EXHIBIT 10.50
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PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
RESTRUCTURING
AGREEMENT
This RESTRUCTURING AGREEMENT
(“Agreement”) is entered into as of February 2, 2005
(the “Effective Date”) by and among Baxter Healthcare
S.A., a corporation organized under the laws of Switzerland
(“BHSA”), Baxter Healthcare Corporation, a company
organized under the laws of Delaware (“BHC”), and Cerus
Corporation, a company organized under the laws of Delaware
(“Cerus”). BHSA and BHC are sometimes
collectively referred herein to as “Baxter.” The
foregoing entities are sometimes referred to herein individually as
a “Party” and collectively as the
“Parties.”
WHEREAS, BHC and Cerus are parties to a Development,
Manufacturing and Marketing Agreement, dated as of December 10,
1993, as amended to the date hereof (the “Platelet
Agreement”) relating to products referred to herein as the
“Platelet System” and to a Development, Manufacturing
and Marketing Agreement, dated April 1, 1996, as amended and
restated June 30, 1998, as further amended to the date hereof (the
“RBC/FFP Agreement”) relating to products referred to
herein as the “Plasma System” and the “RBC
System;” (The Platelet System, the Plasma System and the RBC
System are sometimes referred to herein individually as a
“System” and collectively as the “Systems”,
and such terms are intended to have the same meanings herein as
those set forth in the License Agreement and the Manufacturing and
Supply Agreement being entered into concurrently
herewith.)
WHEREAS, concurrently with this Agreement, Baxter Capital
Corporation and Cerus are entering into an Amendment, Mutual
Release and Settlement Agreement (the “BCC Settlement
Agreement”) relating to a Loan and Security Agreement, dated
as of November 15, 2002 (the “Loan
Agreement”);
WHEREAS, BHA and BHSA are parties to a Research and
Development Cost Sharing Agreement, dated January 1, 2001, for the
designing, developing, manufacturing and marketing of various blood
therapy products, including those related to the INTERCEPT Blood
System;
WHEREAS, Baxter and Cerus desire to restructure the
arrangements provided for in the Platelet Agreement and the RBC/FFP
Agreement and resolve certain disputes that have arisen concerning
those agreements, and in furtherance of such objectives Baxter and
Cerus are entering into a License Agreement, Manufacturing and
Supply Agreement, Transition Services Agreement, and a Trademark
License Agreement (to which Baxter International Inc. is also a
party) concurrently with this Agreement (such agreements referred
to collectively as the “Concurrent
Agreements”);
WHEREAS, as used in this Agreement,
“Commercialization Rights” means, as to a particular
country or region, (a) as to Baxter, the right and responsibility
of Baxter to
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EXECUTION
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RESTRUCTURING AND SETTLEMENT
AGREEMENT
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PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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market, distribute and sell the Platelet System
pursuant to the Platelet Agreement, and the Plasma System pursuant
to the RBC/FFP Agreement (and as further provided under this
Agreement), in that country or region; or (b) as to Cerus, all
rights of Cerus hereunder and under the Concurrent Agreements upon
termination of Baxter’s Commercialization rights in that
country or region. For the purposes of this agreement,
references to termination of Baxter Commercialization Rights, or to
Cerus gaining Commercialization Rights, in a particular country or
region means that licenses and related rights under the Platelet
Agreement or the RBC/FFP Agreement, as the case may be, have been
released and relinquished to Cerus, pursuant to Section 4 of this
Restructuring Agreement;
NOW THEREFORE,
in consideration of the premises and
the covenants set forth herein, and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows;
1.
CONDITIONS. SUBSEQUENT
PAYMENT.
1.1
Baxter’s Conditions
Precedent.
The effectiveness of this Agreement and the obligations of Baxter
hereunder are subject to the satisfaction, or waiver by Baxter, of
the following conditions precedent:
(a)
Cerus shall have delivered, or
caused to be delivered, original fully completed, dated and
executed originals of this Agreement and the Concurrent Agreements;
and
(b)
All conditions to be satisfied by
Cerus pursuant to Section 7(a) of the BCC Settlement Agreement
shall have been satisfied.
1.2
Cerus’ Conditions
Precedent. The
effectiveness of this Agreement and the obligations of Cerus
hereunder are subject to the satisfaction, or waiver by Cerus, of
the following conditions precedent:
(a)
Baxter shall have delivered, or
caused to be delivered, original fully completed, dated and
executed originals of this Agreement and the Concurrent
Agreements;
(b)
All conditions to be satisfied by
BCC pursuant to Section 7(b) of the BCC Settlement Agreement shall
have been satisfied.
1.3
Subsequent
Payment. Baxter
shall pay to Cerus the amount of [ * ] Dollars ($ [
* ] ) at the time of the next [ * ] , which
shall occur not later than [ * ] . In connection
with such payment, BHC represents to Cerus that no payments have
been made by BHC to BCC respecting Revenue Sharing Payments (as
defined in the Platelet Agreement) due to Cerus with respect to
Platelet System sales in the fourth quarter of 2004 (or the first
quarter of 2005), any rights to Revenue Sharing payments now
reverting to Cerus.
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PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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2.
COMMERCIALIZATION RIGHTS, MARKET
ACTIVITIES AND FUNDING.
