Exhibit 10.37
***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 September 3, 2003 (the “
Effective Date ”), by and between Cambridge Antibody Technology
Limited , having its principal offices at The Milstein
Building, Granta Park, Cambridgeshire CB1 6GH, England (“
CAT ”), and Micromet AG , having its
principal offices at Staffelseestrasse 2, 81477 Munich, Germany
(“ Micromet ”). CAT and Micromet each may be
referred to herein individually as a “ Party ,”
or collectively as the “ Parties .”
Whereas , CAT is
the owner of (or licensee of) certain patents and know-how in the
field of Antibody Phage Display and is authorised to grant the
licenses and other rights to Licensee pursuant to the terms of this
Agreement;
Whereas , Micromet is
developing the MT201 Product (defined below) and desires to
commercially develop the MT201 Product for the treatment of human
diseases or conditions using the CAT Licensed Patents (defined
below) and pursuant to the terms and conditions set forth in this
Agreement and furthermore owns or controls certain patents that
have claims relating to Phage Display; and
Whereas , CAT desires to
grant a license to Micromet on a non-exclusive basis of the right
to use the CAT Licensed Patents for the purpose of researching,
developing and commercializing the MT201 Product and other products
in respect of the EpCAM 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 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 “ Antibody
Product ” means any composition or formulation containing
or comprising one or more Antibodies in any format for the
prognosis, diagnosis, prophylaxis or treatment of human diseases or
conditions or for use as a research reagent.
1.4 “ Antigen
” means any structure, including an entire protein,
post-translational modifications, lipids, or glyco-lipids, for
which Antibody variable domains have binding affinity.
1.5 “ 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.
1.6 “ 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.
1.7 “ 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 2.5.
1.8 “ 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
Micromet for inclusion pursuant to Section 9.2.
1.9 “ 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 Micromet at any time
during the [***] period following the date that is [***] from the
Effective Date and upon demonstration by Micromet 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 as a result of an
obligation of CAT to a Third Party.
1.10 “ Combination
Product ” means any product manufactured or sold by or on
behalf of Micromet in the Micromet Licensed Field which contains a
Licensed Product and one or more other [***].
1.11 “
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
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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.
1.12 “
Development ” means any development work carried out
on a Lead directed towards eventual commercialization of such Lead
as an Antibody Product.
1.13 “ 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.
1.14 “ 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 (including the MT201
Product) applicable to the EpCAM 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 Micromet and a Third
Party.
1.15 “ EpCAM
Target ” means the whole or part of the human epithelial
cell adhesion molecule EpCAM identified by the SWISS-PROT entry
name TTD1_HUMAN and accession number P16422 with the amino acid
sequence as set out in Schedule III which is
specifically recognized by an Antibody binding to the
foregoing.
1.16 “ EpCAM Target
Program ” means (a) the discovery of Antibodies
binding to the EpCAM Target by practising inventions claimed in any
CAT Licensed Patents or utilizing the CAT Background Know-How; and
(b) development of Antibody Products binding to the EpCAM
Target by practising inventions claimed in any CAT Licensed Patents
or utilizing the CAT Background Know-How.
1.17 “ Excluded
Field ” means the field of research and development as
set out in Schedule IV .
1.18 “ Excluded
Technology ” means the applications and technologies as
set out in Schedule V .
1.19 “ 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.
1.20 “ 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.
1.21 “ Gatekeeping
Procedure ” means the process by which [***] whether,
with respect to a [***], prior to a [***], (a) such
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[***] or
which [***] or (b) [***].
1.22 “
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.
1.23 “ 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 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.
1.24 “ 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).
1.25 “ Lead
” means an Antibody that is selected from a pool of
Antibodies against the EpCAM Target and that has been generated by
Phage Display, in relation to which a Party carries out further
development including, but not limited to, lead optimization.
1.26 “ Licensed
Product ” means (a) the MT201 Product and
(b) any other product, substance or formulation arising from
the EpCAM Target Program, in each case, the Development,
manufacture, importation, use or sale of which (i) would, but
for the provisions of this Agreement, infringe one or more Valid
Claims under the CAT Licensed Patents, or (ii) utilizes the
CAT Background Know-How.
