Exhibit 10.1

 

AMENDMENT 4

TO

COLLABORATION AND COMMERCIAL LICENSE AGREEMENT

 

This Amendment 4 to the Collaboration and Commercial License Agreement
(“Amendment 4”) is entered into  as of the date that  it  is fully executed (the
 “Amendment 4 Effective Date”)  by  and between Mersana Therapeutics, Inc.,
a Delaware corporation, having its principal place of business at 840 Memorial
Drive Cambridge, MA 02139 (hereinafter referred to as “Mersana”)  and
Merck KGaA, a  corporation with general partners having its
principal place of business at  Frankfurter Str. 250, 64293 Darmstadt,
Germany (hereinafter  referred to as “Merck,”  and together  with Mersana,
 the “Parties”). This Amendment 4 amends that certain Collaboration and
Commercial License Agreement by and between Mersana and Merck dated  June 23,
2014, as  amended on June 1, 2016 (“Amendment 1”), August 12, 2016 (“Amendment
 2”), and February 28, 2017 (“Amendment  3”)  (together the “Original
Agreement,”  and together with this Amendment 4, the “Agreement”). Capitalized
terms used but not defined in this Amendment 4 will have the definition set
forth in the Original Agreement.

 

RECITALS

 

WHEREAS, the Parties wish to amend the Original Agreement as set forth in this Amendment
4;

 

WHEREAS, the Parties have agreed to create a Joint Steering Committee to oversee the Project Leaders,
Joint  Project Teams and Joint Intellectual Property Committee; and

 

NOW, THEREFORE, in consideration of the mutual covenants and obligations set
forth herein, the Parties  hereto, intending to be legally bound,
agree as follows:

 

ARTICLE 1 –  AMENDMENTS

 

1.1    New Definitions. The following new definitions are hereby added to Article 1 of
the Original  Agreement in  alphabetical order:

 

(a)

 “Amendment 4 Effective Date” means [·] 2018.

 

(b)

 “Joint Steering Committee” or  “JSC” is defined in Section 2.5.5.1.

 

1.2    Project   Leaders   Functions  and   Authority.  Section  2.5.2.2  of
 the  Original Agreement is hereby deleted in its entirety and replaced with
the following:

 

2.5.2.2     Functions and Authority. The Project Leaders will be responsible
for supervising and managing the Research  Programs;  provided that in the
 event of a conflict  between the JSC’s responsibilities and the
Project Leaders’ responsibilities, the JSC shall have final
decision-making authority. The Project  Leaders’ functions will be:

 

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

 

(a)

Overseeing and coordinating the progress, timelines, budget and results of
the Research  Programs;

 

(b)

Reviewing and approving each Research  Plan (including the budget  therein) and
any proposed  amendments to the Research  Plans proposed pursuant to  Section
Error! Reference source not found.,  provided that the Research  Plan
(including the budget  therein) for the first and second Designated
Targets attached hereto as  Schedule Error! Reference source not found.-1
shall be deemed approved  by the Project Leaders;

 

(c)

Reviewing each  Party’s reports regarding its  activities under each Research
 Plan;

 

(d)

Deciding whether it is scientifically or technically feasible to create an ADC
Directed to the  applicable Designated Target in accordance with each Research
 Plan;

 

(e)

Deciding whether  an ADC meets the  applicable Performance Specifications set
forth in  each Research  Plan;

 

(f)

Approval of any changes to the  Strategic IP  Plan proposed  by the JIPC.

 

(g)

Resolving any disputes delegated to the  Project Leaders by the JPT or
the JIPC, provided that if the Project Leaders are unable to resolve any such
dispute within thirty (30) days of the matter first being submitted to
the Project Leaders, then the dispute shall be elevated to the JSC; and

 

(h)

Such other matters as the Parties may mutually agree in writing.

 

1.3    Joint Project Team Decisions. Section 2.5.3.4 of the Original Agreement is
hereby deleted in its  entirety and replaced with the following:

 

“2.5.3.4     Decisions. The JPT will take action by unanimous consent of the
Parties, with each Party  having a single vote, irrespective of the number of
members actually in attendance at a meeting (but provided that at least one
member from each Party is in attendance), or  by a written resolution signed
 by the
designated members of each of the Parties. In the event the JPT is unable to
secure unanimous consent for a period in excess of thirty (30) days on any
matter
the decision shall be escalated to the Joint Steering Committee. For clarity, the
JPT shall not have the authority to amend the Research  Plan or this Agreement.”

