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Item 1.01.
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Entry into a Material Definitive Agreement
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On March 31, 2016, Discovery Laboratories, Inc., a Delaware corporation (the “Company”), entered into a second amendment (“Amendment”) to the Collaboration Agreement with Battelle Memorial Institute (“Battelle”) dated October 10, 2014, as previously amended (the “Collaboration Agreement”). Under the Collaboration Agreement, the Company and Battelle have agreed to a three stage development plan to further develop the Company’s aerosol delivery system (“ADS”) for potential use in the Company’s planned phase 3 clinical program for AEROSURF
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for the treatment of respiratory distress syndrome (“RDS”) in premature infants and, if AEROSURF is approved, initial commercial supply, and a sharing of development costs.
Under the Amendment, the Company and Battelle agreed to undertake certain additional activities under, and optimize the development schedule provided in, the Project Plan (as defined in the Collaboration Agreement), among other things, to reallocate resources and re-align the Milestone Date (as defined in the Collaboration Agreement) with the anticipated completion date for the Company’s AEROSURF
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phase 2b clinical trial. The parties agreed to increase the Project Plan Fixed Cost (as defined in the Collaboration Agreement) by approximately $230,000, to an amount between $11,181,000 and up to $12,261,100. Accordingly, as of the Amendment date, the Discovery Labs Fixed Fee for Stages 2 and 3 under the Project Plan, which is equal to 50% of the Project Plan Fixed Cost, is adjusted to an amount between $5,590,500 and $6,130,550. In addition, the parties agreed to amend the Collaboration Agreement to change the definition of “Milestone Date,” or the anticipated date for completion of Stage 3 activities under the Project Plan, from July 15, 2016 to November 15, 2016.
The foregoing summary is qualified in its entirety by reference to the text of the Collaboration Agreement and related documents, that were filed as Exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014; the First Amendment to the Collaboration Agreement, dated August 4, 2015, which was filed as Exhibit 10.3 to the Company’s Quarterly Report for the quarter ended June 30, 2015; and the Amendment, a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K.