Exhibit 10.38
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
Non-Exclusive Product
License Agreement
This Non-Exclusive Product License
Agreement (“ Agreement ”) is made and
entered into effective as of November 3, 2003 (the “
Effective Date ”), by and between Cambridge Antibody Technology
Limited , having its principal offices at The Milstein
Building, Granta Park, Cambridgeshire CB 1 6GH, England (“
CAT ”), and Micromet AG , having its
principal offices at Staffelseestrasse 2, 81477 Munich, Germany
(“ Licensee ”). CAT and Licensee each may be
referred to herein individually as a “ Party ,”
or collectively as the “ Parties .”
Whereas , the Parties have
entered into that certain Research Cross-License Agreement dated as
of September 3, 2003 (the “ Research Cross-License
Agreement ”), under which Licensee may elect to receive
licenses under the CAT Licensed Patents (as defined below) for the
purpose of developing and commercializing antibody products towards
specified targets;
Whereas , Licensee has
elected to receive such a license for the purpose of developing and
commercializing antibody products towards the GM-CSF target;
and
Whereas , CAT desires to
grant a license to Licensee on a non-exclusive basis of the right
to use the CAT Licensed Patents for the purpose of developing and
commercializing such products in respect of such target.
Now , Therefore , in
consideration of the premises and the mutual covenants and
agreements herein contained, the Parties agree as follows:
1. Definitions
When used in this Agreement,
capitalized terms will have the meanings as defined below and
throughout the Agreement.
1.1 “ Affiliate
” means a legal entity that, directly or indirectly, through
one or more intermediaries, controls, is controlled by, or is under
common control with a Party. For purposes of this definition only,
“control” and, with correlative meanings, the terms
“controlled by” and “under common control
with” means (a) the possession, directly or indirectly,
of the power to direct the management or policies of a legal
entity, whether through the ownership of voting securities or by
contract relating to voting rights or corporate governance, or
(b) the ownership, directly or indirectly, of more than 50% of
the voting securities or other ownership interest of a legal
entity; provided that, if local law restricts foreign ownership,
control will be established by direct or indirect ownership of the
maximum ownership percentage that may, under such local law, be
owned by foreign interests.
1.2 “ Antibody
” means a molecule or gene encoding such a molecule
comprising or
1.
containing more than one immunoglobulin variable domain or parts of
such domain or any existing or future fragments, variants,
modifications or derivatives thereof.
1.3 “ Antigen
” means any structure, including an entire protein,
post-translational modifications, lipids, or glyco-lipids, for
which Antibody variable domains have binding affinity.
1.4 “ BiTE
Product ” means any composition or formulation containing
or comprising a bi-specific Single Chain Antibody, wherein one arm
of the Single Chain Antibody binds to T-cells.
1.5 “ Business
Day ” means any day (other than a Saturday or Sunday)
upon which major commercial banks are open for business in the
cities of London and Munich.
1.6 “ CAT Background
Know-How ” means the Know-How Controlled by CAT relating
to the CAT Licensed Patents and described in
Schedule II , which the Parties may amend from time to
time at their sole discretion in accordance with
Section 2.4.
1.7 “ CAT Licensed
Patents ” means (a) those Patents identified in
Schedule I , and (b) any Patents that claim or cover
any CAT Phage Display Improvements and that are selected by
Licensee for inclusion pursuant to Section 9.2.
1.8 “ CAT Phage
Display Improvements ” means any Improvement of a Phage
Display process or any other technology, process, or methodology
(each as claimed in or covered by either of the CAT Licensed
Patents or CAT Background Know-How) that satisfies all of the
following criteria: (a) is first conceived or reduced to
practice within [***] of the Effective Date; provided ,
however , that upon the request of Licensee at any time
during the [***] period following the date that is [***] from the
Effective Date and upon demonstration by Licensee of good
commercial, technical, or legal reasons for extension of the
foregoing [***] period, the Parties agree to negotiate in good
faith the potential extension of such period for one
(1) additional [***] period, with the consent by CAT to such
extension not to be withheld absent demonstration of good
commercial, technical, or legal reasons for opposing such
extension; and (b) is developed by or on behalf of CAT or its
Affiliates; provided , however , that the foregoing
will exclude in respect of CAT only any such improvement,
modification or adaptation to the extent that CAT is not permitted
to disclose, license or sublicense such improvement, modification
or adaptation to Licensee as a result of an obligation of CAT to a
Third Party.
