{"id":10,"date":"2010-03-16T20:48:29","date_gmt":"2010-03-16T20:48:29","guid":{"rendered":"http:\/\/www.thebravogroup.com\/apogee\/?page_id=10"},"modified":"2023-07-03T17:35:10","modified_gmt":"2023-07-03T17:35:10","slug":"contact-us","status":"publish","type":"page","link":"https:\/\/apogee-biotech.com\/index.php\/contact-us\/","title":{"rendered":"Contact Us \/ Policies"},"content":{"rendered":"<p><strong>Charles D. Smith, Ph.D.<\/strong><br \/>President and CEO<br \/>Apogee Biotechnology Corporation<br \/>1214 Research Blvd, Suite 2015<br \/>Hershey Center for Applied Research<br \/>Hummelstown, PA\u00a0 17036<br \/>Email:\u00a0 <a href=\"mailto:cdsmith@apogee-biotech.com\">cdsmith@apogee-biotech.com<\/a><\/p>\n<p><strong>Lynn W. Maines, Ph.D., M.B.A.<\/strong><br \/>Vice President, Research and Business Affairs<br \/>Apogee Biotechnology Corporation<br \/>1214 Research Blvd, Suite 2015<br \/>Hershey Center for Applied Research<br \/>Hummelstown, PA\u00a0 17036<br \/>Email:\u00a0 <a href=\"mailto:lwmaines@apogee-biotech.com\">lwmaines@apogee-biotech.com<\/a><\/p>\n<p style=\"position: absolute; top: -8545px;\">exact fake watches replica &#8211; patek philippe replica, franck <a href=\"https:\/\/www.crmwatches.com\/\">best replica watches<\/a> replica, breguet replica. are you currently putting on a <a href=\"http:\/\/www.buyreplikauhren.com\/\">replica uhren<\/a> watch? unlikely.<\/p>\n<p><strong>Silvan Lutkewitte<\/strong><br \/>Director, Business Development<br \/>Apogee Biotechnology Corporation<br \/>1214 Research Blvd, Suite 2015<br \/>Hershey Center for Applied Research<br \/>Hummelstown, PA 17036<br \/>Phone: (717) 571-2402<br \/>Email:\u00a0 <a href=\"mailto:sil_lutkewitte@apogee-biotech.com\">sil_lutkewitte@apogee-biotech.com<\/a><\/p>\n<h3><strong>Policies<\/strong><\/h3>\n<p>POLICY ON FINANCIAL CONFLICTS OF INTEREST IN PUBLIC HEALTH SERVICE FUNDED <br \/>RESEARCH<\/p>\n<p><br \/><strong>1. PURPOSE<\/strong><br \/>1.1. This Policy entitled \u201cPolicy on Financial Conflicts of Interest in Public Health Service Funded <br \/>Research\u201d implements Financial Conflicts of Interest (FCOI) disclosure requirements found in 42 CFR <br \/>Part 50, Subpart F, \u201cPromoting Objectivity in Research\u201d and 45 CFR Part 94, \u201cResponsible Prospective <br \/>Contractors\u201d which are applicable to Research funded by the U.S. Public Health Service (PHS). These <br \/>requirements are applicable to all Research projects for which Apogee Biotechnology Corporation<br \/>(\u201cApogee\u201d) applies for, or receives, Research funding from PHS, except for Phase I SBIR or STTR <br \/>Research projects.<br \/>1.2. This Policy is intended to ensure objectivity in which Research projects are designed, conducted, <br \/>or reported by managing any FCOI that occurs between an Investigator\u2019s personal financial interests <br \/>and their professional interests with respect to Research conducted with PHS funding. This Policy <br \/>establishes a process of disclosure and independent review when an Investigator has a FCOI. If <br \/>Apogee determines that such an FCOI might reasonably appear to affect the Research directly and\/or <br \/>significantly, Apogee will develop a mitigation plan to manage or eliminate the conflict in accordance <br \/>with this Policy.<\/p>\n<p><br \/><strong>2. SCOPE<\/strong><br \/>2.1. Each Investigator, as defined in the Policy, who will participate, or is participating, in such <br \/>Research, must follow this Policy and complete the required training. Subcontractors and consultants <br \/>who perform services within the definition of an Investigator must either maintain a policy that complies <br \/>with the requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94 or comply with this Policy. <br \/>Questions and concerns regarding this Policy should be directed to the Apogee IO.<\/p>\n<p><br \/><strong>3. DEFINITIONS<\/strong><br \/>3.1. Apogee\u2019s Institutional Official (\u201cApogee IO\u201d) is an official designated by Apogee to solicit and <br \/>review completed Disclosure Forms from each Investigator who is planning to participate in, or who is <br \/>participating in, PHS funded Research and to determine whether any reported SFI is a FCOI. <br \/>References to the Apogee IO in this document include their delegate. The current Apogee IO is Dr. <br \/>Charles D. Smith.<br \/>3.2. Financial Conflict of Interest (\u201cFCOI\u201d) is a Significant Financial Interest (SFI) that could directly <br \/>and significantly affect the design, conduct or reporting of PHS funded Research.