[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
Exhibit 10.54
COMMERCIALIZATION TRANSITION
AGREEMENT
This C OMMERCIALIZATION T RANSITION A GREEMENT (“Agreement”) is entered into on
February 12, 2006 (the “Execution Date”) and is
effective as of February 1, 2006 (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.”
R ECITALS
A. Baxter and Cerus are parties to certain
agreements, each dated as of February 2, 2005, including
Restructuring Agreement, License Agreement, Manufacturing and
Supply Agreement, Transition Services Agreement, Trademark License
Agreement and Escrow Agreement. Each such agreement will be
referred to in this Agreement by the title stated in the preceding
sentence, and such agreements will be collectively referred to as
the “February 2005 Agreements.”
B. Capitalized terms in this Agreement will have
the definitions provided in the February 2005 Agreements, except to
the extent a different definition is expressly stated in this
Agreement for any capitalized term.
C. Pursuant to the February 2005 Agreements, Cerus
gained Commercialization Rights to the Plasma System in North
America and to the RBC System worldwide.
D. Baxter and Cerus now desire that Cerus gain
Commercialization Rights to the Platelet System and the Plasma
System worldwide in all territories where Cerus does not already
hold such rights, subject to Baxter’s retention of rights in
the BioOne Territory, as described in Section 1.1
below.
E. The parties also wish to provide for an
effective transition of commercialization activities from Baxter to
Cerus.
N OW T HEREFORE , 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. C OMMERCIALIZATION R IGHTS .
a. Transfer.
Effective on the Effective Date,
Baxter’s Commercialization Rights shall terminate, and Cerus
shall gain Commercialization Rights, (i) as to the Platelet
System, worldwide, and (ii) as to the Plasma System, in all
parts of the world in which Cerus had not previously gained
Commercialization Rights. Notwithstanding the foregoing, Baxter
shall maintain Commercialization Rights for the Platelet System and
Plasma System as to the BioOne Territory, as further provided in
Section 4.4 of Restructuring Agreement.
b. Effect.
As of the Effective Date, except as
to the BioOne Territory, (i) the entire world, will be
considered a Reverted Rights Region as to the Platelet System and
the Plasma System, (ii) Baxter automatically releases and
relinquishes to Cerus all of its licenses and related rights under
the Platelet Agreement and the RBC/FFP Agreement as provided in
Section 4.2 of the Restructuring Agreement, and
(iii) Baxter and Cerus will each henceforth have all rights
and obligations allocated to it under the February 2005 Agreements
applicable to regions in which Cerus has gained Commercialization
Rights, as such rights and obligations may be modified pursuant to
the express terms of this Agreement.
c. Regulatory Registration and Applications in
Europe. Notwithstanding the foregoing, following the Effective
Date, (i) for the Pathogen Inactivation Disposables for the
Platelet System, Baxter shall remain as the registrant under the CE
Marking regulation and as the registrant or applicant, as the case
may be, and as self-declarent for CE marking for any INTERCEPT
Illuminators labeled as Baxter units, under national European
regulations, and (ii) for the Pathogen Inactivation
Disposables for the Plasma System, Baxter shall remain as the
applicant for the CE Marking regulation and as applicant under
national European regulations, if applicable. Baxter will perform
all necessary regulatory activities related to the maintenance of
the CE Marking registration for the Pathogen Inactivation
Disposables for the Platelet System and the application and CE
Marking registration for the Pathogen Inactivation Disposables for
the Plasma System, and all necessary regulatory activities relating
to INTERCEPT Illuminators, including, but not limited to, complaint
handling and vigilance reporting, until the transfer to Cerus
occurs pursuant to Section 1(d). Cerus will have the primary
discretion to determine the strategy for communications with the
European regulatory agencies, subject to Baxter’s approval,
and Baxter will conduct such communications, including meetings,
with the participation of Cerus, where possible. Baxter will notify
Cerus of any communications from the European (including European
Union and national) regulatory agencies concerning the Platelet
System or the Plasma System promptly, but in any event not later
than [ * ] , following Baxter’s receipt of the
communications, including providing Cerus with copies of such
communications. Baxter will not make any submission to the European
regulatory agencies concerning the Pathogen Inactivation
Disposables for the Platelet System or the Pathogen Inactivation
Disposables for the Plasma System or the INTERCEPT Illuminators
without Cerus prior written consent, which will not be unreasonably
withheld. Baxter shall not be required to obtain such consent if a
communication to a European regulatory agency is required by law or
as a matter of patient safety, but shall notify Cerus in advance of
such intended
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
communication. Cerus will reimburse
Baxter for Baxter’s cost of such activities as provided in
Section 8 of this Agreement.
