- The Client shall place an order with us for the Products (an “Order”) in accordance with this clause 3. An Order shall be treated as an offer by the Client to contract with Neovii, but shall not be binding until accepted by Neovii. Neovii may, at its sole discretion, accept or reject the Order. Failure to provide such confirmation should not be deemed acceptance of the Order.
- Client’s commercial terms that have not been explicitly accepted by Neovii in writing shall be void even if Neovii has not explicitly rejected such commercial terms. Any contract between the Parties shall be effective only upon Neovii’s written confirmation or delivery of the Products.
- Unless agreed otherwise in writing, Neovii shall deliver each Order in accordance with clause 7 (“Delivery”). Time shall not be of the essence in respect of Delivery.
- Neovii will only supply restricted medicines where Client holds the appropriate license to purchase such Products. Client agrees to submit to Neovii such license prior to any purchase of the Products or upon written request.
- Orders of Products with a value of less than Euro €5,000 will not be accepted.
- A minimum order of Products of a value of not less than €5,000 may be placed no more than once a calendar quarter.
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Price
- Orders from Client for the Products, or services ordered will be supplied by Neovii at a price which Neovii shall establish from time to time, and:
- is inclusive of the costs of Delivery; and may be increased if Neovii incurs higher freight, insurance or import charges or higher foreign exchange costs after the order is placed, or if Neovii incurs extra costs because of an increase of the German CPI or PPI or if Client did not provide us with information by the time Neovii required; and
- is exclusive of any Products and Services Tax. Client shall indemnify Neovii and hold Neovii harmless from all claims and liability arising from Client’s failure to support or pay any such Products and Services Tax.
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Payment
- Payment for Products or services supplied by Neovii to Client must be received by Neovii in cleared funds prior to the supply by Neovii of the Products or services to Client, unless otherwise agreed in writing, in which case such agreed terms shall apply, including the terms set out in the invoice rendered by Neovii to Client. Client. A failure to comply with this clause 5 is deemed a material breach of these Terms and Conditions by Client.
- Neovii may at its discretion demand immediate settlement of credit accounts, should the balance of the account exceed Client’s normal trading terms.
- If Client does not pay Neovii on the due date for payment in accordance with clauses 5.1 or 5.2, Neovii will be entitled to any one or more of the following:
- withdraw account facilities offered to Client at any time without prejudice to any other right Neovii may have and without being liable for the consequences. If Neovii so act then Client must immediately pay the account balance in full in cleared funds;
- charge Client interest on all late payments (calculated on a daily basis) at a rate of eight per cent (8%) per annum above the European Central Bank base rate from time to time;
- treat the contract as having been cancelled by Client;
- recover from Client (as a debt owing to Neovii) all costs incurred by Neovii in recovering any monies owing by Client to Neovii, including all legal expenses (on a client/solicitor basis), debt collection costs, administration charges, and/or collection fees as the case may be, including charges for dishonored cheques;
- charge Client the standard list price for the Products or services, where those Products or services supplied to Client were supplied at a discounted price.
- If Neovii reasonably believes that Client will not pay any monies owing to Neovii for any reason, then Neovii may demand from Client:
- payment in full of any monies owing to Neovii; and
- that Client provide Neovii with adequate collateral to secure the payment of all monies owing to Neovii before Neovii commences, or continues to deliver Products or services to Client.
- Neovii may in its discretion apply any payments Neovii receives from Client towards any indebtedness Client may have with Neovii. Neovii is not bound by any conditions or qualifications that Client may make in relation to any payments made to Neovii.
- Client may not withhold payment, or make deductions on account of any Products or services, which Client claims to be defective or incomplete. Client will make all payments to Neovii without set-off or counter claim and without deduction of any charges, fees or taxes.
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Title and Risk
- Risk and Ownership
- Risk of any loss, damage or deterioration of, or to, the Products passes to Client on the sooner of Delivery to the delivery point (pursuant to clause 7.1), or Delivery into Client’s control.
- Ownership of the Products remains with Neovii and does not pass to Client until you:
- a) have paid all sums owing to Neovii on any account whatsoever; or
- b) resell the Products pursuant to the authority granted by these Terms and Conditions.
- While ownership of the Products remains with us:
- Client must take proper care of the Products including store the Products in accordance with any instructions Neovii have provided;
- Client must keep the Products free from any charge, lien or other encumbrance and store them separately and clearly identify them as belonging to us; and
- hold the proceeds of any claim on an insurance policy in trust for Neovii and Client shall forthwith account to Neovii for such proceeds.
