THE INFORMATION MARKED BY * AND [ ] HAS BEEN OMITTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTIONS HAVE BEEN SEPARATELY FILED
WITH THE COMMISSION.
AMENDED AND RESTATED
SPONSORED RESEARCH AND LICENSE AGREEMENT
THIS AGREEMENT, entered into as of the 1st day of May, 1995 by and
between Progenitor, Inc., 0000 Xxxxxxxx Xxxx, Xxxxxxxx, Xxxx 00000-0000
("Progenitor"), and Novo Nordisk A/S, c/o ZymoGenetics, Inc., 0000 Xxxxxxxx
Xxxxxx Xxxx, Xxxxxxx, Xxxxxxxxxx 00000 ("Novo Nordisk"),, is amended and
restated in its entirety as stated herein as of the 21 day of February, 1997
(the "date of this Restated Agreement").
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-l. Novo Nordisk and its Affiliates have experience in
isolating and cloning ligands to receptors and cloning growth factors and in
developing products therefrom.
B. The parties have terminated their prior collaborative research
effort with respect to the Hu-B1.219 receptor, as stated in a letter from
Progenitor to Novo Nordisk dated March 17, 1996. This termination ended the
Ligand Research Phase and occurred prior to any "Ligand Stage 2" and,
accordingly, all references to Ligand Stage 2 have been omitted from this
Restated Agreement. The parties acknowledge that no "Ligand" was discovered or
developed, and no "Ligand" arose in or from such Ligand Research Phase, as the
Ligand to the Receptor had been separately discovered to be leptin, and this was
disclosed in publications of third parties. Nevertheless, certain work and
technologies were performed and developed during the "Ligand Research Phase,"
all of which relate solely to the Receptor.
C. 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 YSDF-1 growth factor, on the terms and
conditions set forth in this Agreement, and 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 identified
from the supernatant of the murine yolk-sac-derived cell line YS-4 or any human
homologe (Hu-YSDF-1) of Mu-YSDF-1, wherein such protein molecule is stimulatory
to any hematopoietic
1
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.
1.4 JOINT COMMITTEE shall mean the committee described in Section 2.4
of this Agreement.
1.5 JOINT TECHNOLOGY shall mean either the "Receptor Joint
Technology," which is, as to information, data, property and rights existing at
or prior to March 17, 1996, any partial or complete sequence information, data,
property and rights describing or covering the Receptor 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 Receptor Research Phase at or on
behalf of Novo Nordisk, Progenitor or any Affiliate of either, or the "Growth
Factor Joint Technology," which is any partial or complete sequence information,
data, property and rights describing or covering any 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 Growth Factor 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 Growth Factor Research
Phase. The parties agree that any and all Joint Technology shall be jointly
owned by Novo Nordisk and Progenitor.
1.6 LICENSED JOINT PATENT RIGHTS shall mean those Licensed Patent
Rights arising under patents and patent applications covering any Growth Factor
Joint Technology.
1.7 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
also include, without limitation, Progenitor's rights arising under patents and
patent applications covering any Growth Factor Joint Technology.
1.8 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 Growth Factor Joint Technology as if they
were solely owned by Progenitor.
1.9 LICENSED TECHNOLOGY shall mean any and all material, information,
property and rights in or coming into the possession or control of Progenitor or
any Affiliate of
2
Progenitor or any licensee or collaborator of any of them which has received the
YS-4 cell line or any rights therein from Progenitor or its Affiliate (other
than Novo Nordisk and its Affiliates) that is necessary or useful in the
discovery, isolation, development, production or use of any Growth Factor in the
Field, including without limitation the Growth Factor(s) themselves and the
materials or information referred to in Exhibit 2.1.1.
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 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 Growth Factor Joint Technology arising from the
research conducted pursuant to this Agreement in the course of Stage 1 and
Stage 2 of the Growth Factor Research Phase 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 RECEPTOR PATENT RIGHTS shall mean Novo Nordisk's
rights in and to Receptor Joint Technology that arose from the research
conducted pursuant to this Agreement in the course of the Receptor Research
Phase that is covered at any time by any patent or patent application in any
country worldwide, and all divisions, conditions, 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 Receptor 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 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
3
more Valid Claims of Novo Nordisk Growth Factor Patent Rights, treating, for
this purpose only, all patents covering Growth Factor Joint Technology arising
from the research conducted pursuant to this Agreement in the course of Stage 1
and Stage 2 of the Growth Factor Research Phase as if they were owned solely by
Novo Nordisk.
