Mist Pharmaceuticals is an emerging, specialty pharmaceutical company dedicated to improving the lives of patients.

Mist’s commercialization of products that provide unique and meaningful clinical advantages improves the lives of patients who are suffering from cardiovascular and metabolic disease as well acute and chronic pain.
 

Mist acquires under-promoted, under-utilized products and those in late stage clinical development, in order to enhance their market acceptance via reformulation or revitalized promotion. The end result is newer therapeutic options for providers and patients.
 
 



Uniquely qualified to optimize the potential of new or under-utilized therapies.

A fully integrated specialty pharmaceutical company, Mist’s commercialization team covers all key commercial and scientific disciplines including:
 

          Product Development
          Regulatory and Medical Affairs
          Sales and Marketing
          Finance
          Quality Assurance
          Manufacturing
          Business Development
          Managed Markets and Trade Relations
 
 



Proven successes of an experienced team.

The core leadership at Mist is comprised of individuals who have more than 100 years of collective experience building and operating successful companies in the healthcare industry.

Joseph J. Krivulka, Founder and Chairman
Mr. Krivulka has more than 30 years of pharmaceutical management and product experience. He has founded a number of successful companies, including Reliant Pharmaceuticals and Triax Pharmaceuticals. He has also served as president of Bertek Pharmaceuticals, Inc., (a subsidiary of Mylan Laboratories).
Mr. Krivulka has also held management positions in marketing, product strategy, clinical development and manufacturing at several major pharmaceutical companies, including Janssen Pharmaceuticals (a Johnson & Johnson company), Sandoz Pharmaceuticals, and Lederle Labs.

 
Keith Rotenberg, Ph.D., Founder and President
Dr. Rotenberg has close to 25 years experience in various clinical and regulatory settings within global pharmaceutical companies. Early in his career, he led the Regulatory Affairs and Quality Operations for Forest Laboratories, worked as a Senior Licensing Executive for G.D. Searle, and led Regulatory Affairs for Lorex Pharmaceuticals. He also was a Technical Supervisor and Pharmacologists with the FDA where he developed expertise on various regulatory and quality assurance issues. Dr. Rotenberg founded Rotenberg Consultants, LLC, where he advised clients on FDA interaction with respect to regulatory and quality assurance issues. In 2003 he became Vice President, Regulatory Affairs with Reliant Pharmaceuticals, Inc. where he was later promoted to Senior Vice President, Research & Development.

 
Timothy J. Soule, Founder and Corporate Secretary
Mr. Soule has over 20 years of business development and management experience in the pharmaceutical industry and government. Prior to Mist Pharmaceuticals he served as Senior Director, Human Resources with Reliant Pharmaceuticals. From 1986 to 2000, he served as President of Franklin County Industrial Development Corporation where he managed numerous industrial expansion and business development projects. Mr. Soule earned his BA degree in economics and political science from Middlebury College.

 
Todd K. Noe, Vice President of Sales
Mr. Noe has over 15 years of experience in pharmaceuticals sales management. He began his career with Abbott Laboratories as sales representative, quickly rising through the ranks as a sales specialist, district sales manager and national sales trainer. Mr. Noe also served as a district sales manager with Ferndale Laboratories before moving on to become a Regional Manager with Triax Pharmaceuticals during a critical period of growth for the company. Mr. Noe spent 3 years with Akrimax Pharmaceuticals where he developed and managed a large sales region for the company through its inception and subsequent growth, highlighted by a series of product launches that took place on very aggressive timelines. In addition to his experience in pharmaceutical sales management, Mr. Noe is a veteran of the United States Marine Corps where he taught leadership, team building and discipline.

 

 

Our Products

At Mist Pharmaceuticals, our expertise allows us to provide innovative solutions for patients suffering from cardiovascular or metabolic disease or from conditions causing significant pain. Our portfolio currently includes the following prescription drug therapies:

 

Inderal ® XL (propranolol HCI) extended release capsules. For more information about Inderal® XL, including Full Prescribing Information, visit www.InderalXL.comPlease click here to see Full Prescribing Information including Black Box Warning.

 

NitroMist ® (nitroglycerin lingual aerosol). For more information about NitroMist, including Full Prescribing Information, please visit www.NitroMist.com. Please click here to see Full Prescribing Information including Black Box Warning.

 

Primlev ™ (oxycodone HCl/acetaminophen) CII. For more information about Primlev including Full Prescribing Information, please, go to www.Primlev.com. Please click here to see Full Prescribing Information including Black Box Warning.

