Foundation Medicine, Inc. (Form: 8-K, Received: 09/13/2017 16:32:33)

Date: September 13, 2017

FOUNDATION MEDICINE, INC.

/s/ Robert W. Hesslein

Robert W. Hesslein

Senior Vice President and General Counsel

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): September 8, 2017

Foundation Medicine, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-36086

27-1316416

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

150 Second Street

Cambridge, MA

02141

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code (617) 418-2200

Not Applicable

(Former name or former address, if changed since last report)

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:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 1.01.

Entry into a Material Definitive Agreement.

On September 8, 2017, the Company and Roche entered into a Fifth Amendment (“Amendment”) to the Collaboration Agreement, by and among the Company, F. Hoffmann-La Roche Ltd, and Hoffmann-La Roche Inc., dated January 11, 2015, as amended (the “R&D Collaboration Agreement”), which reduced certain exclusivity provisions relating to blood-based tumor mutational burden assays.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, which is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated herein by reference, and by reference to the full text of the R&D Collaboration Agreement, which was attached as Exhibit 10.2 to the Company’s Current Report on Form 8-K/A filed on August 21, 2015.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits


Exhibit No.		Description

10.1		Fifth Amendment to Collaboration Agreement, by and among the Company, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc., dated September 8, 2017.

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.

EXHIBIT INDEX


Exhibit No.		Description

10.1		Fifth Amendment to Collaboration Agreement, by and among the Company, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc., dated September 8, 2017.

Exhibit 10.1

***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

FIFTH AMENDMENT TO

COLLABORATION AGREEMENT

This Fifth Amendment (“ Fifth Amendment ”) to the Collaboration Agreement (the “ Agreement ”) by and between F. Hoffmann-La Roche Ltd, with an office and place of business at Grenzacherstrasse 124, 4070, Basel, Switzerland, and Hoffmann-La Roche Inc., with an office and place of business at 150 Clove Road, Suite 8, Little Falls, New Jersey 07424, U.S.A. (together, “ Roche ”), on the one hand, and Foundation Medicine, Inc., with an office and place of business at 150 Second Street, Cambridge, MA 02141, U.S.A. (“ FMI ”), on the other hand (each a “ Party ,” and collectively, the “ Parties ”), as such Agreement has been amended from time to time, is entered into by and between the Parties and shall be considered effective as of the 8 ^th of September, 2017 (the “ Fifth Amendment Effective Date ”). Capitalized terms used in this Fifth Amendment and not otherwise defined herein are used with the meanings ascribed to them in the Agreement.

Section 1.27. Section 1.27 of the Agreement is hereby replaced with the following:

“ 1.27 Excepted Activities

The term “Excepted Activities” shall mean […***…].

[Signature page follows.]

IN WITNESS WHEREOF , the Parties hereto have caused this Fifth Amendment to be executed and effective as of the Fifth Amendment Effective Date. All other terms and conditions of the Agreement remain in force and effect.


FOUNDATION MEDICINE, INC.		F. HOFFMANN-LA ROCHE LTD

Signed:	/s/ Steven J. Kafka	Signed:	/s/ Luc Schnitzler
Name:	Steven J. Kafka, Ph.D.	Name:	Luc Schnitzler
Title:	President & Chief Operating Officer	Title:	Global Alliance & Asset Director

		F. HOFFMANN-LA ROCHE LTD

		Signed:	/s/ Stefan Arnold
		Name:	Stefan Arnold
		Title:	Head Legal Pharma

		HOFFMANN-LA ROCHE INC.

		Signed:	/s/ John P. Parise
		Name:	John P. Parise
		Title:	Authorized Signatory