2.1
EU Commercialization Rights
Through 2006. Subject to
the terms of this Agreement, Baxter shall maintain
Commercialization Rights for the Platelet System under the Platelet
Agreement and the Plasma System under the RBC/FFP Agreement through
December 31, 2006 in the countries listed on Exhibit A to this
Agreement, (the “European Territory”). Pursuant
to such Commercialization Rights, Baxter shall (a) continue
activities to achieve national and local approvals and gain market
penetration of the Platelet System, and (b) activities to achieve
national and local approvals (assuming CE mark approval) and market
penetration of the Plasma System, in the countries of the European
Territory. These activities will include pre-launch
activities for the Plasma System to be approved by the Governance
Committee. Through December 31, 2006 and any Extension
Period, as defined below, Baxter will provide, at its expense all
the necessary sales and marketing, distribution, regulatory,
clinical/education and governmental affairs support to implement
the plan to be approved by the Governance Committee. To carry
out these activities, Baxter agrees to commit, at its own expense,
through December 31, 2006, Baxter personnel comprising not less
than [ * ] full-time-equivalent (FTE) employees in the
European Territory in the areas itemized above, including not less
than [ * ] employees, dedicated full-time, and [ * ]
employees dedicated half-time, to marketing sales
activities.
2.2
EU Commercialization Rights
Extension 2007 — 2008.
(a)
Baxter will have the option to
continue Commercialization Rights for the Platelet System and the
Plasma System in the European Territory from January 1, 2007
through December 31, 2008 (together with any the “Extension
Period”); provided that prior to [ * ] , Baxter
(i) provides Cerus with written notice of such election, (ii) the
Platelet Agreement or the RBC/FFP Agreement has not been previously
terminated pursuant to Section 12.1 hereof, and (iii) Baxter
provides Cerus with assurance, satisfactory to Cerus in its
reasonable judgment (and which could include further escrow of
funds for marketing/promotional expenditures), that the funds and
resources will be available as committed. As used herein, the
term “Extension Period” will mean such period of
extension and any period of further extension pursuant to Section
2.3 below. In the event that such conditions are not met by
[ * ] , Baxter’s Commercialization Rights shall
terminate effective January 1, 2007.
(b)
If Baxter exercises the election in
Section 2.2(a), Baxter will be obligated, in each of calendar years
2007 and 2008, to (i) expend not less than [ * ] Dollars ($
[ * ] ) per year on marketing/promotional activities in the
European Territory for the Platelet System and Plasma System, to be
allocated between such programs as approved by the Governance
Committee, and (ii) commit, at Baxter’s own expense, not less
than [ * ] full-time-equivalent (FTE) employees in the
European Territory in the areas itemized above, including not less
than [ * ] employees, dedicated full-time and [ * ]
employees dedicated half-time, to marketing and sales activities
for the Platelet System, and not less than [ * ] additional
employees dedicated full-time to marketing and
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AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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sales activities for the Plasma System, unless
these commitments are revised through mutual agreement at the
Governance Committee. However, if the Plasma System has not then
received CE mark approval, and is not expected to receive such
approval within such calendar year, the total expenditures for such
year will be [ * ] Dollars ($ [ * ] ) and the [ *
] additional employees dedicated to marketing and sales
activities for the Plasma System shall not be required for such
calendar year.
2.3
EU Commercialization Rights
Extension Post-2008.
(a)
Subject to Section 8.1 hereof,
Baxter will have the option to continue Commercialization Rights
for the Platelet System and the Plasma System in the European
Territory from January 1, 2009 through December 31, 2010 and for
subsequent successive two-year periods; provided that prior
to [ * ] of the calendar year preceding the commencement of
any such period, Baxter (i) provides Cerus with written notice of
such election, (ii) the Platelet Agreement or the RBC/FFP Agreement
has not been previously terminated pursuant to Section 12.1 hereof,
and (iii) Baxter provides Cerus with assurance, satisfactory to
Cerus in its reasonable judgment (and which could include further
escrow of funds for marketing/promotional expenditures), that the
funds and resources will be available as committed. In the
event that such conditions are not met by such February 28,
Baxter’s Commercialization Rights shall terminate effective
[ * ] of the succeeding calendar year.
(b)
If Baxter exercises the election in
Section 2.3(a), Baxter will be obligated, in each of calendar years
of the further Extension Period, to (i) expend not less than [ *
] Dollars ($ [ * ] ) per year on marketing/promotional
activities in the European Territory for the Platelet System and
Plasma System, to be allocated between such programs as approved by
the Governance Committee, and (ii) commit, at Baxter’s own
expense, not less than [ * ] full-time-equivalent (FTE)
employees in the European Territory in the areas itemized above,
including not less than [ * ] employees, dedicated full-time
and [ * ] employees dedicated half-time, to marketing and
sales activities for the Platelet System, and not less than [ *
] additional employees dedicated full-time to marketing and
sales activities for the Plasma System, unless these commitments
are revised through mutual agreement at the Governance
Committee. However, if the Plasma System has not then
received CE mark approval, and is not expected to receive such
approval within such calendar year, the total expenditures for such
year will be [ * ] Dollars ($ [ * ] ) and the [ *
] additional employees dedicated to marketing and sales
activities for the Plasma System shall not be required for such
calendar year.
2.4
Reporting.
The Baxter INTERCEPT Marketing
Manager for Europe will be the primary contact for the Governance
Committee, and will be responsible for reporting on the status and
progress of the agreed-upon activities. Baxter will provide a
monthly report to Cerus on market activities, including status and
progress.
