Exhibit 10.2
 

AMENDMENT N° 1 TO THE
 
COLLABORATION AGREEMENT
 

 
BY AND BETWEEN

 
PHARMACYCLICS, INC.,
 

 
AND

 

 
LES LABORATOIRES SERVIER
AND
INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
 
 
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This Amendment No. 1 to Collaboration Agreement (“Amendment 1”) is entered into
as of January 5, 2012 (the “Amendment Effective Date”) by and between
Pharmacyclics, Inc., a corporation organized under the laws of the State of
Delaware, U.S.A., having offices at 995 East Arques Avenue, Sunnyvale,
California 94085, United States of America, (“Pharmacyclics”), Les Laboratoires
Servier, a company organized under the laws of France, having offices at 50 rue
Carnot, 92150 Suresnes, France (“Servier”) and Institut de Recherches
Internationales Servier, a company organized under the laws of France, having
offices at 6, Place des Pléiades, 92415 Courbevoie.  Pharmacyclics and and
Servier are sometimes referred to herein individually as a “Party” and
collectively as the “Parties.”

- Whereas, the Parties have signed a Collaboration agreement (hereinafter the
“Agreement”) on April 9th, 2009;

- Whereas the Parties wish to amend SEVERAL TERMS AND CONDITIONS OF THE
AGREEMENT as indicated below;

IN WITNESS THEREOF THE PARTIES HAVE AGREED AS FOLLOWS.

ARTICLE 1

1.           Section1.14 of the Agreement is hereby deleted in its entirety and
superseded as follows: “Combination Product” means a product that contains a
Licensed Product and either :

 
a)
a Pharmacyclics Combination Product (s); or

 
b)
a Servier Combination Product (s); or

 
c)
a Third Party Combination Product(s).

2.           Section 1.45 of the Agreement is hereby deleted in its entirety and
superseded as follows:

“Licensed Product(s)” means any pharmaceutical preparation in final form (or,
where the context so indicates, the form under development) containing a
Collaboration Compound as a primary active therapeutic ingredient.

3.           Section 1.81 of the Agreement is hereby deleted in its entirety and
superseded as follows:

“Servier Patent Rights” means any Patent Right Controlled by Servier before or
during the Term and necessary or useful to Manufacture, have Manufactured, use,
sell, have sold, import and export Licensed Products and Combination Products,
including Servier’s interest in Joint Patents.
 
 
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Three new definitions are inserted as follows:

“Pharmacyclics Combination Product(s)” means a product that contains a Licensed
Product and one (1) or more Active Component(s) Controlled by Phamacyclics.

“Servier Combination Product(s)” means a product that contains a Licensed
Product and one (1) or more Active Component(s) Controlled by Servier.

“Third Party Combination Product(s)” means a product that contains a Licensed
Product and one (1) or more Active Component(s) Controlled by a Third Party.

ARTICLE 2

1.           Article 2 shall be deleted in its entirety and superseded as
follows:

2.1           Joint Steering Committee.
 
(a)           Establishment.  Within fifteen (15) Business Days after the
Amendment Effective Date, the Parties shall establish a joint steering committee
(the “Joint Steering Committee” or “JSC”) to manage the overall Collaboration
and resolve any disputed matter of the JRDC all in accordance with this Section
2.1.  Each Party shall initially appoint at least three (3) representatives to
the JSC.  The JSC membership and procedures are further described in Section
2.3.
 
(b)           Specific Responsibilities of the JSC.  The JSC shall in
particular, in accordance with the decision-making principles set forth in
Section 2.4:
 
(i)            coordinate the activities of the Parties under this Agreement,
including facilitating communications between the Parties with respect to the
research, development and Manufacture of the Collaboration Compound(s) and the
Licensed Product;
 
(ii)           provide a forum for discussion of the research,
development,  Manufacture , registration and commercialization of the
Collaboration Compound(s) and the Licensed Product;
 
(iii)          review and discuss the Research Program, the Research Plan and
the Development Plans and associated  budgets and any annual or interim updates
and proposed amendments thereto;
 
(iv)          direct and oversee the JRDC and any other operating committee
established by the JSC, on all significant issues that fall within the purview
of such committees;
 
(v)           attempt to resolve issues presented to it by, and disputes within,
the other Committees, including the JRDC, in accordance with Section 2.4; and
 
(vi)          perform such other duties as are expressly assigned to the JSC in
this Agreement, and perform such other functions as appropriate to further the
purposes of this Agreement as may be allocated to it by written agreement of the
Parties.
 
