Legal Information and Privacy and FCOI Policy

Legal Information

Terms of Use
Thank you for visiting the Hillhurst Biopharmaceuticals, Inc. (“Hillhurst”) website.  The materials on this Web site are provided as a service to our investors, to the media, and to research and medical professionals seeking general information about our technology and our products. The information contained in this Web site is not intended to provide investment and/or medical advice. While Hillhurst intends to periodically update the information contained in this Web site, it makes no representations or warranties as to its accuracy or completeness. Access to and use of the Hillhurst Web site is subject to the terms and conditions set forth in this Legal Information and Privacy Policy page and any other applicable laws, statutes and/or regulations. Hillhurst may revise these terms and conditions by updating this page in the future.

Ownership of Materials
The information and graphical materials on this Web site are copyrighted and are protected. You may bookmark these pages, distribute URL address information, and print or copy pages published on our Web site for your own non-commercial reference use only, provided that any copies you make retain all copyright notices and legal information contained herein. Any other use of the materials on this Web site without Hillhurst’ prior written permission is prohibited.

Links to Third Party Web Pages and Web Sites
Any links to third party Web pages from this Web site are provided for your convenience only. Hillhurst does not monitor, author, edit, or endorse any information provided in these third party pages and assumes no responsibility for the accuracy of their content.

Communications with Hillhurst
Please do not send Hillhurst any information that you consider to be confidential. Unless Hillhurst has previously entered into a written Nondisclosure Agreement signed by both you and Hillhurst, Hillhurst, its successors, assigns, licensees and collaborators, may make full use of any communications that you have with Hillhurst, including any information, suggestion or idea you may communicate, without obligation to you. Such communication will not be maintained by Hillhurst as confidential, and Hillhurst may reproduce, publish, broadcast or post such communication at its sole discretion.

Regulatory Approval
Hillhurst products have not yet been approved for medical use by regulatory authorities in the United States, Europe or other geographies

 

Privacy Policy

Hillhurst respects your privacy, and recognizes the need for appropriate protection and management of personally identifiable information you may share with us.  The term “personally identifiable information” as used in this Policy refers to any information by which you can be identified, including your name, e-mail address, mailing address and telephone number. This Privacy Policy describes how we will treat any personally identifiable information that you provide to us in the course of using the Hillhurst.com web site.

Intended Use of Personal Data
You can generally visit Hillhurst.com without revealing any personally identifiable information.  However, to access certain options and services we may ask you to provide personally identifiable information, and without providing such information you may be unable to access certain options and services.  We collect personally identifiable information about you only if you voluntarily provide it to us.  The following is personally identifiable information that you may voluntarily provide to us and how we use it: 

• Employment. When you apply for a position at Hillhurst, you may provide us with personally identifiable information such as name, e-mail address, mailing address, phone number, employment history and any other personally identifiable information contained in your resume and correspondence with Hillhurst. We may use your personally identifiable information for employee recruitment purposes and to respond to your requests for information.

• Investor and Business Development Inquiries. If you contact our investor or business development departments, your correspondence may include personally identifiable information such as name, e-mail address, phone number and other personally identifiable information related to your inquiry. We may use your personally identifiable information for business development purposes and to respond to your requests. In addition, please see our Legal Information for additional information regarding contacting us with potentially confidential or proprietary information.

Sharing and Disclosure
We may provide your personally identifiable information that we collect to vendors and service agencies that we may engage to assist us. For example, we may provide your personally identifiable information to an organization in order to complete a service (e.g., send out investor mailings you have requested), to assist us in reviewing the data or to provide marketing or advertising on our behalf.  We will also disclose your personally identifiable information if we believe we are required to do so by law, regulation or other government authority. We will not sell your personally identifiable information to any other company or organization except we may transfer your personally identifiable information to a successor entity upon a merger, consolidation or other corporate reorganization in which Hillhurst participates or to a purchaser of all or substantially all of Hillhurst’s assets. Such successor entity shall be bound by the terms and conditions of this Privacy Policy.

