EXHIBIT 10.56

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24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

EXHIBIT A

FIRST AMENDMENT AND SUPPLEMENT (“this Amendment”) dated as of November 15, 2005
to the DEVELOPMENT AND LICENSING AGREEMENT (“the Original Agreement” and, as
amended and supplemented by this Amendment, “the Agreement”) dated as of
September 27, 1996, by and between GILEAD SCIENCES, INC., a Delaware Corporation
(“Gilead”), on the one hand, and F. HOFFMANN-LA ROCHE LTD, a corporation
organized under the laws of Switzerland, and HOFFMANN-LA ROCHE INC., a
corporation organized under the laws of New Jersey, on the other hand
(collectively “Roche”). Capitalized terms used but not defined herein shall have
the meanings assigned them in the Original Agreement.

WHEREAS pursuant to the Original Agreement Gilead granted to Roche and its
Affiliates, among other things, a sole and exclusive worldwide license under
certain intellectual property rights only for the manufacture, importation, use,
sale and offer for sale of Products for any and all uses on the terms set forth
therein;

WHEREAS pursuant to a Settlement Agreement and Release executed by the parties
as of the date hereof (“the Settlement Agreement”) the parties have resolved all
disputes that have arisen under the Original Agreement and have agreed to
execute this Amendment;

NOW, THEREFORE, in consideration of the foregoing premises and the covenants and
obligations set forth in this Amendment, the parties hereby agree as follows:

Section 1. Amendment of Original Agreement.

(a) Deletion Of Redundant Provision. Article 4 of the Original Agreement is
hereby amended by deleting Section 4.4 of the Original Agreement in its entirety
and substituting therefor the word “Reserved”.

(b) Elimination Of Cost Of Goods Sold Adjustment. Article 5 of the Original
Agreement is hereby amended by deleting Section 5.3(d) of the Original Agreement
in its entirety and substituting therefor the word “Reserved.” Notwithstanding
anything in the Original Agreement to the contrary, no pending or future Royalty
payments to be made by Roche to Gilead under the Agreement shall be subject to
any reduction relating to any “COGS Adjustment Amount” and Gilead shall not be
entitled to any recovery relating to any “COGS Adjustment Amount”.

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(c) Modification of Royalty Payment Schedule: Article 5 of the Original
Agreement is hereby amended by replacing 5.3(b) with the following: “Roche shall
pay Gilead the Royalty owing to Gilead at the rates set forth in section 5.3(a)
of the Original Agreement. By way of example, if, in the calendar year 2006,
Roche’s total calendar 2006 Net Sales is equal to $700 million, and the fourth
quarter of calendar 2006 Net Sales is equal to $150 million, the total Royalty
Payment from Roche to Gilead related to Net Sales in the fourth quarter of
calendar 2006 shall equal $33 million (22% of $150 million). And if, in the
first quarter of calendar 2007, Net Sales is equal to $250 million, then the
Royalty Payment from Roche to Gilead related to Net Sales in the first quarter
of calendar 2007 shall equal $37 million (14% of the first $200 million, and 18%
of the next $50 million).”

Section 2. Sale and Purchase of shikimic acid: Roche agrees to purchase from
Gilead, and Gilead agrees to sell to Roche, a specific quantity of shikimic acid
as set out in Attachment 1 (the “shikimic acid”) for a total purchase price of [
* ] (the “Purchase Price”) and on the following terms: (i) Gilead shall deliver
the shikimic acid to Roche to the location or locations specified by Roche to
Gilead, as soon as reasonably practicable and no later than [ * ] after the date
of this Amendment; (ii) together with delivery of the shikimic acid, Gilead
shall provide to Roche certificates of analysis and samples to determine
usability in respect of each batch of the shikimic acid; (iii) Roche shall pay
Gilead the Purchase Price within [ * ] of delivery of the shikimic acid; and
(iv) Gilead warrants to Roche that the shikimic acid shall be useable and free
from defects [ * ].

Section 3. Communication Regarding Public Health Initiatives.

(a) Coordination of Communications. Roche shall through the Commercial Working
Group (as defined in Section 6(f)) use its good faith reasonable efforts to keep
Gilead reasonably informed of Roche’s key message points and communications
strategies regarding the Product and Product positioning, and Roche shall
consider in good faith Gilead’s input and comment regarding such message points
and strategies. Gilead shall use its good faith reasonable efforts to ensure
that its public communications are consistent with such message points and
strategies, including with respect to (i) engaging in public health initiatives
relating to the Product and other educational initiatives relating to the
Product for the medical and scientific communities, (ii) developing and
discussing treatment guidelines and protocols relating to the Product and
(iii) communicating with public health advocates on scientific and medical
matters relating to the Product.