 

Tirosint ® levothyroxine sodium) capsules, a co-promotion with Akrimax Pharmaceuticals. For more information about Tirosint including Black Box Warning, please visit www.Tirosint.com. Please click here to see Full Prescribing Information including Black Box Warning



Our commitment to patient-focused innovation does not stop with our current commercial portfolio.

At Mist Pharmaceuticals, we constantly look to expand our product offering with the goal of becoming a company that is recognized for its ability to aid health care professionals and patients with best in class therapies.
 

If you would like more information about Mist Pharmaceuticals or would like to discuss business development or partnering opportunities, please contact:
 

          Mist Pharmaceuticals Business Development Dept.
          E-mail: businessdev@mistpharma.com

 

Our employees are our biggest asset and are at the core of our company.

At Mist Pharmaceuticals, we offer entrepreneurially-minded employees the opportunity to work collaboratively in a small team of highly-skilled and motivated professionals dedicated to improving the lives of patients suffering from cardiovascular and metabolic disease and acute pain.
 

We believe that our employees are our biggest asset and are at the core of our company. That’s why at Mist we work to create an environment in which smart, compassionate and knowledgeable employees can work in a fast-paced and supportive environment. If you’re a seasoned pharmaceutical pro who might like the challenge of helping to build a new best-in-class pharmaceutical company, Mist may be right for you.
 

Applying for a job at Mist is easy. Simply send a copy of your most recent resume to careers@MistPharma.com. We’ll review your credentials and will respond quickly if we think there’s an opportunity.



Terms of Use

Agreement Between User And Mist Pharmaceuticals
 

The Mist Pharmaceuticals Web Site is comprised of various Web pages operated by Mist Pharmaceuticals. The Mist Pharmaceuticals Web Site is offered to you conditioned on your acceptance without modification of the terms, conditions, and notices contained herein. Your use of the Mist Pharmaceuticals Web Site constitutes your agreement to all such terms, conditions, and notices.
 

Modification Of These Terms Of Use
 

Mist Pharmaceuticals reserves the right to change the terms, conditions, and notices under which the Mist Pharmaceuticals Web Site is offered, including but not limited to the charges associated with the use of the Mist Pharmaceuticals Web Site.
 

Links To Third Party Sites
 

The Mist Pharmaceuticals Web Site may contain links to other Web Sites (“Linked Sites”). The Linked Sites are not under the control of Mist Pharmaceuticals and Mist Pharmaceuticals is not responsible for the contents of any Linked Site, including without limitation any link contained in a Linked Site, or any changes or updates to a Linked Site. Mist Pharmaceuticals is not responsible for webcasting or any other form of transmission received from any Linked Site. Mist Pharmaceuticals is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Mist Pharmaceuticals of the site or any association with its operators.
 

No Unlawful Or Prohibited Use
 

As a condition of your use of the Mist Pharmaceuticals Web Site, you warrant to Mist Pharmaceuticals that you will not use the Mist Pharmaceuticals Web Site for any purpose that is unlawful or prohibited by these terms, conditions, and notices. You may not use the Mist Pharmaceuticals Web Site in any manner which could damage, disable, overburden, or impair the Mist Pharmaceuticals Web Site or interfere with any other party’s use and enjoyment of the Mist Pharmaceuticals Web Site. You may not obtain or attempt to obtain any materials or information through any means not intentionally made available or provided for through the Mist Pharmaceuticals Web Sites.
 

Use of Communication Services
 

The Mist Pharmaceuticals Web Site may contain bulletin board services, chat areas, news groups, forums, communities, personal web pages, calendars, and/or other message or communication facilities designed to enable you to communicate with the public at large or with a group (collectively, “Communication Services”), you agree to use the Communication Services only to post, send and receive messages and material that are proper and related to the particular Communication Service. By way of example, and not as a limitation, you agree that when using a Communication Service, you will not:
 

Defame, abuse, harass, stalk, threaten or otherwise violate the legal rights (such as rights of privacy and publicity) of others.
 
Publish, post, upload, distribute or disseminate any inappropriate, profane, defamatory, infringing, obscene, indecent or unlawful topic, name, material or information.
 
Upload files that contain software or other material protected by intellectual property laws (or by rights of privacy of publicity) unless you own or control the rights thereto or have received all necessary consents.
 
