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These Terms of Use (“Terms”) govern your use of our website at www.advantagetherapeutics.com as well as any other online services that ADvantage Therapeutics Inc. (“ADvantage Therapeutics,” “we,” or “us”) operates and that links to these Terms (collectively, the “Online Resources”).
Please review these Terms carefully before using the Online Resources. We may change these Terms or modify any features of the Online Resources at any time. The most current version of the Terms can be viewed by clicking on the “Terms of Use” link posted on the Online Resources. You accept the Terms by using the Online Resources, and you accept any changes to the Terms by continuing to use the Online Resources after we post the changes.
Our Online Resources are directed to a general audience and not to children. By accessing or using the Online Resources, you represent and warrant to us that you are at least 18 or the age of majority in your jurisdiction required to form a binding contract. If you are accessing or using the Online Resources on behalf of an entity, you represent and warrant that you have the authority to bind that entity to the Terms.
1. By using the Online Resources, you consent to our processing your information consistent with the ADvantage Therapeutics Website Privacy Policy.
2. Information and Educational Purposes. The Online Resources and the information we provide through the Online Resources is for general information and educational purposes only. For example, such information may include information relating to medical conditions and treatment of those conditions. That information is provided only for informational purposes and is not intended to be a substitute for advice provided by a doctor or other qualified healthcare professional. It should not be used for diagnosis or treatment of a health condition. For advice or information about diagnosis or treatment of a health condition, you should always consult with a competent, licensed doctor or other healthcare professional.
3. Content. We use reasonable efforts to ensure that the information we make available through the Online Resources is accurate, current, and complete. However, due to various factors, we make no representations or warranties of any kind (either express or implied) as to the quality, accuracy, completeness, timeliness, or currency of any such information. The ONLINE RESOURCES AND ANY INFORMATION ON THEM is provided to you “as is” for your use in accordance with these terms only. You agree that you must evaluate, and bear all risks associated with, your use of any such information. ADvantage Therapeutics (and all other parties involved in creating, producing, and delivering such information and the online resources) disclaim any and all liability in connection therewith. The Online Resources may contain information provided by third parties or may contain links to third-party websites, content, and services. We do not control, endorse, sponsor, recommend, or otherwise accept responsibility for the information provided by third parties, or the websites, content, or services of third parties to which we provide links. We expressly disclaim any liability for any errors or omissions in the content included in the Online Resources or any third party sites linked to or from the Online Resources.
4. Copyrights. The Online Resources contain copyrighted material and other proprietary information, and the entire content of the Online Resources is protected by United States copyright laws. You may not publish, reproduce, distribute, display, perform, edit, adapt, modify, or otherwise exploit any part of the Online Resources without our written consent. ADvantage Therapeutics makes no representations or warranties that your use of content available through the Online Resources will not infringe a third party’s rights.
5. Trademarks and other Proprietary Rights. ADvantage Therapeutics and other names, logos, designs, slogans, trademarks, service marks and trade dress on the Online Resources are owned by ADvantage Therapeutics or its affiliates or licensors, and may not be copied, imitated or used, in whole or in part, without prior written consent from ADvantage Therapeutics. No license to, or right in, any such proprietary rights of ADvantage Therapeutics or other parties is granted to, or conferred upon, you.
6. Prohibited Conduct. You many not access or use, or attempt to access or use, the Online Resources to take any action that could harm us or any third party, interfere with the operation of the Online Resources, or use the Online Resources in a manner that violates any laws. For example, and without limitation, you may not:
Violations of system or network security may result in civil or criminal liability. We may investigate and work with law enforcement authorities to prosecute visitors who violate the Terms. We may suspend or terminate your access to the Online Resources for any or no reason at any time without notice.
7. Indemnity. YOU AGREE TO INDEMNIFY, DEFEND, AND HOLD US AND OUR AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, REPRESENTATIVES, AND THIRD-PARTY PARTNERS (collectively, the “INDEMNIFIED PARTIES”) HARMLESS FROM AND AGAINST ANY AND ALL LOSS, COSTS, EXPENSES (INCLUDING REASONABLE ATTORNEYS’ FEES AND EXPENSES), CLAIMS, DAMAGES, AND LIABILITIES RELATED TO OR ASSOCIATED WITH YOUR USE OF THE ONLINE RESOURCES AND ANY ALLEGED VIOLATION BY YOU OF THESE TERMS. WE RESERVE THE RIGHT TO ASSUME THE EXCLUSIVE DEFENSE OF ANY CLAIM FOR WHICH WE ARE ENTITLED TO INDEMNIFICATION UNDER THIS SECTION. IN SUCH EVENT, YOU SHALL PROVIDE US WITH SUCH COOPERATION AS WE REASONABLY REQUEST.
