Technical Services Agreement
made on ...... (the “Effective Date”)
Parties:Drugs for Neglected Diseases initiative, a Swiss foundation having its principal office at 15 ch. Louis-Dunant, 1202 Geneva, Switzerland ("DNDi");
and
complete, a public/privatechoose the appropriate term institutionincorporated under the laws of complete, having its principal office at complete (the“Service Provider”),
hereinafter referred to individually as a “Party” and collectively as the “Parties”.
WHEREAS
DNDi’s mission is to develop safe, effective and affordable new treatments for patients suffering from neglected diseases and to ensure equitable access to such treatments.
The Service Provider is specialized in providing services in clinical supplies management(the “Field”).
DNDi wishes to use certain services of the Service Provider which is willing to provide such services to DNDi, in the following project:
“Eumycetoma clinical trial supplies”
IT WAS THEREFORE AGREED AS FOLLOWS:
- Definition and Provision of the Services:
1.1.Under the terms and conditions hereinafter set out, DNDi hereby appointsthe Service Providerfor providing the services described in Column A of Annex I hereto (the “Services”) and the Service Provider hereby agrees to provide the Services to DNDi by such target dates as set out in Column B of Annex I hereto (the “Target Dates”).
1.2.The Service Provider shall provide the Services through its own employees, consultants and agents with all care and diligence as usually applicable in the Field and in strict accordance with the terms of this Agreement, and in particular with all applicable laws, regulations and standards, in particular with current Good Manufacturing Practices, required by the provisions of EC Commission Directive 2003/94/CE together with the Guide to Good Manufacturing Practice published by the EC Commission in 1992 (ISBN 92-826-3180-X), Good Distribution Practices and the applicable ICH Guidelines.
1.3.The Service Provider shall provide the Services to DNDi in accordance with the terms and conditions of this Agreement and Annex I, to the exclusion of the Service Provider’s general terms and conditions.
1.4.Unless otherwise agreed in advance with DNDi in writing, the Service Provider shall not be entitled to sub-contract or assign the performance of any of the Services to any third party. In case of subcontracting, the Service Provider shall be liable for any breach of the terms of this Agreement by such subcontractors.
1.5.The Service Provider agrees that it shall be solely responsible and liable for the consequences of any fault or negligence of any of its employees, consultants or agents in providing the Services hereunder and that it shall fully indemnify DNDi, at DNDi’s request, for any cost, expense, damage, loss, injury or claim which DNDi or any of DNDi’s employees, consultants or agents may incur or suffer as a result thereof.
1.6.Each Party shall notify the other Party in writing, as soon as it becomes aware thereof, of any changes in the pending processes, methods, specifications, which could affect the performance of the Services pursuant to Annex I. To that respect both Parties shall endeavor to agree upon any necessary actions and schedule modification resulting therefrom. Such modification shall be approved, in writing, by the Parties before implementation.
1.7.The Service Provider agrees that it shall maintain an adequate insurance policy with a reputable insurance company for covering its liability under § 1.5. If required by DNDi, the Service Provider shall provide DNDi with a copy of such insurance policy and with appropriate evidence of payment of all premiums due thereunder.
1.8.The Service Providerrepresents and commits that (i) the negotiation and the performance of this Agreement did not and shall not give rise to any act of corruption or fraud; and (ii) it has anti-fraud and anti-corruption mechanisms in place which are effectively implemented throughout the Term of this Agreement.
- Remuneration and Payment Schedule:
2.1.In remuneration for the Services, DNDi shall pay the Service Provider the total amount set out at the bottom of Column C of Annex I hereto (which is exclusive/inclusive < choose what is appropriate > of value added tax or equivalent) and such amount shall be payable in such instalments as set out in the same Column.
2.2.Unless otherwise agreed in advance between the Parties in writing, the Service Provider shall not be entitled to get or claim from DNDi any remuneration or payment whatsoever in excess of the total amount set out in §2.1.
2.3.Payment is due on presentation of invoices, pursuant to the payment schedule set forth in Annex I, provided that the relevant milestones have been achieved and that DNDi has received satisfactory reports. Invoices shall be sent to:
Donia Tourki
Finance Officer
DNDi
15 Chemin Louis Dunant
1202 GENEVA
SWITZERLAND
Tel: +41 22 906 92 62
Fax: +41 (0)22 90692 34
Email:
With a copy to: Christine Crettenand, Accounting Manager
Email:
2.4.DNDi shall make the payments within thirty (30) days from receiving the respective invoices that will contain all relevant banking information required for payment.
- Material and Safety Instructions.
