BioInformatiCo (Pty) Ltd
Registration Number: 2023/005185/07
13th Floor, Green Park Corner, 3 Lower Road, Sandton, Johannesburg, Gauteng 2000, South Africa
This Agreement is a legally binding contract between BioInformatiCo Proprietary Limited, a private company with limited liability incorporated under the laws of the Republic of South Africa (“BioInformatiCo”) and the legal entity you represent (“Customer”, “you”).
BY CLICKING ‘I ACCEPT’, OR BY ACCESSING OR USING THE LEOVA PLATFORM, YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREE TO BE BOUND BY THE TERMS OF THIS AGREEMENT. IF YOU ARE ENTERING INTO THIS AGREEMENT ON BEHALF OF A COMPANY OR OTHER LEGAL ENTITY, YOU WARRANT THAT YOU HAVE THE LEGAL AUTHORITY TO BIND SUCH ENTITY TO THESE TERMS.
1.1. Introduction. This Agreement governs your participation in testing Leova, BioInformatiCo’s clinical trial configuration platform. Leova processes clinical trial protocol documents and generates Electronic Data Capture (EDC) configurations, schedules of events, Electronic Case Report Forms (eCRFs), and edit checks that can be exported to your chosen EDC system.
1.2. Purpose. The purpose of the Beta Programme is to evaluate Leova’s functionality and usability in a pre-commercial environment. You may test the Leova platform with your own protocols, provide Feedback on features and performance, and assess its potential fit for future use in your organisation. This collaborative testing helps BioInformatiCo refine the platform before commercial launch.
1.3. Beta Testing. Leova is pre-production software designed to accelerate trial database configuration and build. As a configuration tool used at the start of trial setup, Leova generates EDC configurations that you then implement in your chosen EDC system. The platform is in beta testing, which means outputs should be reviewed by qualified Personnel and thoroughly tested before implementing in your production EDC environment.
2.1 Definitions.For purposes of this Agreement, the following terms shall have the following meanings:
2.1.1. “Affiliate” means any person or entity that directly or indirectly controls, is controlled by or is under common control with a Party and, in the case of BioInformatiCo, also includes any Group Company;
2.1.2. “Agreement” means this Beta Programme Agreement, as may be amended by BioInformatiCo from time to time in accordance with clause 11.6;
2.1.3. “Beta Programme” means the pre-commercial testing and evaluation period during which BioInformatiCo provides you with access to Leova free of charge;
2.1.4. “Confidential Information” means any non-public information of a confidential, sensitive or proprietary nature (whether in oral, written, electronic or other form) disclosed by one Party to the other, including the performance and features of Leova, the Leova IP, Feedback and your Customer Data;
2.1.5. “Customer Data” means any clinical trial protocols, data or information you upload to Leova;
2.1.6. “Data Protection Legislation” means all applicable law relating to the processing of personal information, including the Protection of Personal Information Act, 4 of 2013 (“POPIA”), the General Data Protection Regulation (Regulation (EU) 2016/679) (“GDPR”) and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended from time to time;
2.1.7. “Effective Date” means the date upon which you accept this Agreement by clicking ‘I Accept’ or by first accessing Leova;
2.1.8. “Feedback” means all suggestions, comments, ideas, improvements, bug reports or other feedback you provide to BioInformatiCo regarding Leova;
2.1.9. “Group Company” means any member of the BioInformatiCo group of companies and all subsidiaries, associates and affiliates which operate and/or manage businesses under the “BioInformatiCo” name, including any successor-in-title or variation or addition to the BioInformatiCo group of companies, and any entity which is managed by or on behalf of any member of the BioInformatiCo group of companies;
2.1.10. “Intellectual Property Rights” means all patents, copyrights, design rights, trademarks, service marks, trade secrets, know-how and other intellectual property rights, whether registered or unregistered, including applications for the grant of any of the foregoing and all rights or forms of protection having equivalent or similar effect;
2.1.11. “Leova” means BioInformatiCo’s proprietary, cloud-based, AI-assisted, pre-production clinical trial configuration tool, including all underlying logic, templates, algorithms, software code (both source and object code), updates and associated documentation provided as part of the Beta Programme;
2.1.12. “Leova IP” means BioInformatiCo’s Intellectual Property Rights in and to Leova, including all source code, software architecture, demonstrated workflows, user interface (UI) design, automation logic and AI prompt-engineering methodologies;
2.1.13. “Output” means the output generated by Leova based on your Customer Data, including configurations, schedules of events, eCRFs and edit checks;
2.1.14. “Parties” means BioInformatiCo and Customer collectively, and “Party” means either of them individually as the context requires; and
2.1.15. “Personnel” means any director, officer, employee, agent, consultant, advisor, contractor or other representative of a Party.
2.1. Headings. Headings and sub-headings are inserted for information purposes only and shall not be used in the interpretation of this Agreement.
2.2. Examples. Whenever a term is followed by the word “including” or “include” or “excluding” or “exclude” and specific examples, the examples shall not limit the ambit of the term.
