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                Non-Profit and Other MOUs

Non-Profit and Other MOUs Home
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          Partnerships: Enhancing Science Through Collaborations With FDA
          FDA Memoranda of Understanding
          Non-Profit and Other MOUs
          MOU 225-10-0021Non-Profit and Other MOUs MOU 225-10-0021
  
  	
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    PrintMEMORANDUM OF UNDERSTANDING U.S. FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES,MEDSCAPE, LLC AND WEBMD LLC (each a "Party" and collectively the "Parties")**I. Purpose**This Memorandum of Understanding (MOU) defines the framework in which theFood and Drug Administration (FDA) will provide publicly available content tobe used in health professional informational, educational, and training programsthat will be run by WebMD LLC ("WebMD") and Medscape, LLC ("Medscape"),an entity accredited by the Accreditation Council for Continuing MedicalEducation (ACCME), the American Nurses Credentialing Center (ANCC) and theAccreditation Council for Pharmacy Education (ACPE) to provide continuingprofessional education to physicians, nurses and pharmacists, respectively.These programs will provide information, education and training for physicians,nurses, pharmacists, and health professionals (collectively referred to herein as"HCP’s") on medical product safety and efficacy issues and, in certain cases, willoffer HCP’s the opportunity to obtain continuing medical education (physicians)and continuing education (nursing, pharmacy) credit (collectively, "CME") inconnection with such programs. This collaboration will complement FDA’s capacityto educate and communicate with HCP’s.  It will also promote the timelydissemination to HCP’s of accurate information on public health and emergingsafety issues and product safety recalls.**II. Background**The FDA is responsible for protecting the public health by assuring that foods aresafe, wholesome, sanitary, and properly labeled; biologics for human use andhuman and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of medical devices intended for human use;cosmetics are safe and properly labeled;public health and safety are protectedfrom electronic product radiation; and tobacco products are labeled and marketed in accordance with applicable statutes and regulations.The FDA is also responsible for advancing the public health. FDA helps to speedinnovations that make medicines and medical devices more effective, safer, andmore affordable; and helps the public get the accurate, science-based informationthey need to use FDA-regulated products to improve their health ("FDA Health Information").Through their respective online portals and mobile applications (collectively, the"WebMD Health Professional Network"), Medscape and WebMD offer HCP’s avariety of information resources and communications services including, but notlimited to, peer-reviewed original medical journal articles, CME, a customizedversion of the National Library of Medicines MEDLINE database, daily medicalnews, major conference coverage, and drug information including a drugdatabase (Medscape Drug Reference, or MDR) and drug interaction checker andMedscape Physician Connect, a physician-only social network.**III. Authority**FDA has authority to provide information to the public pursuant to section 705(b)and section 903(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.§§ 3 75(b)and 393(d)(2)(D).**IV. Substance of Understanding**FDA will work with Medscape and WebMD, as applicable depending on thenature of the services being developed, to define approaches for web links, thedelivery and sharing of content, and CME program assessment, development anddelivery protocols in order to facilitate the dissemination of FDA HealthInformation. As part of this effort, FDA and Medscape will identify FDA publichealth and product alerts, guidance, service descriptions and educational programsfor HCP’s.**V. General Provisions**A. This MOU does not grant exclusivity to either Party, nor does it restrict FDA,Medscape or WebMD from participating in similar initiatives with otherpublic or private agencies, organizations or individuals.B. FDA Health Information must be easily distinguishable from non-FDAcontent on Medscape and WebMD web pages. FDA Health Informationplaced on Medscape and WebMD web pages should be clearly identified assuch.C. Printed and online web pages containing FDA Health Information provided byFDA pursuant to this MOU must be free of advertisements, and otherwisemust avoid implying FDA’s endorsement or support for a particular product,service or website.D. FDA, Medscape and WebMD recognize that this MOU is not intended to, andmay not be relied on to create any right or benefit, substantive or procedural,enforceable by law by any party against the United States, Medscape orWebMD.E. All materials and programming produced pursuant to this collaboration mustbe accessible by and free of cost to the general public.F. All activities within the scope of this MOU must comply with section 508 ofthe Rehabilitation Act (29 U.S.C. § 794d), as amended by the WorkforceInvestment Act of 1998, Pub. L. No. 105-220, Aug. 7,1998 (see U.S.Department of Health and Human Services policy on section 508complianceat http://ww.hhs.gov/od/508policy/index/html; and Office of Managementand Budget policies for protecting private information atwww.usa.gov/webcontent/reqsbestpractices/lawsregs/prjvacy/shtml),G. Both parties agree that content provided to Medscape or WebMD by FDA inconnection with the collaboration shall be public domain material and as such,FDA shall have full rights to reuse such content for all FDA purposes and theright to share with other collaborators or requestors.H. Medscape and WebMD agree to maintain current FDA Health Informationwithin their web pages. FDA Health Information must be removed fromMedscape and WebMD websites in the following circumstances: (1) withinthree years of the date of its first publication, unless an extension of a definiteterm is agreed to by FDA in advance of expiration of the three-year period; (2)upon termination of this MOU, if the MOU terminates less than three yearsafter the material is posted; (3) upon FDA’s request in circumstances in whichthe information becomes outdated; or (4) as soon as is commerciallypracticable but no longer than 72 hours after receipt of FDA’s written requestto remove the material, regardless of reason. Medscape or WebMD ’S failureto display current information or to remove information in accordance withthis MOU may result in termination of this MOU and related activities.I.  