Non-Exclusive Product License Agreement
Exhibit 10.37
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
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 Xxx Xxxxxxxx Xxxxxxxx, Xxxxxx
Xxxx, Xxxxxxxxxxxxxx XX0 0XX, Xxxxxxx (“CAT”), and Micromet AG, having its
principal offices at Xxxxxxxxxxxxxxxxx 0, 00000 Xxxxxx, Xxxxxxx (“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$[***].
5.2 Therapeutic Licensed Product Milestone Payments and Royalty Rates. The
milestone payments and royalty rates set forth in this Section 5.2 will apply to each Therapeutic
Licensed Product.
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5.2.1 Milestones. Micromet will pay to CAT the following non-refundable,
non-creditable milestone payments for each Therapeutic Licensed Product Exploited by Micromet, its
Affiliates or sublicensees:
Milestone Event | Milestone Payment | |
Acceptance of the filing of the first Marketing Approval
for such Therapeutic Licensed Product in the first Major
Market Country |
US$[***] | |
Receipt of first Marketing Approval for such Therapeutic
Licensed Product in the first Major Market Country |
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:
Milestone Event | Milestone Payment | |
Acceptance of the filing of the first Marketing Approval
for each such Diagnostic Licensed Product in the first
Major Market Country |
US$[***] | |
Receipt of first Marketing Approval for each such
Diagnostic Licensed Product in the first Major Market
Country |
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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12
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, Xxxxxxxxx, XX0 0XX, Xxxxxxx, 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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13
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 representative, upon reasonable request in
writing and no more than [***], access to Micromet’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 Micromet 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 Micromet 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, Micromet will make such additional
payments promptly after the accounting firm’s written report is delivered to both Parties. If,
based on the results of any audit, payments made by Micromet pursuant to Sections 5.2 or 5.3
exceeded payments indicated by the audit as being due thereunder, such excess will be credited
against future amounts owed by Micromet under Sections 5.2 or 5.3.
5.7 Confidentiality. CAT will treat all information provided to it pursuant to any
audit performed under Section 5.5 in accordance with the confidentiality provisions of Section 7
and will cause its accounting firm or other designated representative to enter into a reasonably
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14
acceptable confidentiality agreement with Micromet obligating such firm or representative to
maintain all such financial information in confidence pursuant to such confidentiality agreement.
5.8 Withholdings.
5.8.1 Micromet will be entitled (if required to do so) to deduct tax from the
payments it makes to CAT under this Section 5 above (“Withholding Tax”) provided that:
(a) Micromet will pay over such Withholding Tax to the relevant revenue authority
and will provide to CAT such documentary evidence as CAT may reasonably require regarding (i) the
amount so deducted, and (ii) evidence of payment to such authority; and
(b) Micromet will provide to CAT such assistance as CAT may reasonably require
(including submission of documents to relevant revenue authorities) to obtain a repayment of the
Withholding Tax or (as the case may be) to obtain the benefit of such Withholding Tax whether by
credit against taxes or otherwise.
5.8.2 If, pursuant to a relevant double taxation agreement, a Party has the right to
claim relief (whether in whole or in part) from any Withholding Tax, then:
(a) Micromet will co-operate with CAT in seeking a written direction from the
relevant revenue authorities to the effect that either: (i) no Withholding Tax should be operated
in respect of payments under this Agreement, or (ii) the rate of Withholding Tax will be such lower
rate as specified by the relevant revenue authority, and Micromet will comply with any such
direction given; and
(b) pending such written direction, Micromet will deduct Withholding Tax in
accordance with Section 5.8.1 above, but will, in addition to the sums otherwise payable under this
Agreement, pay to CAT such further sum as will ensure that, after operation of Withholding Tax on
all such sums, the net amount received by CAT equals the amount that CAT would have received had
the relevant revenue authority already issued the written direction described in Section
5.8.2(a)(i) above or, as the case may be, Section 5.8.2(a)(ii) above.
5.8.3 If, as a result of any change in corporate status or location of CAT, or
permitted assignment of this Agreement by CAT, Withholding Tax becomes due on payments from
Micromet to CAT or its permitted assignee and CAT is not able to claim a credit or reimbursement
for such tax, in whole or in part, then any amount of Withholding Tax deducted by Micromet on
amounts payable by Micromet to CAT hereunder will be treated as if the amount of Withholding Tax
was paid directly to CAT, to the extent that a credit or reimbursement could not be claimed by CAT.
5.8.4 If, as a result of any change in corporate status or location of Micromet, or
permitted assignment of this Agreement by Micromet, Withholding Tax becomes due on payments from
Micromet to CAT or its permitted assignee and CAT is not able to claim a credit or reimbursement
for such tax, in whole or in part, then Micromet will deduct Withholding Tax in accordance with
Section 5.8.1 above, but will, in addition to the sums otherwise payable under this Agreement, pay
to CAT such further sum as will ensure that, after operation of Withholding Tax on all such sums,
the net amount received by CAT equals the amount that CAT would have
15
received had the
non-creditable or non-deductible amount of such Withholding Tax not been deducted. To the extent
that any such amount deducted by Micromet in accordance with this Section 5.8.4 is in fact
subsequently able to be claimed by CAT as a credit or reimbursement for such tax otherwise
deducted, then CAT will pay to Micromet the corresponding amount of any such credit or
reimbursement for such tax otherwise eligible to be deducted by CAT.