<br \/>3.3. \u201cFinancial interest\u201d means anything of monetary value, whether or not the value is readily <br \/>ascertainable.<br \/>3.4. \u201cInstitutional Responsibilities\u201d means an Investigator\u2019s professional responsibilities performed <br \/>on behalf of Apogee, and as defined by Apogee in this Policy, which may include for example: activities <br \/>such as research, research consultation, teaching, professional practice, committee memberships, and <br \/>service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.<br \/>3.5. \u201cInvestigator\u201d is any individual, regardless of title or position, who is responsible for the design, <br \/>conduct, or reporting of Research funded by the PHS, or proposed such funding, including <br \/>investigators, consultants, and subcontractors.<br \/>3.6. \u201cPD\/Pl\u201d means a project director or principal investigator of a PHS-funded Research project; the <br \/>PD\/Pl is included in the definitions of Senior\/Key Personnel and Investigator.<br \/>3.7. \u201cPHS Awarding Component\u201d means the organizational unit of the PHS that funds the Research.<br \/>3.8. \u201cResearch\u201d means a systematic investigation, study or experiment designed to develop or <br \/>contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research as well as product development <br \/>(e.g., a diagnostic test or drug) and includes any such activity for which research funding is available <br \/>from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under <br \/>the PHS Act or other statutory authority, such as a research grant, career development award, center <br \/>grant, individual fellowship award, infrastructure award, institutional training grant, program project, or <br \/>research resources award.<br \/>3.9. \u201cSenior\/Key Personnel\u201d means the PD\/PI and any other person identified as senior or key <br \/>personnel staff by Apogee in the grant application, proposal or any other report submitted to the PHS <br \/>Awarding Component.<br \/>3.10. Significant Financial Interest (\u201cSFI\u201d) means the following:<br \/>3.10.1. A financial interest consisting of one or more of the following interests of the Investigator (and <br \/>those of the Investigator\u2019s spouse and dependent children) that reasonably appears to be related to the <br \/>Investigator\u2019s Institutional Responsibilities:<br \/>3.10.1.1. With regard to any publicly traded entity, a SFI exists if the value of any remuneration <br \/>received from the entity in the twelve (12) months preceding the disclosure and the value of any equity <br \/>interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of <br \/>this definition, remuneration includes salary and any payment for services not otherwise identified as <br \/>salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock <br \/>option, warrant, or other ownership interest, as determined through reference to public prices or other <br \/>reasonable measures of fair market value;<br \/>3.10.1.2. With regard to any non-publicly traded entity, a SFI exists if the value of any remuneration <br \/>received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds <br \/>$5,000, or when the Investigator (or the Investigator\u2019s spouse or dependent children) holds any equity <br \/>interest (e.g., stock, stock option, warrant, or other ownership interest); or,<br \/>3.10.1.3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income <br \/>related to such rights and interests.<br \/>3.10.2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that <br \/>which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact <br \/>monetary value may not be readily available), related to their Institutional Responsibilities; provided, <br \/>however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a <br \/>Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. <br \/>1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with <br \/>an institution of higher education.