A sample data sharing agreement is an essential legal document for any company that collects, aggregates, or sells data. A data-sharing agreement can ensure a company complies with the law and protects its intellectual property rights.
These agreements include information about how data is collected, how it’s stored, and how long the company can keep or use the data. It will also protect the customer’s rights, like whether their data can be sold or used by other parties.
Below is a list of common sections included in Sample Data Sharing Agreements. These sections are linked to the below sample agreement for you to explore.
DATA SHARING AGREEMENT
This Data Sharing Agreement (this “ Agreement ”) is entered into effective as of May 22, 2018 (the “ Effective Date ”), by and between Urovant Sciences GmbH, a limited liability company organized under the laws of Switzerland (“ Urovant GmbH ”), and Datavant, Inc., a company organized under the laws of the State of Delaware (“ Datavant ”). Urovant GmbH and Datavant are referred to individually as a “ Party ” and collectively as the “ Parties. ”
WHEREAS, each Party is the owner of, or otherwise has the right to license, applicable Data to the other Party for the purposes set forth herein;
WHEREAS, Datavant desires to license the Urovant Data from Urovant GmbH, and Urovant GmbH is willing to license the Urovant Data to Datavant for the purposes stated in this Agreement;
WHEREAS, Urovant GmbH desires to license the Datavant Data from Datavant, and Datavant is willing to license the Datavant Data to Urovant GmbH for the purposes stated in this Agreement;
WHEREAS, Urovant GmbH expects to derive a substantial benefit from its licensing of all of the Datavant Data for use in achieving its strategic goals; and
WHEREAS, Datavant will license a limited amount of Data from Urovant GmbH that is subject to certain use limitations, transfer restrictions and confidentiality obligations under this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, rights and obligations set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
| 1. | DEFINITIONS |
“ Affiliate ” means, with respect to any person, any other person, directly or indirectly through one or more intermediaries, controlling or controlled by or under direct or indirect common control with such person. For purposes of this definition, “control” (including, with correlative meanings, the terms “controlling”, “controlled by” and “under common control with”), as used with respect to any person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such person, whether through the ownership of voting securities, by agreement or otherwise (it being understood that for purposes of this Agreement, Datavant and its subsidiaries, on the one hand, and Urovant GmbH and its subsidiaries, on the other hand, shall not be deemed to be Affiliates of one another).
“ Change of Control ” means (a) any consolidation or merger or amalgamation of either Party with or into any other corporation or other Person, or any other corporate reorganization or similar transaction, in which the holders of outstanding voting securities of either Party immediately prior to such consolidation, merger, amalgamation, reorganization or similar transaction hold, directly or indirectly, less than fifty percent (50%) of the outstanding voting securities of either Party or of the surviving or resulting entity (or the power to direct or cause the direction of the management and policies of the surviving or resulting entity) immediately after such consolidation, merger, reorganization or similar transaction; or (b) any transaction or series of related transactions as a result of which the holders of outstanding voting securities of either Party immediately prior to
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
such transaction or transactions hold, directly or indirectly, less than fifty percent (50%) of the outstanding voting securities of either Party (or the power to direct or cause the direction of the management and policies of either Party) immediately after such transaction or transactions.
“ Competing Program ” means [***].
“ Data ” means data and results relating to pre-clinical trials, clinical trials, drug study design, and drug study protocol, including, but not limited to, pharmacological and patient-level data. Data does not include accounting, financial, legal instruments including patents, trademarks and copyrights, licensing, consumer, marketing and employee data, and data relating to transactions.
“ Datavant Data ” means: (a) all Data owned and/or licensed by Datavant for which Datavant has the right to license or sublicense, and lawfully disclose, to Urovant GmbH for the purposes stated in this Agreement without violation of any contractual, regulatory or legal obligations; (b) all data offered by Datavant as part of Datavant Products made available in connection with this Agreement; (c) all derived data and data sets, in each case, derived or resulting from the use of products or services of Datavant and for which Datavant has the right to license or sublicense, and lawfully disclose, to Urovant GmbH for the purposes stated in this Agreement; and (d) all other data mutually agreed by the Parties to be provided pursuant to this Agreement. Notwithstanding the foregoing, unless otherwise approved by both parties, Datavant Data shall not include any data sets where Datavant would incur an incremental fee or expense from licensing or disclosing the data to Urovant GmbH.
