Getting your medical device to market
1. Scope and Services
1. These General Terms & Conditions (the “Terms””) govern the offering and rendering by Qmed Consulting A/S, CVR. No. DK 3056 4278, (“Qmed”), of life science related services within the areas of regulatory affairs, training, engineering, quality assurance & control, clinical trial consultancy, concept and product development, and/or legal representation in the EU (the “Services”) to clients (each a “Client”) having contracted Qmed by entering into a Project Agreement, including corresponding Work Orders defining the scope of services to be rendered, under separate cover (a “Contract”).
2. Client and Qmed (each a “Party” or collectively the “Parties”) may subsequently agree to amend the Contract. For amendments to be valid any Work Order in issue shall be amended and be attached to the Contract forming an integral part thereof. Any amendment shall specifically stipulate to which extent the original Work Order has surviving provisions. If no language to this effect is added, the amendment shall be deemed to replace the original Work Order entirely.
2. Service Standards, Delivery & Acceptance
2.1 In its capacity as professional Service provider, Qmed will use its reasonable commercial efforts to perform the Services in line with applicable industry standards in the EU and to the best of Qmed’s skill and ability. Qmed shall, within the scope of the Contract, 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.
2.2 Qmed shall use its reasonable commercial efforts to render the Services to Client by the dates set out in any Work Order, provided that all delivery dates shall automatically be extended to the extent that Client has not supplied agreed or necessary Client deliverables to Qmed in time.
2.3 Upon delivery Client 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.
2.4 Qmed shall in no event be deemed obligated to deliver a given result to the Client, merely to render Services as per the standards set out in Clause 2.1 above, and to render the Contracted number of working hours.
3. Prices, Currency Fluctuations & Terms of Payment
3.1 The fees payable for the rendering of Services by Qmed are budgeted or fixed in the Work Order. All prices are exclusive of and may be loaded for taxes, 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. Unless specifically stipulated by Qmed qualifying a price as a “FIXED PRICE”, all Service fees are budgeted only and subject to adjustment reflecting the actual use of service hours. Qmed may in- or decrease the budgeted number of service hours by up to five (5) hours per twenty (20) working days or by up to ten percent (10%) of the price budget if based on differentiated professional rates, all without renegotiation with or approval by the Client.
3.2 Travel-, communication-, printing-, audit-, project-on-hold- (delayed or suspended recruitment, adverse reactions, etc.) and Service follow-up costs are not included and will be billed at cost, or, upon service completion, at Qmed’s standard hourly rates. None of the price indications include VAT the loading for which may be applicable. All costs will be billed based upon the time sheets provided by Qmed staff, monitors and other collaborators and will be charged in addition to costs set out in the Contract.
3.3 Invoices are payable in the currency/ies stated in the Contract (the “Contracted Currency/ies”), which may contain quotes in several currencies if the Services are to be rendered in different jurisdictions. The prices and/or budgets stipulated in the Contract are based on the rate of exchange (“RoE”) between Danish Kroner and the Contracted Currency/ies on the date of the Contract, 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/ies at any given invoice date has developed by more than +/- three percent (“3%”) compared to the date of the Contract, whereas prices and hourly rates, subject to Clause 3.7 below, shall remain as determined in the Contract, if the RoE is within the span of +/- 3%.
3.4 Service fees may be invoiced monthly in arrears, whereas reimbursable expenses, including in-house costs and mileage, may be invoiced in arrears after disbursement or up to forty-five (45) days before Qmed expecting the expense to fall due. 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, and (iv) for pass-through-costs incurred or incurable, a reasonably detailed breakdown of expenses. Copies of cost vouchers shall be provided to Client upon request, however no earlier than after elapse of the month in which the costs are defrayed + sixty (60) days.
3.5 Client shall effectively pay all invoices within thirty (30) days following the date of Qmed’s invoice.
3.6 In case of late payment by Client, interest shall incur and accrue by the lower of one and one-half percent (1½%) per month or the highest late payment rate legally permissible. Interest shall be compounded annually on 31 December. Qmed may exercise a lien on any Service deliverables and other items belonging to Client and may suspend the rendering of Services, until any rightful claims that Qmed may have against the Client, have been settled.
3.7 All transfer fees charged by the outgoing and/or receiving bank shall be shared by the Parties, provided however that loadings charged by Qmed’s bank receiving payments, shall be considered reimbursable expenses invoiceable as per Clause 3.4 above. Financial costs related to foreign exchange risk coverages shall be borne by the Client.
3.8 Inflation: As the development in the global economy is unpredictable and may cause excessive inflation and increasing interest rates, the Parties agree that Service fees may be adjusted by Qmed on basis of the developments in the consumer price index (first business day in each calendar month = 100). Adjustments, if any, may take effect as from and including the first business day in the following calendar month applying for Service fees earned as from such first business day.
