Voor wie wil weten wat we nu vervangen, hier de oude info die ik kan vinden:
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended: December 31, 2013
Form 10-K
Annual Report
Filed Feb 28, 2014
MDx Health
In July 2010, we entered into a technology license and royalty agreement with MDx Health S.A. (formerly Oncomethylome Sciences, S.A.) ("MDx Health"). Under the license agreement, MDx Health granted us an exclusive, worldwide license to sell products, and a U.S. license to sell services, in the field of in vitro diagnostic testing of fecal samples for detection of colorectal cancer and colorectal pre-cancer to certain patents and patent applications related to DNA methylation biomarkers. The licensed patents and patent applications contain both method and composition-of-matter claims. The jurisdictions covered by these patents and patent applications include the U.S., Canada, the European Union, China and Japan. Under the agreement, we are obligated to make commercially reasonable efforts to bring to market products using the licensed MDx Health patents. We paid MDx Health $100,000 upon executing the agreement in July 2010 and we are required to pay MDx Health a minimum royalty fee of $100,000 on each anniversary of the agreement for the life of the contract. We are also required to pay MDx Health $100,000 upon the first commercial sale of a licensed product
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after the receipt of FDA approval, $150,000 after we have reached net sales of $10 million of a licensed product after receipt of FDA approval, $750,000 after we have reached net sales of $50 million, and $1 million after we have reached net sales of $50 million in a single calendar year. We are also required to pay MDx Health a low single digit royalty on our net sales of products and services using the licensed patents. Unless earlier terminated by the parties in accordance with the agreement, the license agreement will remain in effect until the last of the licensed patents expires in 2028. The agreement contains customary termination provisions which, among other things, permit termination in the event of material uncured breaches.
CONFIDENTIAL PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR SUCH PORTIONS. ASTERISKS DENOTE OMISSIONS.
ADDENDUM
TO
LICENSE AGREEMENT
This is an Addendum to the License Agreement dated July 26, 2010 (the “Agreement”) by and between MDxHealth S.A. (“MDxH” formerly OncoMethylome Sciences, S.A. or “Onco”) and Exact Sciences Corporation (“Exact”). The terms of this Addendum shall take precedence over, and shall supersede any conflicting terms contained in, the Agreement. Any terms which are defined in the Agreement shall have the same meaning in this Addendum, unless otherwise defined herein; provided further that all references to “Onco” in the Agreement shall be deemed to be replaced with “MDxH”. The effective date of this Addendum is May 6, 2011.
NOW, THEREFORE, the parties agree as follows:
1. Section 3.4(a) is hereby revised in its entirety to read as follows: “In the event that Exact elects to discontinue its right and license to MSP in the notice provided by Exact pursuant to Section 2.5, the royalty rate shall equal [***]% of the Royalty Base for the MDxH Methylation Marker that is included in the Licensed Products or Licensed Services, whether the applicable marker is a Primary MDxH Methylation Marker or a Supplementary MDxH Methylation Marker. In the event that Exact is required or agrees to pay running royalties for rights under a Third Party patent(s) covering an additional DNA methylation marker, including associated know how (if any), incorporated into a Licensed Product or Licensed Service, then Exact shall be entitled to deduct such royalties actually paid to said Third Party on sales of such Licensed Product or Licensed Service from the royalties payable to MDxH under this Section 3.4(a) on sales of such Licensed Product or Licensed Service; provided that in no event shall the royalty rate payable to MDxH by operation of this Section 3.4(a) be less than [***]% of the Royalty Base.”
2. Section 3.4(b) is hereby revised in its entirety to read as follows: “In the event that Exact elects to continue its right and license to MSP in the notice provided by Exact pursuant to Section 2.5, the royalty rate shall equal [***]% of the Royalty Base for the MDxH Methylation Marker that is included in the Licensed Products or Licensed Services, whether the applicable marker is a Primary MDxH Methylation Marker or a Supplementary MDxH Methylation Marker; provided, however, that upon expiration of all United States Patents applicable to MSP as referenced on Exhibit B, the royalty rate provided in Section 3.4(a) shall be applicable with respect to all sales of Licensed Products or Licensed Services following the date of such expiration regardless of whether Exact uses MSP in Licensed Products or Licensed Services.”