<Page>
EXHIBIT 10.37
CERTAIN CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
--------------------------------------------------------------------------------
DEVELOPMENT AND SUPPLY AGREEMENT
BY AND BETWEEN
ALLOS THERAPEUTICS, INC.
AND
BAXTER HEALTHCARE CORPORATION
CONFIDENTIAL
[ * ] = 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.
<Page>
TABLE OF CONTENTS
<Table>
<Caption>
ARTICLE
PAGE
-------
----
<S>
<C>
1
PROJECT MANAGEMENT
2
DEVELOPMENT PROGRAM
3
PRODUCT REGISTRATIONS
4
COMMERCIAL SUPPLY
5
MANUFACTURING FEE AND PRODUCT MAINTENANCE FEE
6
API
7
QUALITY MANAGEMENT AND ONGOING QUALITY RESPONSIBILITIES
8
SALES SUPPORT AND USE OF TRADEMARKS
9
TERM AND TERMINATION
10
EFFECTS OF TERMINATION
11
INTELLECTUAL PROPERTY
12
CONFIDENTIALITY
13
REPRESENTATIONS AND WARRANTIES
14
INDEMNIFICATION AND INSURANCE
15
ALTERNATE DISPUTE RESOLUTION
16
MISCELLANEOUS
</Table>
[ * ] = 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.
i
<Page>
EXHIBITS
EXHIBIT A PRODUCT SPECIFICATIONS
API SPECIFICATIONS
EXHIBIT B DEVELOPMENT PLAN (SECTION
2.1)
EXHIBIT C REGULATORY PLAN (SECTION
2.2)
EXHIBIT D DEVELOPMENT FEE AND
DELIVERABLES (SECTION 2.1)
EXHIBIT E MINIMUM LOT SIZES (SECTION
4.4)
MANUFACTURING FEE AND PRODUCT MAINTENANCE FEE (SECTIONS 5.1 AND
5.2)
EXHIBIT F CONFIDENTIAL DISCLOSURE
AGREEMENT (SECTION 12.1)
[ * ] = 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.
ii
<Page>
DEVELOPMENT AND SUPPLY AGREEMENT
This
DEVELOPMENT AND SUPPLY AGREEMENT, (the "Agreement") is effective
as
of December ____, 2003 (the "Effective
Date"), between ALLOS THERAPEUTICS, INC.
a corporation organized and existing under
the laws of the State of Delaware and
having its principal office at 11080
Circlepoint Road, Suite 200, Westminster,
Colorado 80020 ("Allos") and BAXTER
HEALTHCARE CORPORATION, a corporation
organized and existing under the laws of
the State of Delaware and having its
principal office at One Baxter Parkway,
Deerfield, Illinois 60015 ("Baxter").
All references to "Allos" and "Baxter" will
include their respective Affiliates.
BACKGROUND
Allos is developing a synthetic allosteric
modifier of hemoglobin, RSR13
("Compound"), indicated for use in cancer
treatment to increase the efficiency
of cancer radiotherapy. The Compound
enhances the release of oxygen from
hemoglobin making oxygen more available for
use by the tissues. . Allos has
developed a solution of RSR13 in an aqueous
carrier presented in a glass
container, [ * ]
Baxter manufactures and markets premix,
ready-to-use solutions [ * ] for
parenteral administration of pharmaceutical
preparations. [ * ].
Allos is also interested in transferring
the technology for the current
production of premix RSR13 in a glass
container to Baxter, such that Baxter
would manufacture and package the solution
of the Compound in an aqueous carrier
in Baxter's glass container
Allos and Baxter are therefore interested
in forming a relationship to develop
and manufacture premix forms of the
Compound, [ * ], in accordance with the
terms and conditions set forth in this
Agreement.
[ * ]
DEFINITIONS
As used in this Agreement the following
terms will have the following meanings:
"ADR" will have the meaning set forth in
ARTICLE 15.
"AFFILIATE" will mean any corporation or
business entity that controls, is
controlled by, or is under common control
with, Allos or Baxter. A corporation
or business entity will be deemed to
control another corporation or business
entity if it owns, directly or indirectly,
fifty percent (50%) or more of the
securities or other ownership interests
representing the equity, the voting
stock or general partnership interest of
such corporation or business entity.
"ALLOS INVENTIONS" will have the meaning
set forth in SECTION 11.1.2.
"API" will mean all active pharmaceutical
ingredients supplied to Baxter by
Allos in accordance with the terms of this
Agreement and the Specifications set
forth in EXHIBIT A.
"API/FORMULATION SPECIFICATIONS" will have
the meaning set forth in SECTION
11.2.1.
"API SPECIFICATIONS" will mean the Baxter
Procedure Specification D2-01-30-788.
Upon Regulatory Approval for the Product
the API Specification will mean the
Baxter Procedure Specification
02-01-30-788.
[ * ] = 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.
<Page>
"BACKGROUND INTELLECTUAL PROPERTY RIGHTS"
will mean all patents, patent
applications, copyrights, trade secrets,
and other intellectual property rights
owned by either Party or under which a
Party otherwise has the right to grant
licenses without accounting to any third
party or to the other Party, where the
inventions claimed, the works of
authorship, or the know-how, trade secrets and
the like, were not made in performance of
activities pursuant to, or in
anticipation of, this Agreement.
"BAXTER INVENTIONS" will have the meaning
set forth in SECTION 11.1.3.
"COMMUNICATIONS" will have the meaning set
forth in SECTION 3.4.
"COMPOUND" will mean the synthetic
allosteric modifier of hemoglobin, RSR13,
having the chemical formula:
2-[-[[(3,5-Dimethylanilino)carbonyl]methyl]phenoxy]-2-methylpropionic
acid].
"CONFIDENTIAL DISCLOSURE AGREEMENT" will
mean the two-way disclosure agreement
signed by the Parties, a copy of which is
attached to this Agreement as EXHIBIT
F.
"CONFIDENTIAL INFORMATION" will have the
meaning set forth in ARTICLE 12.
"CONTAINER" will mean [ * ] and will mean
the container portion of the Product
as described in EXHIBIT A.
"CONTRACT YEAR" will have the meaning set
forth in SECTION 9.1.1.
"CONTROL" will mean possession of the
ability to grant the licenses or
sublicenses as provided for herein without
violating the terms of any agreement
or arrangement with any third party.
"cGMP" or "CURRENT GOOD MANUFACTURING
PRACTICES" will mean (i) the good
manufacturing practices required by the FDA
and set forth in the FD&C Act or FDA
regulations, policies, or guidelines in
effect at a particular time, for the
manufacture and testing of pharmaceutical
materials and (ii) the corresponding
regulatory requirements of each
jurisdiction in the Territory relating to the
manufacture and testing of Product.
"DELIVERABLES" will mean the materials set
forth on EXHIBIT D.
"DEVELOPMENT FEES" will have the meaning
set forth in SECTION 2.1.5.
"DEVELOPMENT PLAN" will mean the plan for
development of the Product, as set
forth in EXHIBIT B and described generally
in SECTION 2.1.1.
"DEVELOPMENT PROGRAM" will mean the
collaborative research and development
effort between the Parties to develop the
Product which will enable Allos to
file Regulatory Submissions with Regulating
Groups in the Territory and which
encompasses the tasks set forth on EXHIBIT
B (Development Plan) and EXHIBIT C
(Regulatory Plan) and the Deliverables set
forth on EXHIBIT D.
"DRUG ESTABLISHMENT FEE" will have the
meaning set forth in SECTION 3.5.
"ESTIMATED REQUIREMENTS" will have the
meaning set forth in SECTION 4.3.
"FDA" will mean the United States Food and
Drug Administration and any successor
agency.
"FD&C ACT" will mean the United States
Federal Food, Drug and Cosmetic Act, as
amended.
"FIELD" will mean the research for,
development for, registration and
manufacture of, the Product and any
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
2
<Page>
Formulation.
"FIRST OF CODE" will mean Product resulting
from the manufacture of the first
three (3) production batches intended for
commercial sale.
[ * ]
"FORCE MAJEURE" will have the meaning set
forth in SECTION 16.6.
"FORMULATION" will mean any and all premix
ready-to-use aqueous solutions
containing the Compound that have been
formulated for [ * ].
"FORMULATION SPECIFICATIONS" will mean
those specifications for the final
release of the premix, ready-to-use aqueous
solution that are developed and
finalized by the Parties as part of the
Development Program and which, together
with the Container, are part of the Product
Specifications.
[ * ]
"INFORMATION" will mean (i) techniques and
data relating to the Field,
including, but not limited to, ideas
(including patentable inventions),
inventions, practices, methods, knowledge,
trade secrets, documents, apparatus,
clinical and regulatory strategies, test
data (including pharmacological,
toxicological and clinical test data),
analytical and quality control data,
manufacturing, patent and legal data,
market data, financial data within the
Field and (ii) chemical formulations,
compositions of matter, product samples
and assays within the Field.
"INITIAL TERM" will have the meaning set
forth in SECTION 9.1.1.
"JOINT INVENTIONS" will have the meaning
set forth in SECTION 11.1.4.
"MANUFACTURING FEE" will mean the fee per
unit paid by Allos to Baxter for
Product manufactured under this Agreement
as described in SECTION 5.1 and
EXHIBIT E.
"MANUFACTURING PROCESS(ES)" will have the
meaning set forth in SECTION 6.3.
"MATTER" will have the meaning set forth in
SECTION 14.3.
"NDA" will mean a New Drug Application, as
defined in the FD&C Act and
applicable regulations promulgated
thereunder, as amended from time to time.
"ORIGINAL PRODUCT DATA" will have the
meaning set forth in SECTION 11.2.1.
"PARTY" or "PARTIES" will mean Allos and
Baxter individually, and collectively,
as applicable.
"PATENT" will mean (i) valid and
enforceable letters patent including any
extension, registration, continuation,
reissue, reexamination or renewal thereof
and (ii) to the extent valid and
enforceable rights are granted by a
governmental authority thereunder, a Patent
Application.
"PATENT APPLICATION" will mean an
application for letters patent.
"PRE-EXISTING SPECIFICATIONS" will have the
meaning set forth in SECTION 11.2.1.
"PRODUCT" will mean a premixed solution
incorporating Compound in the
Formulation which has (i) undergone the
development process established under
ARTICLE 2 and (ii) been packaged and
terminally
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
3
<Page>
sterilized within the Container, all in
accordance with the Product
Specifications.
"PRODUCT SPECIFICATIONS" will mean the
Formulation Specifications together with
the Container, which collectively describe
the Product and are developed and
finalized by the Parties as part of the
Development Program. The Product
Specifications are set forth on EXHIBIT A
attached hereto, subject to amendment
as provided in the Quality Agreement.
"QUALITY AGREEMENT" will mean the quality
agreement signed by the Parties on
even date herewith.