6. Representation and Warranties; Covenants
6.1 Representations of CAT. CAT represents to Micromet that as of the Effective
Date: (a) it Controls the CAT Licensed Patents and the CAT Background Know-How licensed under this
Agreement (subject to the exclusions in the Excluded Field and Excluded Technology); (b) the CAT
Licensed Patents includes all Patents relating to Phage Display that both (i) are owned by CAT or
are licensed from the [***] to CAT, and (ii) would be infringed by Micromet’s performance of
activities in the Micromet Research Field or the Development, manufacture, importation, use or sale of
Antibody Products resulting from such activities; provided, however, that it will
not be a breach of the foregoing representation if CAT has in good faith inadvertently omitted a
Patent from Schedule I and is not otherwise in breach of its covenant under Section 6.3
regarding such Patent; (c) except as disclosed in Schedules I and VI, it has not
received any written communication that expressly threatens interference actions or oppositions to
any Patents within the CAT Licensed Patents or other litigation before any patent office, court, or
any other governmental entity in any jurisdiction in regard to the CAT Licensed Patents; (d) except
as disclosed in Schedules I and VI, it has not been served with any complaint
alleging infringement of a Third Party’s patents arising from the practice of the claims in the
Patents within the CAT Licensed Patents; and (e) Schedule VI includes a complete list of
all pending claims of Third Parties (other than oppositions) in regard to the entitlement, validity
or enforceability of the CAT Licensed Patents.
6.2 Reciprocal Representations and Warranties. Each Party represents and warrants to
the other Party that: (a) this Agreement is a legal and valid obligation binding upon its
execution and enforceable against it in accordance with its terms and conditions; and (b) the
execution, delivery and performance of this Agreement by such Party has been duly authorized by all
necessary corporate action, and the person executing this Agreement on behalf of such Party has
been duly authorized to do so by all requisite corporate actions.
6.3 Additional Covenants. CAT hereby covenants and agrees that (a) it will maintain
throughout the Term all agreements with Third Parties granting CAT rights in and to the CAT
Licensed Patents and CAT Background Know-How that are necessary to grant Micromet the licenses
granted in Section 2 of this Agreement (including, without limitation, the [***] Agreement) and (b)
it will promptly upon discovery of any omission amend Schedule I as of the Effective Date
to include any Patent omitted from Schedule I.
6.4 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS
AGREEMENT, EACH PARTY MAKES NO REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED,
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16
EITHER
IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND CAT AND MICROMET EACH SPECIFICALLY
DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF
ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
7. Confidentiality
7.1 Definition. During the Term and subject to the terms and conditions of this
Agreement, a Party (the “Disclosing Party”) may communicate to the other Party (the “Receiving
Party”) confidential information in connection with this Agreement or the performance of its
obligations hereunder, including, without limitation, any Dossier or update thereto, any Know-How,
any information regarding CAT Phage Display Improvements or Micromet Phage Display Improvements,
any reports provided pursuant to this Agreement, any scientific and manufacturing information and
plans, marketing and business plans, and financial and personnel matters relating to a Party or its
present or future products, sales, suppliers, customers, employees, investors or business
(collectively, “Confidential Information”).
7.2 Exclusions.
7.2.1 Notwithstanding the foregoing, information of a Disclosing Party will not be
deemed Confidential Information with respect to a Receiving Party for purposes of this Agreement if
such information:
(a) was already known to the Receiving Party or its Affiliates, other than under an
obligation of confidentiality or non-use, at the time of disclosure to the Receiving Party;
(b) was generally available or known to parties reasonably skilled in the field to
which such information or Know-How pertains, or was otherwise part of the public domain, at the
time of its disclosure to the Receiving Party;
(c) became generally available or known to parties reasonably skilled in the field
to which such information or Know-How pertains, or otherwise became part of the public domain,
after its disclosure to the Receiving Party through no fault of or breach of its obligations under
this Section 7 by the Receiving Party;
(d) was disclosed to the Receiving Party other than under an obligation of
confidentiality or non-use, by a party other than the Disclosing Party who had no obligation to the
Disclosing Party not to disclose such information or Know-How to others; or
(e) was independently discovered or developed by the Receiving Party or its
Affiliates, as evidenced by contemporaneous written records, without the use of or reference to,
and by personnel who had no knowledge of or access to, any Confidential Information of the
Disclosing Party.
17
7.2.2 Specific aspects or details of Confidential Information will not be deemed to
be within the public domain or in the possession of a person or entity merely because the
Confidential Information is embraced by more general information in the public domain or in the
possession of such person or entity. Further, any combination of Confidential Information will not
be considered in the public domain or in the possession of a person or entity merely because
individual elements of such Confidential Information are in the public domain or in the possession
of such person or entity unless the combination and its principles are in the public domain or in
the possession of such person or entity.