- Neovii authorizes Client, in the ordinary course of Client’s business, to sell the Products, subject to any written conditions (including territorial scope) agreed between the Parties. This authority is revoked immediately if:
- payment is not made when it is due; or
- Neovii notifies Client in writing that this authority is revoked.
- Client must advise Neovii immediately of any action by a third party (or any of its creditors) affecting Neovii’s interest in the Products.
- Client grant an irrevocable license to Neovii and our directors, officers, employees and agents, to at any time enter any premises upon which Neovii’s Products are stored, to enable Neovii to inspect the Products and reclaim the Products to which Neovii have retained title where Client is in breach of the Agreement.
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Delivery
- Neovii will deliver an accepted Order of the Products Ex Works Neovii’s manufacturing or storage facility (Incoterms 2020). Neovii in coordination with the Client may choose to facilitate the transportation and freight of said the Order to Client by whatever method and route Neovii considers to be the most expedient, at Client’s cost.
- Products are deemed delivered properly when made available by Neovii in accordance with the Incoterm EXW. All risk in and responsibility for insuring Products supplied by Neovii will pass to Client upon delivery. Client must insure the Products at Client’s own cost from the time the Products are deemed properly delivered until they are paid for in full, against usual risks. Client must note our interest on the insurance policy and produce a certificate to this effect to Neovii on request.
- Where Client requires Neovii to freight the Products to Client urgently, or in a manner which is not usually used by Neovii, Neovii reserves the right to charge Client for any additional freighting expenses incurred.
- If Client has specified a delivery date for an accepted Order, Neovii will try and deliver the Products or services to Client by that date. However:
- Neovii will determine the days and times for the delivery of the Products or services. Any time stated for delivery is an estimate only and Neovii is not liable for any delay. Neovii will be entitled to cancel the contract without being liable to Client in any way if the delay in delivery is in respect of causes outside of our reasonable control.
- Neovii may deliver the Products or services to Client by instalments in any quantities and each delivery will be by separate contract independent from the other deliveries.
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Cold Chain Products
- Client must process, ship, warehouse and distribute the Products pursuant to the instructions set forth in Appendix 3. Failure to comply with this clause 8 will render Client solely liable for any defect in those Products.
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Product Issue Reporting
- Client must notify Neovii by telephone (immediately followed by written confirmation) or facsimile transmission, immediately after Client becomes aware of any information (whether credible or otherwise) that may give rise to a concern regarding the quality of the Products or a recall of the Products.
- Without limiting clause 9.1, Client must notify Neovii as soon as is practicable after Client become aware of any adverse publicity or threatened or pending legal proceedings with respect to the Products or of any other information that might adversely impact upon the goodwill associated with Neovii or the Products.
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Reporting Of Complaints, Adverse Events and Suspected Counterfeit Products
- Client will report Adverse Events to Neovii to Drugsafety@neovii.com within 24 hours of initial awareness.
- Client will report any Complaints as well as Product Information or suspect counterfeit Products to Neovii’s qualified person on +41 89888811 (during business hours: Monday to Thursday 8:30 a.m. to 16:00 p.m. and Friday 8:30 a.m. to 15:00 p.m.) and qp@neovii.com within 24 hours of initial awareness. Complaint samples if available must be securely retained and provided to Neovii in Germany upon request.
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Contracts With Client’s Customers
- Client agrees that Client will include the above clauses 8, 9, 10 and 17 in any contract for the sale of the Products that Client enters into with any purchaser who is not the end consumer of the Products.
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Product Recall
- Client will fully and promptly cooperate with all recalls, withdrawals and retrievals of the Products and related materials.
- Any decision relating to a recall of the Products (including any decision relating to the initiation or implementation of strategy relating to a recall of the Products) will be made at Neovii’s discretion, unless otherwise directed by a relevant regulatory authority. Client must not initiate, implement or take any action in relation to a recall of the Products without Neovii’s prior consent.
- The Client’s obligations
- Client must maintain procedures relating to a withdrawal of the Products, recall and tampering, and records necessary to support a recall of the Products, and allow Neovii to inspect those procedures and records at any time on reasonable notice.
- Client must provide any services, resources or facilities to Neovii as may be reasonably required in respect of a recall of the Products.