3.1.DNDi will, either through itself or through an authorized nominee, provide the Service Provider, free of charge, with materials as defined in Annex I in sufficient quantity, to enable the Service Provider to perform the Services, as well as scientific data and Safety Data Sheet (MSDS) related to these materials.
3.2.Upon completion of the Services, any remaining material supplied by either DNDi or its authorized nominee will, at DNDi’s sole discretion, either be returned to either DNDi or to its authorized nominee, stored by the Service Provider or destroyed.
3.3.It is agreed between the Parties that no materials may be destroyed without the prior written approval of either DNDi or its authorized nominee, such approval shall not to be unreasonably withheld.
3.4.The Service Provider shall not copy or reverse engineer, reverse compile or attempt to derive the composition or underlying information of any of the materials.
- Intellectual Property Rights:
All inventions, discoveries, improvements and know-how (whether patentable or not) arising out of, as well as all data, analysis of data, methods and descriptions thereof, information, materials and reports generated through the performance of the Services by the Service Provider under this Agreement (“Results”) including without limitation patents, trade secrets and copyright relating thereto shall be vested exclusively in DNDi which shall have the sole and exclusive right to claim and seek legal protection thereupon and to use the same in any manner which it sees fit. To the extent that any Result does not vest automatically in DNDi, the Service Provider hereby irrevocably and unconditionally assigns to DNDi all right, title and interest in and to all such Result, and will execute - and will cause its employees and consultants to execute – all documents which may be necessary to give effect to this provision.
- Confidential Information:
5.1.In this Agreement, “Confidential Information” means any data or information of any kind (whether or not marked ‘confidential’) in any form or medium which is disclosed, divulged, communicated or made available (whether before or after the date of this Agreement) by DNDi to the Service Provider, irrespective of whether it is in oral or a written form, or recorded or stored by electronic, magnetic, electromagnetic or otherform, process or otherwise in a machine readable form or translated from the original language.
5.2.The Service Provider agrees to maintain in confidence all Confidential Information and to refrain, without the prior written permission of DNDi, from:
(a)using any part thereof for any purpose other than for providing the Services hereunder; and
(b)disclosing any part thereof to any third party except only to those of the officers, employees, consultants and representatives of the Service Providerwho shall need to have access to the Confidential Information for the purpose of providing the Services hereunder and who shall be subject to non-use and non-disclosure obligations at least as strict as those set out in this §5.2.
5.3.The obligations mentioned under §5.2 shall not apply to information that:
(a)was known to the Service Provider prior to the disclosure hereunder; or
(b)was or became part in the public domain other than through breach of this Agreement by the Service Provider; or
(c)was rightfully received by the Service Provider on a non-confidential basis by a third party free of any obligation of confidence; or
(d)was developed independently by the Service Provider without reliance upon the Confidential Information of DNDi.
The Service Provider shall bear the burden of proof if it invokes one of these exceptions.
5.4.The Service Provider shall have the right to disclose to the relevant authority any Confidential Information which is required by law, a competent court or a governmental entity to be disclosed, provided however that DNDi shall first have been given an opportunity to obtain a protective order precluding or limiting the disclosure of such Confidential Information.
5.5.The Service Provider shall take at its own cost all reasonable measures to protect all Confidential Information from any loss or damage or any unauthorized use or disclosure and shall be liable for any breach of such obligation by any of its officers, employees, consultants or agents.
5.6.At any time upon request of DNDi for any reason, the Service Provider shall promptly return (and shall cause its officers, employees, consultants and agents to return promptly) to DNDi (or its authorized nominee) all Confidential Information in any form, including all copies or extracts thereof in its possession.
5.7.The confidentiality obligations under this article 5 shall continue in force after expiration or termination of this Agreement for a period until such information falls within any of the exemptions listed in §5.3 of this Agreement.
- Reporting:
The Service Provider shall present a final written report upon completion of the Services.
- Inspections and Audits:
7.1.The Service Provider shall maintain the original of receipts for all direct costs included in the invoices and make them available upon DNDi’s request.
7.2.The Service Provider shall notify DNDi promptly of any governmental or regulatory inspection of its facilities or inquiry concerning the Services. Upon a reasonable prior request from the Service Provider, a representative of DNDi could participate during such inspection or inquiry. The Service Provider has the right to share relevant documents required for inspection by the governmental or regulatory authority. The Service Provider undertakes to keep DNDi informed regarding the outcome and results of the inspections by the governmental or regulatory authority relating to the Services.