d. Cerus to Obtain Regulatory
Certificates. Baxter and
Cerus will meet with TUV to discuss the requirements and strategy
for transferring the CE Marking design dossier certificates. Cerus
shall use [ * ] to obtain the necessary regulatory quality
system certificates in order to allow the transfer of the design
dossier certificate for the Pathogen Inactivation Disposables for
the Platelet System and the design dossier certificate or
application for the Pathogen Inactivation Disposables for the
Plasma System from Baxter to Cerus. Transfer of the design dossier
certificates or application shall be initiated with TUV no later
than upon Cerus’ attainment of the necessary quality system
certificates. Cerus shall be responsible for any payments required
to effectuate the transfer. The parties intend that such transfer
shall be completed no later than [ * ] . If Cerus is unable
to obtain the necessary regulatory quality system certificates by
[ * ] , Cerus shall reimburse Baxter for any additional fees
incurred for holding the TUV design dossier certificates after that
date.
e. Self-Declaration for
Illuminator. Cerus will
use [ * ] to comply with the applicable regulatory
requirements to make a self-declaration for the Illuminators sold
to Cerus and re-labeled as Cerus devices. For this purpose, Baxter
will transfer the existing Technical File, as is, to Cerus to allow
Cerus to construct its own Technical File for self-declaration
purposes. Once the self-declaration has been completed, the
regulatory responsibility for the Illuminator will transfer to
Cerus and Cerus will remove any Baxter trademark or trade name or
other reference to Baxter, except as provided in
Section 16(b). Baxter will maintain a Technical File and
Self-Declaration for those Illuminators that continue to bear the
Baxter mark.
f. Vigilance Records.
Upon transfer to Cerus of regulatory
responsibility, Baxter will transmit to Cerus copies of all
vigilance records relating to the Platelet System and Plasma
System.
g. Cerus Plasma System
Launch. It is understood
and agreed that the Plasma System will be launched as a Cerus
product, not as a Baxter product, following Cerus’ receipt of
the CE Marking registration. As such, prior to launch, Cerus will
have assumed all regulatory responsibilities, including design
control, label specifications and operator manual. For the purpose
of clarity, Baxter continues to have responsibility for manufacture
of labels during the term of the Manufacturing Agreement in
accordance with Cerus specifications. To assist Cerus in a
transition to Cerus manufacturing, Baxter will introduce Cerus to
Baxter’s labeling supplier.
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
2. E SCROW A CCOUNT .
a. Any funds remaining in the Escrow Account as of
December 31, 2005 shall be subject to the provisions of this
Section 2 and shall not be disbursed to the parties pursuant
to Section 2.9 of the Restructuring Agreement. Such
Section 2.9 is superseded by the provisions of this Agreement.
Any funds deposited in the Escrow Account subsequent to
December 31, 2005 shall also be subject to the provisions of
this Section 2.
b. Within five days after the Execution Date (the
“Disbursement Date”), funds will be distributed from
the Escrow Account as follows:
(i) To Baxter [ * ] ($[ * ]) with respect to
marketing and promotional expenses pursuant to Section 2.7 of
the Restructuring Agreement allocable to 2005;
(ii) To Baxter, the accrued interest on the funds
deposited in the Escrow Account earned through the Execution
Date;
(iii) To Baxter, the amount of [ * ] Dollars ($[ * ]),
in consideration of the sale to Cerus of Illuminators, as provided
in Section 7 of this Agreement;
(iv) To Cerus, the amount of [ * ] ($[ * ]) with
respect to marketing and promotional expenses pursuant to
Section 2.7 of the Restructuring Agreement allocable to
2005.
