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1) General
This Confirmation establishes the terms and conditions (“Terms”) for sale and license to the purchaser (“Buyer”) of the reagents, instruments and other products and related services (“Products”) from AlphaThera LLC. (“Seller”). Reference to any proposal from Buyer is made only to specify basic information concerning price, the description of goods, quantities, terms of payment and delivery, and the like, and provided only if such terms are consistent with the Terms. If this Confirmation is an offer or a quote, Buyer’s acceptance shall be subject to, and conditioned upon the Terms, and Seller hereby objects to those portions of any acceptance that contradict, modify or add to the Terms. If this Confirmation is issued as a confirming order, the Terms shall supersede those terms applying to all prior orders. Any of Buyer’s terms (including in a purchase order) which are added to or are inconsistent with the Terms will be considered proposals for addition or modification to this Confirmation, and will not be added to the Terms or binding on Seller unless agreed to in writing by Seller. The Terms constitute the complete and exclusive agreement of the parties concerning the subject matter of this Confirmation.
2) Invoices and Payment
All prices are in U. S. dollars and are exclusive of insurance, freight, taxes, fees, duties, and levies which shall be payable by Buyer. “Taxes” shall include any and all sales, use, excise, import or export, value-added or similar tax or duty, and any other tax not based on Seller’s net income, including any penalties and interest, due to the sale of Products or any payment to be made by Buyer pursuant to this Confirmation, and any costs associated with the collection of or withholding of any of the foregoing items. Buyer shall pay the total amount due as specified on the front of this Confirmation, by cash, or by the delivery of an executed letter of credit, if agreed to by Seller in writing within thirty (30) days of delivery. Further shipment of Products may be declined if Buyer fails to make any payment when due, or if the financial condition of Buyer becomes unsatisfactory to Seller. Buyer shall pay interest at a rate equal to 1.5% per month for late payments.
3) Changes
Buyer may not make changes to this Confirmation without Seller’s written consent. If any such change affects the cost of or the time required for Seller’s performance under this Confirmation, or affects any other provision of this Confirmation, an equitable adjustment agreed to by Seller shall be made in the price and/or delivery schedule of this Confirmation or in such other provisions of the Confirmation as may be affected.
4) Shipment and Delivery
Products will be packed in Seller’s standard shipping packages and shipped via a carrier selected or approved by Seller. Delivery dates set forth on a purchase order accepted by Seller are subject to change and are dependent on conditions existing at that time. Seller does not guarantee any delivery dates and shall not be responsible for any loss or damage of any kind or nature whatsoever caused by any delay in delivery irrespective of the cause of such delay. If shipment is delayed at Buyer’s request, Buyer will reimburse Seller for all costs of storage. Products delivered will be deemed accepted by the Buyer unless written notice of defect or shortage is received by Seller within 72 hours after receipt of such shipment. Title (except for software, in which case AlphaThera shall retain title) and Risk of loss or damage shall pass to Buyer upon delivery of the Products to the carrier. For Deliveries Within Europe and the UK: Incoterms 2010 for shipments to these countries will be CIP (Carriage and Insurance paid) to the nearest port of international entry. The Buyer will be the importer for the Products and be responsible for paying VAT or similar taxes within the Buyer’s country. Title (except for software, in which case Seller shall retain title) and risk of loss or damage will pass to Buyer upon delivery of the Products to the seller’s carrier/broker in the respective country.
5) Intellectual Property
Any materials, instructions, protocols, know-how, other intellectual property, and designs covering or relating to Products and provided by Seller to Buyer as part of the Products pursuant to this Confirmation (the “Components”) shall remain the sole property of Seller. Buyer may only use such Components as expressly permitted by the Seller in the Product package insert. Buyer shall not reverse engineer any Component or otherwise make any attempt to determine the composition of the Components.
Research Use Only; Limited License.
