Terms and Conditions
This terms and conditions was updated 2023-12-08 16:43:27.224.
Third-Party Outgoing Data Use Agreement
THIS THIRD-PARTY OUTGOING DATA USE “AGREEMENT (this "Agreement") is entered into by and between Bill & Melinda Gates Foundation (“BMGF”), Bill & Melinda Gates Medical Research Institute (“Gates MRI”), Janssen Pharmaceutica NV (“Janssen”), GlaxoSmithKline Intellectual Property Development (“GSK”), Otsuka Pharmaceutical Co. Ltd (“Otsuka”), The Global Alliance for TB Drug Development, Inc. (“TBA”) and Evotec International GmbH (the "Collaboration Member(s)"), and the Approved Third Party User. The Collaboration Member(s) and the Approved Third Party User being sometimes individually referred to herein as a “Party” and collectively as the “Parties”.
Terms and Conditions
The Collaboration Member(s) agree that, upon the Approved Third-Party User signing of this Agreement, the Approved Third-Party User may have access to the Data (as defined below) specified in the relevant Data Access Request Form (as defined below) for the sole purposes of using the Data as the Approved Third-Party User has specified in said Data Access Request Form and as approved by the relevant Collaboration Member(s). Terms for accessing and using data obtained from the C-Path managed TB data repository (the “Data”):
1. By accessing the Data, the Approved Third-Party User agrees that it is entering into these terms and conditions of use (the “Terms”), the details of which are further specified in the data access request issued to C-Path (such request, the “Data Access Request Form”) when accessing the Data on the C-Path managed Pan-TB data repository and approved by the Pan-TB Platform Access Review Committee (such approval, the “Data Access Approval”).
2. The Approved Third-Party User represents and warrants that the information in the Data Access Request Form that it has submitted for access to the Data is complete and accurate, including a complete and accurate description of the research to be conducted by the Approved Third-Party User using the Data (the “Approved Purpose”) and that the Approved Third-Party User shall comply with the terms set forth herein.
3. Nature of the Data. The Approved Third-Party User understands that the Data does not include personal data and/or personal information collected about human subjects. For the avoidance of doubt, the Approved Third-Party User acknowledges that the General Data Protection Regulation (EU) 2016/679 (“GDPR”), national legislation implementing the GDPR, and the United States Health Insurance Portability and Assurance Act do not apply to the Data.
4. Grant of Licenses.
(a) To Use the Data. The Collaboration Member(s) grants to the Approved Third- Party User a non-exclusive, non-transferable, paid-up, revocable license throughout the world to use the Data for the Term, solely for the Approved Purposes (as such term is defined in the Data Access Request Form).
(b) Prohibitions. The Approved Third-Party User shall not sell, rent, transfer, redistribute or otherwise disclose the Data to persons or entities.
(c) No Further Rights. The Collaboration Members do NOT grant any rights or licenses under this Agreement to any other third party or grant the Approved Third-Party User the right to grant any such rights or licenses.
(d) Not to seek intellectual property rights. The Approved Third-Party User shall not either use the Data to, or to attempt in any way to, apply for, obtain, or secure or enforce, any registered or unregistered intellectual property rights, title, or interest in or to any results or intellectual property therein generated by the use of the Data unless otherwise previously expressly approved in writing by the applicable Collaboration Member(s) of said Data.
(e) No Implied Rights. The Approved Third-Party User acknowledges and agrees that no express or implied licenses or other rights are provided to them to use the Data, or any related patents, patent applications, copyright, trade secrets, confidential information or other intellectual property or proprietary rights of the Collaboration Member(s) or any other third party, for any purpose other than as expressly set forth in Sections 4(a), 4(b), 4(c) and 4(d) herein.
5. The Approved Third-Party User agrees to maintain Data to which it has access as confidential and that it will limit access thereto to persons who have a need to know and who have written obligations of confidentiality thereto that are no less strict than those provided for herein. The foregoing notwithstanding, subject to, and except as expressly permitted by this Agreement or otherwise expressly consented to in writing by the Collaboration Member(s) in advance, the Approved Third-Party User agrees not to disclose the Data to any third party or publish the Data.
6. Publication. For the meaning of this section, “Publication” means dissemination in a presentation or document or in any other way.