- Reimbursement of recall costs
- Client’s reasonable costs incurred, in connection with the recall of any Products will be borne by Neovii, except where Client’s conduct or that of Client’s employees, contractors, customers or other persons Client have engaged, has given rise to the recall of the Products (in which case the reasonable costs incurred by Neovii in connection with the recall of the Products will be borne by Client).
- To the extent that a Party pays costs in connection with the recall of any Products for which the other is responsible under clause 12.4.1, the other Party must, after receiving a written request together with sufficient evidence to substantiate the request for reimbursement, reimburse the first Party within seven days.
- Failure to comply with this clause 12 shall be considered a material breach of these Terms and Conditions..
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Exclusions and Limitations To Our Liability
- Nothing in these Terms and Conditions shall limit either Party’s liability in respect of (i) any claim for death or personal injury caused by the negligence of that Party; (ii) fraud or fraudulent misrepresentation; (iii) any other liability which may not be limited or excluded at law.
- Subject to clause 13.1, in no event will Neovii’s total cumulative liability in any calendar year arising out of or in relation to these Terms and Conditions, whether in contract or tort (including negligence), exceed the sum of the price paid by Client or invoiced by Neovii to Client for the Products in that calendar year during which the cause of action for such claim first arises.
- In no event shall Neovii shall have any liability under these Terms and Conditions to Client or any third party under any contract, negligence, strict liability or other legal or equitable theory for (i) any special, consequential, punitive, incidental, reputational damages, indirect or consequential Losses; (ii) any loss of profits, business, income, earning or opportunity (whether direct or indirect); (iii) for any costs of procurement of substitute goods, and (iv) any Losses whatsoever arising from Client’s act(s) or omission(s). Neovii shall not be liable to Client or any other party for any Losses caused by failure to make shipment on any order or contract or for delay in delivery of any Product. These limitations shall apply notwithstanding any failure of essential purpose of any limited remedy provided herein or in the warranty found in the Products.
- Neovii will not be bound by any representations that Neovii makes unless they are in writing and provided by an authorized officer.
- Neovii gives all technical advice or assistance entirely at Client’s risk.
- Neovii warrants only that the Products comply with Neovii’s specifications where Neovii is the manufacturer, or that they comply with the manufacturer’s specifications where Neovii is not the manufacturer.
- All descriptions of the Products are only to enable their identification and do not mean that the sale of the Products is a sale by description.
- Neovii warrants to Client that on deemed Delivery of the Products to Client, the Products are free from manufacturing defects. Client shall inspect Product prior to Delivery and once accepted shall be deemed to be satisfactory to Client and free from defects, unless Clients shall notify Neovii of any defects immediately on inspection of Products and no later than within 3 days of Delivery.
- To the extent permitted by law, our liability, if any, arising from a breach of or otherwise under these Terms and Conditions, is at our option, limited to and completely discharged:
- in the case of defected Products proven to Neovii’s satisfaction, by either;
- the supply by Neovii of equivalent Products; or
- the replacement by Neovii of the Products supplied to Client; or
- the payment of the cost of replacing the Products or of acquiring equivalent Products; and
- in the case of advice, recommendation(s), information or services, by either:
- supplying the advice, recommendation(s) information or services again; or
- the payment of the cost of having the advice, recommendation(s) information or services supplied again.
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Claims
- Neovii will, at its option, replace or give a credit to Client for any Products which are proven to Neovii’s satisfaction to contain a manufacturing defect, if:
- Client advises Neovii of Client’s claim within 3 days of receiving the Products, quoting the dispatch number and/or invoice number where appropriate.
- Client’s claim identifies the manufacturing defect, and the nature of Client’s claim;
- Client’s claim is accompanied by a specimen of the Products, prior to returning the Products to us;
- Client obtains a Returns Number from Neovii, prior to returning the Products to us; and
- the Products are returned to Neovii in the same condition in which they were received by Client.
- If Client disputes any item or amount contained in any invoice, Client must advise Neovii of such a claim within seven days after receipt of that invoice. If Client fails to give Neovii such notice Client will be deemed to have accepted the contents of the respective invoice.
- Except as set out in this clause and clause 16 (Return of Products), to the extent permitted by law, the Products or services are deemed to have been accepted “as is” by Client, and Client must pay for the Products or services in accordance with these Terms and Conditions. In this case, Client will be taken to have waived any claim Client may have had against Neovii.