1.9 “ Combination
Product ” means any product manufactured or sold by or on
behalf of Licensee in the Field which contains a Licensed Product
and one or more other [***].
1.10 “
Controlled ” or “ Controls ” means,
with respect to any Know-How, Patent, or other intellectual
property right, possession of the right, whether directly or
indirectly, and whether by ownership, license or otherwise, to
assign, or grant a license, sublicense or other right to or under,
such Know-How, Patent or right as provided for herein without
violating the terms of any agreement or other arrangements with any
Third Party.
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2.
1.11 “
Development ” means any development work carried out
on a Lead directed towards eventual commercialization of such Lead
as a Licensed Product.
1.12 “ Diagnostic
Licensed Product ” means any Licensed Product (including
a composition, formulation, device, assay or other product, but
excluding Microarrays (as defined in Schedule V ))
(a) for sale as an in vitro or in vivo
diagnostic for use in or in relation to humans, or (b) for
sale separately from but in support of a therapeutic product for
use in or in relation to humans.
1.13 “ Dossier
” means a written summary setting forth a brief description
of the proposed use, application or clinical indication of a
particular product composition or formulation applicable to the
Target Program and its origin, amino acid sequence, nucleotide
sequence and Genbank or other accession number (if available);
provided , however , that the foregoing will exclude
any information that is subject to an obligation of confidentiality
between Licensee and a Third Party.
1.14 “ Excluded
Field ” means the field of research and development as
set out in Schedule IV .
1.15 “ Excluded
Technology ” means the applications and technologies as
set out in Schedule V .
1.16 “ Exploit
” or “ Exploitation ” means to make, have
made, import, export, use, sell, offer for sale, or otherwise
dispose of a product, including all discovery, research,
development, registration, modification, enhancement, improvement,
manufacture, storage, formulation, exportation, transportation,
distribution, promotion and marketing activities related
thereto.
1.17 “ FDA
” means the United States Food and Drug Administration, or
any successor agency thereto having the administrative authority to
regulate the marketing of human pharmaceutical products or
biological therapeutic products, delivery systems and devices in
the United States of America.
1.18 “ Field
” means the prognosis, diagnosis, prophylaxis or treatment of
human diseases or conditions by modulation of the Target;
provided , however , that the foregoing will exclude
the Excluded Field.
1.19 “ Gatekeeping
Procedure ” means the process by which [***] whether,
with respect to a [***], prior to a [***], (a) such [***] or
which [***] or (b) [***].
1.20 “
Improvement ” means any improvement, modification or
adaptation of any technology, process or methodology each as
claimed in or covered by either of the CAT Licensed Patents or CAT
Background Know-How, as applicable, which may be developed by or on
behalf of a Party, its sublicensees or its Affiliates during the
Term.
1.21 “ Insolvency
Event ” means, except for the event of a solvent
reorganization or amalgamation, (i) the filing by a Party in
court or agency pursuant to any applicable statute or
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regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of a Party or of its assets,
or (ii) the filing by a Third Party against a Party of an
involuntary petition in bankruptcy or seeking reorganization,
liquidation, dissolution, winding up arrangement, composition or
readjustment of such Party’s debts or any other relief under
any bankruptcy, insolvency, reorganization or other similar act or
law of any jurisdiction now or hereafter in effect, or the issuance
of a warrant of attachment, execution or similar process against a
Party, and, in each case, only if the applicable petition, warrant
of attachment, execution or similar process is not dismissed within
ninety (90) days after the filing thereof, or (iii) if
any Party proposes or is a Party to any dissolution or liquidation
under applicable law, or makes an assignment for the benefit of
creditors.
1.22 “ Know-How
” means all non-public inventions, data, information,
methods, procedures, processes and materials, including but not
limited to, biological, chemical, biochemical, toxicological,
pharmacological, metabolic, formulation, clinical, analytical and
stability information and data (other than such Know-How which is
or becomes the subject of a patent or of a provisional or filed
patent application or which otherwise becomes public).