2.5
Intentionally
Omitted.
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2.6
Escrow Account.
(a)
Baxter will deposit in a joint
BHC/Cerus escrow account (the “Escrow Account”)
pursuant to an Escrow Agreement to be entered into substantially in
the form of Exhibit B to this Agreement (the “Escrow
Agreement”):
i.
[ * ] Dollars ($ [ * ] ) on or before the [
* ] day following [ * ] ;
ii.
[ * ] Dollars ($ [ * ] ) on or before [ *
] ; Baxter represents that this amount equals the difference
between (x) [ * ] Dollars ($ [ * ] ) and (y) [ *
] by Baxter in the third and fourth calendar quarters of 2004
on marketing and promotional activities for the INTERCEPT Blood
System, pursuant to the plan outlined and agreed upon by the
Governance Committee, not including Baxter FTE and fringe benefit
expenses; and
iii.
[ * ] Dollars ($ [ * ] ) on or before [ *
] .
(b)
The Governance Committee will meet
periodically (not less frequently than quarterly) to review and
approve expenditures that have been made for marketing/promotional
activities to assure consistency with the previously-approved
budget and plan. Upon such approval, duly authorized
signatures of Cerus and BHC will jointly sign instructions to the
escrow agent to release funds to the Party (BHC, BHSA or Cerus)
that incurred the expenditures. With respect to expenditures
pursuant to Section 2.8, a duly authorized signatory of Cerus may
solely sign instructions to the escrow agent to release funds to
BHC for qualifying expenditures under Section 2.8.
2.7
2005–2006 Commitment;
Release From Escrow For Marketing/Promotional
Activities. Amounts
deposited into the Escrow Account in 2005 and 2006 will be used to
fund marketing/promotional expenses for the 2005 calendar year and
2006 calendar year, respectively, as further discussed in Section
8.1 below. For the avoidance of doubt, these funds will be
over and above, and will not be used to fund, Baxter FTE expenses
committed in Section 2.1 hereof; provided, however, they may fund
expenses of consultants and of additional employees (beyond the
FTEs committed pursuant to Section 2.1 hereof) dedicated full-time
to sales and marketing of INTERCEPT, if engagement of such
resources is approved by the Governance Committee. Approval
of marketing and promotional expenditures will be governed by the
terms of the Platelet Agreement and the Plasma Agreement, which
provide for final plans and strategies to be established by the
Management Board (now the Governance Committee) reasonably and in
good faith. Baxter and Cerus each agrees that the objective
is to expend the full amount of these funds in each respective
calendar year, and neither will unreasonably withhold its consent
to such expenditures.
2.8
Release From Escrow For Plasma
Development. Notwithstanding the foregoing, Cerus may, in its
sole discretion, direct that an amount not exceeding Two Million
Two Hundred Thousand Dollars ($2,200,000) be released from the
Escrow Account to reimburse Baxter for activities that Baxter may
undertake at Cerus’ request to
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continue development activities for the Plasma
System directed toward CE Mark approval in the European Territory,
and related manufacturing and validation, thereby releasing Cerus
of the obligation for such payment from Cerus’ own
funds. Not more than (a) [ * ] Dollars ($ [ * ]
) of such funds will be released in 2005 (to reimburse Baxter for
activities in [ * ] ), and not more than (b) [ * ]
Dollars ($ [ * ] ) of such funds will be released in [ *
] (to reimburse Baxter for activities in [ * ] ).
Such release of funds will reduce the amount of the funds in the
Escrow Account that would otherwise be dedicated to
marketing/promotional expenses for the Plasma System, which the
Parties agree is [ * ] Dollars ($ [ * ] ) for [ *
] , combined, before such reductions.
2.9
Distribution, Payment of Unused
Funds. Subject to
Section 2.7, in the event the Governance Committee does not approve
expenditure of the full amount of the escrowed funds allocated to
[ * ] in that calendar year, or does not approve expenditure
of the full amount of funds committed pursuant to Section 2.2(b)
hereof in any year of the Extension Period, or if for any reason
there are any such escrowed or committed amounts remaining unspent
at the end of any such calendar year, the amount of unspent funds
in the escrow account will be distributed equally to Baxter and
Cerus within [ * ] days following the end of the calendar
year. With respect to any amounts committed pursuant to
Section 2.2 or Section 2.3 for any Extension Period (if funds
representing such amounts are not in the Escrow Account) one-half
of the amounts so committed, but unspent, in any calendar year,
will be paid by Baxter to Cerus within [ * ] days following
the end of the calendar year.
2.10
Marketing Plans and
Activities. For
2005, 2006 and of each year of the Extension Period, the joint
Baxter/Cerus INTERCEPT marketing team will prepare and present to
the Governance Committee a detailed marketing plan and budget for
that calendar year for the Platelet System and Plasma System in the
countries in the European Territory where Baxter retains
Commercialization Rights. The Governance Committee will
approve such marketing plan and budget not later than [ * ]
and [ * ] respectively of each respective year, and will
also by [ * ] agree on a retention plan for dedicated
INTERCEPT marketing personnel in the European Territory for 2005
and 2006 and each year of any Extension Period. The
Governance Committee must approve any subsequent changes to such
plan or budget. Neither Baxter nor Cerus will unreasonably
withhold its approval of such plan or budget or subsequent
revisions thereto. Cerus will not unilaterally make any
commitments to any customers that any studies will be funded by
Baxter (including funding through the Escrow Account) relative to
such customers. In the event that Cerus does unilaterally
make any such commitment, Cerus shall bear the expense of such
study.