 

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(b) Roche’s Exclusive Right to Communicate with Regulatory and Governmental
Authorities. Roche retains the exclusive right under the Original Agreement to
sell, offer for sale and otherwise promote the Product to potential government
purchasers in the United States and around the world, and has the exclusive
right to communicate with governmental and regulatory authorities (including the
FDA) regarding regulatory and commercial issues (including governmental licenses
and/or approvals to market the Product) associated with the Product. Roche
understands, however, that Gilead will be communicating with government
agencies, public officials and members of the public health, medical and
scientific communities in the course of carrying out the types of activities
described in the final sentence of Section 1(a) above.

Section 4. Coordination With Respect To Voluntary And Compulsory Licensing.

(a) General Strategy. The parties shall collaborate and attempt in good faith to
develop and review on an ongoing basis a strategy for responding to threats of
compulsory licensing of the Product and for related requests by Third Parties
for sublicenses to make, use and sell the Product under circumstances other than
normal commercial circumstances (a “Voluntary License”). Such collaboration
shall be arranged through representatives from each party who shall be
designated by Roche and Gilead in writing. Nothing in this Amendment shall
affect Roche’s pre-existing right to grant sub-licenses under Article 2 of the
Original Agreement.

(b) Communication with Gilead. Gilead acknowledges that Roche will be
responsible for responding to requests for Voluntary Licenses and for
communications with governments regarding compulsory licensing of the Product.
Each party shall use reasonable efforts to inform the other through its
designated representative as to material developments regarding Voluntary
License proposals and threats of compulsory licensing. In addition, each party
will use reasonable efforts to respond to requests from the other for
information regarding such proposals and threats.

(c) Voluntary Licensing Proposals. Any proposal by Roche to grant a Voluntary
License shall be presented promptly to Gilead for review. The parties will work
together promptly in good faith to reach agreement as to such proposal. Gilead
shall advise Roche of its agreement or objection to Roche’s proposal (including
the reasons for any objections) within [ * ] of the notice by Roche. Any
disagreement with respect to such a proposal (a “Voluntary License Dispute”)
will be resolved promptly through the applicable dispute resolution

 

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procedures set forth in Sections 10(e) and 11 hereof. A Voluntary License to
which Gilead has consented in writing or to which the arbitrator has determined,
prior to its issuance, is not unreasonable shall be referred to as an
Apportioned License.

(d) Apportionment of Licensing Consideration. Consideration, if any, paid by the
licensee under either an Apportioned License or compulsory license of the
Product shall be shared 50% by Roche and 50% by Gilead, and any sales by Third
Parties under any such licenses (and the related payments under this clause (d))
[ * ].

Section 5. Joint Manufacturing Committee.

(a) Formation of Committee. Gilead and Roche shall form a Joint Manufacturing
Committee (“the Manufacturing Committee”) with two representatives designated by
Gilead and two representatives designated by Roche. The initial representatives
to the Manufacturing Committee from each party are set forth in Schedule 5(a).
Either party may replace its representatives at any time upon written notice to
the other party, provided such replacement representative is of similar status
and authority as the representative being replaced.

(b) Responsibilities of the Manufacturing Committee. The Manufacturing Committee
shall be responsible for (i) reviewing Roche’s existing worldwide capacity for
Product manufacture currently in place and plans for the expansion of such
capacity consistent with Roche’s obligations under the Agreement; and
(ii) considering and evaluating Roche’s global plans for manufacturing the
Product (“Roche’s global manufacturing plans”) consistent with Roche’s
obligations under the Agreement. The Manufacturing Committee shall also review
Roche’s efforts to make process improvements such as improvements in equipment
throughput and yield efficiencies. Roche shall provide Gilead with a report on
Roche’s global manufacturing plan reasonably in advance of each scheduled
meeting of the Manufacturing Committee, and in any event at least [ * ] in
advance of the meeting, which report shall include information about current and
anticipated manufacturing requirements and capacity, sources of supply, and
process improvements such as improvements in equipment throughput and yield
efficiencies with respect to the Product (inclusive of raw materials and
intermediates).