1.23 “ Lead
” means an Antibody that is selected from a pool of
Antibodies against the Target and that has been generated by Phage
Display, in relation to which the Licensee carries out further
development including, but not limited to, lead optimization.
1.24 “ Licensed
Product ” means any product, substance or formulation
arising from the Target Program, and (a) the Development,
manufacture, importation, use or sale of which would but for the
provisions of this Agreement infringe one or more Valid Claims
under the CAT Licensed Patents, or (b) which utilizes the CAT
Background Know-How.
1.25 “ Licensee
Phage Display Improvement ” means any Improvement of a
Phage Display process or any other technology, process, or
methodology that is developed by or on behalf of Licensee, its
Affiliates or sublicensees and that satisfies all of the following
criteria: (a) is first reduced to practice, or described in a
patent application, publication, or abstract within [***] after the
Effective Date; provided , however , that upon the
request of CAT at any time during the [***] period following the
date that is [***] from the Effective Date and upon demonstration
by CAT of good commercial, technical, or legal reasons for
extension of the foregoing [***] period, the Parties agree to
negotiate in good faith the potential extension of such period for
one (1) additional[***] period, with the consent by Licensee to
such extension not to be withheld absent demonstration of good
commercial, technical, or legal reasons for opposing such
extension; (b) may not lawfully be Exploited without a license
to one or more Valid Claims within the CAT Licensed Patents;
(c) is not a human therapeutic or diagnostic product, a
manufacturing method applicable to that product, or a method of
using that product; and (d) is not claimed in or covered by
any Patent Controlled by Licensee and is not an improvement,
modification or adaptation of any such invention; and (e) does
not relate to any BiTE Product.
1.26 “ MAA
” means a marketing approval application filed with the
European Medicines Evaluation Agency or a Biologics License
Application filed with the FDA, and any
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4.
corresponding applications in other countries or territories.
1.27 “ Major Market
Country ” means the [***].
1.28 “ Marketing
Approval ” means the approval of an MAA for a Licensed
Product and any pricing and reimbursement approvals to the extent
the applicable Regulatory Authorities in a country require a
pricing or reimbursement approval prior to the marketing and sale
of such Licensed Product in such country.
1.29 “ [***]
Agreement ” means that certain license agreement by and
between [***] and CAT dated as of [***], as may be then in effect,
pursuant to which CAT is the exclusive licensee of certain of the
CAT Licensed Patents and certain other Know-How related
thereto.
1.30 “ Net Sales
” means the gross amount invoiced by Licensee, its Affiliate
or its sublicensee for sales of Licensed Products to any Third
Party (and in all cases amounts actually received to the extent not
invoiced), less any (a) normal trade, cash and quantity
discounts actually allowed, including charge backs;
(b) amounts allowed for returned or defective Licensed
Products; (c) insurance and transportation charges to the extent
included in the invoiced amount; and (d) custom duties, VAT,
sales taxes or other governmental charges paid in connection with
such sales (but excluding what is commonly known as income taxes).
Any of the deductions listed above that involves a payment by
Licensee, its Affiliate or sublicensee will be taken as a deduction
in the calendar quarter in which the payment is actually made by
such entity; provided , however , to the extent that
the aggregate of such deductions in any calendar quarter for a
Licensed Product exceeds the gross amount invoiced by Licensee, its
Affiliate or its sublicensee for sales of such Licensed Product,
then Licensee may carry forward any excess amounts and reduce the
gross amounts invoiced in connection with the applicable sale of
Licensed Products in one or more subsequent calendar
quarter(s).
Any amounts received on account of
transfers of Licensed Products between Licensee, its Affiliates or
sublicensees of Licensed Products hereunder will be excluded from
the calculation of Net Sales, and Net Sales will be calculated
based on the final sale of such Licensed Product by Licensee, its
Affiliates or sublicensees to any Third Party.
