SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act 1934
Date of Report: May 16, 1995
INTERNEURON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in charter)
DELAWARE
(State of other jurisdiction of incorporation)
0-18728 043047911
(Commission File Number) (IRS Employer Identification No.)
ONE LEDGEMONT CENTER, 99 HAYDEN AVENUE, LEXINGTON, MASSACHUSETTS 02173
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(Address of principal executive offices) (Zip Code)
Registrant's telephone no. including area code: (617) 861-8444
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Item 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(c) EXHIBITS
10.70* License and Collaboration Agreement by and between Progenitor, Inc. and
Chiron Corporation dated as of March 31, 1995 (1)
10.72* Sponsored Research and License Agreement dated as of May 1, 1995
between Progenitor, Inc. and Novo Nordisk
* Confidentiality requested for a portion of this Exhibit
(1) Supersedes Exhibit 10.70; filed as an exhibit to and incorporated by
reference to Form 8-K filed July 30, 1995
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
INTERNEURON PHARMACEUTICALS INC.
By: /S/ GLENN L. COOPER
-------------------------------
Glenn L. Cooper, M.D., President
Dated: October 2, 1995
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EXHIBIT INDEX
10.72 Sponsored Research and License Agreement dated as of May 1, 1995
between Progenitor, Inc. and Novo Nordisk*
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* Confidentiality requested for a portion of this Exhibit.
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Exhibit 10.72
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by an * and [ ], have been
separately filed with the Commission.
SPONSORED RESEARCH AND LICENSE AGREEMENT
THIS AGREEMENT is entered into as of the 1st day of May, 1995
by and between Progenitor, Inc., 1507 Chambers Road, Columbus, Ohio 43212-1566
("Progenitor"), and Novo Nordisk, c/o ZymoGenetics, Inc., 1201 Eastlake Avenue
East, Seattle, Washington 98102 ("Novo Nordisk").
A. Progenitor has rights in technology related to: (a) a
hematopoietic receptor homologue referred to as Hu-B1.219, and (b) an activity
present in the supernatant of the murine yolk-sac-derived cell line YS-4,
referred to as Mu-YSDF-I. Novo Nordisk and its Affiliates have experience in
isolating and cloning ligands to receptors and purifying and cloning growth
factors and in developing products therefrom.
B. Novo Nordisk and its Affiliates desire to obtain, and
Progenitor desires to grant to Novo Nordisk and its Affiliates, a license under
Progenitor's rights with respect to the Hu-B1.219 receptor and the YSDF-1 growth
factor, on the terms and conditions set forth in this Agreement.
C. In addition, the parties desire to collaborate in a
research effort as described in this Agreement.
NOW, THEREFORE, the parties hereby agree as follows:
1. DEFINITIONS.
1.1 AFFILIATE of a party shall mean any entity that
controls, is controlled by or is under common control with such party or such
party's Affiliates.
1.2 FIELD shall mean any and all human therapeutic
uses and all small molecule drug design uses, but excluding all non-therapeutic
uses (including but not limited to diagnostic and cell-sorting uses).
1.3 GROWTH FACTOR shall mean any protein molecule
which is purified from the supernatant of the murine yolk-sac-derived cell line
YS-4 and any human homologue (Hu-YSDF-1) of Mu-YSDF-1, wherein such protein
molecule is stimulatory to any hematopoietic stem cell, hematopoietic blast cell
or any hematopoietic progenitor cell found in the bone marrow, including without
limitation any erythrocyte progenitors, megakaryocyte progenitors and/or
macrophage progenitors, and any nucleic acid molecule corresponding to such
protein molecule, including but not limited to cDNA, genomic DNA and RNA in both
the sense and anti-sense orientations, any homologous nucleic acid and/or
protein sequence and any small molecular weight mimetic, as well as any
functional equivalents of any of the foregoing, all as further described in
Exhibit 1.3.
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1.4 JOINT COMMITTEE shall mean the committee
described in Section 2.4 of this Agreement.
1.5 JOINT TECHNOLOGY shall mean any partial or
complete sequence information describing any Ligand or Growth Factor and any
other information, data, property and rights, as well as any inventions, whether
patentable or not, developed from the materials provided to Novo Nordisk by
Progenitor pursuant to this Agreement and arising from the research conducted
pursuant to this Agreement in the course of the Research Phase at or on behalf
of Novo Nordisk, Progenitor or any Affiliate of either. Work done by or on
behalf of Novo Nordisk and/or its Affiliates pursuant to Section 2.2 shall not
be considered to be done in the course of the Research Phase. The parties agree
that any and all Joint Technology shall be jointly owned by Novo Nordisk and
Progenitor.
1.6 LICENSED PATENT RIGHTS shall mean all of
Progenitor's rights in and to Licensed Technology that is covered at any time by
any patent or patent application in any country worldwide, and all divisions,
continuations, continuations-in-part, reissues, reexaminations or extensions
thereof and any period of marketing exclusivity relating thereto. Licensed
Patent Rights shall include, without limitation, rights arising under those
patents and/or patent applications listed in Exhibit 1.6. Licensed Patent Rights
shall also include, without limitation, Progenitor's rights arising under
patents and patent applications covering any Joint Technology.
1.7 LICENSED PRODUCT shall mean any material, the
relevant manufacture, use, sale, offer for sale or import of which by Novo
Nordisk or an Affiliate of Novo Nordisk would, in the absence of the licenses
granted herein, infringe one or more Valid Claims of Licensed Patent Rights,
treating, for this purpose only, all patents covering any Joint Technology as if
they were solely owned by Progenitor.
1.8 LICENSED TECHNOLOGY shall mean any and all
material, information, property and rights in or coming into the possession or
control of Progenitor that is necessary or useful in the development, production
or use of any Receptor, Ligand, and/or Growth Factor in the Field.
1.9 LIGAND shall mean any protein molecule that
specifically binds to the Receptor and any nucleic acid molecule corresponding
to such protein molecule, including, but not limited to, cDNA, genomic DNA, and
RNA in both the sense and anti-sense orientations, any homologous nucleic acid
and/or protein sequence and any small molecular weight mimetic, as well as any
functional equivalents of any of the foregoing, all as further described in
Exhibit 1.9.
1.10 NET SALES shall mean the gross proceeds actually
received by Novo Nordisk or an Affiliate of Novo Nordisk, or a sublicensee of
either, pursuant to sales of a
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Licensed Product (except sales by Novo Nordisk or one of its Affiliates or
sublicensees to Novo Nordisk or one of its Affiliates or sublicensees other than
for end use), less, to the extent included in such gross proceeds, sales and/or
use taxes, income taxes withheld at the source, import and/or export duties,
outbound transportation and insurance, wholesaler and cash discounts, sales
commissions and incentives, returns and allowances, and third party royalties.
1.11 NOVO NORDISK GROWTH FACTOR PATENT RIGHTS shall
mean Novo Nordisk's rights in and to Joint Technology arising from the research
conducted pursuant to this Agreement in the course of Growth Factor Stage 1 and
Growth Factor Stage 2 that is covered at any time by any patent or patent
application in any country worldwide, and all divisions, continuations,
continuations-in-part, reissues, reexaminations or extensions thereof, and any
period of marketing exclusivity relating thereto.
1.12 NOVO NORDISK LIGAND PATENT RIGHTS shall mean
Novo Nordisk's rights in and to Joint Technology arising from the research
conducted pursuant to this Agreement in the course of Ligand Stage 1 and Ligand
Stage 2 that is covered at any time by any patent or patent application in any
country worldwide, and all divisions, continuations, continuations-in- part,
reissues, reexaminations or extensions thereof, and any period of marketing
exclusivity relating thereto.
1.13 NOVO NORDISK PATENT RIGHTS shall mean Novo
Nordisk's rights in and to Joint Technology that is covered at any time by any
patent or patent application in any country worldwide, and all divisions,
continuations, continuations-in-part, reissues, reexaminations or extensions
thereof, and any period of marketing exclusivity relating thereto. Novo Nordisk
Patent Rights shall include, without limitation, all Novo Nordisk Growth Factor
Patent Rights and all Novo Nordisk Ligand Patent Rights.
1.14 PROGENITOR GROWTH FACTOR NET SALES shall mean
the gross proceeds actually received by Progenitor or an Affiliate of
Progenitor, or a sublicensee of either, pursuant to sales of Progenitor Growth
Factor Product (except sales by Progenitor or one of its Affiliates or
sublicensees to Progenitor or one of its Affiliates or sublicensees other than
for end use), less, to the extent included in such gross proceeds, sales and/or
use taxes, income taxes withheld at the source, import and/or export duties,
outbound transportation and insurance, wholesaler and cash discounts, sales
commissions and incentives, returns and allowances, and third party royalties.
1.15 PROGENITOR LIGAND NET SALES shall mean the gross
proceeds actually received by Progenitor or an Affiliate of Progenitor, or a
sublicensee of either, pursuant to sales of Progenitor Ligand Product (except
sales by Progenitor or one of its Affiliates or sublicensees to Progenitor or
one of its Affiliates or sublicensees other than for end use), less, to the
extent included in such gross proceeds, sales and/or use taxes, income taxes
withheld at the source, import and/or export duties, outbound transportation and
insurance, wholesaler and cash discounts, sales commissions and incentives,
returns and allowances, and third party royalties.
1.16 PROGENITOR NET SALES shall mean the gross
proceeds actually received by Progenitor or an Affiliate of Progenitor, or a
sublicensee of either, pursuant to sales
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
of Progenitor Product (except sales by Progenitor or one of its Affiliates or
sublicensees to Progenitor or one of its Affiliates or sublicensee, other than
for end use), less, to the extent included in such gross proceeds, sales and/or
use taxes, income taxes withheld at the source, import and/or export duties,
outbound transportation and insurance, wholesaler and cash discounts, sales
commissions and incentives, returns and allowances, and third party royalties.
1.17 PROGENITOR GROWTH FACTOR PRODUCT shall mean any
material, the relevant manufacture, use, sale, offer for sale or import of which
by Progenitor or an Affiliate of Progenitor would, in the absence of the
licenses granted in Section 8.6 hereof, infringe one or more Valid Claims of
Novo Nordisk Growth Factor Patent Rights, treating, for this purpose only, all
patents covering Joint Technology arising from the research conducted pursuant
to this Agreement in the course of Growth Factor Stage I and Growth Factor Stage
2 as if they were owned solely by Novo Nordisk.
1.18 PROGENITOR LIGAND PRODUCT shall mean any
material, the relevant manufacture, use, sale, offer for sale or import of which
by Progenitor or an Affiliate of Progenitor would, in the absence of the
licenses granted in Section 8.5 hereof, infringe one or more Valid Claims of
Novo Nordisk Ligand Patent Rights, treating, for this purpose only, all patents
covering Joint Technology arising from the research conducted pursuant to this
Agreement in the course of Ligand Stage 1 and Ligand Stage 2 as if they were
owned solely by Novo Nordisk.