1.27 “ MAA
” means a marketing approval application filed with the
European Medicines Evaluation Agency or a Biologics License
Application filed with the FDA, and any corresponding applications
in other countries or territories.
1.28 “ Major Market
Country ” means the [***].
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1.29 “ 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.
1.30 “ Micromet
Licensed Field ” means the prognosis, diagnosis,
prophylaxis or treatment of human diseases or conditions by
modulation of the EpCAM Target; provided , however ,
that the foregoing will exclude the Excluded Field.
1.31 “ Micromet
MT201 Patents ” means the following Patents owned as of
the Effective Date by Micromet: [***].
1.32 “ Micromet
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 Micromet, 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 Micromet
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; (d) is not claimed in or covered by any
Patent Controlled by Micromet and is not an improvement,
modification or adaptation of any such invention; and (e) does
not relate to any BiTE Product.
1.33 “ Micromet
Research Field ” means the identification or development
of Antibody Products for the prognosis, diagnosis, prophylaxis or
treatment of human diseases or conditions by modulation of the
EpCAM Target; provided , however , that the foregoing
will exclude any research and development activities (a) in
the Excluded Field, or (b) that involve administration of any
composition or formulation of Antibodies to humans.
1.34 “ [***]
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.
1.35 “ MT201
Product ” means a human Antibody developed by Micromet
binding to the EpCAM Target, as described in further detail in the
Dossier to be submitted by Micromet to CAT pursuant to
Section 3.1.2.
1.36 “ Net Sales
” means the gross amount invoiced by Micromet, its Affiliate
or its sublicensee for sales of Licensed Products to any Third
Party (and in all cases amounts actually
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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 Micromet, 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
Micromet, its Affiliate or its sublicensee for sales of such
Licensed Product, then Micromet 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 Micromet, 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 Micromet, 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 Micromet, 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 Micromet, its Affiliate or sublicensee. In the
event that no such separate sales are made by Micromet, 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
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 Micromet, its Affiliate or sublicensee, as
applicable.
1.37 “ 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.
1.38 “ Phage
Display ” means the technology, process or methodology
whereby Antibodies are cloned, expressed, produced and screened on
the surface of filamentous bacteriophage.
1.39 “ 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.
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1.40 “ 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.
1.41 “ Ribosome
Display ” means the technology, process or methodology
whereby Antibodies are cloned, expressed, produced and screened
in vitro involving a step where an Antibody or Antibodies
are tested for binding to Antigen when said Antibody or Antibodies
are attached to its coding RNA and to ribosomes.
1.42 “ 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.
1.43 “ Term
” has the meaning assigned to it in Section 10.1.
1.44 “ Therapeutic
Licensed Product ” means any Licensed Product sold for
therapeutic or prophylactic use in humans.
1.45 “ Third
Party ” means any party other than CAT, Micromet or their
respective Affiliates.
1.46 “ 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 Research License .
Subject to the terms and conditions of this Agreement, CAT hereby
grants to Micromet a nonexclusive, worldwide license under the CAT
Licensed Patents and the CAT Background Know-How to perform
research and development activities in the Micromet Research Field.
