XTL BIOPHARMACEUTICALS LTD.

Bicifadine
There are currently several patent families filed by DOV relating to Bicifadine: (i) methods and compositions containing Bicifadine for the
treatment and prevention of hyperthermia; (ii) solid compositions containing the polymorph Form B of Bicifadine as characterized by certain infrared
peaks and a distinct x-ray powder diffraction (XPRD) profile, and methods of treating pain in mammals using the same; (iii) methods and compositions
employing a therapeutically effective amount of Bicifadine for preventing and treating a condition or symptom of acute pain, chronic pain, and/or a
neuropathic disorder in mammalian subjects; (iv) methods and compositions containing Bicifadine HCl to prevent or treat neuropathic disorders in
mammals, including, but not limited to, diabetic neuropathy; (v) methods and compositions containing Bicifadine for the prevention and treatment of
lower urinary tract disorders; (vi) methods of making Bicifadine; (vii) methods and compositions for preventing or treating chronic pain comprising
Bicifadine in combination with a non-steroidal anti-inflammatory drug (NSAID).
Of these eight patent families, there is one issued patent, U.S. Patent No. 7,094,799, generally directed to solid compositions containing the
polymorph Form B of Bicifadine and “substantially free” of polymorph Form A. Pending patent applications filed by DOV in 2006 include:
In addition, there is one issued patent to Wyeth directed to a method of treating an addictive, compulsive disorder caused by alcohol or
cocaine abuse using Bicifadine HCl. There are also three pending US applications filed by Wyeth in 2005 directed to methods for treating neuropathic
disorders or conditions. At least one of these patent applications covers the use of Bicifadine in the treatment of neuropathic pain.
Under the license agreement with DOV, we have exclusive worldwide rights to the above patents and patent applications for all therapeutic
uses, with the exception of the the Wyeth Retained Field. Under the terms of the DOV/Wyeth agreement, Wyeth can only develop Bicifadine for use in
the Wyeth Retained Field in collaboration with DOV, and under the license agreement between DOV and XTL Development, DOV will not conduct
research or development with Wyeth for the use of Bicifadine in the Wyeth Retained Field. See “Item 3. Key Information-Risk Factors-Risks Related
to Our Intellectual Property.”
DOS
• A patent application directed to sustained release formulations of Bicifadine.
• A patent application directed to the use of Bicifadine for treating a disability or reducing a functional impairment associated with acute pain,
chronic pain, and/or neuropathic disorders.
• A patent application directed to the use of Bicifadine for preventing and treating neuropathic disorders, including, but not limited to,
diabetic neuropathy, diabetic peripheral neuropathy, and neuropathy associated with alcoholism, sciatica, multiple sclerosis, spinal cord
injury, chronic low back pain, HIV, cancer, etc.
The lead molecules that are included in the VivoQuest license are covered by two issued patents and four patent applications. The patent
applications describe both the structure of the compounds and their use for treating HCV infection. The two issued VivoQuest patents will expire in
2023. Additional patent applications, if issued, will expire in 2023, 2024 and 2025. We have also filed additional patent applications that cover the lead
compounds discovered since the licensing of the DOS from VivoQuest. These additional patent applications, if issued, will expire in 2026 and 2027.
Based on the provisions of the Patent Term Extension Act, we currently believe that we would qualify for certain patent term extensions.
We believe that Presidio will have sufficient time to commercially utilize the inventions from our small molecule development program
directed to the treatment and prevention of hepatitis C infection.
Other Intellectual Property Rights
We depend upon trademarks, trade secrets, know-how and continuing technological advances to develop and maintain our competitive
position. To maintain the confidentiality of trade secrets and proprietary information, we require our employees, scientific advisors, consultants and
collaborators, upon commencement of a relationship with us, to execute confidentiality agreements and, in the case of parties other than our research
and development collaborators, to agree to assign their inventions to us. These agreements are designed to protect our proprietary information and to
grant us ownership of technologies that are developed in connection with their relationship with us. These agreements may not, however, provide
protection for our trade secrets in the event of unauthorized disclosure of such information.
21