“ Datavant Products ” means data, or other data products or data analytics products, that Datavant makes generally available to its users, customers, licensees and channel partners (e.g., resellers).
“ Healthcare Products ” means products, devices, compounds, drugs, substances, apparatuses, instrumentalities or equipment, in each case that may be or actually are used, marketed, promoted, sold, licensed or commercialized in the medical, health care, pharmaceutical, biosciences, genetics or life sciences fields, industries or sectors.
“ Laws ” means all laws, by-laws, rules regulations, orders, ordinances, protocols, codes, guidelines, instruments, policies, notices, directions and judgments or other requirements of any governmental entity whether foreign or domestic.
“ Licensed Data ” means, collectively, Urovant Data and Datavant Data.
“ Marks ” means trademarks, service marks, trade names, domain names, trade dress, logos, and similar designations and indicia of origin, whether registered or unregistered, and all applications and registrations therefore together with all goodwill arising from any of the foregoing.
“ Person ” means any individual, corporation, trust, estate, partnership, joint venture, company, association, governmental bureau or agency, or any other entity regardless of the type or nature thereof.
“ Third Party ” means any entity other than a Party or an Affiliate.
“ Urovant Entities ” means Urovant Sciences Ltd. and those non-public subsidiaries that, now or in the future, are wholly-owned, directly or indirectly by Urovant Sciences Ltd., including Urovant Holdings Limited, a corporation formed under the laws the United Kingdom, Urovant Sciences, Inc., a corporation formed under the laws of the State of Delaware, and Urovant Sciences GmbH, a limited liability company formed under the laws of Switzerland.
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
“ Urovant Data ” means: (a) all Data collected as part of clinical trials or other patient-level data that is owned and/or licensed by Urovant GmbH and/or the Urovant Entities for which Urovant GmbH and/or the Urovant Entities have the right to license or sublicense, and lawfully disclose, to Datavant for the purposes stated in this Agreement without violation of any contractual, regulatory or legal obligations; and (b) all other data mutually agreed by the Parties to be provided pursuant to this Agreement.
| 2. | GRANT OF LICENSES |
| 2.1 | Subject to the conditions set forth in Sections 3.1 , 3.2 , 5 and 9 , Urovant GmbH hereby grants to Datavant a royalty-free, worldwide (excluding jurisdictions prohibited by the United States government), non-exclusive, irrevocable license to the Urovant Data solely for Datavant to (a) use, reproduce, modify, translate, or analyze such Urovant Data to develop Datavant Products or (b) provide the Urovant Data to Third Parties (provided that such Third Parties do not then have a Competing Program; provided, further, that the Parties shall work in good faith to determine the conditions by which Datavant would be able to provide the Urovant Data to Third Parties, including, but not limited to, through Datavant Products, prior to any provision thereof, but only to the extent necessary to meet contractual, regulatory or legal obligations). To the extent that Urovant inadvertently provides Datavant with Personally Identifiable Information, Datavant shall not have the right to include or incorporate into any Datavant Products, or otherwise disclose, any Personally Identifiable Information that may be included in any Urovant Data. |
| 2.2 | Subject to the conditions set forth in Sections 3.1 , 3.3 , 5 and 9 , Datavant hereby grant(s) to Urovant GmbH a royalty-free, worldwide (excluding jurisdictions prohibited by the United States government), non-exclusive, irrevocable license to use the Datavant Data and applicable Datavant Products for the following internal purposes within Urovant GmbH and the Urovant Entities: |
| (a) | identifying, evaluating and acquiring (regardless of whether through a merger, acquisition, license, joint venture or other business combination) Healthcare Products; |
| (b) | supporting the regulatory filings of Urovant GmbH and the Urovant Entities, including applications for regulatory approvals, rights of reference to any such Datavant Data and disclosures to regulatory authorities in support of any of the foregoing; |
| (c) | optimizing the strategies for Urovant GmbH and the Urovant Entities relating to corporate and business development, discovery, research, development, study design, study protocol, safety, efficacy, pharmacovigilance, adverse event reporting, manufacturing and quality of any Healthcare Product; and |
| (d) | any other purpose mutually agreed by the Parties. |