c. [ * ] Dollars ($[ * ]) shall be retained in the
Escrow Account and shall be available for disbursement from the
Escrow Account at Cerus’ direction to reimburse Baxter for
activities that Baxter may undertake after [ * ] at Cerus’
request to continue development activities for the Plasma System
directed toward CE Marking approval and launch in the European
Territory and related manufacturing and validation, thereby
releasing Cerus of the obligation for such payment from its own
funds. All interest on this amount shall be paid to Baxter at the
end of the [ * ].
d. Following the disbursements pursuant to
subparagraph (b) above, and subject to amounts retained in the
Escrow Account pursuant to subparagraph (c) above, there shall
be disbursed to Cerus on the Disbursement Date the entire remaining
amount of the Escrow Account, being not less than [ * ] Dollars ($[
* ]). The amount disbursed to Cerus pursuant to this subsection
(d) shall be referred to in this Agreement as the
“Commercialization Disbursement.”
e. The parties each agree to execute and deliver to
the Escrow Agent disbursement instructions consistent with the
provisions of this Section 2.
f. Baxter will submit to Cerus all qualified
expenses incurred by Baxter from [ * ]. Cerus shall promptly
reimburse such expenses, unless there is a reasonable basis to
object to the payment of the expense.
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
3. E XPENSES C ONCERNING C OMMERCIALIZATION D ISBURSEMENT .
a. Cerus will use the Commercialization
Disbursement to support expenses incurred in 2006 (including
expenses from January 1, 2006 to the Effective Date as well as
expenses after the Effective Date) for activities directly and
exclusively associated with European commercialization of the
Platelet System and Plasma System (“Qualifying
Expenses”).
(i) Examples of Qualifying Expenses are:
A. Sales, marketing, regulatory, reimbursement,
publication and training expenses.
B. All direct expenses associated with Phase IV,
customer experience and product surveillance trials or
studies.
C. All expenses associated with advocate
development and customer meetings, congresses and
conventions.
D. All fees and expenses of consultants retained to
execute programs associated with the functions identified
above.
E. All fully-loaded salary and fringe benefit
expenses for Cerus European employees retained to execute programs
associated with the functions identified above [ * ] Dollars
($ [ * ] ).
F. All consultant or Cerus employee travel and
travel-associated business expenses.
G. Illuminator upgrade expenses.
H. [ * ] as requested by customers for [ * ]
purposes.
(ii) Examples of expenses that are not Qualifying
Expenses are:
A. Any expenses that Cerus was incurring prior to
[ * ] unless those expenses were reimbursable from the
Escrow Account.
B. The [ * ] Dollars ($[ * ]) of fully-loaded
salary and fringe benefit expenses for Cerus European employees
added to the project after [ * ].
C. Facilities charges (rent, utilities, etc.)
relating to Cerus Europe’s incorporation, excluding the
development of a demonstration suite.
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
D. Any expenses for initiatives that directly
promote the Red Blood Cell System, other Cerus products (other than
the Platelet System and the Plasma System) or the Cerus corporate
brand.
b. Following [ * ] and [ * ] , Cerus
will submit to Baxter an itemization of Qualifying Expenses and
associated activities for the preceding [ * ] . If Baxter
disputes that any of the expenses constitute Qualifying Expenses,
Baxter will so notify Cerus in writing within [ * ] of
receipt of Cerus’ itemization. Any expenses not disputed
within such time period are accepted as Qualifying Expenses, not
subject to dispute. If not otherwise resolved, any disputes will be
resolved through arbitration pursuant to Section 26(l)
hereof.
c. If Cerus has any question whether particular
activities represent Qualifying Expenses, Cerus may make a written
request to Baxter asking for Baxter’s response to such
question. In the event that Baxter concurs that the activities
represent Qualifying Expenses, or in the event that Baxter fails to
respond in writing [ * ] after receipt of Cerus’
request, the expenses associated with such activities will be
considered Qualifying Expenses, not subject to dispute. If not
otherwise resolved, any disputes will be resolved through
arbitration pursuant to Section 26(l) hereof. Cerus may
decide, in its sole discretion, whether to make such request
concerning particular activities, and the failure to make such
request in any instance shall not imply that the activities do not
represent Qualifying Expenses.
d. Following [ * ] , Cerus and Baxter will
compare the aggregate amount of the Qualifying Expenses to the
amount of the Commercialization Disbursement. If the aggregate
Qualifying Expenses are less than the Commercialization
Disbursement, Cerus shall remit to Baxter one-half of the amount by
which the Commercialization Disbursement exceeds the Qualifying
Expenses. Such remittance shall be made on or before [ * ] ;
provided that if there is a dispute concerning the calculation of
Qualifying Expenses, such remittance shall be made upon resolution
of such dispute by mutual agreement or through arbitration pursuant
to Section 26(l) hereof.
