Exhibit 10.2

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Amendment No. 1 to Project Schedule #1

 

This Amendment No. 1 to Project Schedule #1, dated as of July 14, 2017 (this
“Amendment”), between Blueprint Medicines Corporation (“Blueprint”) and QIAGEN
Manchester Limited (“QIAGEN”) amends that certain Project Schedule #1, dated
August 22, 2016 (“Project Schedule #1”) to the Master Collaboration Agreement,
 dated August 22, 2016, between Blueprint and QIAGEN (together with Project
Schedule #1, the “Agreement” or “MCA”).  Blueprint and QIAGEN are each referred
to herein as a “Party” and, collectively, as the “Parties.” Capitalized terms
used and not otherwise defined in this Amendment shall have the meanings set
forth in the Agreement.

 

Recitals

 

WHEREAS, pursuant to the Agreement, the Parties have agreed to certain
activities, timelines and payments related to the development and
commercialization of an assay as a companion diagnostic test to identify
gastrointestinal stromal tumor patients with the PDGFRα D842V mutation for use
with Blueprint’s drug candidate BLU-285; and

 

WHEREAS, as recommended by the Joint Project Team, the Parties desire to amend
certain activities, timelines and payments under Project Schedule #1;

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the parties hereby agree as follows:

 

1.           Part B (CDx development and validation) of Section 12 of Project
Schedule #1 is hereby deleted in its entirety and replaced as set forth in
Exhibit A attached hereto.

 

2.           The table set forth in Section 13 of Project Schedule #1 under the
heading “CDx Development and Validation Milestone Schedule” is hereby deleted in
its entirety and replaced as set forth in Exhibit B attached hereto.

 

3.           The table set forth in Section 14 of Project Schedule #1 under the
heading “Pass-Through Cost Estimate for CDx Development and Validation” is
hereby deleted in its entirety and replaced as set forth in Exhibit C attached
hereto.

 

4.           Project Schedule #1, as supplemented and modified by this
Amendment, constitutes the entire agreement and understanding of the parties
thereto with respect to the subject matter thereof and supersedes all prior
agreements and understandings relating to such subject matter.

 

5.           This Amendment shall be effective as of the date first set forth
above (the “Amendment Effective Date”).  On and after the Amendment Effective
Date, each reference in the Project Schedule #1 to “this Schedule,” “hereunder,”
“hereof,” “herein” or words of like

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

import, and each similar reference in the other documents entered into in
connection with Project Schedule #1, shall mean and be a reference to Project
Schedule #1, as amended hereby.  Except as specifically amended above, the
Agreement and Project Schedule #1 shall remain in full force and effect and are
hereby ratified and confirmed.

 

6.           This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.  Counterparts may be delivered via facsimile,
electronic mail (including pdf or any electronic signature complying with the
U.S.  Federal ESIGN Act of 2000) or other transmission method and any
counterpart so delivered shall be deemed to have been duly and validly delivered
and be valid and effective for all purposes.

 

7.           This Amendment shall be construed and interpreted in accordance
with the internal laws of the State of Delaware, without giving effect to the
principles of conflicts of law thereof.

 

[Remainder of page intentionally left blank.]

 

 

 

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

IN WITNESS WHEREOF, the undersigned have executed this Amendment No. 1 to
Project Schedule #1 as of the date first set forth above.

 

 

Blueprint Medicines Corporation

 

 

 

 

 

 

 

 

 

 

By:

/s/ Jeffrey W. Albers

 

Name:

Jeffrey W. Albers

 

Title:

President and Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

QIAGEN Manchester Limited

 

 

 

 

 

 

 

 

 

 

By:

/s/ Douglas Liu

 

Name:

Douglas Liu

 

Title:

SVP Global Operations

 

 

 

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Exhibit A

 

Section 12 – Part B (CDx development and validation)

 

Milestone 11:  

 

Design Control Planning (CDx)

 

[***]

 

Milestone 12:

 

Completion of Design Inputs; Design Input Lock and Design & Development Plan
(CDx)

 

[***]

 

Milestone 13:  

 

Manufacturing Robustness Study 

 

[***]

 

Milestone 14:  

 

Manufacturing Transfer and Prototype Batch Production (CDx) required for assay
performance studies

 

[***]

 

Milestone 15:  

 