In the event a Licensed Product is
sold in the form of a Combination Product, Net Sales for purposes
of royalty payments on the Combination Product will be calculated
by multiplying the Net Sales of the Combination Product by the
fraction A/(A+B), where A is the invoice price of the Licensed
Product if sold separately (i.e., without the other active
ingredients or components) by Licensee, its Affiliate or
sublicensee; and B is the aggregate invoice price of the other
active ingredients or components in the Combination Product, if
sold separately by Licensee, its Affiliate or sublicensee. In the
event that no such separate sales are made by Licensee, its
Affiliate or sublicensee, then Net Sales for purposes of royalty
payments on the Combination Product will be calculated by
multiplying the Net Sales of the Combination Product by the
fraction C/(C+D) where C is the fully allocated cost of the
Licensed Product taken separately from the Combination Product
(i.e., not including the other active ingredients or
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5.
components); and D is the aggregate fully allocated cost of the
other active ingredients or components; in each case, such costs
being determined using generally accepted accounting procedures
consistently applied by Licensee, its Affiliate or sublicensee, as
applicable.
1.31 “ Non-Adjusted
Royalty Rate ” means with respect to any Licensed Product
the rate equal to the sum of the maximum royalty rates payable by
Licensee to CAT and Third Parties on net sales (as defined in the
applicable agreements) with regard to the sale or other disposition
of such Licensed Product in accordance with the terms and
conditions of this Agreement.
1.32 “ Patents
” means (a) all patents and patent applications in any
country or supranational jurisdiction, and (b) any
substitutions, divisions, continuations, continuations-in-part,
reissues, renewals, registrations, confirmations, re-examinations,
extensions, supplementary protection certificates and the like, and
any provisional applications, of any such patents or patent
applications.
1.33 “ Phage
Display ” means the technology, process or methodology
whereby Antibodies are cloned, expressed, produced and screened on
the surface of filamentous bacteriophage.
1.34 “ Phase I
Clinical Trial ” means, as to a specific Licensed
Product, the first controlled and lawful study in humans of the
safety of such Licensed Product, which is prospectively designed to
generate sufficient data (if successful) to commence a Phase II
clinical trial (or foreign equivalent) of such Licensed Product, as
further defined in Federal Regulation 21 C.F.R. 312.21.
1.35 “ Primary
Application ” means a major application of a product
containing an Antibody binding to a target, as ascertained at the
time of assessment of such Antibody as a potential Licensed Product
using objective and reasonable scientific and/or commercial
criteria data and/or information. Primary Application does not mean
any minor or incidental application.
1.36 “ Regulatory
Authorities ” means the European Medicines Evaluation
Agency, the FDA, any successor agencies thereto, and any equivalent
health regulatory authorities in any applicable country or
territory.
1.37 “ Single Chain
Antibody ” means an Antibody having binding affinity for
an Antigen whereby such Antibody comprises (i) a polypeptide
segment having a light chain variable region, (ii) a
polypeptide having a heavy chain variable region, and (iii) at
least one peptide linker linking those polypeptides into a single
chain polypeptide.
1.38 “ Target
” means the whole or part and natural variants of the
granulocyte-macrophage colony stimulating factor (GM-CSF)
identified by the SWISS-PROT entry name CSF2_HUMAN and accession
number P04141 with the amino acid sequence as set out in
Schedule III which is specifically recognized by an
Antibody binding to the foregoing.
1.39 “ Target
Program ” means (a) the discovery of Antibodies
binding to the Target by practicing inventions claimed in any CAT
Licensed Patents or utilizing the CAT Background Know-How; and
(b) development of Antibodies binding to the Target by
practicing inventions
6.
claimed
in any CAT Licensed Patents or utilizing the CAT Background
Know-How.
1.40 “ Term
” has the meaning assigned to it in Section 10.1.
1.41 “ Therapeutic
Licensed Product ” means any Licensed Product for which
Marketing Approval is sought or received for therapeutic or
prophylactic use in humans.
1.42 “ Third
Party ” means any party other than CAT, Licensee or their
respective Affiliates.
1.43 “ Valid
Claim ” means (i) any claim of an issued and
unexpired patent within the CAT Licensed Patents which has not been
held unenforceable or invalid by a court or other governmental
agency of competent jurisdiction in a decision that is not appealed
or cannot be appealed, and which has not been disclaimed or
admitted to be invalid or unenforceable through reissue or
otherwise, or (ii) a pending claim in a pending patent
application within the CAT Licensed Patents. Notwithstanding the
foregoing clause (ii), in the event that a pending claim in a
pending patent application does not issue as a valid and
enforceable claim in an issued patent within [***] after the
earliest date from which such patent application claims priority,
such a pending claim will not be a Valid Claim, unless and until
such pending claim subsequently issues as a valid and enforceable
claim in an issued patent, in which case such claim will be
reinstated and be deemed to be a Valid Claim as of the date of
issuance of such patent.