1.16 PROGENITOR RECEPTOR 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 Receptor
Patent Rights, treating, for this purpose only, all patents covering Receptor
Joint Technology arising from the research conducted pursuant to this Agreement
in the course of the Receptor Research Phase as if they were owned solely by
Novo Nordisk.
1.17 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.
1.18 RESEARCH PHASE shall mean either the "Receptor Research Phase"
which was the initial phase of the term of this Agreement prior to March 17,
1996, when the parties were actively conducting research regarding the Receptor,
or the "Growth Factor Research Phase", which will be the initial phase of the
term of this Agreement, beginning with the date of this Restated Agreement, when
the parties are actively conducting research regarding Growth Factors. (The
Receptor Research Phase was formerly called the "Ligand Research Phase," but
because no Ligand resulted therefrom, the parties have renamed it herein.) The
Growth Factor Research Phase will consist of two stages, which are described in
Section 2.1 below. The Growth Factor Research Phase shall continue until
termination of the final stage thereof or the earlier termination of this
Agreement.
1.19 ROYALTIES shall mean all royalties payable by Novo Nordisk to
Progenitor hereunder.
1.20 TARGET GROWTH FACTOR shall mean a Growth Factor, as defined in
Section 1.3, and which is more specifically described in Exhibit 1.20.
1.21 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).
4
2. RESEARCH.
2.1 The Growth Factor Research Phase will consist of one or two
stages, as described below:
2.1.1 (i) During Stage 1 of the Growth Factor Research Phase,
Novo Nordisk and/or one or more of its Affiliates will attempt to clone and
sequence a Growth Factor, and more specifically a Target Growth Factor, pursuant
to the work plan attached as Exhibit 2.1.1. Also during such Xxxxx 0, Xxxxxxxxxx
will promptly provide to Novo Nordisk any Licensed Technology in the form of any
Growth Factor (and any related material, information, property and rights) not
previously provided to Novo Nordisk by Progenitor, and which come into the
possession or control of Progenitor or its Affiliates. Progenitor will exert
all continuing reasonable efforts to obtain the agreement of its or its
Affiliates' licensees and collaborators who have received the YS-4 cell line or
any rights therein from Progenitor or its Affiliate similarly to provide any
such Growth Factor or Growth Factor-related Licensed Technology to Progenitor or
its Affiliate in support of Progenitor's compliance with this Agreement.
(ii) As required by Novo Nordisk, and at no additional
charge, Progenitor will provide Novo Nordisk with samples of the materials or
assistance described in Exhibit 2.1.l and will exert all commercially reasonable
efforts as may be required to enable Novo Nordisk to carry out Novo Nordisk's
obligations during Stage 1. Xxxxxx Xxxxx 0, Xxxx Xxxxxxx 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
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 Xxxxx 0, Xxxx Xxxxxxx will not use any
Growth Factor provided to Novo Nordisk by Progenitor except in connection with
any Identified Growth Factor (as defined below).
(iii) The parties anticipate that Stage 1 will continue for
approximately [***]. Stage I will end upon the "Stage 1 Termination Date,"
which shall occur on the earliest of (A) the date Novo Nordisk notifies
Progenitor in writing that Novo Nordisk has successfully completed the tasks of
cloning and sequencing a Target Growth Factor that is Growth Factor Joint
Technology, (B) Progenitor notifies Novo Nordisk that a Target Growth Factor has
been cloned and sequenced that is Licensed Technology, or (C) Stage 1 ends as
described in clause (iv)(B) below.