1.19 PROGENITOR PRODUCT shall mean any material, the
relevant manufacture, use, sale, offer for sale or import of which by Progenitor
or an Affiliate of Progenitor would, in the absence of the licenses granted in
Section 8.7 hereof, infringe one or more Valid Claims of Novo Nordisk Patent
Rights, treating, for this purpose only, all patents covering Joint Technology
as if they were owned solely by Novo Nordisk.
1.20 RECEPTOR shall mean the protein molecule
[******************************************************************************
****************************************] and any nucleic acid molecule
corresponding to such protein molecule, including, but not limited to, cDNA,
genomic DNA, and RNA in both the sense and anti-sense orientations, any
homologous nucleic acid and/or protein sequence and any small molecular weight
mimetic, as well as any functional equivalents of any of the foregoing.
1.21 RESEARCH PHASE shall mean the initial phase of
the term of this Agreement when the parties are actively conducting research
regarding Ligands and Growth Factors. The Research Phase will consist of two
stages for Ligands and two stages for Growth Factors, which are described in
Section 2.1 below. The Research Phase shall begin on the date of this Agreement
and shall continue until termination of the final stage thereof or the earlier
termination of this Agreement.
1.22 ROYALTIES shall mean all royalties payable by
Novo Nordisk to Progenitor hereunder.
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
1.23 VALID CLAIM shall mean: (i) a claim of an
unexpired patent, or one whose expiration date has been extended by law, so long
as such claim shall not have been held invalid in an unappealed or an
unappealable decision, in a court of competent jurisdiction; or (ii) any
subsisting right of market exclusivity granted on the basis of any of the claims
described in clause (i)
2. RESEARCH.
2.1 The Research Phase will consist of two Ligand
stages and/or two Growth Factor stages, as described below:
2.1.1 Prior to the commencement of Ligand Stage 1,
Novo Nordisk will determine whether or not the Receptor sequence provided by
Progenitor to Novo Nordisk is full-length, and, if Novo Nordisk determines that
such sequence is not full-length, Novo Nordisk will complete such sequence.
During Ligand Stage 1 of the Research Phase, Novo Nordisk and/or one or more of
its Affiliates will attempt to isolate, clone and sequence a Ligand pursuant to
the work plan attached as Exhibit 2.1.1. As required by Novo Nordisk or
requested by the Joint Committee, and at no additional charge, Progenitor will
provide Novo Nordisk with samples of cDNA encoding the Receptor and any other
materials or assistance required to enable Novo Nordisk to determine that the
Receptor sequence provided by Progenitor to Novo Nordisk is full-length (or, if
Novo Nordisk determines that it is not full length, to enable Novo Nordisk to
complete such sequence) and to carry out Novo Nordisk's obligations during
Ligand Stage 1. During Ligand Stage 1, Novo Nordisk will limit its use of the
Receptor and any related tools and reagents provided to it by Progenitor to
carrying out the tasks contemplated by this Section 2.1. Novo Nordisk will not
screen the Receptor against any material, or commingle the Receptor with any
material, that is the property of any person or entity other than Novo Nordisk,
Progenitor and/or any Affiliate of either such party, except with the prior
approval of the Joint Committee. Following the end of Ligand Stage 1, Novo
Nordisk will not use the Receptor except in connection with any Identified
Ligand (as defined below). The parties anticipate that Ligand Stage 1 will
continue for approximately [*********]. If Novo Nordisk has not isolated, cloned
and sequenced a Ligand within [*********] after the date of the commencement of
Ligand Stage 1, Progenitor may deliver written notice to Novo Nordisk at any
time after expiration of such [*********] period but before completion of such
tasks by Novo Nordisk demanding that Novo Nordisk complete such tasks within 60
days after delivery of such notice, and, if Novo Nordisk does not complete such
tasks within such 60-day period, Progenitor may terminate Ligand Stage 1 and the
license granted to Novo Nordisk pursuant to this Agreement with respect to the
Receptor and all Ligands by delivery of written notice to Novo Nordisk, and,
after such termination, Progenitor shall have the rights granted in Section 8.5.
Ligand Stage 1 will begin on the date that Novo Nordisk notifies Progenitor in
writing that: (i) Progenitor has completed delivery of the samples of cDNA
encoding the Receptor and other materials to be delivered to Novo Nordisk
pursuant to this Section 2.1.1, and (ii) Novo Nordisk has possession of the
full-length Receptor sequence. Ligand Stage l will continue until Novo Nordisk
has notified Progenitor in writing that Novo Nordisk has successfully completed
the tasks of isolating, cloning and sequencing a Ligand (the "Ligand Stage 1
Termination Date"), or until Ligand Stage
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
1 or this Agreement is terminated, whichever occurs first. Each determination of
whether or not Novo Nordisk has successfully isolated, cloned and sequenced a
Ligand will be made by Novo Nordisk in its sole discretion, based on some or all
of the criteria set forth in Exhibit 1.9 having been met and based on the
recommendation, if any, of the Joint Committee. Within 60 days after the Ligand
Stage 1 Termination Date, Novo Nordisk will notify Progenitor in writing (the
"Identified Ligand Notice") stating whether or not Novo Nordisk desires to go
forward with Ligand Stage 2 of the Research Phase and what Ligand or Ligands, if
more than one, (or other result of the work conducted pursuant to Ligand Stage
1) Novo Nordisk desires to go forward with (each is referred to herein as an
"Identified Ligand"). If Novo Nordisk states in the Identified Ligand Notice
that it does not desire to proceed to Ligand Stage 2 with any Ligand (or other
result of the work conducted pursuant to Ligand Stage 1), the licenses granted
to Novo Nordisk pursuant to this Agreement with respect to the Receptor and all
Ligands will terminate as of the date of delivery to Progenitor of the
Identified Ligand Notice, and, after such termination, Progenitor shall have the
rights granted in Section 8.5.
2.1.2 During Ligand Stage 2 of the Research Phase,
Progenitor will perform the studies described in Exhibit 2.1.2 and will work
with Novo Nordisk to establish the biological function of each Identified Ligand
to Novo Nordisk's satisfaction. Progenitor will notify Novo Nordisk in writing
when Progenitor is ready to commence such activities (the "Ligand Stage 2
Commencement Notice"), which notice will be delivered to Novo Nordisk no later
than 30 days after Progenitor's receipt of the Identified Ligand Notice. Ligand
Stage 2 will begin on the date Novo Nordisk receives the Ligand Stage 2
Commencement Notice and shall continue for a period of [********] thereafter.
Novo Nordisk will be responsible for producing, at no additional charge, all
recombinant Identified Ligand protein required by Progenitor (as determined by
the Joint Committee) to complete its tasks during Ligand Stage 2. Progenitor
will limit its use of such protein to performance of its obligations under this
Agreement. Within 60 days after the end of Ligand Stage 2, Novo Nordisk will
notify Progenitor in writing (the "Ligand Development Notice") stating whether
or not Novo Nordisk desires to go forward with development of a Licensed Product
based on an Identified Ligand or any other result of the work performed pursuant
to Ligand Stage 2. If Novo Nordisk states in the Ligand Development Notice that
it does not desire to proceed with development of any such Licensed Product, the
licenses granted to Novo Nordisk pursuant to this Agreement with respect to the
Receptor and all Ligands will terminate as of the date of delivery to Progenitor
of the Ligand Development Notice, and, after such termination, Progenitor shall
have the rights granted in Section 8.5.
2.1.3 During Growth Factor Stage 1 of the Research
Phase, Novo Nordisk and/or one or more of its Affiliates will attempt to purify,
clone and sequence a Growth Factor pursuant to the work plan attached as Exhibit
2.1.3. As required by Novo Nordisk, and at no additional charge, Progenitor will
provide Novo Nordisk with samples of Growth Factor-producing cell lines and any
other materials or assistance required to enable Novo Nordisk to carry out Novo
Nordisk's obligations during Growth Factor Stage 1. During Growth Factor Stage
1, Novo Nordisk will limit its use of all Growth Factors and any related tools
and reagents provided to it by Progenitor to carrying out the tasks contemplated
by this Section 2.1. Novo Nordisk will not screen any Growth Factor provided to
Novo Nordisk by Progenitor
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
against any material, or commingle any such Growth Factor with any material,
that is the property of any person or entity other than Novo Nordisk, Progenitor
and/or any Affiliate of either such party, except with the prior approval of the
Joint Committee. Following the end of Growth Factor Stage 1, Novo Nordisk will
not use any Growth Factor provided to Novo Nordisk by Progenitor except in
connection with any Identified Growth Factor (as defined below). The parties
anticipate that Growth Factor Stage 1 will continue for approximately
[***********]. If Novo Nordisk has not purified, cloned and sequenced a Growth
Factor within [***********] after the date of the commencement of Growth Factor
Stage I, Progenitor may deliver written notice to Novo Nordisk at any time after
expiration of such [**********] period but before completion of such tasks by
Novo Nordisk demanding that Novo Nordisk complete such tasks within 60 days
after delivery of such notice, and, if Novo Nordisk does not complete such tasks
within such 60- day period, Progenitor may terminate Growth Factor Stage 1 and
the license granted to Novo Nordisk pursuant to this Agreement with respect to
all Growth Factors by delivery of written notice to Novo Nordisk, and, after
such termination, Progenitor shall have the rights granted in Section 8.6.
Growth Factor Stage 1 will begin on the later of the date of this Agreement or
the date that Novo Nordisk notifies Progenitor in writing that Progenitor has
completed delivery of the samples of Growth Factor cell lines and other
materials to be delivered to Novo Nordisk pursuant to this Section 2.1.3 and
will continue until Novo Nordisk has notified Progenitor in writing that Novo
Nordisk has successfully completed the tasks of purifying, cloning and
sequencing a Growth Factor (the "Growth Factor Stage 1 Termination Date"), or
until Growth Factor Stage 1 or this Agreement is terminated, whichever occurs
first. Each determination of whether or not Novo Nordisk has successfully
purified, cloned and sequenced a Growth Factor will be made by Novo Nordisk in
its sole discretion, based on some or all of the criteria set forth in Exhibit
1.3 having been met and based on the recommendation, if any, of the Joint
Committee. Within 60 days after the Growth Factor Stage 1 Termination Date, Novo
Nordisk will notify Progenitor in writing (the "Identified Growth Factor
Notice") stating whether or not Novo Nordisk desires to go forward with Growth
Factor Stage 2 of the Research Phase and what Growth Factor or Growth Factors,
if more than one, (or other result of the work conducted pursuant to Growth
Factor Stage 1) Novo Nordisk desires to go forward with (each is referred to
herein as an "Identified Growth Factor"). If Novo Nordisk states in the
Identified Growth Factor Notice that it does not desire to proceed to Growth
Factor Stage 2 with any Growth Factor (or other result of the work conducted
pursuant to Growth Factor Stage 1), the licenses granted to Novo Nordisk
pursuant to this Agreement with respect to all Growth Factors will terminate as
of the date of delivery to Progenitor of the Identified Growth Factor Notice,
and, after such termination, Progenitor shall have the rights granted in Section
8.6.
