General Provisions

1.  License Agreement. This is the document which any user of the inCytes™ platform, including Benchmarc™, should automatically accept upon his/her first use of the platform. We should also automatically generate and maintain in an easily findable location a record of that acceptance. It may be electronic. The License Agreement will incorporate by reference – that does not mean merge with or bethe same document as – the company’s Privacy Policy. Because of this, there isno need for a separate acceptance of the Privacy Policy.

2.  Privacy Policy. This is, as the name suggests, a statement of our policy regarding the maintenance and use of, and access to, personal data, PHI and similar information which may be deemed private or personal in the legal structure of various countries. As mentioned, it need not be signed or accepted since it is incorporate by reference in the License Agreement, which is (should be) automatically accepted by any user of inCytes™. 

3.  Sponsorship Agreement. This is the commercial document signed by RegenMed and an industry sponsor. It also incorporates by reference the License Agreement and the Privacy Policy. Individual HCP’s which pay as they go, and are not required by our pricing terms (as set out in the Sponsorship Agreement) to pay an initial $3,000 base fee, do not need to execute a Sponsorship Agreement. Of course, they like any other user of inCytes will automatically accept the License Agreement.

4.  Consent Forms. The foregoing three documents are our standard documents, each with its own purpose. inCytes™ accommodates other agreements, in particular specific patient consent forms. These are particularly important in clinical trials and studies, and will almost always be specified by the client. The principal beneficiary of such consent forms is not RegenMed – we are covered by the License Agreement, but rather the Sponsor or other client.

5.  Confidentiality Agreements. (Also, called NDA’s or Non-Disclosure Agreements). We have a standard form of this, which is used on a case-by-case basis upon request by our client or ourselves.

6.  Other Legal Documents. There will be inevitably other legally-binding documents which we will prepare or enter into from time to time. 

7.  Creation and Amendment of Legal Documents. The wording of our legal documents can of course have important implications for us in the context of legal disputes, regulatory review, and other matters. No changes should be made to any templates our outside counsel or I prepare. This isn’t because I like the work of preparing legal documents – I don’t – but because they there should be a single point of review for all legal matters and for now that is myself. I am always available to review any questions regarding any legal document or other legal matter. Please do not hesitate to call.

8.  Maintenance of Legal Documents. All current templates of the License Agreement, Privacy Policy and Sponsorship Agreement should be maintained in an easily accessible SP location for all to find. That location should not contain any former versions, drafts etc.; rather, such former versions and drafts should be kept in separate locations clearly identified as drafts or prior versions so no one mistakes them for the current versions. Executed legal documents – that is, legal documents which have been signed or accepted by the parties and therefore are legally binding – should have clearly descriptive file names and stored/maintained in folders or other locations where they are easily to find. In the great majority of cases, these documents will be specific to a particular client, and should be in a folder associated with that client.

Visibility within the inCytes™ platform

Legend:

• Permissions: R - Read, W - Write;
• Accessibility: * - indirect (by following the link from knowledge base).

Description:

• "License Agreement" and "Privacy Policy" are located as independent pages with reciprocal links in publicly available Knowledge Base for Investigators.
• "License Agreement" could be viewed during the Sign Up process on inCytes™ (both investigator or patient) by clicking the "Terms & Conditions" checkbox or by following the corresponding article in Knowledge Base for Investigators. We store each version of "License Agreement" in inCytes™ database, so each time the page on Knowledge Base is updated, inCytes™ administrator need to update the version on Settings page as well ("Clinician's Terms and Conditions" and "Patient's Terms and Conditions" sections).
• "Healthcare Consent" could be viewed by patient during the sign-up process or at any time from the Homepage (bottom message) on BenchmarC™, or edited by inCytes™ administrator on Circle Detail page.
• "Sponsorship Agreement": can be accessed in the Knowledge Base for Investigators