 

1.4    Creation of the Joint Steering Committee. The following new Section 2.5.5 is
hereby inserted immediately following Section 2.5.4.4 of the Original Agreement:

 

“2.5.5    Joint Steering Committee.

 

2.5.5.1       Formation and Composition.   Within  ten  (10)  days   of   the
Amendment 4 Effective Date, the Parties shall establish a joint steering
committee

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

 

(the “Joint  Steering Committee” or “JSC”)  composed of three (3)  appointed
members of each of Merck and Mersana. A Party may  change one or more of its
members on the JSC at any time, subject to  written notice to the other Party’s
alliance   manager,  or  elect   to  have  one  (1)  of  its  members
 represented  by  a delegate at a meeting of the
 JSC, subject to the confidentiality provisions of
Section 7. One (1) member from each Party shall alternate in acting as the
chairperson of the JSC for one (1) Calendar Year term, with Mersana’s member
 chairing the JSC for the
first Calendar Year. The chairperson shall not have any  greater authority
than any other member on the JSC. The Parties may allow
additional employees, including the Parties’ alliance managers, Project Leaders
and project managers, to attend meetings of the
JSC subject to the confidentiality provisions in Section 7. Each Party’s JSC
members shall collectively have sufficient expertise and sufficient seniority
 and authority with respect to the applicable Party
to make other decisions within the scope of the JSC’s authority, including with
respect  to strategic decisions under the Agreement.

 

2.5.5.2       Functions and Authority. The JSC shall have responsibility for:

 

(a)

attempting to resolve any disputes arising under  any subcommittee of the JSC;

 

(b)

overseeing the performance  and decisions of any subcommittee of the JSC;

 

(c)

overseeing the performance  and decisions of the JPT  and Project  Leaders and
resolving any disputes arising with the Project  Leaders or under the JPT or
JIPC;

 

(d)

monitoring the implementation of the Research  Programs and Research  Plans and
approving the going-forward strategy for the Research  Programs and Research
 Plans;

 

(e)

managing the overall allocation of  FTEs and other resources used under  each
Research  Program and approving deviations from the Research  Plans with
 respect  to resources  allocated  by each  Party;

 

(f)

overseeing the activities conducted and any subcommittee formed pursuant to
 each  Supply Agreement;

 

(g)

overseeing the research, development and manufacturing of

 

(h)

Licensed Products; and performing such other functions as appropriate to further
the purposes of this Agreement, as mutually agreed upon by the Parties in
writing.

 

2.5.5.3       Subcommittees. The Parties may establish such subcommittees of
the JSC as required under this Agreement or as deemed necessary  by the Parties.
Each such subcommittee shall consist of an equal number of members designated
by 

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

 

each Party, which number shall be mutually  agreed by the Parties. Each Party
shall be free to change its members upon notice  to the other or to  send a
 substitute member to any subcommittee meeting, subject to the confidentiality
provisions of Section 7; provided, however, that each Party
shall ensure that at all times during the existence of any
subcommittee, its members on such subcommittee have
appropriate expertise and seniority, in each case to the extent applicable to the
role of the subcommittee. Each subcommittee shall report to, and any disputes
under a subcommittee shall be referred to the JSC, subject  to  Section 2.5.5.5.

 

2.5.5.4       Meetings. During the Term of the  Agreement, the  JSC will  meet
 in person or by  teleconference or videoconference at least twice during every
Calendar Year. The JSC may meet either (a) in person at either Party’s facilities
or at such locations as the Parties may otherwise agree or (b) by audio or video
teleconference; provided, that no less than one (1) meeting of
the JSC during each
Calendar Year shall be conducted in person. The JSC also may each choose to
meet more frequently on an as needed basis. The Project Leaders will attend all
meetings of the JSC, and will report to the
JSC progress, timelines and results of each Research  Program  and under
 each Research Plan and propose going-forward strategic
directions with respect to  each Research Program and Research Plan for approval
 by  the JSC. Each Party’s alliance manager will alternate in being
responsible for (a) organizing, coordinating and steering  each meeting of the
 JSC  and (b) for preparing  and distributing an agenda
 for each meeting. The applicable alliance manager will include on the
 agenda any item within the scope of the responsibility
of the JSC that is requested to be  included by  either Party, and will
distribute the agenda to the Parties no less than five (5) days  before
 each meeting of the  JSC.  Each Party shall be
 responsible for all of its own expenses incurred in connection with
participating in the JSC meetings.

