exv10w24



 






[ * ] = 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.





Exhibit 10.24




LICENSE AND SUPPLY AGREEMENT



This License and Supply Agreement (this “Agreement”) is entered into as of February
28th, 2002 (the “Effective Date”) by and between Corixa Corporation, a Delaware
corporation having offices at 1124 Columbia Street, Suite 200, Seattle, Washington 98104, USA and
its Affiliates (“Corixa”), and Rhein Biotech N.V. having offices at Gaetano Martinolaan 95, 6229 GS
Maastricht, The Netherlands and its Affiliates, a Netherlands corporation (“Rhein”).




RECITALS




     A. Corixa owns intellectual property rights in an immunostimulatory material known as
Ribi.529TM adjuvant, which is a potentially useful component of vaccines to treat various human
disorders.



     B. Rhein is developing prophylactic and therapeutic vaccines for Hepatitis B and
desires to license from Corixa Ribi.529TM for use in such vaccines.




     C. Corixa is willing to provide Rhein access to Ribi.529TM adjuvant including the
supply thereof by Corixa and to grant Rhein a license under such intellectual property
rights in accordance with the terms and conditions set forth in this Agreement.



AGREEMENT



For good and valuable consideration, including the covenants and obligations expressed herein,
receipt of which is hereby acknowledged, intending to be legally bound, the parties hereto agree
as follows:




1. Definitions.




     1.1 “Affiliate” shall mean any business entity that Controls, is Controlled by, or is
under common Control with another corporation or business entity. The direct or indirect ownership
of at least fifty percent (50%) or, if smaller, the maximum allowed by applicable law, of the
voting securities or an interest in the assets, profits or earnings of a business entity shall be
deemed to constitute “Control” of the business entity.



     1.2 “cGMP” shall mean current good manufacturing practices as defined in the United
States Food and Drug Administration (FDA) rules and regulations, 21 CFR Part 211 for finished
pharmaceuticals, manufactured in the USA. “cGMP” shall also mean current good manufacturing
practices as defined in FDA’s “Guidance for Industry, Q7A Good Manufacturing Practice, Guidance for
Active Pharmaceutical Ingredients” for manufacturing of bulk Licensed Adjuvant in the USA.



     1.3 “Co-exclusive” shall mean that only the following entities shall have rights: On
the one hand, Rhein and its Affiliates and authorized Sublicensees, on the other hand
either (a) Corixa and its Affiliates or (b) a third party, including its Affiliates and
authorized Sublicensees, licensed by Corixa to use the Licensed Adjuvant in the Disease Field.



     1.4
“Confidential Information” shall have the meaning
assigned thereto in Section 13.1



[ * ] = 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.





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     1.5 “Contract Manufacturer” shall have the meaning assigned thereto in Section 3.4.



     1.6 “Disease Field” shall mean the field of inducing an active, long-term prophylactic
or therapeutic immune response against Hepatitis B (including chronic status) in humans.



     1.7 “European Union” shall mean United Kingdom, Denmark, Sweden, Finland, Germany, The
Netherlands, Belgium, Luxembourg, France, Spain, Portugal, Italy, Greece, Austria, and Ireland, and
all other countries that become members at any time during the term of this Agreement.



     1.8 “Fill and Finish Manufacturer” shall have the meaning assigned thereto in Section
2.3(c).



     1.9 “Government Approval” shall mean any approvals, licenses, registrations or
authorizations of any Regulatory Authorities, necessary for the use, development, testing,
production, marketing, sale or distribution of the Licensed Product in a regulatory
jurisdiction.



     1.10 “Licensed Adjuvant” shall mean the aminoalkyl glucosamine phosphate
compound and compositions comprising such compound as described or claimed in the Licensed
Patents and including, without limitation, that compound identified as
2-[(R)-3-tetradecanolyloxytetradecanoyl-amino]ethyl2-deoxy-4-O-phosphono-3-O-[(R)-3tetradeca
noyloxytetradecanoyl]-2-[(R)-3-tetradecanoyloxytetradecanoylamino]-b-D-glucopyranoside
triethylammonium salt and formulations of the same.



     1.11 “Licensed Patents” shall mean (a) the patents and patent applications set forth
in Appendix A hereto, (b) all continuations and divisionals of the foregoing, (c) all
patents issuing from any of the foregoing, and (d) all foregoing counterparts of any of the
foregoing.



     1.12 “Licensed Product” shall mean a prophylactic and/or therapeutic vaccine comprised
of antigen(s) owned or controlled by Rhein that also contains Licensed Adjuvant and that
potentially utilizes additional delivery or adjuvant technology, in pharmaceutical dosage forms
suitable for human use.



     1.13 “Manufacturing and Supply” shall mean the commercial manufacture, processing,
packing, holding, inkjet labeling, testing, storage, release and supply to Rhein or its designee of
Adjuvant in accord with the terms and conditions set forth in this
Agreement.



     1.14 “Net Sales” shall mean the gross amount invoiced by Rhein for the sale or other
disposition to an unaffiliated third party of Licensed Product, less the following deductions for
amounts actually incurred related to the sale or other disposition:



          (a) normal, customary trade discounts (including volume discounts), credits and rebates and
allowances and adjustments for rejections, recalls or returns; and




          (b) freight, insurance, sales, use, excise, value-added and similar taxes or duties imposed on
the sale and included in the gross amount invoiced.




     1.15 “Proposed Publication” shall have the meaning assigned thereto in Section 7.1.



     1.16 “Quality Plan” shall mean the mutually agreed upon quality plan that details
specific understandings related to product quality which is hereto attached as Appendix B
and incorporated herein by this reference, as such Quality Plan may be amended from time to time by
agreement of the parties in writing.



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





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     1.17 “Regulatory Authorities” shall mean those government agencies or authorities
responsible for the regulation of Licensed Product and/or Licensed Adjuvant (including without
limitation the manufacture, supply and sale thereof) in the Territory.



     1.18 “Specifications” shall mean those specifications set forth in Appendix C
with respect to pre-clinical and clinical supply of Licensed Adjuvant and the Quality Plan with
respect to commercial supply of Licensed Adjuvant.



     1.19 “Sublicensee” shall mean any permitted sublicensee of the license granted to
Rhein under this Agreement, except for the rights granted under Section 3.5, as further

described in Section 2.3.




     1.20 “Territory” shall mean worldwide.



2. License Grant.




     2.1 Subject to the terms and conditions of this Agreement, Corixa hereby grants to Rhein for
the term of this Agreement, unless earlier terminated in accordance with Section 16, a Co-exclusive
license, with the right to sublicense solely in accordance with Section 2.3, to research, use,
make, market, distribute and sell Licensed Products in the Territory for use solely in the Disease
Field. Such license grant does not permit (a) the manufacture by Rhein of Licensed Adjuvant save
for the right granted to Rhein under Section 3.5 or (b) the transfer by Rhein to any third party of
Licensed Adjuvant, other than as part of assembled Licensed Products or in accordance with Section
2.3, without the prior written approval of Corixa.