4. P AYMENT . On
or before the Disbursement Date, Baxter will pay to Cerus the
amount of [ * ] Dollars ($ [ * ] ). On or before [
* ] , Baxter will pay to Cerus the amount of [ * ]
Dollars ($ [ * ] ).
5. S OFTWARE .
a. Delivery of Code and Documentation.
Promptly following the execution of this Agreement, Baxter will
deliver to Cerus true and correct copies of the source code and
object code and documentation for all software pertaining used or
being developed for use in connection with Products, including the
data management system (IDMS). No software, including Derivative
Works, shall be released or sold into the market by Cerus which
includes, or causes to be displayed, any Baxter trademark or trade
name or other reference to Baxter, except as provided in
Section 16.b.
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
b. Completion of Illuminator Software
Development. Baxter will complete the Priority 1 and Priority 2
modifications of the software for the Plasma System INTERCEPT
Illuminator (and corresponding changes in the Platelet System
software) according to the agreed work plan attached as Exhibit A,
enabling CE Marking self-declaration for the Plasma System
INTERCEPT Illuminator. Baxter shall use its [ * ] to complete such
modifications by [ * ] and in any event shall complete such
activities by [ * ]. Baxter warrants that such software, including,
Priority 1 and Priority 2 changes identified on such Exhibit A,
will function properly, including operation in accordance with
specifications and compliance with applicable European medical
device regulations. Except as set forth in this Agreement and in
the License Agreement, Baxter makes no warranties, written, oral,
express or implied, with respect to the INTERCEPT Illuminator
software. EXCEPT AS SET FORTH IN THIS AGREEMENT AND IN THE
LICENSE AGREEMENT, BAXTER DISCLAIMS ALL WARRANTIES, EXPRESS OR
IMPLIED WITH RESPECT TO THE INTERCEPT ILLUMINATOR SOFTWARE,
INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGMENT.
c. IDMS. The parties agree that Baxter shall have no
obligation for development of IDMS software for the Plasma System.
Except as set forth in the License Agreement, as to IDMS
software for the Platelet System, Baxter makes no warranties,
written, oral, express or implied. EXCEPT AS SET FORTH IN
THIS AGREEMENT AND IN THE LICENSE AGREEMENT, BAXTER DISCLAIMS ALL
WARRANTIES, EXPRESS OR IMPLIED WITH RESPECT TO THE IDMS SOFTWARE,
INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGMENT.
6. A SSIGNMENT OF C USTOMER C ONTRACTS AND P URCHASE O RDERS . As
of the Effective Date, the customer contracts and purchase orders
relating to the Platelet System are automatically assigned to
Cerus, to the extent assignment is permitted; provided that Cerus
shall not be assigned any rights, or assume any obligations not
pertaining to sales of the Platelet System. Notwithstanding the
foregoing, within [ * ] after receipt of the translated
customer contracts or [ * ] after the Execution Date,
whichever is later, Cerus may reject the assignment and assumption
of any contract obligations that Cerus deems onerous, in which case
the parties will negotiate in good faith to resolve such matter.
For contracts and purchase orders requiring customer consent to
assignment, Baxter will use [ * ] to obtain such consent or
transition to direct customer relationship with Cerus. To the
extent Cerus receives after the Effective Date any payment from a
customer allocable to delivery of Platelet System products prior to
the Effective Date, Cerus will remit the amount of such payment to
Baxter. To the extent that Baxter receives any payment from a
customer allocable to delivery of Platelet System products after
the Effective Date, Baxter will remit the amount of such payment to
Cerus. Baxter will indemnify Cerus for any defense, right of
set-off or claim by a Customer, which arose prior to the Effective
Date, that would interfere with Cerus’ ability to collect
payment for products delivered after the Effective Date or
create
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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
potential liability of Cerus. Baxter and Cerus
will cooperate on notification to customers concerning the
assignment of contracts and purchase orders pursuant to this
Agreement.