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Credit Information
- Neovii may disclose any information contained in Client’s credit application to a credit reporting agency and Neovii may obtain a credit report containing personal credit information about Client (or any of Client’s partners or directors if Neovii considers it relevant to determine whether to supply Client with Products or services on credit, or to collect unpaid accounts from you) in accordance with the provisions of the Consumer Credit Act 1974.
- Neovii may obtain from a credit reporting agency a credit report concerning Client’s credit information if Neovii considers it relevant to determine whether to supply Client with Products on credit, or to collect unpaid accounts from Client.
- Neovii may provide any third party with credit information about Client when requested and report any overdue payments Client owe to Neovii to other credit providers or credit reporting agencies.
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Return of Products
- Products are not sold on a sale or return basis.
- Except as set out in clause 12 (Product Recall), Neovii will provide Client with credit for Products only where Products have been sent to Client in error, or in excess of the written order.
- All Products supplied within 6 months of the specified expiry date for those Products will be accompanied by a notice to this effect. These Products may be returned for replacement if not sold before the specified expiry date, subject to our right to accept or reject any Products returned to us.
- Neovii will, at its option, replace or give a credit to Client for Products which Client has incorrectly or mistakenly ordered if the Products are:
- returned within 7 days of the date of the invoice for the Products (if applicable);
- in good condition and fit for resale;
- Client obtains a Returns Number from Neovii, prior to returning the Products to us; and
- the Products are returned to Neovii in the same condition in which they were received by Client.
- Neovii reserves the right to only accept returns if the Products are valued at Euro 5.000 or greater.
- Any returns of the Products must always be made with our prior written consent. Neovii reserves the right to destroy, at Client’s expense, any unsolicited returned Products.
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Storage and Packaging
- The Products are supplied to Client for sale to the end-user of the Products in the packaging in which the Products are supplied to Client within the Client’s resident state or country. Client must not interfere with, or alter, the original packages insofar as they set out our marks, numbers, references and other information as this may disadvantage or mislead the end-users of the Products.
- Client is obliged to return to Neovii any containers and refrigeration units which are delivered to Client by Neovii with the Products. The containers shall not be used by Client for storing any other products.
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Intellectual Property and Proprietary Information
- All our trade-marks or other intellectual property rights in respect of the Products or services remain our property, and Client must not in any way interfere with, alter or infringe upon our intellectual property rights relative to our “trade-marks”, “trade dress” or “get-up” associated with the Products or services.
- Client must consult Neovii as to the proper use of our intellectual property whenever Client are going to use our intellectual property.
- All advertising materials supplied to Client for Client’s business use, and not for dissemination to the end-user of the Products or services, remains Neovii’s property, and Client will return it to Neovii immediately upon our request to do so.
- All documents, procedural manuals, know-how, training materials, guides, specifications, plans, drawings, designs, copyrights, service marks and trademark rights, computer programs, program descriptions and similar materials, lists of present, past or prospective customers, proposals, marketing and public relations materials, invitations to submit proposals, fee schedules and data relating to customers and the pricing of the Products and services, records, notebooks and similar repositories of or containing confidential information and inventions (including all copies thereof) (“Proprietary Information”): (a) are the property of the disclosing party, (b) will not be used by the recipient party in any way adverse to the disclosing party and/or in breach of Clause 18.5, (c) will not be removed from the disclosing party’s premises (except as may be permitted by the disclosing party) and (d) at the termination of the Agreement will be left with, or forthwith returned and/or restored to the disclosing party, and the recipient party shall discontinue use of such materials. For purposes of this Clause 18.4, the term “recipient party” includes any owner, agent, independent contractor or employee of the party.
- Each party agrees to hold the Proprietary Information of the other party and its affiliates in the strictest confidence and not to disclose it or allow it to be disclosed, directly or indirectly, to any person or entity other than those persons or entities who are employed by or affiliated with the party owning such Proprietary Information, without such party’s prior written consent or except as otherwise set forth in this Clause 18.5. Each party acknowledges its fiduciary obligations to the other party and their respective affiliates and the confidentiality of their relationship with the other party and of any Proprietary Information which any of them may obtain from another party. No party shall at any time, disclose to anyone (other than employees or independent contractors engaged by any of the parties in connection with carrying out the Agreement) any Proprietary Information obtained by any of them from another party or any of its affiliates. Each of the parties further agrees to place any persons not otherwise employed by it or its affiliates and to whom such information is disclosed for the purpose of their performance of services for Client under a legal obligation to treat such Proprietary Information as strictly confidential.