     2.2 The license granted in Section 2.1 is specific to the Disease Field. For the purpose of
clarification, Rhein shall have no right to include the Licensed Adjuvant in any product intended
for therapeutic or prophylactic use in any other disease field, whether such other product is
formulated as part of the Licensed Product or sold as in bundled package together with the Licensed
Product, unless a separate license for such other product and other disease field is expressly
granted in writing by Corixa to Rhein.



     2.3 Corixa hereby grants to Rhein for the term of this Agreement, unless earlier terminated in
accordance with Section 16, the right to sublicense the right to manufacture, use, market,
distribute and sell Licensed Product in the Territory in the Disease Field as follows:



          (a) Prior to the grant of a sublicense, Rhein shall notify Corixa in writing of the identity
of the intended Sublicensee, and Corixa shall have thirty (30) days to consent to the Sublicensee,
such consent not to be unreasonably withheld. If Corixa does not notify Rhein in writing within
such thirty (30) day period that Corixa does not consent to such Sublicensee, Corixa shall be
deemed to have consented. All sublicense agreements shall expressly bind the Sublicensee to the
terms of this Agreement and shall provide for the automatic assignment of the sublicense agreement
to Corixa if this Agreement is terminated. Rhein shall promptly furnish Corixa with a fully
executed copy of any sublicense agreement.




          (b) For the avoidance of doubt, either Rhein or its Sublicensee may manufacture, use, market
distribute and sell Licensed Product in any part of the Territory. In no event shall Rhein and its
Sublicensee exercise the license granted hereunder in the same country nor shall more than one
Sublicensee exercise the license granted hereunder in the same country. Furthermore, the right to
manufacture granted to Rhein under Section 3.5 is not sublicensable.



[ * ] = 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 3 of 24









 








          (c) For purposes of clarity, ‘manufacture’ includes the combining of the
Licensed Adjuvant and the antigen(s) to create the Licensed Product, but does not include the
manufacture of Licensed Adjuvant other than in accordance with Section 3.5. For further clarity,
the use of a third party (the “Fill and Finish Manufacturer”) solely for the combining of
the Licensed Adjuvant and the antigen(s) to create the Licensed Product, which will then be given
to Rhein or its Sublicensee for sale or other distribution, shall not be considered a
Sublicensee per se.




     2.4 Corixa hereby grants to Rhein for the term of this Agreement, unless earlier terminated in
accordance with Section 16, a non-exclusive license, without the right to sublicense, to use the
Licensed Adjuvant solely for preclinical and clinical research and
preclinical and clinical development in the Disease Field.



3. Supply of Licensed Adjuvant.




     3.1 Title to Licensed Adjuvant. Corixa shall retain all title and interest in and to any and
all Licensed Adjuvant provided by Corixa hereunder except as otherwise provided in this Agreement.



     3.2 Supply Price.




          (a) Corixa agrees to provide Rhein with quantities of Licensed Adjuvant reasonably required by
Rhein for use in Licensed Product. Corixa will provide clinical and commercial grade Licensed
Adjuvant on a bulk basis for incorporation into Licensed Product, at the following prices:





     (i) For pre-clinical and clinical grade (cGMP) Licensed Adjuvant, [ * ] per
milligram at [ * ] for Licensed Adjuvant in aqueous formulation and [ * ] per
milligram for lyophilized formulation and reference standard;




     (ii) For commercial grade (cGMP) Licensed Adjuvant, lyophilized formulation, [ * ] per gram for orders equal to or less than
[ * ] grams per year; [ * ] per
gram for orders greater than [ * ] grams and less than [ * ] grams per year; and [ * ] per gram for orders equal to or greater than [ * ] grams per year;


In all cases, the foregoing costs shall be plus shipping and insurance.




          (b) If Corixa’s manufacturing costs increase due to Rhein’s requirements for new or modified
Specifications or formulations of Licensed Adjuvant, the parties shall negotiate in good faith a
new pricing system. Corixa shall not be obligated to manufacture in accordance with any such new or
modified Specifications or formulations until the parties have agreed to a price.




          (c) Corixa shall have the right as from the first anniversary after the first commercial
supply of Licensed Adjuvant to annually increase its transfer prices in an amount not to exceed the
increase in the United States Consumer Price Index for all Urban Consumers (“CPI”) for the
immediately preceding twelve (12) month period over the index value at the beginning of such
period, provided that the permissible percentage increase in the



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






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transfer price on a given adjustment date shall not exceed three percent (3%) unless the increase
in the CPI for the immediately preceding twelve (12) month period exceeds ten percent (10%), in
which case for each percent the CPI for such period is over ten percent (10%) one additional
percent (1%) shall be added to the three percent (3%) cap.




     3.3 Forecasts. Within [ * ] after the Effective Date and on the first day of each quarter
thereafter, Rhein shall provide Corixa with a rolling forecast for the amount of Licensed Adjuvant
required for the [ * ] period that commences [ * ] following the date of the forecast. The
amounts for the [ * ] shall be [ * ]
. The amounts for the following [ * ] shall be [ * ] . The amounts forecasted for the [ * ] of the forecast (the “Ordered
Amount”) shall be automatically [ * ] firm and binding; [ * ] of the amounts forecasted for
the following [ * ] of the forecast shall be automatically [ * ] firm and binding; [ * ] and the amounts
forecasted for the [ * ] shall be non-binding.



          (a) The minimum of each Ordered Amount after Rhein has obtained a first registration in any
country in the Territory shall be [ * ] for the first and second year, [ * ] for the third year,
and [ * ] for the fourth year and thereafter.




          (b) Corixa shall fill each Ordered Amount within [ * ] from receipt of such order from Rhein;
provided, however, in the event a given order exceeds the requirements estimated in Rhein’s latest
[ * ] rolling forecast for the month in question, Corixa shall have up to [ * ] from receipt of
such order
to fill such excess requirements.




          (c) Notwithstanding any other provision of this Agreement, unless otherwise agreed to in
writing by Corixa, Corixa shall not be obligated to supply to Rhein in a given [ * ] more Licensed
Adjuvant than [ * ] above the amount estimated in Rhein’s latest [ * ] rolling forecast for the [
* ] in question, even if such quantity falls
within production capacities.




     3.4 Alternative Manufacturer. Rhein and Corixa agree that Corixa shall have the right in
connection with Corixa’s supply obligations hereunder to contract with one or more third parties
(the “Contract Manufacturer(s)”) for the manufacture and supply of the Licensed Adjuvant to
Rhein; provided, however, that (a) such Contract Manufacturer is reasonably acceptable to Rhein,
(b) Corixa shall cause each Contract Manufacturer to comply with the terms and conditions set forth
in this Agreement with respect to the manufacture and supply of such Licensed Adjuvant to Rhein,
and (c) Corixa shall remain fully responsible for the manufacture and supply of such Licensed
Adjuvant to Rhein.



