“[ * ]”
= omitted, confidential material, which material has been
separately filed with the Securities and Exchange Commission
pursuant to a request for confidential treatment.
Exhibit 10.2
License and Transfer Agreement
for IL-21 Protein
This License and Transfer Agreement
for IL-21 Protein (“ Agreement ”) is
effective as of January 16, 2009 (the “
Effective Date ”) and is entered into by and
between ZymoGenetics, Inc., a Washington corporation having a
principal place of business at 1201 Eastlake Avenue East, Seattle,
Washington 98102 (“ ZGEN ”), and Novo
Nordisk A/S, a Danish corporation having a principal place of
business at Novo Alle, DK-2880, Bagsvaerd, Denmark (“
NN ”).
WHEREAS, ZGEN and NN are parties to
a certain Restated License Agreement for IL-21 effective as of
January 1, 2003, which was amended and restated by the Second
Restated License Agreement effective as of January 16,
2009;
WHEREAS, ZGEN and NN are parties to
a certain Collaborative Data Sharing and Cross-License Agreement
for IL-21 Protein (“ Cross-License Agreement
”) effective as of August 11, 2005, which has been
terminated as of the Effective Date pursuant to a letter agreement
(“ Cross-License Letter Agreement ”),
which Cross-License Letter Agreement provides for the survival of
certain provisions of the Cross-License Agreement;
WHEREAS, NN desires to cease
development of the IL-21 Protein;
WHEREAS, ZGEN has retained all
rights in NA for IL-21 Protein and desires to develop and
commercialize IL-21 Protein in the RoW as well;
WHEREAS, ZGEN is interested in
obtaining rights to NN’s data, Regulatory Submissions and
Product Approvals, intellectual property, and other information
generated pursuant to the Cross-License Agreement or otherwise
related to the research and development of IL-21 Protein, pursuant
to the terms of this Agreement;
WHEREAS, NN is willing to return its
rights to IL-21 Protein formerly granted by ZGEN to NN while
maintaining rights to remaining IL-21 Embodiments, as well as grant
ZGEN worldwide access and rights to NN’s data, Regulatory
Submissions and Product Approvals, intellectual property, and other
information generated pursuant to the Cross-License Agreement or
otherwise related to the research and development of IL-21 Protein,
pursuant to the terms of this Agreement; and
WHEREAS, ZGEN is willing to
compensate NN for return of RoW IP rights to IL-21 Protein, in
exchange for obtaining rights to NN’s data, Regulatory
Submissions and Product Approvals, intellectual property, and other
information generated pursuant to the Cross-License Agreement or
otherwise related to the research and development of IL-21 Protein,
in each case pursuant to the terms of this Agreement.
NOW THEREFORE, IT IS HEREBY AGREED
AS FOLLOWS:
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ARTICLE 1
Definitions
SECTION 1.1. “
Affiliate ” means: with respect to a party, any other
business entity which directly or indirectly controls, is
controlled by or is under common control with the party. The direct
or indirect ownership of at least fifty percent (50%) or, if
smaller, the maximum allowed by applicable law, of the voting
securities of a business entity or of an interest in the assets,
profits or earnings of a business entity shall be deemed to
constitute control of the business entity. For the avoidance of
doubt, ZGEN and NN are not Affiliates of each other.
Notwithstanding the above, the Novo Nordisk Foundation, Novo A/S
and Novozymes A/S shall not be considered Affiliates of
NN.
SECTION 1.2. “ Agency
” means: the FDA, EMEA or foreign equivalent of
either.
SECTION 1.3. “ Approval
” means: any approval, registration, license or authorization
from any Regulatory Authority required for the clinical trials or
the marketing of a Product, including, without limitation, an
approval, registration, license or authorization granted in
connection with any Regulatory Submission.
SECTION 1.4. “ Assignee
Party ” shall have the meaning set forth in SECTION
10.1.
SECTION 1.5. “ Assigning
Party ” shall have the meaning set forth in
SECTION 10.1.
SECTION 1.6. “ BLA
” or “ PLA ” means: a biologics license
application or product license application filed with an Agency
pursuant to the Agency’s regulations, including all
amendments and supplements to the application, and any equivalent
foreign filing with a Regulatory Authority.