2.1.4 During Growth Factor Stage 2 of the Research
Phase, Progenitor will perform the studies described in Exhibit 2.1.4 and will
work with Novo Nordisk to establish the biological function of each Identified
Growth Factor to Novo Nordisk's satisfaction. Progenitor will notify Novo
Nordisk in writing when Progenitor is ready to commence such activities (the
"Growth Factor Stage 2 Commencement Notice"), which notice will be delivered to
Novo Nordisk no later than 30 days after Progenitor's receipt of the Identified
Growth Factor Notice. Growth Factor Stage 2 will begin on the date Novo Nordisk
receives the Growth Factor Stage 2 Commencement Notice and shall continue for a
period of
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
two years thereafter. Novo Nordisk will be responsible for producing, at no
additional charge, all recombinant Identified Growth Factor protein required by
Progenitor (as determined by the Joint Committee) to complete its tasks during
Growth Factor Stage 2. Progenitor will limit its use of such protein to
performance of its obligations under this Agreement. Within 60 days after the
end of Growth Factor Stage 2, Novo Nordisk will notify Progenitor in writing
(the "Growth Factor Development Notice") stating whether or not Novo Nordisk
desires to go forward with development of a Licensed Product based on an
Identified Growth Factor or any other result of the work performed pursuant to
Growth Factor Stage 2. If Novo Nordisk states in the Growth Factor Development
Notice that it does not desire to proceed with development of any such Licensed
Product, the licenses granted to Novo Nordisk pursuant to this Agreement with
respect to all Growth Factors will terminate as of the date of delivery to
Progenitor of the Growth Factor Development Notice, and, after such termination,
Progenitor shall have the rights granted in Section 8.6.
2.1.5 Progenitor will devote no less than the
equivalent of [**] qualified scientists working full-time on completion of its
obligations throughout Ligand Stage 2 and Growth Factor Stage 2; provided,
however, that during any period during which Progenitor is simultaneously
performing work in Ligand Stage 2 and Growth Factor Stage 2, Progenitor will
devote no less than the equivalent of [******] qualified scientists working
full-time on completion of its obligations hereunder; provided further, however,
that, throughout any period during which Progenitor is simultaneously performing
work in Ligand Stage 2 and Growth Factor Stage 2, the Joint Committee will
consider whether or not (i) the tasks to be completed by Progenitor during
Ligand Stage 2 and Growth Factor Stage 2 justify the devotion of such greater
resources by Progenitor (in terms of additional qualified scientists working on
the project), and (ii) Progenitor has such additional resources available to
devote to completion of such tasks. If the Joint Committee, in its sole
discretion, determines that such additional effort is not justified and/or that
Progenitor does not have such additional resources available, the Joint
Committee may authorize Progenitor to devote less than the equivalent of
[******] qualified scientists working full-time on such project, in which case
the research fees to be paid to Progenitor during such period shall be reduced
as provided in Section 4.1 below. For purposes of this Agreement, the phrase
"full- time" shall mean forty hours per week, excluding holidays.
2.1.6 If Novo Nordisk determines at any time that
any Growth Factor is also a Ligand (or part of a Ligand), Novo Nordisk will
provide Progenitor with written notice of such determination, and such Growth
Factor shall thereafter be treated as a Ligand (and not as a Growth Factor) for
purposes of this Agreement.
2.2 If Novo Nordisk elects to go forward with
development of any Licensed Product, Novo Nordisk and/or one or more of its
Affiliates will attempt through commercially reasonable efforts to develop and
commercialize such Licensed Product and to secure all necessary regulatory
approvals in connection therewith. Progenitor acknowledges that Novo Nordisk
may, but shall not be required to, begin such activities before the end of
Ligand Stage 2, Growth Factor Stage 2 and/or the Research Phase. As between the
parties, all results of such efforts by or on behalf of Novo Nordisk and/or its
Affiliates, regardless of when such
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
efforts are made, shall be owned by Novo Nordisk, and shall not be deemed to be
part of the Joint Technology. Progenitor will assist Novo Nordisk in this effort
as and when reasonably requested by Novo Nordisk. Novo Nordisk does not
guarantee that it will develop, produce or market a Licensed Product or that it
will generate Royalties for Progenitor.
2.3 As requested by Novo Nordisk, Progenitor will
share with personnel of Novo Nordisk, its Affiliates, and their sublicensees and
subcontractors, to the extent it can do so without violating any obligation of
Progenitor and/or any of its Affiliates to any third party (and Progenitor
warrants that any such obligations existing on the date of this Agreement that
would prohibit Progenitor from sharing pertinent materials or information with
Progenitor have been disclosed by Progenitor to Novo Nordisk in writing prior to
the date hereof), all materials and documents in Progenitor's possession, and
all Progenitor's knowledge and know-how, related to the Receptor, Ligands,
Growth Factors, the mammalian cells expressing any of the foregoing, methods of
isolating any of the foregoing, the Licensed Patent Rights and Licensed
Technology, including without limitation all such materials, documents,
knowledge and know-how obtained by Progenitor from any third party, subject to
the applicable confidentiality provisions contained in this Agreement; provided,
however, that nothing in this Section shall be construed as requiring Progenitor
to describe to Novo Nordisk the exact method employed by Progenitor in
identifying the partial cDNA sequence disclosed in the United States patent
application filed on behalf of Progenitor on [***************], except as
required to be disclosed to the United States Food and Drug Administration
("FDA") or any other regulatory agency in connection with gaining approval to
market and/or distribute any Licensed Product. As requested by Progenitor, Novo
Nordisk will share with personnel of Progenitor, its Affiliates, and their
sublicensees and subcontractors, to the extent it can do so without violating
any obligation of Novo Nordisk and/or any of its Affiliates to any third party,
all materials and documents in Novo Nordisk's possession, and all Novo Nordisk's
knowledge and know-how, related to the Receptor, Ligands, Growth Factors, the
Licensed Patent Rights and Licensed Technology and acquired or developed by Novo
Nordisk and/or its Affiliates in the course of the Research Phase.
2.4 The parties hereby establish the Joint Committee,
to be comprised of three representatives appointed by Novo Nordisk and three
representatives appointed by Progenitor. The initial representatives of Novo
Nordisk to the Joint Committee shall be Dr. Don Foster, Dr. John Forstrom, and
Dr. Luciana Simoncini and the initial representatives of Progenitor to the Joint
Committee shall be Dr. H. Ralph Snodgrass, Dr. Doros Platika, and Dr. Stephen
Williams. One representative from each party shall be that party's project
leader for this Agreement. Each party will promptly notify the other party of
any change in its appointed representatives. In addition, if any designated
representative of a party is unable to attend any meeting of the Joint
Committee, such party may designate a replacement for such designated
representative; provided, however, that if all three designated representatives
of either party are unable to attend any meeting of the Joint Committee, such
meeting shall be rescheduled.
2.4.1 Where the Joint Committee is specifically
authorized by this Agreement to make determinations, any such determinations
shall be made by majority vote,
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and each representative shall have one vote. During the Research Phase, the
Joint Committee shall meet in person at least twice each calendar year and by
teleconference at least once each calendar quarter (excluding the calendar
quarters in which it meets in person). Following the Research Phase, the Joint
Committee shall meet in person or by teleconference at least once each calendar
year. Each party shall bear its own expenses for its personnel attending such
meetings. The representatives of each party shall prepare and distribute to both
parties written minutes of each such meeting, both during and after the Research
Phase, which minutes will, without limitation, describe each recommendation and
determination made by the Joint Committee pursuant to Section 2.1. Such minutes
of each meeting shall be reviewed, amended if necessary and approved at the
following meeting of the Joint Committee, and copies of all such final minutes
shall immediately be distributed to both parties.
2.4.2 The purpose of the Joint Committee during
the Research Phase shall be: (i) to advise the parties regarding the overall
strategy for the Research Phase, as contemplated by this Agreement; (ii) to
coordinate the parties' activities hereunder; (iii) to review all results of
work done in the Research Phase and suggest modifications to the scope and goals
of such work, if the Joint Committee deems it necessary; and (iv) to undertake
the responsibilities and make the recommendations and determinations delegated
to it pursuant to Section 2.1 of this Agreement.
2.4.3 Outside the course of the Research Phase,
the role of the Joint Committee shall be to advise Novo Nordisk with respect to
development and commercialization of Licensed Product, as requested by Novo
Nordisk.
2.5 All rights in any partial or complete sequence
information describing any Ligand or Growth Factor, and other technology, data,
information and inventions, whether or not patentable, developed from the
materials provided to Novo Nordisk by Progenitor pursuant to this Agreement and
arising from the research conducted by or on behalf of either or both parties
pursuant to this Agreement in the course of the Research Phase shall be jointly
owned by Novo Nordisk and Progenitor. Work performed by or on behalf of Novo
Nordisk and/or its Affiliates pursuant to Section 2.2 shall not be considered to
be conducted in the course of the Research Phase. Each party will ensure that
all third parties that conduct any portion of the research to be conducted by
such party or on such party's behalf pursuant to this Agreement sign appropriate
documents transferring their rights therein to such party consistent with the
terms of this Agreement.
2.6 Progenitor acknowledges that Novo Nordisk may,
now or in the future, conduct its own research and/or enter into one or more
agreements with third parties that involve identification and/or
characterization of putative ligands and/or receptors in general, and of
cytokine-like ligands and/or receptors in particular. The parties recognize that
such efforts on behalf of Novo Nordisk may result in identification and/or
characterization of a molecule that is identical or substantially similar to the
Receptor, a Ligand or a Growth Factor. Alternatively, a molecule discovered by
Novo Nordisk or obtained by Novo Nordisk from a third party may be a portion of
the Receptor, a Ligand or a Growth Factor, or the Receptor, a Ligand or a Growth
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Factor may be a portion of such a molecule. In such case, Novo Nordisk will have
the sole right to determine, in its discretion, which molecule or molecules
(whether a Ligand, a Growth Factor or a molecule discovered by Novo Nordisk or
obtained from a third party), if any, to develop into a product. Except as set
forth in Section 2.5, all technology, data, information and inventions, whether
or not patentable, arising from any research conducted by or on behalf of Novo
Nordisk shall, as between the parties, be the sole property of Novo Nordisk.
Novo Nordisk will not disclose to Progenitor any confidential information
received by Novo Nordisk from a third party, and, as set forth in Section 5
below, Novo Nordisk will not disclose to any third party any confidential
information received by Novo Nordisk from Progenitor. Novo Nordisk will not
intentionally seek a collaboration with any third party with respect to any
molecule that is identical or substantially similar to the Receptor, a Ligand or
a Growth Factor. Novo Nordisk will notify Progenitor in writing within 24 hours
after Progenitor discloses Progenitor's sequence for the Receptor to Novo
Nordisk whether or not Novo Nordisk and/or any of its Affiliates is then working
with any molecule that is identical or substantially similar to the Receptor.