2.11
North America Commercialization
Rights.
(a)
Subject to the terms of this
Agreement, Baxter shall maintain Commercialization Rights as to the
Platelet System in North America. It is understood that the
Parties, intend to carry out discussions with the U.S. Food and
Drug Administration (“FDA”) to gain clarification
whether the Platelet System may be approved for marketing in the
United States without additional clinical or other
activities,
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or whether additional such activities will be
required. When such question is answered with reasonable
clarity (which the Parties anticipate will occur at a meeting with
the FDA, and will not require formal written response from the
FDA), Cerus will provide Baxter with a notice requesting Baxter to
confirm whether Baxter desires to continue to maintain
Commercialization Rights as to the Platelet System in North
America. Baxter will have [ * ] days from the date of
Cerus’ notice to respond by written notice to Cerus. If
Baxter responds that Baxter does not desire to maintain
Commercialization Rights as to the Platelet System in North
America, or if Baxter fails to respond strictly within such [ *
] day period, Baxter’s Commercialization Rights to the
Platelet System in North America will immediately terminate upon
such event.
(b)
If Baxter’s written notice of
response states that Baxter desires to maintain Commercialization
Rights as to the Platelet System in North America, then Baxter
shall have the following obligations:
(i)
Baxter will fund one hundred percent
(100%) of further clinical, development or other activities,
including without limitation Phase 3b or Phase 4 studies, if
required by the FDA for approval to market the Platelet System, and
will use commercially reasonable efforts to carry out such
activities and gain such approval;
(ii)
Baxter will use commercially
reasonable efforts to launch the Platelet System in the United
States as promptly as possible following FDA approval. Baxter
will expend not less than [ * ] Dollars ($ [ * ] )
per year on marketing/promotional activities in North America for
the Platelet System during the calendar year preceding market
launch and the next following calendar year, and will expend not
less than [ * ] Dollars ($ [ * ] ) per year on
marketing/promotional activities in North America for the Platelet
System each calendar year thereafter. In addition, Baxter
will commit not less than [ * ] FTEs to sales and marketing
of the Platelet System in North America. The
marketing/promotional expenses specified above will be over and
above such FTE expenses, unless otherwise agreed by the Governance
Committee.
2.12
BioOne Territory
Commercialization Rights. With respect to the countries of Japan, China
(including all Special Administrative Regions), Taiwan, South
Korea, Thailand, Vietnam and Singapore (the “BioOne
Territory”), Commercialization Rights continue to the extent
provided in Section 4.4 of this Agreement; provided that if
a transaction of the nature described in Section 3.2(c) hereof is
not entered into with BioOne or another entity within [ * ]
months of the date of this Agreement; Commercialization Rights as
to the Plasma System will terminate in China (including Hong Kong
and other specific administrative regions) and Japan. In such
event, the remainder of countries in the BioOne Territory will be
considered ROW as to the Plasma System for the purposes of this
Agreement.
2.13
Rest of World Commercialization
Rights.
(a)
As used herein, “Rest of
World” or “ROW” means all countries other than
the countries of the European Territory, North America and the
BioOne
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Territory, as such terms are defined herein;
provided however that certain countries may be added to the ROW
pursuant to the express provisions hereof.
(b)
Subject to the terms of this
Agreement, Baxter shall maintain Commercialization Rights for the
Platelet System under the Platelet Agreement and the Plasma System
under the RBC/FFP Agreement in the countries of the ROW through the
period provided for in this Section 2.13.
(c)
Baxter’s Commercialization
Rights for the ROW will continue in effect for the same period as
Baxter’s Commercialization Rights for the European Territory,
subject to Section 8 hereof and to the following. For 2005,
2006 and each year of the Extension Period, Baxter will prepare and
present to the Governance Committee a detailed marketing plan and
budget for that calendar year for the Platelet System and the
Plasma System for specific countries in the ROW. For 2005,
such plan and budget for such specific countries will be presented
not later than [ * ] days after the Effective Date, for
approval by the Governance Committee its second calendar quarter
meeting (if not approved sooner). For subsequent calendar
years, such budget and plan will be presented for approval by the
Governance Committee not later than [ * ] of each respective
year. Not later than [ * ] of each succeeding year,
the Governance Committee will review whether or not Baxter has
performed the activities specified in the marketing plan and budget
previously approved for each such country. If Baxter has not
performed the specified activities in any country, Cerus may elect,
by written notice to Baxter, to terminate Baxter’s
Commercialization Rights in such country.
(d)
If the marketing plan and budget for
a particular ROW country presented by Baxter pursuant to Section
2.13(c) above is not approved by the Governance Board, Cerus may
elect, by written notice to Baxter, to terminate Baxter’s
Commercialization Rights in such country. If Baxter and Cerus
disagree at the Governance Committee level on whether the plan
should be approved, the matter will be submitted for arbitration
pursuant to Section 15.12 hereof.
(e)
If Baxter does not provide a
marketing plan and budget for any year, as provided in Section
2.13(c) above for a country in the ROW, Cerus may request that
Baxter provide such a plan and budget for such country. If
Baxter does not provide such a plan for such country within [ *
] days after such request, Cerus may elect, by written notice
to Baxter, to terminate Baxter’s Commercialization Rights in
such country.