(iv) If Novo Nordisk has not so cloned and sequenced a
Target Growth Factor within [***] after the date of this Restated Agreement, and
no Target Growth Factor has then been cloned and sequenced that is Licensed
Technology, Progenitor may deliver written notice to Novo Nordisk at any time
after expiration of such [***] period but before Novo Nordisk so clones and
sequences a Target Growth Factor demanding that Novo Nordisk complete such tasks
within 60 days after delivery of such notice. If Novo Nordisk does
5
not complete such cloning and sequencing of a Target Growth Factor within such
60-day period, then:
(A) if no Growth Factor has been cloned and sequenced that
is Growth Factor Joint Technology or that is Licensed Technology prior to the
end of such 60-day period, Progenitor may terminate the Growth Factor Research
Phase 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, or
(B) if Novo Nordisk notifies Progenitor in writing prior to
the end of such 60-day period that a Growth Factor other than a Target Growth
Factor has theretofore been cloned and sequenced that is Growth Factor Joint
Technology, or that Novo Nordisk will treat as such any Growth Factor(s) that
have been cloned and sequenced that is Licensed Technology (and as Progenitor
has so notified Novo Nordisk), Stage 1 will be deemed completed on the basis of
those Growth Factor(s) so cloned and sequenced, and the date of such notice
shall be the Stage 1 Termination Date. If Novo Nordisk does not give such
notice prior to the end of such 60-day period, clause (iv)(A) above shall apply.
(v) Each determination of whether or not Novo Nordisk has
successfully cloned and sequenced a Target Growth Factor that is Growth Factor
Joint Technology will be made by Novo Nordisk in its sole discretion, based on
the criteria set forth in Exhibit 1.20 having been met. Each determination of
whether or not Novo Nordisk has successfully cloned and sequenced a Growth
Factor other than a Target Growth Factor that is Growth Factor Joint Technology,
or by or for Progenitor that is Licensed Technology, will be made by Novo
Nordisk in its sole discretion, based on the definition in Section 1.3 and on
the recommendation, if any, of the Joint Committee.
(vi) Within 120 days after the 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 Stage 2
of the Growth Factor Research Phase and what Growth Factor or Growth Factors, if
more than one, (or other result of the work conducted pursuant to 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 Stage 2 with any Growth Factor (or other
result of the work conducted pursuant to Stage 1), there will be no Stage 2 of
the Growth Factor Research Phase, and 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 such Identified Growth Factor Notice,
and, after such termination, Progenitor shall have the rights granted in
Section 8.6. If Novo Nordisk fails to give any Identified Growth Factor Notice,
this will, as of the 180th day after the Stage 1 Termination Date, be treated as
if Novo Nordisk had given an Identified Growth Factor Notice stating that it
does not desire to proceed to Stage 2 with any Growth Factor (or other result of
the work conducted pursuant to Stage 1), and the immediately preceding sentence
shall be applicable.
6
2.1.2 Stage 2 will begin on the date Novo Nordisk gives
Progenitor an Identified Growth Factor Notice stating that Novo Nordisk desires
to proceed to Stage 2. During at least the initial twenty-five months of Stage 2
of the Growth Factor Research Phase, Progenitor will make itself and its
personnel available to perform the studies described in Exhibit 2.1.2 to Novo
Nordisk's satisfaction and at Novo Nordisk's option. Novo Nordisk may, in its
discretion, perform some or all of such studies itself or engage one or more
third parties to do some or all of such studies on terms to be agreed by Novo
Nordisk and such third party(ies), provided that no such third party terms shall
reduce or impair any of Progenitor's rights under this Agreement. If and to the
extent that Novo Nordisk engages Progenitor to perform one or more of such
studies, Novo Nordisk will be responsible for producing, at no additional
charge, all recombinant Identified Growth Factor protein reasonably required by
Progenitor to complete its tasks during Stage 2. Progenitor will limit its use
of such protein to performance of its obligations under this Agreement.
2.1.3 If Novo Nordisk engages Progenitor to perform all of
the Stage 2 studies described in Exhibit 2.1.2, Progenitor will devote no less
than the equivalent of [***] qualified scientists working full-time on
completion of its obligations throughout the 2nd through the 25th months of
Stage 2, and Novo Nordisk will pay Progenitor a quarterly research fee of U.S.
$500,000 during such portion of Stage 2. Each such research fee shall be due, in
such event, 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. If
Novo Nordisk engages Progenitor to perform less than all of such Stage 2
studies, such personnel and research fee commitments shall be proportionately
reduced to equitably reflect the Progenitor work actually engaged and performed.
For purposes of this Agreement, the phrase "full-time" shall mean forty hours
per week, excluding holidays.
