Item 1.01. Entry Into a Material Definitive Agreement.
Subsidiary 1: Detection of rheumatoid arthritis (RA) initially using Tc-99m
tilmanocept, commercially known as Lymphoseek® (technetium Tc 99m tilmanocept) Injection,
Subsidiary 2: Combination of the Manocept platform with Tin-117m for detection
and treatment of RA
Subsidiary 3: Detection and treatment of human and veterinary osteoarthritis (OA)
using the Tin-117m technology, and
Subsidiary 4: Treatment of hemophilic arthropathy (HA), a rare pediatric
The Company has three-year call options to acquire, at its sole discretion, all of the equity of subsidiary 1 prior to the launch of a Phase III clinical trial for its development program, and all of the equity of subsidiary 2 upon completion of radiochemistry and biodistribution studies for its development program. Navidea has an equity ownership position in R-NAV and each of its subsidiaries of approximately 30% on a fully converted basis, subject to potential future dilution.
Both Rheumco and Navidea have contributed licenses for intellectual property and technology to R-NAV in exchange for common units in R-NAV. Each of the licenses has grant-back provisions with respect to inventions and other intellectual property developed in these programs outside of the exclusive fields of use specified in the license.
R-NAV will be initially capitalized through a
The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the Series A Preferred Unit Purchase Agreement and Promissory Note, copies of which are attached as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an
Off-Balance Sheet Arrangement of a Registrant.
The contents of Item 1.01 are incorporated by reference into this item.
Item 8.01. Other Events.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Exhibit Description
10.1* Series A Preferred Unit Purchase Agreement, dated
R-NAV, LLC, and the other Purchasers named therein.
10.2* Promissory Note, dated
entitled "Navidea Joins Essex Woodland's Rheumco to Develop Radiopharmaceuticals for Detection and Treatment of Arthritic Diseases." * Filed herewith.
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements contained or incorporated by reference in this Current Report on Form 8-K, which relate to other than strictly historical facts, such as statements about the Company's plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company's products are forward-looking statements within the meaning of the Act. The words "believe," "expect," "anticipate," "estimate," "project," and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company's continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the