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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953...
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`8-K 1 d8k.htm FORM 8-K
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`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`WASHINGTON, D.C. 20549
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`CURRENT REPORT
`PURSUANT TO SECTION 13 OR 15(d) OF THE
`SECURITIES EXCHANGE ACT OF 1934
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`Date of report (Date of earliest event reported): April 4, 2008
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`(Exact name of Registrant as Specified in its Charter)
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`Delaware
`(State or other jurisdiction
`of incorporation)
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`000-51967
`(Commission
`File Number)
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`33-0960223
`(I.R.S. Employer
`Identification No.)
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`400 Oyster Point Boulevard, Suite 200
`South San Francisco, California 94080
`(Address of Principal Executive Offices)
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`(650) 228-1800
`(Registrant’s telephone number, including area code)
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`Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
`any of the following provisions (see General Instruction A.2. below):
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`¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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` ¨
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`Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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`Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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`Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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`002007
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`AVENTIS EXHIBIT 2028
`Mylan v. Aventis, IPR2016-00712
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`Form 8-K
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953...
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`Item 1.02. Termination of a Material Definitive Agreement
`On April 4, 2008, Schering Corporation (“Schering”), a wholly-owned subsidiary of Schering-Plough 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 (DN-101) 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 ASCENT-2 Phase 3 clinical trial, that there had been a technical failure
`related to Asentar™. In November 2007, Novacea and Schering terminated the ASCENT-2 trial of Asentar™ due to an unexplained
`imbalance of deaths between the treatment and control arms of the trial.
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`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 wind-down 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 wind-down 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.
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`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 six-year period.
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`Novacea disclosed the material terms of the Collaboration Agreement and filed a copy of the Collaboration Agreement in its
`current report on Form 8-K filed with the Securities and Exchange Commission on June 1, 2007.
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`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.
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`Forward-Looking Statements. This report includes forward-looking 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 forward-looking statements by
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`* * * * *
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`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 forward-looking 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 10-K,
`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 forward-looking statements. We
`disclaim any intent or obligation to update these forward-looking statements.
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`Item 9.01. Financial Statements and Exhibits.
`(d) Exhibits.
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` Description
`Exhibit No.
`99.1 Press Release dated April 9, 2008
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`Form 8-K
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953...
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`SIGNATURES
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`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.
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`Date: April 9, 2008
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` NOVACEA, INC.
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` /s/ Edward C. Albini
` By:
` Name: Edward C. Albini
` Title: Chief Financial Officer
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`Form 8-K
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953...
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` Description
`Exhibit No.
`99.1 Press Release dated April 9, 2008
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`EXHIBIT INDEX
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