2.7 So long as Novo Nordisk is producing any
Identified Ligand and/or any Identified Growth Factor, and so long as the Joint
Committee determines that supply of such materials by Novo Nordisk to Progenitor
and its Affiliates pursuant to this Section would not interfere with the
development or commercialization of any Licensed Product pursuant to this
Agreement, Novo Nordisk will supply Progenitor with reasonable quantities of
such Identified Ligand and/or Identified Growth Factor, in any form produced by
Novo Nordisk for its own purposes, for use only by Progenitor and its Affiliates
solely in conducting research activities outside the Field. Progenitor shall not
provide any such materials to any third party without Novo Nordisk's prior,
written consent in each instance. Any such materials shall be provided to
Progenitor for no additional charge, except that Progenitor will reimburse Novo
Nordisk, as requested by Novo Nordisk, for any expenses incurred in packaging
such materials and shipping them to Progenitor. Any and all such materials shall
be provided by Novo Nordisk AS IS AND WITHOUT WARRANTY OF ANY KIND.
3. LICENSE.
3.1 Subject to the terms of this Agreement,
Progenitor hereby grants Novo Nordisk and its Affiliates the worldwide, sole and
exclusive license, with right to sublicense, under the Licensed Patent Rights
and Licensed Technology, to make, have made, use, sell, have sold, offer for
sale and import Licensed Product for use in the Field and to otherwise carry out
its rights and obligations pursuant to this Agreement.
3.2 Subject to the terms of this Agreement, Novo
Nordisk hereby grants Progenitor and its Affiliates the worldwide, royalty-free,
sole and exclusive license, with right to sublicense, under Novo Nordisk's
rights in any Novo Nordisk Patent Rights, to make, have made, use, sell, have
sold, offer for sale and import products for use outside the Field. SUCH LICENSE
IS GRANTED AS IS, WITHOUT WARRANTY OF ANY KIND, AND PROGENITOR AGREES TO
INDEMNIFY NOVO NORDISK FOR ANY LOSS, DAMAGE, LIABILITY AND EXPENSE, INCLUDING
WITHOUT LIMITATION ATTORNEYS' FEES
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
AND COSTS OF DEFENSE, ARISING OUT OF ANY EXERCISE OF SUCH RIGHTS, AND/OR OUT OF
ANY USE OF MATERIALS PROVIDED BY NOVO NORDISK TO PROGENITOR HEREUNDER, BY OR ON
BEHALF OF PROGENITOR, ITS AFFILIATES AND/OR ITS OR THEIR LICENSEES AND
ASSIGNEES, EXCLUDING ANY SUCH LOSS, DAMAGE, LIABILITY OR EXPENSE INTENTIONALLY
CAUSED BY NOVO NORDISK AND/OR ITS AFFILIATES.
3.3 Within 15 days after the date of this Agreement,
Progenitor will deliver to Novo Nordisk all documentation regarding patent
applications and other filings made with the patent authority of any country
with respect to Licensed Patent Rights. Progenitor shall have the sole right to
file and prosecute any patent applications relating to the Receptor and its uses
and to maintain such patent rights. Except as provided in Section 8.5.2, 8.6.2
and 8.7.2, Novo Nordisk shall have the sole right to file and prosecute any
patent applications giving rise, in whole or in part, to the Licensed Patent
Rights, with the exception of patents and patent applications relating to the
Receptor and its uses, and to maintain patents under such Licensed Patent
Rights. Each party will provide the other party with copies of all such patent
applications and amendments filed by it and all other correspondence between it
and the patent authority of any country regarding such patent applications and
amendments. Each party shall bear all expenses of the patent, filing,
prosecution and maintenance activities undertaken by it. If at any time during
the term of this Agreement either party elects not to file or to abandon any
patent or patent application which such party has the right to file and
prosecute pursuant to this Section, such party shall notify the other party of
that decision at least 30 days prior to any deadline for the filing of any such
patent application or any response or the taking of any other action necessary
to maintain such patent or patent application in existence. Thereafter, AS ITS
SOLE AND EXCLUSIVE REMEDY THEREFOR, such other party shall have the right to
take over responsibility for the maintenance of such patent or the prosecution
of such patent application, at its sole expense and discretion.
3.4 Except for the rights and licenses explicitly
granted as stated in this Agreement, each party retains all rights and ownership
in and to its technology and intellectual properties, and makes no grant of
rights by implication. It is understood that Progenitor retains the
non-exclusive right, without the right to sublicense, to make, have made, use
and import the Licensed Product and the Licensed Technology for research
purposes.
4. FEES AND ROYALTIES.
4.1 Novo Nordisk will pay Progenitor a quarterly
research fee of U.S. $[******] during Ligand Stage 2 and/or Growth Factor Stage
2; provided, however, that during any period in which Progenitor is
simultaneously performing work in Ligand Stage 2 and Growth Factor Stage 2, such
total research fee shall be $[******] per quarter (or a pro rata portion thereof
for any partial quarter); provided further, however, that if, pursuant to
Section 2.1.5, the Joint Committee authorizes Progenitor to devote less than the
equivalent of fifteen qualified scientists to the completion of its obligations
hereunder during any period in which Progenitor is simultaneously performing
work in Ligand Stage 2 and Growth Factor Stage 2, the
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
research fee to be paid hereunder shall be reduced pro rata according to the
reduced amount of effort (in terms of the number of qualified scientists working
on the project) required to be devoted by Progenitor.
4.1.1 Notwithstanding any of the foregoing, the
total of all research fees payable by Novo Nordisk pursuant to this Section 4.1
shall not exceed the following amounts: (i) if Novo Nordisk elects, pursuant to
Section 2.1.1 and 2.1.3, to proceed to Stage 2 with a Ligand or Ligands or with
a Growth Factor or Growth Factors, but not with both, such research fees shall
not exceed $4,000,000; and (ii) if Novo Nordisk elects, pursuant to Section
2.1.1 and 2 1.3, to proceed to Stage 2 with both a Ligand or Ligands and a
Growth Factor or Growth Factors, such research fees shall not exceed $6,000,000.
4.1.2 Each such research fee shall be due within
60 days after Novo Nordisk's receipt of an invoice therefor, but no sooner than
the tenth day of each January, April, July, and October; provided, however, that
the first such payment shall be due 60 days after receipt of an invoice therefor
following the commencement of the first Stage 2 of the Research Phase (Ligand
Stage 2 or Growth Factor Stage 2), but no earlier than [************]. Novo
Nordisk will not be obligated to make any research fee payment due on or after
the effective date of any termination of this Agreement.
4.2 In addition, if Novo Nordisk elects to go forward
with development of a Licensed Product, Novo Nordisk will pay Progenitor a
license fee of U.S. $5,000,000 within 90 days after the earlier of: (i) the
delivery to Progenitor of the first Ligand Development Notice or Growth Factor
Development Notice stating that Novo Nordisk desires to go forward with
development of a Licensed Product; or (ii) the commencement by or on behalf of
Novo Nordisk of production of an active ingredient for any Licensed Product
under Good Manufacturing Practices (GMP). Nothing in this Agreement shall be
construed as requiring Novo Nordisk to pay more than one such license fee.
4.3 In addition, Novo Nordisk will make the following
milestone payments to Progenitor:
4.3.1 Novo Nordisk will pay Progenitor U.S.
$1,000,000 within 60 days after the earlier of (i) the date that, pursuant to an
Investigational New Drug filing, if any, made by Novo Nordisk or an Affiliate of
Novo Nordisk for a Licensed Product, Novo Nordisk or an Affiliate of Novo
Nordisk is permitted for the first time by the FDA to proceed with clinical
testing of a Licensed Product; or (ii) the date of the first human
administration of a Licensed Product by or on behalf of Novo Nordisk or an
Affiliate of Novo Nordisk in any country. Regardless of the number of Licensed
Products, nothing in this Agreement shall be construed as requiring Novo Nordisk
to pay any milestone payment pursuant to this Section 4.3.1 more than once.
4.3.2 Novo Nordisk will pay Progenitor U.S.
$3,000,000 within 60 days after the first initiation of Phase III clinical
trials (or the first initiation of equivalent
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
steps under the laws of any country other than the United States) for use of
each separate Licensed Product to treat any specific indication.
4.3.3 Novo Nordisk will pay Progenitor U.S.
$5,000,000 within 60 days after the first Product License Application ("PLA"),
New Drug Application ("NDA") or equivalent filing, if any, made by Novo Nordisk
or an Affiliate of Novo Nordisk for each separate Licensed Product is granted
final approval by the FDA.
4.3.4 Novo Nordisk will pay Progenitor U.S.
$5,000,000 within 60 days after the first PLA-equivalent filing, if any, made by
Novo Nordisk or an Affiliate of Novo Nordisk for each separate Licensed Product
is granted final approval by the appropriate regulatory authority of Germany, or
the United Kingdom, or any European central drug agency with authority for
regulating such matters in Germany and/or the United Kingdom. One-half of each
such payment (or $2,500,000) shall be deemed to be an advance on Royalties
payable on Net Sales in Europe.
4.3.5 Novo Nordisk will pay Progenitor U.S.
$5,000,000 within 60 days after the first time final approval is granted by the
appropriate regulatory authority for sale of each separate Licensed Product in
Japan. The entire amount of each such payment shall be deemed to be an advance
on Royalties payable on Net Sales in Japan.
4.3.6 Except as set forth in Sections 4.3.4 and
4.3.5 above, the milestone payments shall be nonrefundable once paid and
noncreditable against Royalties.
4.4 In addition, Novo Nordisk shall pay to Progenitor
a Royalty on annual Net Sales with respect to each separate Licensed Product
(which shall be calculated separately for each "separate Licensed Product," as
defined in Section 4.5), at the following rates:
4.4.1 Novo Nordisk shall pay Progenitor a Royalty
of [*****************] of Net Sales with respect to such Licensed Product up to
and including $100,000,000 in any calendar year;
4.4.2 Novo Nordisk shall pay Progenitor a Royalty
of [*****************] of Net Sales with respect to such Licensed Product over
$100,000,000 up to and including $250,000,000 in any calendar year;
4.4.3 Novo Nordisk shall pay Progenitor a Royalty
of [*****************] of Net Sales with respect to such Licensed Product over
$250,000,000 up to and including $500,000,000 in any calendar year; and
4.4.4 Novo Nordisk shall pay Progenitor a Royalty
of [**************************] of Net Sales with respect to such Licensed
Product over $500,000,000 in any calendar year.
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All such Royalties (after allowing credit for advances on Royalties paid
pursuant to Sections 4.3.4 and 4.3.5 and any reduction of royalties pursuant to
Section 4.6) shall be due and payable within 60 days after the end of each
calendar half year for Net Sales received in such calendar half year, as
follows: Within 60 days after the end of each first and third calendar quarter
for which Royalties are payable hereunder (that is, the calendar quarters ending
on March 31 and on September 30 of each such year), Novo Nordisk will submit to
Progenitor a report stating the approximate Net Sales and Royalties due for such
quarter, together with payment of such approximate amount. Within 60 days after
the end of each calendar half year for which Royalties are payable hereunder
(that is, the periods ending on June 30 and on December 31 of each such year),
Novo Nordisk will submit to Progenitor a statement of actual Net Sales for such
half year, separated as to Net Sales within Europe, Japan and all other
countries, and the calculation of Royalties payable hereunder with respect to
such Net Sales, together with payment of all remaining Royalties due with
respect to such Net Sales, as adjusted for any amount previously paid as
approximate Royalties with respect to such Net Sales.