Subject to the terms and conditions of this Agreement, Micromet
will have the right to grant a sublicense to any of its rights
under the foregoing license to (i) its Affiliates and (ii) any
Third Party that enters into a research and/or collaboration
agreement with Micromet in order to perform research activities on
behalf of Micromet in the Micromet Research Field; 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
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Micromet
and grant CAT the rights contained in Sections 2.4, 5.5, 5.7,
7, 8 and 9 of this Agreement; and provided , further
, that Micromet has no right to grant to such Third Party a right
to grant further sublicenses, except to Affiliates of such Third
Party. Micromet will provide CAT with the identity of each Third
Party licensee of Micromet that receives a sublicense of the rights
under this Section 2.1 within thirty (30) days of
execution of the applicable agreement. Micromet 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 Commercialization License
. Subject to the terms and conditions of this Agreement, CAT hereby
grants to Micromet a nonexclusive, worldwide, royalty-bearing
license under the CAT Licensed Patents and the CAT Background
Know-How to Exploit Licensed Products in the Micromet Licensed
Field. Subject to the terms and conditions of this Agreement,
Micromet 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 Micromet and
grant CAT the rights contained in Sections 2.4, 5.5, 5.7, 7, 8
and 9 of this Agreement. Micromet will provide CAT with the
identity of each Third Party licensee of Micromet that receives a
sublicense of the rights under this Section 2.2 within thirty
(30) days of execution of the applicable agreement. The
Parties understand and agree that the terms and conditions of this
Section 2.2 (including the right to sublicense and authorize
further sublicenses) will apply to any product, composition, or
formulation upon the submission by Micromet of a Dossier for such
product pursuant to Section 3.1.1. Micromet hereby covenants
and agrees not to use or sublicense any of its rights under the
foregoing license except as expressly permitted in this
Agreement.
2.3 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.
2.4 Excluded Technology .
Notwithstanding anything in this Agreement to the contrary, CAT
grants no rights to Micromet 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 Micromet 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 Micromet by CAT as of the
Effective Date.
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CAT will
promptly notify Micromet of any modification or amendment to the
[***] License Agreement and deliver to Micromet 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.
2.5 Know-How Transfer .
Within ninety (90) days after the Effective Date, CAT will
disclose in writing and deliver to Micromet all CAT Background
Know-How. CAT may during the Term at its sole discretion propose to
Micromet that additional CAT Background Know-How (developed by or
on behalf of CAT after the Effective Date) be disclosed to Micromet
and added to Schedule II . Micromet will be entitled to
accept or reject such additional Know-How at its sole discretion.
If Micromet 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 and Reporting
3.1 Identification of Licensed
Products .
3.1.1 General . Micromet will provide to CAT a Dossier in
respect of each Licensed Product conceived or developed within the
EpCAM Target Program that Micromet desires to Exploit under this
Agreement. During the Term, Micromet will submit such a Dossier to
CAT for a particular product composition or formulation prior to
the time Micromet begins administration to humans of such
composition or formulation in a human clinical trial with respect
to such product composition or formulation.
3.1.2 MT201 Product . The Parties agree and acknowledge that
MT201 Product is a Licensed Product hereunder (and has already been
administered to humans in a clinical trial) and Micromet will
submit a Dossier in respect of the MT201 Product within [***]
following the Effective Date.
3.1.3 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 Micromet’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, Micromet 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 ”), Micromet 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 Micromet sets forth in such notification. In the case of any
Abandoned Product, the Parties will [***].
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3.3 Dossier Updates . Within
[***] Business Days of each anniversary of the Effective Date
during the Term, Micromet 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
Micromet as licensee under this Agreement, unless such update would
constitute a breach by Micromet of a non-disclosure obligation to a
Third Party.
4. Gatekeeping and
the Excluded Field
4.1 EpCAM Target . The
Parties hereby acknowledge and agree that the EpCAM Target has been
cleared through CAT’s Gatekeeping Procedure as of the
Effective Date.
4.2 Micromet Representations
. Subject to Section 4.3 below, Micromet hereby represents and
warrants to CAT that as of the Effective Date: (a) it is not
developing and does not intend to develop a Licensed Product for a
Primary Application in the Excluded Field; (b) its primary
purpose in using the CAT Licensed Patents under the licenses
granted under this Agreement is outside the Excluded Field;
(c) it has provided CAT with the sequence of the EpCAM Target
detailed in Schedule III to allow CAT (i) to
conduct an assessment, as of the Effective Date, of [***]
containing Antibodies to the EpCAM Target and the intended or
actual use of such Licensed Products, and (ii) to subject the
EpCAM Target to such [***] or other customary or scientifically
established techniques as may be used to determine whether or not
[***] of the Licensed Products containing Antibodies to the EpCAM
Target is [***]; and (d) it believes that the Primary
Application of the Licensed Products containing Antibodies to the
EpCAM Target is outside the Excluded Field.