Products supplied by Seller are labeled for research use only and do not have the approval of the U.S. Food and Drug Administration (“FDA”) or any other regulatory approval, clearance or registration for in vitro diagnostic use (“IVD”) use. In particular, the purchase of this product under these terms does not include or carry any right or license to use, develop, or otherwise exploit this product commercially and no rights are conveyed to the buyer to use the product or components of the product for therapeutic or diagnostic purposes. All Products shall be used by qualified professionals in accordance with any user guide, protocols, or other documentation provided by Seller in connection with the Products. The user guides, protocols, or other documentation provided by Seller in connection with specific Products may include other license terms, and Buyer agrees that such terms are incorporated herein by reference. The burden for safe use and handling of all Products sold by Seller to Buyer is entirely the responsibility of Buyer. Subject to the Terms, Seller hereby grants to Buyer a non-exclusive, non-transferable, non-sublicenseable license to use the Products for research use only, and only in accordance with the manuals and written instructions provided herewith by Seller for Buyer’s internal research and development activities (and educational activities if Buyer is a not-for-profit institution). No right or license to any intellectual property owned or licensable by Seller is conveyed or implied by this Confirmation, except as expressly set forth above. In particular, no right or license is conveyed or implied to use any Product provided hereunder in combination with a product not provided, licensed, or specifically recommended by Seller for such use. Buyer shall not transfer, resell or distribute Products to any third party.
Purchaser is solely responsible for determining whether Purchaser has all intellectual property rights that are necessary for Purchaser’s intended uses of the Product.
Use Restrictions.
Buyer is not licensed to, and agrees not to: (a) resell any Seller-supplied Products, (b) transfer, or distribute any Seller-supplied Products, directly or indirectly, to any third party for any purpose or use, except as otherwise approved by Seller in writing; (c) use or allow anyone to use Seller-supplied cartridges more than once, or dilute any Seller-supplied reagent other than in accordance with Seller’s instructions for use; or (d) decompile, deconstruct, disassemble or make other attempts to reverse engineer Seller supplied Products including software, cartridges, instruments, or kits. Unless otherwise agreed by Seller in writing, Buyer agrees not to use any instrument or cartridge Products provided hereunder in combination with any cartridges, reagents, instruments, software and/or other products which are not provided by Seller or from a source authorized by Seller. Buyer acknowledges that failure to comply with any restriction of use set forth herein or in any user guide, protocols, or other documentation provided by Seller in connection with the Products will (i)constitute a breach of these Terms and Conditions, (ii) invalidate any warranty provided herein and any applicable service agreement, and (iii) constitute a violation or infringement of Seller’s and/or a third party’s intellectual property rights.
Product Improvement Inventions.
Buyer hereby grants to Seller a non-exclusive, worldwide, fully sublicensable, fully paid-up, royalty-free, irrevocable, perpetual license to all Product Improvement Inventions. Buyer need not disclose any Product Improvement Inventions to Seller except as may be reasonably required to comply with the foregoing license. For purposes of this paragraph, “Product Improvement Inventions” shall mean any invention conceived or reduced to practice by or on behalf of Buyer using Products that relate to (a) designing, manufacturing, composition of matter, use or packaging of Products, (b) manual or automated assay technologies that may be used in connection with Products, or (c) software analysis techniques relating to the extraction or storage of data generated using the Products. Product Improvement Inventions shall not include data generated using Products, or discovery derived therefrom, except as expressly set forth above.
6) Cancellation
Seller may cancel this Confirmation, in whole or in part, if Buyer fails to comply with any of the Terms, or if Buyer takes or is subject to any act of bankruptcy or insolvency. Upon such cancellation, Seller shall not be liable for any amount, and Buyer shall be liable to Seller for any and all damages (including but not limited to indirect or consequential damages) sustained by reason of Seller’s default. Buyer may only cancel this Confirmation by providing written notice no later than thirty (30) days prior to the scheduled shipment of the applicable Products. Buyer shall submit request for reschedule of shipment to Seller in writing and such reschedule shall only effective upon Seller’s written consent. Any reschedule for a period of ninety (90) days or more maybe considered by Seller as a cancellation of the affected order of Products. Buyer shall hold Seller harmless for all costs incurred and any consequential damages Seller may incur as a result of any reschedule or cancellation of this Confirmation. Seller shall use reasonable efforts to minimize the liability of Buyer under this paragraph.