- The obligations under Clause 18.5 above shall not apply to such Proprietary Information which is or becomes generally available to the public other than as a result of a disclosure by the receiving party, or by any other person who obtained or gained access to such Proprietary Information (whether or not authorized) from or through the receiving party. In the event that a party becomes legally compelled to disclose any of such Proprietary Information, such party will provide the other party with prompt notice where it is legally able to do so and shall provide reasonable assistance if the other party seeks a protective order or other remedy. In the event that such protective order or other remedy is not obtained, the party under a legal obligation to disclose will disclose only that portion of such Proprietary Information which such party is advised by written opinion of counsel is legally required and will use best efforts to obtain a protective order or other reasonable assurance that such Proprietary Information will be treated confidentially.
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Limitation On Sale
- Client may not sell on, use or dispose of the Products or services otherwise than in accordance with the Agreement and all applicable laws and regulations.
- The Products are suitable for “dispensing purposes only” on a medical practitioner’s prescription and may not be sold on without such a prescription.
- In the event that Client breach clauses 19.1 or 19.2, Neovii may at its discretion defer supplying Client with any more Products or services on credit or otherwise, and may cancel any contract for the supply of Products or services to Client.
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Anti-Bribery and Corruption
- Client agrees to perform Client’s obligations under the Agreement in compliance with the Anti-Bribery and Corruption Provisions and Anti-Corruption Policy (as set out in Appendix 2) and as updated, replaced or amended.
- Neovii shall be entitled to terminate any business relationship with Client immediately on written notice to Client, if Client fails to perform Client’s obligations in accordance with these Terms and Conditions. Client shall have no claim against Neovii for compensation for any loss of whatever nature by virtue of the termination of the Agreement in accordance with this clause. To the extent (and only to the extent) that the laws of the countries where Client conducts its business with Neovii and where Client conducts its business provide for any such compensation to be paid to Client upon the termination of the Agreement, Client hereby expressly agrees to waive (to the extent possible under the applicable laws) or to repay to Neovii any such compensation.
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Indemnity
- Client indemnifies Neovii and its affiliates against all Losses and liabilities, whether direct or indirect, incurred by Neovii and its affiliates in relation to or arising in connection with a default or breach of any agreement by Client, or Client’s directors, officers, employees or agents.
- Where a Client is a limited liability company, then Neovii reserves the right to require a guarantee and indemnity (in a form and for an amount satisfactory to us) from the directors of that company, such guarantee and indemnity to be current for the term of any intended transaction under these Terms and Conditions.
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Insurance
- Client declares that it has subscribed to a product liability insurance policy covering its legal liability with respect to any loss or damage caused as a result of and/or in connection with the Agreement and that Client shall provide the corresponding updated certificate of insurance upon our first request. This certificate shall mention at least the nature and the amounts of the warranties subscribed.
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Termination for Cause
- Any transaction or agreement subject to these Terms and Conditions may be terminated by Neovii for material breach by Client within fifteen (15) days after receipt of a written termination notice, without prejudice to the Neovii’s right to claim any Losses for the default or the breach hereof.
- A material breach of such transaction or agreement is deemed to occur if Client become bankrupt or insolvent or are unable to pay Client’s debts as they fall due, or enter any form or administration or receivership and Neovii may terminate such agreement with immediate effect in any such event.
- These Terms and Conditions shall terminate automatically in the event such agreement terminates.
- If Neovii terminates such agreement, Neovii reserves the right to fulfill any outstanding Orders which were placed prior to termination.
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Warranty
- Client (and any of Client’s partners or directors) warrants that: Client will comply with all applicable laws and regulations; Client (or he or she), is authorized to enter into the Agreement and purchase the Products from Neovii and hold all legally required licenses, permits authorizations to receive, handle and sell the Products and; Client has never gone into liquidation or administration, or had a receiver or administrator appointed, or been declared bankrupt, or been a director of a company which has gone into liquidation, or had a receiver or administrator appointed.