     3.5 Inability to Supply.



          (a) In the event of Corixa’s or the Contract Manufacturer’s inability or failure to supply all
or any portion of Rhein’s requirements for Licensed Adjuvant [ * ] , other than as a result of
force majeure as
described in Section 17.9, Corixa hereby grants to Rhein a non-exclusive, non-assignable,
non-sublicensable royalty bearing right and license, to make or have made Licensed Adjuvant solely
for use in the production and manufacture of Licensed Product. If such event occurs, Corixa
shall transfer all relevant information and documentation to Rhein, including manuals and standard
operating procedures. All information provided by Corixa pursuant to this Section 3.5 shall be
Confidential Information and subject to the terms of Section 13 hereto. Rhein shall use
its best efforts to enter into any such manufacturing agreement on customary commercial



[ * ] = 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 5 of 24









 







terms that will allow for termination upon Corixa’s ability to again supply Licensed Adjuvant.
Such right and license shall not be revoked until such time as Corixa is once again in a position
to meet its supply obligation under this Agreement, at which time Rhein’s agreement with any third
party manufacturer will be terminated early in accordance with the terms therein. To the extent
Rhein makes or has made Licensed Adjuvant pursuant to the foregoing right and
license, Rhein shall be obligated to pay to Corixa a manufacturing royalty equal to the royalty on
Net Sales set forth in Section 4.4.




          (b) In order to meet its obligations to Rhein under this Section 3, Corixa agrees to
maintain as a back-up supply of Licensed Adjuvant for Rhein in the amount set forth in Rhein’s then
current [ * ] forecast for the Licensed Adjuvant as set forth in Section 3.3 above.




     3.6 Conformance to Specifications. The Licensed Adjuvant supplied by Corixa or its
manufacturing designee hereunder shall conform at the time of delivery to Rhein to the applicable
Specifications. Rhein may test any Licensed Adjuvant delivered hereunder to determine conformance
of such Licensed Adjuvant with the applicable Specifications. If Rhein determines that such
Licensed Adjuvant does not meet such Specifications, Rhein shall within [ * ] of receipt of the
nonconforming Licensed Adjuvant notify Corixa in writing of such nonconformance, including test
results supporting Rhein’s determination. Corixa shall at
no charge to Rhein replace nonconforming Licensed Adjuvant with Licensed Adjuvant that meet such
Specifications. If Corixa disagrees with the alleged nonconformity of the Licensed
Adjuvant with the specifications, an independent laboratory, mutually agreed upon in writing by the
parties, shall analyze samples of the alleged nonconforming Licensed Adjuvant to
determine compliance with the Specification. Rhein and Corixa shall be bound by the
laboratory analysis of such Licensed Adjuvant. The cost incurred in connection with retaining
the independent laboratory shall be borne by Rhein if the Licensed Adjuvant in question is
found to conform to the Specifications and by Corixa if it is found to not conform to the
Specifications.



     3.7 Permitted Uses. Rhein shall use the Licensed Adjuvant supplied by Corixa hereunder only
for purposes of development, manufacture, marketing and sale of Licensed Product. Rhein shall use
the Licensed Adjuvant in compliance with this Agreement and with all applicable federal, state and
local laws and regulations. Rhein shall not transfer the Licensed Adjuvant or any related
information to any person who is not under the immediate and direct supervision of Rhein, except as
may otherwise expressly be provided in this Agreement.



     3.8 Access to Facilities. Corixa shall permit Rhein, Rhein bearing its own costs, and the
Regulatory Authorities and their respective agents and representatives reasonable access to the
facilities where the Manufacturing and Supply is being carried out at times mutually agreed to by
Corixa and Rhein.



     3.9 Shipping. Delivery shall be EXW Corixa’s facility, Hamilton, Montana lncoterms 2000. Title
to and risk for Licensed Adjuvant shall pass to Rhein upon delivery from said location.



     3.10 Maintenance of Records. Corixa shall keep or cause to be kept complete, accurate and
current records relating to all of its Manufacturing and Supply activities in accordance with all
applicable laws, cGMP and the requirements of the Regulatory Authorities in the United States and
European Union.



[ * ] = 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 6 of 24









 




3.11 Access to Records. Corixa shall provide Rhein with copies of all documentation
under Corixa’s control relating to its Manufacturing and Supply of Licensed Adjuvant to the extent
such documentation is required by any Regulatory Authority to be included in any Licensed Product
regulatory approval submission to the FDA or such other regulatory agency. Corixa hereby grants
Rhein and its Sublicensees the right to reference Corixa’s regulatory approvals, if any, for
Licensed Adjuvant and the drug master file for each Licensed Adjuvant on file with the FDA or any
other regulatory agency. Upon Rhein’s request, Corixa shall execute letters of authorization
evidencing Rhein’s and its Sublicensees’ reference rights as set forth above.




4. Payments and Reports.




     4.1 License Fee. As partial consideration for the rights and licenses granted hereunder,
Rhein shall pay Corixa a non-refundable, non-creditable license fee of [ * ] within ten (10) days
of execution of this Agreement.



     4.2 Milestones. As partial consideration for the rights and licenses granted hereunder, Rhein
shall pay Corixa the following non-refundable, non-creditable milestone payments:



          (a) [ * ] within thirty (30) days after trial AgB/RC-210-04 (the Supervax-trial) using
Licensed Product demonstrates statistically significant clinical benefit in terms of efficacy, as
defined as the primary endpoint in the efficacy evaluable population in Protocol CCHB001-01 based
on the clinical study database that has been locked at Corixa.




          (b) [ * ] within thirty (30) days following the first Licensed Product product registration
anywhere in the Territory.




     4.3 Annual Maintenance Fees; Minimum Annual Royalty. Rhein shall pay Corixa an annual license
fee on each anniversary of the Effective Date until commercial launch of the Licensed Product,
after which such fee shall be paid as the minimum annual royalty payment, in accordance with the
following schedule: [ * ] on the first anniversary of the Effective Date; [ * ] on the second
anniversary of the Effective Date; and [ * ] on the third and subsequent anniversaries of the
Effective Date. All such annual maintenance fees or minimal annual royalties, as applicable, shall
be guaranteed, non-
refundable and non-creditable, except, however, that after commercial launch of the Licensed
Product, the minimal annual royalty payments shall be credited against the royalty payment
paid to Corixa in the calendar year of such minimum annual royalty payment. All payments
made under this Section 4.3 shall be in accordance with the schedule set forth in Section 4.5
below.



     4.4 Royalties. As partial consideration for the rights and licenses granted hereunder, Rhein
shall pay Corixa royalty payments in accordance with the following rates on annual Net Sales made
by Rhein or its sublicensee of each Licensed Product, commencing with the first commercial sale of
the Licensed Product anywhere in the Territory: [ * ] on Net Sales in the United States or the
European Union, and [ * ] on Net Sales in the rest of the world.



     4.5 Payment Schedule. Royalties shall be calculated on a semi-annual basis, specifically, the
periods January 1 through June 30 and July 1 through December 31, (“Semi-Annual Period”) and shall
be due and payable within forty-five (45) days after the end of such



[ * ] = 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 7 of 24









 




Semi-Annual Period, commencing upon the completion of the first Semi-Annual Period during
which the first commercial sale occurs.