2. Grant Of
Licenses
2.1 License . Subject to the
terms and conditions of this Agreement, CAT hereby grants to
Licensee a nonexclusive, worldwide, royalty-bearing license under
the CAT Licensed Patents and the CAT Background Know-How to Exploit
Licensed Products in the Field. Subject to the terms and conditions
of this Agreement, Licensee may grant and authorize the grant of
further sublicenses under the foregoing license to any of its
Affiliates or to a Third Party; provided , however ,
that any such sublicense will be consistent with the terms and
conditions of this Agreement, and will impose on the sublicensee
the obligations of Licensee and grant CAT the rights contained in
Sections 5.5, 7, 8.3 and 9.1 of this Agreement. Licensee will
provide CAT with the identity of each Third Party licensee of
Licensee that receives a sublicense of the rights under this
Section 2.1 within thirty (30) days of execution of the
applicable agreement. The Parties understand and agree that the
terms and conditions of this Section 2.1 (including the right
to sublicense and authorize further sublicenses) will apply to any
product, composition, or formulation upon the submission by
Licensee of a Dossier for such product pursuant to Section 3.1.1.
Licensee hereby covenants and agrees not to use or sublicense any
of its rights under the foregoing license except as expressly
permitted in this Agreement.
2.2 Reservation of Rights .
Except for the rights specifically granted herein, CAT reserves all
rights to all CAT Licensed Patents and the CAT Background Know-How
Controlled by it and reserves the right to utilize or allow Third
Parties to utilize the CAT Licensed Patents and the CAT Background
Know-How consistent with the terms of this Agreement. No implied
licenses are granted under this Agreement.
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7.
2.3 Excluded Technology .
Notwithstanding anything in this Agreement to the contrary, CAT
grants no rights to Licensee under this Agreement (a) to
research, develop, manufacture, use, or sell Licensed Products
using the Excluded Technology set forth in items [***] of
Schedule V , or (b) to develop, manufacture, use, or
sell any Licensed Product that is a Research Product or Microarray,
as those terms are defined in Schedule V . CAT will
notify Licensee promptly if:
(a) CAT ceases to be bound by the Excluded Field
restriction pursuant to its agreement with [***] dated [***];
or
(b) CAT no longer needs to exclude Research Products
from the license granted hereunder pursuant to its agreement with
[***] dated [***] (the “ [***] License Agreement
”), a copy of which has been provided to Licensee by CAT as
of the Effective Date. CAT will promptly notify Licensee of any
modification or amendment to the [***] License Agreement and
deliver to Licensee a redacted copy of any such amended
agreement.
The restrictions set out in this
Agreement relating to the Excluded Field or Research Products set
forth above (as the case may be) will, subject to any other
restrictions on CAT and to the provisions of this Agreement, cease
to apply from the date of removal of such restriction pursuant to
the terms of the foregoing agreements.
2.4 Know-How Transfer .
Within ninety (90) days after the Effective Date, CAT will
disclose in writing and deliver to Licensee all CAT Background
Know-How. CAT may during the Term at its sole discretion propose to
Licensee that additional CAT Background Know-How (developed by or
on behalf of CAT after the Effective Date) be disclosed to Licensee
and added to Schedule II . Licensee will be entitled to
accept or reject such additional Know-How at its sole discretion.
If Licensee accepts such additional Know-How, then
Schedule II of this Agreement will be amended in
accordance with Section 13.5.
3. Identification
Of Licensed Products; Reporting; Diligence
3.1 Identification of Licensed
Products .
3.1.1 General . Licensee will provide to CAT a Dossier in
respect of each Licensed Product conceived or developed within the
Target Program that Licensee desires to Exploit under this
Agreement. During the Term, Licensee will submit such a Dossier to
CAT for a particular product composition or formulation prior to
the time Licensee begins administration to humans of such
composition or formulation in a human clinical trial with respect
to that product composition or formulation.