Upload files that contain viruses, corrupted files, or any other similar software or programs that may damage the operation of another’s computer.
 
Advertise or offer to sell or buy any goods or services for any business purpose, unless such Communication Service specifically allows such messages.
 
Conduct or forward surveys, contests, pyramid schemes or chain letters.
 
Download any file posted by another user of a Communication Service that you know, or reasonably should know, cannot be legally distributed in such manner.
 
Falsify or delete any author attributions, legal or other proper notices or proprietary designations or labels of the origin or source of software or other material contained in a file that is uploaded.
 
Restrict or inhibit any other user from using and enjoying the Communication Services.
 
Violate any code of conduct or other guidelines which may be applicable for any particular Communication Service.
 
Harvest or otherwise collect information about others, including e-mail addresses, without their consent.
 
Violate any applicable laws or regulations.
 

Mist Pharmaceuticals has no obligation to monitor the Communication Services. However, Mist Pharmaceuticals reserves the right to review materials posted to a Communication Service and to remove any materials in its sole discretion. Mist Pharmaceuticals reserves the right to terminate your access to any or all of the Communication Services at any time without notice for any reason whatsoever.
 

Mist Pharmaceuticals reserves the right at all times to disclose any information as necessary to satisfy any applicable law, regulation, legal process or governmental request, or to edit, refuse to post or to remove any information or materials, in whole or in part, in Mist Pharmaceuticals’ sole discretion.
 

Always use caution when giving out any personally identifying information about yourself or your children in any Communication Service. Mist Pharmaceuticals does not control or endorse the content, messages or information found in any Communication Service and, therefore, Mist Pharmaceuticals specifically disclaims any liability with regard to the Communication Services and any actions resulting from your participation in any Communication Service. Managers and hosts are not authorized Mist Pharmaceuticals spokespersons, and their views do not necessarily reflect those of Mist Pharmaceuticals.
 

Materials uploaded to a Communication Service may be subject to posted limitations on usage, reproduction and/or dissemination. You are responsible for adhering to such limitations if you download the materials.
 

Materials Provided To Our Website
 

Mist Pharmaceuticals does not claim ownership of the materials you provide to Mist Pharmaceuticals (including feedback and suggestions) or post, upload, input or submit to any Mist Pharmaceuticals Web Site or its associated services (collectively “Submissions”).
 

Liability Disclaimer
 

THE INFORMATION, SOFTWARE, PRODUCTS, AND SERVICES INCLUDED IN OR AVAILABLE THROUGH OUR WEB SITE MAY INCLUDE INACCURACIES OR TYPOGRAPHICAL ERRORS. CHANGES ARE PERIODICALLY ADDED TO THE INFORMATION HEREIN. MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS MAY MAKE IMPROVEMENTS AND/OR CHANGES IN THE SITE AT ANY TIME. ADVICE RECEIVED VIA THE MIST PHARMACEUTICALS WEB SITE SHOULD NOT BE RELIED UPON FOR PERSONAL, MEDICAL, LEGAL OR FINANCIAL DECISIONS AND YOU SHOULD CONSULT AN APPROPRIATE PROFESSIONAL FOR SPECIFIC ADVICE TAILORED TO YOUR SITUATION.
 

MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS MAKE NO REPRESENTATIONS ABOUT THE SUITABILITY, RELIABILITY, AVAILABILITY, TIMELINESS, AND ACCURACY OF THE INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS CONTAINED ON THIS WEB SITE FOR ANY PURPOSE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ALL SUCH INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS ARE PROVIDED “AS IS” WITHOUT WARRANTY OR CONDITION OF ANY KIND. MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS, INCLUDING ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON- INFRINGEMENT.
 

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL MIST PHARMACEUTICALS AND/OR ITS SUPPLIERS BE LIABLE FOR ANY DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF USE, DATA OR PROFITS, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OR PERFORMANCE OF THE MIST PHARMACEUTICALS WEB SITE, WITH THE DELAY OR INABILITY TO USE THE WEB SITE OR RELATED SERVICES, THE PROVISION OF OR FAILURE TO PROVIDE SERVICES, OR FOR ANY INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS OBTAINED THROUGH THIS WEB SITE, OR OTHERWISE ARISING OUT OF THE USE OF THIS WEB SITE, WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHER-WISE, EVEN IF MIST PHARMACEUTICALS OR ANY OF ITS SUPPLIERS HAS BEEN ADVISED OF THE POSSIBILITY OF DAMAGES.
 