     4.6 Payment Reports. Forty-five (45) days following the end of each Semi-Annual Period, Rhein
shall furnish to Corixa a written report that includes (a) the identity of the countries in which
sales of Licensed Product have been made and (b) the Net Sales of each Licensed Product and the
number thereof sold in each such country. Such reports shall be due together with the royalty
payments under Section 4.4 subsequent to launch of the Licensed Products. Such reports shall be
made whether or not Rhein has engaged in any sales of Licensed Product during the Semi-Annual
Period. All information provided by Rhein pursuant to this Section 4.6 shall be Confidential
Information and subject to the terms of Section 13 hereto.



     4.7 Audits. Rhein shall keep, and shall cause its Sublicensee to keep, full, complete and
accurate records and accounts of Net Sales of each Licensed Product in sufficient detail to enable
the royalties payable to Corixa to be determined. Upon reasonable notice to Rhein,
Corixa shall have the right to have an independent certified public accountant audit Rhein’s
and its Sublicensee’s records pertaining to Licensed Products during normal business hours to
verify the royalties payable pursuant to this Agreement; provided, however that (a) such audit
shall not take place more frequently than once a year, and (b) shall not cover such records for
more than the preceding three (3) years. Such audits shall be at Corixa’s expense unless such
audit determines that Rhein has paid Corixa less than ninety-five percent (95%) of the amount
determined to be due for a given time period, in which case such audit shall be at Rhein’s expense
and Rhein shall pay to Corixa the cost of such audit and any shortfall in payments due
to Corixa within thirty (30) days following Corixa’s invoice to Rhein therefor. Rhein shall
preserve and maintain all such records and accounts required for audit for a period of three
(3) years after the calendar year to which such records and accounts apply.



     4.8 Payment Instructions. All payments due hereunder shall be made in U.S. Dollars by wire
transfer of immediately available funds to the following account:


Account No. [ * ]

Bank: [ * ]

ABA Code: [ * ]



or to such other account as Corixa may designate from time to time.




     4.9 Past Due Amounts. Any past due payments under this Agreement shall accrue interest until
paid at [ * ] per annum, or the maximum rate permitted by law, whichever is less.



     4.10 Foreign Currency. Currency conversions to U.S. Dollars shall be calculated using an
average rate of exchange, which rate of exchange shall be computed by adding the rate of exchange
quoted under Foreign Exchange in the Wall Street Journal as of the end of the current quarter to
the rate as of the end of the prior month and dividing by 2.



     4.11 Withholding Tax. Rhein shall be entitled to deduct from amounts otherwise due and
payable hereunder, any withholding taxes, value-added taxes or other taxes, levies or charges with
respect to amounts payable hereunder, other than United States taxes and/or
taxes imposed on or measured by net income, payable by Rhein, or any taxes required to be
withheld by Rhein, to the extent Rhein pays to the appropriate governmental authority on behalf of
Corixa such taxes, levies or charges. Rhein shall use reasonable efforts to minimize any
such taxes, levies or charges required to be withheld on behalf of Corixa by Rhein. Rhein



[ * ] = 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 8 of 24









 




promptly shall deliver to Corixa proof of payment of all such taxes, levies and other charges,
together with copies of all communications from or with such governmental authority with
respect thereto. Rhein shall cooperate in full with Corixa regarding the characterization of
payments so that it may take advantage of any and all benefits under any treaties or in efforts
required by Corixa to receive any reimbursement or refund of amounts so paid or withheld.




5. Performance Obligations.




     5.1 Commercial Development. Rhein shall use its best commercial efforts to meet the
development schedule attached hereto as Appendix D. Rhein shall at all times keep Corixa
generally informed of Rhein’s updated development plans, which Rhein shall provide to Corixa
in writing semi-annually, for each Licensed Product, including Rhein’s planned timing for Licensed
Product commercial launch dates on a country-by-country basis. All dates and other information
provided by Rhein in such plan shall be used for planning purposes only, and shall be subject to
reasonable modification by Rhein based on its actual progress in the development process. Corixa
and Rhein shall meet annually regarding Rhein’s efforts under this Agreement. Not more than two
representatives from each Rhein and Corixa shall attend such meeting, which may take place either in person in a location equidistant from each party’s facilities or via
teleconference. At least [ * ] prior to each such meeting, Rhein shall submit an annual written
report to Corixa that summarizes Rhein’s efforts toward development and commercialization of
Licensed Products.



     5.2 Marketing Documentation. At all times during the term of this Agreement, Rhein agrees to
furnish reasonably promptly to Corixa all documentation and data that is or may hereafter be in
Rhein’s possession relating to Rhein’s marketing of Licensed Products, including, but not limited
to, marketing support data. All such information and data shall be Confidential lnformation subject
to Section 13 hereof.



     5.3 Training. Corixa shall provide a total of [ * ] of training and technical support on
formulation, including but not limited to liquid and lyophilized, and analysis at Corixa’s Montana
facility. Rhein shall bear all of its costs related thereto, including but not limited to travel
expenses. Should Rhein require training in excess of [ * ] , Rhein shall reimburse Corixa for FTE
costs at Corixa’s then current rate. All formulation and analysis information and know-how provided
by Corixa shall be Confidential lnformation pursuant to Section 13.



6. Governmental Approvals.




     6.1 Rhein shall be responsible at Rhein’s expense for obtaining all Government Approvals in
any country where Licensed Product shall be manufactured or sold or otherwise distributed. Corixa
agrees to provide Rhein, at Rhein’s expense, with any assistance reasonably requested by Rhein, in
obtaining such Governmental Approvals.



     6.2 Within sixty (60) days following receipt by Rhein, Rhein shall promptly provide Corixa
with notice of all Government Approvals received by Rhein regarding Licensed Product.



7. Publications.




     7.1 In General. Rhein shall not publish or present, orally or in writing, including without
limitation at symposia, national or regional professional meetings, or to publish in journals or
other publications, any Confidential lnformation derived from or in any way relating to any aspect
of the Licensed Adjuvant, whether separately or as part of Licensed Product, or



[ * ] = 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 9 of 24









 




Licensed Patents, including, but not limited to, the development or manufacture of the
Licensed Adjuvant, whether separately or as part of Licensed Product (the “Proposed
Publication”), without providing Corixa the opportunity for prior review. The Proposed
Publication will be submitted to Corixa at least [ * ] prior to the date on which it is to be
submitted or disclosed to any person or entity not a party to this Agreement. During the
[ * ] period, Corixa will review the Proposed Publication for accuracy, disclosure of patentable
material or disclosure of its Confidential Information. If, in Corixa’s sole opinion, a Proposed
Publication contains patentable material, Corixa will so notify Rhein before the expiration of the
[ * ] review period. After such notice, Corixa may delay publishing
for a period of up to [ * ] , to permit filing of appropriate patent applications. Corixa shall
have the right to remove its Confidential Information from any Proposed Publication.