FDA retains the right to review all materials produced through thiscollaboration prior to WebMD’s or Medscape’s public distribution or postingof such materials, and the right to prohibit the public distribution or posting ofsuch materials.J.  Medscape and WebMD will include the following disclaimer language in aclearly distinguishable manner on any web pages on which FDA HealthInformation provided by FDA pursuant to this MOU is placed: "Informationprovided by FDA and/or its employees on this website is for educationalpurposes only, and does not constitute medical advice. Any statement oradvice given by an FDA employee on this website does not represent theformal position of FDA. FDA and/or any FDA employee will not be liable forinjury or other damages resulting to any individuals who view FDA-relatedmaterials on this website." FDA reserves the right to modify this disclaimerlanguage.K. FDA and Medscape and WebMD will cooperate in the maintenance of eachparty’s trademarks and logos. Medscape and WebMD agree that they will notuse FDA’s logo for marketing purposes other than to promote activitiesengaged in pursuant to this agreement. The use of FDA names and logos shallnot imply any exclusive arrangement. Any use of FDA logos must beapproved, in advance, by FDA’s Office of Special Health Issues and adhere topublished FDA logo policies (seehttp ://www. fda, gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ucm2 18116.htm).L. This MOU does not and is not intended to transfer to any Party any rights inany technology or intellectual property of any other Party hereto, other thanMedscape’s ability to display the FDA logo subject to the restrictions specifiedunder Paragraph J above. For avoidance of doubt, any intellectual propertyincluding, without limitation, content, products, technology, data and otherinformation, provided by Medscape or WebMD for use in the collaborationshall in all cases remain solely owned by Medscape or WebMD, as applicable,and no license to use such information is granted under this MOU.M.  FDA and Medscape and/or WebMD may in the future engage in activitiesrelating to certain funded activities. Those activities are entirely independentof this MOU and shall in no respect be subject to any term of this MOU.N. Except as required by law or regulation, including but not limited topublication of this MOU and related materials in the Federal Register, neitherparty will make any public announcement (including press releases) about thisMOU or the subject matter thereof without first obtaining the other party’sprior written approval of such announcement.**VI. Resource Obligations:**All activities undertaken pursuant to the MOU are subject to the availability ofpersonnel, resources, and funds. Medscape and WebMD are not beingcompensated by FDA for the activities conducted under the MOU, and funds arenot otherwise being obligated under the MOU. This MOU does not affect orsupersede any existing or future agreements or arrangements among the Parties.This MOU and all associated agreements will be subject to the applicable policies,rules, regulations, and statutes under which FDA, Medscape and WebMD operate.**VII. CONTACT POINTS**A. Food and Drug AdministrationAnna FineOffice of Special Health IssuesOffice of External AffairsU.S. Food and Drug Administration301-796-8471Anna.wojasfda.hhs.govB. Medscape, LLC or WebMD LLCAmy Nadel825 Eighth Avenue, 11 "’ FloorNew York, NY 10019212-301-6727anadel@rnedscape.net**VIII.  LIMITATIONS ON LIABILITY**In no event will any party hereto be liable to the other under any theory ofliability, however arising, for any costs or cover or for indirect, special,incidental, or consequential damages of any kind arising out of this MOU.The provision shall survive termination, cancellation or expiration of thisMOU or any reason whatsoever.**IX. Term, Termination, and Modification:**This MOU, when accepted by all Parties, will have an effective period ofperformance from the date of the latest signature until three years and may bemodified or terminated by mutual written consent by both Parties. Any partymay terminate the agreement at any time, but such Party should provide 60-day advance written notice to the other Parties of such termination.By signing below, the Parties accept the conditions that accurately represent theunderstanding reached between them.**Approved and Accepted for the Food and Drug Administration**Signed by: Margaret A. Hamburg, M.D.Commissioner of Food and DrugsDate: June 8, 2011**Approved and Accepted for Medscape, LLC**Signed by: Ezra T. ErnstSenior Vic-President, General ManagerDate: May 19, 2011**Approved and Accepted for WebMD LLC**Signed by: Steve Zatz, MDExecutive Vice-PresidentWebMD Health Corp.Date: May 19, 2011**Amendment 1**MEMORANDUMOF UNDERSTANDING BETWEENU.S. FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESMEDSCAPE, LLC AND WEBMD LLC (each a "Party" and collectively the "Parties"This is an amendment to the Memorandum of Understanding (MOU) number 225-10-0021to grant an additional five years to the agreement beginning June 8, 2014 and continuinguntil June 9, 2019. The time extension is permissible under Section IX Term, Termination, and Modification of the MOU. The purpose of the time extension is to provide for continuityin the collaboration.Allother content of the MOU Number 225-10-0021 executedon June 8, 2011, remains unchanged.**Approvedand Accepted**U.S. FOODANDDRUG ADMINISTRATIONHeidi C. MarchandAssistant Commissioner for Health and Constituent AffairsMay 1, 2014**Approved andAccepted**MEDSCAPE, LLC, ANDWEB MD LLCJo-Ann Strangis, Senior Vice PresidentApril 20, 2014

                                                                                  Content current as of:
      12/18/2017Non-Profit and Other MOUs
 
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