 
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2.2           Joint Research and Development Committee.
 
(a)           Establishment.  Within fifteen (15) Business Days after the
Amendment Effective Date, the Parties shall establish a joint research and
development committee (the “Joint Research and Development Committee” or “JRDC”)
to monitor the implementation of the Research Program and to exchange their
views over the development of the Collaboration Compound(s), the Licensed
Product under this Agreement.  Each Party shall initially appoint at least three
(3) representatives to the JRDC.  The JRDC membership and procedures are further
described in Section 2.3.
 
(b)           Specific Responsibilities of the JRDC.  The JRDC shall in
particular, in accordance with the decision-making principles set forth in
Section 2.4:
 
(i)            coordinate the activities of the Parties under and oversee the
implementation of the Research Program, under the Research Plan, and prepare
annual and interim updates to the Research Program;
 
(ii)           review and discuss the development activities of the Parties,
including the Development Plans;
 
(iii)          provide a forum for and facilitate communications between the
Parties with respect to the research and development of the Collaboration
Compound(s) and Licensed Product;
 
(iv)          review and discuss the Data and results generated under the
Research Program;
 
(v)           coordinate the exchange of Data between the Parties;
 
2.3           General Committee Membership and Procedures.
 
(a)           Membership.  Each of Servier and Pharmacyclics shall designate
representatives with appropriate expertise to serve as members of each
Committee, and each representative may serve on more than one Committee as
appropriate in view of the individual’s expertise.  Each Party may replace its
Committee representatives at any time upon written notice to the other Party. 
Each Committee shall have co-chairpersons.  Servier and Pharmacyclics shall each
select from their representatives a co-chairperson for each of the Committees,
and each Party may change its designated co-chairpersons from time to time upon
written notice to the other Party.  The co-chairpersons of each Committee shall
be responsible for calling meetings and preparing and circulating meeting
agendas and minutes, but the co-chairpersons shall have no additional powers or
rights beyond those held by other Committee members.
 
(b)           Meetings.  Each Committee shall hold meetings at such times as it
elects to do so, provided that unless the Parties otherwise agree in writing to
a different frequency for such meetings, each Committee shall meet at least
twice each calendar year, and provided further that the Parties shall, to the
extent practicable, schedule meetings of different Committees on the same day
and in the same location.  Either Party may also call a special meeting of a
Committee (by videoconference or teleconference) by at least fifteen (15)
Business Days prior written notice to the other Party in the event such Party
reasonably believes that a significant matter must be addressed prior to the
next regularly scheduled meeting, and such Party shall provide the applicable
Committee no later than fifteen (15) Business Days prior to the special meeting
with materials reasonably adequate to enable an informed decision.  No later
than five (5) Business Days prior to any Committee meeting, the co-chairpersons
of such Committee shall prepare and circulate an agenda for such meeting;
provided, however, that either Party may propose additional topics to be
included on such agenda, either prior to or in the course of such meeting.  Each
Committee may invite non-members (including consultants and advisors of a Party
who are under an obligation of confidentiality consistent with this Agreement)
to participate in its meetings, provided that such non-member participants shall
have no voting authority at such meetings.  Each Committee may meet in person,
by videoconference or by teleconference, provided however, at least one (1)
meeting of each Committee per calendar year shall be in person unless the
Parties mutually agree in writing to waive such requirement in lieu of a
videoconference or teleconference.  In-person Committee meetings shall be held
alternately in Sunnyvale, California, U.S. and Paris, France.  Each Party shall
bear the expense of its respective Committee members’ participation in Committee
meetings.  Committee meetings shall be effective only if at least one (1)
representative of each Party is present or participating in such meeting.  The
co-chairpersons of a Committee shall be responsible for preparing reasonably
detailed written minutes of all meetings of such Committee that reflect, without
limitation, all material decisions made at such meetings.  The co-chairpersons
shall send draft meeting minutes to each member of such Committee for review and
approval promptly after each Committee meeting.  Such minutes shall be deemed
approved unless one or more members of such Committee objects to the accuracy of
such minutes within thirty (30) days of receipt.
 
 
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2.4           Decision Making.
 