     7.2 Public Announcements.



          (a) Within 7 days of the execution of this Agreement, parties agree to issue a joint press
release on the same date. This press release must receive the prior written approval
of each party prior to issuance, which approval shall not be unreasonably withheld.




          (b) During the term of this Agreement, the parties agree to consult with each other before
issuing any press release or making any public statement based on new or previously undisclosed
information with respect to this Agreement or any other transaction contemplated herein and, except
as may be required by applicable law or any listing agreement with any national securities
exchange, shall not issue any such press release or make any
such public statement prior to obtaining the written consent of the other party.




8. Ownership of Inventions.



lnventorship of all inventions or discoveries shall be determined in accordance with the patent
laws of the United States. Rhein hereby assigns to Corixa all of its right, title and interest in
and to any and all inventions or discoveries that are improvements, including new uses, of or to
the Licensed Adjuvant or any other subject matter disclosed in the Licensed Patents. All such
improvements shall be included within the license granted to Rhein hereunder.




9. Representations and Warranties.




     9.1 Nontransfer. Rhein represents and warrants that it will not transfer the Licensed
Adjuvant, other than as part of the Licensed Products, to any third party without the prior written
consent of Corixa, save for Rhein’s transfer of Licensed Adjuvant to its Sublicensee or Fill and
Finish Manufacturer, if any, solely to allow such Sublicensee or Fill and Finish Manufacturer to
exercise its right to manufacture Licensed Product as stipulated in Section 2.3.



     9.2 Compliance with Law. Rhein warrants that all Licensed Products manufactured and/or sold
or distributed by Rhein will be manufactured, sold and distributed in accordance with all
applicable laws, rules and regulations of the country of manufacture, sale or distribution of such
Licensed Products.



     9.3 No Conflict. Each party hereby represents and warrants that it is authorized to enter
into this Agreement and that this Agreement does not create a conflict with any other right or
obligation provided under any other agreement or obligation that party has with any third party.



[ * ] = 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 10 of 24









 





     9.4 Infringement. Corixa represents and warrants that as of the Effective Date, to Corixa’s
actual knowledge, the manufacture, use, offer for sale, and sale of the Licensed Adjuvant does not
infringe or involve the misappropriation of any intellectual property of any third party.



10. Indemnification.




     10.1 Rhein hereby agrees to indemnify, defend and hold harmless Corixa, its Affiliates and
their officers, agents and employees from and against any and all claims, actions, proceedings,
liabilities or losses, including reasonable legal expenses and costs, including attorney fees
(collectively, “Losses”), that arise from (a) any material breach of this Agreement,
including a breach of any representation, warranty or covenant made by Rhein hereunder, by Rhein or
its Sublicensee(s), (b) the negligence or willful misconduct of Rhein, its Affiliates or
Sublicensee(s) and the employees, agents and contractors thereof, (c) any manufacturing of Licensed
Adjuvant or Licensed Product, (d) the Licensed Product infringing upon or violating
any third party’s patent or other proprietary rights, except for infringements caused by the
Licensed Adjuvant as warranted under Section 9.4, or (e) any handling, possession, use, marketing,
distribution or sales of Licensed Product; provided, however, that Rhein shall have
no obligation to indemnify Corixa to the extent that such Losses are the result of Corixa’s gross
negligence or willful misconduct.



     10.2 Corixa hereby agrees to indemnify, defend and hold harmless Rhein from and against any
and all losses arising from or based on Corixa’s gross negligence or willful misconduct.



     10.3 Insurance. Rhein shall obtain and maintain in effect during the term of this Agreement
and for five (5) year thereafter, with financially strong insurance carriers (AM Best Rating of “A”
V or higher), commercial general liability insurance covering bodily injury and property damage
necessary to meet its liability obligations under this Agreement or amounts comparable to other
companies of the same size and having the same business as Rhein. Rhein shall provide a statement
to Corixa in which Rhein identifies its insurer and warrants that its coverage is sufficient to
meet its obligations set forth herein. The insurance limits will be increased as a function of
increasing sales levels. There shall be a thirty (30) day notice of cancellation with respect to
the insurance coverage, and Corixa shall be notified in the event of any material change directly
affecting Corixa in the insurance contract or coverages afforded. Rhein shall be solely responsible
for the payment of any deductible.



11. Limitation of Liability.


IN NO EVENT WILL EITHER PARTY HERETO BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
INDIRECT DAMAGES SUFFERED BY THE OTHER PARTY ARISING IN ANY WAY OUT OF THIS AGREEMENT, HOWEVER
CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.




12. Disclaimer of Warranties.




          ALL LICENSED ADJUVANT ARE LICENSED AND SUPPLIED HEREUNDER “AS IS,” AND CORIXA HEREBY DISCLAIMS ANY
AND ALL REPRESENTATIONS AND WARRANTIES WITH REGARD TO THE LICENSED ADJUVANT, THE LICENSED PRODUCTS
AND THE LICENSED PATENTS, EXPRESS OR IMPLIED, AND SPECIFICALLY DISCLAIMS ANY OTHER EXPRESS OR
IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES



[ * ] = 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 11 of 24









 








OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE AND ANY OTHER STATUTORY WARRANTIES OR
ANY WARRANTY OF PATENTABILITY OR NONINFRINGEMENT.




13. Confidentiality.




     13.1 Confidential Information. “Confidential Information” shall mean any proprietary
information that is specifically designated as such and that is disclosed by either party to the
other in any form in connection with this Agreement. For the term of this Agreement and five
(5) years from the date of expiration or termination, each party (a) shall treat as confidential
all Confidential lnformation provided by the other party, (b) shall not use such Confidential
lnformation except as expressly permitted under the terms of this Agreement or otherwise authorized
in writing by the disclosing party, (c) shall implement reasonable procedures to
prohibit the disclosure, unauthorized duplication, misuse or removal of such Confidential
Information, and (d) shall not disclose such Confidential lnformation to any third party. Without
limiting the foregoing, each of the parties shall use at least the same procedures and degree of
care to prevent the disclosure of Confidential lnformation as it uses to prevent the disclosure of
its own confidential information of like importance, and shall in any event use no less than
reasonable procedures and a reasonable degree of care.



     13.2 Exceptions. Notwithstanding the above, neither party shall have liability to the other
with regard to any Confidential lnformation that:



          (a) was generally known and available to the public domain at the time it was disclosed, or
becomes generally known and available to the public domain through no fault of
the receiver;




          (b) was known to the receiver at the time of disclosure as shown by the written records in
existence at the time of disclosure;




          (c) is disclosed with the prior written approval of the disclosing party;




          (d) becomes known to the receiving party from a source other than the disclosing party without
breach of this Agreement by the receiving party and in a manner which is otherwise not in violation
of the disclosing party’s rights; or




          (e) is disclosed pursuant to the order or requirement of a court, administrative agency, or
other governmental body; provided, that the receiving party shall provide reasonable advance notice
to enable the disclosing party to seek a protective order or otherwise prevent such disclosure.