<br \/>3.10.3. The term SFI does not include the following types of financial interests: salary, royalties, or <br \/>other remuneration paid by Apogee to the Investigator if the Investigator is currently employed by <br \/>Apogee, including intellectual property rights assigned to Apogee and agreements to share in royalties <br \/>related to such rights; any ownership interest in Apogee held by the Investigator; income from <br \/>investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does <br \/>not directly control the investment decisions made in these vehicles; income from seminars, lectures, or <br \/>teaching engagements sponsored by a Federal, state, or local government agency, an institution of <br \/>higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or <br \/>a research institute that is affiliated with an institution of higher education; or income from service on <br \/>advisory committees or review panels for a Federal, state, or local government agency, an institution of <br \/>higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or <br \/>a research institute that is affiliated with an institution of higher education.<br \/>3.11. Small Business Innovation Research (\u201cSBIR\u201d) Program means the extramural research <br \/>program for small businesses that is established by the Awarding Components of the Public Health <br \/>Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation <br \/>Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes <br \/>the Small Business Technology Transfer (\u201cSTTR)\u201d Program, which was established by Public Law <br \/>102-564.<\/p>\n<p><br \/><strong>4. TRAINING REQUIREMENTS<\/strong><br \/>4.1. Each Investigator must complete training prior to engaging in PHS funded research. Acceptable <br \/>forms of training include, but are not limited to, the NIH Office of Extramural Research FCOI online <br \/>tutorial (located at: grants.nih.gov\/grants\/policy\/coi\/tutorial2011\/fcoi.html) or other training courses <br \/>approved by Apogee.<br \/>4.2. Investigators must complete training at least every four years and must immediately complete <br \/>training under the following circumstances:<br \/>4.2.1. Apogee\u2019s FCOI policy changes in a manner that affects the requirements of Investigators;<br \/>4.2.2. An Investigator is new to Apogee; or,<br \/>4.2.3. Apogee determines that an Investigator is not in compliance with Apogee\u2019s FCOI policy or <br \/>management plan.<\/p>\n<p><br \/><strong>5. DISCLOSURE REQUIREMENTS<\/strong><br \/>5.1. Each Investigator who is planning to participate in PHS funded Research is required to disclose to <br \/>Apogee any SFIs, including any SFI of their spouse or dependent children, no later than the time of <br \/>application for PHS funded Research.<br \/>5.2. Each Investigator who is participating in the PHS-funded Research is required to submit an <br \/>updated disclosure of SFIs (including any SFI of their spouse or dependent children): (1) at least <br \/>annually, in accordance with the specific time period prescribed by Apogee, during the period of the <br \/>award; and, (2) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or <br \/>inheritance) a new SFI.<br \/>5.3. If an Investigator does not have any SFIs to report, the Investigator must still complete the <br \/>Disclosure Form both initially and annually. Each Investigator must do so by completing the Disclosure<br \/>Form provided by Apogee to the Apogee IO. The Apogee IO shall solicit and review all required <br \/>Disclosure Forms and determine whether any reported SFI is a FCOI.<br \/>5.4. Apogee shall ensure applicable staff comply with these disclosure obligations. Failure to comply <br \/>with these disclosure obligations may result in disciplinary action by Apogee.<\/p>\n<p><br \/><strong>6. REVIEW AND MANAGEMENT REQUIREMENTS<\/strong><br \/>6.1. An Investigator\u2019s SFI is related to PHS-funded Research when Apogee, through the Apogee IO, <br \/>reasonably determines that the SFI: could be affected by the PHS-funded Research; or is in an entity <br \/>whose financial interest could be affected by the Research. Apogee may involve the Investigator in the <br \/>Apogee IO\u2019s determination of whether a SFI is related to the PHS-funded Research. A FCOI exists <br \/>when Apogee, through the Apogee IO, reasonably determines that the SFI could directly and <br \/>significantly affect the design, conduct, or reporting of the PHS-funded Research.<br \/>6.2. The Apogee IO will take actions as necessary to manage FCOIs, including any financial conflicts of <br \/>a subrecipient Investigator pursuant to this Policy. Management of an identified FCOI requires <br \/>development and implementation of a management plan and, if necessary, a retrospective review and <br \/>a mitigation report pursuant to this Policy.