Exhibit 10.2

CT0078946-05

Certain information marked as [***] has been excluded from this exhibit because
it is both (i) not material and (ii) would be competitively harmful if publicly
disclosed.

 

AMENDMENT NO. 5 TO DEVELOPMENT AND COMMERCIAL LICENSE AGREEMENT

 

This   AMENDMENT   NO.   5   TO   DEVELOPMENT    AND   COMMERCIAL LICENSE

AGREEMENT (this "Amendment"), effective as of September 18, 2019, amends that
certain Development and Commercial License Agreement, effective February 24,
2016 (as  previously amended by that certain Amendment No. 1 to Development and
Commercial License Agreement, effective as of February 24, 2017, that certain
Amendment No. 2 to Development and Commercial License Agreement, effective as of
August 21, 2017, that certain Amendment No. 3 to Development and Commercial
License Agreement, effective as of February 5, 2018, and that certain Amendment
No. 4 to Development and Commercial License Agreement, effective as of May 23,
2018, the "DCLA"), by and among BAXALTA INCORPORATED, a Delaware corporation
with its principal place of business at 1200 Lakeside Drive, Bannockburn, IL
60015 ("BI"), BAXALTA US INC., a Delaware corporation with its principal place
of business at 1200 Lakeside Drive, Bannockburn, IL 60015 ("BUSI"), BAXALTA
GMBH, a company organized under the laws of Switzerland with its principal place
of business at Postfach 8010, Zurich,  Switzerland  ("BGMBH" and, together
jointly  and severally with BI and BUSI, collectively, "Baxalta"), and PRECISION
BIOSCIENCES, INC., a Delaware corporation with its principal place of business
at 302 E Pettigrew St A-100, Durham, NC 27701 ("Precision"). On August 31, 2018,
LES LABORATOIRES SERVIER, a corporation incorporated under the laws of France
having a principal place of business at 50 rue Carnot, 92150 Suresnes,
France  ("LLS") and  INSTITUT  DE RECHERCHES  INTERNATIONALES SERVIER, a
corporation incorporated under the laws of France having its principal place of
business at 50 rue Carnot, 92150 Suresnes, France ("IRIS") (LLS and IRIS
together jointly and severally, "Servier") acquired Baxalta's oncology business,
including the DCLA, and assumed all rights and obligations of Baxalta under the
DCLA, and therefore all references  in the DCLA to Baxalta shall be
deemed  to  refer to Servier, and Precision and Servier may each be referred to
herein individually as a "Party" and collectively as the "Parties." All
capitalized terms not otherwise defined in this Amendment shall have the meaning
set forth in the DCLA.

 

RECITALS

 

WHEREAS, the Parties have determined to modify certain aspects of the role of
the JSC as further described in this Amendment;

 

WHEREAS, the Parties have determined to modify certain Precision reporting
requirements as further described in this Amendment;

 

WHEREAS, the Parties have determined to further extend the date for negotiation
and execution of the CDCP Agreement; and

 

WHEREAS, the Parties desire to amend the DCLA as set forth below in accordance
with Section 17.8 of the DCLA.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual promises and covenants set forth
below and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties agree as follows:

 

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1.

Additional Definitions.The following definitions are hereby added to Article I
of the DCLA, as un-numbered definitions:

 

 

a.

"CMC" means chemistry, manufacturing and controls.

 

 

b.

"Dedicated Regulatory JSC Members" means each Party's members of  the JSC that:
(i) are specifically designated in writing by such Party to review Regulatory
Filings and related submissions; and (ii) do not have access to or any role with
respect to Regulatory Filings or other regulatory submissions for any
genetically engineered human T cells with Chimeric Antigen Receptor(s) based on
a technology other than the Precision Platform Technology.

 

c.

"Dedicated CMC JSC Members" means each Party's members of the JSC that: (i) are
specifically designated in writing by such Party to perform the activities
described in Section 3.1.l(g); and (ii) do not have access to
or  any  role  with respect to any manufacturing and supply
activities  (including any CMC  program or process) for any genetically
engineered human T cells with Chimeric Antigen Receptor(s) based on a technology
other than the Precision Platform Technology.

 

 

d.