(c) Procedures of the Manufacturing Committee. The Manufacturing Committee shall
meet in person on a quarterly basis for the first two years following the
execution of this Amendment, and thereafter on a semi-annual basis, and shall
attempt in good faith to reach consensus on all issues. Meetings

 

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of the Manufacturing Committee shall be held in [ * ], with [ * ] meetings held
in [ * ] and the [ * ] meeting held in [ * ]. The first meeting shall be held in
[ * ]. In the event that the Gilead representatives disagree with Roche’s plans
or any aspect thereof, Gilead shall have the right to appeal the determination
of the Roche representatives through the applicable dispute resolution
procedures set forth in Sections 9 and 10 of this Amendment. Each of Gilead and
Roche may advise the other if it desires the agenda for any meeting of the
Manufacturing Committee to include reasonable topics beyond those which are
evident from the report submitted to it in advance by the other. Each party
shall supply to the other any information related to Product manufacture which
is reasonably requested by the other party, without placing undue burden on the
supplying party consistent with the responsibilities of the Manufacturing
Committee.

(d) Formation of Manufacturing Working Group; Informal Communications. In
addition to forming the Manufacturing Committee, Gilead and Roche shall each
appoint three individuals to a Manufacturing Working Group. The initial
representatives to the Manufacturing Working Group from each party are set forth
in Schedule 5(d). Either party may replace its representatives at any time upon
written notice to the other party, provided such replacement representative is
of similar status and authority as the representative being replaced. The
Manufacturing Working Group shall meet on a regular basis to exchange
information regarding the development of Roche’s global manufacturing plan,
activities and progress under such plan (such as reviewing existing inventory
levels versus current demand forecasts) and manufacturing issues related to the
Product. Meetings of the Manufacturing Working Group (“Manufacturing Working
Group Meetings”) shall be held on such schedule as the members of such working
group may jointly agree, provided, however, that each of Gilead and Roche shall
make its representatives available to participate in Manufacturing Working Group
Meetings at least once per month, for meetings of at least two hours in length.
Each party may provide agenda items to the other party in advance of each
meeting of the Manufacturing Working Group. Manufacturing Working Group Meetings
shall be held by telephone or video conference unless the Gilead and Roche
representatives mutually agree otherwise.

Section 6. U.S. Commercial Committee.

(a) Formation of Committee. Gilead and Roche shall form a U.S. Commercial
Committee (“the Commercial Committee”) with two representatives designated by
Gilead and two representatives designated by Roche. The initial representatives
to the Commercial Committee from each party are set forth in Schedule 6(a).
Either party may replace its representatives at any time upon written notice to
the other party, provided such replacement representative is of similar status
and authority as the representative being replaced.

 

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(b) Responsibilities of the Commercial Committee. The Commercial Committee shall
be responsible for considering and evaluating Roche’s commercial plans and
strategies for the Product in the United States (“Roche’s U.S. commercial
plans”) consistent with Roche’s obligations under the Agreement. The Roche U.S.
commercial plans shall consist of the “plan of action” used by Roche for its
internal planning purposes, which shall address in reasonable detail at least
the topics identified on Attachment 2 to this Amendment. Roche shall provide
Gilead with a report on Roche’s U.S. commercial plans reasonably in advance of
the scheduled pre-season meeting of the Commercial Committee, and in any event
at least [ * ] in advance of the meeting. Nothing in this Amendment shall in any
way affect or modify Roche’s exclusive rights under Article 7.1 of the Original
Agreement.

(c) Marketing Presentations. The Commercial Committee shall meet in person twice
per year [ * ]. One meeting shall be a “pre-season meeting” to be held early in
[ * ]. Roche shall use its reasonable efforts to deliver to Gilead at least [ *
] in advance of such meeting a copy of the U.S. marketing “plan of action” used
by Roche for its internal planning purposes, which shall set forth at least the
information described above with respect to Roche’s U.S. commercial plans, and
such plan of action shall include an analysis assessing in reasonable detail
U.S. sales and marketing progress against the activities and targets set forth
in the prior year’s plan. The other meeting shall be a mid-season review to be
held early in [ * ]. The mid-season review shall among other things assess U.S.
sales and marketing progress against the activities and targets set forth in the
pre-season plan. Roche shall present to Gilead at least [ * ] in advance of such
mid-season meeting a report setting forth in reasonable detail such progress
against the pre-season plan.