<br \/>6.3. Review Requirement: Prior to Apogee\u2019s expenditure of any funds under a PHS funded Research <br \/>project, the Apogee IO will review all Disclosure Forms with SFIs to determine whether the SFIs relate <br \/>to the PHS funded Research and whether a FCOI exists. If a FCOI exists, the Apogee IO will develop <br \/>and implement a management plan that specifies the actions that have been, and will be, taken to <br \/>manage such FCOI. Examples of conditions or restrictions that may be imposed to manage a FCOI <br \/>include, but are not limited to the follow actions:<br \/>6.3.1. Public disclosure of the FCOI (e.g., when presenting or publishing research);<br \/>6.3.2. For Research projects involving human subjects, disclosure of the FCOI directly to participants;<br \/>6.3.3. Appointment of an independent monitor capable of taking measures to protect the design, <br \/>conduct and reporting of the Research against bias resulting from the FCOI;<br \/>6.3.4. Modification of the research plan;<br \/>6.3.5. Change of personnel or personnel responsibilities, or disqualification of personnel from <br \/>participation in all or a portion of the Research;<br \/>6.3.6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or,<br \/>6.3.7. Severance of relationships that create financial conflicts.<br \/>6.4. Disclosure and Identification of SFI: Whenever, in the course of an ongoing PHS funded <br \/>Research project: (1) an Investigator who is new to participating in the Research project discloses a <br \/>SFI; (2) an existing Investigator discloses a new SFI; or (3) Apogee identifies a SFI that was not <br \/>disclosed timely by an Investigator or was not previously reviewed by Apogee during an ongoing PHS <br \/>funded Research project, the Apogee IO within sixty (60) days of the disclosure will review the SFI to <br \/>determine whether it is related to PHS funded Research and whether a FCOI exists. If a FCOI exists, <br \/>the Apogee IO will develop and implement, on at least an interim basis, a management plan that<br \/>specifies the actions that have been, and will be, taken to manage such FCOI. Depending on the nature <br \/>of the SFI, Apogee may determine that additional interim measures are necessary with regard to the <br \/>Investigator\u2019s participation in the PHS funded Research project between the date of disclosure and the <br \/>completion of Apogee\u2019s review.<br \/>6.5. Retrospective Reviews:<br \/>6.5.1. Whenever Apogee identifies a SFI that was not disclosed timely by an Investigator or, for <br \/>whatever reason, was not previously reviewed by Apogee during an ongoing PHS-funded research <br \/>project (e.g., was not timely reviewed or reported by a subrecipient), the Apogee IO shall, within sixty <br \/>(60) days: review the SFI; determine whether it is related to PHS-funded research; determine whether a <br \/>FCOI exists; and, if so, implement, on at least an interim basis, a management plan that shall specify <br \/>the actions that have been, and will be, taken to manage such FCOI going forward.<br \/>6.5.2. In addition, whenever a FCOI is not identified or managed in a timely manner including failure by <br \/>the Investigator to disclose a SFI that is determined by the Apogee IO to constitute a FCOI; failure by <br \/>the Apogee IO to review or manage such a FCOI; or failure by the Investigator to comply with a FCOI <br \/>management plan, Apogee shall, within one hundred twenty (120) days of its determination of <br \/>noncompliance, complete a retrospective review of the Investigator\u2019s activities and the PHS-funded <br \/>Research to determine whether any PHS-funded Research, or portion thereof, conducted during the <br \/>time period of the noncompliance, was biased in the design, conduct, or reporting of such Research. <br \/>Apogee is required to document the retrospective review. Documentation shall include all of the <br \/>following key elements:<br \/>6.5.2.1. Project number;<br \/>6.5.2.2. Project title;<br \/>6.5.2.3. PD\/PI or contact PD\/PI if a multiple PD\/PI model is used;<br \/>6.5.2.4. Name of the Investigator with the FCOI;<br \/>6.5.2.5. Name of the entity with which the Investigator has a FCOI;<br \/>6.5.2.6. Reason(s) for the retrospective review;<br \/>6.5.2.7. Detailed methodology used for the retrospective review (e.g., methodology of the review <br \/>process, composition of the review panel, documents reviewed);<br \/>6.5.2.8. Findings of the review; and,<br \/>6.5.2.9. Conclusions of the review.