"Top Management Expert" means Servier's executive officer  that:  (i)  is
specifically designated in writing by Servier to perform the activities
described in Section 3.l.5A; (ii) has access to or a role with respect to
activities for any genetically engineered human T cells with Chimeric Antigen
Receptor(s) based on a technology other than the Precision Platform Technology;
(iii) has decision­ making authority for all genetically engineered human T
cells with Chimeric Antigen Receptor(s) programs of Servier; and (iv) unless
agreed otherwise by the Parties in accordance with Section 3.1.5A, is only
provided by Servier's JSC members with high level information strictly necessary
to enable such executive officer to provide guidance on or approval of Servier's
JSC members' recommendations, in accordance with Section 3.1.5A.

 

 

e.

"Quarterly Reports" means each quarterly status report delivered  by
Precision  to the JSC within fifteen (15) days after the end of each Calendar
Quarter in accordance with Section 3.1.4, which report will provide summary
updates with respect to such Calendar Quarter regarding the Development status
of each Licensed Product Candidate that is currently subject to a Development
Plan, using the reporting format in Exhibit I.

 

 

 

2.

Amendments   to  Section  2.2.3  of the DCLA.Section 2.2.3 of the DCLA is hereby
amended and restated in its entirety as follows:

2.2.3 Precision shall be solely responsible for, shall use Commercially
Reasonable Efforts to carry out, and shall pay all costs and expenses  incurred
by Precision in carrying out, Development activities for each Licensed Product
Candidate in accordance with the applicable Development Plan (including any fees
and associated costs and expenses for Regulatory Filings to be made by Precision
pursuant to the Development Plans). Precision may subcontract any

 

 

 

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of Precision's Development obligations in the ordinary course of its business
(other than to a CMO or other contract service provider that must be approved
pursuant to Section 6.2) without the JSC's consent  to  the subcontracting of
such obligations, provided that Precision agrees that any subcontractor
(including any contract research organization or CMO) shall be bound by written
obligations consistent with those required under Section 11.1.l(a) and written
obligations of confidentiality and non-use consistent with this Agreement, and
such other provisions to permit Precision  to comply with all the terms and
conditions of this Agreement. Precision shall: (a) inform the JSC of the names
of the applicable subcontractors and provide a description of the applicable
subcontracted activities with respect to (i) the initial Licensed Product
Candidate with respect to CD19 by no later than October 1, 2019 and (ii) any
other Licensed Product Candidate by at least  six (6) months prior to  the
anticipated date of Phase II Ready Status for such Licensed Product Candidate;
and (b) shall thereafter provide reasonably prompt  updates regarding any
additional subcontractors and subcontracted activities. Precision shall remain
responsible for compliance with this Agreement and shall be fully responsible
for any breach of this Agreement by any of its subcontractors.

3.

Amendments to Section 3.1.1 of the DCLA. Each of the applicable subsections of
Section 3.1.1 of the DCLA noted below is hereby amended and restated in its
entirety as follows:

 

(a) reviewing and approving the Development Plan, and in each case through
review of the Quarterly Reports provided by Precision, overseeing and evaluating
implementation of the Development Plan, with respect to each Included Target,
including monitoring progress of preclinical and clinical studies of the
Licensed Product Candidates and Licensed Products and otherwise monitoring
compliance with the Development Plan;

 

(c) through the Dedicated Regulatory JSC Members and under appropriate
protections to restrict access to such information by other JSC members (with
such appropriate protection as to each Party's respective other JSC members
being reasonably determined by such Party), reviewing, commenting on and
approving all Regulatory Filings and other regulatory submissions and all
material correspondence with Regulatory Authorities occurring prior to the
Commercial Option Exercise Date;

 

(g) through the Dedicated CMC• JSC Members and under appropriate protections to
restrict access to such information by other JSC members (with such appropriate
protection as to each Party's respective other JSC members being reasonably
determined by such Party), overseeing manufacture  and supply of pre-clinical
and clinical trial materials necessary for Development of Licensed Product
Candidates through Phase II Ready Batch Success by Precision or its CMO(s) and
reviewing all Changes to the manufacturing process for clinical trial materials
manufactured by Precision or its CMO(s);

 

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4.

