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| CEMP > SEC Filings for CEMP > Form 8-K on 15-Jun-2012 | All Recent SEC Filings |
15-Jun-2012
Entry into a Material Definitive Agreement, Other Events, Financial Statements and E
Effective June 12, 2012, Cempra Pharmaceuticals, Inc., our wholly owned subsidiary, entered into a license agreement with The Scripps Research Institute, or TSRI, whereby TSRI licensed to us rights, with rights of sublicense, to make, use, sell, and import products for human or animal therapeutic use that use or incorporate one or more macrolides as an active pharmaceutical ingredient and is covered by certain patent rights owned by TSRI claiming technology related to copper-catalysed ligation of azides and acetylenes. The rights licensed to us are exclusive as to the People's Republic of China (excluding Hong Kong), South Korea and Australia, and are non-exclusive in all other countries worldwide, except the member-nations of the Association of Southeast Asian Nations, which are not included in the territory of the license. Under the terms of the agreement with TSRI, we will pay a one-time only, non-refundable license issue fee in the amount of $350,000. Our rights under the agreement are subject to certain customary rights of the U.S. government that arise or result from TSRI's receipt of research support from the U.S. government.
We are also obligated to pay annual maintenance fees to TSRI in the amount of
(i) $50,000 each year for the first three years (beginning on the first
anniversary of the agreement), and (ii) $85,000 each year thereafter (beginning
on the fourth anniversary of the agreement). Each calendar year's annual
maintenance fees will be credited against sales royalties due under the
agreement for such calendar year. Under the terms of the agreement, we must pay
TSRI low single-digit percentage royalties on the net sales of the products
covered by the TSRI patents for the life of the TSRI patents, a low single-digit
percentage of non-royalty sublicensing revenue received with respect to
countries in the nonexclusive territory and a mid-single-digit percentage of
sublicensing revenue received with respect to countries in the exclusive
territory, with the sublicensing revenue royalty in the exclusive territory and
the sales royalties subject to certain reductions under certain circumstances.
TSRI is eligible to receive milestone payments of up to $1.1 million with
respect to regulatory approval in the exclusive territory and first commercial
sale, in each of the exclusive territory and nonexclusive territory, of the
first licensed product to achieve those milestones that is based upon each
macrolide covered by the licensed patents. Each milestone is payable once per
each macrolide. Each milestone payment made to TSRI with respect to a particular
milestone will be creditable against any payment due to TSRI with respect to any
sublicense revenues received in connection with the achievement of such
milestone.
Under the terms of the agreement, we are also required to pay additional fees on royalties, sublicensing and milestone payments if we, an affiliate, or a sublicensee challenges the validity or enforceability of any of the patents licensed under the agreement. Such increased payments would be required until all patent claims subject to challenge are invalidated in the particular country where such challenge was mounted.
The term of the license agreement (and the period during which we must pay royalties to TSRI in a particular country for a particular product) will end, on a country-by-country and product-by-product basis, at such time as no patent rights licensed from TSRI cover a particular product in the particular country.
The license agreement is otherwise subject to such terms and conditions as are reasonably customary for license agreements of similar type. The description of the license agreement with TSRI provided above is qualified in its entirety by reference to the full and complete terms contained in the agreement, which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the quarter ending June 30, 2012.
On June 12, 2012, we issued a press release announcing the dosing of the first two patients enrolled in a Phase 2 clinical trial to evaluate the efficacy, safety and tolerability of solithromycin in the treatment of uncomplicated urogenital gonococcal infections. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(d) Exhibits
Exhibit
No. Description
99.1 Press release issued June 12, 2012.
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