Companion Diagnostics Agreement Sample Contracts

COMPANION DIAGNOSTICS AGREEMENT BETWEEN EPIZYME, INC. and EISAI CO., LTD. on the one side AND ROCHE MOLECULAR SYSTEMS, INC. on the other side
Companion Diagnostics Agreement • March 1st, 2022 • Epizyme, Inc. • Pharmaceutical preparations • Delaware

This Companion Diagnostics Agreement (“Agreement”) is entered into and made effective this 18th day of December 2012 (the “Effective Date”) by and between Epizyme, Inc., having a place of business at 325 Vassar Street, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koishikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually, “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”) on the one side and Roche Molecular Systems, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A. (“RMS”) on the other side.

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Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. COMPANION DIAGNOSTICS AGREEMENT BETWEEN CLOVIS ONCOLOGY, INC. AND ROCHE MOLECULAR SYSTEMS, INC.
Companion Diagnostics Agreement • October 31st, 2011 • Clovis Oncology, Inc. • Pharmaceutical preparations • Delaware

This COMPANION DIAGNOSTICS AGREEMENT (this “Agreement”) is made and entered into as of the latest date of signature below (the “Effective Date”) by and between Clovis Oncology, Inc., a Delaware corporation, having a place of business at 2525 28th Street, Suite 100, Boulder, CO 80301 (“Clovis Oncology”) and Roche Molecular Systems, Inc., a Delaware corporation having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588 (“RMS”).

EX-10.28 2 d573151dex1028.htm EX-10.28 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions. FIRST AMENDMENT TO COMPANION DIAGNOSTICS AGREEMENT
Companion Diagnostics Agreement • May 5th, 2020

This First Amendment (“Amendment”) shall be effective as of this 31st day of May 2013 (“Amendment Effective Date”), by and between Epizyme, Inc., having a place of business at 400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koishikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually, “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”), on the one side, and Roche Molecular Systems, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A. (“RMS”), on the other side, as an amendment to the Companion Diagnostics Agreement, dated 18th December 2012 (“Agreement”). Capitalized terms used in this Amendment and not defined in this Amendment shall have the meanings ascribed to them in the Agreement.

December 21, 2012
Companion Diagnostics Agreement • March 22nd, 2013 • Epizyme, Inc. • Pharmaceutical preparations

Reference is hereby made to (a) the Collaboration and License Agreement dated as of April 1, 2011 (as amended, the “Collaboration Agreement”), by and between Eisai Co., Ltd. (“Eisai”) and Epizyme, Inc. (“Epizyme”) and (b) the Companion Diagnostics Agreement of even date herewith (the “RMS Agreement”), by and between Epizyme and Eisai, on the one side, and RMS, on the other side.

FOURTH AMENDMENT TO COMPANION DIAGNOSTICS AGREEMENT
Companion Diagnostics Agreement • October 31st, 2019 • Epizyme, Inc. • Pharmaceutical preparations

This Fourth Amendment (“Fourth Amendment”) shall be effective as of this 26 day of July, 2019 (“Amendment Effective Date”), by and between Epizyme, Inc., having a place of business at 400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koshikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”), on the one side, and Roche Molecular Systems, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A (“RMS”) and Roche Sequencing Solutions, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A (“RSS”), on the other side, as an amendment to the Companion Diagnostics Agreement dated 18 December 2012, as first amended on 31 May 2013, second amended on 16 November 2015 (the “Second Amendment”), and third amended on 7 March 2018 (the “Third Amendment”) (collectively, th

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions. FIRST AMENDMENT TO...
Companion Diagnostics Agreement • March 1st, 2022 • Epizyme, Inc. • Pharmaceutical preparations

This First Amendment (“Amendment”) shall be effective as of this 31st day of May 2013 (“Amendment Effective Date”), by and between Epizyme, Inc., having a place of business at 400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koishikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually, “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”), on the one side, and Roche Molecular Systems, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A. (“RMS”), on the other side, as an amendment to the Companion Diagnostics Agreement, dated 18th December 2012 (“Agreement”). Capitalized terms used in this Amendment and not defined in this Amendment shall have the meanings ascribed to them in the Agreement.