4.3 Limitation .
Notwithstanding Section 4.2, if, following the Effective Date,
it is subsequently discovered by either Party that products
containing Antibodies to the EpCAM Target do have a Primary
Application in the Excluded Field, the discovering Party will
promptly notify the other in writing of such discovery.
Notwithstanding any such discovery or notice thereof, Micromet will
be entitled to continue with the research, development, use, or
sale of any Antibody or Licensed Product, including any application
within the Excluded Field, under the terms and conditions set forth
herein, and such research, development, use or sale (together with
any prior research, development, use or sale) will not constitute a
breach of Section 4.2 or any other provision of this
Agreement.
5. Payments
5.1 Initial License Fee . On
the Effective Date, Micromet will pay to CAT a non-refundable,
non-creditable license fee of US$[***].
5.2 Therapeutic Licensed Product
Milestone Payments and Royalty Rates . The milestone payments
and royalty rates set forth in this Section 5.2 will apply to
each Therapeutic Licensed Product.
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5.2.1 Milestones . Micromet
will pay to CAT the following non-refundable, non-creditable
milestone payments for each Therapeutic Licensed Product Exploited
by Micromet, its Affiliates or sublicensees:
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Milestone Event |
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Acceptance of the
filing of the first Marketing Approval for such Therapeutic
Licensed Product in the first Major Market Country
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US$[***] |
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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$[***] |
5.2.2 Royalties .
(a) Subject to the terms and conditions of this Agreement,
Micromet will pay to CAT a royalty payment equal to [***]% of Net
Sales of each Therapeutic Licensed Product sold by Micromet, its
Affiliates or sublicensees throughout the world. The royalty
payment obligation of Micromet 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 Micromet 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 Micromet 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.
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5.3.1 Milestones . Micromet
will pay to CAT the following non-refundable, non-creditable
milestone payments for each Diagnostic Licensed Product Exploited
by Micromet, 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 each 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 each such Diagnostic Licensed Product in the
first Major Market Country
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US$[***] |
5.3.2 Royalties .
(a) Subject to the terms and conditions of this Agreement,
Micromet will pay to CAT a royalty payment equal to [***]% of Net
Sales of each Diagnostic Licensed Product sold by Micromet, its
Affiliates or sublicensees throughout the world. The royalty
payment obligation of Micromet 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 Micromet 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 Micromet 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 Micromet, 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
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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 Micromet achieving a
development milestone that triggers a milestone payment obligation
pursuant to Sections 5.2.1 or 5.3.1, Micromet 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 Micromet to CAT under
Sections 5.2.2 or 5.3.2, Micromet will provide notice to CAT
within [***] days after the end of each such calendar quarter and a
written report with Micromet’s good faith estimate of Net
Sales accrued in the preceding calendar quarter and the royalties
payable thereon. Micromet will make royalty payments to CAT for
Licensed Products or Diagnostic Licensed Products sold during a
calendar quarter within [***] 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 Micromet, 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
Micromet. 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.
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5.4.5 Credit for Royalties Paid on Uncollected Amounts . As
set forth in this Section 5.4.5, Micromet will be entitled to
a credit on royalties paid by Micromet hereunder with respect to
any invoiced amounts that are included in Net Sales but are not
collected by Micromet, 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 Micromet to CAT in any
calendar quarter. The amount of such credit will be equal to the
difference between (x) the royalty actually paid by Micromet
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 Micromet in connection with this
Section 5.4.5, CAT will provide to Micromet payment records
supporting payment to [***] by CAT in respect of such Uncollected
Amount. Micromet agrees that an Uncollected Amount will only be
recorded as not receivable once Micromet 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 Uncollected Amount recorded as not receivable is
in fact subsequently received by Micromet, Micromet will pay to CAT
the corresponding amount of any credit previously taken by Micromet
in accordance with Section 5.4.2.
5.5 Records; Audits .
Micromet 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 Micromet 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. Micromet will give to or procure for CAT’s
nominated re
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