AMENDMENT NUMBER 1 TO ADJUVANT LICENSE AGREEMENT AND ADJUVANT SUPPLY AGREEMENT
Exhibit 10.4
THIS AMENDMENT NUMBER 1 (the “Amendment”) to the ADJUVANT LICENSE AGREEMENT (the “License
Agreement”) and the ADJUVANT SUPPLY AGREEMENT (the “Supply Agreement”) each dated OCTOBER 20, 2004
is made and entered into as of the eighth day of August, 2008, by and between CORIXA CORPORATION,
d/b/a GlaxoSmithKline Biologicals N.A., a Delaware corporation, having offices at 000 Xxx Xxxxxxxxx
Xxxx Xxxxxxxx, XX 00000, (hereinafter referred to as GSK, (the acquiring entity of all stock and
assets of CORIXA CORPORATION)) and BIOMIRA MANAGEMENT INC. (the assignee of the rights of Biomira
International, Inc. under the License Agreement and the Supply Agreement), a Delaware corporation,
having offices at 0000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, XX 00000 (“Biomira”).
WHEREAS, Biomira and GSK are parties to the License Agreement and the Supply Agreement,
providing for the license and supply of MPL ADJUVANT to develop and market Products;
AND WHEREAS, Biomira and GSK desire to amend the License Agreement and the Supply Agreement
upon the terms and conditions noted below;
NOW, THEREFORE, in consideration of the premises, the mutual covenants contained herein and
other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereby agree as follows:
1. Section 2.5 of the License Agreement is amended by deleting of such provision in its
entirety and replacing it with the following clause;
“2.5 Diligence. Biomira agrees to use its reasonable commercial efforts in
conducting clinical studies, and to use its reasonable commercial efforts to obtain
the appropriate regulatory approval for Products in those countries in the Territory
where it is economically reasonable for Biomira to do so. Biomira shall use
reasonable commercial efforts to have a commercial launch of a Product in the United
States or in a country in a Major Market by the end of the calendar year 2015,
provided, however, if such commercial launch has not occurred by the end of the
calendar year 2015 and GSK has not provided Biomira with written notice by no later
than the end of the calendar year 2013 of GSK’s intent to require the parties to
negotiate in good faith an amendment to the Supply Agreement or a new supply
agreement that sets forth the terms and conditions of the continued supply by GSK to
Biomira of Licensed Adjuvant post-2013, then GSK shall determine, in its sole
discretion, if GSK desires to continue the supply Licensed Adjuvant to Biomira
beyond December 31, 2015.”
2. Section 2.1 of the Supply Agreement is amended by deleting such provision in its entirety
and replacing it with the following clause;
“2.1 Firm Forecast. Subject to the terms and conditions of this Agreement
including, without limitation, those of Xxxxxxx 0, XXX agrees to supply Biomira, and
Biomira agrees to purchase from GSK, Biomira’s requirements for Licensed Adjuvant
for use in any and all preclinical and clinical research and trials for, and for the
manufacture of, Products during the Term of this Agreement. On or before December
10, 2008 (the “Forecast Date”), Biomira shall provide GSK with a forecast
(each forecast provided pursuant to this Section 2.1 shall be referred to herein as
a “Firm Forecast”), substantially in the form attached hereto as Appendix 3,
of Biomira’s requirements for quantities of Licensed Adjuvant in each of the eight
(8) calendar quarters for the period commencing on April 1, 2009 and ending on
March 31, 2011. On each three month anniversary of the Forecast Date thereafter
during the Term, Biomira shall deliver to GSK an undated Firm Forecast of its
requirements of Licensed Adjuvant in each of the eight (8) calendar quarters during
the period beginning where the first quarter of the prior Firm Forecast left-off and
ending one (1) quarter after the prior Firm Forecast, With respect to any such
updated Firm Forecast, Biomira’s specified requirements for Licensed Adjuvant in the
fourth, fifth, sixth and seventh quarters thereof will be between minimum fifty
(50%) percent and maximum one hundred and twenty-five (125%) percent of the quantity
of Licensed Adjuvant specified for, respectively, the fifth, sixth, seventh and
eight quarters of the prior Firm Forecast. In addition, the parties agree to meet
(in person or by telephone) once per calendar year during the Term to discuss
Biomira’s ten (10)-year projections of its needs for Licensed Adjuvant and such
discussions and projections shall be non-binding and are intended simply to aid the
parties in planning.”