SECOND AMENDMENT TO COMPANION DIAGNOSTICS AGREEMENT
Companion Diagnostics Agreement • March 9th, 2016 • Epizyme, Inc. • Pharmaceutical preparations

This Second Amendment (“Second Amendment”) shall be effective as of this 16th day of November (“Amendment Effective Date”), by and between Epizyme, Inc., having a place of business at 400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koishikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually, “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”), on the one side, and Roche Molecular Systems, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A. (“RMS”), on the other side, as an amendment to the Companion Diagnostics Agreement, dated 18th December 2012 as previously amended on 31 May 2013 (“Agreement”). Capitalized terms used in this Amendment and not defined in this Amendment shall have the meanings ascribed to them in the Agreement.

COMPANION DIAGNOSTICS AGREEMENT
Companion Diagnostics Agreement • August 11th, 2020 • Aprea Therapeutics, Inc. • Pharmaceutical preparations

This Companion Diagnostics Agreement (this “Agreement”) dated August 11, 2020 (the “Effective Date”), by and between Invivoscribe, Inc., a California corporation with offices located at 10222 Barnes Canyon Rd., Building 1, San Diego, CA 92121 (“IVS”), and Aprea Therapeutics, Inc., a Delaware corporation (“APR”) with offices located at 535 Boylston Street, Boston, MA 02116 (each a “Party” and collectively the “Parties”).

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions. SECOND AMENDMENT TO...
Companion Diagnostics Agreement • March 1st, 2022 • Epizyme, Inc. • Pharmaceutical preparations

This Second Amendment (“Second Amendment”) shall be effective as of this 16th day of November (“Amendment Effective Date”), by and between Epizyme, Inc., having a place of business at 400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koishikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually, “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”), on the one side, and Roche Molecular Systems, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A. (“RMS”), on the other side, as an amendment to the Companion Diagnostics Agreement, dated 18th December 2012 as previously amended on 31 May 2013 (“Agreement”). Capitalized terms used in this Amendment and not defined in this Amendment shall have the meanings ascribed to them in the Agreement.

Via E-mail Paolo Tombesi
Companion Diagnostics Agreement • February 18th, 2020
By Telefacsimile (81-3-3811-1459) With Follow Up by E-mail Eisai Co., Ltd. Attention: Chief Product Creation Officer Koishikawa 4-6-10 Bunkyo-Ku Tokyo 112-8088 Japan
Companion Diagnostics Agreement • March 16th, 2015 • Epizyme, Inc. • Pharmaceutical preparations • New York

Reference is hereby made to (a) the Amended and Restated Collaboration and License Agreement dated as of March 12, 2015 (the “Amended and Restated Collaboration Agreement”), by and between Eisai Co., Ltd. (“Eisai”) and Epizyme, Inc. (“Epizyme”), (b) the Companion Diagnostics Agreement dated December 18, 2012, as amended by the First Amendment thereto dated May 31, 2013 (the “RMS Agreement”), by and between Epizyme and Eisai, on the one side, and RMS, on the other side and (c) the prior letter agreement dated December 21, 2012 (the “Prior Letter Agreement”), by and between Epizyme and Eisai, regarding the RMS Agreement.

THIRD AMENDMENT TO COMPANION DIAGNOSTICS AGREEMENT
Companion Diagnostics Agreement • May 8th, 2018 • Epizyme, Inc. • Pharmaceutical preparations

This Third Amendment (“Third Amendment”) shall be effective as of this 7th day of March, 2018 (“Amendment Effective Date”), by and between Epizyme, Inc., having a place of business at 400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, U.S.A. (“Epizyme”) and Eisai Co., Ltd., having a place of business at Koishikawa 4-6-10, Bunkyo-ku, Tokyo 112-8088, Japan (individually “Eisai” and collectively with Epizyme, “Pharmaceutical Partners”), on the one side, and Roche Molecular System, Inc., having a place of business at 4300 Hacienda Drive, Pleasanton, California 94588, U.S.A (“RMS”), on the other side, as an amendment to the Companion Diagnostics Agreement dated 18th December 2012, as first amended on 31 May 2013 and second amended on 16 November 2015 (the “Second Amendment”) (collectively, the “Agreement”). Capitalized terms used in this Third Amendment and not defined in this Third Amendment shall have the meanings ascribed to them in the Agreement.

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