Memorandum of Understanding Between the Food and Drug Administration and Medical Management International, Inc.
This Memorandum of Understanding (this “MOU”), dated effective as of February 27, 2018 (the “Effective Date”), is between the Food and Drug Administration of the United States of America (“FDA”) and Medical Management International, Inc. doing business as Banfield Pet Hospital® (“Banfield”). FDA and Banfield are each referred to in this MOU individually as a “Party” and, collectively, as the “Parties”.
A. FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA promotes and protects the public health by assuring the safety, effectiveness, and security of drugs, biologics, veterinary products, and medical devices; as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. The Center for Veterinary Medicine is charged with ensuring the safety, effectiveness, and security of veterinary medical products and animal feed.
B. On August 2, 2004, “The Minor Use and Minor Species Animal Health Act of 2004,” commonly referred to as the “MUMS act”, was enacted. The law is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in the major animal species.
This law provides innovative ways to bring products to market for these small populations and is designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs. Before this legislation, pharmaceutical companies would rarely attempt to bring such drugs to market, because the markets were too small to generate an adequate financial return.
In support of seeking designation or conditional approval animal drug sponsors (each, an “Animal Drug Sponsor”) can request from the FDA a determination of minor use status under sections 571 & 573 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal drugs intended for minor use in a major species. Sponsors of such drugs may also be entitled to waiver of user fees under the user fee provisions of the FD&C Act, sections 739-741.
C. Banfield is a full service, nationwide small-animal practice. They have information on nearly 8 million pet visits per year from more than 975 hospitals across the United States and Puerto Rico.
D. From time to time during the Term (as defined below), the Office of Minor Use & Minor Species Animal Drug Development of the FDA’s Center for Veterinary Medicine (FDA-OMUMS), acting on behalf of the FDA, may request that Banfield provide FDA-OMUMS with certain Banfield data relating to disease prevalence in dogs and/or cats (the “Banfield Data”) to aid FDA-OMUMS in assessing whether a particular intended use of a proposed new animal drug product “occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually” and thus meets the definition of “minor use” under section 201(oo) of the FD&C Act and implementing regulations (21 CFR part 516) (the “Permitted Purpose”).
E. Banfield is willing to provide Banfield Data to FDA-OMUMS for use in connection with, and only in connection with, the Permitted Purpose, on and subject to the terms and conditions set forth in this MOU.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained in this MOU, the Parties agree as follows:
1. Term and Termination.
(a) Unless earlier terminated in accordance with Section 1(b) of this MOU, this MOU is effective for an initial term beginning on the Effective Date and ending on the one-year anniversary of the Effective Date (the “Initial Term”). After the Initial Term, this MOU will renew, subject to termination in accordance with Section 1(b) of this MOU, for additional one-year terms (each, a “Renewal Term” and, together with the Initial Term, the “Term”).
(b) Either Party may terminate this MOU (i) at any time for any reason upon at least 30 days’ prior written notice to the other Party, and (ii) immediately upon written notice if the other Party breaches this MOU and fails to cure such breach (if capable of cure) within 30 days after delivery of such notice.
(c) Before the beginning of each Renewal Term, the Parties will cause representatives of each Party to meet on a date and at a time and place mutually acceptable to the Parties to discuss the terms and conditions of this MOU and the Parties’ ongoing relationship under and pursuant to this MOU.
2. Data Requests.
(a) Subject to Section 2(c) of this MOU, FDA-OMUMS may request Banfield Data for the Permitted Purpose by delivering a request (each, a “Data Request”) to Banfield. Each Data Request will (i) be submitted to Banfield in writing (including via e-mail), (ii) specify in reasonable detail the Banfield Data being requested by FDA-OMUMS and any other information Banfield may reasonably require to compile the requested Banfield Data, and (iii) specify the date by which FDA-OMUMS wishes to receive the requested Banfield Data (the “Requested Delivery Date”), which date will be no sooner than 45 days after the date on which Banfield received the Data Request.
(b) Subject to Section 2(c) of this MOU, Banfield will use its commercially reasonable efforts to respond to a properly submitted Data Request on or before the Requested Delivery Date by submitting a report in a mutually agreeable form to FDA-OMUMS for the Banfield Data requested in such Data Request (each, a “Banfield Data Report”).
(c) In no event will Banfield have any obligation under this MOU to: (i) respond to more than four Data Requests in any 12-month period during the Term, or (ii) respond to any Data Request if Banfield determines, in its reasonable discretion, that doing so would violate any federal, state, or local law, rule, regulation, or order or any contractual restriction applicable to Banfield, and, in any such case, Banfield will have the option to limit the Banfield Data Report and/or the Banfield Data included in such Banfield Data Report to the extent that Banfield reasonably determines is necessary to comply with any such law, rule, regulation, order, or contractual restriction. Banfield will notify FDA-OMUMS of any such restriction.
