Legal Information and Privacy and FCOI Policy
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Links to Third Party Web Pages and Web Sites
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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.
Hillhurst products have not yet been approved for medical use by regulatory authorities in the United States, Europe or other geographies
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
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
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.
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:
3.1.1 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.
3.2.1 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:
220.127.116.11 Prior to expenditure of funds on an approved project (may be done as a Just In Time (JIT) submission)
18.104.22.168 Within 60 days of FCOI identification for a new participant or a new FCOI for existing investigators
22.214.171.124 Annually (may be done with the annual progress report)
126.96.36.199 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:
188.8.131.52 Bias in design, conduct or reporting of NIH funded research (a mitigation report will also be submitted)
184.108.40.206 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.
3.4.1 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.
3.5.1 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:
220.127.116.11 The FCOI will be disclosed in any public presentation
18.104.22.168 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
3.7.1 All investigators on a PHS funded project shall receive training to include:
22.214.171.124 Awareness of applicable U.S. Federal regulations
126.96.36.199 Review of this procedure
188.8.131.52 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:
184.108.40.206 Prior to engaging in PHS funded research
220.127.116.11 At least every 4 years
18.104.22.168 Immediately, if
22.214.171.124.1 This Procedure is revised in a way that affects requirements of investigators
126.96.36.199.2 A new employee is engaged on a PHS funded project
188.8.131.52.3 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:
184.108.40.206 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:
220.127.116.11 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