 

2.5.5.5       Decisions.

 

2.5.5.5.1       Quorum. A quorum is  required for any meeting of the JSC,
which quorum will exist if at least one (1) member of each Party
is present. If a quorum exists, then the  unanimous consent of all attending
members  of the JSC is required in order for any
decision to be approved or action taken on behalf of the JSC.

 

2.5.5.5.2       Decision Making. In the event the JSC is unable to secure
unanimous consent on a matter that is subject to its decision-making  authority
within fourteen (14)  days of the matter first being submitted to the JSC, the
Chief
Executive Officer (or equivalent) of Mersana and the Chief Executive Officer (or equivalent) of Merck will meet at a mutually agreed upon time and location for
the purpose of resolving such dispute.  If such officers are not able to resolve
such dispute within fourteen (14) days of such meeting, then Merck, acting
 reasonably and in good faith, shall make the final determination on any
 matter related to the Research Programs, which shall be binding
on the Parties as though it had been
made by a consensus of the JSC; provided, that any amendments to a Research
 Plan that would require that Mersana use more FTEs in any period than the

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

 

maximum number of FTEs required under such Research Plan would require
Mersana’s consent, which consent may be withheld in Mersana’s reasonable
discretion.

 

2.5.5.6       JSC Meeting Minutes. The alliance managers shall alternate in
preparing and issuing minutes of each meeting of the JSC, which shall be
circulated to each member of the JSC for review within twenty (20) days after
 each meeting of the JSC.   Minutes will be deemed approved unless any member
of the JSC objects to the accuracy of such minutes by
providing written notice to the other members of the JSC within five (5) days of
receipt of the minutes. In the
event that any such objection is not resolved by the mutual agreement of each
 Party’s members on the JSC, such minutes will be amended to reflect such
unresolved dispute.

 

2.5.5.7       Duration.   The  JSC   shall  remain  constituted  until   the
 Parties mutually agree to disband the JSC.

 

2.5.5.8       Limitations of Powers of the JSC.   The JSC shall not have the
power or authority to amend the Agreement and shall only have those powers that
are specifically delegated to it hereunder.”

 

ARTICLE 2 –  MISCELLANEOUS

 

2.1     Effectiveness. Except  as set forth in this Amendment 4, all of the
terms and
conditions of the Original Agreement are hereby ratified and shall remain in full force and effect.
Amendments made pursuant to this Amendment 4 shall be effective as of the Amendment 4 Effective Date.

 

2.2    Conflicts.   In   the  event  of  a   conflict   between   a   provision
 of  the  Original
Agreement and a provision of this Amendment 4, the provisions of this Amendment 4 will
control to the extent of such  conflict.

 

2.3    Counterparts. This Amendment 4 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 signed or delivered  by facsimile or
 electronically scanned signature page.

 

 

(The remainder of this page has been intentionally left
blank.  The signature page follows.)

 

 

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

 

 

IN WITNESS WHEREOF, the Parties have executed this Amendment 4 to be effective as of the

Amendment 4 Effective Date.

 

 

 

 

MERSANA THERAPEUTICS, INC.

 

 

 

 

 

By :

/s/ Michael Kaufman

 

Name:

Michael Kaufman

 

Title:

SVP, CMC

 

 

 

 

Date:

5/10/2018

 

 

 

 

 

MERCK KGaA

 

 

 

 

 

By :

/s/  Axel Hoffmann

 

Name:

Axel Hoffmann

 

Title:

Director Alliance Management GBD&AM

 

 

 

 

Date:

5/11/2018

 

 

 

 

 

 

 

 

 

By :

/s/ Tobias Greven

 

Name:

Tobias Greven

 

Title:

Head of Legal Business Development

 

 

 

 

Date:

5/15/2018

 

[Signature Page to Third Amendment to Amended and Restated Research
Collaboration and Commercial License Agreement]

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