(d) Utilization of Gilead’s Sales Force. Gilead shall have the option to provide
a specialized sales force of no more than 200 representatives (e.g. a specialty
sales force such as pediatrics) to supplement Roche’s marketing efforts in the
United States for the Product as provided in this paragraph (the actual number
of representatives at Gilead’s election up to 200). Gilead may exercise such
option by providing written notice to Roche which shall include Gilead’s
determination of appropriate sales force involvement. The Commercial Committee
shall determine the appropriate type of specialty sales force that will be
utilized; including determining, in good faith, which type of sales force would
most effectively enhance sales of the Product. In doing so, the Commercial
Committee will seek to avoid duplication or overlap with the sales efforts of
Roche’s U.S. sales force or its contract sales organizations. If the Commercial
Committee cannot avoid duplication or overlap, it will seek to minimize such
duplication or overlap. The Commercial Committee may not, without Gilead’s
written consent, reduce the number of representatives elected by Gilead. The

 

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parties will negotiate reasonable fee-for-service compensation based on such
Gilead sales force achieving agreed-upon activity levels (such as the number of
details performed). Such fee-for-service compensation shall be in addition to
the royalties payable under the Agreement. In the event Gilead exercises such
option, the parties shall promptly negotiate in good faith a definitive
co-promotion agreement giving effect to the foregoing and containing such other
commercially reasonable, arm’s length terms consistent with the foregoing as are
customary in the industry for the promotion of pharmaceutical products. Upon the
execution and delivery of such definitive agreement, this sub-section (d) shall
be superseded by such definitive agreement.

(e) Procedures of the Commercial Committee. The Commercial Committee shall
attempt in good faith to reach consensus on all issues. In the event that the
Gilead representatives disagree with Roche’s U.S. commercial plans or any aspect
thereof or with the Commercial Committee’s determination of the appropriate
involvement of the Gilead specialty sales force, Gilead shall have the right to
appeal the determination of the Roche representatives through the applicable
dispute resolution procedures set forth in Sections 9, 10 and 11 of this
Amendment. Gilead may advise Roche if it desires the agenda for any meeting of
the Commercial Committee to include reasonable topics beyond those which are
evident from the report submitted to it in advance by Roche.

(f) Formation of U.S. Commercial Working Group; Informal Communications. In
addition to forming the Commercial Committee, Gilead and Roche shall each
appoint two individuals to a U.S. Commercial Working Group (the “Commercial
Working Group”). The initial representatives to the Commercial Working Group
from each party are set forth in Schedule 6(f). Either party may replace its
representatives at any time upon written notice to the other party, provided
such replacement representative is of similar status and authority as the
representative being replaced. The Commercial Working Group shall meet on a
regular basis to exchange information regarding the development of Roche’s U.S.
commercial plans and coordination between Gilead and Roche in the event Gilead
exercises its option in Section 6(d). Meetings of the Commercial Working Group
(“Commercial Working Group Meetings”) shall be held on such schedule as the
members of such working group may jointly agree, provided, however, that each of
Gilead and Roche shall make its representatives available to participate in
Commercial Working Group Meetings at least once per month, for meetings of at
least two hours in length. Commercial Working Group Meetings shall be held by
telephone or video conference unless the Gilead and Roche representatives
mutually agree otherwise.

Section 7. Gilead Participation In Life Cycle Team. Gilead shall be entitled to
designate a representative to become a core member of Roche’s Life

 

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Cycle Team with respect to the Product. Roche shall in good faith provide the
Gilead representative with access to information regarding the Product provided
to other core members of the Life Cycle Team for purposes of Life Cycle Team
Meetings, including any materials relating to the Product that are referred to
or discussed in Life Cycle Team meetings; excluding in each case as to matters
that Roche reasonably and in good faith believes are proprietary business
secrets unrelated to the Product, legal opinions or other privileged materials.
The Gilead representative shall be entitled to participate in all Life Cycle
Team meetings and phone calls, provided, however that Roche shall have no
obligation to schedule team meetings or phone calls around the availability of
the Gilead representative. Through the Life Cycle Team, Roche and Gilead shall
in good faith coordinate with respect to Gilead’s participation in relevant
global scientific advisory committees pertaining to the Product.

Section 8. Joint Supervisory Committee.

(a) Formation of Committee. Gilead and Roche shall form a Joint Supervisory
Committee (“the Joint Supervisory Committee”) with three representatives
designated by Gilead and three representatives designated by Roche. The initial
representatives to the Joint Supervisory Committee from each party are set forth
in Schedule 8(a). Either party may replace its representatives at any time upon
written notice to the other party, provided such replacement representative is
of similar status and authority as the representative being replaced.