(f)
If at any time for any reason, the
rights granted to a partner revert to Baxter and Cerus with respect
to any country of the ROW, then Baxter’s Commercialization
Rights will automatically terminate as to such country, which shall
be thereafter considered a Reverted Right Region.
(g)
Subject to Section 4.3,
Baxter’s Commercialization Rights will automatically
terminate as to all ROW countries upon termination of
Baxter’s Commercialization Rights as to the European
Territory, upon non-exercise by Baxter of its election pursuant to
Section 2.3 (a); provided, however, that if the termination
of
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European Territory Commercialization Rights
occurs through exercise by Cerus of the European Territory Buy-Out
rights pursuant to Section 8.1 hereof, Cerus may obtain such rights
as to the ROW country only through exercise of its ROW country
Buy-Out Rights pursuant to Section 8.2 hereof.
2.14
Condition to
Extensions. It
shall be a condition to exercise of Baxter’s options to
extend any Commercialization Rights into any Extension Period that
Baxter shall be in compliance, in all material respects, with the
requirements of this Agreement, the Platelet Agreement, the RBC/FFP
Agreement (as to Plasma System matters) and the Concurrent
Agreements at the time of such exercise.
3.
DEVELOPMENT.
3.1
Platelets.
(a)
Cerus and Baxter acknowledge and
agree that the Cooperative Development Work, as defined in the
Platelet Agreement:
(i)
is completed, effective January 1,
2005, with respect to activities directed toward the European
Territory;
(ii)
continues with respect to activities
directed toward North America, subject to the following:
After the Effective Date, the Cooperative Development Work will be
initially limited to preparing (to the extent not already
prepared), and submitting to the FDA, such documents as Cerus
deems appropriate, and participating in one or more meetings with
the FDA. The purpose of such activities is to gain
clarification whether the Platelet System may be approved for
marketing in the United States without additional clinical or other
activities, or whether additional such activities will be
required. Cerus will have the primary discretion to determine
the strategy for communications with the FDA, subject to
Baxter’s approval, and Baxter will conduct such
communications, including meetings, with the participation of
Cerus. Each Party will bear its own expenses of such
activities. Following such activities, if Baxter, pursuant to
the Section 2.11(b), provides notice that Baxter desires to
maintain Commercialization Rights as to the Platelet System in
North America, then the Cooperative Development work will continue
(if additional development activities are required) with Baxter
thereafter bearing all costs of such activities as provided in
Section 2.11(b)(i). If, pursuant to Section 2.11(a), Baxter
does not maintain Commercialization Rights as to the Platelet
System in North America, the Cooperative Development Work will then
be considered terminated as to the Platelet System in North
America.
(b)
With respect to the BioOne
Territory, Baxter and Cerus acknowledge that development and
commercialization will be carried on by BioOne Corporation
(“BioOne”) pursuant to agreements previously entered
into with BioOne BHC, BHSA and Cerus each agrees to perform its
obligations under such agreements in support of BioOne’s
activities. Such activities will not be considered Cooperative
Development work that is subject to joint funding under the
Platelet Agreement.
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(c)
With respect to activities
concerning the Platelet System directed to the ROW, the parties
will pursue commercialization as provided in Section 2.13
hereof. Such activities will be at Baxter’s expense and
will not be considered Cooperative Development work that is subject
to joint funding under the Platelet Agreement, unless the parties
otherwise agree at the Governance Committee level. It is
understood that Baxter has no obligation to make any System
modifications, or fund any clinical studies, that may be necessary
to gain approval in any ROW country, but Baxter agrees that the
expenses of any regulatory personnel and activities in such country
will be solely Baxter’s responsibility.
3.2
Plasma.
(a)
Cerus and BHC acknowledge and agree
that the Cooperative Development Work, as defined in the RBC/FFP
Agreement, for the Plasma System;
(i)
continues with respect to activities
directed toward obtaining CE Mark in the European
Territory;
(ii)
is terminated, effective January 1,
2005, with respect to activities directed to North
America;
(b)
With respect to activities directed
toward obtaining CE Mark for the Plasma System and related
manufacturing and validation, Baxter agrees, at Cerus’
request and expense, to carry out the further development
activities set forth on Exhibit C to this Agreement within the time
schedules set forth on such Exhibit for such activities. The
charge for such activities will not exceed the amount set forth on
such Exhibit, provided that the scope of such activities is not
expanded. Cerus agrees to fund those Baxter activities, as
well as Cerus activities, directed toward completing the
application for CE Mark, including through funding from the Escrow
Account pursuant to Section 2.8, above.
(c)
With respect to the countries of the
BioOne Territory, it is acknowledged that Cerus has been discussing
with BioOne and Baxter a potential transaction related to the
Plasma System that is similar to the transaction previously entered
into for the Platelet System. In the event such a transaction
is entered into, it is anticipated that development and
commercialization will be carried on by BioOne. Pending the
completion of the transactions, the Parties do not expect that any
Cooperative Development work will be funded specifically directed
to the countries of the BioOne Territory. The parties agree
to cooperate to supply information to BioOne and engage in
discussions with BioOne to facilitate the completion of such
transaction. Such activities will not be considered Cooperative
Development work that is subject to funding under the RBC/FFP
Agreement. In the event that such transaction is not entered
into with BioOne or another entity within [*] months of the date of
this Agreement, the Cooperative Development Work for the Plasma
System will be considered terminated with respect to the countries
of the BioOne Territory.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(d)
With respect to activities
concerning the Plasma System directed to the ROW, the parties will
pursue commercialization as provided in Section 2.13 hereof.