8. Limitations of Liability. In no event will we OR ANY OF THE INDEMNIFIED PARTIES be liable For any direct or indirect, special, incidental, consequential or punitive damages, lost profits, or other damages whatsoever arising in connection with the use of the online resources, any interruption in availability of the online resources, delay in operation or transmission, computer virus, loss of data, or use, misuse, reliance, review, manipulation, or other utilization in any manner whatsoever of the online resources or the data collected through the online resources, even if one or more of them has been advised of the possibility of such damages or loss. ANY CLAIM ARISING OUT OF OR CONNECTED WITH THE ONLINE RESOURCES WILL BE LIMITED TO THE GREATER OF $50 OR THE AMOUNT YOU HAVE PAID US IN THE PAST TWELVE MONTHS.
9. Governing Law; Venue; Limitation of Claims. The Terms shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, USA without regard to its conflicts of laws principles. You hereby consent to exclusive jurisdiction and venue in the state and federal courts of Middlesex County, Commonwealth of Massachusetts, USA for resolution of any and all controversies, disputes, demands, counts, claims, or causes of action arising out of or relating to these Terms. You and ADvantage Therapeutics submit to the personal jurisdiction of such courts for those purposes. Any claim either party has against the other under these Terms must be brought within one (1) year after the cause of action arises.
10. General. The Terms constitute the entire agreement between you and us, superseding any prior or contemporaneous communications and proposals (whether oral, written, or electronic) between you and us. In the event any provision of these Terms is held unenforceable, it will not affect the validity or enforceability of the remaining provisions and will be replaced by an enforceable provision that comes closest to the intention underlying the unenforceable provision. You agree that no joint venture, partnership, employment, or agency relationship exists between you and us as a result of the Terms or your access to and use of the Online Resources.
Our failure to enforce any provisions of these Terms or respond to a violation by any party does not waive our right to subsequently enforce any terms or conditions of the Terms or respond to any violations. We reserve the right to assign our rights and obligations under the Terms. However, except with our prior written consent, you may not assign any of your rights or obligations under the Terms. All rights and remedies of ADvantage Therapeutics hereunder are cumulative and in addition to those at law and in equity. Nothing contained in these terms is in derogation of our right to comply with governmental, court, and law enforcement requests or requirements relating to your use of the Online Resources or information provided to or gathered by us with respect to such use.
11. Contacting Us. You may contact ADvantage Therapeutics at:
ADvantage Therapeutics Inc.
195 NW 40th Street
Miami, FL 33127
FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY
ADVANTAGE THERAPEUTICS INC.
The Federal Department of Health and Human Services (HHS) has developed Regulations described in 42 CFR Part 50 Subpart F and 45 CFR Part 94 that are designed to promote objectivity in research by establishing standards to ensure that the design, conduct, and reporting of research funded under all Public Health Service (PHS) grant awards is not biased by any conflicting financial interests of an Investigator. In addition, the policy serves to protect the safety of animals and human research participants, the reputation of the recipient institution and of the Investigator who participates in PHS-funded research. These requirements work together to preserve the public’s trust that the research supported by the PHS is conducted without bias and with the highest scientific and ethical standards.
The regulations were first developed in 1995 and revised in 2011. These regulations describe the actions an individual and an organization must take to promote objectivity in Public Health Service (PHS) funded research. The regulations apply to all PHS (e.g., National Institutes of Health [NIH]) funded grants, cooperative agreements, and research contracts, with the exception of Phase 1 Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications and/or awards.
The regulation places the responsibility for the identification and management of Investigators’ FCOI with ADVANTAGE, which oversees the Investigator’s activities. The NIH, as the grantor agency, has primary responsibility for overseeing compliance with these requirements, and ADVANTAGE, an institution that is a recipient of NIH funding and supporter of this regulation, has responsibility for ensuring that all Investigators, including those at Subrecipient Institutions and Vendors that are paid with grant funds, comply with these requirements. Herein states ADVANTAGE’S FCOI policy that implements the regulatory requirements provided in 42 CFR Part 50 Subpart F to identify, collect, review, determine, manage and report FCOIs to NIH.
This policy is applicable to “Investigators” (as defined below) who are planning to participate in, or who participate in NIH-funded research.