7) Custom Products
Certain Products sold by Seller are manufactured to certain criteria specifically for a Buyer or are combination products which include customization of standard products as specified by a Buyer (“Custom Products”). These Products may not meet specifications of Seller’s standard or off the shelf Products. A Buyer may elect to purchase Custom Products by providing Seller with the information pertaining to its specific needs. Seller shall provide the Buyer with a Quote based on the information provided by Buyer. Any change to the Buyer information must be made within twenty four (24) hours after confirmation and Quote is received by the Buyer. Failure to do so may result in additional costs to the Buyer. Seller will not disclose to any third party any proprietary information that Buyer may have provided to Seller, or any confidential information of Buyer. Notwithstanding the foregoing, Seller may market and make available for commercial sale to its other customers through its normal distribution channels the Custom Products including those based on information that is the same or similar to that provided by any given Buyer, provided that such information is independently provided by a subsequent or another Buyer. No additional warranties other than those described below shall be available for Custom Products. Buyer acknowledges and accepts sole responsibility for providing accurate information to Seller and Seller shall have no liability for Product defects caused or related in whole or in part to Buyer’s negligence in providing accurate information to Seller.
8) LIMITATION OF LIABILITY
SELLER SHALL HAVE NO LIABILITY TO BUYER FOR ANY INDIRECT, CONSEQUENTIAL, INCIDENTAL OR SPECIAL DAMAGES OF ANY KIND, HOWEVER CAUSED AND REGARDLESS OF FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT PRODUCT LIABILITY OR OTHERWISE, EVEN IF SELLER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. AS TO ANY SELLER’S LIABILITY NOT LEGALLY SUBJECT TO THE FOREGOING, IN NO EVENT SHALL SELLER’S LIABILITY TO BUYER EXCEED THE AMOUNT PAID BY BUYER TO SELLER FOR THE APPLICABLE PRODUCT. BUYER UNDERSTANDS THAT SUCH ALLOCATION OF RISK IS REFLECTED IN THE PRICE OF THE PRODUCTS AND THAT THE TERMS WOULD HAVE BEEN DIFFERENT IF THERE WAS A DIFFERENT ALLOCATION OF RISK
9) Compliance with Laws; Indemnification
Buyer shall comply with all applicable federal, state or local laws, rules, regulations or ordinances (“Laws”) in performing under this Confirmation and in storage and use of Products. Seller agrees to indemnify Buyer from and against any final judgment or settlement amounts as a result of any legal action or proceeding brought by a third party against Buyer to the extent that such action is based on a claim that the use of a Product in a manner expressly authorized by any applicable label or other written license furnished by or otherwise in writing by Seller infringes any United States patents of such third party. If any Product or any component thereof is subject to a legal proceeding claiming that the Product infringes a third party’s intellectual property right, or in Seller’s opinion is (are) likely to become subject of such a claim, Seller may, at its option either: (a) procure for Buyer the right to continue using the Product; or (b) replace or modify the Product so that it becomes non-infringing; or (c) require Buyer to return the Product and upon return, refund to Buyer the price actually paid by Buyer for the Product, less a reasonable amount for use, damage or obsolescence; or (d) substitute for the infringing Product with suitable, non-infringing products. Notwithstanding the foregoing, Seller shall have no liability or obligation hereunder for any claim arising out of: (i) the use of Product in combination with any product, equipment or material not provided by Seller, (ii) any modification to Product made by Buyer or a third party, or (iii) any modification to Product made by Seller at the request of the Buyer. THE FOREGOING STATES THE ENTIRE LIABILITY OF SELLER, AND THE EXCLUSIVE REMEDY OF BUYER, FOR ANY INFRINGEMENT OR CLAIMED INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHT BY PRODUCT OR ANY PART THEREOF OR USE THEREOF. Buyer shall indemnify Seller against all losses, damages, liabilities, judgments, costs and expenses (including attorney’s fees) due to any suit, claim, action or proceeding against Seller resulting from Buyer’s non-compliance with Laws, or any infringement of intellectual property right resulting from use of Product or combining Product with other components or products.