Termination/Access Restriction
 

Mist Pharmaceuticals reserves the right, in its sole discretion, to terminate public access to the Mist Pharmaceuticals Web Site and the related services or any portion thereof at any time, without notice. GENERAL To the maximum extent permitted by law, this agreement is governed by the laws of the State of New Jersey, U.S.A. and you hereby consent to the exclusive jurisdiction and venue of courts in Union County, New Jersey, U.S.A. in all disputes arising out of or relating to the use of the Mist Pharmaceuticals Web Site. Use of the Mist Pharmaceuticals Web Site is unauthorized in any jurisdiction that does not give effect to all provisions of these terms and conditions, including without limitation this paragraph. You agree that no joint venture, partnership, employment, or agency relationship exists between you and Mist Pharmaceuticals as a result of this agreement or use of the Mist Pharmaceuticals Web Site. Mist Pharmaceuticals’ performance of this agreement is subject to existing laws and legal process, and nothing contained in this agreement is in derogation of Mist Pharmaceutical’s right to comply with governmental, court and law enforcement requests or requirements relating to your use of the Mist Pharmaceuticals Web Site or information provided to or gathered by Mist Pharmaceuticals with respect to such use.
 

If any part of this agreement is determined to be invalid or unenforceable pursuant to applicable law including, but not limited to, the warranty disclaimers and liability limitations set forth above, then the invalid or unenforceable provision will be deemed superseded by a valid, enforceable provision that most closely matches the intent of the original provision and the remainder of the agreement shall continue in effect. Unless otherwise specified herein, this agreement constitutes the entire agreement between the user and Mist Pharmaceuticals with respect to the Mist Pharmaceuticals Web Site and it supersedes all prior or contemporaneous communications and proposals, whether electronic, oral or written, between the user and Mist Pharmaceuticals with respect to the Mist Pharmaceuticals Web Site. A printed version of this agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to this agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. It is the express wish to the parties that this agreement and all related documents be drawn up in English.
 

Copyright and Trademark Notices
 

All contents of the Mist Pharmaceuticals Web Site are: Copyright 2014 Mist Pharmaceuticals, LLC. All rights reserved.
 

Trademarks
 

The names of actual companies and products mentioned herein may be the trademarks of their respective owners.
 

The example companies, organizations, products, people and events depicted herein are fictitious. No association with any real company, organization, product, person, or event is intended or should be inferred. Any rights not expressly granted herein are reserved.
 

Notices And Procedure For Making Claims Of Copyright Infringement
 

ALL INQUIRIES NOT RELEVANT TO THE FOLLOWING PROCEDURE WILL RECEIVE NO RESPONSE. Pursuant to Title 17, United States Code, Section 512(c)(2), notifications of claimed copyright infringement under United States copyright law should be sent to Service Provider’s Designated Agent: Tara D’Orsi, Mist Pharmaceuticals, 11 Commerce Dr, Cranford, NJ, telephone (973) 597-6202.
 



Privacy Policy

Mist Pharmaceuticals is committed to protecting your privacy and developing technology that gives you the most powerful and safe online experience. This Statement of Privacy applies to the Mist Pharmaceuticals Web site which is comprised of various web pages operated by Mist Pharmaceuticals (collectively the “Sites”) and governs data collection and usage. By using, you consent to the data practices described in this statement.

Collection of your Personal Information

Through interaction with the Sites, you may choose to provide Mist Pharmaceuticals with personally identifiable information, such as your e-mail address, name, home or work address or telephone number. For example, this may occur through your registering for use of certain portions of the Sites, signing up for a mailing list, choosing to fill out and submit a form on the Sites that requests such information, or your sending Mist Pharmaceuticals an e-mail to an address you find on the Sites. Please not that we only collect personally identifiable information from you in the event that you choose to provide it to us. Mist Pharmaceuticals may also collect anonymous demographic information, which is not unique to you, such as your ZIP code, age, gender, preferences, interests and favorites.

There is also information about your computer hardware and software that is automatically collected by Mist Pharmaceuticals. This information can include: your IP address, browser type, domain names, access times and referring Web site addresses. This information is used by Mist Pharmaceuticals for the operation of the service, to maintain quality of the service, and to provide general statistics regarding use of the Sites.

Please keep in mind that if you directly disclose personally identifiable information or personally sensitive data through Mist Pharmaceuticals public message boards, this information may be collected and used by others. Note: Mist Pharmaceuticals does not read any of your private online communications.