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Miscellaneous
- Applicable Laws. Client shall comply fully at all times with all applicable laws (which shall include all regional, national and international law, rules, regulations and standards including those imposed by any governmental or regulatory authority (including but not limited to applicable anti-corruption laws) and all applicable industry standards and standards determined by any self-regulatory body which apply from time to time to the person or activity in the circumstances in question);
- Entire Agreement. These Terms and Conditions (and any documents referred to in it) constitutes the entire agreement between the Parties with respect to the subject matter of it and supersedes all prior agreements and understandings of the Parties.
- Amendments. Neovii may amend these Terms and Conditions at any time as shall be provided on its website or by providing to Client. Client’s continued purchase of Products and/or services after such notification will evidence Client’s consent to such amendment.
- Severability. If any provision or part of these Terms and Conditions are determined to be invalid, illegal or unenforceable, then that provision will, to the extent required, be given no effect and will be treated as though it were not included in these Terms and Conditions without, as far as is possible, modifying any other clause or part of these Terms and Conditions and the validity or enforceability of the remaining provisions of these Terms and Conditions will not be affected.
- Remedies; Waiver. All rights and remedies existing under these Terms and Conditions are cumulative to, and not exclusive of, any rights or remedies otherwise available under applicable law unless otherwise stipulated. No failure or delay on the part of any Party to exercise any right, power or remedy hereunder shall be deemed a waiver of that right.
- Relationship of the Parties. Nothing in these Terms and Conditions shall constitute a partnership, a joint venture, or the relationship of principal and agent between the parties and neither party has authority or power to bind the other in any way.
- Operations and Expenses. Client’s detailed operations under these Terms and Conditions are subject to Client’s sole control and management. Client shall be responsible for all of Client’s own expenses and employees. Client shall provide, at Client’s own expense, such office space and facilities, and hire and train such personnel as may be required to carry out Client’s obligations under the Agreement. Client agrees that it shall incur no expense chargeable to Neovii, except as may be specifically authorized by Neovii in advance in writing.
- Assignment. The Client may not assign, license or otherwise transfer any obligations or rights or delegate the performance under these Terms and Conditions without Neovii’s prior written consent. A Party’s successors and permitted assigns will be bound by these Terms and Conditions.
- Publicity. The Client will not issue a press release, publicity statement, news release or other public announcement relating to the transactions or purchase of Products or services from Neovii without Neovii’s prior written consent, other than to comply with applicable laws, rules or regulations solely to the extent such disclosure is required to comply with under any applicable jurisdiction and conditioned upon providing Neovii with a prior written notice.
- Dispute Resolution. The parties shall settle any disputes arising out of or in connection with the Agreement under the Rules of Arbitration of the International Chamber of Commerce in accordance with the said Rules. The number of arbitrators shall be three (3). The seat of the arbitration shall be Zurich. The arbitral proceedings shall be conducted in English. Article 29 of the ICC Rules (Emergency Arbitrator) shall not apply. Notwithstanding the above, Neovii, but not Client, shall be entitled, at our sole discretion, to instigate legal proceedings against Client with either the competent courts at Client’s seat or, if different, the courts of England and Wales.
- Governing Law. These Terms and Conditions (and any other documents that the Parties enter into under it that are not expressly governed by another law) and all non-contractual obligations arising in any way whatsoever out of or in connection with these Terms and Conditions shall be governed by and construed in accordance with the laws of England and Wales without considering any conflict of law provisions therein. The Parties hereby expressly disclaim the applicability of the International Convention on the Sale of Products to the Agreement, and it shall not apply to the Agreement.
- Force Majeure. A Party will promptly notify the other Party if its performance of its obligations under these Terms and Conditions is prevented or delayed by any cause beyond its reasonable control, including but not limited to earthquake, fire, flood, storm, other acts of nature, explosion, strikes or other labor unrests, embargoes, delays in transportation, and liability to obtain necessary labor, supplies, or manufacturing facilities, as well as war, embargo or other governmental actions or regulations that would prohibit or limit either Party from furnishing or manufacturing Products or from performing any other aspects of the obligations hereunder, civil strife, terrorism, transportation shortage or delay, breakage of machinery or inability to manufacture Products, including but not limited to obtaining fuel, raw materials, labor or containers to manufacture Products directly or by its service providers. On giving the notice, the Party will be excused from performance of the affected obligation(s) for the duration of the cause, provided, that it uses and continues to use commercially reasonable efforts to overcome that cause.
- Language. These Terms and Conditions have been prepared in English, and the English language version thereof shall prevail and be binding over any other translation into any other language.