Conditions to Indemnification Obligations. The parties’ indemnification obligations are conditioned upon the party seeking indemnification (i) promptly notifying the other party in writing of such claim or action, (ii) giving the other party exclusive control and authority over the defense and settlement of such claim or action, (iii) not admitting infringement of any intellectual property right without prior written consent of the other party, (iv) not entering into any settlement or compromise of any such claim or action without the other party’s prior written consent, and (v) providing reasonable assistance to the other party in the defense of the claim or action; provided that, the indemnifying party reimburses the indemnified party for its reasonable out-of-pocket expenses incurred in providing such assistance.
10) Assignment
Buyer shall not assign or delegate any obligation under this Confirmation. Any attempted assignment or delegation shall be void.
11) Limited Warranty.
For reagents
reasonably determined by Seller to be defective, independent of user error, shall be replaced by Seller on a 1:1, like-kind basis at no cost to Buyer or at Seller’s sole discretion, the amount paid by Buyer shall be credited to the Buyer against future Products purchased from Seller, provided that such defective reagents were used by Buyer prior to their expiration date, or if there is no expiration date, the Products were used within six (6) months of receipt, and the defect was promptly reported with appropriate detail to Seller’s technical support. For Custom Products (see section 7 above), Buyer bears all responsibility for the performance of the Custom Products when used in combination with any other Products.
For Products other than reagents,
reasonably determined by Seller to be defective, independent of user error, shall be replaced by Seller on a 1:1, like-kind basis at no cost to Buyer, or at Seller’s sole discretion, the amount paid by Buyer shall be credited to the Buyer against future Products purchased from Seller, provided that such defective Products were used by Buyer within six (6) months of receipt, and Seller disclaims any and all other warranties, express or implied. Except as provided above, any warranty provided herein does not apply to other consumables, or to any defect caused by unsuitable storage, use, or operating environment, use of non-recommended reagents, spills, or the use of the Products for a purpose or in a manner other than that for which they were designed, modifications or repairs done by Buyer or a third party, or any other abuse, misuse, or neglect of the Products, or transfer of Products to a country where Seller does not enter into business transactions as part of its normal course of business.
All warranties specified herein apply only to Buyer, and not third parties.
12) Force Majeure
Seller shall not be liable for any delay of delivery or other performance under this Confirmation if performance is rendered impracticable by the occurrence of any condition beyond its reasonable control. Events beyond Seller’s reasonable control shall include (without limitation) government action or inaction, strikes, fire, flood, earthquake, severe weather or other casualty, or the like. In the event of any such delay or failure in performance, Seller shall have such additional time within which to perform its obligations hereunder as may be reasonably necessary under the circumstances and Seller shall have the right, to the extent necessary in its sole judgment, to apportion available Products fairly among its various customers.
13) Non-Waiver; Modifications
A waiver on one or more occasions of any of the provisions by either party shall not be deemed a waiver of the right to enforce such or any other provision at a later time. Any modification to this Confirmation may be made only by the written agreement of both Seller and Buyer.
14) Export Controls
Buyer agrees that it will not directly or indirectly export Products in violation of any United States export laws or regulations.
15) Miscellaneous Provisions
Applicability of Terms and Conditions. This Confirmation constitutes the entire agreement between Buyer and Seller and is the final, complete, and exclusive statement of the terms of the agreement, superseding all prior oral and written agreements (other than any formal supply agreements between Buyer and Seller), understanding, and undertaking with respect to the subject matter hereof.
Arbitration. In Seller’s sole discretion, any dispute, claim or controversy arising out of or relating to these terms and conditions, shall be determined by confidential binding arbitration conducted in the English language, under generally accepted arbitration rules and procedures in a venue to be determined by Seller. In all cases of arbitration each party shall bear its own costs and expenses and an equal share of the arbitrator’s and administrator’s fees of arbitration; neither party nor an arbitrator may disclose the existence, content, or results of any arbitration without the prior written consent of both parties, unless required by law; the decision of the arbitrator shall be final and binding on the parties, provided that, the arbitrator shall not have the authority to alter any explicit provision of these terms and conditions; judgment on the award may be entered in any court having jurisdiction. This clause shall not preclude the parties from seeking provisional remedies in aid of arbitration from a court of appropriate jurisdiction.