14. Infringement.




     14.1 If any patent infringement action is brought against Rhein or any of suppliers,
distributors, or customers because of actual or anticipated manufacture, use or sale of a Licensed
Product and such action claims that such manufacture, use, or sale infringes the intellectual
property rights of a third party, Rhein shall promptly notify Corixa and send Corixa copies of all
papers that have been served. Corixa shall have the first right to control the defense of such
action at its own expense, provided that such first right to control will be limited to the
Licensed Patents covering the Licensed Adjuvant, and Rhein shall at all times cooperate with Corixa
and continue to pay royalties on any Net Sales of Licensed Product during the pendency of such
action and any appeals.



[ * ] = 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 12 of 24









 





     14.2 If Corixa fails to defend such infringement action after being notified by Rhein, Rhein
shall have the right, but not the obligation, to defend the action itself. If Rhein does undertake
such defense, Corixa shall cooperate with Rhein and shall be entitled to select
legal counsel of its choice. All costs and expenses incurred by Rhein, including settlement
costs, damages assessed against Rhein, and reasonable attorney fees, shall be paid by Rhein.



     14.3 Neither party shall be permitted to settle a legal action without the prior written
consent of the other party, which consent shall not be unreasonably withheld; provided, however,
that Corixa shall have the right to settle, without Rhein’s consent, any legal action, or part
thereof, that relates solely to the Licensed Adjuvant.



15. Enforcement




     15.1 If during the term of this Agreement, either party becomes aware of a third party
infringement or threatened infringement of any Licensed Patents, the following provisions shall
apply:



          (a) The party having such knowledge shall promptly give notice to the other party, with all
available details.




          (b) Corixa shall have the right, but not the obligation, to bring suit in its name at its own
expense to restrain such infringement and to recover profits and damages. Rhein agrees at Corixa’s
request to be joined as a party plaintiff and to cooperate in the prosecution thereof, as is
reasonably necessary, at Corixa’s expense. If Corixa decides to undertake such suit, then Corixa
shall have the sole right to control prosecution and shall retain all proceeds therefrom.




          (c) If Corixa fails to take action within [ * ] after becoming aware of such infringement, in
the first instance or by notice from Rhein, then Rhein, at any time prior to Corixa thereafter
filing an action and solely to the extent such infringement or threatened infringement involves a
vaccine product for use in the Disease Field, shall have the right, but not the obligation to take
such action in its own name. Corixa shall cooperate with Rhein, at Rhein’s expense, as is
reasonably necessary in any such action brought by Rhein. If Rhein brings legal action, Rhein shall
have the sole right to control prosecution and shall retain all proceeds therefrom.




          (d) In the event of a cooperative legal action involving both Corixa and Rhein and a monetary
recovery in connection with such action is obtained, such recovery shall be applied in the
following priority: (i) to reimburse Corixa and Rhein by proportion and up to the extent of their
actual out-of-pocket expenses (including reasonable attorney fees) in
prosecuting such infringement, (ii) to be shared by the proportion and up to the extent of any
damages established, including but not limited to Rhein’s lost profits and Corixa’s lost royalties,
and (iii) the balance, if any, to be shared one-half by Corixa and one-half by Rhein.




16. Term and Termination.




     16.1 Term. The term of this Agreement shall be for a period of fifteen (15) years from the
Effective Date.



     16.2 Termination by Agreement. This Agreement may be earlier terminated by either party upon
mutual written agreement.



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





Page 13 of 24









 





     16.3 Termination for Breach. Upon any material breach of this Agreement by either party, the
non-breaching party may terminate this Agreement upon thirty (30) days written
notice to the breaching party. The notice shall become effective at the end of the thirty (30) day
period unless the breaching party shall cure such breach within such period. For purposes of
this Agreement, Material breach shall be deemed to include, but not be limited to, (a) the sale of
Licensed Product outside of the Disease Field, (b) distribution of Licensed Adjuvant other than as
allowed under this Agreement, (c) failure to pay the royalties payable under Section 4, (d) failure
to comply with the publication obligations specifically related to Licensed Adjuvant and/or
Licensed Patents under Section 7.1, and (e) failure to comply with the insurance requirements under
Section 10.3.



     16.4 Bankruptcy. Either party may terminate this Agreement by giving thirty (30) days written
notice to the other party if such other party (a) files a petition of bankruptcy or has any such
petition filed against such other party; (b) goes into compulsory liquidation; (c) has its business
placed in the possession of a receiver, a government or a government agency; (d) makes an
assignment for the benefit of creditors; or (e) is subject to a dissolution or winding up.



     16.5 Effects of Termination. Neither expiration nor termination shall relieve either party of
its obligations under Sections 4.6 through 4.10, 7, 8, 9 through 14 or 17. Further,
Rhein shall make all reports and payments as are required for the final quarter. Upon
expiration or termination hereof, at Corixa’s option, Rhein shall return or destroy, and certify
destruction of, any Licensed Adjuvant in Rhein’s possession or control.



17. General Provisions.




     17.1 Independent Contractors. Corixa and Rhein shall be independent contractors and shall not
be deemed to be partners, joint venturers or each other’s agents, and neither party shall have the
right to act on behalf of the other except as is expressly set forth in this Agreement.



     17.2 Entire Agreement; Amendment. This Agreement sets forth the entire agreement and
understanding between the parties and supersedes all previous agreements, promises,
representations, understandings, and negotiations, whether written or oral between the parties with
respect to the subject matter hereof. There shall be no amendments or modifications to this
Agreement, except by a written document signed by both parties.



     17.3 Assignment. This Agreement shall be binding upon and shall inure to the benefit of any
successor or successors of Corixa and Rhein by reorganization, merger, consolidation or otherwise,
and any assignee that has acquired all of substantially all of the business and properties of
either. Corixa and Rhein shall not otherwise assign their rights and obligations hereunder unless
having obtained the prior written consent of the other party hereto, which consent will not be
unreasonably withheld or delayed.



     17.4 Governing Law; Injunctive Relief.



          (a) This Agreement shall be construed and enforced in accordance with the laws of the state of
Washington, without giving effect to its or any other jurisdiction’s principles
of conflicts of law.




          (b) Corixa shall have the right to such injunctive relief or other legal or equitable relief
as is reasonable to ensure that Rhein does not transfer the Licensed Adjuvant to a third party,
except as allowed under this Agreement, without Corixa’s prior written consent.



[ * ] = 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 14 of 24









 








     17.5 Dispute Resolution. Any dispute or claim arising out of or in connection with this
Agreement shall be resolved as follows: (a) for a period of thirty (30) days after a dispute arises
the respective chief executive officers of the parties or their designees shall negotiate in good
faith in an effort to resolve the dispute, and (b) if the dispute has not been resolved at the
close of such thirty (30) day period, the matter will be finally settled by binding arbitration
under the Rules of Arbitration of the American Arbitration Association, by one arbitrator appointed
in accordance with said rules; provided, that if the parties cannot agree on the arbitrator, the
dispute shall be resolved by a panel of three arbitrators, wherein each party shall appoint one
arbitrator and those arbitrators shall in turn jointly appoint the third arbitrator. The language
of the arbitration shall be in English. Judgment on an award rendered by an arbitrator or
arbitrators may be entered in any court having jurisdiction. Notwithstanding the foregoing,
the parties may apply to any court of competent jurisdiction for preliminary or interim equitable
relief without breach of this arbitration provision. Such arbitration shall be held in Seattle,
Washington.