2.1.4 Stage 2 will continue until Novo Nordisk is satisfied
that the studies described in Exhibit 2.1.2 have been completed and the results
thereof have been analyzed and understood. Within 120 days after the end of
Xxxxx 0, Xxxx Xxxxxxx will notify Progenitor in writing (a "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 Stage 2. If Novo Nordisk desires to go forward with
the development of more than one Licensed Product, it will give a separate
Development Notice for each such Licensed Product. If Novo Nordisk states in a
Development Notice that there is no Licensed Product the development of which it
desires to proceed with, 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 Development Notice, and, after such termination,
Progenitor shall have the rights granted in Section 8.6. If Novo Nordisk fails
to give any Development Notice, this will, as of the 180th day after the end of
Stage 2, be treated as if Novo Nordisk had given a Development Notice stating
that there is no Licensed Product the development of which it desires to proceed
with, and the immediately preceding sentence shall be applicable.
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
7
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 the Growth Factor 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 efforts are made, shall be owned by Novo
Nordisk, and shall not be deemed to be Joint Technology. Progenitor will exert
all commercially reasonable efforts to 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 Growth Factors, the
mammalian cells expressing any of the Growth Factors, 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. 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 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 Growth Factor 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. Xxx Xxxxxx, Dr. Si Lok, and Xx. Xxxxxxx Xxxxxxxxx
and the initial representatives of Progenitor to the Joint Committee shall be
Dr. H. Xxxxx Xxxxxxxxx, Xx. Xxxxxxxx Given, and Dr. Xxxxxxx Xxxxxxxx. 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, and each representative shall have one vote. During Stage 1 of
the Growth Factor Research Phase, the Joint Committee shall meet in person at
least twice each calendar year and by teleconference
8
at least once each calendar quarter (excluding the calendar quarters in which it
meets in person). Following Stage 1 of the Growth Factor 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 Stage 1 of the Growth Factor 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 Stage 1 of
the Growth Factor Research Phase shall be: (i) to advise the parties regarding
the overall strategy for Stage 1, as contemplated by this Agreement; (ii) to
coordinate the parties' activities hereunder; (iii) to review all results of
work done in Stage I of the Growth Factor 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 Stage 1 of the Growth Factor
Research Phase, the role of the Joint Committee shall be to advise Novo Nordisk
with respect to further development, testing, and commercialization of Licensed
Product, as requested by Novo Nordisk.
2.5 All rights in any partial or complete sequence information
describing or covering any 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 Growth Factor 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 Growth Factor 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 Novo Nordisk affirms that it has prior to the date of this
Restated Agreement delivered to Progenitor all of the Receptor Joint Technology
arising from the research conducted pursuant to this Agreement in the course of
the Receptor Research Phase. 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 growth factors in general. 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 a
Growth Factor. Alternatively, a molecule discovered by Novo Nordisk or obtained
by Novo Nordisk from a third party may be a portion of a Growth
9
Factor, or a Growth 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 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, nor use the
same except as contemplated herein and in such Section 5. Novo Nordisk will not
intentionally seek a collaboration with any third party with respect to any
molecule that is identical or substantially similar to a Growth Factor.
2.7 So long as Novo Nordisk is producing 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 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 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 any products or processes for
use in the Field and to otherwise carry out its rights and obligations pursuant
to this Agreement, which license shall be nonexclusive except to the extent
provided in the following sentence. 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 the Licensed Technology describing, covering, constituting, or otherwise
with respect to, any Growth Factor; the Licensed Joint Patent Rights; and the
Growth Factor Joint Technology, to make, have made, use, sell, have sold, offer
for sale and import products or processes 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
10
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 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 Except as to filings covering any of the technology exclusively
licensed to Novo Nordisk pursuant to the second sentence of Section 3.1,
Progenitor shall have the sole right to file and prosecute any patent
applications relating to the Licensed Patent Rights and the Licensed Technology,
and to maintain such patent rights. Except as provided in Section 8.5.1 and
8.6.2, Novo Nordisk shall have the sole right to file and prosecute any patent
applications giving rise, in whole or in part, to the Licensed Joint Patent
Rights or any other Licensed Patent Rights exclusively licensed to Novo Nordisk
pursuant to the second sentence of Section 3.1, and to maintain patents under
such Licensed Joint Patent Rights and such other 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 or Sections 8.5.1 or 8.6.2, 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 If Novo Nordisk elects to go forward with development of one or
more Licensed Product(s) pursuant to Section 2.1.4, Novo Nordisk will pay
Progenitor a license fee of U.S. $2,000,000 within 90 days after the earlier of:
(i) the delivery to Progenitor of the first 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).