4.5 Whether or not a Licensed Product is considered a
"separate Licensed Product" for purposes of making milestone payments pursuant
to Sections 4.3.2 through 4.3.5 and for purposes of calculating Royalties
pursuant to Section 4.4 will be determined on the basis of whether or not such
Licensed Product contains any active ingredient different than or in addition to
the active ingredient(s) in any other Licensed Product. That is, each Licensed
Product will be considered to be a "separate Licensed Product" for which any
additional milestone payment is due and for which Royalties are calculated
separately only if such Licensed Product contains one or more active ingredients
not also contained in any Licensed Product for which such milestone payment has
then already been made or for which Royalties have then already been calculated,
respectively.
4.6 If subsequent to the date of this Agreement, Novo
Nordisk determines in its sole discretion, which it will exercise in good faith,
after consulting with Progenitor with respect thereto, that royalties must be
paid to one or more third parties in order for Novo Nordisk to exercise the
rights granted in Section 3.1, each party will share such third-party royalty
obligation as follows: the royalty payments by Novo Nordisk under Section 4.4
shall be reduced by one-half of such third party royalties, except that such
reduction shall be limited so that the royalty paid to Progenitor under Section
4.4 is not reduced by more than one-half.
4.7 All payments to be made by Novo Nordisk to
Progenitor under this Agreement shall be made in United States dollars.
Conversion of foreign currency to United States dollars for payments of
Royalties shall be made at the conversion rate published in the Wall Street
Journal, Eastern edition, on the last business day of the calendar quarter to
which such payments relate.
4.8 If laws or regulations require withholding by
Novo Nordisk of any taxes imposed upon Progenitor on account of any Royalties
paid under this Agreement, such taxes will be deducted by Novo Nordisk as
required by law from such remittable Royalty and
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shall be paid by Novo Nordisk to the proper taxing authority. Official receipt
of such taxes shall be secured and sent to Progenitor as evidence of such
payment. The parties will use reasonable efforts to ensure that any withholding
taxes imposed are reduced as far as possible under the provisions of the current
or any future double taxation treaties or agreements between foreign countries
and the parties shall cooperate with each other with respect thereto, with the
appropriate party under the circumstances providing the documentation required
under such treaty or agreement to claim benefits thereunder.
4.9 Novo Nordisk shall keep accurate records in
sufficient detail to enable the amounts of Royalties due to Progenitor to be
determined. Upon Progenitor's request and after reasonable prior notice, Novo
Nordisk shall permit an independent certified public accountant selected by
Progenitor to have access during ordinary business hours to Novo Nordisk's
records necessary to determine the correctness of any report or payment made
with respect to any half year and to obtain information as to the amount payable
to Progenitor for any such period. Such examination shall be at Progenitor's
expense and shall not take place more than once each year. These rights with
respect to any year shall terminate two (2) years after the end of such year.
Information supplied to Progenitor by such independent certified public
accountant shall not include any proprietary information not required to be
disclosed to it under other Sections of this Agreement. If such accounting firm
concludes that additional Royalties are owed for any half year, Progenitor will
provide Novo Nordisk with access to such accounting firm's work product with
respect to such conclusion, and Novo Nordisk shall have a period of up to 60
days after receipt of such work product in which to review such findings. If,
after such 60-day review period, Novo Nordisk agrees with the conclusion reached
by such accounting firm with respect to such additional Royalties, Novo Nordisk
shall promptly pay the additional Royalties owed. If, after such 60-day review
period, the parties are not in agreement as to the amount of any additional
Royalties owed, the parties will negotiate in good faith for a period of 60 days
with respect thereto. If the parties are unable to agree on the amount of any
such additional Royalties owed after such 60-day period of negotiation, the
parties will submit such question to binding arbitration pursuant to Section
9.9.
5. CONFIDENTIALITY.
5.1 Each party (the "Receiving Party") acknowledges
and agrees that the other party (the "Disclosing Party") may, in the course of
performing this Agreement and the parties' other dealings, disclose confidential
information belonging to the Disclosing Party in writing, orally or by
demonstration or sample. All such confidential information of the Disclosing
Party shall be maintained in confidence by the Receiving Party and will not be
used by the Receiving Party for any purpose except as authorized hereunder. The
Receiving Party shall exercise the same degree of care to preserve the
confidentiality of such information of the Disclosing Party as it uses to
protect its own confidential information of similar nature, and the Receiving
Party shall safeguard such information against disclosure to third parties,
including without limitation employees and persons working or consulting for the
Receiving Party. This obligation of confidentiality does not apply to
information and material that:
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(i) were properly in the possession of the
Receiving Party, without any restriction on use or disclosure, prior to receipt
from the Disclosing Party, and such possession can be properly demonstrated by
the Receiving Party;
(ii) are in the public domain by public use,
publication, general knowledge or the like, or after disclosure hereunder become
general or public knowledge through no fault of the Receiving Party;
(iii) are properly obtained by the Receiving
Party from a third party not under a confidentiality obligation;
(iv) are independently developed by or on
behalf of the Receiving Party without the assistance of the confidential
information of the Disclosing Party; or
(v) are required to be disclosed by order of
any court or governmental authority.
5.2 The Receiving Party shall not acquire any rights
with respect to confidential information disclosed to it by the Disclosing
Party, except as expressly set forth in this Agreement. The Receiving Party
shall not disclose any confidential information of the Disclosing Party to any
third party or to any employees, officers or directors of the Receiving Party
except those who reasonably require such disclosure for purposes of performing
the Receiving Party's obligations under this Agreement without the prior,
written consent of the Disclosing Party.
5.3 Upon termination of this Agreement, the Receiving
Party shall return to the Disclosing Party or destroy any tangible copies of any
confidential information provided to it hereunder by the Disclosing Party;
provided, however, that the Receiving Party may retain one (1) copy of
confidential information disclosed to it by the Disclosing Party in its
confidential legal files for archival purposes.
5.4 Each party agrees that it will not make any
public announcement or other publication regarding any results of the research
conducted hereunder before a patent application has been filed with respect
thereto, except upon the prior written approval of the other party in each
instance. In addition, each party will refrain from issuing any press release or
making any public announcement or other publication regarding this Agreement or
the relationship of the parties hereto, except for announcements or disclosures
which are required by law to be made, without the prior, written consent of the
other party in each instance, which consent will not be unreasonably withheld.
Progenitor will also refrain from publishing or disclosing any information or
material that is in any way related to this Agreement or any Receptor, Ligand,
Growth Factor or Licensed Product without the prior, written consent of Novo
Nordisk in each instance, which consent will not be unreasonably withheld. Each
party will respond to any request for consent pursuant to this Section 5.4 as
soon as reasonably possible.
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6. WARRANTIES AND INDEMNIFICATION.
6.1 Each party hereby represents and warrants that:
6.1.1 It has full right and authority to enter
into this Agreement, has taken all corporate action necessary on its part to
authorize the execution and delivery of this Agreement and the performance of
its obligations hereunder, and its respective obligations under this Agreement
are not subject to prior commitments or obligations to any third party.
6.1.2 It has not entered into any contract,
agreement, partnership, joint venture or other arrangement, whether oral or
written, with any third party relating to any Receptor, Ligand, Growth Factor,
Licensed Product, Licensed Patent Right or Licensed Technology that is
inconsistent with the terms of this Agreement.
6.2 Progenitor represents and warrants that, to the
best of Progenitor's knowledge, the technology developed by or on behalf of
Progenitor covered by the Licensed Patent Rights and Licensed Technology, as it
exists on the date of this Agreement, has been made and developed without the
use of, or infringement upon, the secrets, patents or other proprietary rights
or interests of any third party and without the use of any equipment, supplies
or facilities of any third party that would create any right to any Licensed
Patent Right, Licensed Technology or Joint Technology in such third party.
6.3 Novo Nordisk assumes all risks of damage or
injury to persons and to property arising out of any manufacture, use or sale of
Licensed Product by or on behalf of Novo Nordisk and its Affiliates and
sublicensees, and shall hold harmless and indemnify Progenitor and its
Affiliates from and against any and all personal injury, property damage,
product liability or similar claims, losses and liabilities arising out of such
manufacture, use or sale of Licensed Product, except for such claims, losses and
liabilities caused by a breach of Progenitor's representations under any other
Section of this Agreement and except as set forth in Section 6.4. Progenitor
assumes all risks of damage or injury to persons and to property arising out of
any manufacture, use or sale of Progenitor Ligand Product, Progenitor Growth
Factor Product and Progenitor Product by or on behalf of Progenitor and its
Affiliates and sublicensees, and shall hold harmless and indemnify Novo Nordisk
and its Affiliates from and against any and all personal injury, property
damage, product liability or similar claims, losses and liabilities arising out
of such manufacture, use or sale of Progenitor Ligand Product, Progenitor Growth
Factor Product and/or Progenitor Product, except for such claims, losses and
liabilities caused by a breach of Novo Nordisk's representations under any other
Section of this Agreement and except as set forth in Section 6.4
6.4 Nothing in this Agreement shall be construed as a
warranty, representation or undertaking with respect to the utility, efficacy,
nontoxicity, safety or appropriateness of using any Receptor, Ligand, Growth
Factor, Licensed Product or any other product; provided, however, that
Progenitor represents and warrants that it has fully disclosed to Novo Nordisk,
and Progenitor covenants that it will fully disclose to Novo Nordisk, to the
extent
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it can do so without violating any obligation of Progenitor and/or any of its
Affiliates to any third party, all data and information in Progenitor's
possession, knowledge or control relating to the use, manufacture, utility,
efficacy, nontoxicity, safety and appropriateness of each Receptor, Ligand,
Growth Factor and Licensed Product. Otherwise, the physical quantities of
materials provided by each party to the other hereunder are provided "as is,"
and neither party makes any representation or warranty of any kind, express or
implied, written or oral, including, without limitation, any representation or
warranty with respect to the value, adequacy, freedom from fault, or the
quality, efficiency, suitability, characteristics, usefulness, merchantability
or fitness for a particular purpose of, such physical quantities of materials,
except as otherwise set forth in this Agreement.
6.5 NOVO NORDISK ACKNOWLEDGES THAT, EXCEPT AS
OTHERWISE SET FORTH IN THIS AGREEMENT, THE LICENSES GRANTED BY PROGENITOR IN
THIS AGREEMENT ARE GRANTED WITHOUT WARRANTY OF ANY KIND.
6.6 Each party agrees to indemnify and hold the other
party harmless from and against any loss, damage, liability and expense,
including, without limitation, reasonable attorneys' fees and costs of defense,
arising out of any breach of such party's representations, warranties or
covenants under this Agreement. Progenitor agrees that Novo Nordisk shall have
the right to set off any such amounts owed to Novo Nordisk from fees and
Royalties payable to Progenitor hereunder.