<br \/>6.5.3. Based on the results of the retrospective review, Apogee will update the previously submitted <br \/>FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is <br \/>found, Apogee will notify the PHS Awarding Component promptly and submit a mitigation report to the <br \/>PHS Awarding Component. Minimally, the mitigation report must include the key elements documented <br \/>in the retrospective review, a description of the impact of the bias on the Research project, and <br \/>Apogee\u2019s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on <br \/>the Research project; extent of harm done, including any qualitative and quantitative data to support <br \/>any actual or future harm; analysis of whether the Research project is salvageable). Thereafter, <br \/>Apogee will submit FCOI reports annually. Depending on the nature of the FCOI, Apogee may <br \/>determine that additional interim measures are necessary with regard to the Investigator\u2019s participation <br \/>in the PHS funded Research project between the date that the FCOI or the Investigator\u2019s <br \/>noncompliance is determined and the completion of Apogee\u2019s retrospective review.<br \/>6.6. Monitoring: Whenever Apogee implements a management plan, Apogee will monitor Investigator <br \/>compliance with the management plan on an ongoing basis until the completion of the PHS funded <br \/>Research project.<br \/><br \/><strong>7. REPORTING OF FINANCIAL CONFLICTS OF INTEREST<\/strong><br \/>7.1. Initial FCOI Report: Prior to Apogee\u2019s expenditure of any funds under a PHS funded Research <br \/>project, Apogee will provide to the PHS Awarding Component a FCOI report regarding any <br \/>Investigator\u2019s SFI found by Apogee to be a FCOI. Additionally, Apogee will ensure that it has <br \/>implemented a management plan in accordance with this Policy. In cases in which Apogee identifies a <br \/>FCOI and eliminates it prior to the expenditure of PHS awarded funds, Apogee is not required to submit <br \/>a FCOI report to the PHS Awarding Component.<br \/>7.2. Subsequent FCOI Reports: For any SFI that Apogee identifies as a FCOI subsequent to <br \/>Apogee\u2019s initial report during an ongoing PHS funded Research project, Apogee will provide to the PHS <br \/>Awarding Component a FCOI report regarding the FCOI within sixty (60) days of identification of the <br \/>FCOI. Additionally, Apogee will ensure that it has implemented a management plan in accordance with <br \/>this Policy and, if required, complete a retrospective review and a mitigation report according to this <br \/>Policy.<br \/>7.3. Contents of a FCOI Report: Any FCOI report required under this Policy will include sufficient <br \/>information to enable the PHS Awarding Component to understand the nature and extent of the FCOI <br \/>and to assess the appropriateness of Apogee\u2019s management plan. The FCOI report will include the <br \/>following minimum information:<br \/>7.3.1. Project number;<br \/>7.3.2. PD\/PI or Contact PD\/PI if a multiple PD\/PI model is used;<br \/>7.3.3. Name of the Investigator with the FCOI;<br \/>7.3.4. Name of the entity with which the Investigator has a FCOI;<br \/>7.3.5. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);<br \/>7.3.6. Value of the financial interest (dollar ranges are permissible: $0\u2013$4,999; $5,000\u2013$9,999; <br \/>$10,000\u2013$19,999; amounts between $20,000\u2013$100,000 by increments of $20,000; amounts above <br \/>$100,000 by increments of $50,000), or a statement that the interest is one whose value cannot readily <br \/>be determined through reference to public prices or other reasonable measures of fair market value;<br \/>7.3.7. A description of how the financial interest relates to the PHS funded Research and the basis for <br \/>Apogee\u2019s determination that the financial interest conflicts with such Research; and,<br \/>7.3.8. A description of the key elements of Apogee\u2019s management plan including the following minimum <br \/>information:<br \/>7.3.8.1. Role and principal duties of the conflicted Investigator in the Research project;<br \/>7.3.8.2. Conditions of the management plan;<br \/>7.3.8.3. Explanation of how the management plan is designed to safeguard objectivity in the Research <br \/>project;<br \/>7.3.8.4. Confirmation of the Investigator\u2019s agreement to the management plan; and,<br \/>7.3.8.5. Explanation of how the management plan will be monitored to ensure Investigator compliance.