"REGULATING GROUPS" will mean the FDA and
its successors and similar
governmental agencies outside the United
States and in the Territory which are
responsible for granting manufacturing,
marketing, price and/or reimbursement
price authorizations and includes
applicable national, supra-national (e.g. the
European Commission or the Council of the
European Union), state or local
Regulating Groups, department, bureau
commission, council or other governmental
entity in the Territory that has
jurisdiction over the API, Compound,
Formulation or Product, whether the
development, manufacture, handling, storage,
transportation, destruction, or
otherwise.
"REGULATORY APPROVAL" means (a) in the
United States, approval by the FDA of any
applicable filing and satisfaction of any
related applicable FDA registration
and notification requirements (if any)
required to market and sell a
pharmaceutical product or device; or (b) in
any country other than the United
States, approval by Regulating Groups
having jurisdiction over such country of a
single application or set of applications
or other applicable filing and
satisfaction of any related applicable
regulatory and notification requirements,
if any, necessary to market and sell
pharmaceutical products or devices
commercially in such country.
"REGULATORY PLAN" will mean the principal
regulatory considerations that are
associated with Product development during
the Development Program as set forth
in EXHIBIT C and described generally in
SECTION 2.2.
"REGULATORY SUBMISSIONS" will mean those
applications and filings identified in
the Regulatory Plan and required by FDA
regulations, as amended from
time-to-time, and the equivalent
applications and filing for each country or
super-national jurisdiction in the
Territory, including but not limited to, the
Product's NDA or Investigational New Drug
Application (INDA).
"REPORTS" will have the meaning set forth
in SECTION 11.2.1.
"REQUIREMENTS" will have the meaning set
forth in SECTION 4.1.
"STEERING COMMITTEE" will have the meaning
set forth in SECTION 1.3.
"SUPPORTIVE DOCUMENTS" will have the
meaning set forth in the Quality Agreement.
"TEAM LEADERS" will have the meaning set
forth in SECTION 1.1.
"TERM OF THE AGREEMENT" will have the
meaning set forth in SECTION 9.1.1.
"TERRITORY" will mean the United States,
Canada, and member states of the
European Union, and any additional
countries added by written agreement of the
Parties.
"USCDMF" means Baxter's United States
Container Drug Master File for the
Container.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
4
<Page>
TERMS
1. PROJECT MANAGEMENT. In
order to facilitate collaboration between the
Parties to achieve the objectives of this
Agreement, the Parties agree to the
following organizational provisions:
1.1
TEAM LEADER. Baxter and Allos will each identify one
employee with appropriate authority to
serve as the primary contact with the
other Party about the Product and the
Parties' relationship under this Agreement
(each a "Team Leader"). Each Team Leader
will be responsible for obtaining
cooperation and input from other
individuals within such Team Leader's
organization whose expertise and ability
may be required from time to time to
maximize the potential for successful
collaboration under this Agreement. The
Team Leader will be a member of the
Steering Committee described in SECTION 1.3.
The Parties will determine whether or not
the Team Leader during the Product's
Development Program should continue to
serve as the Team Leader during the
commercialization of the Product, or
whether another individual should be serve
this function under this Agreement.
1.2
TEAM LEADER RESPONSIBILITIES. Without limiting the scope of
the Team Leader's responsibilities,
particular consideration will be given to
key operational aspects of the
relationship, including: (i) product development
and regulatory matters highlighted in the
Development Plan (EXHIBIT B) and
Regulatory Plan (EXHIBIT C); (ii)
transitioning team leadership responsibilities
to a corresponding team leader, if
appropriate, once commercialization of the
Product is undertaken, including such
matters as Product manufacturing, quality
and sales support considerations; (iii)
coordinating pre launch inventory
assessments and inventory planning
activities in connection with the launch of
the Product into the marketplace; (iv)
reviewing the status of ongoing
contractual commitments under the
Agreement; and (v) identifying and
implementing those actions as are permitted
under the terms of this Agreement
which would improve the value of the
Product to customers and the Parties. The
Team Leaders will develop a process and
procedures to optimize communication and
collaboration between the Parties in order
to timely refine the Development Plan
and Regulatory Plan and achieve the
objectives of this Agreement. The Team
Leaders will communicate regularly during
the Term of the Agreement at mutually
agreeable times (not less frequently than
once per month), and when necessary
hold meetings at mutually agreeable places,
to review progress and the
challenges and opportunities for effective
collaboration under this Agreement.
The Team Leaders will analyze issues that
arise during the Development Program
and subsequent commercialization of the
Product and offer recommendations to the
Steering Committee as to the appropriate
course of action.
1.3
STEERING COMMITTEE. A steering committee, consisting of the
Team Leaders and at least one senior
management representative from each Party
("Steering Committee"), will meet at least
once per calendar quarter during the
Term of this Agreement, either in person or
by telephone or video conference.
The Steering Committee will (i) oversee and
provide management direction for the
achievement of the objectives of the
collaborative effort; (ii) review the
program of research and development
activities set forth in the Development Plan
and Regulatory Plan; (iii) review requests
by Regulating Groups, or a Party,
that additional tests, studies or
activities be performed beyond those
encompassed in the Exhibits, make
recommendations, and appropriate allocations
of additional expenses in accordance with
the provisions of SECTION 2.1.5.2;
(iv) be responsible for obtaining from
their respective organizations approval
of the Regulatory Plan prior to Product
stability batch production (the
Regulatory Plan will be finalized during
the Development Program as described in
SECTION 2.2); (v) periodically review
performance of the Product in the
Territory with respect to unit volume and
quality, including any customer
feedback and complaints that relate to
manufacturing, Formulation and/or
Container-related quality issues; (vi)
develop a plan for [ * ]; (vii) be
responsible for approving any non-material
changes, and obtaining from their
respective organizations approval of any
material changes approved by the
Steering Committee that require amendments
to this Agreement, to the Development
Plan, or Regulatory Plan set forth in
EXHIBITS B and C respectively; and (viii)
attempt to resolve any issues that arise
concerning activities under the
Development Plan or Regulatory Plan. The
Steering Committee will
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
5
<Page>
establish a process for timely review and
approval of non-material changes to
the Development Plan and Regulatory Plan
submitted by the Team Leaders. Any
decisions upon which the Steering Committee
is unable to reach a consensus shall
be subject to resolution pursuant to
ARTICLE 15.0.
2. DEVELOPMENT
PROGRAM
2.1
DEVELOPMENT
PLAN.
2.1.1 GENERAL.
The activities and key milestones to occur during
the Development Program include, but are
not limited to, the following
activities or topics: (i) technical
feasibility assessment for the Product [ *
]; (ii) formulation and analytical
development for the Product in the Container;
(iii) stability studies and Product batch
production to support Regulatory
Submissions for the Product in the
Container; (iv) Regulatory Submissions for
the Product in the Container, and (v)
Regulating Groups' review and approval for
the Product in the Container. The
Development Program covered by this Agreement
is solely related to presentation of the
Formulation in the Container, and does
not include [ * ].
In
general, during the Term of this Agreement, Allos will be
responsible
for (i) providing Information about the API
that is necessary for Baxter to
conduct the Development Program, (ii)
timely providing the API and applicable
reference standards required for
implementation of the activities described in
the Development Plan, (iii) compliance with
Regulatory Submission reporting
requirements regarding manufacture and
control of the API, and (iv) timely
review, drafting and filing of all
necessary submissions with Regulating Groups
consistent with Allos's obligations under
the Regulatory Plan. Allos will also
be responsible for providing Baxter with
(i) all information controlled by Allos
developed by or on behalf of Allos prior to
the date of this Agreement related
to manufacture of the Formulation [ * ],
and (ii) [ * ].
In general, during the
Term of this Agreement, Baxter will be responsible
for (a) expeditiously conducting all
development studies identified as a Baxter
Deliverable in the Development Plan, (b)
providing the reports described in
SECTION 11.2 of this Agreement, (c)
manufacturing Product for Regulatory
Submissions and as otherwise provided in
the Development Plan and pursuant to
the Regulatory Plan set forth as part of
EXHIBITS B and C, respectively, (d)
preparing those portions of necessary
Regulatory Submissions with Regulating
Groups consistent with Baxter's obligations
under the Regulatory Plan, (e)
supporting Allos in its efforts to obtain
and maintain Regulating Group approval
to sell the Product in the Territory, and
(f) manufacturing Product for
commercial supply in accordance with the
procedures specified in ARTICLE 4
below.
2.1.2
DELIVERABLES. Baxter will promptly disclose to Allos during
the Term of this Agreement, in English and
in writing, all Baxter materials set
forth in EXHIBIT D which include such
interim progress reports and test results
agreed upon by the Parties. Allos will
promptly disclose to Baxter during the
Term of this Agreement, in English and in
writing, all Allos materials set forth
in EXHIBIT D. Baxter represents that the
Deliverables reflect Baxter's best
estimate of what is required to obtain and
maintain approval to sell the Product
in the Territory, based upon Baxter's
experience and the regulations in effect
on the Effective Date, but Baxter cannot
guarantee that the Deliverables will be
sufficient to fulfill the requirements of
the Regulating Groups.
2.1.3 ADDITIONAL
DELIVERABLES. If the Deliverables set forth in
EXHIBIT D prove to contain insufficient
Information for a Party to carry out its
responsibilities under this Agreement to
obtain and maintain Regulating Group
approval and registration of the Product in
the Territory in accordance with
ARTICLE 3, including information required
for Allos to complete the FDA's Annual
Report and similar reports required by
other Regulating Groups in the Territory,
or to obtain patent protection in
accordance with ARTICLE 11.0, the Parties
will, subject to SECTION 2.1.5.2, amend
EXHIBIT D to include as a Deliverable
the additional Information which is
necessary for such purpose upon a Party's
reasonable request for such additional
Information.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
6
<Page>
2.1.4 PROCESS
FINALIZATION AND SCALE-UP. Baxter shall conduct all
work necessary for finalization of the
manufacturing process for the Product,
including all documentation specified in
the Development Plan. The required
documentation includes all Supportive
Documents required for stability and
consistency batches, process scale-up and
validation (including but not limited
to validating cleaning, sampling and
analytical methods, sterilization),
stability and consistency studies necessary
to obtain regulatory approval.
Baxter shall also conduct such further work
as may be needed to satisfy any
pre-approval inspection or other
inspections by Regulating Groups and to
finalize any amendments or supplements to
any prior Regulatory Submission. All
validation and other protocols, and all
final reports, shall be reviewed and
approved by the Team Leaders for each
Party. Baxter and Allos shall share
equally the costs of replicating any tests
that are unsatisfactory to the
Regulating Groups, except that: (1) Baxter
shall bear the costs of replicating
any tests, studies or other activities that
were not performed in accordance
with protocols approved by the Team
Leaders; (2) tests that must be repeated due
to deficiencies that result from the
written rejection by Allos of Baxter's
recommendation shall be handled as provided
in SECTION 2.1.3; and (3) Baxter
shall bear the costs of conducting any
tests, studies or other activities that
Allos had recommended Baxter perform and a
Regulatory Agency subsequently
requires that such tests, studies or other
activities must be performed in
connection with the Regulatory Approval of
the Product.