The Approved Third-Party User shall submit in writing to C-Path, for review by the Collaboration Member(s), the details of any Data that it intends to publish, at least sixty (60) days before the date of the proposed Publication. Within thirty (30) days after receiving details of the proposed Publication, an approval from Collaboration Member(s) may be given, and, if so, the Approved Third-Party Users shall comply with, written notice by the Collaboration Member(s), that:
(a) require(s) the Approved Third-Party User to delay the proposed Publication up to one hundred twenty (120) days after receipt of details of the proposed Publication, if, in the Collaboration Member(s)’s reasonable opinion(s), that delay is necessary in order to seek patent or similar protection for any confidential information owned by it(them), that are to be published; or
(b) prevents the Publication of any confidential information that is not publicly known by removing the same from the proposed publication (with Publication
being permitted after such removal).
If approval from Collaboration Member(s) is not given within (30) days after receiving details of the proposed Publication, the request of Publication is deemed denied by the Collaboration Member(s).
As part of the terms and conditions for the use of Data, the Approved Third-Party User agrees that any Publication arising in whole or in part from the Data shall acknowledge the contribution of the Data. Approved Third Party Users will also be required to agree that, if Publication of any results using the Data is sought in a peer reviewed journal, the Publication must be under “open access” terms consistent with BMGF’s Open Access Policy available at: www.gatesfoundation.org/How-We- Work/General-Information/Open-Access Policy, which may be modified from time to time.
7. The Approved Third-Party User will use the Data only for legitimate interests in compliance with all applicable federal, state, local, international, health authority and institutional laws, rules, regulations, orders, and guidelines and in any manner, for the purpose stated within the Data Access Request Form.
8. The Approved Third-Party User shall use appropriate administrative, physical, and technical safeguards to prevent the unauthorized use or disclosure of the Data including but not limited to the information protections detailed in Annex 1.
9. Data Ownership.
(a) For the purpose of this section, "Research Results" means all information, data, formulae, outcomes or other results, and all intellectual property rights therein, produced by Approved Third Party Users, or a person or entity performing activities for an Approved Third-Party User, using the Data.
(b) Ownership of the Data. As between the Collaboration Member(s) on one hand, and any Approved Third-Party User on the other hand, the Collaboration Member(s) shall retain ownership and/or control of all rights, title, and interest in and to the Data.
(c) Ownership of Research Results. As between the Collaboration Member(s) on one hand, and any Approved Third-Party User on the other hand, ownership and public availability of all Research Results shall be owned by the Approved Third-Party User.
10. Provision and use of Research Results. The Approved Third-Party User agrees to provide all Research Results generated using the Data to C-Path using the Data Contributor Record Form (Annex 2) and through a secure data transfer process to avoid a breach for inclusion on the C-Path managed Pan-TB data repository. Each Collaboration Member will have a non-exclusive, royalty-free right to use all said Research Results provided to C-Path under Section 9c for research purposes (including the right to have third parties use such Research Results for them) only. Each Collaboration Member that is the asset owner of the asset(s) and/or compound(s) relating to the Data that was used to generate such Research Results, will have an exclusive, royalty-free right to use all such Research Results (and to have such Research Results used for them) provided to C-Path under Section 9c for commercial purposes in connection with the asset(s) and/or compound(s) of such Collaboration Member that is the subject of the Data. In the case of unauthorized access and/or use or disclosure of the Data and/or results generated by the use thereof, the Approved Third-Party User will notify C-Path, who, in turn, will notify the Collaboration Member(s) of such unauthorized use or disclosure as soon as practicable but, in any event, not later than twenty-four (24) hours after becoming aware thereof.
11. Waiver of Implied Representations and Warranties. EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES OF THE COLLABORATION MEMBER(S) SET FORTH IN THIS AGREEMENT, THE DATA IS PROVIDED "AS IS" AND THE COLLABORATION MEMBER(S) MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE DATA WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, TRADE SECRET OR OTHER PROPRIETARY RIGHT.
12. Waiver of consequential damages. NO COLLABORATION MEMBER NOR C-PATH, NOR ITS(THEIR) RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS AND AFFILIATES WILL BE LIABLE TO THE APPROVED THIRD PARTY USER OR ITS AFFILIATES FOR ANY CONSEQUENTIAL, SPECIAL, DIRECT, INDIRECT, INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES OR OTHER SIMILAR OR LIKE DAMAGES (INCLUDING LOSS OF PROFITS) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY FOR ITS POSSESSION OR USE OF THE DATA UNDER THIS AGREEMENT EVEN IF SUCH PARTY OR AFFILIATE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
13. By accessing the Data, the Approved Third Party User agrees to indemnify, defend and hold harmless C-Path, the Collaboration Member(s), and their respective directors, officers, employees, agents and affiliates (each an “indemnified party” and collectively, the “indemnified parties”), from and against any and all liabilities, losses, damages, costs and expenses (and all legal costs including reasonable attorneys’ fees, court costs, expenses and settlements resulting from any action or claim) incurred by, or asserted against any indemnified party arising from or relating to any claim or action that arises from or results from use of any of the Data by the Approved Third-Party User or any of its representatives, whether by download or Otherwise.