Such activities will be at Baxter’s expense and will not be
considered Cooperative Development work that is subject to joint
funding under the RBC/FFP Agreement, unless the parties otherwise
agree at the Governance Committee level. It is understood
that Baxter has no obligation to make any System modifications, or
fund any clinical studies, that may be necessary to gain approval
in any ROW country, but Baxter agrees that the expenses of any
regulatory personnel and activities in such country will be solely
Baxter’s responsibility.
3.3.
Red Blood Cells.
Cerus and BHC acknowledge and
agree that the Cooperative Development Work, as defined in the
RBC/FFP Agreement, for the RBC System is terminated, effective
January 1, 2005, with respect to activities directed to all
countries of the world; provided that Baxter shall promptly
complete in 2005 the chronic and acute close-out clinical trial
reports on the RBC program that had been scheduled for completion
in 2004, and furnish such reports to Cerus, which shall be at
Baxter’s own expense with respect to any activities in
2005.
4.
RELINQUISHMENT OF
RIGHTS.
4.1
Rights
Relinquished. BHC
and BHSA each hereby releases and relinquishes to Cerus all of its
licenses and related rights under the Platelet Agreement and the
RBC/FFP Agreement to Cerus Patents, Cerus Know-How, Cerus Licensed
Patents, Cerus Licensed Know-How and Cerus Compounds, Cerus
Inventions, Cerus Project Inventions and Contractor Inventions, as
such terms are defined in such agreements respectively, as follows
in the following regions (the “Reverted Right Regions,”
each a “Reverted Right Region” as to the particular
System or Systems):
(a)
Plasma.
Under the RBC/FFP Agreement, as to
the field of inactivation of pathogens in plasma components of
blood: all licenses and related rights in North America;
(b)
Red Blood Cells.
Under the RBC/FFP Agreement, to the
field of inactivation of pathogens in red blood cells: all licenses
and related rights worldwide;
(c)
Other.
Under the RBC/FFP Agreement, as to
any other part of the Field (as such term is defined in such
agreement) that is not mentioned in Sections 4.1(a) and 4.1(b)
above: all licenses and related rights worldwide.
4.2
Rights Relinquished on Subsequent
Termination of Commercialization Rights.
Effective upon the termination of
Commercialization Rights as to the Platelet System or the Plasma
System in any country as to which licenses and rights were not
previously released and relinquished pursuant to Section 4.1, BHC
and BHSA each will automatically release and relinquish to Cerus
all of its licenses and related rights under the Platelet Agreement
and the RBC/FFP Agreement, as the case may
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
11
be, to Cerus Patents, Cerus Know-How, Cerus
Licensed Patents, Cerus Licensed Know-How and Cerus Compounds,
Cerus Inventions, Cerus Project Inventions and Contractor
Inventions, except to the extent that Commercialization Rights are
expressly retained by Baxter hereunder after such date. At
such time, such country will become part of the Reverted Right
Regions.
4.3
Rights Retained for Third Party
Agreements. If an
agreement is reached, on or before [ * ] , or during [ *
] , if applicable, with a partner or partner(s) for
commercialization of the Platelet System or the Plasma System in
any country (outside the BioOne Territory) in which Baxter then
retains Commercialization Rights for such System, licenses and
related rights in such country will remain subject to the Platelet
Agreement or the RBC/FFP Agreement, case may be, as necessary to
support such third party agreement. (Any such third party agreement
will require the approval of Baxter and Cerus.) Revenues from such
agreement [ * ] . However, if at any time for any
reason, the rights granted to such third party revert to
Baxter/Cerus with respect to such country, then Baxter’s
license and related rights shall automatically be released and
relinquished to Cerus as to such System in such country, which
shall be thereafter considered a Reverted Right Region. If
the Parties are unable to complete such mutually acceptable
agreements in a country on or before the date on which
Baxter’s Commercialization Rights terminate in such country,
such country will become part of the Reverted Rights Region as of
the date of termination of the Commercialization Rights.
4.4
Rights Retained For Performance
of BioOne Agreements. Notwithstanding Section 4.2, Baxter will retain
any licenses and related rights necessary to support the licenses
granted by Baxter to BioOne and to enable Baxter to carry out its
commitments (a) to BioOne under the BioOne Agreements concerning
the Platelet System, and (b) under future agreements (with respect
to the BioOne Territory) that may be entered into between Cerus,
Baxter and BioOne or another entity pursuant to the terms of the
Agreement. However, if at any time for any reason, the rights
granted to BioOne or other entity as to the Platelet System or the
Plasma System revert to Baxter/Cerus with respect to China or
Japan, then Baxter’s license and related rights shall
automatically be released and relinquished to Cerus as to such
country, which shall be thereafter considered a Reverted Right
Region as to such System (subject to Baxter’s rights under
section 5.6 of the License Agreement). If such rights revert
to Baxter/Cerus as to a System in any other country of the BioOne
Territory, such country will thereafter be considered part of ROW
for the purposes of this Agreement.