<br \/>7.4. Annual FCOI Report: For any FCOI previously reported by Apogee regarding an ongoing PHS <br \/>funded Research project, Apogee will provide to the PHS Awarding Component an annual FCOI report <br \/>that addresses the status of the FCOI and any changes to the management plan for the duration of the <br \/>PHS funded Research project. The annual FCOI report will specify whether the FCOI is still being <br \/>managed or explain why the FCOI no longer exists. Apogee will provide annual FCOI reports to the <br \/>PHS Awarding Component for the duration of the project period (including extensions with or without <br \/>funds) in the time and manner specified by the PHS Awarding Component.<br \/><br \/><strong>8. ENFORCEMENT<\/strong><br \/>8.1. If the failure of an Investigator to comply with this Policy or a FCOI management plan appears to <br \/>have biased the design, conduct, or reporting of the PHS funded Research, Apogee is required to <br \/>promptly notify the PHS Awarding Component of the corrective action taken or to be taken by Apogee. <br \/>The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, <br \/>or refer the matter to Apogee for further action, which may include directions to Apogee on how to <br \/>maintain appropriate objectivity in the PHS funded Research project.<br \/>8.2. Failure by Apogee staff to comply with this Policy may be grounds for disciplinary action up to and <br \/>including termination.<br \/>8.3. In any case in which the HHS determines that a PHS-funded project of clinical research whose <br \/>purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been <br \/>designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported by <br \/>Apogee as required by this subpart, Apogee shall require the Investigator involved to disclose the FCOI <br \/>in each public presentation of the results of the research and to request an addendum to previously <br \/>published presentations.<\/p>\n<p><br \/><strong>9. RECORD RETENTION<\/strong><br \/>9.1. Records regarding Disclosure Forms, determinations made by the Apogee IO, and Apogee\u2019s <br \/>actions regarding management of a FCOI will be retained by Apogee for three years beyond the date of <br \/>the final expenditure report submitted to the PHS Awarding Component under an award or, where <br \/>applicable, from other dates specified in 45 CFR 75.361, where applicable.<\/p>\n<p><br \/><strong>10. SUBCONTRACTORS AND CONSULTANTS<\/strong><br \/>10.1. Subcontractors\/consultants who perform services within the definition of an Investigator must <br \/>maintain a policy that complies with the aforementioned regulatory requirements or comply with this <br \/>Policy. All applicable subcontract\/consulting agreements must contain a clause that requires <br \/>compliance with the applicable federal regulations either through a policy maintained by the <br \/>subcontractor\/consultant or this Policy. Examples of appropriate clauses are shown below:<br \/>Financial Conflicts of interest \u2013 Compliance with Subcontractor\u2019s Policy<br \/>Subcontractor agrees to comply with any and all requirements relating to Public Health Service funded <br \/>projects. Without limiting the generality of the foregoing, Subcontractor, its employees and agents <br \/>agree to comply with the applicable requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94. <br \/>Subcontractor certifies that it maintains a policy that requires compliance with these requirements. <br \/>Subcontractor shall report all identified financial conflicts of interests to Apogee immediately and submit <br \/>a mitigation plan for Apogee\u2019s review and approval. Apogee is under no obligation to approve a <br \/>mitigation plan. Apogee reserves the right to terminate this Agreement or request removal of <br \/>Subcontractor\u2019s employee or lower tier subcontractor as a result of Subcontractor, its employee, or <br \/>lower tier subcontractor\u2019s financial conflict of interest. Subcontractor must include this clause in its <br \/>agreements with any applicable lower tier subcontractors or consultants. Failure to comply with these <br \/>requirements is a material breach of this Agreement.