7.3.During the Term and five (5) years thereafter, the Service Provider shall allow DNDi or its representatives, at the cost of DNDi, to audit any remuneration and payment of expenses made under this Agreement. DNDi or its representatives shall have access to the relevant books and records of the Service Provider necessary or useful to determine the accuracy of any delivered financial report.
7.4.During the Term and five (5) years thereafter, the Service Provider shall allow DNDi or its representatives, at the cost of DNDi, to examine or audit the Services performed hereunder. DNDi shall access all documents which are directly pertinent to the Services in order to verify the performance of the Services, ascertain compliance with any applicable laws and regulations, and proceed with all monitoring activities deemed necessary by DNDi. The Service Provider shall maintain complete and adequate records of the activities performed hereunder to enable DNDi to conduct such audit.
7.5.The audit rights under this article 7 include timely and reasonable access to the Service Provider’s personnel for the purpose of interview and discussion related to any documents. Any audit will be performed with at least fifteen (15) working days’ advance written notice, during the Service Provider’s standard business hours and in a manner intended not to unreasonably interfere with the Service Provider’s business.
- Contact Persons:
For DNDi:
Beatrice Bonnet
Pharmaceutical Development Manager
DNDi
Chemin Louis-Dunant 15
1202 Geneva
Switzerland
Tel: +41 (0)22 90692 25
Email:
Stephen Robinson, PhD
Head of Pharmaceutical Development, R&D
DNDi
Chemin Louis-Dunant 15
1202 Geneva
Switzerland
Tel: +41 (0)22 90692 52
Fax: +41 (0)22 90692 34
Email:
For legal matters/notices, with a copy to: Dr. Dominique Junod, Head of Legal
Email:
For The Service Provider:
complete
- Relationship between the Parties:
This Agreement is a technical service agreement. It does not and is not intended to create any employer/employee relationship or any partnership between the Parties.
- Term and Termination:
10.1.This Agreement enters into force on the Effective Date and, subject to the provisions of §10.2, it shall continue until full and satisfactory completion of the Servicesadddatethe date of receipt by DNDi of the last written report from the Service Provider as set out in § 6 > (the “Term”).amend/complete as relevant
10.2.DNDi may terminate this Agreement upon a thirty (30) day written notice given to the Service Provider at any time before the Term and DNDi shall then paythe Service Provider for all justified out-of-pocket expenses incurred or committed by the Service Provider for the Services until the date of receipt of DNDi’s notice of termination, as evidenced by vouchers attached to the relevant invoice issued by the Service Provider.
10.3.The obligations mentioned under articles4, 5, 1, 6, 7 and 0 and this § 10.3shall survive expiration or termination of this Agreement, as well as any other obligation which by its nature is intended to survive.
- Entire Agreement and Amendments:
11.1.This Agreement including its Annexes constitutes the entire agreement between the Parties as to its subject matter and supersedes any prior oral or written understanding or agreement relating to the same subject matter. < The version in English language of this Agreement shall prevail over any version of the same in other languages. > < keep only if relevant
11.2.In the event of any inconsistency between this Agreement and Annex I, the terms of this Agreement shall prevail.
11.3.This Agreement may be amended only in writing with the signature of a duly authorized representative of each Party.
- Governing Law and Dispute Resolution:
12.1.This Agreement is governed by and shall be construed in accordance with Swiss law.
12.2.The Parties shall use their best reasonable endeavors to resolve amicably any dispute which may arise between them in relation to this Agreement. If the dispute is not settled within thirty (30) days from the first discussion, it shall be submitted exclusively to the competent courts of the Canton of Geneva, Switzerland, subject to appeal to the Swiss Federal Tribunal in Lausanne.
< SIGNATURE PAGE FOLLOWS >
Executed as an Agreement.
Authorized Representatives of Drugs for Neglected Diseases initiative (DNDi)
Signature……………………………………Signature …………………………………
NameName
TitleTitle
Date……………………………………Date……………………………………
Authorized Representative of complete(the Service Provider)
Signature…………………………………… Signature …………………………………
NameName
TitleTitle
Date……………………………………Date……………………………………
Annex I -the Services – Target Dates – Payment Schedule
A. Description of the Services (*) / B. The Target Dates / C. Total amount (<currency**) and Payment ScheduleTotal amount:
internal instructions – to be deleted when the above table is complete :
(*) Description of the Services includes for instance:
- Research protocols for in vitro and in vivo experimentation.
- Ethical approvals if required.
- Scope of reports for consultancy.
- Research certification and adherence to specific standards if necessary.
(**) in USD, GBP or EUR, as applicable(includingallocation of fixed costs such as FTEs to specific projects).
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