(b) Responsibilities of the Joint Supervisory Committee. The Joint Supervisory
Committee will consider and evaluate Roche’s overall commercial plans for the
Product on a global basis (“Roche’s global commercial plan”). The Joint
Supervisory Committee shall also seek to resolve any disputes of the
Manufacturing Committee or Commercial Committee referred to it pursuant to
Section 9 of this Amendment. Roche shall provide Gilead with Roche’s global
commercial plans reasonably in advance of each meeting of the Joint Supervisory
Committee, and in any event at least [ * ] prior to the meeting, which plans
shall include historical and budgeted promotional spending levels, sales force
activities, sales force size, major marketing activities, commercialization
strategies, pricing strategies, forecasts and marketing analyses, in each
Specified Market and Japan. Such plans shall also set forth Roche’s activities,
plans and budgets with respect to government sales and pandemic planning. In
reviewing and evaluating Roche’s global commercial plans, Gilead recognizes that
activities in Japan for the Product are conducted through a majority-owned
subsidiary of Roche acting under a sublicense, and that Roche’s access to
information and control of activities in that country are more limited than
elsewhere in the world. Nothing in this Amendment shall in any way affect or
modify Roche’s exclusive rights under Article 7.1 of the Original Agreement.

 

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(c) Spending Levels For Seasonal Sales in Specified Markets. The Joint
Supervisory Committee shall review Roche’s annual budget for aggregate spending
in Specified Markets on promotional, marketing and sales activities for the
Product related to Seasonal Sales. As used herein, the “Specified Markets” shall
mean the 10 countries comprising the top 10 commercial markets for the Product
(excluding Japan). “Seasonal Sales” shall mean sales of the Product during
influenza season, excluding purchases and stockpiling by governmental or
regulatory authorities and Third Parties for pandemic planning.

(d) Budgeting. Roche’s ordinary course accounting and budgeting processes,
procedures and calculations shall be utilized for all purposes under this
Amendment. The parties acknowledge that the amount actually spent by Roche on
marketing, promoting and selling the Product in Specified Markets may,
consistent with Roche’s Best Efforts obligations under the Original Agreement,
vary from the budgeted amount based upon circumstances that arise during the
year or matters not otherwise within the reasonable control of Roche; it being
understood and agreed that (i) any variance from budget of less than 10% of the
aggregate budgeted amount shall be deemed to be immaterial for purposes of this
Amendment and (ii) a variance from budget of 10% or more shall not by itself be
deemed to be a violation of Roche’s obligations under this Amendment or the
Agreement.

(e) Procedures of the Joint Supervisory Committee. The Joint Supervisory
Committee shall meet in person on a semi-annual basis, or on such further
occasions as set forth in Section 8(f), as either Roche or Gilead reasonably may
request, and shall attempt in good faith to reach consensus on all issues.
Meetings of the Joint Supervisory Committee shall be held in [ * ], with [ * ]
and the [ * ]. The parties shall endeavor to schedule the semi-annual meetings
of the Joint Supervisory Committee following a meeting of the Manufacturing
Committee and the Commercial Committee. If Gilead believes there are topics that
should be taken up by the Joint Supervisory Committee which are not covered by
the Roche report delivered to it in advance of such meeting, Gilead may add such
reasonable topics to the agenda by notice to Roche. In the event that the Gilead
representatives disagree with Roche’s plans or any aspect thereof, Gilead shall
have the right to appeal the determination of the Roche representatives to the
respective designated executive officers for Roche and Gilead as set forth in
Section 10.

(f) Informal Communications. The representatives of Gilead and Roche on the
Joint Supervisory Committee shall be reasonably available during the course of
the year for informal communications regarding matters within the ambit of the
Joint Supervisory Committee, including the informal resolution of issues arising
within the Manufacturing Committee and Commercial Committee.

 

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Section 9. Right To Escalate Disputes To The Joint Supervisory Committee.

(a) Escalation to JSC. In the event that the Manufacturing Committee or the
Commercial Committee is unable to reach consensus on any matter relating to the
Product, Gilead shall have the right to escalate the dispute for attempted
resolution by good faith negotiations among the members of the Joint Supervisory
Committee. Any such escalation of a dispute must be made in writing within [ * ]
after either party has notified the other in writing that it believes that an
impasse has been reached on such matter by the Manufacturing Committee or the
Commercial Committee, and if Gilead does not escalate such dispute, Roche’s
position shall prevail.

(b) Procedure for Referring Disputes to the Joint Supervisory Committee. If
Gilead wishes to refer a dispute to the Joint Supervisory Committee, Gilead
shall provide written notice to Roche and to the Joint Supervisory Committee
describing the background to the dispute and the resolution it seeks (“the
Notice of Dispute”) and shall include in the Notice of Dispute all materials it
wishes to advance in support of its proposed resolution. Roche shall have [ * ]
to provide its written response to Gilead and to the Joint Supervisory
Committee.