3.1.2 Confidentiality . CAT will treat all information
contained in any Dossier (or update thereto) provided to CAT under
this Section 3.1, or Section 3.3 as Licensee’s
Confidential Information in accordance with the confidentiality
provisions of Section 7.
3.2 Abandonment of a Licensed
Product . If at any time during the Term, Licensee
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8.
decides
in its discretion that it no longer wishes to Exploit a Licensed
Product itself or with or through an Affiliate or Third Party (an
“ Abandoned Product ”), Licensee will promptly
notify CAT in writing of such decision and any license granted by
Section 2.2 of this Agreement will be deemed to have been
terminated solely with regard to such Abandoned Product from the
date Licensee sets forth in such notification. In the case of any
Abandoned Product, the Parties will [***].
3.3 Dossier Updates . Within
[***] Business Days of each anniversary of the Effective Date
during the Term, Licensee will prepare and provide to CAT an update
to any Dossier submitted that summarizes the current status of the
research and development regarding each Licensed Product. Such
update may include, by way of example, a brief description of any
collaborations, business transactions, changes of control,
publications, conference presentations and intellectual property or
legal matters where such events are relevant to CAT as licensor or
Licensee as licensee under this Agreement, unless such update would
constitute a breach by Licensee of a non-disclosure obligation to a
Third Party.
4. Gatekeeping And
The Excluded Field
The Parties hereby acknowledge and
agree that the Target has been cleared through CAT’s
Gatekeeping Procedure as of the Effective Date.
5. Payments
5.1 Initial License Fee . On
the Effective Date, Licensee will pay to CAT a non-refundable,
non-creditable license fee of US$[***].
5.2 Therapeutic Licensed Product
Milestone Payments and Royalty Rates . The milestone payments
and royalty rates set forth in this Section 5.2 will apply to
each Therapeutic Licensed Product.
5.2.1 Milestones . Licensee will pay to CAT the following
non-refundable, non-creditable milestone payments for each
Therapeutic Licensed Product Exploited by Licensee, its Affiliates
or sublicensees:
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Milestone Event |
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Milestone Payment |
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Initiation of Phase
I Clinical Trials for such Therapeutic Licensed Product in the
first Major Market Country
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US$[***] |
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Acceptance of the
filing of the first Marketing Approval for such Therapeutic
Licensed Product in the first Major Market Country
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US$[***] |
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Receipt of first
Marketing Approval for such Therapeutic Licensed Product in the
first Major Market Country
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US$[***] |
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5.2.2 Royalties .
(a) Subject to the terms and conditions of this
Agreement, Licensee will pay to CAT a royalty payment equal to
[***]% of Net Sales of each Therapeutic Licensed Product sold by
Licensee, its Affiliates or sublicensees throughout the world. The
royalty payment obligation of Licensee under this
Section 5.2.2 will expire on a Therapeutic Licensed
Product-by-Therapeutic Licensed Product and country-by-country
basis (in which such Therapeutic Licensed Product is sold) upon the
later of: (a) expiration of the last to expire Valid Claim of
the CAT Licensed Patents which, but for the license granted in this
Agreement, would be infringed by the Development, manufacture,
importation, use or sale of such Therapeutic Licensed Product in
such country; and (b) ten (10) years from first
commercial sale for use or consumption by the general public of
such Therapeutic Licensed Product by or on behalf of Licensee
anywhere in the world. In the event that the period described in
clause (b) of the preceding sentence extends beyond the period
described in clause (a) of the preceding sentence with respect
to a Therapeutic Licensed Product in a country (a “
Therapeutic Product Extended Period ”), then the
royalty rate of [***]% set out above will be reduced to [***]% of
Net Sales of such Therapeutic Licensed Product in such country
during such Therapeutic Product Extended Period.
(b) Notwithstanding anything herein to the contrary,
the Parties agree that no royalties will be payable by Licensee for
a particular country in respect of any Therapeutic Licensed Product
which does not utilize the CAT Background Know-How and which is
first sold commercially after the expiration of the last to expire
Valid Claim of the CAT Licensed Patents in such country, which, but
for the license granted in this Agreement, would be infringed by
the Development, manufacture, importation, use or sale of such
Therapeutic Licensed Product in such country.