7. INFRINGEMENT.
7.1 Except as set forth in Sections 8.5.3, 8.6.3 and
8.7.3, in the event that any of the Licensed Patent Rights are infringed or
believed to be infringed by a third party, Novo Nordisk may, at its option,
elect to prosecute such infringement claims. If Novo Nordisk elects to commence
such an action, Novo Nordisk shall have control of such action and shall have
the right to settle or compromise the same, and Progenitor agrees that it shall
fully cooperate in every reasonable way with the prosecution of such action. If
Novo Nordisk elects to commence such an action, Progenitor hereby grants Novo
Nordisk the right to do so in Progenitor's name, and, if Progenitor is a legally
indispensable party to such action, Novo Nordisk may cause it to be joined as a
party in such action at Novo Nordisk's expense. Novo Nordisk shall notify
Progenitor of any action filed by Novo Nordisk pursuant to this Section and
shall keep Progenitor generally informed as to the progress of such action.
7.2 Recoveries or reimbursements from any such action
shall first be applied to reimburse Novo Nordisk for its expenses, costs and
fees in connection with the action. Any remaining recoveries or reimbursements,
to the extent they constitute the equivalent of, or damages or payments in lieu
of, reasonable royalties on the infringer's sales (but not in excess of the
amount that would be payable pursuant to Section 4.4), shall be shared with
Progenitor in accordance with Section 4.4, and otherwise shall be retained by
Novo Nordisk as its own property.
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<PAGE>
7.3 In the event that Novo Nordisk decides not to
commence or continue prosecution of an infringement of the Licensed Patent
Rights pursuant to the above paragraphs, Novo Nordisk will promptly give written
notice of such decision to Progenitor. Progenitor shall thereafter have the
right, but not the obligation, to commence or continue such action at its own
expense, controlling such action and retaining all recoveries therefrom. If
Progenitor elects to bring an action to prosecute the infringement of any
Licensed Patent Rights under this Section, Progenitor shall have sole control of
such action and may settle or compromise such action in its sole discretion,
provided that no such settlement or compromise conflicts with any provision of
this Agreement. If Progenitor elects to commence such an action, Novo Nordisk
hereby grants Progenitor the right to do so in Novo Nordisk's name, and, if Novo
Nordisk is a legally indispensable party to such action, Progenitor may cause it
to be joined as a party in such action at Progenitor's expense, and Novo Nordisk
agrees to cooperate fully in every reasonable way with the prosecution of such
action.
8. TERM AND TERMINATION.
8.1 The term of this Agreement shall begin on the
date set forth above and shall continue until the earlier of the date of
termination in accordance with Section 8.3 or the date of expiration of the last
to expire of any Valid Claim of the Licensed Patent Rights.
8.2 Novo Nordisk may terminate the licenses granted
to it pursuant to this Agreement with respect to Receptor and all Ligands at any
time during Ligand Stage 1 or after the end of Ligand Stage 2 upon delivery of
30 days' written notice to Progenitor, or at any time during Ligand Stage 2 upon
delivery of 90 days' written notice to Progenitor. Novo Nordisk may also
terminate the licenses granted to it pursuant to this Agreement with respect to
all Growth Factors at any time during Growth Factor Stage 1 or after the end of
Growth Factor Stage 2 upon delivery of 30 days' written notice to Progenitor, or
at any time during Growth Factor Stage 2 upon delivery of 90 days' written
notice to Progenitor. Novo Nordisk may also terminate this Agreement at any time
before the commencement of Ligand Stage 2 or Growth Factor Stage 2 or after
termination of the Research Phase upon delivery of 30 days' written notice to
Progenitor, or at any other time upon delivery of 90 days' written notice to
Progenitor.
8.3 Either party may terminate this Agreement upon
120 days' written notice to the other party at any time that such other party is
in material breach of any obligation hereunder if such breach is not cured
within such 120-day period. Neither party shall be deemed to be in material
breach of this Agreement during any period in which a good faith dispute between
the parties exists regarding performance or breach of its obligations hereunder.
8.4 The provisions in this Agreement regarding
payment of fees and Royalties accrued as of the date of termination,
confidentiality, indemnification and the provisions set forth in Sections 1, 6,
8.5, 8.6, 8.7, 8.8, 8.9 and 9 shall survive any expiration or termination of
this Agreement. In addition, Novo Nordisk shall have a continuing, non-exclusive
right to use the Licensed Technology, but not to exercise any Licensed Patent
Rights, following any termination or expiration of this Agreement.
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
8.5 Effective only upon any termination of the
licenses granted pursuant to this Agreement with respect to the Receptor and all
Ligands by Novo Nordisk pursuant to Section 8.2 or by Progenitor pursuant to
Section 2.1.1, which termination becomes effective prior to the payment by Novo
Nordisk of the license fee pursuant to Section 4.2, Novo Nordisk hereby grants
to Progenitor and its Affiliates the worldwide, sole and exclusive license, with
right to sublicense, under Novo Nordisk's rights in Novo Nordisk Ligand Patent
Rights and Joint Technology arising from the research conducted pursuant to this
Agreement in the course of Ligand Stage 1 and Ligand Stage 2 (the "Ligand Joint
Technology"), to make, have made, use, sell, have sold, offer for sale and
import Progenitor Ligand Product for use in the Field. Novo Nordisk will deliver
to Progenitor, within 90 days after any such termination, all materials
constituting Ligand Joint Technology and copies of all data in Novo Nordisk's
possession regarding the Ligand Joint Technology. If such a termination occurs,
the following terms shall apply until expiration of the last to expire of any
Valid Claim of the Novo Nordisk Ligand Patent Rights or until such license is
terminated by Novo Nordisk, which Novo Nordisk may do by delivery of 120 days'
written notice to Progenitor at any time that Progenitor is in breach of any
obligation under this Section 8.5, if such breach is not cured within such
120-day period:
8.5.1 If such termination occurs after Novo
Nordisk has paid at least $[********] in research fees to Progenitor pursuant to
Section 4.1, Progenitor shall pay Novo Nordisk a royalty on annual Progenitor
Ligand Net Sales with respect to each separate Progenitor Ligand Product, at the
following rates:
(i) Progenitor shall pay Novo Nordisk a royalty
of [***************] of Progenitor Ligand Net Sales with respect to such
Progenitor Ligand Product up to and including $100,000,000 in any calendar year;
(ii) Progenitor shall pay Novo Nordisk a
royalty of [***************] of Progenitor Ligand Net Sales with respect to
such Progenitor Ligand Product over $100,000,000 up to and including
$250,000,000 in any calendar year;
(iii) Progenitor shall pay Novo Nordisk a
royalty of [***************] of Progenitor Ligand Net Sales with respect to
such Progenitor Ligand Product over $250,000,000 up to and including
$500,000,000 in any calendar year; and
(iv) Progenitor shall pay Novo Nordisk a
royalty of [***************************] of Progenitor Ligand Net Sales with
respect to such Progenitor Ligand Product over $500,000,000 in any calendar
year.
Whether or not a product is considered a "separate Progenitor Ligand Product"
for the purpose of calculation of the applicable royalty rate will be determined
on the basis of whether or not such Progenitor Ligand Product contains any
active ingredient different from or in addition to the active ingredient(s) in
any other Progenitor Ligand Product (in which case such product will be treated
as a separate Progenitor Ligand Product for such purpose). All such royalties
shall be due and payable within 60 days after the end of each calendar half year
for Progenitor Ligand Net
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<PAGE>
Sales received in the preceding calendar half year, as follows: Within 60 days
after the end of each first and third calendar quarter for which royalties are
payable by Progenitor under this Section 8.5 (that is, the calendar quarters
ending on March 31 and on September 30 of each such year), Progenitor will
submit to Novo Nordisk a report stating the approximate Progenitor Ligand Net
Sales and royalties due for such quarter, together with payment of such
approximate amount. Within 60 days after the end of each calendar half year
during which royalties are payable by Progenitor under this Section 8.5 (that
is, the periods ending on June 30 and on December 31 of each such year),
Progenitor will submit to Novo Nordisk a written statement of actual Progenitor
Ligand Net Sales for the half year, separated as to Progenitor Ligand Net Sales
within Europe, Japan and all other countries, and the calculation of royalties
payable hereunder with respect to such Progenitor Ligand Net Sales, together
with payment of all remaining royalties due with respect to such Progenitor
Ligand Net Sales, as adjusted for any amount previously paid as approximate
royalties with respect to such Progenitor Ligand Net Sales. Progenitor shall
keep, and shall cause its sublicensees to keep, complete, true and accurate
records for the purpose of showing the derivation of all royalties payable to
Novo Nordisk under this Agreement. During any period in which such royalties are
payable by Progenitor to Novo Nordisk hereunder, the provisions of Sections 4.7,
4.8 and 4.9 above, regarding conversion of foreign currency, withholding and
payment of taxes, and retention and inspection of records, shall apply to Novo
Nordisk as licensor and Progenitor as licensee just as applicable under those
Sections to Progenitor as licensor and Novo Nordisk as licensee.
8.5.2 Following any termination giving rise to the
rights granted in this Section 8.5, Progenitor shall have the right, at its
expense, to file, prosecute and maintain patent applications and other patent
filings in or with respect to any Novo Nordisk Ligand Patent Rights and Ligand
Joint Technology.
8.5.3 In addition, following any termination
giving rise to the rights granted in this Section 8.5, Progenitor shall have the
sole and exclusive right, as between the parties, to institute suit against any
third party for infringement of Novo Nordisk Ligand Patent Rights and Ligand
Joint Technology.
(i) If Progenitor elects to commence such an
action, Progenitor shall have control of such action and shall have the right to
settle or compromise the same, and Novo Nordisk agrees that it shall fully
cooperate in every reasonable way with the prosecution of such action. If
Progenitor elects to commence such an action, Novo Nordisk hereby grants
Progenitor the right to do so in Novo Nordisk's name, and, if Novo Nordisk is a
legally indispensable party to such action, Progenitor may cause it to be joined
as a party in such action at Progenitor's expense. Progenitor shall notify Novo
Nordisk of any action filed by Progenitor pursuant to this Section and shall
keep Novo Nordisk generally informed as to the progress of such action.
(ii) Recoveries or reimbursements from any such
action shall first be applied to reimburse Progenitor for its expenses, costs
and fees in connection with the action. Any remaining recoveries or
reimbursements, to the extent they constitute the
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
equivalent of, or damages or payments in lieu of, reasonable royalties on the
infringer's sales (but not in excess of the amount that would be payable
pursuant to Section 8.5.1), shall be shared with Novo Nordisk in accordance with
Section 8.5.1, and otherwise shall be retained by Progenitor as its own
property.
(iii) In the event that Progenitor decides not
to commence or continue prosecution of an infringement of the Novo Nordisk
Ligand Patent Rights pursuant to the above paragraphs, Progenitor will promptly
give written notice of such decision to Novo Nordisk. Novo Nordisk shall
thereafter have the right, but not the obligation, to commence or continue such
action at its own expense, controlling such action and retaining all recoveries
therefrom. If Novo Nordisk elects to bring any such action, Novo Nordisk shall
have sole control of such action and may settle or compromise such action in its
sole discretion. If Novo Nordisk elects to commence such an action, Progenitor
hereby grants Novo Nordisk the right to do so in Progenitor's name, and, if
Progenitor is a legally indispensable party to such action, Novo Nordisk may
cause it to be joined as a party in such action at Novo Nordisk's expense, and
Progenitor agrees to cooperate fully in every reasonable way with the
prosecution of such action.