(c) Consideration by the Joint Supervisory Committee. At such time as either
Roche or Gilead reasonably may request, but in any event no later than at the
next regulatory scheduled meeting of the Joint Supervisory Committee, the Joint
Supervisory Committee shall consider the viewpoints of each of Gilead and Roche
and shall attempt, in good faith, to resolve the dispute.

Section 10. References To Executive Officers.

(a) If the Joint Supervisory Committee is unable to resolve a dispute (other
than a Voluntary License Dispute) referred to it by Gilead within the earlier of
(i) [ * ] after its first meeting to discuss the dispute, or (ii) [ * ] after
such dispute has arisen, then Gilead shall be entitled to refer the dispute,
upon written notice to Roche, to the executive officers of each of Roche and
Gilead designated below, or their successors, who shall attempt, in good faith,
to resolve the dispute. Any such escalation of the dispute must be made within [
* ] of the failure of the Joint Supervisory Committee to resolve the dispute
within the period described in this paragraph, and if Gilead does not escalate
such dispute, Roche’s position shall prevail.

 

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(b) The said designated executive officers are as follows:

For Roche: CEO of Pharma Division

For Gilead: Chief Executive Officer

(c) The designated executive officers shall have [ * ] to attempt to resolve the
dispute or such further time as they may agree.

(d) If the designated executive officers are unable to resolve the dispute, and
if Gilead reasonably concludes that the dispute is material, Gilead shall be
entitled to refer the dispute to Gilead’s Chief Executive Officer and Roche’s
Chairman, who shall attempt, in good faith, to resolve the dispute. Any such
escalation of the dispute must be made within [ * ] of the failure of the
designated executive officers to resolve the dispute within the period described
in paragraph (c) above and in the event Gilead does not escalate such dispute,
Roche’s position shall prevail, except as provided in clause (e) below with
respect to Voluntary License Disputes. The Chief Executive Officer of Gilead and
the Chairman of Roche shall have [ * ] to attempt to resolve the dispute, or
such further time as they may agree.

(e) Voluntary License Disputes. If the parties are unable in good faith to
resolve a Voluntary License Dispute, such dispute shall be referred directly to
the Chairman of Roche and the Chief Executive Officer of Gilead who shall
attempt, in good faith, to resolve the dispute. Any such escalation of a
Voluntary License Dispute must be made within [ * ] of the failure of the
parties to resolve the Voluntary License Dispute within the period described in
Section 4(c) of this Amendment. The Chairman of Roche and the Chief Executive
Officer of Gilead shall have [ * ] to attempt to resolve the dispute, or such
further time as they may agree, after which either party may initiate an
arbitration proceeding pursuant to Section 11(e). In the event that a Voluntary
License Dispute is not resolved as provided in this Section 10(e) and is not
arbitrated pursuant to Section 11(e) below, then the proposed Voluntary License
that is the subject of such Voluntary License Dispute [ * ].

(f) Final Decision-Making Authority. [ * ] consultation, coordination and input
rights under this Amendment [ * ], and the parties agree that [ * ] over all
disputes relating to matters set forth in Sections 3 through 8 of this Amendment
that are not Arbitrable Disputes (as defined below), after taking into account
in good faith the views of [ * ] in accordance with the procedures set forth in
Sections 8, 9 and 10 hereof. Without limiting the generality of the foregoing,
in the event a committee or working group created under this Amendment fails to
reach consensus on any issue before it, the [ * ] committee or working group
shall have the [ * ] to determine the act or decision of the committee or
working group on such issue, subject in each case to the right of Gilead to
escalate disagreements as provided in this Amendment.

 

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Section 11. References To Arbitration.

(a) Arbitrable Disputes. The parties recognize that resort to arbitration should
only occur in exceptional circumstances and with respect to disputes concerning
major commercial decisions (“Arbitrable Disputes”) as to the following matters:

(i) The annual budget for aggregate spending in Specified Markets on
promotional, marketing and sales activities for the Product relating to seasonal
influenza (“Specified Markets Spending Disputes”), excluding Roche’s annual
budget for 2006. [ * ] in the annual budget for 2008 or later for aggregate
spending in Specified Markets on promotional, marketing and sales activities for
[ * ] of the budget for the immediately preceding year; and

(ii) A Voluntary License Dispute.