7.3 Disclosure and Use Restriction. Except as expressly provided herein, the
Parties agree that, during the Term and for [***] years thereafter (unless one or more of the
exceptions described in 7.2.1 apply), a Receiving Party and its Affiliates and sublicensees will
keep completely confidential and will not publish or otherwise disclose and will not use for any
purpose except for the purposes contemplated by this Agreement any Confidential Information of the
Disclosing Party, its Affiliates or sublicensees.
7.4 Authorized Disclosure. A Receiving Party may disclose Confidential Information
of the Disclosing Party to the extent that such disclosure is:
7.4.1 made in response to a valid order of a court of competent jurisdiction or
other governmental or regulatory body of competent jurisdiction; provided, however,
that the Receiving Party will first have given notice to the Disclosing Party and given the
Disclosing Party a reasonable opportunity to quash such order and to obtain a protective order
requiring that the Confidential Information and documents that are the subject of such order be
held in confidence by such court or governmental or regulatory body or, if disclosed, be used only for the purposes for which the
order was issued; and provided, further, that if a disclosure order is not quashed
or a protective order is not obtained, the Confidential Information disclosed in response to such
court or governmental order will be limited to that information which is legally required to be
disclosed in response to such court or governmental order;
7.4.2 otherwise required by law or mandatory regulation; provided,
however, that the Disclosing Party will provide the Receiving Party with notice of such
disclosure in advance thereof to the extent practicable;
7.4.3 made by the Receiving Party to the regulatory authorities as required in
connection with any application, filing, or similar requests for regulatory approvals;
provided, however, that reasonable measures will be taken to assure confidential
treatment of such information;
7.4.4 made by the Receiving Party, in connection with the performance of this
Agreement, to Affiliates, permitted sublicensees, employees, consultants, representatives or
agents, each of whom prior to disclosure must be bound by obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Section 7;
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7.4.5 made by the Receiving Party to existing or potential acquirers or merger
candidates, potential collaborators (to the extent contemplated hereunder), investment bankers,
existing or potential investors, venture capital firms or other financial institutions or investors
for purposes of obtaining financing, each of whom prior to disclosure must be bound by obligations
of confidentiality and non-use at least equivalent in scope to those set forth in this Section 7;
or
7.4.6 a disclosure of the terms of this Agreement and disclosed in accordance with
Section 7.6.
7.5 Use of Name. Neither Party will make public use of the other Party’s name
except (i) in connection with announcements and other permitted disclosures relating to this
Agreement and the activities contemplated hereby, (ii) as required by applicable law, and (iii)
otherwise as agreed in writing by such other Party.
7.6 Terms of Agreement to be Maintained in Confidence. Subject to the other
provisions of this Section 7 (including the exception for any public disclosures made in compliance
with the terms of this Section 7.6), the Parties agree that the terms of this Agreement are
confidential and will not be disclosed by either Party to any Third Party (except to a Party’s
professional advisor) without advance written permission of the other Party; provided,
however, that either Party may make any filings of this Agreement required by law or
regulation in any country so long as such Party uses its reasonable efforts to obtain confidential
treatment for portions of this Agreement as available, consults with the other Party, and permits
the other Party to participate, to the extent practicable, in seeking a protective order or other
confidential treatment; and provided, further, that either Party may disclose the
terms of this Agreement to a Third Party (and its professional advisors) when such disclosure is
reasonably necessary in connection with (i) the grant of a license or sublicense of the CAT
Licensed Patents to such Third Party, (ii) a merger, acquisition, placement, investment, or other
such transaction with such Third Party, or (iii) the sale of securities to or other financing from
such Third Party or a financing underwritten by such Third Party, in which case disclosure may be
made to any person or entity to whom such Third Party sells such securities (and its professional
advisors). Advance written permission for disclosure will not be required when a Party is ordered
to disclose information concerning the Agreement by a competent tribunal or such disclosures are
required by law, regulation, or stock exchange rules, except that such Party will make all
reasonable efforts to limit any disclosure as may be required in the course of legal
proceedings by entry of an appropriate protective and confidentiality order, and will provide
the other Party with as much advance notice of such circumstances as is practicable.
7.7 Press Release.
7.7.1 The Parties will make a joint press release regarding the execution of this
Agreement, the final form of which will be subject to approval of the Parties prior to its release
to the public. For subsequent press releases and other written public disclosures relating to this
Agreement or the Parties’ relationship hereunder (each, a “Proposed Disclosure”), each Party will
use reasonable efforts to submit to the other Party a draft of such Proposed Disclosure for
19
review
and comment by the other Party at least [***] prior to the date on which such Party plans to
release such Proposed Disclosure, and in any event will submit such drafts at least [***] prior to
the release of such Proposed Disclosure, and will review and consider in good faith any comments
provided in response.
