General Terms and Conditions

1.            Scope and Services

1.1           These General Terms & Conditions (the “Terms””) govern the offering and rendering by Qmed Consulting A/S, CVR. No. DK 3056 4278, Koebmagergade 53.1, DK-1150 Copenhagen K, Denmark (“Qmed”) of life science related services within the areas of regulatory affairs, training, engineering, quality assurance & control, clinical trial consultancy and/or concept and product development (the “Services”) to clients having contracted Qmed as per Section 2 below (“Customer”).


2.             Service Offers, Acceptances & Contract Amendments

2.1           On basis of Customer input, Qmed will provide an offer by Qmed comprising the Project Agreement format overleaf (an “Offer”). If not counter-signed by the Customer within ninety (90) days from the date of the Offer, the Offer shall be deemed null and void, whereas Offers, amended as required, counter-signed within said ninety (90) days period shall be deemed closed contracts (a “Contract”) entered into between Qmed and Customer. Contracts may subsequently be amended by the parties signing a change order and attaching same to the Contract. Any amendment shall specifically stipulate to which extent the original Contract has surviving provisions. If no language to this effect is added, the amended Contract shall be deemed to replace the original Contract entirely. 


3.             Service Standards, Delivery & Acceptance

3.1           In its’ capacity as professional Service provider, Qmed will use its best commercial efforts to perform the Services in line with applicable industry standards in Denmark and to the best of Qmed’s skill and ability. Qmed shall comply with all applicable laws, regulations and quality standards related to Services required according to the Contract, including but not limited to accuracy of documents preparation, submissions to and communications with relevant regulatory entities, if so required by Customer.
3.2           Qmed shall use its reasonable commercial efforts to render the Services to Customer by the dates set out in the Contract, provided that all delivery dates shall automatically be extended to the extent that Customer has not supplied agreed Customer deliverables to Qmed in time.
3.3           Upon delivery Customer shall examine the deliverables and satisfy itself that the Services rendered meet all Contractual requirements. Services rendered shall be deemed accepted, unless written, including by e-mail, complaints have reached Qmed no later than thirty (30) days from the date of delivery.
3.4           If Customer requires assistance from Qmed for the purpose of construing, exploiting and/or implementing Services rendered, such assistance shall be invoiced by the hour by Qmed using its standard rates applicable for the Qmed resources assisting Customer.


4.             Prices, Currency Fluctuations & Terms of Payment

4.1          The service fees applicable for the rendering of Services by Qmed shall be quoted or budgeted in the Offer. All prices are exclusive of and may be loaded for bank transfer fees (where the parties share the costs, Qmed may load for compensation), taxes, pass-through costs, impositions and other charges, including but not limited to sales, use, value added and other taxes imposed by any government authority, including any subsequent increases of such impositions.
4.2          Invoices are payable in the currency stated in the Contract (the “Contracted Currency”), normally Euros. If a Contract contains budgets in several currencies, which may be the case, if Services are to be rendered in different jurisdictions or sub-contractors are domiciled in different jurisdictions, the prices and/or budgets stipulated in the Contract in other currencies than Euros are based on the rate of exchange (“RoE”) between Euros and the Contracted Currency applicable on the date of the Offer, as published by the Danish National Bank. Qmed reserves the right to adjust prices and hourly rates as set out in the Contract, if the RoE between Danish Kroner and the Contracted Currency at any given invoice date has developed by more than +/- three percent (“3%”) compared to the date of the Offer, whereas prices and hourly rates shall remain as determined in the Contract, if the RoE is within the span of 3%.
4.3          Service fees may be invoiced monthly in arrears, whereas reimbursable expenses and pass-through costs loaded by a 5% handling fee may be invoiced forty-five (45) days before Qmed expecting the expenditure, including in-house costs and mileage, to fall due. The deposit shall not carry interest. Each invoice or payment requisition may state (i) the Contract number, (ii) the period during which invoiced Services have been rendered and a brief description of these Services, (iii) sub-contractors used, if any, (iv) for pass-through-costs incurred, a reasonably detailed breakdown of expenses, and (v) Qmed’s bank account details comprising IBAN, BIC (SWIFT-address), bank registration No. and bank account number and holder. Copies of cost vouchers shall be provided to Customer upon request, however no earlier than after elapse of the month in which the costs are defrayed + sixty (60) days.
4.4          Customer shall effectively pay all invoices within thirty (30) days following the date of Qmed’s invoice. If the Customer requires an invoice to include information beyond what has been stipulated in Sub-section 4.3 above, and/or in case of late payment triggered invoicing as per Sub-section 4.5 below, Qmed may charge Customer EUR 200 + VAT per amendment, or in case of late payments, per year, to cover the administration involved in connection with issuing a credit note and a replacement invoice. A Customer request for an invoice to be replaced shall not postpone the due date, which shall remain to be (30) days following the Customer’s receipt of Qmed’s original standard invoice.
4.5          In case of late payment by Customer, interest shall incur and accrue by one and one-half percent (1.5 %) per month. Interest shall be compounded annually on 31 December. Qmed may exercise a lien on any Service deliverables and other items belonging to Customer and may suspend the rendering of Services, until any claim that Qmed may have against the Customer, has been settled.
4.6          All transfer fees charged by the outgoing and/or receiving bank shall be paid by the Customer as well as all financial costs related to foreign exchange risk coverage.
4.7          Service fees stipulated in the Contract may be adjusted annually by Qmed for inflation and cost increases without separate notice being provided to Customer. Adjustments, if any, shall take effect as from and including the following 01 January.