(a) Within JSC and Operating Committees.  All decisions within the JSC, JRDC, or
any other operating Committee shall be made by consensus, with the
co-chairperson from each Party having each one (1) vote.  If a dispute arises
which cannot be resolved within any Committee other than the JSC, the
representatives of either Party may cause such dispute to be referred to the JSC
for resolution. If after reasonable discussion and good faith consideration of
the other Party’s views on a particular matter before the JSC, including any
disputes referred to the JSC by another Committee, the JSC is still unable to
reach a unanimous decision on such matter for a period of fifteen (15) days,
then either Party may upon notice to the other Party, refer such matter to the
executive officers (or their representatives) of the Parties for attempted
resolution by good faith negotiations within thirty (30) days after such notice
is received, including at least one (1) in person meeting within twenty (20)
days after such notice is received.  If the Executive Officers (or their
representatives) are not able to resolve such disputed matter within thirty (30)
days and either Party wishes to pursue the matter, then such matter may be
referred to arbitration as indicated in Section 12.2.2.
 
(b)           Exceptions. Notwithstanding the preceding Section 2.4(a), any and
all decision regarding the development of the Licensed Product in the Territory
shall be taken solely by Servier, Pharmacyclics being only entitled to give
advices to Servier via the Committees.
 
 
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(c)           Limitations of Committee Authority.  Each Committee shall have
solely the powers expressly assigned to it in this Article 2 and elsewhere in
this Agreement or as otherwise agreed to by the Parties in writing.  A Committee
shall not have any power to amend, modify, or waive compliance with the terms of
this Agreement.  It is expressly understood and agreed that the control of
decision-making authority by Pharmacyclics or Servier, as applicable, pursuant
to this Section 2.4, so as to resolve a disagreement or deadlock on a Committee
or between the executive officers for any matter will not authorize either Party
to unilaterally modify or amend, or waive its own compliance with, the terms of
this Agreement.
 
(d)           Good Faith.  In conducting themselves on Committees, and in
exercising their rights under this Section 2.4, all representatives of both
Parties shall consider, reasonably and in good faith, all input received from
the other Party, and shall use reasonable efforts to reach consensus on all
matters before them. Notwithstanding anything to the contrary in this Agreement,
neither Party nor any of its Affiliates shall be required to take, or shall be
penalized for not taking, any action that is not in compliance with such Party’s
ethical business practices and policies or that such Party reasonably believes
is not in compliance with applicable Laws.
 
ARTICLE 3

1.           The third sentence of Section 4.2 of the Agreement is hereby
amended by replacing the words “commercialization of Products in the Territory”
with the words “commercialization of Licensed Products and Combination Products
in the Territory.”

2.           The fifth sentence of Section 4.2 is amended by replacing the words
“useful for registration and commercialization of Licensed Products outside the
Territory” with the words “useful for development, Manufacture, registration,
promotion, distribution, and commercialization of Licensed Products and
Combination Products in connection with seeking and obtaining Regulatory
Approval outside the Territory and/or commercialization outside the Territory,
and/or as is necessary or useful to exercise the rights or practice the licenses
granted in Section 6.1.3.”

ARTICLE 4

1.           Section 6.1.3 of the Agreement is hereby deleted in its entirety
and superseded as follows:

“Development and Commercialization License to Pharmacyclics.  Subject to the
terms and conditions of this Agreement, Servier hereby grants to Pharmacyclics a
fully-paid, royalty free, exclusive right and license, with the right to grant
sublicense rights, under the Servier IP to develop, have developed, make, have
made, use, have used, import, offer for sale, lease, market, sell, and have sold
Licensed Products, Collaboration Compounds (whether or not in final form), and
Pharmacyclics Combination Products outside the Territory.   Notwithstanding the
foregoing and the licenses granted to Servier in Section 6.1.1 above,
Pharmacyclics retains a nonexclusive right under the Pharmacyclics IP to, and
Servier hereby grants to Pharmacyclics a fully-paid, royalty free, nonexclusive
right and license, with the right to grant sublicense rights, under the Servier
IP to directly, or through others, Manufacture Collaboration Compounds (whether
or not in final form), Pharmacyclics Combination Products or Licensed Products
in the Territory.  Notwithstanding the foregoing, Pharmacyclics agrees that it
will not conduct human clinical trials of any Collaboration Compounds, Licensed
Products or Pharmacyclics Combination Products in the Territory without first
obtaining Servier’s written consent.
 
 
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2.           Section 6.2 of the Agreement is hereby amended by insertion of the
words “within the Territory” at the end of the first sentence of such section.