7.7.2 If a Party is unable to comply with the foregoing [***] notice
requirement because of a legal obligation or stock exchange requirement to make more rapid
disclosure, such Party will not be in breach of this Agreement but will in that case give telephone
notice to a senior executive of the other Party and provide a draft disclosure with as much notice
as possible prior to the release of such Proposed Disclosure.
7.7.3 A Party may publicly disclose without regard to the preceding requirements of
this Section 7.7 information that was previously disclosed in a Proposed Disclosure that was in
compliance with such requirements.
8. Filing, Prosecution and Maintenance of Patent Rights
8.1 Prosecution and Maintenance. As between the Parties, CAT will be solely
responsible and bear all costs for the preparation, filing, prosecution and maintenance of the CAT
Licensed Patents in its discretion, subject to the terms and conditions of this Agreement.
8.2 Costs. As between the Parties, CAT will be solely responsible and bear all
costs for (and enjoy all recovery from) any actions concerning the CAT Licensed Patents, including
but not limited to reexaminations, oppositions, interferences, and infringement actions, all in its
sole and absolute discretion.
8.3 No Challenge. CAT will be permitted to terminate this Agreement if Micromet or
its Affiliates challenge, or intentionally direct or intentionally assist (other than under
compulsion of a legal process) a third party to challenge, the validity or enforceability of any of
the Patents within CAT Licensed Patents; provided, however, that the foregoing
termination right will not apply in the event that such challenge to a patent within the CAT
Licensed Patents is brought by Micromet or its Affiliates in response to a suit or proceeding on
such patent brought by CAT (or its Affiliates) against Micromet or its Affiliates. If a
sublicensee of Micromet or its Affiliates (or an Affiliate of such sublicensee) challenges the
validity or enforceability of or otherwise opposes any such Patent under which such sublicensee is
sublicensed, then Micromet upon notice by CAT will terminate such sublicense. Micromet and its
Affiliates will include provisions in all agreements that grant sublicense rights under the Patents
within CAT Licensed Patents that if the sublicensee or its Affiliates challenge the validity or
enforceability of or otherwise oppose any such Patents under which the sublicensee is sublicensed, Micromet may
terminate its sublicense agreement with such sublicensee.
8.4 Notice. CAT will notify Micromet of any successful challenge to the CAT
Licensed Patents by any Third Party and will, upon request by Micromet, provide Micromet with
reasonable documentation regarding any such challenge. Micromet will notify CAT of any
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infringement by a Third Party of any Patent in the CAT Licensed Patents of which Micromet becomes
aware and will provide CAT with the available evidence, if any, of such infringement.
8.5 Enforcement. As between the Parties, CAT will have the exclusive right and sole
discretion during the Term to stop infringement of the CAT Licensed Patents, including by bringing
suit or other proceeding against the infringer in its own name. Upon request by CAT, Micromet will
provide reasonable assistance to CAT as a party to the lawsuit or other proceeding, at CAT’s
expense; provided, however, that CAT will retain control of the prosecution of such
suit or proceeding. CAT will bear all its costs incurred in connection with such lawsuit or other
proceeding, and, consequently, will be entitled to collect and retain for its own account such
damages and profits as may be accrued as a result of such lawsuit or other proceeding.
8.6 Release. As of the Effective Date, each of CAT, and its Affiliates, assigns,
successors, and predecessors, and any directors and officers of the foregoing (each, a “CAT
Entity”), hereby releases and forever discharges Micromet, its Affiliates, assigns, successors, and
predecessors, and any directors and officers of the foregoing (each, a “Micromet Entity”), from any
and all actions, causes of action, claims or demands for damages, suits, debts, sums of money,
accounts, costs, expenses, compensation, consequential damages, covenants, interest, liens or any
other thing whatsoever, in law, equity or otherwise, whether now known or unknown or which have
ever existed, now exist or which may exist in the future (except to enforce the terms of this
Agreement), which any CAT Entity may have against any Micromet Entity arising out of, or relating
to, agreements, events or conduct related to any use by Micromet of the CAT Licensed Patents prior
to and including the Effective Date in relation to the EpCAM Target. For the avoidance of doubt
nothing in this Section 8.6 will prevent CAT from pursuing Micromet for any injunctive relief or
any loss, damage, claim or expense suffered or incurred by CAT as a result of any breach by
Micromet of the terms of this Agreement.
9. Improvements; Ownership
9.1 Phage Display Improvements.
9.1.1 Disclosure of Micromet Phage Display Improvements. Within [***] following
conception or discovery by or on behalf of Micromet, its Affiliates or sublicensees of any Micromet
Phage Display Improvements, Micromet will provide CAT with notice of such Micromet Phage Display
Improvements.