     17.6 Severability. If any provision of this Agreement is finally held to be invalid, illegal
or unenforceable by a court of competent jurisdiction, the validity, legality and enforceability of
the remaining provisions shall not be affected or impaired in any way.



     17.7 Waiver. Any delay or failure in enforcing a party’s rights under this Agreement or any
waiver as to a particular default or other matter shall not constitute a waiver of a party’s right
to the future enforcement of its rights under this Agreement.



     17.8 Trademark Ownership and Usage.




          (a) Rhein, at its expense, shall be responsible for the selection, registration and
maintenance of all trademarks that it employs in connection with Licensed Product and
shall own and/or control such trademarks. Nothing in this Agreement shall be construed as a grant
of rights, by license or otherwise, to Corixa to use such trademarks for any purpose.




          (b) Rhein shall, where legally permitted and at Corixa’s request, include in the packaging of
Licensed Products wording that is mutually agreeable to the parties (Rhein’s agreement not to be
unreasonably withheld), to indicate Corixa’s licensor status in relation to Licensed Products.
Notwithstanding the foregoing, if Rhein sells, offers for sale, imports or manufactures Licensed
Product in the United States, Rhein shall include the U.S. patent numbers that have been issued or
published as applications on the packaging, which shall be reviewed and approved by Corixa, such
approval shall not be unreasonably withheld, prior to use.




          (c) In marketing Licensed Products, Rhein will clearly label such Licensed Products sold by
Rhein in compliance with the law and Rhein shall procure from its Sublicensee hereunder an
agreement to clearly label such Licensed Products in compliance with the law. In marketing Licensed
Products, Rhein’s labeling of such Licensed Products shall include Corixa’s trademarks, “Ribi.529TM
adjuvant” and “Powered by CorixaTM” in a manner that the parties agree is commercially reasonable
and Rhein shall require its Sublicensee to so label Licensed Products marketed by such Sublicensee.




     17.9 Notice. Any notice required or permitted by this Agreement to be given to either party
shall be in writing and shall be deemed given when delivered personally, by confirmed telecopy to a
fax number designated in writing by the party to whom notice is given, or by registered, recorded
or certified mail, return receipt requested, and addressed to the party to whom such notice is
directed, at:



[ * ] = 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 15 of 24









 




If to Corixa:



Corixa Corporation

1124 Columbia Street, Suite 200

Seattle, Washington 98104, USA

Attention: Senior Vice President, Chief Operating Officer

Copy: General Counsel

[ * ]



If to Rhein:



Rhein Biotech N.V.

Gaetano Martinolaan 95

6229 GS Maastricht, The Netherlands

Attention: President and CEO

Copy: VP Legal Affairs

[ * ]



or at such other address or telecopy number as such party to whom notice is directed may
designate to the other party in writing.




     17.10 Force Majeure. If the performance of this Agreement or any obligations hereunder is
prevented, restricted or interfered with by reason of fire or other casualty or accident, strikes
or labor disputes, war or other violence, any law, order, proclamation, ordinance, demand or
requirement of any government agency, or any other act or condition beyond the control of the
parties hereto, the party so affected, upon giving prompt notice to the other party shall be
excused from such performance (other than the obligation to pay money) during such prevention,
restriction or interference.



     17.11 Headings. The section headings appearing in this Agreement are inserted only as a
matter of convenience and in no way define, limit, construe or describe the scope or extent of such
section or in any way affect such section.



     17.12 Counterparts. This Agreement may be signed in counterparts, each of which shall be
deemed an original and all of which together shall constitute one instrument.



{Signature page follows}



[ * ] = 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 16 of 24









 







     IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first
above written.



	 	 	 	 	 
	 

	 	CORIXA CORPORATION	 	 
	 

	 	1124 Columbia Street, Suite 200	 	 
	 

	 	Seattle, Washington 98104, USA	 	 
	 
	 	 	 	 
	 

	 	/s/ Steven Gillis
 

	 	 
	 

	 	Steven Gillis, Ph.D.	 	 
	 

	 	Chairman and Chief Executive Officer	 	 
	 
	 	 	 	 
	 

	 	RHEIN BIOTECH N.V.	 	 
	 

	 	Gaetano 95 he Netherlands	 	 
	 

	 	6229 GS Maastrieht, The Netherlands	 	 
	 
	 	 	 	 
	 

	 	/s/ T. Y. Thio	 	 
	 

	 	 	 	 
	 

	 	Dr. T. Y. Thio	 	 
	 

	 	Sr. Vice President Business Development	 	 
	 
	 	 	 	 
	 

	 	/s/ C.P.E. Moonen	 	 
	 

	 	 	 	 
	 

	 	Vice President Legal Affairs	 	 





[ * ] = 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 17 of 24









 





APPENDIX A




Licensed Patents




	 	 	 	 	 	 	 	 	 
	Docket	 	 	 	 	 	 	 	 
	Number	 	TITLE	 	Country	 	Serial No/Filing Date	 	Status
	[ * ]

	 	AMINOALKYL

GLUCOSAMINE

PHOSPHATE COMPOUNDS

AND THEIR USE AS

ADJUVANTS AND

IMMUNOEFFECTORS
	 	U.S.
	 	[ * ]

Filed: 5/8/97
	 	Issued 9/5/00 as
Patent No. 6,113,918
(Expires 5/8/17)
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	U.S.
	 	[ * ]

Filed: 5/7/98
	 	Notice of Allowance
dated 10/18/99—Issue
Fee paid 1/18/00
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	AMINOALKYL

GLUCOSAMIDE

PHOSPHAT COMPOUNDS

AND THEIR USE AS

ADJUVANTS AND

IMMODEPRESSORS
	 	U.S.
	 	[ * ]

Filed: 11/12/99
	 	Issued 10/16/2001 as
Patent No. 6,303,347
(Expires 5/8/17)
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	U.S.
	 	[ * ]
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	PCT
	 	[ * ]
	 	Converted
	 

	 	 	 	 	 	Filed 5/7/98
	 	Publication No. WO
9850399; published
10/12/98
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	ARIPO
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Australia
	 	[ * ]

Filed 5/7/98
	 	Allowed
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Brazil
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Canada
	 	[ * ]

Filed 5/7/98
	 	Pending
Request Exam May 2003
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	China
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Europe
	 	[ * ]

Filed 5/7/98
	 	Pending
EP Publication No.
983286
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Hong Kong
	 	[ * ]

Filed 5/7/98
	 	EP Publication No.
983286





[ * ] = 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 18 of 24









 





	 	 	 	 	 	 	 	 	 
	Docket	 	 	 	 	 	 	 	 
	Number	 	TITLE	 	Country	 	Serial No/Filing Date	 	Status
	[ * ]