4.5
Regulatory
Transfer. Baxter
hereby transfers to Cerus the regulatory rights and future
responsibility for the Platelet System, the Plasma System and the
RBC System in the respective Reverted Rights Regions applicable to
each such System as of such date. Baxter will make a prompt
subsequent orderly transfer of the related regulatory documents to
Cerus.
4.6
Regulatory Transfer on Other
Events. Upon any
event resulting in addition of a country or region to the Reverted
Rights Regions as to any System, there shall be automatically
transferred to Cerus the regulatory rights and future
responsibility
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
12
for such Systems in such country or
region. Baxter will, as early as reasonably possible, make an
orderly transfer of the related regulatory documents to
Cerus.
4.7
Cross-Reference to Baxter
Regulatory Files. Following the transfers of regulatory rights and
responsibilities described above, Cerus shall continue to be able
to cross-reference any regulatory files of Baxter as necessary or
useful to support regulatory submissions for the Platelet System
the Plasma System and the RBC System. Baxter shall, at
Cerus’ request, execute and provide to Cerus such other
documents as are necessary or appropriate to notify any regulatory
agency of such authorization.
5.
LICENSE AGREEMENT; TRADEMARK
LICENSE.
5.1
License
Agreement. Concurrently with this Agreement, Baxter and
Cerus are entering into a License Agreement (the “License
Agreement”) whereby Baxter licenses to Cerus certain rights
to certain patents, know-how and materials, all as described in the
License Agreement, related to the INTERCEPT Blood System in the
Reverted Rights Regions.
5.2
No Diligence
Obligations. For
the purpose of dispute avoidance, it is agreed that Cerus has no
diligence obligations to develop or commercialize products under
this Agreement or the License Agreement, except as set forth in
Section 3.2(b) concerning activities related to the application for
CE Mark for the Plasma System.
5.3
Trademark License
Agreement .
Concurrently with this Agreement, Baxter and Cerus are entering
into a Trademark License Agreement (the “Trademark
License”) whereby certain rights in the INTERCEPT Blood mark,
other marks that include the INTERCEPT name, and any designs
associated therewith, are licensed to Cerus in the countries in
which Cerus gains Commercialization Rights.
6.
MANUFACTURING AND
SUPPLY.
6.1
Platelets and Plasma in the
Countries Where Baxter Retains Commercialization
Rights.
(a)
For the purpose of clarity, so long
as Baxter retains Commercialization Rights hereunder for the
Platelet System or the Plasma System, as the case may be, for a
particular country or region, Baxter will continue to manufacture
Platelet Systems and related products as provided in the Platelet
Agreement, and Plasma Systems and related products as provided in
the RBC/FFP Agreement, for such country or region, as well as sets
for use in development and clinical testing of such Products in
such country or region. Except for costs Cerus has previously
expressly agreed to incur in connection with design transfer for
relocation of Plasma System manufacturing from [ * ] to [
* ] , Baxter will bear all costs of relocation and revalidating
manufacturing facilities. Any costs involved with such
relocation will not increase the Cost of Goods to Cerus over the
Cost of Goods that was in effect as to manufacture of any System at
the previous location.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
13
(b)
Notwithstanding Section 6.1(a), the
Parties will cooperate to attempt to identify suppliers that could
manufacture or assemble complete Platelet Sets and Plasma Sets at
lower cost than Baxter’s Cost of Goods and at equal or
superior quality to Baxter’s manufacture or assembly.
(Such supplier would be permitted to obtain at cost Baxter raw
materials for such use in manufacture or components for use in
assembly). In the event that the Parties’ identify such
a supplier, or Cerus individually identifies such a supplier, Cerus
may provide written notice to Baxter of its request that Baxter
utilize such supplier in order to reduce the Cost of Goods for a
particular System. (Cerus may provide such notice, however,
only if Baxter has elected to extend its Commercialization Rights
into an Extension Period.) Within [ * ] months of its
receipt of such notice Baxter shall either (a) reduce its Cost of
Goods for the particular System to be no greater than that which
would pertain by use of such supplier, or (b) commence payment to
Cerus of additional Revenue Sharing Payments (as defined under the
Platelet Agreement and the RBC/FFP Agreement) equal to the
additional amounts that Cerus would receive if the supplier were
utilized, or (c) commence transition to such supplier and
thereafter use commercially reasonable efforts to expeditiously
complete such transition. As used herein, the terms
“Platelet Sets” and “Plasma Sets” shall
mean “Inactivation Packages” (as defined in the
Platelet Agreement and the RBC/FFP Agreement) for the Platelet
System and the Plasma System, respectively.
6.2
Manufacturing and Supply
Agreement. To
assure Cerus a supply of products for a certain period in those
countries and regions in which Cerus gains Commercialization
Rights, Baxter and Cerus are entering into a Manufacturing and
Supply Agreement of even date herewith.
6.3
Obligations to BioOne.
Baxter agrees, for the
benefit of Cerus, to manufacture products and materials, components
and subassemblies for BioOne pursuant to the Manufacturing and
Supply Agreement previously entered into with BioOne for the
Platelet System, and agreements, if any, that may be entered into
with BioOne or other party for the Plasma System, and to otherwise
comply with its obligations under the BioOne Agreements and such
other agreements, if any.
7.