SECTION 1.7. “ Breaching
Party ” shall have the meaning set forth in SECTION
8.4.
SECTION 1.8 “ CEO
” means: chief executive officer.
SECTION 1.9 “ Claim(s)
” shall have the meaning set forth in SECTION 7.1.
SECTION 1.10 “
Collaborative Agreement ” means: the Collaborative
Agreement for IL-21 effective as of December 14, 2002, between
ZGEN and NN.
SECTION 1.11. “
Commercialization Partner ” means: a Sublicensee to
whom ZGEN has extended certain commercialization rights that it
received or reserved under this Agreement including the right to
develop, promote, market, offer to sell, import, export,
distribute, sell or have sold Products as part of a co-marketing
agreement, co-commercialization agreement, strategic partnership,
joint venture relationship or the like with ZGEN.
SECTION 1.12. “ Common
Product ” means: a Product having as an active agent the
IL-21 Protein identified as
[ * ].
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SECTION 1.13. “ Confidential
Information ” means: information disclosed pursuant to
this Agreement including all proprietary information and materials,
patentable or otherwise, of a party that is disclosed by or on
behalf of such disclosing party to the receiving party or its
Affiliates, such as DNA sequences, amino acid sequences, vectors,
cells, substances, formulations, techniques, methodology,
equipment, plans, data, reports, know-how, assay results,
preclinical studies and clinical trials and the results thereof,
patent positioning and business plans, including negative
developments.
SECTION 1.14. “
Controls ” and “ Controlled ” mean:
the entity referenced has the ability to exploit and to license or
sublicense the right to exploit the referenced technology or
rights, without (assuming the timely payment of all applicable
royalties) violating the terms of any agreement or other
arrangement between the entity referenced and a third
party.
SECTION 1.15 “ CRO
” means: contract research organization.
SECTION 1.16: “
Cross-License Agreemen t” means: the Collaborative
Data Sharing and Cross-License Agreement for IL-21 Protein,
effective as of August 11, 2005, between ZGEN and
NN.
SECTION 1.17. “
Cross-License Letter Agreement ” means: the Letter
Agreement between ZGEN and NN regarding Termination of the Cross
License Agreement, entered into as of the Effective
Date.
SECTION 1.18. “ EMEA
” means: the European Medicines Evaluation Agency or any
successor agency thereto.
SECTION 1.19. “ FDA
” means: the United States Food and Drug Administration or
any successor agency thereto.
SECTION 1.20. “ Force
majeure ” shall have the meaning set forth in
SECTION 10.6.
SECTION 1.21. “ IL-21
Antagonist Protein ” means: a protein, and all species,
fragments and modifications of such polypeptide sequence, encoded
by an IL-21 Gene that act solely as (i) an antagonist protein
on the IL-21 receptor (i.e., such protein binds the receptor but
does not illicit receptor signaling), and (ii) competitively
inhibits the binding of IL-21 Protein on the IL-21
receptor.
SECTION 1.22. “ IL-21
Embodiment ” shall have the meaning as defined in the
Second Restated License Agreement.
SECTION 1.23. “ IL-21
Gene ” means: the polynucleotide sequence identified in
[ * ], and all
species, fragments and modifications of such polynucleotide
sequence that are disclosed in such application or any patents or
patent applications included in Appendix A and Appendix
C.
SECTION 1.24. “ IL-21
Protein ” means: the protein identified in
[ * ] and any protein
encoded by an IL-21 Gene and all species, fragments and
modifications of such polypeptide sequence that are disclosed in
such application or any patents or patent applications included in
Appendix A and Appendix C. For the avoidance of doubt, IL-21
Protein includes the Common
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Product. Notwithstanding the above, any IL-21
Antagonist Protein shall be expressly excluded from the definition
of IL-21 Protein.
SECTION 1.25. “ IL-21 ZGEN
Know-How ” means: all inventions, discoveries, know-how,
methodologies, technology, data and tangible materials (including
nucleic acids, peptides, vectors, proteins, cells, cell lines,
transgenic and knock-out animals, and the like) that:
(a) relate to an IL-21 Gene, IL-21 Protein or Common Product;
(b) were invented, discovered, developed or otherwise
generated by ZGEN or its Affiliates as of the Effective Date and
(c) are Controlled by ZGEN or its Affiliates as of the
Effective Date.