9.1.2 Ownership. As between the Parties, and subject to the licenses granted in
Section 9.1.3, Micromet will retain all right, title and interest in and to any and all Micromet
Phage Display Improvements. Micromet will ensure that to the extent permitted by law, any Third
Party, including Micromet’s sublicensees, performing work related to Phage Display is under an
obligation: (a) to assign all inventions, Patents, and Know-How relating to any Micromet Phage
Display Improvements to Micromet, or where this obligation is not permitted, (b) to exclusively
license all such inventions, Patents, and Know-How to Micromet, with the
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21
right to sublicense, or where neither of the
obligations described in the preceding clause (a) or (b) is permitted then, (c) to non-exclusively
license all such inventions, Patents, and Know-How to Micromet, with the right to sublicense.
9.1.3 License to CAT. Subject to the terms and conditions of this Agreement,
Micromet hereby grants to CAT a perpetual, irrevocable, non-exclusive, worldwide, royalty-free,
fully paid license, with the right to grant and authorize the grant of sublicenses (in accordance
with the terms of Section 2.1 relating to sublicenses by Licensee, mutatis mutandis), under the
Micromet Phage Display Improvements and any intellectual property rights therein to use and
practice any Micromet Phage Display Improvements for the purpose of identifying, producing,
developing, making, importing and selling products (other than BiTE Products) containing or
comprising one or more Antibodies or for any other purpose. CAT hereby covenants and agrees not to
use or sublicense any of its rights under the foregoing license except as expressly permitted in
this Agreement. The license set forth in this Section 9.1.3 will survive expiration or termination
of this Agreement, except if this Agreement (or, after expiration or termination of this Agreement,
this Section 9.1.3) is terminated by Micromet for breach of the foregoing covenant by CAT, in which
case such license will terminate immediately and entirely.
9.2 CAT Phage Display Improvements. Within [***] following conception or discovery
by or on behalf of CAT or its Affiliates of any CAT Phage Display Improvements, CAT will promptly
provide Micromet with written notice of such CAT Phage Display Improvements (to the extent that
such disclosure would not violate CAT’s non-disclosure obligations to one or more Third Parties).
If Micromet elects to include any Patents claiming or covering one or more of such CAT Phage
Display Improvements, then Micromet will provide CAT with written notice of such election and, upon
receipt by CAT of such notice, any such Patents will be deemed CAT Licensed Patents hereunder.
Subject to the licenses granted in Section 2, CAT will retain all right, title and interest in and
to any and all CAT Phage Display Improvements.
9.3 Further Assurances. Each Party agrees to take all necessary and proper acts,
and will cause its employees, Affiliates, contractors, sublicensees, and consultants to take such
necessary and proper acts, to effectuate the ownership provisions set forth in this Section 9.
10. Term and Termination
10.1 Term. This Agreement is effective as of the Effective Date and will expire
upon the last date upon which the royalties payable by Micromet to CAT under Section 5.2.2 or 5.3.2
expire unless terminated earlier as expressly provided otherwise in this Agreement (the “Term”).
10.2 Termination for Material Breach.
10.2.1 Any material breach or failure by a Party to comply with any of its
obligations contained herein (including, without limitation any such breach or failure during an
Insolvency Event) will entitle the Party not in default to give to the Party in default written
notice
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22
specifying the nature of the default, requiring the defaulting Party to make good or
otherwise cure such default. The Parties agree and acknowledge that in no event will a material
breach or failure of any of Micromet’s obligations with regard to the research license granted in
Section 2.1 be deemed to be a material breach of any obligation with regard to any Licensed Product
nor otherwise permit termination by CAT of this Agreement, including without limitation, the license rights granted by Section 2.2 with respect to any
Licensed Product.
10.2.2 Subject to Section 10.2.3 below if, after a Party’s receipt of notice
pursuant to Section 10.2.1 above, such default is not cured within [***] days (or, if such default
cannot be cured within such [***]-day period, if the Party in default does not commence actions to
cure such default within such [***]-day period and thereafter diligently continue such actions and
cure such default within [***] days after the receipt of such notice, except in the case of a
payment default, as to which the defaulting Party will have only a [***]-day cure period), then the
Party not in default will be entitled, on written notice to the other Party and without prejudice
to any other rights conferred on it by this Agreement or available to it or them by law or in
equity, to terminate this Agreement immediately.
10.2.3 If a Party receiving a notice pursuant to Section 10.2.1 above, is also at
the time of receiving such notice subject to an Insolvency Event and such default is not cured
within [***] days (except in the case of payment default, as to which the defaulting party will
only have a [***] day cure period), then the Party not in default will be entitled, on written
notice to the other Party and without prejudice to any other rights conferred by this Agreement or
available to it or them by law or in equity, to terminate this Agreement immediately.
10.3 Amendment or Termination of [***] Agreement.
10.3.1 Upon any amendment of the [***] Agreement that materially reduces the
obligation of CAT to pay royalties to [***] in connection with a sale of “Products” (as defined
therein) by CAT or its sublicensee (without a corresponding material payment by CAT of cash or
in-kind consideration therefor), then CAT will promptly notify Micromet of such amendment and the
Parties will in good faith promptly amend the applicable provisions of this Agreement in order to
provide to Micromet, as best as practicable, the economic benefits (or reduction of obligations)
resulting from such amendment to the [***] Agreement.