7. S ALE O F I NVENTORY .
a. INTERCEPT Illuminators. As of the Effective
Date, Baxter hereby transfers, assigns and conveys to Cerus [ *
] INTERCEPT Illuminator devices currently held by Baxter in
inventory, identified by Serial number on Exhibit B to this
Agreement, and [ * ] Illuminators in the field, owned by
Baxter for the Platelet System (the “Illuminators”), in
consideration of the disbursement referenced in
Section 2(b)(iii) above. Cerus will pay Baxter’s actual
cost for Baxter to upgrade all Illuminators to version/model R008
before transfer to Cerus. Exhibit C specifies the estimated cost
for such upgrade. Baxter warrants that the transferred Illuminators
met applicable Baxter acceptance tests and release tests, and
Baxter does not have any reason to believe they are defective.
Otherwise, the Illuminators are transferred [ * ] Baxter
warrants that the upgrade will comply with applicable
specifications and European medical device requirements and will be
free from deficiencies impairing the operability or safety of the
systems. The Baxter mark will be eliminated by Baxter from all
upgraded Illuminators in a manner that does not detract from the
operation or appearance of the Illuminators. The terms of the
Transition Services Agreement relating to warehousing and
distribution services and related systems (including inventory
maintenance, shipping and receiving) will apply to the
Illuminators. Baxter will protect the Illuminators against loss,
damage or destruction during the period they are in Baxter’s
possession.
b. Disposables Safety
Stock. Baxter will
maintain at all times an inventory reserve of specified Components
and finished Platelet System and Plasma System disposables (in
excess of products designated for immediate shipment), as Cerus may
specify from time to time. Baxter will invoice Cerus for such
Components and finished product as it is initially placed in
inventory, and for any increases in the reserve inventory
thereafter requested by Cerus and placed in inventory by
Baxter.
c. Disposables
Inventory. As of the
Effective Date, Cerus purchases, under the Manufacturing Agreement,
Baxter’s presently existing Platelet System inventory
consisting of an approximately [ * ]. Baxter will invoice Cerus for
such sale and Cerus shall pay such invoice within [ * ].
8. S UPPLEMENTAL T RANSITION S ERVICES . In
addition to the services already provided for in Section 10
hereof and in the Transition Services Agreement, at Cerus’
reasonable request, Baxter will provide the following supplemental
transition services relating to European activities. Baxter
personnel will provide such services at [ * ] specified in
Exhibit D. Certain Baxter regulatory and technical support is also
included in the Plasma System development services specified in
Exhibit F to this Agreement, and Cerus shall not have any payment
obligation to Baxter for such specific services beyond the payment
amount specified in such Exhibit.
a. Clinical study sponsorship activities to
continue the currently registered clinical studies in Europe until
Cerus is qualified, under the applicable regulatory guidelines, to
take over the sponsorship;
8
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
b. Regulatory and clinical support, including
product vigilance reporting and complaint handling, until the CE
Marking registrations are transferred, as further defined in
Exhibit E;
c. Installation, maintenance and calibration of
INTERCEPT Illuminators in the field until December 31, 2006;
as part of such services Baxter will maintain an inventory of spare
parts, which it will sell to Cerus [ * ] as of
December 31, 2006, it being understood that Baxter has no
obligation to avoid obsolescence of spare parts
inventory;
d. Clinical education and training until
December 31, 2006;
e. Manufacturing technical information and advice
until December 31, 2008, to the extent that Cerus requires it
beyond the technical advice meetings provided for under the
Manufacturing Agreement, which is limited to [ * ] meetings per
year.
The services will be provided by
Baxter personnel in the positions identified on such Exhibit
D.