| 2.3 | Except for these rights and licenses expressly granted, no other intellectual property rights are granted or should be implied. As between the Parties, Urovant GmbH shall retain all title and ownership in the Urovant Data, and Datavant shall retain all rights and ownership in the Datavant Data and Datavant Products. Unless otherwise mutually agreed by the Parties, all data derived by Datavant from use of Urovant Data shall become part of Datavant Data and shall be licensed to Urovant GmbH pursuant to the terms of this Agreement. The Parties may share Data with each other, but only to the extent that the Data is in an anonymized or otherwise de-identified form that permits the Parties to combine the data in a commercially reasonable and legal way. |
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
| 3. | REPRESENTATIONS, WARRANTIES AND ADDITIONAL OBLIGATIONS |
| 3.1 | Mutual Representations, Warranties and Covenants . |
| (a) | Each Party represents and warrants to the other Party that: (i) it is qualified and registered to transact business in all locations where the performance of its obligations hereunder would require such qualification; (ii) it has and shall maintain all necessary rights, powers and authority, including all permits and licenses required, to enter into and perform this Agreement and to grant any and all rights or licenses granted or required to be granted by it under this Agreement; and (iii) the execution and performance of this Agreement by it shall not conflict with or violate any applicable Laws, rule, regulation, or governmental order and shall not breach any agreement, covenant, court order, judgment or decree to which it is a party or by which it is bound. |
| (b) | Each Party shall implement a data privacy, data security and compliance program compliant with applicable U.S. state, federal and International data security and privacy laws and legal requirements (“ Privacy Laws ”) and that is reasonably acceptable to the other Party prior to receipt of any Licensed Data from the other Party pursuant to this Agreement, and shall maintain such program for the duration of this Agreement. |
| (c) | Datavant agrees to license software that de-identifies patient identifiable data for purposes of compliance with the Health Insurance Portability and Accountability Act of 1996 (“ HIPAA ”) to Urovant GmbH as a Datavant Product without charging a license fee, and Urovant GmbH agrees that it shall exclusively use such software to de-identify patient identifiable data, provided that such use satisfies Urovant GmbH’s compliance obligations under HIPAA. For clarity, neither Party is making an admission that such Party is a “covered entity” or a “business associate” as such terms are defined under 45 C.F.R. §160.103. |
| 3.2 | Urovant GmbH Covenants . Urovant GmbH shall: |
| (a) | use commercially reasonable efforts to share, disclose, and transfer to Datavant the Urovant Data; provided, however, that Urovant GmbH shall have no obligation to provide Urovant Data related to any clinical trial prior to completion of such clinical trial and the publication or presentation by Urovant GmbH of the data generated in connection with such clinical trial; |
| (b) | protect Datavant Data as Confidential Information of Datavant in accordance with Article 5 to the extent such Datavant Data constitutes Confidential Information as defined in Article 5 ; provided, however, that Article 5 shall not be construed to limit the license rights granted to Urovant GmbH under this Agreement; and |
| (c) | use commercially reasonable efforts to obtain applicable Data from the Urovant Entities and sublicense such Data to Datavant. |
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
| 3.3 | Datavant Covenants . Datavant shall: |
| (a) | use commercially reasonable efforts to secure the right to license to Urovant GmbH, in accordance with the license rights set forth in this Agreement, all Datavant Data that is owned, licensed or controlled by, or otherwise comes into the possession of, Datavant; |
| (b) | use commercially reasonable efforts to share, disclose and transfer to Urovant GmbH (or its designees) the Datavant Data requested by Urovant GmbH; |
| (c) | provide Urovant GmbH access to any Datavant Products that are required for Urovant GmbH to use the Datavant Data for the purposes intended by Urovant GmbH, provided there is no additional cost to Datavant; |
| (d) | communicate to Urovant GmbH in a manner reasonably acceptable to Urovant GmbH if Datavant becomes aware of material information regarding Urovant GmbH’s clinical trial results; to the extent that Datavant becomes aware of anything material it will let Urovant GmbH know as soon as is practicable; |
| (e) | protect Urovant Data as Confidential Information of Urovant GmbH in accordance with Article 5 to the extent such Urovant Data constitutes Confidential Information as defined in Article 5 ; provided, however, that Article 5 shall not be construed to limit the license rights granted to Datavant under this Agreement. |
| 4. | RELATIONSHIP OF THE PARTIES |
The Parties are each independent contractors and not joint venturers, partners, agents, or representatives of the other. Neither Party nor its employees, subcontractors or agents shall be deemed to be agents, servants or employees of the other Party, nor shall the Parties be deemed or construed solely by this Agreement to be partners or joint venturers.
| 5. | CONFIDENTIAL INFORMATION |