2.1.5
DEVELOPMENT FEES; PAYMENT.
2.1.5.1 GENERAL. Fees
payable by Allos to Baxter for the
activities set forth in EXHIBIT D that are
to be performed by Baxter under this
Agreement, are described in EXHIBIT D,
together with payment milestones
("Development Fees"). No payment required
under EXHIBIT D is due and payable
until the Allos Team Leader confirms that
the applicable milestone event has
been achieved. Any dispute regarding
whether an applicable milestone event has
been achieved shall be subject to
resolution pursuant to ARTICLE 15.0.
2.1.5.2 ADDITIONAL WORK.
The activities described in the
Exhibits are the basis for determination of
the Development Fees. Baxter will
not be required to perform, nor be entitled
to reimbursement for, any work
beyond that described in the Exhibits
unless and until the Parties reach written
agreement (coordinated through the Steering
Committee under SECTION 1.3) on the
scope of any additional work and the
related additional expenses.
Notwithstanding the foregoing, if any
tests, studies or other activities beyond
those encompassed by the Exhibits are
requested by the Steering Committee
pursuant to SECTION 1.3 which are required
for obtaining or maintaining
approvals or registrations of the Product
in the Territory, then such tests,
studies or other activities will be
conducted as determined by the Steering
Committee, at Allos's expense. To the
extent Baxter assists Allos in conducting
such additional tests, studies or other
activities, Allos will pay Baxter a fee
to be negotiated in good faith between the
Parties. By way of example,
additional development work might be
required in response to Regulating Group
requests during review of Regulatory
Submissions (such as laboratory work or
environmental assessment), additional tests
to demonstrate compliance with other
compendia, or country specific import
testing requirements. However, any
Deliverables, tests, studies or other
activities that must be repeated due to
Baxter's negligence or that were omitted
from the Exhibits due to Baxter's
negligence will be performed at Baxter's
expense; any disagreement regarding
whether Baxter was negligent shall be
referred to the Steering Committee and, if
the Steering Committee is unable to resolve
the disagreement, shall be handled
as provided in SECTION 15.0.
2.1.5.3.
CHANGES TO MANUFACTURING PROCESS. Baxter will
follow its established procedures for
changes (if any) which are made to its
manufacturing process and which relate to
the manufacture of the Product. Any
such changes in the manufacturing process
initiated by Baxter will be done at
Baxter's expense. Such established
procedures shall be disclosed to Allos in
advance, subject to SECTION 12 of the
Agreement. The review of changes must
follow the change control process outlined
in section 12 of the Quality
Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
7
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2.1.5.4 PAYMENT.
Development Fees and authorized
additional Development Fees will be paid by
Allos in United States dollars
within [ * ] of invoicing by Baxter
following completion of the designated
activities. Invoices for amounts that are
not subject to good faith dispute and
not timely paid will be subject to a late
payment charge of [ * ], or the
highest rate allowed by law if lower, until
paid in full.
2.2
REGULATORY PLAN.
EXHIBIT C sets forth a Regulatory Plan for
obtaining Regulatory Approval of the
Product. [ * ] Collaboration and approvals
will be coordinated through the Steering
Committee as provided in SECTION 1.3.
Allos will be solely responsible for the
reporting to Regulatory Groups adverse
experiences with respect to the
Product.
2.3
PRODUCT.
2.3.1 PRODUCT
SPECIFICATIONS. EXHIBIT A includes Product
Specifications in provisional form as of
the Effective Date and will be refined
and agreed upon by the Parties prior to
launch of the Product as part of the
Development Program. Allos will be
responsible for and provide final approval of
Formulation Specifications, and all changes
thereto, and will approve [ * ].
Baxter must obtain Allos's prior written
approval of any changes to the Product
Specifications, as provided in the Quality
Agreement ("CHANGES TO PRODUCT
SPECIFICATIONS"). Allos's approval of
Formulation Specifications and [ * ] will
be deemed to constitute approval of Product
Specifications by Allos for
regulatory purposes. Collaboration and
approvals will be coordinated through the
Steering Committee as provided in SECTION
1.3.
2.3.2 LABEL
COPY. Subject to the Quality Agreement ("PRODUCT
LABELS AND LABELING"), all label copy and
changes therein, on the Product label
itself and other label copy that Allos uses
to market Product in the Territory,
will be the responsibility of Allos, except
that Baxter will be responsible for
that portion of the Product label and other
label copy related to the
description, characteristics and/or use of
the Container.
3.0 PRODUCT REGISTRATIONS
3.1
PRODUCT
REGISTRATION APPLICATION OWNERSHIP. Allos will be the sole
owner of any registration applications
submitted to Regulating Groups for the
Product and [ * ]. Allos will have the
primary responsibility for the
documentation and submission of the
registration applications to Regulating
Groups for the Product in the Territory and
for completing the FDA Annual Report
and similar reports required by other
Regulating Groups for Product, with
support from Baxter in the carrying out of
responsibilities by Baxter in
accordance with the terms of this
Agreement. Communications to and from the FDA
and other Regulating Groups that involve
the NDA or any other Regulatory
Submissions to Regulating Groups for the
Product are subject to the provisions
of SECTION 3.4.
3.2
PRODUCT
REGISTRATION IN THE UNITED STATES.
3.2.1 RIGHT OF
REFERENCE CONTAINER DRUG MASTER FILE. During the
Term of this Agreement, Baxter grants Allos
a right of reference to relevant
elements of the USCDMF filed with the FDA
for the Container, including, but not
limited to, cGMP and safety data for the
Container, for the purpose of
Regulatory Submissions and obtaining
Regulatory Approval or other product
registrations for the Product in the
Territory in the name of Allos, and to any
other extent provided in the Development
Plan and Regulatory Plan. Baxter agrees
that no change described in the USCDMF, any
amendments to the USCDMF, or any
supplemental USCDMF with respect to the
Container, potentially having an impact
on the Product, shall be implemented on the
Product without prior written
approval from Allos. Baxter shall otherwise
fully cooperate with Allos in the
preparation of Regulatory Submissions
relating to manufacturing operations
conducted by Baxter.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
8
<Page>
3.2.2 ADDITIONAL
FILING DATA. During the Term of this Agreement,
Baxter will, following prior written notice
to Allos, provide the FDA and all
other Regulating Groups in the Territory,
with Container-related data and
information which are required for Allos to
obtain and maintain registration and
approval of the Product in good standing in
the Territory. Baxter reserves the
right to inform the FDA and other
Regulating Groups that such information is
confidential and to advise the FDA and such
Regulating Groups that Allos will be
entitled to reference such information on a
confidential basis during the Term
of this Agreement.
3.3
PRODUCT
REGISTRATION OUTSIDE THE UNITED STATES. Allos recognizes
that Baxter data and information required
for the purpose of obtaining Product
registrations in the Territory outside the
United States is highly confidential
and agrees that it is reasonable for Baxter
to use appropriate and available
means to maintain the confidentiality of
such information provided that
regulatory approvals of the Product are not
hindered. In this regard, Baxter
will determine which of any jurisdictions
in the Territory will accept a
separate application from Baxter similar to
a USCDMF. In these jurisdictions,
Baxter, in its reasonable discretion and in
consultation with Allos, may [ * ].
For purposes of this SECTION 3.3, Baxter
may determine, in its reasonable
discretion and in consultation with Allos,
what data and information are
required for Product registration; PROVIDED
that in the event that a Regulating
Group requests additional data or
information in order to approve Product
registration, Baxter will fully cooperate
with Allos to meet such request. In
addition, Baxter and Allos will carry out
all Territory-specific strategies
described in the Regulatory Plan for
obtaining Regulatory Approval in such
Territories.
3.4
COMMUNICATIONS
TO/FROM REGULATING GROUPS. In the event of any
communication from or to the FDA, or any
other Regulating Groups, in connection
with the manufacture of the Product
(collectively "Communications"), the Party
first becoming aware of the same will
promptly notify the other Party of such
Communications and, before taking action
with Regulating Groups, the Parties
will discuss and use reasonable efforts to
agree on (i) whether copies of such
Communications and/or other Information
should be provided to each other as
additional Deliverables pursuant to SECTION
2.1.3; (ii) which Party should
respond to Communications received; and
(iii) which individuals need to
collaborate on a response to Communications
received. In the event that Baxter
and Allos are unable to agree on the
foregoing items, then Allos's position will
prevail as it pertains to all
Communications sent to Regulating Groups relating
to the API, Formulation, and the Product,
except with respect to that portion of
the responses which relates solely to the
Container and then Baxter's position
will prevail. All information relating to
any Communication disclosed under this
SECTION 3.4 is subject to confidential
treatment pursuant to the terms of
ARTICLE 12.
3.5
USER FEES.
Baxter will pay all user and/or filing fees charged by
Regulating Groups in the Territory which
relate to separate Container
submissions (including DMF submissions) and
the Drug Establishment Fee ("DEF")
charged by the FDA. In the event that a
Regulating Group other than the FDA
requires payment of a manufacturing
facility fee similar to the DEF charged by
the FDA, then Baxter and Allos will
mutually agree on an appropriate allocation
of that fee between the Parties, provided
that, if the fee is solely
attributable to manufacture of the Product,
Allos will pay the entire fee. Allos
will pay all user and/or filing fees
charged by Regulating Groups in the
Territory which relate to the registration
application and ongoing marketing of
the Product, including, but not limited to,
the Application Fee and the Drug
Product Fee charged by the FDA.
4.0 COMMERCIAL SUPPLY
4.1
EXCLUSIVE SUPPLY
AND PURCHASE OBLIGATIONS DURING TERM OF AGREEMENT.
[ * ] In addition, for the Term of the
Agreement, Allos shall purchase [ * ] of
its annual commercial requirements up to
Allos's total projected requirements
for each Contract Year (as specified in
EXHIBIT E) for sale, distribution and
use in the Territory of ready-to-use
aqueous solution containing the Compound in
an intravenous form [ * ] from Baxter, and
Baxter will manufacture and sell
ready-to-use aqueous solution containing
the Compound in an intravenous form [ *
] exclusively for/to Allos, for sale,
distribution and use
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
9
<Page>
in the Territory. Baxter agrees to maintain
adequate facilities with capacity to
satisfy such requirements based upon the
forecasts provided by Allos. [ * ]
Except with respect to API, Baxter shall be
responsible for establishing the
necessary procedures, vendors, inventory,
capacity and management practices
needed to ensure its ability to meet
Allos's requirements for Product, in
accordance with SECTION 4.4.1. Allos's
obligations under this SECTION 4.1 will
be waived (and Allos may thereafter
purchase Product units from another
supplier) to the extent that Baxter fails
to satisfy Allos's Product
requirements or if the Steering Committee
identifies circumstances that which
provide a reasonable basis for concluding
that Baxter will likely not be able to
satisfy Allos's Product requirements and
such failure is not due to Allos's
failure to meet its obligations under this
Agreement. The Parties' obligations
under this SECTION 4.1 may be terminated [
* ], or modified [ * ], as provided
in SECTION 9.2.2 of this Agreement.