Log Files and Aggregate Information
We may track the total number of visitors to our website, the number of visitors to each page of our website, IP addresses, and the domain names of our users’ Internet Service Providers, and we may analyze these data for trends and statistics in the aggregate, but such information will be in aggregate form only and it will not contain personally identifiable data. Such aggregate information is not linked to any personally identifiable information that can identify any individual person.

We may use such aggregate information to analyze trends, administer the website, track user’s movement, and gather broad demographic information for aggregate use. We may share this aggregate information with our corporate partners and contracted vendors to assist us in operating the Web site and to enable them to better understand our business.

Personal Information and Children
Hillhurst.com will not knowingly collect, use or disclose personal data from a minor under the age of 13 without obtaining prior consent from a person with parental responsibility (i.e. a parent or guardian).

Links to Other Sites
This Privacy Policy applies only to Hillhurst.com and does not include third-party websites. Hillhurst.com may include links to other web sites that we believe may be of interest to our visitors. We aim to ensure that such websites are of the highest standard. However, due to the nature of the World Wide Web, Hillhurst cannot guarantee the standards of every web site link it provides or be responsible for the contents of non-Hillhurst sites.

Privacy Policy Updates
We may need to update this Privacy Policy from time to time. If so, we will post the updated Privacy Policy to this page so users are always aware of what personally identifiable information we may collect and how we may use this information. Hillhurst encourages you to review this Privacy Policy regularly for any changes. Your continued use of this website will be subject to the then-current Privacy Policy.

Security
We will make commercially reasonable efforts to protect your personally identifiable information.  However, you should be aware that there is always some risk that an unauthorized third party could intercept an Internet transmission or find a way to thwart our security systems.

 

Financial Conflict of Interest (FCOI) Policy for National Institutes of Health (NIH) grants.

1. General Principles

Hillhurst Biopharmaceuticals, Inc. (Hillhurst) is committed to the principle that its research be carried out with integrity, free from conflicts of interest, financial or otherwise. This Procedure provides a mechanism for ensuring the integrity of Hillhurst’s research with regard to financial conflicts of interest.

 

 2. Scope:

 This Procedure applies to the conduct of research projects receiving funding from any agency of the US Public Health Service (PHS), including the National Institutes of Health (NIH). It is intended to comply with the 2011 Revised Financial Conflict of Interest Regulation, 42 CFR Part 50, Subpart F, for PHS grants and cooperative agreements.  The requirements do not apply to SBIR/STTR Phase I awards.

 

3. Financial Conflict of Interest Process:

3.1 Disclosure

3.1.1 Any Significant Financial Interest (SFI) as defined in Section 5 shall be disclosed by any investigator prior to the receipt of funding from PHS sources, or within 30 days if a conflicting SFI arises during the project.

3.2 Responsibilities

3.2.1 The Designated Official (DO) is responsible for ensuring that all investigators are aware of this Procedure.

3.2.2 The DO is responsible for ensuring that SFI’s of all investigators are identified and disclosed. The items listed in Section 6 may be used as a guide to the required information.

3.2.3 Disclosures are reviewed by the DO for assessment as to whether the FSI is a FCOI (Financial Conflict of Interest). If a significant FCOI is determined, an FCOI Management Plan is defined and implemented to mitigate the FCOI effect on the project to ensure objectivity of the research.

3.3 Reporting requirements to NIH 

3.3.1 Routine FCOI Reports are provided to NIH:

3.3.1.1 Prior to expenditure of funds on an approved project (may be done as a Just In Time (JIT) submission)

3.3.1.2 Within 60 days of FCOI identification for a new participant or a new FCOI for existing investigators

3.3.1.3 Annually (may be done with the annual progress report)

3.3.1.4 As needed for retrospective changes in previous reports

3.3.2 NIH will be notified and the company will take corrective actions promptly upon findings of:

3.3.2.1 Bias in design, conduct or reporting of NIH funded research (a mitigation report will also be submitted)

3.3.2.2 Failure of an investigator to comply with this Procedure or with an FCOI Management Plan

3.3.3 Reports will normally be submitted via the eRA Commons FCOI Module.

3.4 Records

3.4.1 Records of FCOI documentation shall be maintained by the DO and retained for at least 3 years after submission of the project final expenditure report.