Amendments   to  Section  3.1.2  of the DCLA.Section 3.1.2 of the DCLA is hereby
amended and restated in its entirety as follows:

3.1.2Composition; Voting. Within thirty (30) days after the Effective Date, each
Party shall appoint up to seven (7) employees to serve on the JSC, each of which
(a) shall have such expertise as is appropriate to  the activities  of the JSC,
(b) shall not have access to or any role with respect to Development or
Commercialization of any genetically engineered human T cells with Chimeric
Antigen Receptor(s) based on a technology other than the Precision Platform
Technology, provided that Servier's JSC members  shall have the right, subject
to Section 3.1.5A, to refer to their Top Management Expert to obtain guidance on
or approval of Servier's JSC members recommendations on the topics listed in
Section 3.1.1, and (c) shall be subject to approval for membership by the other
Party. Each Party may replace its JSC representatives by written notice to the
other Party and approval by such other Party. Each Party shall have one (1) vote
on all matters and decisions that are within the responsibility of the JSC,
regardless of the number of such Party's representatives on the JSC, and any
decision or other action by the JSC may only be made by unanimous consensus of
the Parties.  The members of the JSC will use good faith efforts to reach
unanimous consensus on all decisions and other actions that are within the
responsibility of the JSC.

5.

Amendments   to  Section  3.1.4  of the DCLA.Section 3.1.4 of the DCLA is hereby
amended and restated as follows:

3.1.4Quarterly Reports: Meetings. Precision shall be responsible for delivering
Quarterly Reports to the JSC regarding the Development status of each Licensed
Product Candidate that is currently subject to a Development Plan in accordance
with the reporting format attached in Exhibit I. For the avoidance of doubt,
Precision shall not be required to include in any Quarterly Report any
information that is subject to limited disclosure within Precision (e.g.,
preliminary clinical trial information known to the Chief Medical Officer but
not generally known within Precision's executive management team). The JSC
shall, after appointment of its initial members, meet at times mutually agreed
upon by the Parties for the purpose of the JSC determining or approving, as
applicable, any of the matters required to be determined or approved by the JSC
pursuant to the terms of this Agreement. For each such meeting, the Parties may
designate a subset of JSC members to attend such meeting based on the topics
anticipated to be discussed in such meeting. The location of the meetings of the
JSC to be held in person shall be agreed upon by the Parties (which may include
the time and sites of major medical conferences attended by both Parties).
Additionally, either Party may request a special meeting of the JSC upon written
notice to the other (and which meeting shall be scheduled promptly at mutually
agreeable times) for the purpose of resolving disputes in connection with any
material matter  within the purview  of the JSC, the resolution of which cannot
reasonably be postponed until the next JSC meeting described above. Each such
special meeting of the JSC shall be convened at such time as may be mutually
agreed upon by the Parties, but in any event shall be held within fifteen (15)
days after delivery of the written

 

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notice described in the immediately preceding sentence. Each Party shall use
reasonable efforts to cause its representatives to attend the meetings of the
JSC. If a representative of a Party is unable to attend a meeting, such Party
may designate an alternate, subject to approval in advance by the other Party,
to attend such meeting in place of the absent representative. Each Party shall
bear all the expenses of its representatives on the JSC. Either Party may invite
personnel of the Parties (other than the members of the JSC) having applicable
expertise to participate in discussions of the JSC from time to time as
appropriate to assist in the activities of the JSC and subject to approval in
advance by the other Party; provided, that neither Party's legal counsel may
attend a JSC meeting without prior notice to the other Party reasonably
sufficient to allow the other Party's legal counsel to attend  or to expressly
waive attendance, and any such non-member shall be (x) bound by confidentiality
and non-use obligations equivalent in scope to those set forth in ARTICLE XII of
this Agreement and (y) under a written obligation  to assign  to the Party
inviting such non-member any inventions of such non-member in the course of or
as a result of attending any such meeting.

6.