	 	“
	 	Hungary
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Indonesia
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Israel
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Japan
	 	[ * ]

Filed 5/7/98
	 	Pending
Request Exam May 2005
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	North Korea
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	South Korea
	 	[ * ]

Filed 5/7/98
	 	Pending
Request Exam May 2005
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Mexico
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	New Zealand
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	OAPI
	 	[ * ]

Filed 5/7/98
	 	Granted 6/12/2000 as
Patent No. 11214
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Poland
	 	[ * ]

Filed 5/7/98
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	PCT
	 	[ * ]

Filed: 11/13/00
	 	Published 5/17/2001
Publication No. WO
01/34617
30th Mo.
Conversion 5/12/2002
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Argentina
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Colombia
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Gulf Cooperation

Council
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Malaysia
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Philippines
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Pakistan
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Taiwan
	 	[ * ]

Filed: 11/12/00
	 	Pending
	 
	 	 	 	 	 	 	 	 
	[ * ]

	 	“
	 	Venezuela
	 	[ * ]

Filed: 11/12/00
	 	Pending





[ * ] = 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 19 of 24









 





APPENDIX B



Quality Plan



The Quality Plan, as may be amended from time to time by mutual written agreement, is
attached hereto.




[ * ]



[ * ] = 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 20 of 24









 





APPENDIX C




Specifications for Finished Products









	 	 	 	 	 	 	 	 	 
	Item

	 	RC-529
	 	Part Number:
	60529	 
	 

	 	TEA Salt Form	 	 	 	 	 	 
	 	 	 	 	Specification Edition
	 

	 	 	 	#:
	03	 








	 	 	 	 	 	 	 
	 	 	 	 	 	 	Manufacturing
	Active Ingredients	 	Amount/Vial	 	Standard Lot Size	 	Instruction
	RC-529 TEA Salt Form

	 	NA
	 	-5 g
	 	MBR 60529
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	Amt/Vial:
	 

	 	 	 	 	 	5 mg, 10 mg or 250

mg






Container/Closure:




	 	 	 	 	 
	Vials:	 	Stoppers:	 	Seals:
	Type 1 BSG: (blow-molded)

	 	Lyophilization
	 	Aluminum 20 mm (52001)
	10 mL (50301) & 100 mL (50304)

	 	Gray butyl 20 mm (51087)	 	 






	 	 	 	 	 	 	 
	Appearance:

	 	Off-white fluffy cake
	 	QC Sample
	 	4 x 5 mg

11 x 10 mg
	 
	 	 	 	 	 	 
	Fill Volume:

	 	10 mg/mL solution filled at 5 mg

10 mg or 250 mg/Vial
	 	Retention

Sample:
	 	10 x 5 mg

22 x 10 mg
	 
	 	 	 	 	 	 
	Final Form:

	 	Lyophilized
	 	Retest Date:
	 	NA
	 
	 	 	 	 	 	 
	Storage

	 	2°-8°C	 	 	 	 
	Conditions:
	 	 	 	 	 	 






Specifications/Testing:




	 	 	 	 	 	 	 
	Product Attribute		Method	 	Specification
	13C NMR 
		SOP #QC-590
	 	Matches Reference Standard
	Purity by HPLC 
		SOP #QC-172
	 	395% by peak area
	Free fatty acids 
		SOP #QC-185
	 	£2.6% (w/w)
	Melting point 
		SOP #QC-151
	 	Information only; report results
	Residual solvent 
		SOP #QC-830
	 	£ 60ppm chloroform
	 

			 	£ 3000 ppm methanol
	 

			 	£ 5000 ppm 1-butanol
	Counter ion 
		SOP #QC-179
	 	2 – 8% (w/w)
	Residual moisture 
		SOP #QC-341
	 	£ 6.7% (w/w)
	ICP Analysis 
		Contract Laboratory
	 	Information only; report results
	Pyrogenicity 
		SOP #QC-660
	 	Nonpyrogenic at 2.5 mg/kg BW
	Bioburden/Sterility 
		SOP #QC-412
	 	£ 10 CFU/10 mg
	 
	Released Product:          Signed for Release
			 	 





[ * ] = 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 21 of 24









 







Approval Signatures:




	 	 	 
	 

	 	 
	Purchasing

	 	Date
	 
	 	 
	 

	 	 
	Production

	 	Date
	 
	 	 
	 

	 	 
	Quality Control

	 	Date
	 
	 	 
	 

	 	 
	Quality Assurance

	 	Date
	 
	 	 
	 

	 	 




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




Page 22 of 24





 









 








Quality Control Analysis Report

Corixa

RC-529 TEA Salt Form – 60529




	 	 	 	 	 	 	 	 	 
	RC-529 Lot No.:

	 	 	 	 
	 	Manufacture Date:	 	 
	 

	 	 
	 	 	 	 	 	 
	QC Sample Quantity:

	 	 	 	 	 	Date Received:	 	 
	 

	 	 
	 	 	 	 	 	 





	 	 	 	 	 	 	 	 	 	 	 
	Testing Requirements:	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	Tested
	Test	 	Method	 	Edition	 	Specification	 	Results	 	by Date
	 
	1. 13C NMR

	 	SOP #QC-590
	 	 	 	Matches Reference

Standard	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	2. Purity by
HPLC

	 	SOP #QC-172
	 	 	 	3 95% by peak area	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	3. Free fatty acids

	 	SOP #QC-185
	 	 	 	£ 2.6% (w/w)	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	4. Residual solvent

	 	SOP #QC-830
	 	 	 	£ 60 ppm chloroform	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	£ 3000 ppm methanol	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	£ 5000 ppm t-butanol	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	5. Counter ion

	 	SOP #QC-179
	 	 	 	2 – 8 % (w/w)	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	6. Residual moisture

	 	SOP #QC-341
	 	 	 	£ 6.7% (w/w)	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Information only:	 	 	 	 
	7. ICP analysis

	 	Contract Laboratory
	 	 	 	Report results	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	8. Pyrogenicity

	 	SOP #QC-660
	 	 	 	Nonpyrogenic at 2.5
mg/kg BW	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	9. Bioburden/Sterility

	 	SOP #QC-151 and
	 	 	 	£ 10 CFU/10 mg	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Information only:	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	10. Melting point

	 	 	 	 	 	Report results	 	 	 	 






Comments




 





 




 





 




 





 




 





Number of sample to retention: 
                
               
               
           
               
        Date:       
               
                
               
       

Test results for RC-529 TEA Salt Form, lot number       
               
                
               
               
            , have been reviewed and (check one)




	 	 	 
	Meet current product specifications o

	 	Do not meet all specifications o






	 	 	 	 	 	 	 	 	 
	QC Manager Review:

	 	 	 	 
	 	Date:	 	 
	 

	 	 
	 	 	 	 	 	 




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




Page 23 of 24





 









 








Appendix D




Commercial Development Schedule




			
	TERRITORY
	 	ANTICIPATED TIMING






[ * ]



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




Page 24 of 24