- Appendix. All Appendixes hereto shall be deemed to be incorporated herein by reference and constitute an integral part of these Terms and Conditions. To the extent any terms or provisions of an Appendix conflict with the terms and provisions of these Terms and Conditions, the terms and provisions of these Terms and Conditions shall control, except to the extent that the applicable Appendix expressly and specifically states an intent to supersede the Terms and Conditions on a specific matter.
- Captions and Headings. The descriptive headings of the clauses and headings of these Terms and Conditions are for convenience only and do not constitute a part of these Terms and Conditions.
APPENDIX 1
Product Description
Product: Neovii’s proprietary medicinal product known as Grafalon (previously known as ATG-Fresenius-S).
Unit of Product: 20mg/ml sterile concentrate 5ml x 1 vial
Minimum Number of Units per Order – 100 vials or as otherwise agreed by Neovii in writing
Packaging depends on distance and ambient temperature
APPENDIX 2
Anti-Bribery and Corruption Provisions
- Client will not, and will ensure that any Party acting for Client or on Client’s behalf handling the Products sold to Client by Neovii do not, make any payment, contribution or gift to any governmental official, hospital, medical insurance company or similar provider organization, customer or other person (including, without limitation, any payoff, influence payment, bribe, rebate or kickback) for the purpose of obtaining or paying for registration of the Products, regulatory approvals, medical reimbursement coverage, favorable treatment in securing or maintaining business or any other special concession. Client (including any Party acting for Client or on Client’s behalf) will provide Neovii with written certification of its compliance with Section (a) on an annual basis or as requested by Neovii.
- Client acknowledge and agree that there are anti-corruption laws, including the Anti-Corruption Statutes, to which Client, Neovii or Neovii’s Affiliates are subject which prohibit the direct or indirect, offering, promising, or giving of any advantage, or thing of value, to a person (including private individuals or government employees or officials) for the purposes of obtaining or retaining business, or to intend to induce any improper act or decision.
- Client agree to refrain from, and to procure that Client’s representatives refrain from, any activity in connection with the Agreement that would constitute a violation by Client, Neovii or their affiliates of an Anti-Corruption Statute and/or Neovii’s Anti-Corruption Policy as outlined in this Appendix 2 hereunder and as updated, replaced or amended (the “Anti-Corruption Policy”).
- Client agree to cooperate fully and procure cooperation with any audit or inspection by a governmental or judicial authority that Neovii or its affiliates or their contractors, or representatives may become the subject of under any applicable Anti-Corruption Statutes. Such cooperation includes the provision of any information and records that are required as part of such audit or inspection.
- Client acknowledge and agree that the compensation provided under the Agreement constitutes fair market value for the performance of the Agreement and that no part of the payments hereunder shall be paid to or shared with, directly or indirectly, any government or political Party official for any purpose described as prohibited in section (a) above.
- Client agree that neither Client nor Client’s representatives, officers, or any Party acting for Client or on Client’s behalf is an employee of a foreign government nor a candidate for a foreign public office, and Client agree to inform Neovii immediately if any such Party becomes a foreign government official during the term of the Agreement.
Anti-Corruption Policy
Anti-corruption laws, including the US Export Administration Act, the US Anti-Boycott regulations, the UK’s Public Bodies Corrupt Practices Act, the UK’s Prevention of Corruption Act, the UK’s Bribery Act 2010 (“Bribery Act”), the OECD Anti-Bribery Convention, the Organization for Economic Cooperation and Development’s Convention on Combating Bribery of Foreign Public Officials in International Business Transactions (all as updated, replaced or amended) and any additional and equivalent local or multi-national legislation, regulations and guidelines (together, the “Anti-Corruption Statutes”), prohibit international businesses, such as Neovii Pharmaceuticals AG (“Neovii”), from making payments or promising to make payments, directly or indirectly, to foreign officials for the purpose of receiving favorable treatment to obtain or retain business. As a developer of innovative therapeutics to serve unmet medical needs in areas of life-threatening disease, Neovii helps to serve public health in all the territories where its Products are available. Consequently, decisions concerning the approval, pricing and prescription of those Neovii Products must be made solely on the basis of their clinical profiles of safety and efficacy. There is no room for improper or inappropriate influence in those decisions.