DEFINITIONS
For the purpose of these policies and procedures, the following definitions apply:
The term ‘significant financial interest’ does not include, and therefore, Investigators are not required to disclose, the following types of financial interests:
Foreign Financial Interests: Investigators must disclose all foreign financial interests (which include income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).
SIGNIFICANT FINANCIAL INTEREST DISCLOSURE REQUIREMENTS
REVIEW OF SFI DISCLOSURES BY ADVANTAGE’S DESIGNATED OFFICIAL
David Buchsbaum is the Designated Official (DO) at ADVANTAGE. All Investigators fill out a SFI Disclosure Form annually. Within 60 days of the report of an SFI, the DO will conduct reviews of SFI disclosures, and SFIs will be compared to each PHS/NIH research application and/or award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the PHS/NIH-funded research and, if so, whether the SFI creates a FCOI related to that research award. If the SFI creates a FCOI related to a research award, the DO will implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage the FCOI. The institution will submit the FCOI report to the NIH via the eRA Commons FCOI Module within 60 days of identifying the FCOI.
Reviews will occur at the following times:
GUIDELINES FOR DETERMINING ‘RELATEDNESS’ OF SFI TO PHS/NIH-FUNDED RESEARCH AND A FCOI
These guidelines will be used by the DO to determine whether the SFI is a FCOI:
The DO may involve the Investigator in determining whether an SFI is related to the research supported by the PHS/NIH-funded award.
MANAGEMENT OF SFIs THAT ARE DETERMINED TO BE FCOIs
If a FCOI exists, the DO will determine what management conditions and/or strategies will be put in place to manage the FCOI. Examples of conditions that might be imposed to manage a FCOI include, but are not limited to:
participation in all or a portion of the research
Once a management plan has been determined, the DO will communicate this in writing to the individual reporting the SFI, the relevant Principal Investigator/Project Director, and to the appropriate direct supervisor. No expenditures on an NIH award will be permitted until the Investigator has complied with the disclosure requirements of this Policy and has agreed, in writing, to comply with any management plans determined by the DO as necessary to manage the FCOI.
MONITORING INVESTIGATOR COMPLIANCE
During the period of an NIH-funded award, ADVANTAGE will monitor the Investigators’ compliance with the management plan for the duration of the award or until the FCOI no longer exists. Monitoring public disclosure requirements will include reviewing publications and presentations to confirm that the Investigator disclosed the FCOI in such communications. To facilitate additional monitoring, Investigators will be required to disclose the FCOI in writing to research personnel in the study and send a copy of the communication to the DO.
PUBLIC ACCESSIBILITY OF FCOI POLICY AND INFORMATION RELATED TO A FCOI
FCOI Policy: A copy of the FCOI policy is posted on the ADVANTAGE public website per the NIH requirements in the NIH Grants Policy Statement Section 4.1.10 – Financial Conflicts of Interest.
Identified FCOIs held by Senior/Key Personnel: Prior to the expenditure of any funds under an NIH award, ADVANTAGE will ensure public accessibility via a written response within five business days of a request for information concerning any SFI disclosed that meets the following three criteria:
The information that ADVANTAGE will make available via a publicly accessible website or in a written response to any request within five days of request will include, at a minimum, the following:
Should ADVANTAGE choose to use a publicly accessible website to comply with the public disclosure requirements of the Regulation, the information posted will be updated at least annually and within sixty days of receipt or identification of information concerning any additional SFI of the Senior/Key Personnel for the NIH-funded research project that had not been previously disclosed, or upon the disclosure of a SFI by Senior/Key Personnel new to the NIH- funded research project, if it is determined by the DO that the SFI is related to the research and is a FCOI.
Information concerning an individual’s SFI, as limited by this Policy, will remain available for responses to written requests or for posting via ADVANTAGE publicly accessible website for at least three years from the date that the information was most recently updated.
REPORTING OF FINANCIAL CONFLICTS OF INTEREST
The DO will serve as the FCOI Signing Official (SO) and has the authority to submit FCOI reports to the NIH within the eRA Commons FCOI Module. Reports are filed when a grant or cooperative agreement is active and an FCOI is identified (i.e., no award – no FCOI and no FCOI – no FCOI report).
ADVANTAGE will provide to NIH a FCOI report compliant with NIH regulations regarding any Investigator’s SFI found to be an FCOI, and will ensure that the Investigator has agreed to and implemented the corresponding management plan.
A FCOI Module User Guide is available to assist in submitting reports to the NIH.