4.2
MINIMUM PURCHASE
OBLIGATION. During the first Contract Year (as
defined in SECTION 9.1.1), Allos shall
purchase a minimum of [ * ] of the
Product and in each Contract Year
thereafter [ * ] units of the Product, subject
to adjustment in accordance with EXHIBIT E
if development of the Product [ * ]
is terminated as described in SECTION 9.2.2
below (the "Minimum Purchase
Requirement"). If Allos fails to purchase
the Minimum Purchase Requirement in
any Contract Year, within thirty (30) days
after the end of such Contract Year,
Allos shall pay Baxter an amount equal to
the amount per unit set forth in
EXHIBIT E multiplied by the shortfall in
units. In such event, Allos may, upon
written notice to Baxter, request that
Baxter promptly ship to Allos all or any
portion of the units of Product making up
the shortfall for which Allos has paid
Baxter. Allos shall not be obligated to pay
any shortfall amount if Allos's
failure to meet the Minimum Purchase
Requirement is due to Baxter's inability to
supply Allos with its requirements of
Product conforming to the Product
Specifications in the applicable Contract
Year and Baxter's inability to supply
such requirements is not due to Allos's
failure to meet its obligations under
this Agreement.
4.3
FORECASTS. In
order to assist Baxter in its production planning of
Product for supply to Allos, Allos will
provide to Baxter, at least [ * ] days
before the beginning of each calendar
quarter commencing with the first
submission of an NDA (or the foreign
equivalent of an NDA in any country of the
Territory other than the United States) to
a Regulating Group in the Territory
by Allos for the Product and continuing
thereafter during the Term of this
Agreement, a statement of Allos's estimated
purchase requirements ("Estimated
Requirements") and expected delivery dates
for Product for such calendar quarter
and the next succeeding [ * ]. It is
understood that such Estimated Requirements
will NOT constitute commitments to purchase
Product or firm purchase orders.
4.4
FIRM PURCHASE
ORDERS.
4.4.1 GENERAL.
Allos will place firm purchase orders for Product
at least [ * ] days prior to the beginning
of each calendar quarter. [ * ] Firm
purchase orders for Product [ * ] will be
placed in increments of no less than
the minimum number of units specified in
EXHIBIT E, or such other number of
units as then corresponds to the filling
production lot sizes for Product [ * ].
Subject to the provisions of SECTION 4.4.2,
firm purchase orders for Product [ *
] will be not less than [ * ] nor more than
[ * ] of Allos's Estimated
Requirements of Product [ * ] for what was
the [ * ] in the most recent prior
forecast. Notwithstanding the foregoing,
Baxter will use reasonable efforts to
comply with any of Allos's unplanned
changes in firm purchase orders, but will
not be held liable for its inability to do
so. Subject to this Section, SECTIONS
6.3, 13.2 and 16.6, Baxter will meet
Allos's requested delivery dates. Both
Parties agree to work together to reduce
lead time for orders and deliveries.
Firm purchase orders will be made on such
form of documentation as Baxter and
Allos agree from time to time, provided
that the terms and conditions of this
Agreement will be controlling over any
terms and conditions included in any
purchase order form used in ordering
Product. Any term or condition of such
purchase order form that is in addition to,
different from or contrary to the
terms and conditions of this Agreement will
be void, unless the Parties
otherwise agree by a separate written
agreement. The parties will work together
as directed by the Steering Committee to
expedite the manufacture of First of
Code production and the delivery of Allos'
initial Product order as soon as
possible after Regulatory approval.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
10
<Page>
4.4.2
CANCELLATION OF PURCHASE ORDERS AND RESCHEDULING. Allos may
cancel a firm Product purchase order or
reschedule requested delivery dates to a
later date by giving Baxter prior written
notice to such effect. Baxter will use
reasonable efforts to comply with Allos's
requests. If, however, either (i) a
cancellation of a firm purchase order or
(ii) a rescheduling of delivery dates
for a firm purchase order that would cause
a rescheduling by Baxter of the
Product manufacturing date, is requested by
Allos thirty (30) days or less prior
to Baxter's scheduled production date for
the firm purchase order, Baxter shall
so notify Allos. If after such notice,
Allos still desires such cancellation or
rescheduling of delivery dates, Allos will
pay Baxter a cancellation fee or
rescheduling fee equal to [ * ] of the
Manufacturing Fee for that portion of
such firm Product purchase order that has
been cancelled or rescheduled. Partial
cancellations must be in increments of the
minimum lot size specified in EXHIBIT
E.
4.5
DELIVERY;
SHIPMENT. All Product supplied under this Agreement will
be delivered Free Carrier ("FCA" under
Incoterms 2000) Baxter's manufacture site
specified in the Quality Agreement, except
that Product manufactured at Baxter's
Cleveland, Mississippi site shall be
delivered FCA Memphis. Baxter will make
shipping arrangements with the appropriate
carriers designated in writing by
Allos from the FCA point, under the
agreements that Allos has with those
carriers. Title and risk of loss passes to
Allos when the Product has been
quality control released for shipment to
Allos or its designee in accordance
with Product Specifications and transferred
to the carrier designated by Allos,
[ * ], unless acceptance of the Baxter
release is disputed in good faith by
Allos. Accordingly, Allos will be deemed
the exporter of record for Product
shipped outside of the United States (which
should only occur to the extent such
areas are included in the definition of
"Territory"). Allos warrants that all
shipments of Product outside the United
States will be in compliance with all
applicable United States export laws and
regulations, including the Export
Administration Act, and all applicable
import laws and regulations.
5.0 MANUFACTURING FEE AND
PRODUCT MAINTENANCE FEE
5.1
MANUFACTURING
FEE. For each unit of Product requested by Allos
pursuant to a Product purchase order as set
forth in SECTION 4.4.1 above, Baxter
will invoice Allos a Manufacturing Fee per
unit of Product in the amount set
forth in EXHIBIT E, upon release to
finished goods inventory of Product that has
been quality control released for shipment
to Allos or its designee in
accordance with the Product Specifications
set forth in EXHIBIT A. Baxter will
release Products to finished goods
inventory not more than [ * ] days prior to
the scheduled delivery date for such
Products.
5.2
PRODUCT
MAINTENANCE FEE. Baxter will invoice Allos a Product
Maintenance Fee in the amount set forth in
EXHIBIT E on a calendar quarterly
basis. The Product Maintenance Fee is
compensation to Baxter for expenses Baxter
incurs by having manufacturing capacity
allocated to producing the Product,
including but not limited to documentation
and quality control, ongoing
inventory management, regulatory support,
including NDA reporting requirements,
minor label changes requested by Allos, and
annual stability studies.
5.3
ADJUSTMENTS.
Baxter may, following not less than ninety (90) days
prior written notice to Allos, adjust the
Manufacturing Fee and the Product
Maintenance Fee on each annual anniversary
of a Contract Year beginning with the
first day of the third (3rd) Contract Year,
by an amount which does not [ * ]. [
* ].
5.4.
ADDITIONAL WORK AND
FEES. The Manufacturing Fee and Product
Maintenance Fees described in SECTIONS 5.1
and 5.2. are based upon the scope of
activities that Baxter plans to undertake
in the ordinary course to manufacture
and release Product in accordance with the
Product Specifications and other
Exhibits, as well as the Quality Agreement.
The Manufacturing Fee and Product
Maintenance Fees do not cover activities or
expenses related to matters that
might arise outside the ordinary course
of
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
11
<Page>
manufacturing and releasing Product in
accordance with the Product
Specifications, the Development Plan
(EXHIBIT B) and other Exhibits, as well as
the Quality Agreement. By way of example,
additional work might be required for
Product or process changes requested by the
FDA or other Regulating Groups, API
source changes or Manufacturing Process
changes, USP or other regulatory
requirements changes, excessive or untimely
requests by Allos for label changes
or recalls or other actions by Regulating
Groups, or mutually agreed upon
expansion of the Territory. Baxter will not
be required to perform, nor be
entitled to reimbursement for, any such
work until the Parties, coordinated
through the Steering Committee under
SECTIONS 1.3 and 2.1.5.2, reach written
agreement on the scope of the additional
work and the related additional
expenses; PROVIDED that Baxter shall bear
the costs of replicating any tests,
studies or other activities that were not
performed by Baxter in accordance with
protocols approved by the Team Leaders or
that must be repeated due to Baxter's
negligence.
5.5
PAYMENT; LATE
PAYMENT CHARGES. Allos will pay the Manufacturing Fee,
Product Maintenance Fee, and expenses for
additional work under SECTION 5.4, in
United States dollars within [ * ] after
the date of receipt by Allos of
Baxter's invoice, by wire transfer in
United States dollars, to a bank account
designated in writing by Baxter. Invoices
for amounts that are not subject to
good faith dispute and not timely paid will
be subject to a late payment charge
of [ * ], or the highest amount permitted
by law, if lower.
6.0 API
6.1
GENERAL. Allos
will, at its cost, supply API to Baxter at Baxter's
manufacturing facilities designated in the
Development Plan or the Quality
Agreement, as applicable. API will be
supplied timely, in adequate quantities to
enable Baxter to meet its obligations to
develop and manufacture Product in
accordance with the terms of this
Agreement, all in conformance with the API
Specifications. Baxter and Allos will agree
on appropriate inventory levels for
API and Product and Baxter will manage
these inventory levels; provided that
Baxter will reserve inventory space for at
least two (2) calendar quarters of
Allos's forecasted API requirements (based
on the API required to fill the
average quarterly Product purchase
requirements stated in Allos' then most
current Product forecast pursuant to
SECTION 4.3) to ensure flexibility in order
fulfillment and delivery. Each Party will
promptly notify the other Party
following receipt of any information that
might impact Allos's ability to supply
API. Allos will retain title to API while
it is in Baxter's possession. Baxter
will not use API supplied by Allos for any
purposes other than to manufacture
Product pursuant to the terms of this
Agreement or as otherwise expressly
permitted under the Quality Agreement or by
Allos in writing. Baxter will
provide to Allos the results and all data
generated in the course of any
authorized studies or tests performed by
Baxter using API.