5.             Confidentiality

5.1           Information and data disclosed by either party in connection with the rendering of Services shall be held in confidence for a period of five (5) years calculated from the date of the last invoice issued by Qmed for the rendering of Services. Qmed may retain a copy of all documentation for compliance purposes.


6.             Intellectual Property Rights

6.1           Deliverables and information provided to Qmed by Customer enabling Qmed to render the Services (”Customer Property”), shall remain the property of Customer and nothing in these Terms shall be construed as granting Qmed any rights to such Customer Property other than the right to exploit same for the purpose of rendering the Services.
6.2           Qmed deliverables specifically relating to the Services rendered as well as intellectual property rights incorporating Customer Property shall be the sole and exclusive property of Customer. Title to rights, whether intellectual or tangible, which do not incorporate Customer Property, (“Qmed Rights”), shall vest in Qmed. If required for Customer to exploit the services rendered by Qmed to Customer, Qmed shall grant to Customer a fully paid-up, irrevocable and global license to exploit the Qmed Rights.


7.             Liability & Limitation of Liability

7.1           Subject to Sub-sections 7.2 and 7.3 below, Qmed may assume liability only for direct causal losses incurred by Customer as result of Qmed rendering its’ Services to Customer. Such liability shall extend only to losses incurred as result of Services rendered under the Contract being non-Contractual and be subject to Qmed being considered liable for such losses as per Danish Law and Danish legal doctrines.
7.2           Neither party shall be liable to the other, or Qmed be liable, whether directly or indirectly, for third party claims made against Customer, for any special, indirect or consequential damages, including, but not limited to, defective devices, product and third party liability, liability for loss of time, profit, interest, production, goodwill, bargain, revenue or anticipated savings.
7.3           In case of Qmed assuming liability as per Sub-section 7.1 above, Qmed’s liability shall in no event exceed one (1) time the total service fees, excl. VAT, invoiced by and effectively paid to Qmed by Customer during the twelve (12) months period preceding the date as per which a claim is being made. Service fees do not include pass-through-costs, sub-contractor payments and reimbursable expenses / disbursements.
7.4           Within the earlier of three (3) months from Customer becoming aware of circumstances leading to any claim, and six (6) months from completion of the Contract, Customer must notify Qmed in writing of any claim or threatened claim and the circumstances related to such claim. Claims not so notified, shall be deemed barred.


8.             Suspension & Termination

8.1           Customer may terminate any Contract by giving ten (10) days prior written, incl. by e-mail, notice, if Qmed unjustified refuses to or is unable to perform the Services in a timely manner or is in breach of any material provision of a Contract. Otherwise a Contract may be terminated by Customer at Customer’s discretion, subject to Customer choosing between i) giving ninety (90) days’ notice to the end of a calendar month, OR ii) by Customer giving ten (10) working days’ notice AND paying a termination fee comprising the higher of twenty percent (20%) of the total payments that would otherwise be payable as per the terminated Contract and such costs, which Qmed incurs laying off or reallocating staff involved in the Services terminated , in either case in addition to paying for Services rendered prior to termination. In either case Customer shall, in addition, hold Qmed harmless from any sub-contractor claims made as result of early termination.
8.2           If Customer is (a) in default of performance of its’ obligations towards Qmed, or (b) if Customer has been made subject to insolvency proceedings of any kind, Qmed may, without prejudice to any other rights of Qmed, by notice in writing, including by e-mail, forthwith suspend its performance or terminate the Contract.


9.             Assignment & Sub-contracting

9.1           Assignment of the Contract may only take place subject to written approval by both Customer and Qmed. Approval shall not be unreasonably withheld, if the party requesting assignment is in the process of assigning its entire business to a successor in interest. If requested by the non-assigning party, the assigning party shall stand surety for the assignee’s performance under the Contract.
9.2          Customer may direct Qmed to engage sub-contractors to render services auxiliary to the Services, provided however that Customer shall prepay Qmed for any payments that may be due to such sub-contractor and provided that Qmed shall in no event assume liability for the rendering of services by sub-contractors designated or approved by Customer, not even if the quality of Qmed’s own Services are influenced negatively by sub-standard sub-contractor deliverables having been incorporated into Qmed deliverables or otherwise relied upon by Qmed. Sub-contractors identified in the Contract shall be deemed having been designated or approved by Customer.
9.3          Qmed may at its’ discretion sub-contract the rendering of Services to sub-contractors not designated or approved by Customer, provided that Qmed shall be deemed liable for the quality of sub-contracted Services as had Qmed rendered such Services itself, and provided that Qmed shall be solely responsible for payments to such sub-contractors chosen by Qmed.


10.           Force Majeure

10.1         Neither party shall be liable in any way for any damage, loss, cost or expense arising out of or in connection with any delay, restriction, interference or failure in performing any obligation, but payment of money, towards the other party caused by any circumstance beyond its reasonable control.


11.           Governing Law, Dispute Resolution and Jurisdiction

11.1         Any Services rendered by Qmed shall be deemed rendered under Danish law and be deemed rendered for commercial use in the EEA.
11.2         The parties’ rights and obligations arising out of or in connection with any Contract shall be governed by and construed in accordance with the laws of Denmark to the exclusion of any rule that would refer the subject matter to another jurisdiction.
11.3         Matters in dispute shall be settled by the Copenhagen City Court, if the Parties cannot amicably find a settlement solution within ninety (90) days from either Party having informed the other Party that a dispute has arisen.
11.4         The application of the Convention on Terms for the International Sale of Goods (CISG) is hereby excluded.