(b) Application of Article 14 of the Original Agreement. Arbitrable Disputes
that cannot be resolved pursuant to the procedures set forth in Section 8, 9 and
10 shall be resolved through binding arbitration in accordance with this
Section 11. The streamlined arbitration procedures set forth in this Section 11
shall only apply to Arbitrable Disputes. All other disputes under the Original
Agreement shall be resolved in accordance with the procedures set forth in
Article 14 of the Original Agreement.

(c) Selection of Arbitrator. In the event the Chairman of Roche and the Chief
Executive Officer of Gilead fail to resolve an Arbitrable Dispute referred to
them under this Amendment within the applicable time period specified in
Section 10, (x) in the case of a Specified Markets Spending Dispute, Gilead
shall have the right during the [ * ] immediately following such failure to
notify Roche in writing that it wishes to have the dispute resolved by a single
arbitrator pursuant to this Section and, in the event Gilead does not so
escalate such dispute, the position of Roche shall prevail and (y) in the case
of a Voluntary License Dispute, Roche shall have the right during the [ * ]
immediately following such failure to notify Gilead in writing that it wishes to
have the dispute resolved by a single arbitrator pursuant to this Section and,
in the event Roche does not so escalate such dispute, then the proposed
Voluntary License that is the subject of such Voluntary License Dispute shall
not be granted. Within [ * ] of Gilead’s or Roche’s, as applicable, receipt of
such notice, Roche and Gilead shall deliver to each other a list of three
proposed arbitrators, each with (i) at least ten

 

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24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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years of significant management-level experience, or industry-specific
experience as a consultant, in the pharmaceutical industry, (ii) no direct or
indirect affiliation with either party or its Affiliates or sublicensees,
(iii) no conflict of interest as to the parties in general, and (iv) no direct
or indirect interest in the matter in dispute. The parties shall have [ * ] to
attempt to agree in good faith on the choice of arbitrator. If no agreement is
reached within such [ * ] period, each of Roche and Gilead shall be entitled to
strike two of the other party’s proposed arbitrators and the remaining two
proposed arbitrators shall be submitted to the American Arbitration Association
to select a single arbitrator.

(d) Arbitration for Specified Markets Spending Disputes. Specified Markets
Spending Disputes except for Voluntary License Disputes shall be resolved in
accordance with the following procedure:

(i) Within [ * ] of selecting an arbitrator Roche and Gilead shall each submit
to the arbitrator a proposal for the aggregate amount of money to be spent in
Specified Markets on promotional, marketing and sales activities for the coming
year and written materials in support of its proposal, no longer than thirty
pages in length.

(ii) The arbitrator may hear oral argument in New York, NY in support of each
party’s position. The arbitrator shall consider only the parties’ submissions,
any oral arguments and the text of the Agreement and this Amendment, and shall
select either Roche’s proposal or Gilead’s proposal and, to the extent Article 2
and Article 4 of the Original Agreement is applicable, the arbitrator shall
select the proposal that most closely conforms to Roche’s obligations under the
Original Agreement to use Best Efforts. Neither party shall engage in ex parte
communications with the arbitrator. The parties shall use reasonable efforts to
obtain the decision of the arbitrator within [ * ] after his/her selection.

(e) Arbitration for Voluntary License Disputes.

(i) The parties recognize the need to resolve Voluntary License Disputes on an
expedited basis. Following execution of this Amendment, the parties shall work
together to identify an arbitrator with suitable experience to nominate as the
proposed arbitrator for such disputes. The selection criteria as determined in
paragraph (c) of this Section shall apply accordingly.

(ii) Voluntary License Disputes shall be resolved in accordance with the
Commercial Arbitration Rules of the American Arbitration Association, and, to
the extent practicable, those rules governing expedited procedures. The parties
shall use reasonable efforts to obtain the decision of the arbitrator within [ *
] after his/her selection.

 

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24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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(iii) A proposal by Roche to grant a Voluntary License shall be upheld unless
such proposal is determined by the arbitrator to be unreasonable.

(f) Effect of Arbitrator’s Award. An arbitral award issued pursuant to this
Section 11 shall be final and binding upon the parties and not subject to appeal
and otherwise have the effects specified in the Agreement. The parties shall
promptly implement any arbitral award.

(g) Restriction on Number of Arbitrations. If Gilead is the losing party in an
arbitration relating to a Specified Markets Spending Dispute, it shall forfeit
the right to trigger an arbitration with respect to that category of dispute for
[ * ]. In the event Gilead is the losing party in two consecutive arbitrations
relating to a Specified Markets Spending Dispute, Gilead shall forfeit the right
to bring an arbitration under this Section with respect to any further Specified
Markets Spending Disputes for [ * ]. The forfeits described in this
Section 11(g) shall not apply if in a given annual global spending period, Roche
decreases budgeted spending in Specified Markets by more than [ * ].

