`8K 1 d8k.htm FORM 8K
`
`
`Form 8K
`
`
`
`
`
`
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`WASHINGTON, D.C. 20549
`
`FORM 8K
`CURRENT REPORT
`PURSUANT TO SECTION 13 OR 15(d) OF THE
`SECURITIES EXCHANGE ACT OF 1934
`
`Date of report (Date of earliest event reported): April 4, 2008
`
`
`Novacea, Inc.
`
`(Exact name of Registrant as Specified in its Charter)
`
`Delaware
`(State or other jurisdiction
`of incorporation)
`
`
`
`
`
`00051967
`(Commission
`File Number)
`
`
`
`
`
`330960223
`(I.R.S. Employer
`Identification No.)
`
`400 Oyster Point Boulevard, Suite 200
`South San Francisco, California 94080
`(Address of Principal Executive Offices)
`(650) 2281800
`(Registrant’s telephone number, including area code)
`Check the appropriate box below if the Form 8K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
`General Instruction A.2. below):
`
` ¨
`
` ¨
`
`Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
`
`Soliciting material pursuant to Rule 14a12 under the Exchange Act (17 CFR 240.14a12)
`
`Precommencement communications pursuant to Rule 14d2(b) under the Exchange Act (17 CFR 240.14d2(b))
`
`Precommencement communications pursuant to Rule 13e4(c) under the Exchange Act (17 CFR 240.13e4(c))
`
` ¨
`
` ¨
`
`
`
`https://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
`
`1/5
`
`AVENTIS EXHIBIT 2127
`Mylan v. Aventis, IPR2016-00712
`
`
`
`
`10/13/2016
`
`Form 8K
`
`Termination of a Material Definitive Agreement
`Item 1.02.
`On April 4, 2008, Schering Corporation (“Schering”), a whollyowned subsidiary of ScheringPlough Corporation, delivered written notice (the “Termination Letter”) of
`Schering’s termination of the exclusive License, Development and Commercialization Agreement between Novacea, Inc. (“Novacea” or the “Company”) and Schering, dated
`May 29, 2007, for the development and commercialization of AsentarTM (DN101) for all diagnostic, therapeutic and prophylactic uses in humans and animals (the “Collaboration
`Agreement”). Schering elected to terminate the Collaboration Agreement pursuant to Section 16.4(b) based on Schering’s determination, related to the termination of the
`ASCENT2 Phase 3 clinical trial, that there had been a technical failure related to Asentar™. In November 2007, Novacea and Schering terminated the ASCENT2 trial of
`Asentar™ due to an unexplained imbalance of deaths between the treatment and control arms of the trial.
`
`According to the Termination Letter, the termination was effective immediately upon Novacea’s receipt of the Termination Letter. Upon termination of the Collaboration
`Agreement, the licenses and other rights granted by Novacea to Schering pursuant to the Collaboration Agreement terminated and Schering became responsible for conducting an
`orderly winddown of all ongoing development activities with respect to Asentar™ and making all payments due to Novacea and any other third parties with respect to Asentar™,
`as per the terms of the Collaboration Agreement. Novacea anticipates that Schering will honor invoices for all costs incurred through the effective date of termination. However,
`Schering has indicated that they may dispute the costs associated with the currently ongoing winddown activities with respect to Asentar™, which costs would be incurred by
`Novacea subsequent to the effective date of termination and subject to reimbursement by Schering. Any future development of Asentar™ would be at Novacea’s expense.
`Novacea does not anticipate incurring any early termination penalties as a result of the termination of the Collaboration Agreement.
`
`As a result of the termination of the Collaboration Agreement, Novacea anticipates that it will recognize as revenue in 2008 the entire deferred revenue balance ($54.8
`million as of December 31, 2007) related to the $60.0 million in upfront payments, which were being amortized previously over an approximately sixyear period.
`
`Novacea disclosed the material terms of the Collaboration Agreement and filed a copy of the Collaboration Agreement in its current report on Form 8K filed with the
`Securities and Exchange Commission on June 1, 2007.
`
`The foregoing description is qualified in its entirety by reference to the Company’s press release dated April 9, 2008, a copy of which is attached hereto as Exhibit 99.1 and
`incorporated herein by reference.
`
`ForwardLooking Statements. This report includes forwardlooking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
`Securities Exchange Act of 1934. These statements relate to future events or our future clinical or product development, financial performance, regulatory review of our products
`or product candidates, or commercialization efforts. In some cases, you can identify forwardlooking statements by
`
`* * * * *
`
`https://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
`
`2/5
`
`
`
`10/13/2016
`
`Form 8K
`
`terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of those
`terms and other comparable terminology. These statements reflect only management’s current expectations. Important factors that could cause actual results to differ materially
`from the forwardlooking statements we make or incorporate by reference in this report are set forth under the heading “Risk Factors” in our most recent Annual Report on Form
`10K, as may be updated from time to time by our future filings under the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying
`assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by
`these forwardlooking statements. We disclaim any intent or obligation to update these forwardlooking statements.
`
`Financial Statements and Exhibits.
`Item 9.01.
`(d) Exhibits.
`
`
`
`Description
`Exhibit No.
`
`Press Release dated April 9, 2008
`99.1
`
`https://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
`
`3/5
`
`
`
`10/13/2016
`
`Form 8K
`
`SIGNATURES
`
`Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
`authorized.
`
`Date: April 9, 2008
`
` NOVACEA, INC.
`
`
`
`
`
`
`
`
`
`
`
` /s/ Edward C. Albini
` By:
` Name: Edward C. Albini
` Title: Chief Financial Officer
`
`https://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
`
`4/5
`
`
`
`10/13/2016
`
`
`
`Description
`Exhibit No.
`
`Press Release dated April 9, 2008
`99.1
`
`Form 8K
`
`EXHIBIT INDEX
`
`https://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
`
`5/5