For this reason, and because Neovii may also find itself liable under these Anti-Corruption Statutes for prohibited payments made on Neovii’s behalf, Neovii requires all its employees and any third party acting for or on behalf of Neovii to ensure that all dealings with third parties, both in the private and government sectors, are carried out in compliance with all relevant laws and regulations and with the standards of integrity required for all Neovii business including that payments are not made or promised to government officials, if the payments could influence such officials for Neovii’s benefit. Prohibited payments are not limited to cash; they include payments of anything of value or provisions of favors that result in improper influence. Violations of these Anti-Corruption Statutes, even if unintentional, may result in severe penalties to Neovii and can, in some situations, result in fines and penalties to Neovii’s officers and its Board of Directors. Given these serioNeovii fines and penalties, employees and others acting on Neovii’s behalf, who violate these Anti-Corruption Statutes, will be terminated, and may also be subject to prosecution under the relevant law. Neovii values integrity and transparency and has zero tolerance for corrupt activities of any kind, whether committed by Neovii employees, officers, or third-Parties acting for or on behalf of the Neovii.
Policy Statement
The use of Neovii’s funds for any unlawful or unethical purpose is strictly prohibited. Employees and others acting on Neovii’s behalf or associated with Neovii’s Products, including Client and any Party acting for Client or on Client’s behalf, may not offer, give, or cause others to give bribes, kickbacks or illegal payments to advance, promote, expedite or influence Neovii’s business. Such payments include money, favors or costly entertainment gifts. Specifically, Anti-Corruption Statutes prohibit the giving of such payments or favors to foreign officials for the purpose of influencing a foreign government. These laws impose strict record keeping requirements on companies, requiring that all payments and disbursements be recorded to ensure funds are not dispensed for these purposes. Violations are punishable by fines and imprisonment. Neovii will use its best efforts to ensure that third parties comply with these laws when doing business with Neovii. This policy does not prohibit the offering of reasonable and customary business meals or customary entertainment to governmental officials, although care should be taken to ensure that such meals or entertainment are in compliance with applicable laws and government policies.
Additional Guidance Regarding Policy
- Foreign Official. A “foreign official” means any officer or employee of a foreign government, public organization, public institution, or any other organization or institution that regulates, or governs Neovii’s ability to do business in a country. This also includes government-owned businesses and healthcare providers and reimbursement agencies, political Parties, quasi-governmental agencies and any organization that acts on behalf of a government. If Client have any questions regarding whether or not a person is a foreign official, please contact Neovii who will assist Client in that determination.
- “Reasonable and Customary” Business Meals and Entertainment. It can often be difficult to determine whether or not an expense for meals and entertainment is “reasonable and customary.” In all cases, Client will need to use Client’s good judgment. To help Client in this determination, Client should refer to the following guidelines:
- The purpose of these meals and entertainment should be to help maintain good working relationships and communication with these officials. Meals and entertainment should never be extravagant and should not be offered in circumstances when it could be perceived as a means of inducing any particular action by an official.
- The total amount spent on these meals and entertainment should not be excessive.
- All employees should follow local laws, as well as the specific policies, procedures and guidelines of their own companies and operating units regarding approvals and reporting of such meals and entertainment.
- Gifts. Our general policy is not to provide any gifts or favors to government officials. This does not preclude the giving of gifts that are of nominal value and are given in accordance with local laws and cultural traditions, so long as they are not given for the purpose of inducing any particular action by the recipient.
APPENDIX 3
Instructions for Packaging /Shipping /Warehousing /Distribution of the Products
When packaging, shipping, warehousing and distributing Products that are classified as a medicinal products, it is mandatory that the Products are kept at temperatures between +2°C and +8°C.
Freezing must be prevented under all circumstances because Products which have or might have been frozen may not be applied to patients and must be destroyed after having consulted Neovii.
The shipping box must be labeled indicating the mandatory temperature range of +2°C to +8°C.
During warehousing, the Products must be kept in temperature monitored refrigerators, lockable warehouse space and drug surveillance facilities with a pharmacist as the responsible person.
The monitoring of Products stock with regard to quantity, quality, shelf-life and storage conditions is mandatory.
Each shipping box contains at least one temperature logger. Upon receipt of the delivery, temperature logger data must be read out as per instructions and returned immediately to Neovii by e-mail (logistics@neovii.com) Deviations from the recommended temperature range will be evaluated by Neovii’s responsible person. Client must keep the contents of each parcel separate until Client receives the temperature chart. If one or more parcels were out of specification it must be possible to sort out the contents of just the affected parcels.