3. License, Ownership and Confidentiality.
(a) Banfield hereby grants to FDA an irrevocable, perpetual, limited, non-sublicensable, non-transferable, non-exclusive, royalty-free license to use the Banfield Data included in the Banfield Data Reports for, and only for, the Permitted Purpose.
(b) FDA acknowledges and agrees that Banfield and/or its affiliates shall own all right, title, and interest in and to all Banfield Data included in the Banfield Data Reports, including, without limitation, all intellectual and proprietary rights related to such Banfield Data, and nothing in this MOU or otherwise grants to FDA any ownership interest in, or right to use, such Banfield Data, except for the limited license set forth in Section 3(a) of this MOU.
(c) With respect to all Banfield Data, whether received before, on, or after the Effective Date, FDA will: (i) retain such Banfield Data in confidence; (ii) not disclose such Banfield Data to any person or entity, except as expressly provided below or otherwise required by law, including, but not limited to, any Animal Drug Sponsor; and (iii) not use such Banfield Data for its own benefit, to Banfield’s detriment, or for any purpose other than the Permitted Purpose. FDA may disclose Banfield Data to its employees who have a “need to know” but only to the limited extent necessary in connection with the Permitted Purpose, provided that FDA shall deliver a copy of this MOU to each such employee before any Banfield Data is disclosed to such employee (unless the employee is already bound by a confidentiality agreement that covers such Banfield Data). FDA will be fully responsible for any use or disclosure of the Banfield Data by any of its employees in violation of this MOU. FDA’s obligations under this Section 3(c) will survive the termination or expiration of this MOU for any reason.
(d) FDA will not provide Banfield access to any document or information to the extent that providing such access would place the FDA in breach of the Trade Secrets Act, codified at 18 U.S.C. sec. 1905; the Privacy Act, codified at 5 U.S.C. sec. 552a; the Food, Drug, and Cosmetic Act, codified at 21 U.S.C. sec. 301, et seq (particularly 21 U.S.C. sec. 3310); FDA regulations (21 Code of Federal Regulations (CFR)); or any other Federal law or regulation.
4. No Representations or Warranties; No Liability.
(a) FDA understands, acknowledges, and agrees that neither Banfield nor any of its employees or agents: (i) has made or make any representation or warranty under this MOU or otherwise, expressed or implied, as to the accuracy or completeness of any Banfield Data; or (ii) has or will have any liability under this MOU or otherwise to FDA or its employees or agents relating to or resulting from their use of any Banfield Data or from any errors in any Banfield Data or omissions from any Banfield Data.
(b) Neither Banfield nor any of its employees or agents has or will have any liability to any other person or entity, including, but not limited to, any Animal Drug Sponsor, under this MOU or otherwise in connection with FDA’s use of any Banfield Data.
5. Attribution. FDA acknowledges and agrees that Banfield may publish and otherwise disclose, in print and through electronic or social media, the fact that Banfield has provided Banfield Data to FDA-OMUMS for use in connection with the Permitted Purpose.
6. No Other Use of Names or Logos. Except as otherwise expressly provided in or contemplated by this MOU, neither Party will use the other Party’s name, either alone or in connection with another word or words, nor shall it use the other Party’s proprietary marks, trademarks, service marks, trade names, symbols, logos, or designs, for any purpose whatsoever (including, but not limited to, any press release, sales or marketing publication or correspondence, advertisement, or similar communication), without the express prior written approval of the other Party.
7. Relationship of the Parties. The Parties acknowledge and agree that they are, at all times, each acting as independent contractors. Nothing in this MOU will be construed or deemed to create a relationship of employer and employee, partner, joint venturer, or principal and agent between the Parties or any of their employees, agents, or officers. Each Party shall be responsible for its own acts and the acts of its employees, agents, and officers, and for the results thereof, and not for the acts of the other Party or the other Party’s employees, agents, or officers. Neither Party will have the authority to make any statements, representations, or commitments of any kind, or to take any action, that would be binding on the other Party.
(a) All activities carried out by the Parties under this MOU will be conducted in accordance with applicable federal and state laws, rules and regulations.
(b) The Parties may revise or modify this MOU only by a written amendment signed by authorized representatives of each Party.
(c) This MOU contains the entire agreement of the Parties with respect to its subject matter and supersedes all prior and/or contemporaneous agreements or understandings, written or oral, with respect to the subject matter of this MOU.
(d) Neither Party will have the right to assign or otherwise transfer any of its rights or obligations under this MOU without the prior written consent of the other Party. This MOU will bind and inure to the benefit of each party’s successor and permitted assigns.
(e) This MOU may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall constitute a single document.
(f) This MOU shall be governed by and construed under applicable federal and state laws.
This MOU has been executed by a duly authorized representative of each Party as of the Effective Date.
Medical Management International, Inc.
January 3, 2018
Food and Drug Administration:
Steven Solomon, D.V.M., Director
Center for Veterinary Medicine
February 27, 2018