6.2
API REPLACEMENT.
In the event of non-acceptance by Baxter of any
delivery of API due to its failure upon
inspection or testing by Baxter to meet
Allos's warranties set forth in SECTION
13.2.1.1, Allos's sole obligation and
Baxter's exclusive remedy will be [ * ],
provided that if the failure of API to
meet Allos's warranties is not discoverable
upon reasonable physical inspection
and testing but is identified by Baxter
after development or manufacturing
activities utilizing API have commenced
(and such defects are not caused by
Baxter), then Allos's obligation will [ * ]
under SECTION 2.1.5 attributable to
the development activities that Baxter must
repeat with non-defective API or the
Manufacturing Fee per unit of Product
required to be replaced using
non-defective API, as applicable. Following
notice from Baxter and at the
direction of Allos, Baxter will return the
then remaining defective API to Allos
or, at Baxter's option if requested by
Allos, destroy the same or deliver it to
a third party qualified in such waste
disposal. With respect to defective
Product and work-in-process that
incorporates defective API, Baxter will, at its
option, destroy the same or deliver it to a
third party qualified in such waste
disposal. Allos will bear the cost of any
return of API, including freight and
handling, and the costs of destroying any
defective API, Product and/or
work-in-process. Allos will, at its
expense, replace defective API as
expeditiously as possible and pay Baxter
for Product and work-in-process
incorporating defective API to the extent
required under this SECTION 6.2 within
thirty (30) days of receipt of Baxter's
detailed invoice.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
12
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6.3
CHANGE OF API
SOURCE OR MANUFACTURING PROCESS. Allos will neither
change its API source nor any Manufacturing
Process that has a material impact
on Baxter's manufacture of finished Product
unless and until (i) such change is
approved by the FDA and all other
Regulating Groups in the Territory for the
Product and (ii) Allos provides written
notice to Baxter of the proposed change
at least forty five (45) days in advance of
such change. Pursuant to SECTION
5.4, Allos will reimburse Baxter for all
reasonable costs incurred by Baxter
directly related to Baxter work performed
in support of such API source or
Manufacturing Process change relating to
the Product, including but not limited
to the cost of new stability studies,
submissions to the FDA and any other
Regulating Groups and return of unused (if
any) API from the prior source or
manufactured under prior Manufacturing
Processes. Allos will pay Baxter in
accordance with SECTION 5.5. "Manufacturing
Processes" is defined as a process
used in the manufacture of API of such a
type that a change in such process
would require approval by the FDA or other
Regulating Groups in the Territory in
order to market, sell and distribute the
Product in the Territory.
6.4
RISK OF LOSS OF
API. Subject to SECTION 13.2.1, Baxter will have the
risk of loss or damage to API from [ * ].
In the event of loss or damage to the
API during such period, Baxter will
immediately notify Allos and Allos will
provide to Baxter any API required for
replacement thereof at [ * ]. Allos will
provide to Baxter appropriate documentation
evidencing such costs.
Notwithstanding the foregoing, Baxter will
pay no more for the additional API
than [ * ] for the API, plus duty, freight,
rush surcharges and testing costs,
adjusted to account for cumulative CPI-U
Change between the Effective Date and
the date of loss. For purposes of this
SECTION 6.4, the amount due for loss or
damage to API shall not apply to [ * ].
6.5
MANUFACTURING
YIELD LOSSES. On an annual basis the Parties shall
calculate, for all batches of Product
manufactured hereunder during the previous
year, the average yield of Product units as
a percentage of the theoretical
yield of Product units based upon the
amount of API incorporated in such
batches. If the average yield of Product
units for the year is less than the
applicable percentage set forth in EXHIBIT
E, Allos will [ * ].
7.0 QUALITY MANAGEMENT AND
ONGOING QUALITY RESPONSIBILITIES.
7.1
QUALITY
AGREEMENT. The responsibilities of the Parties relating to
quality management are set forth in the
Quality Agreement.
7.2
COMPLIANCE WITH
LAW; INTERFACE WITH REGULATING GROUPS.
7.2.1 GENERAL.
While the API, Formulation, and Product are in its
possession or under its control, a Party
will be responsible for complying with
all applicable statutory and regulatory
requirements of all applicable
Regulating Groups in the Territory
regarding the API, Formulation, and Product.
These statutory and regulatory requirements
include, but are not limited to, the
considerations set forth in SECTIONS 7.2.2
and 7.2.3, and the Quality Agreement.
7.2.2
ENVIRONMENTAL; HEALTH AND SAFETY. In carrying out its
obligations under this Agreement, Baxter
will comply with all applicable
environmental and health and safety laws of
the United States and in the
Territory and, except as otherwise set
forth in this Agreement, Baxter will be
solely responsible, in its reasonable
discretion, for determining how to carry
out these obligations based upon its
experience in product manufacturing. In
addition to the foregoing, at all times
when Baxter has possession of the API,
work-in-process, or Product, Baxter will
take all reasonable actions necessary
to avoid spills and other safety concerns
to persons and damage to property or
the environment resulting from the API,
Formulation, and Product or any
intermediates or raw materials thereof.
7.2.3 OTHER
ADVERSE INFORMATION. Each Party will promptly notify
the other Party following receipt of any
relevant information, including but not
limited to information regarding any
threatened or pending action by Regulating
Groups, that would reasonably be determined
to adversely
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
13
<Page>
affect the activity under the Development
Program or the production or sale of
the Product hereunder. In addition, Baxter
shall promptly notify Allos of any
complaints or adverse experiences of which
it becomes aware relating to any
Baxter container material used in the
Container but that occur in products other
than the Product, that would reasonably be
determined to adversely affect the
activity under the Development Program or
the production or sale of the Product
hereunder. In the event Baxter reports to
Allos any complaints or adverse
experiences relating solely to the
Container, the Parties shall cooperate to
determine if such events are likely to
impact the Product. Promptly upon receipt
of such notice, the Parties will consult
with each other in an effort to arrive
at a mutually acceptable procedure for
taking appropriate action; PROVIDED,
HOWEVER, that (a) nothing contained herein
will be construed as restricting the
right of either Party to make a timely
report of such matter to any Regulating
Groups or take other action that it deems
to be appropriate or required by
applicable law or regulation and (b) all
information disclosed under this
SECTION 7.2.3 is subject to confidential
treatment pursuant to the terms of
ARTICLE 12 .
8.0 SALES SUPPORT AND USE OF
TRADEMARKS
Baxter salespeople will not promote, detail
or give any advice or information
regarding the Compound or its therapeutic
qualities, but may advise potential
customers of the availability of the
Product and may promote the Container
premix, ready-to-use delivery system
aspects of the Product. Baxter will support
the promotional efforts of Allos by
cooperating in the development of the
Container-related aspects of promotional
materials and programs. Allos shall
make no use of any Baxter trademark, name
or logo without the prior written
approval of Baxter, except as otherwise
permitted under the terms of this
Agreement with respect to Product labeling
and promotional materials. Baxter
shall make no use of any Allos trademark,
name or logo without the prior written
approval of Allos, except as otherwise
permitted under the terms of this
Agreement with respect to Product labeling
and promotional materials.
9.0 TERM AND TERMINATION
9.1
TERM AND
EXPIRATION.
9.1.1 INITIAL
TERM. This Agreement will become effective as of the
Effective Date and will terminate at the
end of the [ * ] Contract Year
("Initial Term"), unless earlier terminated
pursuant to the provisions of
SECTION 9.2 ("Term of the Agreement.")
"Contract Year" is defined as (i) the
twelve (12) month period beginning on the
first day of the month in which
Regulatory Approval of the Product in the
U.S. is received by Allos and (ii)
each successive twelve (12) month period. [
* ]
9.1.2 AUTOMATIC
RENEWAL. Upon expiration of the Initial Term, this
Agreement will automatically renew
thereafter for consecutive [ * ] terms on the
anniversary of the Contract Year unless
either Party, by not less than [ * ]
prior written notice to the other Party,
signifies by such notice its intention
to terminate this Agreement effective upon
the expiration of the applicable
Contract Year.
9.2
EARLY
TERMINATION
9.2.1
TERMINATION BY EITHER PARTY. Either Party may terminate this
Agreement as follows:
9.2.1.1 effective
immediately upon the giving of written
notice, if approval of the Product's NDA is
not received within forty-eight (48)
months from the date of this Agreement;
9.2.1.2 effective sixty
(60) days after written notice
given by the non-breaching Party of a
material breach of this Agreement by the
other Party, if such breach is not cured
within sixty (60) days of receipt of
the notice containing details of such
breach; or
9.2.1.3 effective
immediately upon written notice given
by the non-
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
14
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bankrupt Party, if the other Party files a
petition in bankruptcy, or is
adjudicated bankrupt, makes an assignment
for the benefit of creditors, is
voluntarily or involuntarily dissolved, or
has a receiver, trustee or other
court officer appointed for its
property.
9.2.2 PARTIAL
TERMINATION. In the event that development of [ * ],
either Party may terminate this Agreement
as it relates to development of the
Product [ * ] effective [ * ] days after
written notice of an intent to
terminate under this provision[ * ]. [ * ]
In the event either (i) development
of [ * ] but neither Party terminates this
Agreement or (ii) development of [ *
], the Parties will negotiate in good faith
appropriate amendments to this
Agreement, including without limitation,
amendments to the Development Plan
and/or the Regulatory Plan, to attempt to
develop a technically feasible
product. The termination of this Agreement
as it relates to the Product [ * ]
shall not terminate this Agreement as it
relates to the Product [ * ], PROVIDED,
HOWEVER, that the Parties' obligations
shall thereafter be [ * ], and the
Minimum Purchase Requirement shall be
adjusted as provided in EXHIBIT E.
10.0 EFFECTS OF TERMINATION
10.1
PAYMENTS. Termination
will not relieve or release either Party from
making any payments which may be due and
owing prior to the effective date of
termination under the terms of this
Agreement.
10.2
TECHNOLOGY TRANSFER.
At the expiration of the Term of the Agreement,
or in the event of early termination under
SECTION 9.2.1.2 due to a material
breach by Baxter or SECTION 9.2.2, at
Allos's written request, Baxter shall
provide reasonable assistance in technology
transfer of the manufacturing
process [ * ] to another manufacturing site
as directed by Allos. For the
avoidance of doubt, Baxter's obligation to
assist in technology transfer of the
manufacturing process for [ * ], pursuant
to this Section 10.2, is limited to
providing documents relating solely to the
Formulation and [ * ] The reasonable
costs for such technology transfer shall be
reimbursed by Allos if the transfer
results from expiration of the Agreement or
partial termination of the Agreement
under SECTION 9.2.2, and the costs of the
transfer shall be born by Baxter if
the transfer results from a material breach
by Baxter.