11
Nothing in this Agreement shall be construed as requiring Novo Nordisk to pay
more than one such license fee.
4.2 In addition, Novo Nordisk will make the following milestone
payments to Progenitor:
4.2.1 Novo Nordisk will pay Progenitor U.S. [***] 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 (1i) 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 4.2. 1 more than once.
4.2.2 Novo Nordisk will pay Progenitor U.S. [***] within 60
days after the first initiation of Phase III clinical trials (or the first
initiation of equivalent steps under the laws of any country other than the
United States) for use of each separate Licensed Product to treat any specific
indication.
4.2.3 Novo Nordisk will pay Progenitor U.S. [***] within 60
days after the fire 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.
4.2.4 Novo Nordisk will pay Progenitor U.S. [***] 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
[***] shall be deemed to be an advance on Royalties payable on Net Sales in
Europe.
4.2.5 Novo Nordisk will pay Progenitor U.S. [***] 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.
4.2.6 Except as set forth in Sections 4.2.4 and 4.2.5 above,
the milestone payments shall be nonrefundable once paid and noncreditable
against Royalties.
4.3 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 4.4), at the following rates:
12
4.3.1 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;
4.3.2 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;
4.3.3 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
4.3.4 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.
All such Royalties (after allowing credit for advances on Royalties paid
pursuant to Sections 4.2.4 and 4.2.5 and any reduction of royalties pursuant to
Section 4.5) 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 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.
4.4 Whether or not a Licensed Product is considered a "separate
Licensed Product" for purposes of making milestone payments pursuant to
Sections 4.2.2 through 4.2.5 and for purposes of calculating Royalties pursuant
to Section 4.3 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.
4.5 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
13
obligation as follows: the royalty payments by Novo Nordisk under Section 4.3
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 4.3 is not reduced by more than one-half.
4.6 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
average of the "buy" and "sell" conversion rates published in the Wall Street
Journal, Eastern edition, on the last business day of the calendar quarter to
which such payments relate.
4.7 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 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.
4.8 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.
14
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:
(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 property 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.
15
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 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.
6. WARRANTIES AND INDEMNIFICATION.
6.1 Each party hereby represents and warrants that, as of the date of
this Restated Agreement:
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 had not, on or prior to March 17, 1996, entered into
any contract, agreement, partnership, joint venture or other arrangement,
whether oral or written, with any third party relating to the Receptor that is
inconsistent with the terms of this Agreement. It has not, whether before, on,
or after March 17, 1996, entered into any contract, agreement, partnership,
joint venture or other arrangement, whether oral or written, with any third
party relating to any Growth Factor, Licensed Product, Licensed Patent Rights 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 Restated 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
Rights, 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.
16
Progenitor assumes all risks of damage or injury to persons and to property
arising out of any manufacture, use or sale of Progenitor Receptor Product
and/or Progenitor Growth Factor 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 Receptor Product and/or
Progenitor Growth Factor 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, 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
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 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 8.5.2 and 8.6.3, in the event
that any of the Licensed Joint Patent Rights or any other Licensed Patent Rights
exclusively licensed to Novo Nordisk pursuant to the second sentence of
Section 3.1 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
17
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 4.3), shall be shared with Progenitor in
accordance with Section 4.3, and otherwise shall be retained by Novo Nordisk as
its own property.
7.3 In the event that Novo Nordisk decides not to commence or
continue prosecution of an infringement of the Licensed Joint Patent Rights, or
of the other Licensed Patent Rights exclusively licensed to Novo Nordisk,
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 Joint
Patent Rights or other exclusively-licensed 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 of Novo
Nordisk's licenses (whether in accordance with Section 8.2 or as provided in
Section 2.1, whereby the license to Progenitor under Section 8.6 will become
effective) or the date of termination of this-Agreement in accordance with
Section 8.3.
8.2 Novo Nordisk may terminate the licenses granted to it pursuant to
this Agreement with respect to all Growth Factors at any time during Stage 1 or
after the end of Stage 2 of the Growth Factor Research Phase upon delivery of 30
days' written notice to Progenitor, or at any time during 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 Stage 2 or after termination of
the Growth Factor Research Phase upon delivery of 30 days'
18
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 revisions set forth in Sections 1, 6, 8.5, 8.6, 8.7,
8.8, 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 which are
then at any time covered by Valid Claims, following any termination or
expiration of this Agreement.
