22 February 2012 ORDER GRANTING CONFIDENTIAL TREATMENT UNDER THE SECURITIES EXCHANGE ACT OF 1934 NOVADEL PHARMA INC. File No. 1-32177 -- CF# 27475 _____________________ NOVADEL PHARMA INC. submitted an application under Rule 24b-2 requesting confidential treatment for information it excluded from the Exhibits to a Form 10-Q filed on November 1, 2011. Based on representations by NOVADEL PHARMA INC. that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibit(s) will not be released to the public for the time period(s) specified: Exhibit 10.2 through August 17, 2016 For the Commission, by the Division of Corporation Finance, pursuant to delegated authority: Timothy S. Levenberg Special Counsel From an earlier different SEC Filing: Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. LICENSE AGREEMENT THIS LICENSE AGREEMENT (the “Agreement”) is entered into as of August 18, 2011 (the “Effective Date”) by and between NOVADEL PHARMA, INC. (“NovaDel”), having an address at 1200 Route 22 East, Suite 2000, Bridgewater, NJ 08807, and RECHON LIFE SCIENCE AB, (“Rechon”), having an address at Soldattorpsvägen 5, PO Box 60043, 216 10 Limhamn, Sweden. RECITALS WHEREAS, NovaDel develops pharmaceutical products with a focus on developing oral spray formulations of a broad range of marketed treatments for serious diseases, and NovaDel has developed expertise and acquired proprietary rights related to Licensed Product (as defined below); WHEREAS, Rechon has expertise in licensing, developing, manufacturing, marketing and distributing certain pharmaceutical products, and wishes to develop, manufacture and market the Licensed Product as further described herein; and WHEREAS, NovaDel desires to grant a license to Rechon, and Rechon desires to accept a license, with regard to Licensed Product in the Territory on the terms and conditions set forth herein. Less
NovaDel Signs Exclusive License and Distribution Agreement with Rechon Life Science AB to Manufacture and Commercialize Zolpimist®outside the US and Canada
BRIDGEWATER, N.J.--(BUSINESS WIRE)--NovaDel Pharma Inc. (OTC BB: NVDL), a specialty pharmaceutical company that develops oral spray formulations of marketed pharmaceutical products, today announced its entry into an exclusive license and distribution agreement with Rechon Life Science AB to manufacture and commercialize Zolpimist® outside the United States and Canada. Zolpimist is our oral spray formulation of zolpidem tartrate approved by the FDA in December of 2008.
“This agreement expands the market opportunity for Zolpimist to the world outside the U.S. We believe that Rechon, with its relationships with pharmaceutical marketers around the globe, has the ability to build a solid position for Zolpimist in the market for prescription sleep aids.”
Under the terms of the agreement, Rechon will assume responsibility for manufacturing and marketing Zolpimist outside the United States and Canada. In addition, Rechon will pay a royalty on each unit shipped from Rechon’s manufacturing facility. Under the terms of the agreement, Rechon is required to complete and submit a regulatory filing for Zolpimist in the European Union. In addition, Rechon is required to launch Zolpimist in at least three countries outside the European Union within 12 months.
Steven B. Ratoff, Chairman and CEO, said, “This agreement expands the market opportunity for Zolpimist to the world outside the U.S. We believe that Rechon, with its relationships with pharmaceutical marketers around the globe, has the ability to build a solid position for Zolpimist in the market for prescription sleep aids.”
Roland Holmqvist, CEO of Rechon Life Science AB, expressed that, “This license and distribution agreement is offering a great opportunity for a successful introduction of Zolpimist outside the United States and Canada. We look forward to this extended partnership with NovaDel and we are impressed with NovaDel’s efficient oral spray drug delivery technology as used in Zolpimist.” Rechon Life Science AB is a complete pharmaceutical company also providing manufacturing services for pharmaceutical and life sciences companies. To find out more about Rechon Life Science AB, visit the RECHON website.