Policies

Privacy Policy

This privacy policy discloses the privacy practices for the Vast Therapeutics, Inc. website, user dashboards and admin portals (the “Service”). This privacy policy applies solely to information collected by the Service. It will notify you of the following:

  1. What personally identifiable information is collected from you through the Service, how it is used and with whom it may be shared.
  2. What choices are available to you regarding the use of your data.
  3. The security procedures in place to protect the misuse of your information.
  4. How you can correct any inaccuracies in the information.

Information Collection, Use, and Sharing
We only have access to information that you provide to us via email, which you enter directly into a form (including but not limited to your profile information, registration information, and/or contact form submissions) or an answer or selection made from a multiple-choice selection/question/survey within the Service. You are asked to provide this information in order to initiate a conversation regarding goods and services of interest to you. The only information we request is your name and/or email. You are discouraged from providing us any further information and we will not be under any obligation to maintain such other information. We will not sell, rent or provide this information to anyone beyond our organization or parent organization, PhotonMD.

We may use your information to respond to you, regarding the reason you contacted us, or to provide you with relevant newsletters and updates. We may also use your information for analytical purposes to understand ways to better enhance the features or functionality of the Service. Unless you ask us not to, we may contact you via email or other direct contact method in the future to tell you about specials, new products or services, or changes to this privacy policy.

Your Access to and Control Over Information
You may opt out of any future contacts from us at any time. You can do the following at any time by contacting us via the email address or phone number given on our website:

  • See what data we have about you, if any.
  • Change/correct any data we have about you.
  • Have us delete any data we have about you.
  • Express any concern you have about our use of your data.

Security
We do not request nor encourage that you transmit any personally identifying information. We will take reasonable precautions to protect any information you do provide.

Updates
Our Privacy Policy may change from time to time and all updates will be posted on this page.

If you feel that we are not abiding by this privacy policy, you should contact us immediately via email at info@vasttherapeutics.com.

Registration
In order to use this Service, a user must first complete the short registration form or create a profile. During registration, a user is required to give certain information (such as name, phone number and/or email). This information is used to contact you about the products/services within our Service in which you have expressed interest.

Cookies
We use “cookies” on within this Service. A cookie is a piece of data stored on a site visitor’s hard drive to help us improve your access to our Service and identify repeat visitors to our Service. For instance, when we use a cookie to identify you, you would not have to log in a password more than once, thereby saving time while on our site. Cookies can also enable us to track and target the interests of our users to enhance the experience on our site. Usage of a cookie is in no way linked to any personally identifiable information on our site.

Some of our business partners may use cookies on our Service (for example, advertisers). However, we have no access to or control over these cookies.

Links
This Service may contain links to other sites. Please be aware that we are not responsible for the content or privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of any other site that collects personally identifiable information.

Financial Conflict of Interest Policy

Purpose

KNOW Bio, LLC and its subsidiaries, which include EmitBio, Inc., Revian, Inc., and Vast Therapeutics, Inc., (collectively, “KNOW Bio”) are committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal Financial Conflict of Interest. 

The purpose of this Financial Conflict of Interest Policy (the “Policy”) is to comply with applicable law and to ensure the objectivity of the research conducted by KNOW Bio, and their respective employees, contractors, and consultants. KNOW Bio has implemented this Policy to identify, manage, reduce, or eliminate financial conflicts of interest. KNOW Bio requires that each employee, Investigator, subrecipient, subgrantee and collaborator affiliated with grants or contracts funded by National Institute of Health (NIH) or other US government programs, be in compliance with 42 CFR 50, Subpart F – Promoting Objectivity in Research.

Scope

This Policy applies to Investigators applying for and working on government funded programs, including Public Health Services (“PHS”), National Institutes of Health (“NIH”), or National Science Foundation (“NSF”) funded research. It was written to be in conformance with the Code of Federal Regulations (CFR) 42, Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought  and 45 CFR Part 94, Responsible Prospective Contractors  Government funded programs include those from PHS, NIH, or NSF (the foregoing agencies, together with any other organizations providing funding through grant or contract to which the regulations contemplated herein apply, collectively, the “Funding Agencies”), including collaborators or consultants.