Representations and Warranties. Purchaser is not an authorized dealer, representative, reseller, or distributor of any of Seller’s, or its affiliates’, products or services. Purchaser represents and warrants that it (i) is not purchasing the Product on behalf of a third party, (ii) is not purchasing the Product in order to resell or distribute the Product to a third party, (iii) is not purchasing the Product in order to export the Product from the country in which Seller shipped the Product pursuant to the ship-to address designated by Purchaser at the time of ordering (“Ship-To Country”), and (iv) will not export the Product out of the Ship-To Country.
Seller Information. Seller may maintain and use a database of orders and account information pertaining to Purchaser for purposes of order processing, maintaining records, assisting with future orders of Purchaser, and compliance with applicable laws and regulations. Purchaser may not disclose any financial terms of this transaction to any third party without the prior written consent of the Seller, except as (and only to the extent) required by securities or other applicable law. Purchaser grants to Seller a non-exclusive, fully paid-up, royalty-free, worldwide, irrevocable, perpetual right and license, with the right to sublicense, to use and commercialize in any manner suggestions, ideas or comments provided by Purchaser to Seller related to the Products.
Export Compliance. The Products, any related technology, or information provided to Purchaser may be subject to restrictions and controls imposed by the United States Export Administration Act and the regulations thereunder (or the export regulations and laws of another country). Notwithstanding anything to the contrary in these terms and conditions, Purchaser agrees not to use the Products in, or export or re-export the Products, any related technology, or information provided to Purchaser into, any country or to any person or entity, or in any manner, in violation of such controls or any other laws, rules or regulations of any country, state or jurisdiction.
Healthcare Law Compliance. Purchaser acknowledges and agrees that as a healthcare company, Seller, and Seller’s affiliates, may be required by applicable law and regulation (“Healthcare Laws”) to disclose the existence of these terms and conditions, the terms herein including financial terms, and the subject matter (e.g., the U.S. Sunshine Act, and state and foreign equivalents). Seller agrees it, and its affiliates, will disclose the least amount of information as possible in order to comply with such Healthcare Laws.
Governing Law. This Confirmation will be interpreted in accordance with the laws of the State of Delaware without giving regards to conflict of law principles requiring the application of other laws, and in no event by the United Nations Convention on Contracts for the International Sale of Goods. The parties hereby consent to personal jurisdiction in the state and federal courts in Delaware in any suit arising out of this Confirmation. The invalidity in whole or in part of any provision hereof shall not affect the validity of any other provision.
AlphaThera Financial Conflict of Interest Policy
I. Purpose:
AlphaThera (Company) strives to promote objectivity in research by establishing standards such that the design, conduct and reporting of research is free from bias resulting from financial conflict of interest (FCOI). Accordingly, AlphaThera maintains and enforces a general FCOI Policy that applies to all Investigators of the Company who carry out sponsored projects and research supported by the National Institutes of Health, and other PHS agencies.
Company policy requires investigators who are responsible for the design, conduct, or reporting of research funded by PHS, to disclose potential or apparent conflicts of interest or commitment so that the Company can effectively manage, reduce or eliminate such conflicts. This policy has been established to comply with PHS requirements to maintain eligibility for the application and receipt of federal funding, including grants, subawards and cooperative agreements.
II. Investigator Requirements
Any person that meets the federal definition of an Investigator (see Definitions section below) is required to comply with the policy and procedures outlined below. An Investigator is defined as the Project Director (PD), Principal Investigator (PI) or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposal for such funding. Investigators also include collaborators and consultants.