2.3. Days. Any reference to “days” shall mean calendar days unless otherwise specified.
3.1. Limited Licence. BioInformatiCo hereby grants you a limited, non-exclusive, non-transferable, revocable licence to access and use Leova during the Beta Programme solely for your internal evaluation and testing purposes.
3.2. Charges. The Beta Programme is provided free of charge.
3.3. Restrictions. You shall not, and shall ensure your Personnel do not:
3.3.1. reverse engineer, decompile or attempt to derive the source code of Leova;
3.3.2. use Leova to develop a competitive product or service;
3.3.3. permit access to Leova by any person who is affiliated with, employed by or providing services to a competitor of BioInformatiCo; or
3.3.4. sublicense, sell or lease access to Leova to any third party.
4.1. BioInformatiCo Ownership. As between the Parties, BioInformatiCo retains all right, title and interest in and to Leova, including the Leova IP. No rights are granted to you other than the limited access rights expressly set forth in this Agreement.
4.2. Feedback. BioInformatiCo shall automatically own all right, title and interest (including all Intellectual Property Rights) in and to any Feedback you provide. To the extent that ownership of Feedback does not vest in BioInformatiCo by operation of law, you hereby assign all such rights to BioInformatiCo in perpetuity and waive any moral rights therein. 4.3. Customer Ownership of Output. Subject to clause 4.1, you shall own the specific Output generated by Leova for your clinical trials. You are granted a perpetual, non-exclusive right to use such Output in connection with your clinical trials and EDC systems. For the avoidance of doubt, this ownership does not extend to the underlying logic, software or templates used by Leova to generate such Output.
4.3. Customer Ownership of Output. Subject to clause 4.1, you shall own the specific Output generated by Leova for your clinical trials. You are granted a perpetual, non-exclusive right to use such Output in connection with your clinical trials and EDC systems. For the avoidance of doubt, this ownership does not extend to the underlying logic, software or templates used by Leova to generate such Output.
5.1. Confidential Information. Each Party (“Receiving Party”) must treat and safeguard all Confidential Information which it may receive from the other Party (“Disclosing Party”), or which becomes known to it during the currency of this Agreement, as private and confidential, applying at least the same degree of care it uses to protect its own confidential information, but in no event less than a reasonable degree of care.
5.2. Receiving Party’s Obligations. The Receiving Party agrees that, in order to protect the proprietary interests of the Disclosing Party in the Disclosing Party’s Confidential Information:
5.2.1. it shall only use the Confidential Information for the purposes for which it has been disclosed under this Agreement;
5.2.2. it shall only make the Confidential Information available to those of its Personnel who are actively involved in the execution of the Receiving Party’s rights and obligations under this Agreement and, then, only on a “need to know” basis;
5.2.3. it shall not use the Confidential Information for the benefit of itself or any third party or use such information for any commercial purpose, unless authorised in writing by the Disclosing Party or as otherwise expressly permitted by this Agreement. Without limiting the generality of the foregoing, the Receiving Party undertakes, in particular, not to use or permit the use of the Confidential Information, whether directly or indirectly, to obtain a commercial, trading, investment, financial or other advantage over the Disclosing Party or otherwise use it to the detriment of the Disclosing Party;
5.2.4. it shall initiate internal security procedures reasonably acceptable to the Disclosing Party to prevent unauthorised disclosure and will take all practical steps to impress upon those Personnel who need to be given access to Confidential Information, its secret and confidential nature;
5.2.5. subject to the right to make the Confidential Information available to its Personnel under clause 5.2.1, it shall not at any time use any Confidential Information of the Disclosing Party or directly or indirectly disclose any Confidential Information of the Disclosing Party to third parties; and
5.2.6. all written instructions, drawings, notes, memoranda and records of whatever nature relating to the Confidential Information of the Disclosing Party which come into the possession of the Receiving Party and its Personnel shall be, and shall at all times remain, the sole and absolute property of the Disclosing Party and shall promptly be handed over to the Disclosing Party when no longer required for the purposes of this Agreement.
5.3. Duties on Termination. On termination or expiry of this Agreement, the Parties will deliver to each other or, at the other Party’s option, destroy all originals and copies of Confidential Information in their possession.
5.4. Exclusions. These obligations shall not apply to any information which:
5.4.1. is lawfully in the public domain at the time of disclosure;
5.4.2. subsequently and lawfully becomes part of the public domain by publication or otherwise;
5.4.3. subsequently becomes available to the Receiving Party from a source other than the Disclosing Party, which source is lawfully entitled without any restriction on disclosure to disclose the Confidential Information; or
5.4.4. is disclosed pursuant to a requirement or request by operation of law, regulation or court order, provided that the onus shall at all times rest on the Receiving Party to establish that such information falls within the above exclusions.