5.3 Diagnostic Licensed Product
Milestone Payments and Royalty Rates . The milestone payments
and royalty rates set forth in this Section 5.3 will apply to
each Diagnostic Licensed Product.
5.3.1 Milestones . Licensee will pay to CAT the following
non-refundable, non-creditable milestone payments for each
Diagnostic Licensed Product Exploited by Licensee, its Affiliates
or sublicensees:
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Milestone Event |
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Milestone Payment |
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Acceptance of the
filing of the first Marketing Approval for such Diagnostic Licensed
Product in the first Major Market Country
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US$[***] |
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Receipt of first
Marketing Approval for such Diagnostic Licensed Product in the
first Major Market Country
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US$[***] |
5.3.2 Royalties .
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10.
(a) Subject to the terms and conditions of this
Agreement, Licensee will pay to CAT a royalty payment equal to
[***]% of Net Sales of each Diagnostic Licensed Product sold by
Licensee, its Affiliates or sublicensees, throughout the world. The
royalty payment obligation of Licensee under this
Section 5.3.2 will expire on a Diagnostic Licensed
Product-by-Diagnostic Licensed Product and country-by-country basis
(in which such Diagnostic Licensed Product is sold) upon the later
of: (a) expiration of the last to expire Valid Claim of the CAT
Licensed Patents, which, but for the license granted in this
Agreement, would be infringed by the Development, manufacture,
importation, use or sale of such Diagnostic Licensed Product in
such country; and (b) ten (10) years from first
commercial sale for use or consumption by the general public of
such Diagnostic Licensed Product by or on behalf of Licensee
anywhere in the world. In the event that the period described in
clause (b) of the preceding sentence extends beyond the period
described in clause (a) of the preceding sentence with respect
to a Diagnostic Licensed Product in a country (a “
Diagnostic Product Extended Period ”), then the
royalty rate of [***]% set out above will be reduced to [***]% of
Net Sales of such Diagnostic Licensed Product in such country
during such Diagnostic Product Extended Period.
(b) Notwithstanding anything herein to the contrary,
the Parties agree that no royalties will be payable by Licensee for
a particular country in respect of any Diagnostic Licensed Product
which does not utilize the CAT Background Know-How and which is
first sold commercially after the expiration of the last to expire
Valid Claim of the CAT Licensed Patents in such country, which, but
for the license granted in this Agreement, would be infringed by
the Development, manufacture, importation, use or sale of such
Diagnostic Licensed Product in such country.
5.3.3 Acceleration of Milestones . If the first commercial
sale of a Diagnostic Licensed Product by Licensee, its Affiliate or
sublicensee is made in a Major Market Country where no Marketing
Approval has been granted for such Licensed Product, then both of
the milestone payments set forth in Section 5.3.1 will be
payable as if the relevant milestone events had occurred as of the
date of such first commercial sale.
5.4 Payment .
5.4.1 Payment of Milestones . Upon Licensee achieving a
development milestone that triggers a milestone payment obligation
pursuant to Sections 5.2.1 or 5.3.1, Licensee will give notice
to CAT within [***] days of achieving each milestone, and will make
the corresponding milestone payment within [***] days of the
achievement of the corresponding milestone event.
5.4.2 Payment of Royalties . For any quarterly period for
which royalties are payable by Licensee to CAT under
Sections 5.2.2 or 5.3.2, Licensee will provide notice to CAT
within [***] days after the end of each such calendar quarter and a
written report with Licensee’s good faith estimate of Net
Sales accrued in the preceding calendar quarter and the royalties
payable thereon. Licensee will make royalty payments to CAT for
Licensed Products or
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Diagnostic Licensed Products sold during a calendar quarter within
[***] days of the last day of that calendar quarter. Each royalty
payment will be accompanied by a written report for that calendar
quarter showing the cumulative Net Sales of the applicable product
sold by Licensee, its Affiliates and its sublicensees on a
country-by-country basis worldwide during the quarterly reporting
period and the corresponding royalties payable under this
Agreement.