The reports are submitted:
TRAINING REQUIREMENTS
Each Investigator will be informed about ADVANTAGE’s FCOI Policy and be trained on the Investigator’s responsibility to disclose foreign and domestic SFIs per this policy and of the FCOI regulation at 42 CFR Part 50 Subpart F. FCOI training will occur prior to an Investigator engaging in PHS/NIH-funded research, at least every four years and immediately (as defined below) when any of the following circumstances apply:
In fulfillment of the FCOI training requirement of the FCOI regulation, ADVANTAGE requires its Investigators to complete the NIH’s Financial Conflict of Interest Tutorial in accordance with the requirements and expectations of this Policy. All Investigators must print a certification of completion at the end of training and retain it for audit purposes. Additionally, ADVANTAGE also requires its Investigators to acquaint themselves with the NIH Virtual Seminar Presentation containing helpful information on developing or refining institutional FCOI policies to ensure compliance with the FCOI regulation.
FAILURE TO COMPLY WITH THE FCOI POLICY
Whenever ADVANTAGE identifies an SFI that was not disclosed, identified, reviewed or managed in a timely manner, the DO will within 60 days: review the SFI, determine whether the SFI is related to research; determine whether an FCOI exists, and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward. ADVANTAGE will also submit an FCOI report to the PHS/NIH via the eRA Commons FCOI Module, all as described above in this Policy.
In addition, when ADVANTAGE determines that an FCOI was not identified or managed in a timely manner, including:
ADVANTAGE will within 120 days of determining non-compliance:
funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the period of the noncompliance was biased in the design, conduct, or reporting of research
If bias is found, ADVANTAGE shall notify NIH promptly and submit a Mitigation Report per the Regulation and consistent with this Policy to NIH via the eRA Commons FCOI Module that shall address the impact of the bias on the research project, and ADVANTAGE’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, the DO shall submit FCOI reports annually to NIH in accordance with the Regulations, the terms and conditions of the award agreement, and this Policy. Depending on the nature of the FCOI, the DO may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the FCOI is identified and the completion of ADVANTAGE’s independent retrospective review. If bias is not found, no further action is required.
CLINICAL RESEARCH REQUIREMENTS
If HHS determines that one of its funded clinical research projects 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 FCOI that was not managed or reported, the ADVANTAGE shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
SUBRECIPIENT REQUIREMENTS
Subrecipients are subject to ADVANTAGE’s terms and conditions of this Policy, and as such, ADVANTAGE will take reasonable steps to ensure that any Subrecipient Investigator is in compliance with the federal FCOI regulation at 42 CFR Part 50 Subpart F.
ADVANTAGE will incorporate, as part of a written agreement with the Subrecipient, terms that establish whether ADVANTAGE’s FCOI Policy or that of the Subrecipient’s institution will apply to the Subrecipient Investigator(s).
If the Subrecipient’s FCOI policy applies to the Subrecipient Investigator, the Subrecipient institution will certify as part of the agreement with ADVANTAGE that its policy is in compliance with the federal FCOI regulation. In this situation, the agreement shall specify the time period for the subrecipient to report all identified FCOIs to ADVANTAGE in sufficient time to enable ADVANTAGE to provide timely FCOI reports, as necessary, to PHS/NIH as required by the Regulation. Therefore, the written agreement may establish a reporting requirement of FCOIs identified during the period of an award to be submitted to ADVANTAGE within 50 or 55 days of the subrecipient’s identification of an FCOI to allow ADVANTAGE to report the FCOI within the 60 -day period. The DO will submit the Subrecipient FCOI report to the NIH via the e RA Commons FCOI Module.
If the Subrecipient cannot provide the certification of compliance with the FCOI regulation, the agreement shall state that the Subrecipient Investigator is subject to ADVANTAGE’s FCOI Policy for disclosing SFI(s) that are directly related to the Subrecipient’s work for ADVANTAGE
Therefore, ADVANTAGE will require the submission of all Subrecipient Investigator disclosures of SFIs to ADVANTAGE. The agreement will include sufficient time period(s) to enable ADVANTAGE to comply timely with its review, management, and reporting obligations under the Regulation. When an FCOI is identified, ADVANTAGE will develop a management plan, monitor Subrecipient Investigator compliance with the plan, and submit an FCOI Subrecipient report to the NIH through the eRA Commons FCOI Module for any FCOIs identified for a Subrecipient Investigator.