3.           A new section 6.1.5 is inserted as follows:

Third Party Combination Product(s).  Should either Party decide to develop a
Third Party Combination Product, the Parties will discuss the possibility and
the terms and conditions upon which the other Party can be granted a license on
the Third Party Patents and Know-How necessary or useful to exploit the Third
Party Combination Product(s) in its territory.

ARTICLE 5

1.           Article 8.5 shall be deleted in its entirety and superseded as
follows :

Publication and Communication

Prior to the disclosure of any abstracts, press release or communication to
shareholders that includes Data or other information relating to the
Collaboration Compounds or a Licensed Product that has not been previously
disclosed, the Party willing to disclose (hereinafter the “Disclosing Party”)
such shall provide the other Party a copy thereof for its review and approval
for at least seven (7) Business Days before the intended day of disclosure. The
Disclosing Party shall take in good faith consideration the comments received
from the other Party.

For any other type of disclosure (such as but not limited to scientific
communication, publications, etc) that includes Data or other information
relating to the Collaboration Compounds or a Licensed Product that has not been
previously disclosed (each, a “Publication”), the Party proposing such
Publication shall provide the other Party a copy thereof for its review for at
least thirty (30) Business Days unless such Party is required by law to publish
such information sooner.  Such Party shall consider in good faith any comments
provided by the other Party during such period.  In addition, the Party
proposing such Publication shall, at the request of the other Party, remove any
Confidential Information of the other Party therefrom, except each Party shall
have the right to publicly disclose any information, including Confidential
Information, pertaining to safety of a Licensed Product that such Party believes
in good faith it is obligated to disclose.  Without limiting the foregoing, it
is understood that the principles to be observed in any disclosures described in
this Article 8.5 shall be accuracy, compliance with applicable law and
regulatory guidance documents, reasonable sensitivity to potential negative
reactions of the FDA (and its foreign counterparts).  Accordingly, any comments
provided by the other Party on a disclosure submitted to it by the publishing
Party pursuant to this Article and/or any requests for any Confidential
Information to be removed from any such disclosure shall comply with such
principles.  The contribution of each Party shall be noted in all Publications
by acknowledgment or co-authorship, whichever is appropriate.
 
 
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ARTICLE 6

1.           Article 11.6.4. shall be deleted in its entirety and superseded as
follows :

11.6.4.                      Licenses to Data, Confidential Information and
Trademarks. In case of a termination of this Agreement by Pharmacyclics on the
basis of Section 11.3 and 11.4, or by Servier on the basis of Section 11.2 or
11.5 the following shall apply:

(a)           Pharmacyclics shall have a perpetual, fully paid-up, royalty-free
non-exclusive license, which includes the right to sublicense, under the Servier
IP (including any Data and Confidential Information of Servier) to develop,
Manufacture, have Manufactured, use, promote, market, sell, offer for sale,
import, export and otherwise commercialize the Licensed Product, Collaboration
Compounds (whether or not in final form) and Pharmacyclics Combination Products,
outside the Territory, and, if the Data does not include the results of a Phase
III Clinical Trial financed by Servier, inside the Territory.

(b)           In the event that the above mentioned Data includes the results of
a Phase III Clinical Trial financed by Servier, Pharmacyclics shall have a
royalty-bearing (the amount of such royalty to be negotiated in good faith by
the Parties) exclusive license, which includes the right to sublicense, under
the Servier IP (including any Data and Confidential Information of Servier) to
develop, Manufacture, have Manufactured, use, promote, market, sell, offer for
sale, import, export and otherwise commercialize the Licensed Product,
Collaboration Compounds (whether or not in final form) and Pharmacyclics
Combination Products in the Territory.
ARTICLE 7

A new section 13.17 is hereby inserted as follows:

If a Party is entitled to attorney-client or attorney work product privileges
from disclosure established under public policy provisions, such privileges
shall apply and may be invoked by the other Party.

ARTICLE 8

Any and all stipulations of the Agreement not modified herein shall remain in
full force and effect.
 
 
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In Witness whereof the Parties have executed this Agreement by their proper
officers as of January 5, 2012 (the “Amendment Effective Date”).

PHARMACYCLICS INC
LES LABORATOIRES SERVIER
                       
Robert DUGGAN
Christian BAZANTAY
Chairman and CEO
Proxy
                         
INSTITUT DE RECHERCHES
 
INTERNATIONALES SERVIER
                     
Emmanuel CANET
 
President R&D

 
 
 
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