9. M ARKETING M ATERIALS ; INTERCEPT W EB S ITE ; INTERCEPT I NTRANET .
a. Within [ * ] after the Effective Date,
Baxter will deliver to Cerus, at no cost to Cerus except shipping
costs, all marketing materials that have been produced for the
INTERCEPT Blood System products, which Baxter owns. Cerus will
remove Baxter’s mark before making use of the materials,
except for references to Baxter as appropriate to reflect
Baxter’s continuing ownership of regulatory registrations and
applications pursuant to Section 1(c) hereof. Included within
the marketing materials to be provided to Cerus, Baxter will
deliver to Cerus the ELIPS demonstration suite, at no cost other
than shipping cost to the destination designated by
Cerus.
b. Baxter hereby assigns, transfers and conveys to
Cerus all right, title and interest in the website denominated
www.interceptbloodsystem.com including all intellectual
property rights in software, which Baxter owns, associated with
such website. Promptly following the Execution Date, Baxter will
deliver to Cerus true and correct copies of the source code and
object code and documentation pertaining to such system. Promptly
following the Execution Date, the parties will cooperate to adapt
the website to reflect the changes effected by this Agreement, with
each party bearing its own expenses for such activities.
9
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
c. Baxter hereby assigns, transfers and conveys to
Cerus all right, title and interest in the INTERCEPT content of the
Baxter INTERCEPT intranet website. Promptly following the Effective
Date, Baxter will transmit such content to Cerus and Cerus shall
remove the Baxter mark before making use of the content, except for
references to Baxter as appropriate to reflect Baxter’s
continuing ownership of regulatory registrations and applications
pursuant to Section 1(c) hereof. Promptly following the
Effective Date, the parties will cooperate to adapt the website to
reflect the changes effected by this Agreement, with each party
bearing its own expenses such activities.
10. P LASMA D EVELOPMENT . With
respect to activities directed toward obtaining CE Marking for the
Pathogen Inactivation disposables for the Plasma System, and
self-declaration of the Illuminator for such System, and related
manufacturing and validation, Baxter agrees, at Cerus’
request and expense, to carry out the further development
activities set forth on Exhibit F to this Agreement. Baxter shall
use [ * ] to achieve all specified target dates and in any
event shall complete all deliverables as provided in Exhibit F. The
charge for such activities will not exceed the amount set forth in
Section 2(c) hereof, provided that the scope of such
activities is not expanded. Cerus shall own any data, invention,
discovery, improvement, patent right, copyright, trademark or other
intellectual property right made or conceived by Baxter, that is
unique to the Plasma System, and that arises out of the development
activities herein and the development activities conducted by
Baxter under the Restructuring Agreement, and such rights are
hereby assigned to Cerus to the extent not previously assigned. For
the sake of clarity, the above shall not include rights to those
technologies, formulations, sub-assemblies, components and raw
materials excluded in Section 2.4 of the 2005 License
Agreement or anything else not unique to the Plasma System. With
respect to any invention, discovery, improvement, patent right,
copyright, trademark or other intellectual property right made or
conceived by Baxter, that is not unique to the Plasma System, and
that arises out of the development activities herein and the
development activities conducted by Baxter under the Restructuring
Agreement, Baxter grants to Cerus an exclusive license in the Field
of Use for Plasma Systems.
11. P LATELET D EVELOPMENT S UPPORT . Baxter will continue to provide the support
specified on Exhibit G hereto at Baxter’s own expense until
December 31, 2006. Baxter will provide to Cerus written
reports upon completion of such activities and interim updates as
Cerus may reasonably request, and will provide copies of all
records of such activities as Cerus may reasonably request in
support of Cerus’ activities.
12. M ILESTONE P AYMENT . With
respect to the milestone payment pursuant to Section 9.5 of
the Restructuring Agreement, the CE Marking filing date shall be
the date Baxter transmits the complete CE Marking Application via
electronic or other delivery method. All other provisions of
Section 9.5 of the Restructuring Agreement will remain
unchanged.
