On July 2, 2015 Provectus Biopharmaceuticals reported that it has signed a Letter of Intent (the "LOI") with Boehringer Ingelheim (China) Investment Co. Ltd. ("Boehringer") (Press release, Provectus Pharmaceuticals, JUL 2, 2015, http://www.pvct.com/pressrelease.html?article=20150702.2 [SID:1234506020]). The purpose of the LOI is to lay a foundation for the two parties to collaborate in bringing PV-10, Provectus’ novel investigational drug for cancer ("PV-10"), to market in mainland China, Hong Kong and Taiwan. Maxim Group LLC acted as strategic advisor to Provectus in structuring and negotiating the LOI. Schedule your 30 min Free 1stOncology Demo! Under the terms of the LOI, Boehringer will provide certain commercially reasonable support in the aspects of product registration with the China Food and Drug Administration ("CFDA"), communication preparation, market intelligence and other assistance to Provectus in China to the extent that is within Boehringer’s approved business scope and permissible by Chinese laws.
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In return, Provectus will grant Boehringer the first priority to be the exclusive collaborator of Provectus in China for PV-10 in the event that PV-10 is successfully registered and approved by the CFDA. The exclusive collaboration may take the form of exclusive distribution and promotion, exclusive licensing or other agreement, subject to both parties’ mutual agreement. At the appropriate time, Provectus and Boehringer will enter into a definitive agreement, including a non-compete provision, for PV-10 to be exclusively developed, distributed and promoted through the collaboration within China, although there can be no assurance that the parties will enter into a definitive agreement.
In the LOI signed today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2015 in Barcelona, the two parties have agreed to meet regularly and maintain effective communication in order to move forward with the registration and commercialization of the product and assess the potential cooperation between them in China, which may be adopted in a form of exclusive commercial supply, distribution and promotion, partnership or any other forms suitable to both parties’ interests.
Stephen Doyle, Vice President and Head of Specialty Care, China, at Boehringer, said, "We are impressed with the work the management of Provectus and its researchers have done so far in developing PV-10 as a potential treatment option for melanoma and cancers of the liver. At Boehringer Ingelheim we are committed to research and development in areas of high unmet need such as liver cancer. If successful, we believe that many Chinese patients could benefit from being treated with PV-10. Because of this, and the data generated so far, we are prepared to provide the commercially reasonable support Provectus may need to get PV-10 through the drug development and registration approval process in China."
Peter Culpepper, CFO and COO of Provectus, said, "We are excited about the potential of PV-10 in China and in commencing a working relationship with Boehringer Ingelheim to bring PV-10 to market there. We are confident that Boehringer Ingelheim’s expertise in navigating the regulatory requirements in China will prove beneficial to us, and we are also confident that a commercial collaboration will benefit both companies. In addition, we believe that a successful partnership with Boehringer Ingelheim in China will provide us with experience in dealing with regulatory systems outside the US and help us take PV-10 to a global marketplace."