8.5 Novo Nordisk hereby grants to Progenitor and its Affiliates,
effective as of March 17, 1996, the worldwide, sole and exclusive, royalty-free
license, with right to sublicense, under Novo Nordisk's rights in Novo Nordisk
Receptor Patent Rights and Receptor Joint Technology arising from the research
conducted pursuant to this Agreement in the course of Receptor Stage 1 (which
had previously been called "Ligand Stage 1") to make, have made, use, sell, have
sold, offer for sale and import Progenitor Receptor Product for use in the
Field. The following terms shall apply until expiration of the last to expire
of any Valid Claim of the Novo Nordisk Receptor 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 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 Receptor Patent Rights and Receptor Joint
Technology.
8.5.2 In addition, Progenitor shall have the sole and exclusive
right, as between the parties, to institute suit against any third party for
infringement of Novo Nordisk Receptor Patent Rights and Receptor 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.
19
(ii) Recoveries or reimbursements from any such action 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 Receptor 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.
8.5.3 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
the Receptor and each Progenitor Receptor 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. 1 of this
Restated Agreement, 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. 1, 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
Growth Factor Joint Technology arising from the research conducted pursuant to
this Agreement in the course of the Growth Factor Research Phase 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 Progenitor shall pay Novo Nordisk a royalty on annual
Progenitor Growth Factor Net Sales with respect to each separate Progenitor
Growth Factor Product, at the following rates:
20
(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 win 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 an 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 4.6, 4.7, and
4.8 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.
21
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.
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
22
the use, manufacture, utility, efficacy, nontoxicity, safety and appropriateness
of each Growth Factor and Progenitor Growth Factor Product.
8.7 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. 1, regarding a license to Progenitor of rights under
applicable Novo Nordisk Growth Factor Patent Rights and Growth Factor 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.
8.8 PROGENITOR ACKNOWLEDGES THAT THE LICENSES GRANTED IN SECTIONS 8.5
AND 8.6 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 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 xxxx 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 Restated 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, including without
limitation the initial form of this Agreement.
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,
23
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 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.
24
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 A/S
By /s/ Xxxxxxx Xxxxxxxx By /s/ Xxxxx Xxxx
-------------------------------- ----------------------------------
Its Dr. Xxxxxxx Xxxxxxxx Xx. Xxxxx Xxxx, Corporate Vice
-------------------------------- President of Healthcare Discovery
Vice President of and Development
Corporate Development
[Add appropriate notary blocks for Novo Nordisk and Progenitor.]
25
LIST OF EXHIBITS
EXHIBIT 1.20 - Description of Target Growth Factor
EXHIBIT 2.1.1 - Work plan for Stage 1
EXHIBIT 2.1.2 - Stage 2 studies
EXHIBIT 1.20
DESCRIPTION OF TARGET GROWTH FACTOR
[***]
[***]
[***]
[***]
[***]
EXHIBIT 2.1.1
WORK PLAN FOR STAGE 1
SUMMARY PLAN:
[***]
1
[***]
2
EXHIBIT 2.1.2
STAGE 2 STUDIES
[***]
1
[***]
2
ACKNOWLEDGMENT
State of Washington
County of King
On February 21, 1997 before me, Xxxxx X.Xxxxx, Notary Public, personally
appeared Xxxxx Xxxx, proved to me on the basis of satisfactory evidence to be
the person whose name is subscribed to the within instrument and acknowledged to
me that he executed the same in his authorized capacity, and that by his
signature on the instrument the person or the entity upon behalf of which the
person acted, executed the instrument.
WITNESS my hand and official seal.
/s/ Xxxxx X. Xxxxx
----------------------------------
Xxxxx X. Xxxxx, Notary Public
ACKNOWLEDGMENT
State of California
County of San Francisco
On February 18, 1997 before me, Xxxxxxx X. Xxxxxxx, Notary Public,
personally appeared Xxxxxxx X. Xxxxxxxx, proved to me on the basis of
satisfactory evidence to be the person whose name is subscribed to the within
instrument and acknowledged to me that he executed the same in his authorized
capacity, and that by his signature on the instrument the person or the entity
upon behalf of which the person acted, executed the instrument.
WITNESS my hand and official seal.
/s/ Xxxxxxx X. Xxxxxxx
---------------------------------------
Xxxxxxx X. Xxxxxxx, Notary Public