3. Section 2.2, of the Supply Agreement is amended by deleting such provision in its entirety
and replacing it with the following clause:
“Section 2.2 Certain Purchase Obligations. Subject to Section 4.1 of this
Agreement, the amount of Licensed Adjuvant forecast in the first four quarters (4)
of each Firm Forecast automatically shall be Biomira’s firm and biding purchase
order. Therefore, Biomira shall be obligated to purchase, and GSK shall be
obligated to sell; and deliver, one-hundred percent (100%) of the amount specified
within the first four (4) quarters of a Firm Forecast in accordance with this
Agreement. Biomira shall order Licensed Adjuvant in two gram (2 gr) increments, and
GSK shall deliver Licensed Adjuvant in two gram (2 gr) vials. The foregoing vial
configuration may be adjusted by mutual agreement in writing of the parties.”
4. Appendix 3 of the Supply Agreement is amended by deleting such appendix in its entirety and
replacing it with the form of Appendix 3 attached to this Amendment.
5. Except as provided herein, all other terms, conditions and provisions of the License
Agreement and the Supply Agreement remain in full force and effect.
6. This Amendment shall enure to the benefit of and be binding upon the parties hereto and
their respective successors and permitted assigns.
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7. This Amendment, the License Agreement and the Supply Agreement, including all documents
referred to herein and attached hereto, constitute the entire agreement of the parties on the
subject matter hereof and supersede all prior representations, understandings and agreements
between the parties with respect to such subject matter, The documents referred to herein and
attached hereto shall be read together with this Amendment, the License Agreement and the Supply
Agreement to determine the parties’ intent. In the event of a conflict between or among such
documents, the documents shall govern in this order: (1) the License Agreement or the Supply
Agreement, as the case may be, (2) this Amendment, (3) the applicable statement of work, if any,
and (4) a change order, if any, related to the applicable statement of work, if any.
8. This Amendment may be executed in one or more counterparts, each of which shall be deemed
an original, and all of which shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed by their duly
authorized corporate officers or representatives as of the date first above written.
| Biomira Management Inc. | GSK Corporation d/b/a/ | |||||
| GlaxoSmithKline Biologicals N.A. | ||||||
By:
|
/s/ Xxxx Xxxxxxxxxxxx | By: | /s/ Jean Stephenne | |||
Name:
|
Xxxx Xxxxxxxxxxxx | Name: | Jean Stephenne | |||
Title:
|
Chief Operating Officer | Title: | CEO, GSK Bio | |||
Date:
|
August 29, 2008 | Date: | September 2, 0000 | |||
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XXXXXXXX 3 — Firm Forecast Mechanism (Example)
Issued Quarterly |
1st year | 100% binding (no variation allowed) |
||
| 2nd year | 50% binding (max. 25%
increase allowed from one
revision to another one) |
|||
Issued yearly in December |
3 > 10th year | 0% binding (for information only) |
| 2009 | 2009 | 2009 | 2010 | 2010 | 2010 | 2010 | 2011 | 2011 | 2011 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 10g | 10g | 10g | 10g | 20g | 20g | 20g | 20g | 100g |
250g | 300g | 400g | 500g | 600g | 700g | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| done | 10g | 10g | 10g | 10g | 20g | 10g | 15g | 25g | 75g |
250g | 300g | 400g | 500g | 600g | 700g | |||||||||||||||||||||||||||||||||||||||||||||||||||||
done |
done | 10g | 10g | 10g | 25g | 10g | 18.75g | 25g | 25g | 50g |
250g | 300g | 400g | 500g | 600g | 700g | ||||||||||||||||||||||||||||||||||||||||||||||||||||
done |
done | done | 10g | 10g | 25g | 12.5g | 20g | 25g | 25g | 25g | 25g | 250g | 300g | 400g | 500g | 600g | 700g | |||||||||||||||||||||||||||||||||||||||||||||||||||
done |
done | done | done | 10g | 25g | 12.5g | 15g | 25g | 25g | 25g | 25g | 250g | 300g | 400g | 500g | 600g | 700g | |||||||||||||||||||||||||||||||||||||||||||||||||||
Purchase orders must be sent a minimum of 90 days prior the beginning of each calendar quarter.