Mist Pharmaceuticals encourages you to review the privacy statements of Web sites you choose to link to from Mist Pharmaceuticals so that you can understand how those Web sites collect, use and share your information. Mist Pharmaceuticals is not responsible for the privacy statements or other content on Web sites outside of the Mist Pharmaceuticals and Mist Pharmaceuticals family of Web sites.

Use of your Personal Information

Mist Pharmaceuticals collects and uses your personal information to operate the Sites and deliver the services you have requested. Mist Pharmaceuticals also uses your personally identifiable information to inform you of other products or services available from Mist Pharmaceuticals and its affiliates. Mist Pharmaceuticals may also contact you via surveys to conduct research about your opinion of current services or of potential new services that may be offered.

Mist Pharmaceuticals does not sell, rent or lease its customer lists to third parties. Mist Pharmaceuticals may, from time to time, contact you on behalf of external business partners about a particular offering that may be of interest to you. In those cases, your unique personally identifiable information (e-mail, name, address, telephone number) is not transferred to the third party. Mist Pharmaceuticals endeavors to comply with CAN-SPAM and other applicable advertising laws, and will provide unsubscribe information in any commercial e-mails that we may send to you. In addition, Mist Pharmaceuticals may share data with trusted partners to help us perform statistical analysis, send you email or postal mail, provide customer support, or arrange for deliveries. All such third parties are prohibited from using your personal information except to provide these services to Mist Pharmaceuticals, and they are required to maintain the confidentiality of your information.

Mist Pharmaceuticals does not use or disclose sensitive personal information, such as race, religion, or political affiliations, without your explicit consent.

Mist Pharmaceuticals keeps track of the Web sites and pages our customers visit within Mist Pharmaceuticals, in order to determine what Mist Pharmaceuticals services are the most popular. This data is used to deliver customized content and advertising within Mist Pharmaceuticals to customers whose behavior indicates that they are interested in a particular subject area.

Mist Pharmaceuticals will disclose your personal information, without notice, only if required to do so by law or in the good faith belief that such action is necessary to: (a) conform to the edicts of the law or comply with legal process served on Mist Pharmaceuticals or its affiliates; (b) protect and defend the rights or property of Mist Pharmaceuticals; and, (c) act under exigent circumstances to protect the personal safety of users of Mist Pharmaceuticals, or the public.

Use of Cookies

The Sites use “cookies” to help you personalize your online experience. A cookie is a text file that is placed on your hard disk by a Web page server. Cookies cannot be used to run programs or deliver viruses to your computer. Cookies are uniquely assigned to you, and can only be read by a web server in the domain that issued the cookie to you.

One of the primary purposes of cookies is to provide a convenience feature to save you time. The purpose of a cookie is to tell the Web server that you have returned to a specific page. For example, if you personalize Mist Pharmaceuticals pages, or register with Mist Pharmaceuticals Sites or services, a cookie helps Mist Pharmaceuticals to recall your specific information on subsequent visits. This simplifies the process of recording your personal information, such as billing addresses, shipping addresses, and so on. When you return to the same Mist Pharmaceuticals Web site, the information you previously provided can be retrieved, so you can easily use the Mist Pharmaceuticals features that you customized.

You have the ability to accept or decline cookies. Most Web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. If you choose to decline cookies, you may not be able to fully experience the interactive features of the Mist Pharmaceuticals services or Sites you visit.

Security of your Personal Information

Mist Pharmaceuticals uses commercially reasonable physical and technical safeguards to secure your personal information from unauthorized access, use or disclosure. Mist Pharmaceuticals secures the personally identifiable information you provide on computer servers in a controlled, secure environment, protected from unauthorized access, use or disclosure. When personal information (such as a credit card number) is transmitted to other Web sites, it is protected through the use of encryption, such as the Secure Socket Layer (SSL) protocol. We cannot, however, ensure or warrant the security of any information you transmit to Mist Pharmaceuticals, and you do so at your own risk.

International Users

If you are visiting the Sites from the European Union or other non-U.S. territories, please note that any data you provide will be transferred outside the European Union or such other non-U.S. territories for use by Mist Pharmaceuticals for any purpose described herein. By providing any data to Mist Pharmaceuticals, you hereby consent to such transfers of your data to the United States.

Protection of Children

Mist Pharmaceuticals will not knowingly collect, use or disclose personally identifiable information form a minor under the age of 13, without obtaining prior written consent from a person with parental responsibility (parent or guardian). If you are under the age of 13, please do not use the Sites or submit any information in connection with the Sites.