8.5.4 Following any termination giving rise to the
rights granted in this Section 8.5, Novo Nordisk covenants that it will fully
disclose to Progenitor, to the extent it can do so without violating any
obligation of Novo Nordisk and/or any of its Affiliates to any third party, all
data and information in Novo Nordisk's possession, knowledge or control relating
to the use, manufacture, utility, efficacy, nontoxicity, safety and
appropriateness of each Receptor, Ligand, and Progenitor Ligand Product.
8.6 Effective only upon any termination of the
licenses granted pursuant to this Agreement with respect to all Growth Factors
by Novo Nordisk pursuant to Section 8.2 or by Progenitor pursuant to Section
2.1.3, which termination becomes effective prior to the payment by Novo Nordisk
of the license fee pursuant to Section 4.2, Novo Nordisk hereby grants to
Progenitor and its Affiliates the worldwide, sole and exclusive license, with
right to sublicense, under Novo Nordisk's rights in Novo Nordisk Growth Factor
Patent Rights and Joint Technology arising from the research conducted pursuant
to this Agreement in the course of Growth Factor Stage I and Growth Factor Stage
2 (the "Growth Factor Joint Technology"), to make, have made, use, sell, have
sold, offer for sale and import Progenitor Growth Factor Product for use in the
Field. Novo Nordisk will deliver to Progenitor, within 90 days after any such
termination, all materials constituting Growth Factor Joint Technology and
copies of all data in Novo Nordisk's possession regarding the Growth Factor
Joint Technology. If such a termination occurs, the following terms shall apply
until expiration of the last to expire of any Valid Claim of the Novo Nordisk
Growth Factor Patent Rights or until such license is terminated by Novo Nordisk,
which Novo Nordisk may do by delivery of 120 days' written notice to Progenitor
at any time that Progenitor is in breach of any obligation under this Section
8.6, if such breach is not cured within such 120-day period:
8.6.1 If such termination occurs after Novo
Nordisk has paid at least $[*******] in research fees to Progenitor pursuant to
Section 4.1, Progenitor shall pay
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
Novo Nordisk a royalty on annual Progenitor Growth Factor Net Sales with respect
to each separate Progenitor Growth Factor Product, at the following rates:
(i) Progenitor shall pay Novo Nordisk a royalty
of [***************] of Progenitor Growth Factor Net Sales with respect to such
Progenitor Growth Factor Product up to and including $100,000,000 in any
calendar year;
(ii) Progenitor shall pay Novo Nordisk a
royalty of[***************] of Progenitor Growth Factor Net Sales with respect
to such Progenitor Growth Factor Product over $100,000,000 up to and including
$250,000,000 in any calendar year;
(iii) Progenitor shall pay Novo Nordisk a
royalty of [***************] of Progenitor Growth Factor Net Sales with respect
to such Progenitor Growth Factor Product over $250,000,000 up to and including
$500,000,000 in any calendar year; and
(iv) Progenitor shall pay Novo Nordisk a
royalty of [****************************] of Progenitor Growth Factor Net Sales
with respect to such Progenitor Growth Factor Product over $500,000,000 in any
calendar year.
Whether or not a product is considered a "separate Progenitor Growth Factor
Product" for the purpose of calculation of the applicable royalty rate will be
determined on the basis of whether or not such Progenitor Growth Factor Product
contains any active ingredient different from or in addition to the active
ingredient(s) in any other Progenitor Growth Factor Product (in which case such
product will be treated as a separate Progenitor Growth Factor Product for such
purpose). All such royalties shall be due and payable within 60 days after the
end of each calendar half year for Progenitor Growth Factor Net Sales received
in the preceding calendar half year, as follows: Within 60 days after the end of
each first and third calendar quarter for which royalties are payable by
Progenitor under this Section 8.6 (that is, the calendar quarters ending on
March 31 and on September 30 of each such year), Progenitor will submit to Novo
Nordisk a report stating the approximate Progenitor Growth Factor Net Sales and
royalties due for such quarter, together with payment of such approximate
amount. Within 60 days after the end of each calendar half year during which
royalties are payable by Progenitor under this Section 8.6 (that is, the periods
ending on June 30 and on December 31 of each such year), Progenitor will submit
to Novo Nordisk a written statement of Progenitor Growth Factor Net Sales for
the half year, separated as to Progenitor Growth Factor Net Sales within Europe,
Japan and all other countries, and the calculation of royalties payable
hereunder with respect to such Progenitor Growth Factor Net Sales, together with
payment of all remaining royalties due with respect to such Progenitor Growth
Factor Net Sales, as adjusted for any amount previously paid as approximate
royalties with respect to such Progenitor Growth Factor Net Sales. Progenitor
shall keep, and shall cause its sublicensees to keep, complete, true and
accurate records for the purpose of showing the derivation of all royalties
payable to Novo Nordisk under this Agreement. During any period in which such
royalties are payable by Progenitor to Novo Nordisk hereunder, the provisions of
Sections 4.7, 4.8 and 4.9 above, regarding conversion of foreign currency,
withholding and payment of taxes, and retention and inspection of records, shall
apply to Novo Nordisk as
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<PAGE>
licensor and Progenitor as licensee just as applicable under those Sections to
Progenitor as licensor and Novo Nordisk as licensee.
8.6.2 Following any termination giving rise to the
rights granted in this Section 8.6, Progenitor shall have the right, at its
expense, to file, prosecute and maintain patent applications and other patent
filings in or with respect to any Novo Nordisk Growth Factor Patent Rights and
Growth Factor Joint Technology.
8.6.3 In addition, following any termination
giving rise to the rights granted in this Section 8.6, Progenitor shall have the
sole and exclusive right, as between the parties, to institute suit against any
third party for infringement of Novo Nordisk Growth Factor Patent Rights and
Growth Factor Joint Technology.
(i) If Progenitor elects to commence such an
action, Progenitor shall have control of such action and shall have the right to
settle or compromise the same, and Novo Nordisk agrees that it shall fully
cooperate in every reasonable way with the prosecution of such action. If
Progenitor elects to commence such an action, Novo Nordisk hereby grants
Progenitor the right to do so in Novo Nordisk's name, and, if Novo Nordisk is a
legally indispensable party to such action, Progenitor may cause it to be joined
as a party in such action at Progenitor's expense. Progenitor shall notify Novo
Nordisk of any action filed by Progenitor pursuant to this Section and shall
keep Novo Nordisk generally informed as to the progress of such action.
(ii) Recoveries or reimbursements from any such
action shall first be applied to reimburse Progenitor for its expenses, costs
and fees in connection with the action. Any remaining recoveries or
reimbursements, to the extent they constitute the equivalent of, or damages or
payments in lieu of, reasonable royalties on the infringer's sales (but not in
excess of the amount that would be payable pursuant to Section 8.6.1), shall be
shared with Novo Nordisk in accordance with Section 8.6.1, and otherwise shall
be retained by Progenitor as its own property.
(iii) In the event that Progenitor decides not
to commence or continue prosecution of an infringement of the Novo Nordisk
Growth Factor Patent Rights pursuant to the above paragraphs, Progenitor will
promptly give written notice of such decision to Novo Nordisk. Novo Nordisk
shall thereafter have the right, but not the obligation, to commence or continue
such action at its own expense, controlling such action and retaining all
recoveries therefrom. If Novo Nordisk elects to bring any such action, Novo
Nordisk shall have sole control of such action and may settle or compromise such
action in its sole discretion. If Novo Nordisk elects to commence such an
action, Progenitor hereby grants Novo Nordisk the right to do so in Progenitor's
name, and, if Progenitor is a legally indispensable party to such action, Novo
Nordisk may cause it to be joined as a party in such action at Novo Nordisk's
expense, and Progenitor agrees to cooperate fully in every reasonable way with
the prosecution of such action.
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
8.6.4 Following any termination giving rise to the
rights granted in this Section 8.6, Novo Nordisk covenants that it will fully
disclose to Progenitor, to the extent it can do so without violating any
obligation of Novo Nordisk and/or any of its Affiliates to any third party, all
data and information in Novo Nordisk's possession, knowledge or control relating
to the use, manufacture, utility, efficacy, nontoxicity, safety and
appropriateness of each Growth Factor and Progenitor Growth Factor Product.
8.7 Effective only upon any termination of this
Agreement by Novo Nordisk pursuant to Section 8.2 or by Progenitor pursuant to
Section 8.3, which termination becomes effective prior to the payment by Novo
Nordisk of the license fee pursuant to Section 4.2, Novo Nordisk hereby grants
to Progenitor and its Affiliates the worldwide, sole and exclusive license, with
right to sublicense, under Novo Nordisk's rights in Novo Nordisk Patent Rights
and Joint Technology, to make, have made, use, sell, have sold, offer for sale
and import Progenitor Product for use in the Field. Novo Nordisk will deliver to
Progenitor, within 90 days after any such termination, all materials
constituting Joint Technology and copies of all data in Novo Nordisk's
possession regarding the Joint Technology. If such a termination occurs, the
following terms shall apply until expiration of the last to expire of any Valid
Claim of the Novo Nordisk Patent Rights or until such license is terminated by
Novo Nordisk, which Novo Nordisk may do by delivery of 120 days' written notice
to Progenitor at any time that Progenitor is in breach of any obligation under
this Section 8.7, if such breach is not cured within such 120-day period:
8.7.1 If such termination occurs after Novo
Nordisk has paid at least $[*******] in research fees to Progenitor pursuant to
Section 4.1, Progenitor shall pay Novo Nordisk a royalty on annual Progenitor
Net Sales with respect to each separate Progenitor Product, at the following
rates:
(i) Progenitor shall pay Novo Nordisk a royalty
of [**************] of Progenitor Net Sales with respect to such Progenitor
Product up to and including $100,000,000 in any calendar year;
(ii) Progenitor shall pay Novo Nordisk a
royalty of [**************] of Progenitor Net Sales with respect to such
Progenitor Product over $100,000,000 up to and including $250,000,000 in any
calendar year;
(iii) Progenitor shall pay Novo Nordisk a
royalty of [**************] of Progenitor Net Sales with respect to such
Progenitor Product over $250,000,000 up to and including $500,000,000 in any
calendar year; and
(iv) Progenitor shall pay Novo Nordisk a
royalty of [***************************] of Progenitor Net Sales with respect
to such Progenitor Product over $500,000,000 in any calendar year.