10.3.2 Upon termination of the [***] Agreement, and upon request by Micromet, CAT
will use commercially reasonable efforts to obtain a direct license for Micromet from [***], its
successors or assigns to any CAT Licensed Patents licensed to CAT under such agreement upon the
terms set forth herein (including, without limitation, pursuant to Section [***] of the [***]
Agreement); provided, however, that CAT will have no such obligation if Micromet’s
acts or omissions under this Agreement caused such termination of the [***] Agreement.
10.4 Additional Termination Right Regarding the Research License. Subject to the
terms of this Section 10.4, at any time during the Term, CAT will be entitled to terminate the
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23
license to Micromet under Section 2.1 solely in the event that (i) Micromet has ceased all research
and development activities in respect of the EpCAM Target Program for a continuous period of at
least [***] and (ii) Micromet has not [***]. CAT will provide to Micromet written notice at least
[***] in advance of any such proposed termination. If there is any dispute regarding whether the
terms and conditions of this Section 10.4 are satisfied, then CAT will not be entitled to terminate
the license grant under Section 2.1 pending final resolution of such dispute in accordance with
Section 13.3 of this Agreement.
10.5 Consequences of Expiration and Termination.
10.5.1 Material Breach. Upon termination of this Agreement by a Party pursuant to
Section 10.2, (i) all licenses granted by the terminating Party to the defaulting Party will
terminate (except as provided in Section 9.1.3 and Section 10.5.2); (ii) the licenses granted by
the defaulting Party will survive (subject to continued performance by the terminating Party of its
royalty obligations, if any); and (iii) the milestone and royalty obligations set forth in Section
5 with respect to the surviving licenses will continue.
10.5.2 Survival of Certain Sublicenses. Sublicenses granted by a defaulting Party
to a Third Party will survive termination of the defaulting Party’s license under Section
10.5.1(i); provided, however, that (x) such Third Party is not the cause of the
default, (y) such Third Party is not in breach of, and continues to fully perform all obligations
under its sublicense agreement and any surviving provisions in this Agreement applicable to such
sublicensee, and (z) the terminating Party continues to receive from such Third Party all royalty
and milestone payments set forth in Section 5.
10.5.3 Effect of Termination of Research License. Notwithstanding anything herein
to the contrary, termination by CAT of Micromet’s rights under Section 2.1 (as a result of
Micromet’s material breach of that Section or pursuant to Section 10.4 above) will, provided that
Micromet is complying with its other obligations under this Agreement, in no way terminate
Micromet’s rights under Section 2.2 with regard to any Licensed Product or relieve the Parties of
any other obligation under this Agreement.
10.5.4 Return of Confidential Information. Upon any expiration or termination of
this Agreement, each Party will, at the other Party’s option, promptly return or destroy any of
such other Party’s Confidential Information (including all Know-How) in its possession or control;
provided, however, that each Party may retain: (a) a single archival copy of the
Confidential Information of the other Party solely for the availing itself of the rights accorded
to it, or to perform its obligations, under the surviving provisions of this Agreement (including,
without limitation any and all license or sublicense rights expressly made to survive termination
or expiration hereof); and (b) any portion of the Confidential Information of the other Party which
a Party is required by applicable law to retain.
10.6 Survival. Expiration or termination of this Agreement for any reason will not
relieve the Parties of any obligation accruing prior to such expiration or termination, including
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24
without limitation Micromet’s obligation to pay royalties under Section 5 above on the sale of
Licensed Products prior to the effective date of such expiration or termination. The provisions of
Sections 3.1.3, 5 (solely as to accrued and unpaid amounts and Sections 5.5 and 5.7), 6.4, 7, 8.6,
9.1.3, 10.5, 10.6, 11, 12 and 13, together with any definitions used or schedules referenced
therein, will survive termination or expiration of this Agreement.
11. Indemnification and Insurance
11.1 Indemnification By Micromet. Micromet will indemnify CAT, its Affiliates, and
their respective directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all losses, damages, liabilities, costs and expenses (including
reasonable attorneys’ fees and expenses)(collectively, “Losses”) in connection with any and all
liability suits, investigations, claims or demands by Third Parties (each, a “Third Party Claim”)
to the extent arising out of: (a) any theory of product liability (including, but not limited to,
actions in the form of tort, warranty or strict liability) concerning a Licensed Product that is
Exploited by Micromet or its Affiliates pursuant to any right or license granted under this
Agreement, or (b) any failure by any sublicensee of
Micromet to comply with the obligations of Sections 2.4, 5.5, 5.7, 7, 8 and 9 of this
Agreement imposed on such sublicensee pursuant to Sections 2.1 and 2.2 of this Agreement, as
applicable; in each case, except to the extent that such Losses arise out of or result from (i) the
gross negligence or reckless misconduct of a party seeking indemnification hereunder, or (ii) a
material breach by a party seeking indemnification hereunder of any provision of this Agreement.