5.5. Indemnity. The Receiving Party hereby indemnifies the Disclosing Party against any claims, actions, liabilities, losses, damages, fines, costs and expenses (including reasonable legal fees on an attorney-and-own-client scale) which the Disclosing Party may suffer as a result of a breach of this clause 5 by the Receiving Party or its Personnel. 5.6. Survival. This clause 5 is severable from the remainder of this Agreement and shall remain valid and binding on the Parties, notwithstanding any termination, for a period of 5 (five) years after the effective date of termination.
6.1. Compliance with Data Protection Legislation. The Parties shall comply with all applicable Data Protection Legislation.
6.2. Purpose of Processing. BioInformatiCo shall process Personal Information only for the purposes of providing access to Leova and its functionality and managing the Beta Programme. You warrant that you have the necessary legal basis and consents to upload Customer Data (including any Personal Information) to Leova.
6.3. Location of Processing. Your Customer Data is primarily stored in the European Union using Amazon Web Services (AWS) infrastructure. However, because BioInformatiCo is based in South Africa and some of its service providers operate internationally, your personal information may be accessed from or transferred to countries outside the European Economic Area (EEA).
6.4. Data Transfers. When BioInformatiCo transfers Customer Data outside the EEA, it implements appropriate safeguards, including contractual requirements for service providers to maintain appropriate security measures, encryption of data in transit and at rest using industry-standard protocols, access controls and authentication measures, regular security assessments and other appropriate technical and organisational measures. BioInformatiCo’s service providers are contractually required to comply with applicable Data Protection Legislation.
6.5. Data Processing Agreement. If required by applicable law, the Parties shall enter into a separate Data Processing Agreement (DPA) governing BioInformatiCo’s processing of Customer Data.
6.6. Privacy Policy. BioInformatiCo is committed to protecting your privacy. Please refer to BioInformatiCo’s privacy policy for information on how it collects, uses and discloses personal information. The terms of BioInformatiCo’s privacy policy (as amended from time to time) are incorporated herein by this reference.
7.1. Disclaimer. Leova is pre-production software provided on an “as is” and “as available” basis for testing purposes.
7.2. No Representations or Warranties. BioInformatiCo makes no representations and gives no warranties of any kind, whether express, implied, statutory or otherwise. BioInformatiCo specifically disclaims all implied warranties, including any warranties of merchantability, fitness for a particular purpose or non-infringement, to the maximum extent permitted by applicable law.
7.3. Disclaimer of Specific Warranties. Without limiting the foregoing, BioInformatiCo does not warrant that the output of Leova will be accurate, error-free or suitable for live clinical trials. You acknowledge that any use of the output in a production or live environment is at your sole risk and should be subject to independent validation by qualified personnel.
8.1. Exclusion of Damages. To the maximum extent permitted by law, BioInformatiCo shall not be liable for any indirect, incidental, special, consequential or punitive damages, or any loss of profits, data, business or goodwill, arising out of or in connection with this Agreement.
8.2. Liability Cap. Notwithstanding anything to the contrary in this Agreement, BioInformatiCo’s total aggregate liability to you for any claim arising out of or relating to this Agreement, whether in contract, delict (including negligence) or otherwise, shall be limited to the amount of R1,000.00 (one thousand South African rand).
9.1. Indemnity. You hereby indemnify and hold BioInformatiCo, its Affiliates and its officers harmless against any and all claims, damages, liabilities, costs and expenses (including reasonable legal fees) arising out of or related to:
9.1.1. your use of Leova or the Output in a live clinical trial environment;
9.1.2. any breach of third-party Intellectual Property Rights or privacy rights resulting from Customer Data; or 9.1.3. your breach of the restrictions set out in clause 3.3.
10.1. Commencement and Duration. This Agreement commences on the Effective Date and shall continue until the end of the Beta Programme, unless terminated earlier.
10.2. Termination by BioInformatiCo. BioInformatiCo may, in its sole discretion, terminate this Agreement and your access to Leova summarily and without cause at any time upon written notice (which may be provided via e-mail or through the Leova platform).
10.3. Termination by Customer. You may terminate this Agreement at any time by ceasing all use of Leova.
10.4. Consequences of Termination. Upon termination or expiry of this Agreement for any reason, all licences granted herein shall immediately cease. You shall have 30 (thirty) calendar days to export your Customer Data, after which BioInformatiCo may delete such data without further notice.
11.1. Governing Law. This Agreement shall be governed and construed according to the laws of the Republic of South Africa.
11.2 Jurisdiction. You agree to submit to the exclusive jurisdiction of the High Court of South Africa, Gauteng Local Division, Johannesburg.
11.3. Severability. If any part of this Agreement is found to be void, unenforceable or illegal, that part shall be severed and the remainder of the Agreement shall remain in full force and effect.
11.4. No Waiver. No failure or delay by BioInformatiCo in exercising any right under this Agreement shall constitute a waiver of that right.
11.5. Entire Agreement. This Agreement constitutes the entire agreement between the Parties regarding the Beta Programme and supersedes all prior agreements, representations or understandings.
11.6. Amendment. BioInformatiCo reserves the right to amend these terms at any time by posting the updated terms on the Leova platform. Continued use of the platform constitutes acceptance of the amended terms.