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<PAGE>
Whether or not a product is considered a "separate Progenitor Product" for the
purpose of calculation of the applicable royalty rate will be determined on the
basis of whether or not such Progenitor Product contains any active ingredient
different from or in addition to the active ingredient(s) in any other
Progenitor Product (in which case such product will be treated as a separate
Progenitor Product for such purpose). All such royalties shall be due and
payable within 60 days after the end of each calendar half year for Progenitor
Net Sales received in the preceding calendar half year, as follows: Within 60
days after the end of each first and third calendar quarter for which royalties
are payable by Progenitor under this Section 8.7 (that is, the calendar quarters
ending on March 31 and on September 30 of each such year), Progenitor will
submit to Novo Nordisk a report stating the approximate Progenitor Net Sales and
royalties due for such quarter, together with payment of such approximate
amount. Within 60 days after the end of each calendar half year during which
royalties are payable by Progenitor under this Section 8.7 (that is, the periods
ending on June 30 and on December 31 of each such year), Progenitor will submit
to Novo Nordisk a written statement of Progenitor Net Sales for the half year,
separated as to Progenitor Net Sales within Europe, Japan and all other
countries, and the calculation of royalties payable hereunder with respect to
such Progenitor Net Sales, together with payment of all remaining royalties due
with respect to such Progenitor Net Sales, as adjusted for any amount previously
paid as approximate royalties with respect to such Progenitor Net Sales.
Progenitor shall keep, and shall cause its sublicensees to keep, complete, true
and accurate records for the purpose of showing the derivation of all royalties
payable to Novo Nordisk under this Agreement. During any period in which such
royalties are payable by Progenitor to Novo Nordisk hereunder, the provisions of
Sections 4.7, 4.8 and 4.9 above, regarding conversion of foreign currency,
withholding and payment of taxes, and retention and inspection of records, shall
apply to Novo Nordisk as licensor and Progenitor as licensee just as applicable
under those Sections to Progenitor as licensor and Novo Nordisk as licensee.
8.7.2 Following any termination giving rise to the
rights granted in this Section 8.7, Progenitor shall have the right, at its
expense, to file, prosecute and maintain patent applications and other patent
filings in or with respect to any Novo Nordisk Patent Rights and Joint
Technology.
8.7.3 In addition, following any termination
giving rise to the rights granted in this Section 8.7, Progenitor shall have the
sole and exclusive right, as between the parties, to institute suit against any
third party for infringement of Novo Nordisk Patent Rights and Joint Technology.
(i) If Progenitor elects to commence such an
action, Progenitor shall have control of such action and shall have the right to
settle or compromise the same, and Novo Nordisk agrees that it shall fully
cooperate in every reasonable way with the prosecution of such action. If
Progenitor elects to commence such an action, Novo Nordisk hereby grants
Progenitor the right to do so in Novo Nordisk's name, and, if Novo Nordisk is a
legally indispensable party to such action, Progenitor may cause it to be joined
as a party in such action at Progenitor's expense. Progenitor shall notify Novo
Nordisk of any action filed by
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<PAGE>
Progenitor pursuant to this Section and shall keep Novo Nordisk generally
informed as to the progress of such action.
(ii) Recoveries or reimbursements from any such
action shall first be applied to reimburse Progenitor for its expenses, costs
and fees in connection with the action. Any remaining recoveries or
reimbursements, to the extent they constitute the equivalent of, or damages or
payments in lieu of, reasonable royalties on the infringer's sales (but not in
excess of the amount that would be payable pursuant to Section 8.7.1), shall be
shared with Novo Nordisk in accordance with Section 8.7.1, and otherwise shall
be retained by Progenitor as its own property.
(iii) In the event that Progenitor decides not
to commence or continue prosecution of an infringement of the Novo Nordisk
Patent Rights pursuant to the above paragraphs, Progenitor will promptly give
written notice of such decision to Novo Nordisk. Novo Nordisk shall thereafter
have the right, but not the obligation, to commence or continue such action at
its own expense, controlling such action and retaining all recoveries therefrom.
If Novo Nordisk elects to bring any such action, Novo Nordisk shall have sole
control of such action and may settle or compromise such action in its sole
discretion. If Novo Nordisk elects to commence such an action, Progenitor hereby
grants Novo Nordisk the right to do so in Progenitor's name, and, if Progenitor
is a legally indispensable party to such action, Novo Nordisk may cause it to be
joined as a party in such action at Novo Nordisk's expense, and Progenitor
agrees to cooperate fully in every reasonable way with the prosecution of such
action.
8.7.4 Following any termination giving rise to the
rights granted in this Section 8.7, Novo Nordisk covenants that it will fully
disclose to Progenitor, to the extent it can do so without violating any
obligation of Novo Nordisk and/or any of its Affiliates to any third party, all
data and information in Novo Nordisk's possession, knowledge or control relating
to the use, manufacture, utility, efficacy, nontoxicity, safety and
appropriateness of each Receptor, Ligand, Growth Factor and Progenitor Product.
8.8 Upon Progenitor's request, Novo Nordisk will
negotiate with Progenitor in good faith for a reasonable period of time
following any termination of the licenses granted hereunder and/or of this
Agreement, which termination is effective after the payment by Novo Nordisk of
the license fee pursuant to Section 4.2, regarding a license to Progenitor of
rights under applicable Novo Nordisk Patent Rights and Joint Technology, but the
parties acknowledge that no agreement for a grant of any such license is
included in the terms of this Agreement, and Novo Nordisk shall not be required
to grant any such license nor to do so on any particular terms.
8.9 PROGENITOR ACKNOWLEDGES THAT THE LICENSES GRANTED
IN SECTIONS 8.5, 8.6 AND 8.7 ARE GRANTED AS IS, WITHOUT WARRANTY OF ANY KIND,
AND PROGENITOR AGREES TO INDEMNIFY NOVO NORDISK FOR ANY LOSS, DAMAGE, LIABILITY
AND EXPENSE, INCLUDING WITHOUT LIMITATION ATTORNEYS' FEES AND COSTS OF DEFENSE,
ARISING OUT
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OF ANY EXERCISE OF SUCH RIGHTS BY OR ON BEHALF OF PROGENITOR, ITS AFFILIATES
AND/OR ANY LICENSEE OR ASSIGNEE OF PROGENITOR OR AN AFFILIATE OF PROGENITOR.
9. MISCELLANEOUS.
9.1 Novo Nordisk shall have complete control, as
between the parties, over the development, manufacture, testing, pricing,
marketing, sale and distribution of any Licensed Product. All trademark and
service mark rights and all goodwill associated with any trademarks and service
marks used by Novo Nordisk and its Affiliates and sublicensees in connection
with Licensed Product shall, as among the parties, belong solely to Novo
Nordisk.
9.2 This Agreement constitutes the entire agreement
and supersedes all prior agreements and understandings, both written and oral,
among the parties hereto with respect to the subject matter hereof.
9.3 Neither party shall assign or transfer any of its
rights hereunder, or delegate any of its obligations hereunder, to any third
party (other than an Affiliate of such party) without the prior, written consent
of the other party in each instance; provided, however, that (i) either party
may assign all its rights and obligations hereunder to a third party that
acquires all assets of such party associated with the collaboration established
by this Agreement, so long as such assigning party provides the other party with
notice of such assignment at least 30 days before it becomes effective; and (ii)
Novo Nordisk may delegate any duty arising under this Agreement to any third
party so long as Novo Nordisk remains ultimately responsible, as between the
parties, for performance of such duty. This Agreement shall bind and benefit the
parties hereto and their permitted successors and assigns.
9.4 All notices, requests, reports and other
communication provided for or permitted hereunder shall be given in writing and
shall be hand delivered or sent by facsimile, reputable courier or by registered
or certified mail, postage prepaid, return receipt requested, to the address set
forth on the first page of this Agreement, or to such other address as a party
may inform the others of in writing. Notices will be deemed delivered on the
earliest of transmission by facsimile, actual receipt or ten days after mailing
as set forth herein.
9.5 Any terms of this Agreement may be amended,
modified or waived only in a writing signed by all the parties hereto.
9.6 If any provisions of this Agreement shall be held
invalid, illegal or unenforceable, such provision shall be enforced to the
maximum extent permitted by law and the parties' fundamental intentions
hereunder, and the remaining provisions shall not be affected or impaired.
9.7 Nothing herein contained shall constitute this a
joint venture agreement or constitute either party as the partner, principal or
agent of the other, this being an
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Agreement between independent contracting parties. Neither party shall have any
authority to bind the other party in any respect whatsoever.
9.8 This Agreement shall be governed by, and
construed and enforced in accordance with, the laws of the State of Washington,
U.S.A., without regard to its conflict of law rules.
9.9 Any dispute arising between the parties relating
to, arising out of or in any way connected with this Agreement or any term or
condition hereof, or the performance by either party of its obligations
hereunder, whether before or after termination of the Agreement, shall be
finally resolved by binding arbitration. Whenever a party shall decide to
institute arbitration proceedings, it shall give written notice to that effect
to the other party. The party giving such notice shall refrain from instituting
the arbitration proceedings for a period of sixty (60) days following such
notice. During such 60-day period, the parties shall make good faith efforts to
amicably resolve the dispute without arbitration. Any arbitration hereunder
shall be conducted under the Commercial Arbitration Rules of the American
Arbitration Association ("AAA"). Each such arbitration shall be conducted by a
panel of three arbitrators: one arbitrator shall be appointed by each of
Progenitor and Novo Nordisk and the third shall be appointed by such two
arbitrators, or, if such two arbitrators are unable to agree on the third
arbitrator within a period of 30 days after appointment of the second of them,
such third arbitrator shall be appointed by the AAA. Any such arbitration shall
be held in New York, New York. The arbitrators shall have the authority to grant
specific performance and to allocate between the parties the costs of
arbitration in such equitable manner as they determine. Judgment upon the award
so rendered may be entered in any court having jurisdiction, or application may
be made to such court for judicial acceptance of any award and an order of
enforcement, as the case may be. In no event shall a demand for arbitration be
made after the date when institution of a legal or equitable proceeding based on
such claim, dispute or other matter in question would be barred by the
applicable statute of limitations.
IN WITNESS WHEREOF, the parties hereto have caused their duly
authorized officers to execute and acknowledge this Agreement as of the day and
year first above written.
Progenitor, Inc. Novo Nordisk
By: /S/DOUGLASS GIVEN, M.D., PH.D. By: /S/BRUCE CARTER
------------------------------- --------------------------------
Dr. Douglass Given, President and Dr. Bruce Carter, Executive Vice
Chief Executive Officer President, Health Care Discovery and
Development
[Add appropriate notary blocks for Novo Nordisk and Progenitor.]
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(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 1.3 GROWTH FACTOR
[********************************************************************
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 1.6 EXISTING LICENSED PATENT RIGHTS
[********************************************************************
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 1.9 LIGAND
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 2.1.1 WORK PLAN FOR LIGAND STAGE 1: [*******] plan
[********************************************************************
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*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 2.1.2 WORK PLAN FOR LIGAND STAGE 2
[********************************************************************
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*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
[********************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
[********************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 2.1.3 WORK PLAN FOR GROWTH FACTOR STAGE 1: [****] plan
[********************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
EXHIBIT 2.1.4 WORK PLAN FOR GROWTH FACTOR STAGE 2
[********************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
[********************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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<PAGE>
(The information below marked by* and [ ] has been omitted pursuant to a request
for confidential treatment. The omitted portion has been separately filed with
the Commission.)
[********************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
****************************************************************]
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