11.2 Indemnification Procedure.
11.2.1 Notice of Claim. All indemnification claims in respect of a Party, its
Affiliates or their respective directors, officers, employees and agents (collectively, the
“Indemnitees” and each an “Indemnitee”) will be made solely by such Party to this Agreement (the
“Indemnified Party”). The Indemnified Party will give the indemnifying Party (the “Indemnifying
Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or discovery of
fact upon which such Indemnified Party intends to base a request for indemnification under this
Section 11, but in no event will the Indemnifying Party be liable for any Losses that result from
any delay in providing such notice. Each Indemnification Claim Notice must contain a description
of the claim and the nature and amount of such Loss (to the extent that the nature and amount of
such Loss are known at such time). The Indemnified Party will furnish promptly to the Indemnifying
Party copies of all papers and official documents received in respect of any Losses.
11.2.2 Prosecution of Claims. The obligations of an Indemnifying Party under this
Section 11 will be governed by and be contingent upon the following additional terms and
conditions:
(a) Control of Defense.
(i) At its option, the Indemnifying Party may assume the defense of any Third Party
Claim by giving written notice to the Indemnified Party within thirty (30) days after the
Indemnifying Party’s receipt of an Indemnification Claim Notice.
25
(ii) Upon assuming the defense of a Third Party Claim, the Indemnifying Party may
appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the
Indemnifying Party. In the event the Indemnifying Party assumes the defense of a Third Party
Claim, the Indemnified Party will immediately deliver to the Indemnifying Party all original
notices and documents (including court papers) received by any Indemnitee in connection with the
Third Party Claim. Should the Indemnifying Party assume the defense of a Third Party Claim, the
Indemnifying Party will not be liable to the Indemnified Party or any other Indemnitee for any
legal expenses subsequently incurred by such Indemnified Party or other Indemnitee in connection
with the analysis, defense or settlement of the Third Party Claim.
(b) Right to Participate in Defense. Without limiting Section 11.2.2(a), any
Indemnitee will be entitled to participate in, but not control, the defense of such Third Party
Claim and to employ counsel of its choice for such purpose; provided, however, that
such employment will be at the Indemnitee’s own expense unless (i) the employment thereof has been
specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party has
failed to assume the defense and employ counsel in accordance with Section 11.2.2(a) (in which case
the Indemnified Party will control the defense).
(c) Settlement. With respect to any Losses relating solely to the payment of money
damages in connection with a Third Party Claim and that will not result in the Indemnitee’s
becoming subject to injunctive or other relief or otherwise adversely affect the business of the
Indemnitee in any manner, and as to which the Indemnifying Party will have acknowledged in writing
the obligation
to indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole right to
consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss,
on such terms as the Indemnifying Party, in its sole discretion, will deem appropriate, and will
transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay
prior to the time prior to the entry of judgment. With respect to all other Losses in connection
with Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party
Claim in accordance with Section 11.2.2(a), the Indemnifying Party will have authority to consent
to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss provided
it obtains the prior written consent of the Indemnified Party (which consent will be at the
Indemnified Party’s sole and absolute discretion). The Indemnifying Party will not be liable for
any settlement or other disposition of a Loss by an Indemnitee that is reached without the written
consent of the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend
or prosecute any Third Party Claim, no Indemnitee will admit any liability with respect to, or
settle, compromise or discharge, any Third Party Claim without the prior written consent of the
Indemnifying Party.
(d) Cooperation. Regardless of whether the Indemnifying Party chooses to defend or
prosecute any Third Party Claim, the Indemnified Party will, and will cause each other Indemnitee
to, cooperate in the defense or prosecution thereof and will furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings,
trials and appeals as may be reasonably requested in connection therewith. Such cooperation will
include access during normal business hours afforded to the Indemnifying Party to, and reasonable
retention by the Indemnified Party of, records and information that are reasonably relevant to such
Third Party Claim, and making Indemnitees and
26
other employees and agents available on a mutually
convenient basis to provide additional information and explanation of any material provided
hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection therewith.
11.3 Expenses. Except as provided above, the reasonable and verifiable costs and
expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in
connection with any claim will be reimbursed on a calendar quarter basis by the Indemnifying Party,
without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.
11.4 Insurance. During the Term, each Party will have and maintain such types and
amounts of liability insurance as is normal and customary in the industry generally for parties
similarly situated, and will upon request provide the other Party with a copy of its policies of
insurance in that regard, along with any amendments and revisions thereto.
12. Limitation of Liability
12.1 NOTHING IN THIS AGREEEMNT WILL RESTRICT OR LIMIT EITHER PARTY’S LIABILITY FOR
DEATH OR PERSONAL INJURY CAUSED BY SUCH PARTY’S NEGLIGENCE OR WILLFUL MISCONDUCT.
12.2 SUBJECT TO SECTION 12.1 ABOVE, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE
OTHER PARTY FOR LOST PROFITS, LOSS OF DATA, OR FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL
OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS
BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN
ANY WAY OUT OF THIS AGREEMENT. THE FOREGOING
LIMITATIONS WILL NOT APPLY TO DAMAGES ARISING FROM A BREACH OF SECTION 7 ABOVE OR AN AWARD OF
ENHANCED DAMAGES AVAILABLE UNDER THE PATENT LAWS FOR WILLFUL PATENT INFRINGEMENT, AND WILL NOT
LIMIT EITHER PARTY’S INDEMNITY OBLIGATIONS TO THE OTHER PARTY UNDER THIS AGREEMENT.