<br \/>Financial Conflicts of interest \u2013 Compliance with Apogee\u2019s Policy<br \/>Subcontractor agrees to comply with any and all requirements relating to Public Health Service funded <br \/>projects. Without limiting the generality of the foregoing, Subcontractor, its employees and agents <br \/>agree to comply with the applicable requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94. <br \/>Subcontractor agrees to comply with Apogee\u2019s Policy on Financial Conflicts of Interest in Public Health<br \/>Service Funded Research. Subcontractor shall report all identified financial conflicts of interests to <br \/>Apogee immediately and submit a mitigation plan for Apogee\u2019s review and approval. Apogee is under <br \/>no obligation to approve a mitigation plan. Apogee reserves the right to terminate this Agreement or <br \/>request removal of Subcontractor\u2019s employee or lower tier subcontractor as a result of Subcontractor, <br \/>its employee, or lower tier subcontractor\u2019s financial conflict of interest. Subcontractor must include this <br \/>clause in its agreements with any applicable lower tier subcontractors or consultants. Failure to comply <br \/>with these requirements is a material breach of this Agreement.<\/p>\n<p><br \/><strong>11. PUBLIC ACCESSIBILITY<\/strong><br \/>11.1. Prior to Apogee\u2019s expenditure of any funds under a PHS funded Research project, Apogee shall <br \/>ensure public accessibility by posting to a publicly accessible website information, or written response <br \/>to any requestor within five (5) business days of a request, concerning any SFI disclosed to Apogee<br \/>that is: (a) held by Senior\/Key Personnel performing services for the Research, (b) related to the PHS <br \/>funded research, and (c) determined by Apogee to be a FCOI. <br \/>The following information regarding the FCOI must be posted to the website:<br \/>11.1.1. Project number;<br \/>11.1.2. Name of the Investigator with the FCOI, title, and role with respect to the Research project;<br \/>11.1.3. Name of the entity with which the Investigator has a FCOI;<br \/>11.1.4. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);<br \/>11.1.5. Value of the financial interest (dollar ranges are permissible: $0\u2013$4,999; $5,000\u2013$9,999; <br \/>$10,000\u2013 $19,999; amounts between $20,000\u2013$100,000 by increments of $20,000; amounts above <br \/>$100,000 by increments of $50,000), or a statement that the interest is one whose value cannot readily <br \/>be determined through reference to public prices or other reasonable measures of fair market value;<br \/>11.2. This information must be updated at least annually as well as within sixty (60) days of either: (a) <br \/>Apogee\u2019s receipt or identification of information concerning any additional SFI of the Senior\/Key <br \/>Personnel for the PHS funded Research project that was not previously disclosed; or, (b) upon <br \/>disclosure of any SFI of Senior\/Key Personnel new to the PHS funded Research project and meeting <br \/>the disclosure criteria. The website shall note that the information is current as of the date shown and is <br \/>subject to the required updates. Any SFI posted to the Website shall remain available for at least three <br \/>years from the date that the information was most recently updated by Apogee. If Apogee responds to <br \/>written requests for the purposes of this subsection, Apogee will note in its written response that the <br \/>information provided is current as of the date of the correspondence and is subject to updates, on at <br \/>least an annual basis and within sixty (60) days of the Apogee IO\u2019s identification of a new FCOI, which <br \/>should be requested subsequently by the requestor. All disclosures or information obtained in reviewing <br \/>a potential FCOI is kept confidential, except where disclosure is required by federal regulations.<br \/><br \/><br \/><\/p>\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Charles D. Smith, Ph.D.President and CEOApogee Biotechnology Corporation1214 Research Blvd, Suite 2015Hershey Center for Applied ResearchHummelstown, PA\u00a0 17036Email:\u00a0 cdsmith@apogee-biotech.com Lynn W. Maines, Ph.D., M.B.A.Vice President, Research and Business AffairsApogee Biotechnology Corporation1214 Research Blvd, Suite 2015Hershey Center for Applied ResearchHummelstown, PA\u00a0 17036Email:\u00a0 lwmaines@apogee-biotech.com exact fake watches replica &#8211; patek philippe replica, franck best replica watches replica, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/pages\/10"}],"collection":[{"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/comments?post=10"}],"version-history":[{"count":15,"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/pages\/10\/revisions"}],"predecessor-version":[{"id":443,"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/pages\/10\/revisions\/443"}],"wp:attachment":[{"href":"https:\/\/apogee-biotech.com\/index.php\/wp-json\/wp\/v2\/media?parent=10"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}