SECTION 1.26. “ IL-21 ZGEN
Patent Rights ” means: (a) the patents and patent
applications set forth in Appendix C appended hereto;
(b) patents and patent applications Controlled by ZGEN or its
Affiliates that claim an invention with a date of conception as of
the Effective Date and that specifically recite as a claim element
(i) an IL-21 Gene, IL-21 Protein or Product, (ii) a
process, formulation and/or mixture comprising an IL-21 Gene, IL-21
Protein or Product, (iii) a method of making or manufacturing
an IL-21 Protein or Product or (iv) a method of using an IL-21
Gene, IL-21 Protein or Product; (c) all divisional or
continuation (in whole or in part) applications of the applications
in described in (a) and (b); (d) all patents issuing from
the applications described in (a), (b) and (c); and
(e) all extensions, supplemental protection certificates
(including any form of patent term extensions), reissues,
reexaminations, substitutions or renewals of the patents described
in (d). Notwithstanding the foregoing, if any portion of any
application or patent described above does not specifically recite
an IL-21 Gene, IL-21 Protein or Product as a claim element, then
such portion of the application or patent is expressly excluded
from the term “IL-21 ZGEN Patent Rights” but only to
the extent that such portion does not claim an IL-21 Gene, IL-21
Protein or Product.
SECTION 1.27. “ IMPD
” means: an Investigational Medicinal Product Dossier
application or its foreign equivalent.
SECTION 1.28. “ IND
” means: an Investigational New Drug application or its
foreign equivalent.
SECTION 1.29. “ JPT
” shall have the meaning as set forth in SECTION 1.34 of the
Cross-License Agreement.
SECTION 1.30. “ JSC
” shall have the meaning as set forth in SECTION 1.35 of the
Cross-License Agreement.
SECTION 1.31. “ Know-How
Product ” means: a product in final dosage form that
contains an IL-21 Protein as an active agent and is not a Patent
Product but that was developed through use of any Licensed Patent,
Licensed Know-How, IL-21 ZGEN Patent Right or IL-21 ZGEN Know-How,
or which otherwise incorporates or embodies Licensed Know-How or
IL-21 ZGEN Know-How.
SECTION 1.32. “ Licensed
Know-How ” means: all inventions, discoveries, know-how,
methodologies, technology, data and tangible materials (including
nucleic acids, peptides,
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vectors, proteins, cells, cell lines, transgenic
and knock-out animals, and the like), trade secrets, technical
reports and data (including non-clinical data, preclinical data,
toxicological studies, methods of synthesis, methods of production
or manufacture, assay information and clinical trial data)
concerning a Product Controlled by NN as of the Effective Date that
are necessary to make, have made, use or sell a Product.
SECTION 1.33. “ Licensed
Patents ” means: (a) the patents and patent
applications set forth in Appendix A appended hereto; (b) all
worldwide patents and patent applications Controlled by NN as of
the Effective Date that specifically recite as a claim element
(i) an IL-21 Gene, IL-21 Protein or Product, (ii) a
process, formulation and/or mixture comprising an IL-21 Gene, IL-21
Protein or Product, (iii) a method of making or manufacturing
an IL-21 Protein or Product or (iv) a method of using an IL-21
Gene, IL-21 Protein or Product; (c) all divisional or
continuation (in whole or in part) applications of the applications
in described in (a) and (b); (d) all patents issuing from
the applications described in (a), (b) and (c); and
(e) all extensions, supplemental protection certificates
(including any form of patent term extensions), reissues,
reexaminations, substitutions or renewals of the patents described
in (d). Notwithstanding the foregoing, if any portion of any
application or patent described above does not specifically recite
an IL-21 Gene, IL-21 Protein or Product as a claim element, then
such portion of the application or patent is expressly excluded
from the term “Licensed Patents” but only to the extent
that such portion does not claim an IL-21 Gene, IL-21 Protein or
Product.
SECTION 1.34. “ MAA
” means: a Marketing Authorization Application or its foreign
equivalent.