10.3
DISPOSAL OF API OR
PRODUCT. Upon termination of this Agreement,
Baxter will promptly return all then
remaining API to Allos, or if requested by
Allos and at Baxter's option, destroy such
API or deliver it for destruction to
a third party qualified in such waste
disposal. Return or destruction of API
will be at Allos's expense if (i) this
Agreement terminates at the expiration of
its Term; (ii) termination of the Agreement
arises under SECTION 9.2.1.1
(failure of Product NDA to timely issue);
or (iii) termination of the Agreement
is initiated by Baxter pursuant to SECTIONS
9.2.1.2 due to an act or omission of
Allos or event affecting Allos under
SECTION 9.2.1.3. Return or destruction of
API will be at Baxter's expense if
termination is initiated by Allos pursuant to
SECTIONS 9.2.1.2 due to an act or omission
of Baxter or an event affecting
Baxter under SECTION 9.2.1.3. If upon
termination of the Agreement the Parties
are unable to negotiate a mutually
acceptable approach to disposition of Product
and work-in-process, subject to SECTION
10.4 below, Baxter shall promptly
destroy such remaining Product and
work-in-process. The expense of such
disposition will be borne by the Parties
under the same circumstances as
provided above with respect to
responsibility for the expense of disposition of
API. If Allos is responsible for the
expense of disposition of API, Product, or
work-in process, Allos shall pay Baxter all
amounts due Baxter under this
Section within thirty (30) days after the
date of Baxter's detailed invoice
following completion of the designated
return or destruction.
10.4
DELIVERY OF CERTAIN
ITEMS. Upon termination of this Agreement,
Baxter will promptly deliver to Allos all
Deliverables that have been completed
or that are in process as of the date of
such termination, subject to Allos'
payment of the applicable Development Fee
for any such completed Deliverable or
a pro-rated Development Fee for any
partially-completed Deliverable as mutually
agreed upon by the Parties. The Parties
agree that any firm purchase orders that
have been issued pursuant to
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
15
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SECTION 4.4 prior to the effective date of
termination will continue to be
binding on the Parties and subject to all
applicable terms and conditions of
this Agreement after termination.
10.5
SURVIVAL. Expiration
or termination of the Agreement will not
relieve the Parties of any obligation
accruing prior to such expiration or
termination, and the provisions of SECTIONS
3.1 (Product Registration
Application Ownership), 13.2 (Allos
Warranty), and 13.3 (Baxter Warranties), and
ARTICLES 10 (Effects of Termination), 11
(Intellectual Property), 12
(Confidentiality), 14 (Indemnification),
and 16 (Miscellaneous) will survive the
expiration or termination of the Agreement.
Any expiration or termination of
this Agreement will be without prejudice to
the rights of either Party against
the other accrued or accruing under this
Agreement prior to expiration or
termination.
11.0 INTELLECTUAL PROPERTY
11.1
OWNERSHIP OF
INVENTIONS.
11.1.1. OWNERSHIP OF BACKGROUND INTELLECTUAL PROPERTY RIGHTS.
Ownership of Background Intellectual
Property Rights will remain in the Party
owning them on the Effective Date.
11.1.2 ALLOS
INVENTIONS. The entire right, title and interest in
all discoveries, inventions and
improvements which are conceived or reduced to
practice during the course of the work
being performed pursuant to this
Agreement solely by Allos or its employees,
independent contractors, agents or
other representatives (the "Allos
Inventions") will be owned solely by Allos.
11.1.3 BAXTER
INVENTIONS. The entire right, title and interest in
all discoveries, inventions and
improvements which are conceived or reduced to
practice during the course of work being
performed pursuant to this Agreement
solely by Baxter or its employees,
independent contractors, agents or other
representatives (the "Baxter Inventions")
will be owned solely by Baxter,
subject to SECTIONS 11.2.2 and 11.3, except
as provided in this SECTION 11.1.3.
[ * ]
11.1.4 JOINT
OWNERSHIP. Subject to SECTIONS 11.1.2 and 11.1.3, the
entire right, title and interest in all
discoveries, inventions and improvements
which are conceived or reduced to practice
during the course of the work being
performed pursuant to this Agreement by (i)
Allos or its employees, agents or
other representatives and (ii) Baxter or
its employees, agents or other
representatives (the "Joint Inventions")
will be jointly owned by Allos and
Baxter, each of which will own an undivided
one-half (1/2) interest in such
invention where such employees, agents or
other representatives are considered
"joint inventors" under United States
patent laws. Each Party will cooperate
with the other in completing any patent
applications relating to Joint
Inventions.
11.2
REPORTS: INFORMATION
DEVELOPED DURING PROJECT.
11.2.1 CONTENT OF
REPORTS. Baxter will provide to Allos reports
containing the data, test results, and
specifications or procedures for the
Product developed specifically for the
Compound and/or the Formulation
("API/Formulation Specifications"), all as
described in detail under the heading
"Reports" in the Deliverables set forth in
EXHIBIT D. The Reports may also
contain references to (i) pre-existing
Baxter standard operating procedures,
specifications, material codes and their
specifications, and other information
developed by Baxter prior to the execution
of this Agreement ("Pre-Existing
Specifications") that fall within Baxter's
Background Intellectual Property
Rights and (ii) original laboratory
notebooks and other Good Laboratory
Practices documentation generated by Baxter
or its agents pursuant to this
Agreement ("Original Product Data.")
11.2.2 OWNERSHIP OF
REPORTS AND CONTENTS. The Reports, and the
data, test results, and API/Formulation
Specifications therein, will become the
property of Allos and will be treated as
Allos's Confidential Information and be
subject to the provisions of ARTICLE 12 of
this Agreement. Pre-
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
16
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Existing Specifications, Baxter Background
Intellectual Property Rights, as well
as Original Product Data, will remain the
property of Baxter and will constitute
Baxter's Confidential Information and be
subject to the provisions of ARTICLE 12
of this Agreement, subject further to
SECTION 11.3.
11.2.3 ARCHIVAL COPY
OF REPORTS. Baxter may retain a copy of the
Reports for archival purposes.
11.3
LICENSES.
11.3.1 TO BAXTER FROM
ALLOS. [ * ] During the Term of this
Agreement, Allos grants to Baxter a
worldwide, nonexclusive, royalty free
license, without a right to sublicense,
within the Territory, to make, use,
sell, offer for sale, and import the
Product [ * ] under Allos's Background
Intellectual Property Rights and Allos
Inventions, in accordance with and only
to the extent necessary for Baxter to
fulfill Baxter's obligations under this
Agreement. Allos grants to Baxter a
perpetual worldwide, nonexclusive, royalty
free license, with a right to sublicense,
under the Formulation Inventions,
provided Baxter does not use such license
to develop, commercialize or
manufacture the Compound or any other
allosteric modifier of hemoglobin on its
own behalf or on behalf of any third
party.
11.3.2 TO ALLOS FROM
BAXTER. During the Term of this Agreement,
Baxter grants to Allos a, nonexclusive,
royalty free license, without a right to
sublicense, within the Territory, to make,
use, sell, offer for sale, and import
the Product in a Container under Baxter's
Background Intellectual Property
Rights and Baxter's Inventions, in
accordance with and only to the extent
necessary for Allos to fulfill Allos's
obligations under this Agreement. For the
avoidance of doubt, the license granted to
Allos under this Section includes any
such license rights necessary for Allos's
customers, distributors, resellers,
and collaboration partners to promote, use,
sell, distribute and re-sell
Products manufactured by Baxter for Allos
under this Agreement. Baxter will (i)
make Pre-Existing Specifications referenced
in the Reports and Original Product
Data available to Regulating Groups as
required by such Regulating Groups and as
provided in ARTICLE 3, and (ii) upon
Allos's reasonable request, provide copies
of Pre-Existing Specifications referenced
in the Reports and relevant portions
of Original Product Data (but excluding
data or information which is unrelated
to the Product) to Allos for Allos's
retention and use in Regulatory Submissions
outside the United States if, pursuant to
ARTICLE 3, such information is
reasonably required for Allos's Regulatory
Submission for the Product in the
Territory, provided that Allos will treat
all such information as Baxter's
Confidential Information under the
provisions of ARTICLE 12.
11.4
PATENTS.
11.4.1 PATENT FILINGS
ON SOLELY-OWNED INVENTIONS. Each Party will,
in its sole discretion, prepare, file,
prosecute and maintain Patent
Applications for inventions as to which it
has sole ownership under SECTIONS
11.1.2 and 11.1.3 above and will be
responsible for related interference
proceedings. Each Party will endeavor to
ensure that such Patent Applications
are filed before any public disclosure by
either Party in order to maintain the
validity of Patent Applications filed
outside of the United States. Each Party
shall provide the other Party with a copy
of any Patent Application that
discloses any Information of the other
Party at least sixty (60) days prior to
its filing in any patent agency in the
Territory in order to give such Party an
opportunity to object to remove references
to such Party's Confidential
Information. Each Party will bear all costs
under this Section for inventions as
to which it has sole ownership. Baxter will
cooperate with Allos's perfection of
filings relating to API/Formulation
Specifications.
11.4.2 JOINT
INVENTIONS AND PATENT FILINGS. With respect to all
Patent Applications on Joint Inventions
("Joint Patent Applications"), Baxter
will prepare and file Patent Applications
specifically directed to the Field on
behalf of both Parties and will diligently
prosecute same. At least thirty (30)
days prior to the contemplated filing,
Baxter will submit a substantially
completed draft of all such Joint Patent
Applications to Allos for its approval,
which will not be unreasonably withheld.
The Parties
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
17
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will share equally the costs of the
preparation, filing, prosecution and
maintenance of any Joint Patent
Applications and will share equally the costs of
any related interference proceedings.
Baxter will confer with Allos and make
reasonable efforts to adopt Allos's
suggestions regarding the prosecution of
such Patent Applications and will copy
Allos with any official actions and
submissions in such Patent Applications. If
either Party elects not to pay its
portion of any shared costs for a Joint
Patent Application, the other Party may
proceed with such Joint Patent Application
in its own name and at its sole
expense, in which case the Party electing
not to pay its share of costs will
assign its entire right, title and interest
in and to such Joint Patent
Application to the other Party.
11.4.3 PUBLIC
DISCLOSURE. Each Party agrees to delay any public
disclosure of the subject matter of any
Patent Application until after filing of
such Patent Application, but in no event
less than one hundred eighty (180) days
after notice to the other Party of the
intent to disclose such subject matter.
12.0 CONFIDENTIALITY
12.1
PRE-EXISTING
CONFIDENTIALITY AGREEMENT. The Parties have previously
signed a two-way disclosure agreement
("Confidential Disclosure Agreement"), a
copy of which is attached to this Agreement
as EXHIBIT F to cover the exchange
of confidential information and materials
relating to the Compound, Formulation,
API, and the development of the Product.