Definitions

For purposes of this Policy, the following definitions shall apply:

Designated Official is the individual designated by KNOW Bio to oversee the financial conflicts of interest process, including solicitation and review of disclosures of Significant Financial Interests.

Equity Interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.

Financial Conflict of Interest means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research as determined by KNOW Bio through the Designated Official.

Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.

Immediate Family refers to an Investigator’s spouse and dependent children.

Investigator means the project director/principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the research or proposed research, which may include, for example, collaborators or consultants.

PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.

PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.

Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Significant Financial Interest means a Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s responsibilities: 

  1. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any Remuneration received from the entity in the twelve months preceding the disclosure and the value of any Equity Interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); Equity Interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; 
  2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any Remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any Equity Interest (e.g., stock, stock option, or other ownership interest); or 
  3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. 

Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. KNOW Bio requires the details of this disclosure, to will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with this Policy, the Designated Official will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. 

The term Significant Financial Interest does not include the following types of Financial Interests: 

  1. salary, royalties, or other Remuneration paid by KNOW Bio to the Investigator if the Investigator is currently employed or otherwise appointed by KNOW Bio; 
  2. intellectual property rights assigned to KNOW Bio and agreements to share in royalties related to such rights; 
  3. any ownership interest in KNOW Bio (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan); 
  4. income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; 
  5. income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or 
  6. income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Procedures

Responsibilities of KNOW Bio’s Designated Official

The Designated Official shall be responsible for the following:

  1. Informing KNOW Bio Investigators of their obligations under this Policy and any related regulations;
  2. Reviewing disclosures of Significant Financial Interest with KNOW Bio to determine whether they are related to the subject research and, if so, whether they constitute Financial conflicts of interest;
  3. Screening and managing potential Financial conflicts of interest;
  4. Maintaining all records relating to disclosures of Financial Interests, KNOW Bio’s review of and response to such disclosures, and any related actions under this Policy;
  5. Ensuring inclusion of any required certifications in applications for funding or contract proposals; and
  6. Reporting and disclosure as required under this Policy and applicable regulations.

For PHS-funded research, the Designated Official shall also have the following responsibility:

Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this Policy or provide KNOW Bio with sufficient assurances to enable KNOW Bio’s compliance with all applicable laws or regulations. To this end, the written agreement between KNOW Bio and the subrecipient will specify whether KNOW Bio’s or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:

Obtain certification from the subrecipient that its policy complies with KNOW Bio’s Policy and the applicable regulations (absent such certification, KNOW Bio’s Policy will apply to the subrecipient’s Investigators, and

Establish time periods for subrecipient reporting of financial conflicts of interest to KNOW Bio that enable KNOW Bio to report such conflicts in a timely manner, as required under its Policy and the applicable regulations.

If KNOW Bio’s Policy will apply to the subrecipient Investigators, KNOW Bio will be responsible for meeting the requirements of this Policy and the reporting obligations reflected in the applicable regulations.

Internal Reporting Requirements

For PHS-funded research in particular, as part of the funding application or proposal and prior to performing any work on the research, each Investigator who is planning to participate in the research is required by regulation to complete a Significant Financial Interest Disclosure (SFID) Form and submit the SFID Form to KNOW Bio. This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. SFID Forms will be provided to Investigators in conjunction with the annual training and will be otherwise made available. KNOW Bio will review SFID submissions. The information reported on the SFID Form includes a listing of the Investigator’s known Significant Financial Interests and those of his/her Immediate Family that reasonably appear to be related to the research or that are in entities whose Financial Interests could be affected by the research. KNOW Bio Investigators in non-PHS-funded research who have any Significant Financial Interest that may reasonably appear to be affected by the research are also expected to complete the SFID Form and submit it to KNOW Bio.