SECTION 1.35. “ Master
Services Agreements ” means: collectively (i) the
Master Agreement for Pharmaceutical Services effective as of
March 10, 2004 between ZGEN and NN, and (ii) the Master
Services Agreement for Clinical Manufacturing and CMC Development
Services relating to IL-21 effective as of January 5, 2007
between ZGEN and NN and (iii) the Quality Agreement for
Clinical Manufacturing and CMC Development Services relating to
IL-21 effective as of January 5, 2007 between ZGEN and
NN.
SECTION 1.36. “ Master
Services Letter Agreement ” means: the Letter Agreement
between ZGEN and NN regarding Termination of the Master Services
Agreements and work orders related thereto, entered into as of the
Effective Date.
SECTION 1.37. “ Milestone
Fees ” shall have the meaning set forth in SECTION
4.2.
SECTION 1.38. “ NA
” means: Canada, Mexico and the United States of America and
its territories and possessions.
SECTION 1.39. “ NN’s
Existing Regulatory Submissions ” means: the Regulatory
Submissions filed by NN prior to the Effective Date.
SECTION 1.40. “ NN
Prosecuted Patents ” shall have the meaning set forth in
SECTION 3.4(b).
SECTION 1.41. “
Non-Breaching Party ” shall have the meaning set forth
in SECTION 8.4.
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SECTION 1.42. “ Ongoing Clinical
Trials ” means: NN’s clinical trials for the Common
Product identified in Appendix B.
SECTION 1.43. “ Patent
Product ” means: a product in final dosage form that
contains an IL-21 Protein as an active agent the making, using,
importation, exportation, offer for sale, or sale of which would
infringe any unexpired Valid Claim of a Licensed Patent or IL-21
ZGEN Patent Right.
SECTION 1.44. “ Process
Development Agreement ” means: the Agreement to Exchange
Process Development Data for IL-21 Protein effective as of
March 3, 2004, between ZGEN and NN.
SECTION 1.45. “ Product
” means: either a Patent Product or a Know-How
Product.
SECTION 1.46. “ Product
Approval ” means: the Approval from any Regulatory
Authority on a Product specifically granted in connection with the
Regulatory Submission of a BLA or MAA.
SECTION 1.47. “ Regulatory
Authority ” means: any federal, national, multinational,
state, provincial, or local regulatory agency, department, bureau,
or other governmental entity with authority over clinical trials,
safety, marketing, pricing and/or sale of any Product, including
the FDA in the United States, the EMEA in Europe and the TGA in
Australia.
SECTION 1.48. “ Regulatory
Submission ” means: the submission to the relevant
Regulatory Authority of an appropriate application seeking
Approval, registration, license or authorization of any Product,
including any relevant marketing authorization application,
supplementary application or variation thereof, BLA, MAA, IND, IMPD
or equivalent foreign application.
SECTION 1.49. “ Restated
License Agreement ” means the Restated License Agreement
for IL-21 effective as of January 1, 2003 between ZGEN and
NN.
SECTION 1.50. “ RoW
” means: all countries of the world, except those within
NA.
SECTION 1.51. “ RoW Net
Development Milestones ” means: the net cumulative dollar
amount (i.e., after subtracting payments or other reductions
creditable to milestones pursuant to the applicable agreement)
received by ZGEN from a third party Commercialization Partner as
payments for development and regulatory milestone events based on
RoW activities related to Products. Notwithstanding the above,
[ * ] ZGEN receives
from a Commercialization Partner shall be included in the RoW Net
Development Milestones. For the avoidance of doubt, RoW Net
Development Milestones do not include royalty payments received by
ZGEN pursuant to SECTION 5.1 or RoW Net Sales
Milestones.
SECTION 1.52. “ RoW Net
Royalty Rate ” means: the net royalty percentage of the
RoW Net Sales (i.e., after subtracting royalty offsets and other
reductions applied to royalties pursuant to the applicable
agreement) received by ZGEN from a third party Commercialization
Partner based on annual RoW Net Sales related to
Products.