4.1 Information and data disclosed by either Party in connection with Qmed’s rendering of Services under a Contract shall be held in confidence for a period of five (5) years calculated from effective termination of the Contract. Qmed may retain a copy of all documentation solely to be used for compliance purposes.
4.2 If the Parties, prior to closing a Contract, have entered into a Confidential Disclosure Agreement (a “CDA”), inter alia for the purpose of enabling Qmed to make a Service quotation to Client, such CDA shall prevail to the extent that the Qmed obligations stipulated therein are more onerous to Qmed than those stipulated in the otherwise applicable confidentiality provision set out in Clause 4.1 above or in the Contract. If the CDA contains a dispute resolution and/or choice of law model, which is different from what has been provided for in these Terms, the CDA shall prevail to the extent that a dispute solely relates to alleged breach of the CDA by Qmed. Otherwise, these Terms shall govern dispute resolution procedures.
5. Intellectual Property Rights
5.1 Deliverables and information provided to Qmed by Client enabling Qmed to render the Services (”Client Property”), shall remain the property of Client and nothing in these Terms shall be construed as granting Qmed any rights to such Client Property other than the right to use same as required to render the Contracted Services. 5.2 Qmed deliverables as well as intellectual property rights incorporating Client Property shall be the sole and exclusive property of Client. Title to rights, whether intellectual or tangible, which do not incorporate Client Property, (“Qmed Rights”), shall vest in Qmed. If required for Client to exploit the services rendered by Qmed to Client, Qmed shall grant to Client a fully paid-up, irrevocable, global and non-assignable license to exploit the Qmed Rights.
6. Liability & Limitation of Liability
6.1 Subject to Sub-sections 6.2 and 6.3 below, Qmed shall be liable for direct causal losses incurred by Client as result of Qmed rendering the Services to Client. Such liability shall extend only to losses incurred as result of Services rendered under the Contract being non-Contractual and be subject to such liability being vested in Qmed as per Danish Law and Danish legal doctrines, and not excluded as per these Terms.
6.2 Neither Party shall be liable to the other, or Qmed be liable for third-party claims made against Client, 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.
6.3 In case of Qmed assuming liability as per Sub-section 6.1 above, Qmed’s liability shall in no event exceed one (1) time the total Service fees, excl. VAT, invoiced by Qmed and effectively paid to Qmed by Client 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.
6.4 Within the earlier of three (3) years from an alleged defective Service having been rendered and three (3) months from Client having become aware of circumstances that may lead to such claim, Client must notify Qmed in writing of any such claim or threatened claim and the circumstances related to such claim. Claims not so notified, shall be deemed barred. Qmed does not assume any liability for claims caused or incurred as result of Client using or exploiting advice rendered hereunder in or for jurisdictions outside the EU.
7. Suspension & Termination
7.1 Client may terminate any Contract or the rendering of individual Services under a Contract by giving Qmed 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 Client at Client’s discretion, subject to Client choosing between i) giving thirty (30) days’ notice to the end of a calendar month, OR ii) by Client giving ten (10) working days’ notice AND paying a termination fee comprising fifteen percent (15%) of the total payments that would otherwise be payable for the terminated Services had they been rendered, in either case in addition to paying for Services rendered prior to termination.
7.2 If Client is (a) in default of performance of its’ obligations towards Qmed, or (b) if Client 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.
8. Assignment & Sub-contracting
8.1 Assignment of the Contract may only take place subject to written approval by both Client 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. Sub-contractors identified in a Contract shall be deemed to have been pre-approved by Client.
8.2 Client may direct Qmed to engage sub-contractors to render services auxiliary to the Services, provided however that Qmed may require prepayment by Client of 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 or services by such sub-contractor designated by the Client.
8.3 Qmed may at its discretion sub-contract the rendering of Services not designated by the Client, provided however 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 the sole responsible for payments to such sub-contractor chosen by Qmed. Sub-contractors chosen by Qmed shall be identified in the Contract. Sub-contractors not identified in the Contract shall be deemed designated by Client as per Section 8.2 above.
9. Force Majeure
9.1 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, including pandemics and epidemics, even if precautions taken to address such are not mandatory.
10. Governing Law, Jurisdiction & Dispute Resolution
10.1 Any Services rendered by Qmed shall be deemed rendered under Danish law and be deemed rendered for commercial use in the EU.
10.2 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. The application of the Convention on Terms for the International Sale of Goods (CISG) is hereby excluded.
10.3 Matters in dispute shall be settled by the ordinary Danish courts having jurisdiction in Qmed’s home jurisdiction, if the Parties cannot amicably find a settlement solution within either Party having informed the other Party that a dispute has arisen.