In summary, Investigators are required to:
1. Disclose any significant financial interests (SFIs) at the time of application for federal PHS funding by completing and signing a disclosure form, and submitting this to the Policy Coordinator;
2. Disclose SFIs using the disclosure form at least on an annual basis during the course of an award;
3. Disclose within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) any new SFI; and
4. Take part in FCOI training at least once every four years.
III. Investigator FCOI Training Requirements
The Company is responsible for ensuring that each Investigator is informed about this FCOI policy and procedures for disclosure, and ensuring that each Investigator has completed FCOI training prior to engaging in PHS-funded research and at least once every four years. Training will also be required immediately when any of the following occurs:
1. this FCOI Policy, the SFI Disclosure Form, or the Company’s procedures are revised in any manner that affects the requirements of Investigators;
2. a PHS-supported Investigator is newly appointed to the Company; or
3. the Company determines that an Investigator is not in compliance with this policy or an FCOI management plan.
“Immediately” means that training will be provided or made available and that Investigators will participate in the training expeditiously after one of the aforementioned qualifying events. The Policy Coordinator will be responsible for retaining records of FCOI training. The Company uses the Financial Conflict of Interest online tutorial provided by the National Institutes of Health for satisfying training requirements. Investigators must provide assurance they have completed the NIH tutorial by sending a copy of the Certificate of Completion to the Policy Manager. The NIH tutorial is available at:
https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
IV. Procedure for Submitting a Disclosure
The Policy Coordinator is responsible for collecting SFI Disclosure Forms via email prior to proposal submission to external PHS funding agencies. The SFI Disclosure Form conforms to the requirements of PHS FCOI Regulations (42 CFR Part 50.604). The following procedures will be followed:
1. All investigators involved in the project/proposal are required to complete, sign and submit the SFI Disclosure Form prior to the Company submitting a proposal to a PHS agency.
2. The Investigator must list all of their SFIs (and those of the Investigator’s spouse or domestic partner and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities in teaching, scholarship or service.
3. The form requires the Investigator to include, at minimum, the name of the entity, the nature of the financial interest (e.g., equity, consulting fee), the monetary value of the financial interest or its approximate value if the interest is one whose value cannot readily be determined. If needed, the Policy Coordinator may request supporting documentation to determine whether an FCOI exists (e.g., a copy of any applicable consulting agreement or stock purchase agreement).
4. For SFI disclosures related to sponsored or reimbursed travel, the disclosure must include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and the approximate monetary value.
5. The Investigator is required to submit an updated SFI Disclosure Form during the period of the award at least annually, and within 30 days of discovering or acquiring a new SFI. The SFI Disclosure Form notifies the Investigator of this requirement to provide updated disclosures.
V. Review of SFI Disclosures
The Company has designated the Policy Coordinator as the institutional official who initially reviews disclosures and determines whether a disclosed SFI is related to the PHS-funded research, and if so, whether it constitutes an FCOI.
An Investigator’s SFI is related to PHS-funded research when the Institution, through its designated official, reasonably determines that the SFI: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research. An FCOI exists when the institution reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
The Company may request additional information from the Investigator to determine whether an SFI is related to the PHS-funded research. In making these determinations, the Company may take into account financial interests in a previously disclosed entity related to PHS- or other federally-funded research. The Policy Coordinator may consult with appropriate institutional and agency officials during the review process.
If it is determined that an FCOI exists, the conflict will either be approved with conditions or restrictions in place (subject to a management plan), or prohibited. Management plans shall be implemented by an oversight committee comprised of the Chief Executive Officer, Director of Research, and Policy Coordinator. The management plan shall be completed prior to the expenditure of any funds under a PHS grant, cooperative agreement, subaward, or contract. The Company, via the management plan committee, will monitor compliance with management plans on an ongoing basis until the completion of the PHS-funded research project.
For all management plans, examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) public disclosure of SFIs; (2) for research projects involving human subjects, disclosure of FCOIs directly to participants; (3) appointment of independent monitor(s) capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; (4) modification of the research plan; (5) change of personnel or personnel responsibilities, or disqualification of personnel from participation in all, or a portion of the research; (5) reduction or elimination of the financial interest (e.g., sale of an equity interest); or (6) severance of relationships that create financial conflicts.