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SECTION 1.53. “ RoW Net Sales
” means: the gross amount invoiced by ZGEN, its Affiliates,
Commercialization Partners and Sublicensees from sales or other
dispositions of Products in RoW to any independent third party,
less the following with respect to the invoiced Product,
i. any direct or indirect credits
and allowances or adjustments, including credits and allowances on
account of retroactive price adjustments or on account of
rejection, recall or return of Products previously
invoiced;
ii. any price reductions, discounts,
chargebacks and rebates, as well as administrative, management and
other fees, commissions, reimbursements and similar payments to
wholesalers and other third party distributors, government
authorities, benefit management organizations, health insurance
carriers, hospitals, group purchasing organizations and other
institutions;
iii. any sales, excise, turnover,
value added, or similar taxes and any duties and other governmental
charges imposed upon the production, importation, use or sale of
Product(s);
iv. applicable transportation,
importation, insurance and other handling charges; and
v. the per unit cost of special
devices used for administration of Product, comprising the total of
(a) the purchase price paid by ZGEN or its Affiliates if such
device is purchased from third parties or (b) the fully
allocated manufacturing cost of such devices if such devices are
manufactured by ZGEN or its Affiliates. Such special devices shall
not include conventional devices ( e.g. , tablets, standard
syringes, suppositories and/or standard transdermal
patches).
Deductions i, ii and iv in the
aggregate shall not exceed
[ * ] of the gross
amount invoiced for the Product, by ZGEN, or its Affiliates,
Commercialization Partner(s) or Sublicensee(s) during any reporting
period.
In the event that the Product in RoW
is sold as part of a Combination Product (as hereinafter defined)
the RoW Net Sales of the Product, for the purposes of determining
royalty payments, shall be determined by multiplying the RoW Net
Sales of the Combination Product by the fraction, A/(A + B) where A
is the average sale price of the Product when sold separately in
finished form and B is the average sale price of the Other Active
Agents (as hereinafter defined) sold separately in finished form.
In the event that the average sale price of the Product or Other
Active Agents cannot be determined, RoW Net Sales of the Product,
for the purposes of determining royalty payments, shall be
determined by multiplying the RoW Net Sales of the Combination
Product by the fraction C/(C+D), where C is the average per unit
inventory cost of the Product and D is the average per unit
inventory cost of the Other Active Agents. Inventory costs shall be
determined in accordance with ZGEN’s regular accounting
methods.
The fractions set forth in the
preceding two paragraphs, as applicable, for a Combination Product
shall be calculated once each calendar year, for a country, and
shall be used during all
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applicable royalty reporting periods for the
entire calendar year. When determining the average sale price or
inventory cost of a Product or Other Active Agents, data for the
preceding calendar year shall be used for calculating the
applicable fraction; provided, however, that with respect to the
first year of RoW Net Sales of a Combination Product for a country
when there have not been prior separate sales of the corresponding
Product, a reasonable estimate of the applicable fraction shall be
used, and an adjustment made after the end of the year for the
actual fraction calculated for the year. As used above, the term
“Combination Product” means any pharmaceutical product
which is comprises a Product and other pharmaceutically active
compounds which are not moieties that are the subject of
third-party patents pursuant to which royalties are payable to such
third-parties in association with any Patent Products
commercialized in accordance with this Agreement (“
Other Active Agents ”).
Notwithstanding the foregoing, the
RoW Net Sales of a Product in a country shall never be reduced
below [ * ] of the
gross amount invoiced for the Combination Product.
Any Product sold or otherwise
disposed of in other than an arm’s-length transaction or for
other property ( e.g. , barter) shall be deemed invoiced at
its fair market value in the country of sale or
disposition.
SECTION 1.54. “ RoW Net
Sales Milestones ” means: the net cumulative dollar
amount (i.e., after subtracting payments or other reductions
creditable to such milestones pursuant to the applicable agreement)
received by ZGEN from a third party Commercialization Partner for
milestones based upon RoW Net Sales of a Product that would exceed
a designated dollar amount resulting in a Commercialization Partner
being obligated pay to ZGEN a one time fee. For the avoidance of
doubt, RoW Net Sales Milestones do not include royalty payments
received by ZGEN pursuant to SECTION 5.1 or RoW Net Development
Milestones.
SECTION 1.55. “ Second
Restated License Agreement ” means the Second Restated
License Agreement for IL-21 effective as of January 16, 2009
between ZGEN and NN.
SECTION 1.56. “
Sublicensee ” means: a third party to whom ZGEN has
extended rights that it received or reserved under this Agreement.
For the avoidance of doubt, a Commercialization Partner is a
Sublicensee.
SECTION 1.57. “ Term
” means: the period from the Effective Date of this Agreement
through the earlier of