Merger or Sale

In the event Mist Pharmaceuticals is acquired or merged with a third party entity, we reserve the right, in any of these circumstances, to transfer or assign the information that we have collected from users as part of that merger or acquisition.

Regulatory Requirements

If you contact us regarding your experience with using any of our products, we may use the information you provide in submitting reports to the Federal Food and Drug Administration, and as otherwise required by us by law or governmental audit. We may also use the information to contact your healthcare professional to follow-up regarding an unexpected event involving the use of any of our products. You understand that in order to comply with the law, Mist Pharmaceuticals may not be permitted to comply with your request to amend or remove personally identifiable information that was provided to Mist Pharmaceuticals by a healthcare professional or consumer regarding an adverse event or reaction involving medicine, medical products or medical devices.

Changes to this Statement

Mist Pharmaceuticals will occasionally update this Statement of Privacy to reflect company and customer feedback. Mist Pharmaceuticals encourages you to periodically review this Statement to be informed of how Mist Pharmaceuticals is protecting your information.

Contact Information

Mist Pharmaceuticals welcomes your comments regarding this Statement of Privacy. If you believe that Mist Pharmaceuticals has not adhered to this Statement, please contact Mist Pharmaceuticals at support@madriveraccess.com. We will use commercially reasonable efforts to promptly determine and remedy the problem.

Other Terms

Your use of the Sites is subject to Mist Terms of Use

California Compliance Policy Summary and Declaration

Compliance Policy Summary

It is the policy of Mist Pharmaceutical, LLC (“Mist”) to comply with all applicable laws and regulations and industry standards, including the PhRMA Code on Interactions with Healthcare Professionals and the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Guidance”). Our Comprehensive Compliance Program incorporates the following elements from the OIG Guidance:

  • Written Policies and Procedures
  • Compliance Committee
  • Effective Training and Education
  • Effective Lines of Communication
  • Internal Monitoring and Auditing
  • Enforcement Through Discipline Pursuant to Published Guidelines; and
  • Prompt Response and Corrective Action for Detected Problems

Mist sales and marketing personnel interact with healthcare professionals to provide them with information about Mist products and other relevant educational or scientific topics. Mist believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Mist may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals’ practice. Mist may also on occasion offer modest meals to healthcare professionals in connection with educational presentations. The PhRMA Code allows pharmaceutical companies to provide “items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities.” On occasion Mist may approve the distribution of an educational item to a healthcare professional in accordance with the PhRMA Code standards. Mist’s Comprehensive Compliance Program is designed to ensure that these activities are conducted in lawful manner.

California Health and Safety Code §§ 119400-119402 requires pharmaceutical companies to make available their Comprehensive Compliance Program and to set an annual aggregate limit on certain promotional expenditures provide to a healthcare professional as defined under the California law.

Annual Spend Limit

Subject to this California law, Mist has determined that the annual aggregate limit on covered promotional expenditures in California is set at $500.00 per covered healthcare professional for each calendar year. This limit may be revised by Mist from time to time. It is important to note that this annual dollar limit is an upper limit. It is not an accurate representation of the average value of gifts, promotional materials, items or activities that Mist may provide generally to a healthcare professional. The average could be a lower amount. In accordance with the law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:

  • Drug samples provided to healthcare professionals intended for free distribution to patients;
  • Financial support for continuing medical education forums;
  • Financial support for health educational scholarships; and
  • Payments for legitimate professional services, including professional speaking, advising, consulting, training or market research services, that are based on the fair market value of the services provided.

Declaration of Compliance

Mist declares, in good faith, that Mist is in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code §§ 119400-119402. Our declaration is based upon information available during the twelve month period from January 1, 2015 through December 31, 2015. The next declaration will be based upon information captured beginning January 1, 2016.

Conclusion

As appropriate and consistent with applicable law, Mist will amend and make conforming changes to its Comprehensive Compliance Program. Mist is committed to assessing ongoing compliance with its Comprehensive Compliance Program. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling 973-597-6202.

CONTACT US
  • If you would like more information about Mist Pharmaceuticals or would like to discuss business development or partnering opportunities, please contact:

    OUR OFFICE


    Office Address:

    11 Commerce Drive, First Floor,
    Cranford, NJ 07016,
    USA

    (T) 908 - 393 - 7345