Standard Confidentiality Disclosure Agreement for Clinical Trial
Preamble
WHEREAS this Standard Confidentiality Disclosure Agreement was approved by the Danish Regions on May 1, 2012 as version 1;
WHEREAS this Standard Confidentiality Disclosure Agreement shall be used when initiating discussions between two parties, one being the Sponsor of a potential clinical study, the other being a public institution in Denmark;
WHEREAS the purpose of using this Standard Confidentiality Disclosure Agreement is to enable the Parties to enter into an agreement under standardised legal terms;
WHEREAS the main body of this Standard Confidentiality Agreement may not be changed;
WHEREAS the Parties on a project by project basis agree on the specific definition of the Information to be disclosed under this Standard Confidentiality Disclosure Agreement, and define this in detail using Appendix A and sign the complete Standard Confidentiality Disclosure Agreement using Appendix B;
WHEREAS, the Discloser, as defined below, has developed and possesses certain proprietary information relating to clinical trial development;
WHEREAS, the Recipient, as defined below, desires to obtain access to such Information for the purpose of evaluating its interest in engaging in conducting a clinical study;
WHEREAS, Discloser is willing to disclose to the Recipient said Information for evaluation and determination of the Recipient’s interesttherein;
NOW, THEREFORE the Discloser and the Recipient (also individually referred to as a Party and collectively as the Parties) hereto agree as follows:
1. Confidentiality
1.1 In the course of the discussions Recipient may receive or obtain from Discloser certain trade secrets, confidential scientific, technical or commercial information or data (either its own or that of its business partners) relating to Disclosers Study Project as defined in Appendix A (the “Information”), designated as confidential in writing by Discloser, whether by letter or by use of an appropriate proprietary stamp or legend, prior to or at the time of any such Information being disclosed by the Discloser to the Recipient. Notwithstanding the foregoing, information which is orally or visually disclosed to Recipient by Discloser, or is disclosed in writing without an appropriate letter, proprietary stamp or legend, shall constitute Information if Discloser, within thirty (30) days after such disclosure, delivers to Recipient a written document or documents describing such Information and referencing the names of the employees or officers of Recipient to whom such disclosure was made.
2. Obligations of the Recipient
2.1All Information furnished by the Discloserand designated as confidential according to section 1.1 shall be treated by the Recipient as confidential. The Recipient undertakes and agrees as follows:
i) to hold the Information in confidence and not to disclose or permit it to be made available to any third party without the Discloser's prior written consent;
ii) only to use the Information for the Purpose (as defined in Appendix A);
iii) to ensure that each person at the Institution to whom disclosure of Information is made on a need-to-know basis by the Recipient is fully aware in advance of the Recipient's obligations under this Standard Confidentiality Disclosure Agreement and that each such person complies with the terms of this Standard Confidentiality Disclosure Agreement, and
iv)upon request of Discloser, Recipient agrees to promptly return all Information furnished by Discloser, together with all copies thereof in the Recipient’s possession. Recipient shall be entitled to retain one copy of Information in Recipients files only for the purpose of documentation of Information which may not be used for any other purpose except as set forth herein.
2.2The foregoing article 2.1 does not apply to any of the Information which the Recipient can show:
i) is already lawfully known to the Recipient at the date it was disclosed to it by the Discloser and is or later becomes free of restriction on the disclosure or use in question, or
ii) is or becomes generally known or freely available to the public (except by reason of any breach by the Recipient of its obligations hereunder), or
iii) is disclosed to the Recipient, free of restriction on the disclosure or use in question, by a third party who was entitled to make such unrestricted disclosure, or
iv) is independently developed by the Recipient, or
v) is disclosed, retained or maintained by law or to any regulatory or government authority.
3. Ownership and Intellectual Property Rights
3.1 Recipient agrees that Discloser is and shall remain the exclusive owner of Information and all patent, copyright, trade secret, trademark and other intellectual property rights therein. No license or conveyance of any such rights to Recipient is granted or implied under this Agreement.
4. Termination
4.1 Recipient will advise Discloser as soon as possible and no later than within six (6) months from the date of the disclosure of Information hereunder whether Recipient is interested in negotiating a clinical trial agreement regarding the Study Project.
4.2This Standard Confidentiality Disclosure Agreement shall cover Information which is disclosed in a period of one (1) year after the Effective date and the Agreement shall be in force for a period of three (3) years after the Effective date.
4.3 Unless otherwise agreed, the term of this Standard Confidentiality Disclosure Agreement shall be superseded by the terms of a clinical trial agreement regarding the Study Project if an agreement as envisioned in 4.1 is entered into.
5. Law and Venue
5.1In the event of any dispute arising between the Parties in relation to the terms of this Agreement, the Parties shall use their best endeavours to resolve the matter on an amicable basis. This Agreement shall be governed by and shall be construed in accordance with the laws of Denmark without regard to any conflicts of law’s provisions, to the extent that such provisions would result in the application of another country’s law. The Parties consent to the competent courts of Denmark for the resolution of all disputes or controversies between the Parties hereto that the Parties are unable to settle amicably.
6. Effective date of the Standard Confidentiality Disclosure Agreement
6.1 This Standard Confidentiality Disclosure Agreement shall become effective upon signature of Appendix B.
7. Signatures
7.1 Both the Institution’s appointed signee(s) and the psychical recipient for the Institution shall sign this Standard Confidentiality Disclosure Agreement in order for it to be legally binding.
7.2This Standard Confidentiality Disclosure Agreement is executed in three (3) counterparts, each of which shall constitute the original.
Appendix A – The Parties
[Insert name and address]
(in this Standard Confidentiality Disclosure Agreement referred to as the ”Institution” or the “Recipient”).
and
[Insert name and address]
(referred to as the “Discloser”).
- also individually referred to as a “Party” and collectively as “Parties”.
The Parties have entered into a Standard Confidentiality Disclosure Agreement with the purpose of discussing
[Insert topic described in reasonable detail]
(referred to as the “Purpose”) to evaluate its interest in collaborating on the Study Project as defined below,
for the study project named
[Insert Name of the study]
(referred to as “Study”)
Appendix B – Signatures
We hereby sign this Standard Confidentiality Disclosure Agreement and verify that the Standard Confidentiality Disclosure Agreement Section 1 to 7 in its entirety has not been modified.
On behalf of:
For Recipient:For Discloser:
Date:Date:
______
[Insert Name][Insert Name]
[Insert Title][Insert Title]
Physical recipient:
I hereby acknowledge that I have read and agree with the terms of this Standard Confidentiality Disclosure Agreement, and that I will act and perform my duties in accordance with the content of this Standard Confidentiality Disclosure Agreement and the details outlined in the Appendix A
Date:
______
[Insert Name]
[Insert Title]
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