MAINTENANCE OF RECORDS
ADVANTAGE will keep all records of all Investigator disclosures of FCOIs and the review of, or response to, such disclosure (whether or not a disclosure resulted in the ADVANTAGE’s determination of a FCOI), and all actions under this Policy or retrospective review, if applicable. Records of FCOIs and any resulting action will be maintained by the ADVANTAGE for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations. ADVANTAGE will retain records for each competitive segment as provided in the regulation.
ENFORCEMENT ACTIONS: FAILURE TO COMPLY WITH THIS POLICY
Compliance with this Policy is a condition of employment and/or participation in PHS/NIH-funded research for all applicable Investigators. Therefore, such Investigators who fail to comply with this policy are subject to discipline, including letters of reprimand, restriction on the use of funds, termination of employment or contract, and/or disqualification from further participation in any PHS/NIH-funded research, etc., as may be deemed appropriate.
POINT OF CONTACT
For any questions related to this FCOI Policy or to disclose a financial interest, contact:
David A. Buchsbaum
Chief Financial Officer
Advantage Therapeutics, Inc.
195 NW 40th Street
Miami, FL 33127
Mobile: 561-350-0445
Email: [email protected]
For any questions related to FCOI compliance to the Regulations and other FCOI-related questions, contact: [email protected]
This Privacy Policy governs the manner in which ADvantage Therapeutics Inc. (“ADvantage Therapeutics,” “we,” or “us”) collects, uses, maintains and discloses information collected from visitors through our website at www.advantagetherapeutics.com as well as any other online services that we operate and that link to this Privacy Policy (collectively, the “Online Resources”).
By using the website or any of the Online Resources, you consent to our collection, use, and disclosure of your information consistent with this Privacy Policy.
We collect some information automatically when you use our Online Resources, such as your Internet Protocol (IP) address, browser and operating system type and version, Internet service provider, pages that you visit before and after using the Online Resources, the date and time of your visit, information about the links you click and pages you view within the Online Resources, and other standard server information.
We may also use cookies and similar technologies to automatically collect this information. Cookies are small bits of information that are stored by your computer’s web browser. By using the Online Resources, you consent to our use of cookies and similar technologies.
We use information to analyze and improve the Online Resources. We also use information to measure the number of visitors to our site and numbers of visitors to various sections of our site for the purpose of determining trends and visitor needs.
Service Providers. We may use third party service providers to perform certain services on our behalf on the Online Resources, such as hosting the Online Resources, measuring activities on the Online Resources and analytics, and performing other administrative services. We may provide these service providers access to information to carry out the services they are providing.
Analytics. We use Google Analytics to help us understand how visitors use our Online Resources, so that we may improve our services. Information about how Google Analytics uses data, and how you may control what information is shared with Google, can be found here.
We also may access, use, preserve, transfer and disclose your information to third parties: (i) to satisfy any applicable law, regulation, subpoenas, governmental requests or legal process if in our good faith opinion such is required or permitted by law; (ii) to protect and/or defend the policies applicable to the Online Resources, including investigation of potential violations thereof; (iii) to protect the safety, rights, property or security of the Online Resources or any third party; and/or (iv) to detect, prevent or otherwise address fraud, security or technical issues.
We reserve the right to disclose and transfer all information: (a) to a subsequent owner, co-owner or operator of the Online Resources or applicable assets; or (b) in connection with a merger, consolidation, restructuring, the sale of substantially all of our interests and/or assets or other corporate change, including, during the course of any due diligence process.
We will retain your information only for as long as necessary to fulfill the purposes for which it was collected and processed, including for the purposes of satisfying any legal, regulatory, accounting or reporting requirements.
You are responsible for maintaining the accuracy of the information you submit to us. You may provide updates and changes by contacting us at the address below. If so, we will make good faith efforts to make requested changes in our then-active databases as soon as reasonably practicable.
We do not knowingly collect any information from children younger than the age of thirteen (13) as required by U.S. law. We will delete any information collected that we later determine to be from a user younger than the age of thirteen (13). If you are a parent or guardian of a child under the age of thirteen (13) and believe he or she has disclosed information to us, please contact us at the address below.
We reserve the right to change this Privacy Policy at any time. Any changes will be effective immediately upon the posting of the revised Privacy Policy. We encourage visitors to frequently check this Privacy Policy to stay informed about any changes to this Privacy Policy. The date at the bottom of this Privacy Policy will be updated for each revision.
You may direct any questions or concerns regarding the use or disclosure of your information, or any other matter related to this Privacy Policy to:
ADvantage Therapeutics Inc.
195 NW 40th Street
Miami, FL 33127