Section 12. Representations And Warranties. Each party hereby represents and
warrants: (a) such party is duly organized and validly existing under the laws
of the state of its incorporation and has full corporate power and authority to
enter into this Amendment and to carry out the provisions hereof; (b) such party
is duly authorized to execute and deliver this Amendment and to perform its
obligations hereunder; (c) this Amendment, and the Original Agreement as amended
and supplemented hereby, is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms; (d) the execution, delivery and
performance of this Amendment by it does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it may be bound and does not violate any law or regulation or any court,
governmental body or administrative or other agency having authority over it.

Section 13. Effectiveness. The amendments and supplements to the Original
Agreement set forth in this Amendment shall be effective on the date that each
of the parties hereto shall have received executed counterparts of this
Amendment which, when taken together, bear the signatures of Roche and Gilead.

Section 14. Amendments. No amendment or modification of this Amendment shall be
valid or binding upon the parties unless made in writing and signed by each
party.

 

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24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Section 15. Waiver. No waiver by any party hereto on any breach or default of
any of the covenants or agreements herein set forth shall be deemed a waiver as
to any subsequent or similar breach of default.

Section 16. Agreement. The Original Agreement, as amended and supplemented by
this Amendment, is hereby incorporated herein by reference and shall be and
become part of this Amendment as if set forth herein in its entirety. After the
date hereof, any reference to the Original Agreement shall mean the Agreement as
amended and supplemented hereby. Except as specifically set forth herein, this
Amendment shall not by implication or otherwise alter, modify, amend or in any
way affect any of the terms, conditions, obligations, covenants or agreements
contained in the Agreement, all of which are ratified and affirmed in all
respects and shall continue in full force and effect.

Section 17. Entire Agreement. The Agreement as amended and supplemented by this
Amendment, and all Exhibits and Schedules referred to in herein or therein,
together with the Settlement Agreement, embody the entire understanding of the
parties with respect to the subject matter hereof and shall supersede all
previous communications, representations or understandings, either oral or
written, between the parties relating to the subject matter hereof.

Section 18. Governing Law. This Amendment is made in accordance with and shall
be governed and construed under the laws of the State of California, as such
laws are applied to contracts entered into and to be performed within such
state.

[remainder of page left blank]

 

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24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly
executed by their duly authorized representatives as of the date first above
written.

 

F. HOFFMANN-LA ROCHE LTD

By:

 

/s/ William Burns

Name:

  William M. Burns

Title:

  CEO Division Roche Pharmaceuticals

By:

 

/s/ Stefan Arnold

Name:

  Stefan Arnold

Title:

  Deputy Director and Legal Counsel

HOFFMANN-LA ROCHE INC.

By:

 

/s/ Frederick C. Kentz

Name:

  Frederick C. Kentz, III

Title:

 

Vice President, Secretary,

and General Counsel

GILEAD SCIENCES, INC.

By:

 

/s/ John F. Milligan

Name:

  John F. Milligan

Title:

 

Executive Vice President and

Chief Financial Officer

 

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BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Attachment 1

Gilead shikimic acid Inventory and Commitments

Date: November 15, 2005

[ * ]

 

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BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Attachment 2

Items To Be Included in Roche’s Commercial Plans

 

  1. Forecasts of annual and monthly Product sales, and promotional and
educational expenditures

 

  2. Planning for conferences and public presentations

 

  3. Sampling and market research

 

  4. ML activities and plans

 

  5. Pricing strategies and structures

 

  6. Sizes and strategies for all field-based teams involved in promotion of the
Product, including revenue goals, call frequency, and incentive compensation
plans

 

  7. Spending allocations by indication and marketing mix (such as advertising,
direct-to-consumer activities and medical education)

 

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BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Schedule 5(a)

Manufacturing Committee Representatives

From Roche:

[ * ]

From Gilead:

[ * ]

 

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BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Schedule 5(d)

Manufacturing Working Group Representatives

Manufacturing Working Group:

From Roche:

[ * ]

From Gilead:

[ * ]

 

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BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Schedule 6(a)

Commercial Committee Representatives

From Roche:

[ * ]

From Gilead:

[ * ]

 

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[ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Schedule 6(f)

Commercial Working Group Representatives

From Roche:

[ * ]

From Gilead:

[ * ]

 

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[ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Schedule 8(a)

Joint Supervisory Committee Representatives

From Roche:

[ * ]

From Gilead:

[ * ]                                                  

 

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[ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.