3.5 Enforcement

3.5.1 Retrospective reviews of non-compliance for SFI’s not disclosed or managed in a timely manner shall be conducted, documented and reported within 120 days.

3.5.2 If the US Department of Health and Human Services (DHHS)  determines that any PHS funded study to evaluate the safety and effectiveness of a drug has been conducted or reported by an investigator with an unreported or unmanaged FCOI then:

3.5.2.1 The FCOI will be disclosed in any public presentation

3.5.2.2 An addendum will be requested to previous publications

3.6 Subrecipients (Sub-awardees).  Subrecipients shall, as applicable:

3.6.1 Provide certification of a FCOI policy in compliance with the regulation

3.6.2 Provide notice of identified FCOI’s in a timely manner permitting Hillhurst to report to NIH or provide for internal compliance and reporting to NIH

3.7 Training

3.7.1 All investigators on a PHS funded project shall receive training to include:

3.7.1.1 Awareness of applicable U.S. Federal regulations

3.7.1.2 Review of this procedure

3.7.1.3 Disclosure responsibilities

3.7.2 Training may be achieved by use of the NIH provided web based tutorial at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

3.7.3 Training shall be completed:

3.7.3.1 Prior to engaging in PHS funded research

3.7.3.2 At least every 4 years

3.7.3.3 Immediately, if

3.7.3.3.1 This Procedure is revised in a way that affects requirements of investigators

3.7.3.3.2 A new employee is engaged on a PHS funded project

3.7.3.3.3 An investigator is not in compliance with this Procedure or an FCOI Management Plan

3.7.4 Training records are maintained in accordance with this Procedure

 

4. Public Access:

4.1 Procedure:  This Procedure will be placed on a publicly accessible website.

4.2 FCOI’s:  Identified FCOI’s will be made available within 5 calendar days of a legitimate request. See Section 6 for required information.

 

5. Significant Financial Interest (SFI) Definition:

5.1 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 institutional responsibilities:

5.1.1 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;

5.1.2 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

5.1.3 Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

5.2 Third party reimbursed or sponsored travel (i.e., travel paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children by a third party) of greater than $5,000 and reasonably appears related to the Investigator’s project responsibilities.  Excludes travel that is reimbursed or sponsored by an U.S. federal, state, or local government agency, or an U.S. Institution of higher education.

5.3 SFI does not include:

5.3.1 Salary, royalties, or other remuneration paid by Hillhurst or affiliates to the Investigator while employed or otherwise appointed, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;

5.3.2 Any ownership interest in Hillhurst held by the Investigator

5.3.3 Income from investment vehicles (e.g. such as mutual funds and retirement accounts), as long as the Investigator does not directly control the investment decisions

5.3.4 Income from seminars, lectures, or teaching engagements sponsored by a U.S. Federal, state, or local government agency, an institution of higher education, academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;

5.3.5 Income from service on advisory committees or review panels for a U.S. Federal, state, or local government agency, an institution of higher education, academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education;.

 

6.  Public Disclosure Requirements

6.1 Hillhurst will provide within 5 days a response to a written request for information on any SFI that meets both of the following conditions:

6.1.1 The SFI was disclosed and is still held by the PD/PI or any other person identified as senior/ key personnel by Hillhurst in the award application for PHS funding or listed in a progress report; and

6.1.2 Hillhurst has determined that the SFI is related to conduct of the research funded.

6.2. Information made available will include, at a minimum, the following:

6.2.1 The investigator’s name

6.2.2 The investigator’s title and role with respect to the research project

6.2.3 The name of the entity in which the SFI is held

6.2.4 The nature of the SFI

6.2.5 Either of:

6.2.5.1 The approximate dollar value of the SFI in the following dollar ranges: $0-$4,999; $5,000-9,999; $10,000 – $19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), OR:

6.2.5.2 A statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures offair market value