14. If any such claim or proceeding arises, the applicable indemnified party shall give written notice of the claim to the Approved Third-Party User promptly after the indemnified party receives notice of its existence. The Approved Third-Party User shall have the right, at its expense, to employ counsel to defend against the claim, and to compromise, settle or otherwise dispose of the claim, all at its expense, provided that no compromise or settlement of any claim admitting liability of or imposing duties or performance upon any indemnified party may be affected without the prior written consent of such indemnified party. If the Approved Third Party User does not initiate efforts to defend against or resist the claim within thirty (30) calendar days after receiving notice from any indemnified party, the indemnified party shall be free to investigate, defend, compromise, settle or otherwise dispose of the claim and incur other costs in connection therewith, for the account and at the Approved Third Party User’s expense, in such manner as the indemnified party deems in its best interest.
15. IMPORTANT NOTE: It is the policy of C-Path to add additional data to the C-Path managed TB data repository as it becomes available. The Approved Third-Party User understands and acknowledges that any Data it downloads may be preliminary and the results may change as new Data is added.
16. The Approved Third-Party User acknowledges and agrees that failure of it to abide by these Terms may result in termination of its access to the C-Path managed Pan-TB data repository.
17. The Collaboration Member(s) may terminate this Agreement at any time immediately on written notice:
(a) for breach of this Agreement by the Approved Third-Party User, if such breach is not remedied within thirty (30) days of the receipt of notice of such breach from the applicable Collaboration Member(s); or
(b) if the applicable Collaboration Member provides written notice to the relevant Approved Third-Party User.
18. Upon termination of this Agreement, the rights granted to the Approved Third-Party User pursuant to these Terms shall automatically terminate, and it shall (a) immediately cease use of the Data, and (b) permanently delete all Data in its possession and/or under its control.
19. The following clauses shall survive the termination of this Agreement: [7; 9; 11; 12; 18; 20; 21; 22].
20. Notices. Any notice required or given under this Agreement shall be in writing and shall be delivered by personal delivery, email, facsimile (provided the sender has evidence of successful transmission) or next day courier service. Any notice so delivered shall be deemed to be given, delivered, and received, if delivered by personal delivery, on the day of delivery and if delivered by email, facsimile, or courier service, on the day following dispatch. All such notices are to be given or made to the parties at the addresses (or to such other address as a party may designate by a notice given in accordance with the provisions of this section) as are set forth below:
If to Approved Third Party User to the contact details included in the Data Access Request Form.
If to C-Path or Collaboration Members via C-Path to:
Critical Path Institute
1840 E. River Road, Suite 100
Tucson, AZ 85718 USA
Facsimile: +1 520-547 3440
E-Mail: rliwski@c-path.org
Attention: Richard Liwski, Chief Technology Officer
21. Except as explicitly provided for herein, no one except the Approved Third-Party User and the Collaboration Member(s) may enforce any benefit conferred by these Terms, except that the indemnified parties will have the benefit of the indemnity in paragraph 12, under the Contracts (Rights of Third Parties) Act 1999.
22. These Terms and any dispute or claim arising out of or in connection with them or this subject matter or their formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of the State of New York. I irrevocably agree that the Federal courts having jurisdiction in New York shall have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with these Terms.
ANNEX 1
Information Protections
1. The Data will be stored on a password protected institutional network server (Data must not be stored on portable computers, portable storage devices, institutional/personal websites, or public clouds).
2. The network perimeter must be protected by firewall systems to block access from outside the entity.
3. Where Data is required to be on a portable device for a limited period of time – it must be encrypted and deleted from the device when no longer required.
4. In addition to secure network access, the Data will be password protected and only the research team will have access.
5. The Data will be destroyed after the research has been completed. Approved Third Party Users may retain only encrypted copies of the minimum Data necessary at their entity to comply with institutional scientific data retention policy. Notification of Data destruction must be sent to C-Path.
6. Security controls should be on by default; Approved Third Party Users should not have to perform any active action to turn them on.
7. A data security plan is in place under the accountability of the chief information officer (or equivalent) in which security provisions are set-up before the Data are transferred.
8. Approved Third Party Users with access to the Data are trained on the importance of data security and the security plan.
9. Only named individuals on the research team shall have access.