TRANSITION
SERVICES. To assure
a smooth transition of rights and responsibilities concerning
marketing, sales and distribution responsibilities in any country
upon termination of Baxter’s Commercialization Rights in such
country, concurrently with this Agreement, Baxter and Cerus are
entering into a Transition Services Agreement (the
“Transition Services Agreement”).
8.
CERUS BUY-OUT OF
COMMERCIALIZATION RIGHTS.
8.1
European Territory
Buy-Out. If Baxter
exercises the election under Section 2.3(a) to continue
Commercialization Rights into any Extension Period, commencing with
the [ * ] Extension Period, Cerus will have the election
(the “European Territory Buy-Out Rights”) to terminate
Baxter’s Commercialization Rights in the European Territory
as to the Platelet System and the Plasma System, effective as of
[ * ] ,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
14
or as of the first day of any subsequent
Extension Period, as the case may be. For the purpose of
clarity, in such event, Baxter’s Commercialization Rights
will not continue into such Extension Period, even though Baxter
elected to so continue. Such election will apply to
the entire European Territory, and may not be exercised on a
country-by-country basis.
(a)
To make such election, Cerus will so
notify Baxter in writing not later than the [ * ] next
following the [ * ] deadline for Baxter’s exercise of
its election pursuant to Section 2.3(a).
(b)
In consideration of such election,
Cerus shall pay to Baxter an amount (the “European Territory
Buy-Out Price”) computed as follows: The European
Territory Buy-Out Price shall be equal to (i) [ * ] times
Baxter’s Adjusted Gross Margin (as defined in Section 8.3) on
sales of the Platelet System, and (ii) [ * ] times
Baxter’s Adjusted Gross Margin on sales of the Plasma System;
in the European Territory for the [ * ] months preceding
[ * ] of the calendar year of Cerus’ election notice
pursuant to clause (a) immediately above.
8.2
ROW Country Buy-Out.
Cerus will have the election
(the “ROW Country Buy-Out Rights”) to terminate Baxter
Commercialization Rights as to any ROW country as of the first day
of any calendar year commencing with [ * ] .
(a)
To make such election, Cerus will so
notify Baxter in writing not later than July 1of the calendar year
prior to the calendar year in which such termination is to become
effective.
(b)
In consideration of such election,
Cerus shall pay to Baxter an amount (the “ROW Country Buy-Out
Price”) computed as follows: The ROW Country Buy-Out
Price for a particular country shall be equal to (i) [ * ]
times Baxter’s Adjusted Gross Margin on sales of the Platelet
System, and (ii) [ * ] times Baxter’s Adjusted Gross
Margin on sales of the Plasma System; in such country for the [
* ] months preceding [ * ] of the calendar year of
Cerus’ election notice; provided, however, that the ROW
Country Buy-Out price for any country will be not less than the
amount of Baxter’s expenditures (not including FTE costs
except for employees dedicated full-time to commercial activities
concerning the Platelet System and the Plasma System in such
country) on commercial activities dedicated to the Platelet System
and the Plasma System in that country during the [ * ]
months preceding such [ * ] date.
8.3
Adjusted Gross Margin.
As used in this Section 8,
Baxter’s Adjusted Gross Margin means Baxter’s gross
sales revenues, less product return credits and pricing
adjustments, as determined in accordance with generally accepted
accounting principles, consistently applied (GAAP) and in
accordance with Baxter’s normal accounting policies
consistently applied, minus Revenue Sharing Payments (as defined in
the Platelet Agreement and the RBC/FFP Agreement) paid or payable
to Cerus in respect of such sales revenues and minus
Baxter’s Cost of Goods (as defined in such agreements and
amended by this Agreement).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
15
8.4
Buy-Out Process.
Baxter shall notify Cerus in writing
of the amount of Adjusted Gross Margin pertinent to computing the
European Territory Buy-Out Price or the ROW Country Buy-Out Price,
as the case may be, and furnish Cerus with the information
supporting such calculation, as promptly as such information
becomes available to Baxter, following the relevant [*] date.
Cerus shall notify Baxter within [ * ] days following
receipt of such notice whether Cerus accepts such amount or
disputes such amount. If Cerus disputes such amount, Baxter
and Cerus will follow the dispute resolution procedure provided in
Section 15.12(c) hereof to determine the amount. Any dispute
concerning the Adjusted Gross Margin amount will not affect or
delay the termination of the respective Commercialization Rights,
nor the obligation of Cerus to pay the respective Buy-Out Price,
once such amount is finally determined.
8.5
Payment Date.
The European Territory Buy-Out Price
or ROW Country Buy-Out Price will be paid not later than the third
business day of the calendar year in which the termination of
Baxter’s Commercialization Rights becomes effective pursuant
to the European Territory Buy-Out or the ROW Country Buy-Out, as
the case may be.
9.
REVENUE SHARING.
9.1
Under Platelet and RBC/FFP
Agreement. Revenues
from the sale of Platelet Systems and related products, and Plasma
Systems and related products, in any country where Baxter retains
Commercialization Rights, will continue to be shared as provided in
the Platelet Agreement and the RBC/FFP Agreement, respectively,
subject, however to Section 9.3 below. In addition, during
any Extension Period, in computing Premium with respect to Plasma
Systems, Baxter’s Marketing and Administrative Expenses for
any calendar year shall be limited to twelve percent (12%) of
Baxter’s Net Sales for such calendar year (as the terms
“Premium,” “Marketing and Administrative
Expens