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| INFI > SEC Filings for INFI > Form 8-K on 26-Dec-2012 | All Recent SEC Filings |
26-Dec-2012
Entry into a Material Definitive Agreement, Other Events, Financia
On December 24, 2012, Infinity Pharmaceuticals, Inc. ("we," "us" or "our") entered into an amended and restated development and license agreement with Intellikine LLC, successor to Intellikine, Inc.
In July 2010, we entered into a development and license agreement with Intellikine, Inc., or Intellikine, under which we obtained rights under Intellikine intellectual property to discover, develop and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of phosphoinositide-3-kinase, or PI3K, including IPI-145. In January 2012, Intellikine was acquired by Takeda Pharmaceutical Company Limited, or Takeda, acting through its Millennium business unit. We refer to our PI3K program licensor as Millennium.
Under the original agreement, we obtained worldwide development and commercialization rights to Millennium's portfolio of inhibitors of the delta and/or gamma isoforms of PI3K for all indications, and we conducted a collaborative research program with Millennium to identify compounds directed to PI3K-delta and/or PI3K-gamma which meet certain selectivity criteria, with such research collaboration under the original agreement set to expire in July 2013. Also under the original agreement, neither we nor Millennium were permitted to research, develop or commercialize products directed PI3K-delta and/or PI3K-gamma which meet certain selectivity criteria, other than the compounds subject to the collaboration, except that Millennium was permitted to research, develop or commercialize such products that it was researching, developing or commercializing on its own or with a third party prior to its acquisition of Intellikine.
Under the terms of the amended agreement, we retained our worldwide development and commercialization rights for products arising from the agreement for all therapeutic indications. We and Millennium will no longer conduct the collaborative research program and the restrictions on each party's ability to research, develop and commercialize products directed to the delta and/or gamma isoforms of PI3K that meet certain selectivity criteria have terminated, subject, in the case of Millennium, to the exclusive licenses granted to us under the amended agreement.
Additionally, under the amended agreement, Millennium waived the option it had under the original agreement to convert, upon payment of an option fee, its royalty interest in U.S. sales of PI3K products and its right to receive certain milestone payments with respect to such products into the right to share in 50% of profits and losses on U.S. development and commercialization of those PI3K products for which the first Phase 2 clinical trial, as defined in the original agreement, conducted in an oncology indication, and to participate in up to 30% of the detailing effort for these products in the United States. In consideration of such waiver we will make a one-time payment of $15 million (payable in installments). Additionally, we have paid Millennium the $5 million development milestone associated with the August 2012 initiation of our Phase 2a clinical trial of IPI-145 in patients with asthma.
In addition to developing IPI-145, we are seeking to identify additional novel inhibitors of PI3K-delta and/or PI3K-gamma for future development. We are obligated to pay up to $15 million in remaining success-based milestones for the development of two distinct product candidates, and up to $450 million in success-based milestones for the approval and commercialization of two distinct products. As a result of the amendment, such products may include products we license in from a third party. In addition, we are obligated to pay Millennium tiered royalties on worldwide net sales ranging from 7 percent to 11 percent, which are the same royalty levels as those specified under the original agreement, upon successful commercialization of products described in the agreement. Such royalties are payable until the later to occur of the expiration of specified patent rights and the expiration of non-patent regulatory exclusivities in a country, subject to reduction, and limits on the number of products, in certain circumstances.
The foregoing description of the amended and restated development and license agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the agreement, which we intend to file with the Securities and Exchange Commission as an exhibit to our Annual Report on Form 10-K for the period ending December 31, 2012.
We issued a press release on December 24, 2012, announcing the execution of the amended and restated development and license agreement with Intellikine LLC. The full text of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1.
(d) The following exhibits are included in this report:
Exhibit
No. Description
99.1 Press Release, dated December 24, 2012.
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