The Parties agree that all information
exchanged under that agreement prior to the
Effective Date will continue to be
covered by terms of the that agreement. The
provisions of this ARTICLE 12
supersede those with regard to information
exchanged between the Parties on or
after Effective Date.
12.2
CONFIDENTIALITY. All
Information or other information furnished by
one Party to the other Party pursuant to
this Agreement, either in writing or
other tangible form, marked "Confidential"
or, if disclosed orally or visually,
reduced to writing and labeled
"Confidential" by the disclosing Party and sent
to the receiving Party within thirty (30)
days of the initial disclosure thereof
will be deemed to be the disclosing Party's
"Confidential Information". The fact
that Baxter is [ * ] shall also be deemed
to be Baxter Confidential Information.
Information which is not disclosed in the
manner required by this Section will
be conclusively presumed not to be
Confidential Information under this
Agreement. Except as otherwise permitted by
this Agreement, the receiving Party
will keep the disclosing Party's
Confidential Information confidential, will not
disclose, or otherwise make available the
same to any person, firm, corporation
or other entity, will not use the same for
any purpose other than specifically
authorized by this Agreement, and will in
all respects treat such Confidential
Information at least as carefully as it
treats its own confidential and
proprietary information but in no event
using less than commercially reasonable
efforts to protect such Confidential
Information against unauthorized disclosure
or use. Allos and Baxter each may disclose
the other's Confidential Information
to those of its officers, employees,
Affiliates and consultants (other than
competitors of the disclosing Party), whose
review is necessary for the purposes
of this Agreement and who have undertaken
confidentiality, non-disclosure and
non-use obligations to Allos or Baxter, as
the case may be, reasonably identical
in substance to those undertaken
herein.
If the
other Party is acquired by, or merges with, another party having
a
substantial conflict of interest with the
non-acquired Party in respect of the
subject matter of this Agreement, or sells
or transfers a substantial part of
its assets to such party, the acquired
Party shall take any action reasonably
requested by the non-acquired Party to
protect any Confidential Information from
disclosure to or use by any Affiliate of
the acquired Party during the period
commencing with the acquisition or merger
and continuing through the end of the
Term (and thereafter, if appropriate).
12.3
EXCEPTIONS. The
confidentiality and non-use obligations of this
ARTICLE 12 will not apply to information,
including without limitation
Confidential Information, which the
receiving Party is able to demonstrate:
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
18
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(a) was in its possession prior to receipt from the disclosing
Party,
and was not acquired, directly or indirectly from the
disclosing
Party;
(b) was in the public domain at the time of receipt from the
disclosing Party through no fault of the receiving Party:
(c) became part of the public domain through no fault of the
receiving
Party;
(d) was lawfully received by the receiving Party from a third
party
who has no obligation of confidentiality to the disclosing
Party;
(e) was independently developed by the receiving Party as evidenced
by
its written records; or
(f) was released from the restrictions of this Article by the
express
written consent of the disclosing Party.
12.4
AUTHORIZED
DISCLOSURES. Each Party may disclose Confidential
Information belonging to the other Party to
the extent such disclosure is
reasonably necessary in the following
instances:
(a)
to the extent
required to be disclosed by applicable law or
regulation, to the relevant Regulating
Groups; or
(b)
complying with
applicable court orders or governmental regulations.
Notwithstanding the foregoing, in the event that a Party is
required to
make a disclosure of the other Party's
Confidential Information pursuant to this
SECTION 12.4, it will give the other Party
reasonable prior notice thereof and a
copy of the disclosure proposed to be made,
and will also reasonably cooperate
with the other Party to prevent or to limit
such disclosure. The Parties will
consult with each other on the provisions
of this Agreement to be redacted in
any filings made by the Parties with the
United States Securities and Exchange
Commission or as otherwise required by
law.
12.5
PUBLICITY. The Parties
agree that any public announcement of the
execution of this Agreement will be by one
or more press releases mutually
agreed to in advance by the Parties.
12.6
SURVIVAL. The
obligations under this Article will extend for the
longer of the term of this Agreement or ten
(10) years from the date of the
disclosure of the Confidential Information
in question.
13.0 REPRESENTATIONS AND WARRANTIES
13.1
MUTUAL REPRESENTATIONS
AND WARRANTIES. Each Party hereby represents
and warrants to the other Party that (i)
this Agreement is legal and valid and
the obligations binding upon such Party are
enforceable in accordance with their
terms, (ii) the execution, delivery and
performance of this Agreement does not
conflict with any agreement, instrument or
understanding, oral or written, to
which such Party may be bound, nor violate
any law or regulation of any court,
governmental body or administrative or
other agency having jurisdiction over it,
and (iii) the Party owns, controls, or has
the right to grant to the other Party
the licenses and other rights to use the
intellectual property it authorizes the
other Party to use in carrying out the
objectives of this Agreement; and (iv) as
of the Effective Date, the Party is not
aware of any restrictions, limitations
or interests superior to the Party's
intellectual property rights which would
prevent the other Party from using such
intellectual property in carrying out
the objectives of this Agreement or which
would cause the other Party to
infringe the rights of others. During the
Term of this Agreement, if a Party
becomes aware of any events or
circumstances that are reasonably likely to cause
its representations and warranties to be
untrue, the Party will promptly provide
the other Party with written
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
19
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notice of such events or circumstances,
including details reasonably requested
by the other Party in order to evaluate the
impact of such events or
circumstances on this Agreement.
13.2
WARRANTIES OF
ALLOS.
13.2.1 GENERAL. Allos
warrants that API, when delivered to Baxter
hereunder, (i) will be manufactured,
tested, and packaged in accordance with
applicable cGMP regulations and all
applicable laws and regulations of the FDA
and other applicable Regulating Groups in
the Territory; (ii) will meet the API
Specifications; and (iii) will not be
adulterated or misbranded within the
meaning of the FD&C Act or any similar
laws or regulations of applicable
Regulating Groups in the Territory. NO
OTHER EXPRESSED OR IMPLIED WARRANTY
EXISTS REGARDING API, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, AND ALLOS EXPRESSLY
DISCLAIMS ANY SUCH WARRANTIES.
13.2.2 REPLACEMENT.
Subject to Allos's indemnification obligation
under SECTION 14.1, Allos's sole obligation
and Baxter's exclusive remedy for
breach of Allos's warranty set forth in
SECTION 13.2.1 will be [ * ] and [ * ],
or the Manufacturing Fee per unit of
Product required to be replaced using
non-defective API, as applicable. Following
notice from Baxter and at the
direction of Allos, Baxter will return any
then remaining defective API to Allos
or, at Baxter's option if requested by
Allos, destroy the same or deliver it to
a third party qualified in such waste
disposal. With respect to defective
Product and work-in-process that
incorporates defective API, Baxter will, at its
option, destroy the same or deliver it to a
third party qualified in such waste
disposal. Allos will bear the cost of any
return of API, including freight and
handling, and the costs of destroying any
defective API, Product and/or
work-in-process. Allos will, at its
expense, replace defective API as
expeditiously as possible and pay Baxter
for Product and work-in-process
incorporating defective API to the extent
required under this SECTION 13.2.2
within thirty (30) days of receipt of
Baxter's detailed invoice.
13.3
WARRANTIES OF
BAXTER.
13.3.1 GENERAL. Baxter
warrants that Product manufactured under
this Agreement, at the time of release at
Baxter's manufacturing facility (i)
will be manufactured, tested, and packaged
in accordance with applicable cGMP
regulations and all other applicable
regulations of the FDA and other applicable
Regulating Groups in the Territory; (ii)
will meet the Product Specifications;
and (iii) will not be adulterated or
misbranded within the meaning of the FD&C
Act or any similar laws or regulations of
applicable Regulating Groups in the
Territory. Notwithstanding the foregoing,
this warranty will not extend to the
API or the Formulation Specifications
(except to the extent covered in SECTION
13.3.1 (i) and (ii), above)) nor to Product
labeling (to the extent the correct
revision of the Product labeling is used,).
NO OTHER EXPRESSED OR IMPLIED
WARRANTY EXISTS, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, AND BAXTER EXPRESSLY
DISCLAIMS ANY SUCH WARRANTIES.
13.3.2 REPLACEMENT.
Subject to Baxter's indemnification obligation
under SECTION 14.2, Baxter's sole
obligation and Allos's exclusive remedy for
breach of Baxter's warranty set forth in
SECTION 13.3.1 will be limited to a
prompt replacement of the Product at no
cost to Allos. Following Baxter's notice
to Allos that additional API will be
required to replace defective Product,
Allos will promptly provide to Baxter any
API necessary for replacement of such
Product at the actual replacement cost of
the API paid by Allos to its supplier
including duty, freight, rush surcharges
and testing costs. Allos will provide
to Baxter appropriate documentation
evidencing such costs. Notwithstanding the
foregoing, Baxter will pay no more for the
additional API than [ * ] for the
API, plus duty, freight, rush surcharges
and testing costs, adjusted to account
for [ * ].
13.4
LIMITATION OF
WARRANTIES. Except as provided in ARTICLE 14, or as
otherwise expressly stated in this
Agreement, neither Party will be liable to
the other Party for any special, indirect,
incidental
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED 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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or consequential damages arising from a
breach of warranty under this Agreement.
14.0 INDEMNIFICATION AND INSURANCE
14.1
INDEMNIFICATION BY
ALLOS. Allos, on its own behalf, and on behalf of
its Affiliates, will defend, indemnify and
hold harmless Baxter and its
Affiliates and their respective directors,
officers, shareholders, employees and
agents, and each of their successors and
permitted assigns, from and against any
and all third party claims, actions or
causes of action ("Claims") and all
resulting liabilities, losses, damages,
costs or expenses incurred in connection
with the defense of such Claims, and
resulting settlements, awards or judgments,
including reasonable attorneys' fees, which
arise out of or relate to (i) the
failure of API provided by Allos hereunder
to meet the warranties set forth in
SECTION 13.2; (ii) a breach by Allos of any
of its other representations,
warranties, covenants, agreements or
obligations under this Agreement; (iii)
negligence or willful misconduct of Allos
in the performance or nonperformance
of Allos's obligations under this
Agreement; (iv) personal injury or property
damage caused directly by the use of the
Product (including the API) at any time
before or after first commercial sale
(except to the extent covered by Baxter's
indemnification obligations set forth in
SECTION 14.2); or (v) any patent, trade
name, trademark, service mark or copyright
infringement or misuse, or any claim
or judgment of such infringement or misuse
thereof, relating to the Compound or
the Formulation, or the intellectual
property licensed to Baxter under SECTION
11.3.1, or the use or printing of any
trademark(s), trade names or copyrightable
materials of Allos or its Affiliates, as
authorized by this Agreement.