When an Investigator who is new to a PHS-funded research project discloses an SFI or an existing Investigator discloses a new SFI, the Company will within 60 days: review the disclosure; assess whether the SFI constitutes an FCOI with PHS-funded research; and if so, implement, at least, on an interim basis, the actions that have been, and will be, taken to manage such FCOI.
VI. Reporting Financial Conflicts of Interest to PHS
Prior to the Company’s expenditure of any funds under a PHS-funded research project, the Company will provide to the PHS Awarding Component (e.g., NIH) an FCOI report regarding any Investigator’s significant financial interest found by the Company to be conflicting and ensure that the Company has implemented a management plan. In cases in which the Company identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the Company is not required to submit an FCOI report to the PHS Awarding Component.
For any significant financial interest that the Company identifies as conflicting subsequent to the Company’s initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the Company will provide to the PHS Awarding Component, within 60 days, an FCOI report regarding the financial conflict of interest and ensure that the Company has implemented a management plan.
Any FCOI report required by PHS will include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Company’s management plan. Elements of the FCOI report will include, but are not necessarily limited to the following:
Project number; PD/PI or Contact PD/PI if a multiple PD/PI model is used; name of the Investigator with the financial conflict of interest; name of the entity with which the Investigator has a financial conflict of interest; nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); value of the financial interest (dollar ranges are permissible: $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 a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value; a description of how the financial interest relates to the PHS-funded research and the basis for the Company’s determination that the financial interest conflicts with such research; and a description of the key elements of the Company’s management plan, including:
(a) Role and principal duties of the conflicted Investigator in the research project;
(b) Conditions of the management plan;
(c) How the management plan is designed to safeguard objectivity in the research project;
(d) Confirmation of the Investigator’s agreement to the management plan;
(e) How the management plan will be monitored to ensure Investigator compliance; and
(f) Other information as needed.
For any financial conflict of interest previously reported by the Company with regard to an ongoing PHS-funded research project, the Company will provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project.
The annual FCOI report will specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. The Company will provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
VII. Mitigation Reporting Due to Noncompliance
Whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Company to constitute a financial conflict of interest; failure by the Company to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Company will, within 120 days of the Institution’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
The Company is required to document the retrospective review; such documentation will include, but not necessarily be limited to, all of the following key elements:
Project number; project title; PD/PI or contact PD/PI if a multiple PD/PI model is used; name of the Investigator with the FCOI; name of the entity with which the Investigator has a financial conflict of interest; reason(s) for the retrospective review; detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); findings of the review; and conclusions of the review.
Based on the results of the retrospective review, the Company will update any previously submitted FCOI report, as applicable, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Company will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Company’s plan of action or actions taken to eliminate or mitigate the effect of the bias
(e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Company will submit FCOI reports annually, as specified elsewhere in 42 CFR Part 50, Subpart F. The initial and annual FCOI reports will be submitted to the NIH through the eRA Commons FCOI Module. Depending on the nature of the financial conflict of interest, the Company may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the
date that the financial conflict of interest or the Investigator’s noncompliance is determined and
the completion of the Company’s retrospective review.
Whenever the Company implements a management plan pursuant to this policy, the Company will monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.
All FCOI reports, including revised FCOI reports and mitigation reports, will be submitted through the electronic Research Administration (eRA) Commons FCOI Module.
VIII. Subrecipient Requirements
If a portion of PHS-funded research is carried out by a subrecipient, the Company will incorporate as part of a written agreement with the subrecipient terms that establish whether the PHS FCOI policy of the Company (the awardee Institution) or that of the subrecipient will apply to the subrecipient’s Investigators. If the subrecipient requires its Investigators to comply with the subrecipient’s FCOI policy, the subrecipient shall certify as part of the subrecipient agreement that its policy complies with 42 CFR Part 50, Subpart F. If the subrecipient cannot provide such certification, the agreement will state that subrecipient Investigators are subject to the PHS FCOI policy of the Company for disclosing SFIs that are directly related to the subrecipient’s work for the Company. The subrecipient agreement will further include, if applicable, terms that allow the Company to solicit and review subrecipient Investigator disclosures that enable the Company to identify, manage and report identified FCOIs to the PHS Awarding Component.