Investigators are expected to submit an updated SFID Form during the period of the award as necessary (at least annually for PHS-funded research). Such disclosures shall include any information that was not previously disclosed; any change in information regarding any previously disclosed significant financial interest; or, within 30 days of discovery or acquisition, any new significant Financial Interest (e.g., an interest acquired through purchase, marriage, or inheritance).

Determination and Management of Financial Conflicts of Interest

Upon receipt of a completed SFID Form, the Designated Official shall determine whether an Investigator’s Significant Financial Interest is related to the subject research and, if so, whether the interest constitutes a Financial Conflict of Interest under this Policy and any applicable regulations. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose Financial Interest could be affected by the research. A Financial Conflict of Interest exists if the significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the research.

If KNOW Bio determines that a Financial Conflict of Interest exists, a Financial conflicts of interest management plan will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:

Disclosure to research participants or the public of Significant Financial Interests (e.g., when presenting or publishing the research);

Monitoring of research by independent reviewers;

Modification of the research plan;

Disqualification of staff from participation in all or a portion of the research;

Reduction or divestiture of a Financial Interest; or

Severance of relationships that create actual or potential conflicts.

In addition to the conditions or restrictions described above, KNOW Bio may require the management of conflicting Financial Interests in other ways as it deems appropriate.

External Reporting Requirements

KNOW Bio will disclose Financial conflicts of interest as required by applicable laws or regulations. Before expending any funds under a PHS award, KNOW Bio will ensure public accessibility by posting Financial conflicts of interest information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any Financial Conflict of Interest that has not been eliminated and will ensure that KNOW Bio has implemented a plan to manage the conflict.

If a Financial Conflict of Interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, KNOW Bio will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant Financial Interest that was not disclosed by an Investigator or not previously reviewed or managed by KNOW Bio (e.g., not reviewed or reported by a subrecipient in a timely manner), KNOW Bio will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, KNOW Bio will promptly notify the PHS Awarding Component and submit a mitigation report. Upon request, KNOW Bio will provide HHS with information relating to any Investigator disclosure of Significant Financial Interests; KNOW Bio’s review of, and response to, such disclosure; and whether the disclosure resulted in KNOW Bio’s determination of a Financial Conflict of Interest.

Investigator Noncompliance

If an Investigator knowingly fails to comply with this Policy (e.g., fails to identify an actual or potential Financial Conflict of Interest), KNOW Bio may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research. 

In addition, for PHS-funded research, failure to comply with this Policy or the applicable regulations shall result in the following:

If the Investigator’s failure to comply with this Policy or a financial conflicts of interest management plan appears to biased the design, conduct, or reporting of the PHS-funded research, KNOW Bio shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken;

KNOW Bio will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts; and

If HHS determines that a clinical PHS-funded research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a Financial Conflict of Interest that was neither disclosed nor managed, KNOW Bio shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if necessary.

Training and Education

Investigators shall receive training to promote objectivity in research and to ensure Investigator compliance with regard to the applicable regulations and significant Financial Interest disclosure obligations. The training module developed by NIH can be accessed through the NIH Web site.

KNOW Bio requires Investigators to complete such training: 

  1. at least once every four years;
  2. KNOW Bio revises this Policy or procedures in any manner that affects the Investigator’s obligations;
  3. An Investigator is new to KNOW Bio; or
  4. KNOW Bio finds that an Investigator is not in compliance with this Policy or a financial conflicts of interest management plan.

Retention of Records

The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information for at least 3 years. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by KNOW Bio with respect to each Financial Conflict of Interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 74.53(b) or 48 CFR Part 4, Subpart 4.7.

Point of Contact

If you have a conflict of interest or if you have a question to discuss, contact report@knowbiollc.com.

Last Updated September 2024