5.4.3 Payment Method . All amounts due hereunder will be
paid in US Dollars by wire transfer in immediately available funds
to Barclays Bank Plc, Benet Street Business Centre, P O Box No 2,
Cambridge, CB2 3PZ, England, Account Number [***]; Sort Code:
[***], Swift Code: [***] (payments may be routed through Barclays
Bank Plc, New York, ABA Routing Code: [***]; Swift Code: [***]) or
such other bank account as CAT may from time to time notify
Licensee. Any payments or portions thereof due hereunder which are
not paid on the date such payments are due will bear interest from
the due date until the date of payment at the rate which is the
lower of (i) [***]percentage points above the overnight London
Interbank Offering Rate in effect on the due date or (ii) the
highest rate permitted by applicable law.
5.4.4 Currency Conversion for Milestone Payments and Calculation
of Net Sales . For any currency conversion required in
connection with any payment hereunder, or in determining the amount
of royalties due, such conversion will be made at the prevailing
commercial rate of exchange for purchasing the currency into which
an amount is to be converted as publicly announced as the spot rate
quoted by Barclays Bank Plc (or its successor) in London on
(i) the day which is fifteen (15) Business Days following the
date of the achievement of any milestone for which payment is due
pursuant to Sections 5.2.1 or 5.3.1 and (ii) the day
which is the last Business Day of the applicable quarterly period
for any royalty payments made pursuant to Sections 5.2.2 or
5.3.2. For purposes of determining the amount of royalties due, the
amount of Net Sales in any foreign currency will be computed by
converting such amount into US Dollars as provided in this Section.
All payments due under this Agreement will be paid exclusive of
value added tax.
5.4.5 Credit for Royalties Paid on Uncollected Amounts . As
set forth in this Section 5.4.5, Licensee will be entitled to
a credit for royalties paid by Licensee hereunder with respect to
any invoiced amounts that are included in Net Sales but are not
collected by Licensee, its Affiliate or sublicensee, as applicable
(each such amount, an “ Uncollected Amount ”).
Such credit may be taken in the calendar quarter in which the
applicable Uncollected Amount is no longer recorded as a receivable
or in one or more subsequent calendar quarter(s) to the extent that
such credit exceeds the amount payable by Licensee to CAT in any
calendar quarter. The amount of such credit will be equal to the
difference between (x) the royalty actually paid by Licensee
to CAT hereunder for the Uncollected Amount, and (y) the
royalty actually paid by CAT to [***], its successors or assigns
pursuant to the [***] Agreement for the Uncollected Amount. Upon
the request of Licensee in connection with this Section 5.4.5,
CAT will provide to Licensee payment records supporting payment to
[***] by CAT in respect of such Uncollected Amount. Licensee agrees
that an Uncollected Amount will only be recorded as not receivable
once Licensee has used its reasonable endeavors to recover such
amount from the relevant Third Party in accordance with its usual
practice for recovering unpaid debts. To the extent that an
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Uncollected Amount recorded as not receivable is in fact
subsequently received by Licensee, Licensee will pay to CAT the
corresponding amount of any credit previously taken by Licensee in
accordance with Section 5.4.2.
5.5 Records; Audits .
Licensee will at all times keep or cause or procure to be kept and
for at least [***] retain accurate data, accounts and supporting
documentation of all Licensed Products produced and/or sold, used
or disposed of by or on behalf of Licensee and the Net Sales
thereof (collectively, “ Records ”) to the
extent such Records are reasonably required for the computation and
verification of royalties and all other sums payable under this
Agreement. Licensee will give to or procure for CAT’s
nominated representative, upon reasonable request in writing and no
more than [***], access to Licensee’s facilities during
normal business hours to inspect all Records kept in accordance
with this Section 5.5 and to make copies or to take extracts
from these Records. However, CAT’s nominated representative
will not disclose to CAT or any Third Party any Confidential
Information belonging to Licensee but will merely report on any
under or over payment discovered as a result of his inspection. CAT
will bear all costs of such audit, unless the audit reveals an
underpayment of more than [***]% from payments otherwise due and
payable hereunder, in which case Licensee will bear the cost of the
audit.
5.6 Payment of Additional
Amounts . If, based on the results of any audit, additional
payments are owed to CAT under this Agreement, Licensee will make
such additional payments promptly after the accounting firm’s
written report is del
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