Addition of Section 3.l.5A to the DCLA. A new Section
3.l.5A  is  hereby  added  to Article III of the DCLA immediately after Section
3.1.5 and shall read in its entirety as follows:

 

3.1.5A Top Management Expert. Only to the extent that Servier reasonably
determines that it is strictly necessary to enable the Top Management Expert to
provide guidance on or approval of Servier's JSC members' recommendations within
the scope of the JSC's authority,  Servier's  JSC members  may disclose to the
Top Management Expert high level information comprising Precision Confidential
Information disclosed by Precision to Servier's JSC members in accordance with
this Agreement. In no event shall any of Servier's JSC members disclose to the
Top Management Expert or any other Servier personnel, other than Servier's
Dedicated CMC JSC Members, any details of the CMC program or any CMC process,
comprising Precision Confidential Information. Notwithstanding the foregoing,
the Parties may agree in advance upon attendance of a Top Management Expert to
one or more JSC meetings, subject to the final sentence of Section 3.1.4.

 

7.

Amendments to Section 5.1.1 of the DCLA. The second sentence of Section 5.1.1 of
the DCLA is hereby deleted and replaced with the following sentence:

Without limiting the foregoing, Precision shall be responsible for attendance at
all meetings (whether occurring in person or by telephone or other remote means)
with applicable Regulatory Authorities with respect to each such Licensed
Product Candidate; provided that Precision, where permitted by applicable Law,
shall permit or may require Servier to designate up to two (2) Servier Dedicated
Regulatory JSC Members to attend such meetings.

 

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8.

Amendments to Section 7.3.3 of the DCLA. Section 7.3.3 of the DCLA is hereby
amended and restated in its entirety as follows:

 

7.3.3 The key terms of the CDCP Agreement are set forth in Exhibit D. The
Parties will negotiate in good faith a form of CDCP Agreement consistent with
such terms and other terms and conditions that are typical for such agreements
with respect to similarly situated products between similarly situated parties
in the pharmaceutical industry [***], and such form of CDCP Agreement shall be
attached to this Agreement as Exhibit D-1 upon mutual agreement between the
Parties.

 

9.

Discontinuation of Joint Project Team.   The Parties acknowledge and agree that
the joint project team for CD19 is being discontinued in favor of the JSC. Prior
to establishing any joint project teams for additional Licensed Product
Candidates, the Parties shall mutually agree upon the purposes, objectives and
meeting frequency for any new joint project team. Until such new joint project
team is established, the JSC shall retain its authority pursuant to the DCLA to
discuss matters relating to additional Licensed Product Candidates.

 

10.

JSC Meeting. On the effective date of this Amendment, the Parties acknowledge
and agree that [***]

11.

No Other Changes. Except as expressly modified by this Amendment, the DCLA shall
remain unchanged and in full force and effect.  This Amendment shall become a
part of the DCLA as if set forth in full therein, and references to the DCLA
shall be to the DCLA as amended. To the extent of any conflict or inconsistency
between the terms of this Amendment and the DCLA, the terms of this Amendment
shall prevail.

 

12.

Dispute Resolution: Governing Law; Jurisdiction. The Parties acknowledge and
agree that Article XV and Section 17.13 of the DCLA shall apply to this
Amendment as if fully set forth herein.

13.

Counterparts. This Amendment may be executed in more than one counterpart
(including by electronic transmission), each of which shall be deemed an
original, but all of such counterparts taken together shall constitute one and
the same agreement.

 

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment No. 5 to Development
and Commercial License Agreement to be executed by their duly authorized
representatives.

 

For Precision Biosciences , Inc.

 

For Les Laboratoires Servier.

 

 

 

 

 

 

 

By:

 

/s/ Matthew Kane

 

By:

 

/s/ Christian Bazantay

Name:

 

Matthew Kane

 

Name:

 

CHRISTIAN BAZANTAY

Title:

 

CEO

 

Title:

 

Proxy

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Eric Falcand

 

 

 

 

Name:

 

Eric FALCAND

 

 

 

 

Title:

 

Proxy

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For Institut de Recherche Internationales Servier.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

 

 

By:

 

/s/ Dr. Claude Bertrand

Name:

 

Dr Emmanuel CANET

 

 

 

Dr. Claude Bertrand

Title:

 

President R&D

 

 

 

EVP R&D

 

 

 

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EXHIBIT I

[***]

 

8