Amendment 4 to Collaboration and Commercial License Agreement dated May 15, 2018, by and between Mersana Therapeutics, Inc. and Merck KGaA
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. | |
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| By : | /s/ Michael Kaufman |
| Name: | Michael Kaufman |
| Title: | SVP, CMC |
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| Date: | 5/10/2018 |
| MERCK KGaA | |
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| By : | /s/ Axel Hoffmann |
| Name: | Axel Hoffmann |
| Title: | Director Alliance Management GBD&AM |
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| Date: | 5/11/2018 |
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| By : | /s/ Tobias Greven |
| Name: | Tobias Greven |
| Title: | Head of Legal Business Development |
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| Date: | 5/15/2018 |
[Signature Page to Third Amendment to Amended and Restated Research Collaboration and Commercial License Agreement]