14.2
INDEMNIFICATION BY
BAXTER. Baxter will defend, indemnify and hold
harmless Allos and its Affiliates, and
their respective directors, officers,
shareholders, employees and agents, and
each of their successors and permitted
assigns, from and against any and all third
party claims, actions or causes of
action ("Claims") and all resulting
liabilities, losses, damages, costs or
expenses incurred in connection with the
defense of such Claims, and resulting
settlements, awards or judgments, including
reasonable attorneys' fees, which
arise out of or relate to (i) the failure
of Product provided by Baxter
hereunder to meet the warranties set forth
in SECTION 13.3; (ii) a breach by
Baxter of any of its other representations,
warranties, covenants, agreements or
obligations under this Agreement; (iii) the
negligence or willful misconduct of
Baxter in manufacturing Product or in the
performance or nonperformance of any
of Baxter's obligations under this
Agreement; (iv) personal injury or property
damage caused directly by the Container or
any contaminants introduced by Baxter
into the Product during its manufacture; or
(v) any patent, trade name,
trademark, service mark or copyright
infringement or misuse, or any claim or
judgment of such infringement or misuse
thereof, relating to the Container or
the manufacturing processes or equipment
used by Baxter to manufacture the
Product (except to the extent covered by
Allos's indemnification obligations set
forth in SECTION 14.1) or the intellectual
property licensed to Allos under
SECTION 11.3.2, or the use of any
trademark(s), trade names or copyrightable
materials of Baxter or its Affiliates as
authorized by this Agreement.
14.3
NOTICE; PROCEDURE. The
indemnified Party will give the indemnifying
Party prompt written notice of any claim,
proceeding or suit for which it seeks
indemnification under SECTIONS 14.1 or 14.2
(hereafter, a "Matter"). The
indemnifying Party will have fifteen (15)
business days after receipt of the
indemnified Party's notice to notify the
indemnified Party that the indemnifying
Party elects to conduct and control the
defense of such Matter. If the
indemnifying Party does not give the
foregoing notice, the indemnified Party
will have the right to defend or settle
such Matter in the exercise of its
exclusive discretion, and the indemnifying
Party will, upon request from the
indemnified Party, promptly pay to it in
accordance with SECTIONS 14.1 or 14.2,
as the case may be, the amount of any
liabilities, losses, damages, costs and
expenses, including reasonable attorneys'
fees, resulting from such Matter. If
the indemnifying Party GIVES the foregoing
notice, the indemnifying Party will
have the obligation and sole authority to
undertake, conduct and control,
through counsel of its own choosing and at
the sole expense of the indemnifying
Party, the conduct and control of the
defense and any settlement of such Matter
and the indemnified Party will cooperate
with the indemnifying Party in
connection therewith; provided that: (a)
the indemnifying Party will not thereby
permit any lien, encumbrance or other
adverse charge upon any
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED 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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asset of the indemnified Party; (b) the
indemnifying Party will permit the
indemnified Party to participate in the
defense or settlement through counsel
chosen by the indemnified Party, but the
fees and expenses of such counsel will
be borne by the indemnified Party except as
provided in clause (c) below; and
(c) the indemnifying Party will agree to
reimburse promptly under SECTIONS 14.1
or 14.2, as the case may be, the
indemnified Party for the full amount of any
liabilities, losses, damages, costs and
expenses, including reasonable
attorneys' fees, resulting from the Matter,
except for any fees and expenses of
counsel for such indemnified Party incurred
after the assumption of the conduct
and control of such Matter by the
indemnifying Party. So long as the
indemnifying Party is contesting any Matter
in good faith, the indemnified Party
will not pay or settle any such Matter;
except that such indemnified Party will
have the right to pay or settle any such
Matter but in so doing such indemnified
Party will be deemed to have waived any
right to indemnity therefore by the
indemnifying Party under SECTION 14.1 or
14.2, as the case may be.
14.4
NO CLAIM FOR LOSSES.
Except for those liabilities, losses, damages,
cost or expenses payable by a Party
pursuant to this Article 14, in no event
will either Party or their respective
Affiliates be liable for any special,
indirect, incidental or consequential
damages arising out of this Agreement.
14.5
RECALL EXPENSES. If a
recall or withdrawal is initiated due to any
of the matters for which Baxter is
indemnifying Allos under SECTION 14.2 of the
Agreement, then Baxter will, in addition to
its other obligations under this
Agreement, reimburse Allos for (i) all API
incorporated into the recalled or
withdrawn Product at the price set forth in
SECTION 6.4 of the Agreement, (ii)
the Manufacturing Fees and Product
Maintenance Fees paid by Allos associated
with the number of units of recalled or
withdrawn Product; and (iii) all direct,
out-of-pocket expenses which are incurred
and documented by Allos in connection
with such recall or withdrawal. If a recall
or withdrawal is initiated due to
any of the matters for which Allos is
obligated to indemnify Baxter under
SECTION 14.1 of the Agreement, then Allos
will, in addition to its other
obligations hereunder, reimburse Baxter for
all direct, out-of-pocket expenses
which are incurred and documented by Baxter
in connection with such recall or
withdrawal.
14.6
INSURANCE. Baxter is
self-insured for the types of liabilities for
which by Baxter is likely to arise under
SECTION 14.2. Allos will obtain and
keep in force at its sole expense during
the Term of this Agreement, the
following insurance covering Allos and its
agents, employees, representatives
and subcontractors: (i) Comprehensive or
Commercial General Liability in an
amount not less that [ * ] each occurrence
combined single limit for bodily
injury and property damage for
products/completed operations (including vendors
coverage), blanket contractual liability,
personal injury and independent
contractors protective insurance, which
name Baxter as an additional insured and
require at least thirty (30) days written
notice to Baxter prior to any
cancellation, non-renewal or material
change in coverage. Allos will provide
Baxter with a certificate of insurance
evidencing compliance with this insurance
obligation.
15.0 ALTERNATE DISPUTE RESOLUTION
The
Parties will attempt to settle any claim or controversy arising out
of
this Agreement through good faith
negotiations and in the spirit of mutual
cooperation. Any issues that cannot be
resolved by the Steering Committee
pursuant to SECTION 1.3 will be referred to
a senior management representative
from each of the Parties who has the
authority to resolve the dispute. In the
event such senior management
representatives cannot resolve the dispute, the
dispute will be mediated by a mutually
acceptable mediator to be chosen by the
Parties within thirty (30) days after
written notice by the Party demanding
mediation. Neither Party may unreasonably
withhold consent of the selection of
the mediator and the Parties will share the
costs of the mediation equally. The
Parties may agree to replace mediation with
some other form of Alternative
Dispute Resolution ("ADR"), such as neutral
fact-finding or a mini-trial. Any
dispute which cannot be resolved by the
Parties through mediation or another
form of ADR within ninety (90) days of the
date of the initial written demand
for mediation may then, and only then, be
submitted to the Federal or state
courts, as appropriate, for resolution.
Nothing in this Section will prevent
either Party from resorting to judicial
process if (i) good faith efforts to
resolve the dispute under these procedures
have been unsuccessful or (ii)
injunctive relief from a court is necessary
to prevent serious and irreparable
injury to
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED 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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one Party or to others.
16.0 MISCELLANEOUS
16.1
ASSIGNMENT AND BINDING
EFFECT. This Agreement will be binding upon
and inure to the benefit of the Parties and
their successors and permitted
assigns. All rights of either Party under
this Agreement are personal and will
not be assigned, nor will the performance
of either Party's duties be delegated,
without the prior written consent of the
other Party, except that upon prior
written notice either Party may assign its
rights and obligations under the
Agreement to any of its Affiliates, and
either Party may (subject to the
provisions of SECTION12.2) assign its
rights in connection with the sale or
assignment of substantially its entire
business or in connection with the merger
or corporate reorganization of a Party. An
assignment permitted under this
Section will not be effective, however,
unless the purchaser, assignee, or
transferee assumes such Party's obligations
under this Agreement and the
assignment will not relieve the assigning
Party of its responsibilities under
this Agreement.
16.2
ENTIRE AGREEMENT. This
Agreement together with its Exhibits,
including the separate Confidential
Disclosure Agreement set forth in EXHIBIT F,
and the Quality Agreement, together contain
the entire agreement between the
Parties relating to the subject matter
hereof and all prior written or verbal
proposals, discussions, and writings by and
between the Parties and relating to
the subject matter, are superseded hereby.
None of the terms of this Agreement
will be deemed to be waived by either Party
or amended, unless such waiver or
amendment is in writing executed by both
Parties and such writing recites
specifically that it is a waiver of or an
amendment to the terms of this
Agreement. In addition to the matters
referenced in the text of this Agreement
as set forth in attached EXHIBITS A through
F, the Parties agree to be bound by
the additional terms and conditions set
forth in all other Exhibits, if any,
attached to this Agreement, to the same
extent as if such provisions were
referenced in and incorporated into the
text of this Agreement. In the event of
a conflict between any of the provisions of
the Quality Agreement and this
Agreement, the provisions of this Agreement
shall govern.
16.3
GOVERNING LAW. This
Agreement will be deemed to have been entered
into in the State of Illinois and its
interpretation and construction and the
remedies for its enforcement or breach are
to be applied pursuant to and in
accordance with the laws of the State of
Illinois without reference to any rules
of conflict of laws.
16.4
SEVERABILITY. In the
event that any one or more of the provisions
contained in this Agreement should be held
invalid, illegal or unenforceable in
any respect, the validity, legality and
enforceability of the remaining
provisions contained herein will not in any
way be affected or impaired thereby,
unless the absence of the invalidated
provision(s) adversely affect the
substantive rights of the Parties. The
Parties agree to replace any invalid
provision or parts thereof by new
provision(s) which closely approximate the
economic and proprietary results intended
by the Parties.
16.5
WAIVER. The waiver by
either Party hereto of any right hereunder or
of a breach by the other Party will not be
deemed a waiver of any other right
hereunder or of any other breach by said
other Party whether of a similar nature
or otherwise.
16.6
FORCE MAJEURE.
16.6.1 GENERAL.
Neither Party will be liable, or deemed in breach
of its obligations under this Agreement,
for a delay in performance or
nonperformance as the result of an act of
governmental authority (excluding any
act occasioned by a breach of the terms of
this Agreement or willful misconduct
of a Party or where such acts could have
been prevented by reasonable measures
of the affected Party), war, acts of
terrorism, riot, fire, explosion,
hurricane, flood, strike, lockout, or
injunction or any other similar cause
beyond its reasonable control preventing
the manufacture, shipment, or
acceptance, of the Product, or any
component thereof ("Force Majeure") provided
that the affected Party (i) promptly
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMMITTED 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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notifies the other Party of the Force
Majeure event as provided in SECTION
16.6.2 (ii) uses reasonable diligence and
efforts to remedy the situation if
reasonably