CDx Assay Performance Studies Complete

 

[***]

 

Milestone 16:

 

Completion of Verification Batches (Pilot Batches)

 

[***]

 

Milestone 17:  

 

System Design Lock

 

[***]

A-1

Confidential and Proprietary Information of Blueprint and QIAGEN

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Milestone 18:  

 

Design Output and Design Verification Lock (Completion of Verification)

 

[***]

 

Milestone 19:  

 

Assay Software Available

 

[***]

 

Milestone 20:  

 

Completion of Lab Set-up Bridging Study

 

[***]

 

Milestone 21: 

 

[***]

 

Milestone 22:  

 

Design Validation Lock

 

[***]

 

Milestone 23 [***]:

 

PMA Submissions

 

[***]

 

Milestone 24:  

 

CE Marking

 

[***] 

 

Milestone 25:

 

PMA Approval

 

[***]

A-2

Confidential and Proprietary Information of Blueprint and QIAGEN

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Milestone 26:  

 

Product Implementation

 

[***]

 

 

A-3

Confidential and Proprietary Information of Blueprint and QIAGEN

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[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Exhibit B

 

Section 13 – CDx Development and Validation Milestone Schedule

 

Milestone

Description

Estimated
Completion Date

Milestone
Amount ($US)

11

Design Control Planning (CDx)

[***]

[***]

12

Completion of Design Inputs; Design Input Lock and Design & Development Plan
(CDx)

[***]

[***]

13

Manufacturing Robustness Study

[***]

[***]

14

Manufacturing Transfer and Prototype Batch Production (CDx) required for assay
performance studies

[***]

[***]

15

CDx Assay Performance Studies Complete

[***]

[***]

16

Completion of Verification Batches (Pilot Batches)

[***]

[***]

17

System Design Lock

[***]

[***]

18

Design Output and Design Verification Lock (Completion of Verification)

[***]

[***]

19

Assay Software Available

[***]

[***]

20

Completion of Lab Set-up Bridging Study

[***]

[***]

21

Completion of Reproducibility Study

[***]

[***]

22

Design Validation Lock

[***]

[***]

23

PMA Submissions*

 

 

 

[***] 

* Each portion of this milestone will be invoiced separately upon submission of
the respective module.

[***]

[***]

24

CE Marking

[***]

[***]

25

PMA Approval

[***]

[***]

26

Product Implementation

[***]

[***]

Total CDx Development and Validation Milestones

[***] 

 

 

 

B-1

Confidential and Proprietary Information of Blueprint and QIAGEN

--------------------------------------------------------------------------------

 

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED.  ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Exhibit C

 

Pass-Through Cost Estimate for CDx Development and Validation

 

Name

Description

Estimated
Cost ($US)

Reproducibility Studies

Contracting for Reproducibility Studies[***]

[***]

GLP Sequencing

Completion of Clinical Accuracy Study - Outsourced

[***]

GMP Raw  materials

Primers & Probes for the development and manufacture of PDGFRα tests. Estimate in HPLC and Mass determination for each
 oligonucleotide

[***]

Positive control  oligos

Long oligonucleotides for the generation of positive controls

[***]

Sample Costs

Procurement of sample will be required to support development.
 The cost of sample procurement varies depending on the disease
 tissue of interest.

[***]

Clinical Test Site Monitoring

During the course of the clinical trials monitoring of sites carrying
 out clinical testing will be conducted. The number of visits will be
 dependent on recruitment rate and site performance. For clarity, the estimated
cost per visit includes any travel and accommodation costs incurred during each
such visit.

[***]

Travel &  Accommodation

During the course of the program, face-to-face Joint Project Team and Joint
Steering Committee meetings will take place. The frequency of these meetings
will be mutually agreed between QIAGEN and Blueprint in accordance with the MCA.

[***]

Canada Registration

Product implementation together with IVD registration activities and submission
fees for Health Canada

 

(Assumes no additional data generation)

[***]

IP

Analyze third party rights for freedom-to-operate of the assay. Does
 not include licensing fees. – covered under IUO development

[***]

QIAamp DSP DNA FFPE kits

Kits required for sample preparation

[***]

Total Estimated Pass-Through Costs for CDx Development and Validation

[***]

 

C-1

Confidential and Proprietary Information of Blueprint and QIAGEN

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