10
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
13. T RANSITION S ERVICES A GREEMENT .
a. Section 7.0(a) Transition Services
Agreement is amended to read in full as follows: “This TSA
shall be effective for the period beginning on the Effective Date
of the Commercialization Transition Agreement and extending through
December 31, 2006.” As to Section 2.0(a) of the
Transition Service Agreement, Baxter’s compensation for the
Transition Services is reduced from [ * ] percent ( [ *
] %) to [ * ] percent ( [ * ] %) of the total
invoiced amount for Products shipped on behalf of Cerus. For
clarification, Baxter’s compensation for Supplemental
Transition Services, pursuant to Section 8 hereof, shall be in
addition to the compensation under the Transition Services
Agreement.
b. Section 2.0 (b) of the Transition
Services Agreement is deleted in its entirety and replace by the
following: “ Remittal or Revenues . On a monthly
basis, no later than the [ * ] day of each month, Baxter
will remit a payment to Cerus equal to the total invoice amount for
shipments that occurred [ * ] or more prior to the first day
of such month. Baxter will make such payments during the term of
the TSA whether such invoice has been paid or not. All remittals
made pursuant to this Agreement shall be made by direct deposit to
a Cerus account to be specified by written notice from Cerus to
Baxter.”
c. Section 2.0 (c) is amended to add the
following sentence: “Cerus shall pay Baxter for all
transferred open accounts receivable within [ * ] of
receiving Baxter’s reconciliation report.”
d. Section 3.0 (d) is deleted in its
entirety.
14. L ICENSE A GREEMENT .
a. The definition of “Residual
Products” in the License Agreement shall be amended to read
in full as follows: “Residual Products” means any
products within the Field of Use containing amotosalen or S-303
that are not included within the definition of Platelet Products,
the Plasma Products or RBC Products.”
b. Section 2.1(b) of the License Agreement
shall be amended to read in full as follows: “a nonexclusive,
royalty-bearing right and license to use, reproduce, display,
translate, distribute copies of, and to modify and create
derivative works of the Licensed Materials within the respective
parts of the Territory set forth in Clause 2.1(a); provided,
however, that such license shall be an exclusive (even as to
Baxter) license in the Field of Use only as to the Design History
Files, as defined below, relating to (i) amotosalen-treated
blood components, (ii) S-303-treated blood components,
(iii) INTERCEPT Illuminators, and (iv) compound
adsorption devices employed in the Systems except to the extent
necessary for manufacturing or packaging. For purposes of clarity,
the above exclusive license is limited to the actual Design History
Files and does not otherwise include know-how or other Licensed
Materials outside of the Design History Files. Notwithstanding the
foregoing, to the extent that any particular element of Licensed
Materials was developed or obtained by Baxter outside the course of
the Cooperative Development Work (as such term was defined under
the Platelet Agreement
11
[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT
OF 1934, AS AMENDED .
and RBC/FFP Agreement) or
development activities pursuant to the Restructuring Agreement or
this Agreement, Cerus’ license to such element of Licensed
Materials shall be limited to use in connection with systems
involving amotosalen or S-303 as an active agent and Baxter retains
the right to use such element on pathogen inactivation systems not
involving amotosalen or S-303 as an active agent.
c. Section 5.1 of the License Agreement is
amended by adding a Section 5.1 (c) to read as follows:
“(c) Notwithstanding the foregoing, Cerus and its Affiliates
shall not be obligated to pay any royalties to Baxter upon the sale
prior to December 31, 2006 of Platelet Products or Plasma
Products, or upon royalties received upon a sublicensee’s
sale of Platelet Products or Plasma Products prior to such
date.”
d. Section 5.6 of the License Agreement is
amended by deleting all text after the first sentence of such
Section.
e. As used in Section 14(c), “Design
History Files” means identifiable and tangible records
contained in, or comprising, regulatory filings, technical file,
bills of material, drawings, specifications, design test plan,
design requirements definition, requirements traceability matrix,
design verification testing, design reviews and Failure Mode
Effects Analysis.
15. M ANUFACTURING A GREEMENT .
a. Section 3.1(a) of the Manufacturing
Agreement is amended by adding a sentence to read as follows:
“Notwithstanding the foregoing, for Manufactured Products
ordered prior to December 31, 2006, the Manufacturing Fee
shall be limited to [ * ] percent ([ * ]%) of Baxter’s Cost
of Goods, for products that are purchased for commercial use and [
* ] percent ([ * ]%) of Baxter’s actual cost for products
that are purchased for clinical or preclinical
studies.”
b. A new Section 3.1 (c) is added to the
Manufacturing Agreement as follows: “At the end of each
calendar year, Baxter will calculate Manufacturing Variances
fo
