Attached files
| file | filename |
|---|---|
| EX-31.2 - EXHIBIT 31.2 - SEQUENOM INC | d551007dex312.htm |
| EX-31.1 - EXHIBIT 31.1 - SEQUENOM INC | d551007dex311.htm |
| 10-K/A - FORM 10-K/A - SEQUENOM INC | d551007d10ka.htm |
Exhibit 10.57
***Text Omitted and Filed Separately with the Securities and Exchange Commission.
Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
DATED 29 November 2012
ISIS INNOVATION
LIMITED AND
SEQUENOM,
INC.
FOURTH AMENDMENT AGREEMENT
THIS FOURTH AMENDMENT AGREEMENT is made on 29 November, 2012 (The “Fourth Amendment Agreement Effective Date”).
BETWEEN:
| (I) | ISIS INNOVATION LIMITED (company number 2199542) whose registered office is at University Offices, Wellington Square, Oxford OX1 2JD, England (the “Licensor”); and |
| (2) | SEQUENOM, INC., a Delaware Corporation, whose principal place of business is at 3595 |
John Hopkins Court, San Diego, CA 92121-1331 USA (the “Licensee”).
BACKGROUND:
| a) | The Licensor granted a license of certain patents, patent applications and associated know-how relating to non-invasive pre-natal diagnosis to the Licensee on 14 October 2005 accompanied by a Development Plan Agreement made on the same date and this license was amended by three subsequent amendment agreements entered into respectively on 19 October 2006, 5 November 2007 and 3 November 2009 (together the “Licence’’). |
| b) | The Parties wish to further amend the Licence in accordance with the provisions set out below. |
AGREEMENT:
| 1. | Interpretation |
Except as otherwise provided in this Fourth Amendment Agreement, words and expressions used in this Agreement have the same meaning as in the Licence.
| 2. | Payment |
In consideration of the agreement given by the Licensor in clause 3below, the Licensee enters into the covenants in this Fourth Amendment Agreement and the Licensee shall pay to the Licensor (a) the sum of […***…] US dollars (USD […***…]) by wire transfer within fifteen (15) business days of the Fourth Amendment Agreement Effective Date and (b) the further sum of […***…] US dollars (USD […***…]) to be paid by wire transfer in two equal installments of […***…] US dollars (USD […***…]), the first no later than 31 January 2014 and the second no later than 31 January 2015. The sums referred to in this clause 2 are expressed as being exclusive of VAT. The sums referred to in this clause 2 shall not be creditable in favor of Licensee with respect to any other financial obligation of Licensee under the Licence.
*** Confidential Treatment Requested
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| 3. | Amendment of the Licence |
With effect on and from the Fourth Amendment Agreement Effective Date the Parties agree as follows:
| (a) | Clause 11.4.1 shall be amended to read in its entirety as follows |
“In the event that Licensee is in the future precluded from selling its […***…] for the […***…] indication (now offered by Licensee as a […***…] under the U.S. […***…], as the result of any action by regulatory authorities in the United States (including but not limited to the U.S. Food & Drug Administration (FDA), then Licensee shall use all reasonable endeavors to obtain […***…] such that Licensee is able to lawfully […***…]either a […***…] for the […***…] indication in the United States.”
| (b) | Clause 11.4.3 shall be deleted in its entirety, |
| (c) | a new Clause 10.1.7 shall be added to the Licence as follows: |
“(i) report on any changes by the regulatory authorities (including but not limited to the U.S. FDA) that may impact on the Licensee’s ability to lawfully Market Licensed Product for the aneuploidy indication; and
(ii) in the event there is a requirement to obtain regulatory approval to be able to lawfully Market Licensed Product for the aneuploidy indication in the U.S. (other than the requirements for Laboratory Developed Tests under the U.S. Clinical Laboratory Improvement Amendment of 1988 (“CLIA”), now applicable to the testing service currently offered by Licensee), then set out the activities and timelines that Licensee will undertake to complete clinical development and submit for such regulatory approval.”
| 4. | Waiver |
The Licensor hereby irrevocably waives, releases and discharges the Licensee from and against any and all claims and causes including the Licensor’s rights to damages, rights to terminate the Licence or to convert the Licence from exclusive to a non-exclusive basis arising as a result of Licensee’s past performance under the Licence up to and including the Fourth Amendment Agreement Effective Date relating to any alleged failure of the Licensee to achieve certain developmental and commercial Milestones as originally contemplated by the parties.
| 5. | Governing Law |
English Law governs this Fourth Amendment Agreement, and the parties submit to the exclusive jurisdiction of the English Courts for the resolution of any dispute which may arise out of or in connection with this Agreement save for injunctive relief which may be sought in any court of competent jurisdiction.
*** Confidential Treatment Requested
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AS WITNESS this agreement has been executed by the duly authorized representatives of the parties, respectively, the date(s) written below.
| SIGNED for and on behalf of ISIS INNOVATION LIMITED: |
SIGNED for and on behalf of SEQUENOM, INC.: | |||||
| NAME: | Mr. T Hockaday | NAME: | Harry F. Hixson, Jr. | |||
| Managing Director | ||||||
| Isis Innovation Ltd | ||||||
| SIGNATURE: | s/ Mr. T Hockaday | SIGNATURE: | s/ Harry Hixson Jr. | |||
| DATE: | November 29, 2012 | DATE: | November 26, 2012 | |||
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