AlphaThera will comply with all provisions of 42 CFR Part 50.604 regarding subrecipients including, providing FCOI reports to the appropriate PHS awarding agency regarding all FCOIs of all subrecipient Investigators prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
IX. Remedies, Enforcement and Sanctions
If an Investigator fails to comply with this policy or a management plan and the noncompliance appears to have biased the design, conduct or reporting of the PHS-funded research, the Company will promptly notify the agency of the corrective action taken or to be taken. The Company will ensure compliance with the requirements for retrospective review and prepare a mitigation report, as applicable, for submission to the funding agency as required under PHS FCOI regulations. The agency may take its own action as it deems appropriate, which may include suspension of funding, or require the Company to take further action to maintain the objectivity of the research.
All AlphaThera Investigators proposing or conducting PHS-funded research are subject to this policy (except those applying to or funded by the Phase I Small Business Innovative Research or the Small Business Technology Transfer program). Investigators are expected to comply with this policy fully. Whenever an Investigator has violated this policy, the Company will take appropriate action in accordance with disciplinary sanctions incorporated in the Company’s Employee Handbook.
Note on Clinical Research: In any case in which the Department of Health and Human Services determines that a PHS-funded research project of clinical research 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 an FCOI that was not managed or reported by the Company as required by the regulation, the Company will require the Investigator involved to: 1) disclose the FCOI in each public presentation of the results of the research, and 2) request an addendum to previously published presentations.
X. Records and Public Access
The Company will maintain all SFI Disclosure Forms, training certifications, management plans, reports and all related records of actions taken by the Company with respect to disclosures of financial interests for a period of three years from the date of submission of the final expenditures report to the PHS as governed by 42 CFR Part 50 Subpart F, and from other dates specified in 45 CFR 75.361, where applicable.
The Company has posted this policy on AlphaThera’s website, a public website, in accordance with the PHS regulations.
In addition, this policy allows for certain information concerning identified FCOIs held by Investigators to be made available and publicly accessible. The information will:
– Include the minimum elements as provided in the regulation
– Be made available within 5 calendar days of a written request
– Be updated, at least annually (website only but any response to a written request should include the updated information)
– Be updated, within 60 days of a newly identified FCOI (website only but any response to a written request should include the updated information)
– Remain available for three years from the date the information was most recently updated.
Definitions
Disclosure of significant financial interests: an Investigator’s disclosure of significant financial interests to the Company.
Financial conflict of interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report: the Company’s report of a financial conflict of interest to a PHS Awarding Component.
Financial interest: anything of monetary value, whether or not the value is readily ascertainable.
HHS: the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institution: any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding. AlphaThera represents the institution for the purposes of this policy.
Institutional responsibilities: an Investigator’s professional responsibilities on behalf of the Company, and as defined by the Company in its policy on financial conflicts of interest, which include responsibilities of teaching, scholarship and service.
Investigator: the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Manage: taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PD/PI: a Project Director or Principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this policy.
PHS: the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component: the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F.
Public Health Service Act or PHS Act: the statute codified at 42 U.S.C. 201 et seq. the regulation: 42 CFR Part 50, Subpart F: “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought”
Research (according to federal regulations governing this policy): 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). 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.
Senior/key personnel: the PD/PI and any other person identified as senior/key personnel by the Company in the grant application, progress report, or any other report submitted to the PHS by the Company.
Significant financial interest:
(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:
(i) 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;
(ii) 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 12 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
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) 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 institutional 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.
(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; 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; 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 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.
Small Business Innovation Research (SBIR) Program: the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this policy, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.
Additional Information and Resources: Financial Conflicts of Interest, the National Institutes of
Health, Office of Extramural Research: http://grants.nih.gov/grants/policy/coi/
POLICY COORDINATOR
If you believe you have a conflict of interest or if you have any questions, please contact the Policy Coordinator, by email: compliance@alphathera.local.