13. Miscellaneous
13.1 Assignment. Without the prior written consent of the other Party (which such
consent may be granted, withheld or conditioned at the other Party’s sole and absolute discretion),
neither Party will sell, transfer, assign, delegate, pledge or otherwise dispose of, whether
voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights
or duties hereunder; provided, however, that either Party may assign or transfer
this Agreement or any of its rights or obligations hereunder without the consent of the other
Party:
(a) to any Affiliate of such Party; provided, further, that
(i) such Affiliate may not otherwise sell, transfer, assign, delegate, pledge or
otherwise dispose of, whether voluntarily, involuntarily, by operation of law
27
or otherwise (except
pursuant to any merger, consolidation or asset sale subject to Section 13.1(b) below), this
Agreement or any of its rights or duties hereunder without the prior written consent of the other
Party and such consent may be granted, withheld or conditioned at the other Party’s sole and
absolute discretion; and
(ii) that if any such Affiliate is subsequently sold by or otherwise ceases to be an
Affiliate of the relevant Party (except pursuant to any merger, consolidation or asset sale subject
to Section 13.1(b) below) this Agreement must be assigned back to the relevant Party before such
sale or other event becomes effective; or
(b) to any Third Party with which it merges or consolidates, or to which it
transfers all or substantially all of its assets to which this Agreement relates.
In each case described in this Section 13.1 the relevant Affiliate assignee, Third Party assignee
or surviving entity will assume in writing all of the assigning Party’s obligations under this
Agreement and the assigning Party will promptly provide notice to the other Party of such
assignment. The assigning Party (except if it is not the surviving entity) will remain jointly and
severally liable under this Agreement with the relevant Affiliate assignee. Any purported
assignment or transfer in violation of this Section will be void ab initio and of no force or
effect.
13.2 Severability. If any provision of this Agreement is held to be illegal,
invalid or unenforceable under any present or future law, then (a) such provision will be fully
severable, (b) this Agreement will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this
Agreement will remain in full force and effect and will not be affected by the illegal, invalid or
unenforceable provision or by its severance from this Agreement, and (d) the Parties will use good
faith efforts to promptly replace such illegal, invalid or unenforceable provision with a valid and
enforceable provision having similar terms such that the objectives contemplated by the Parties
when entering this Agreement may be realized. To the fullest extent permitted by applicable law,
each Party hereby waives any provision of law that would render any provision prohibited or
unenforceable in any respect.
13.3 Governing Law; Dispute Resolution.
13.3.1 This Agreement, all disputes between the Parties related to or arising out of
this Agreement, the Parties’ relationship created hereby, and/or the negotiations for and entry
into this Agreement, including any dispute concerning its conclusion, binding effect, amendment,
coverage, or termination, will be governed by the laws of England and Wales without reference to
any choice of law principles that would cause the application of the laws of a different
jurisdiction, and will (subject to Section 13.3.2 below) be subject to the non-exclusive
jurisdiction of the courts of competent jurisdiction located in England and Germany.
13.3.2 The Parties will try to settle their differences amicably between themselves.
In the event of any controversy or claim arising out of or relating to any provision of this
Agreement or the performance or alleged non-performance of a Party of its obligations under this
Agreement (“Dispute”), a Party may notify the other Party in writing of such Dispute.
28
If the
Parties are unable to resolve the Dispute within [***] of receipt of the written notice by the
other Party, such dispute will be referred to [***] who will use their good faith efforts to
resolve the Dispute within [***] after it was referred to [***]. If [***] fail to resolve the
Dispute, each Party may pursue its rights and remedies as described in Section 13.3.1 above.
Notwithstanding the foregoing, no Dispute relating to Section 7 will be subject to this Section
13.3.2. In addition, nothing in this Section 13.3.2 will limit either Party’s right to seek
immediate injunctive or other equitable relief whenever the facts or circumstances would permit a
Party to seek such relief in a court of competent jurisdiction.
13.4 Notices. All notices or other communications that are required or permitted
hereunder will be in writing and delivered personally, sent by facsimile (and promptly confirmed by
personal delivery or overnight courier as provided herein), or sent by internationally-recognized
overnight courier addressed as follows:
If to CAT, to:
Cambridge Antibody Technology Ltd
Xxxxxxxx Xxxxxxxx, Xxxxxx Xxxx
Xxxxxxxxxxxxxx XX0 0XX
Xxxxxxx
Attention: the Company Secretary
Facsimile: x00 (0)0000 000000
Xxxxxxxx Xxxxxxxx, Xxxxxx Xxxx
Xxxxxxxxxxxxxx XX0 0XX
Xxxxxxx
Attention: the Company Secretary
Facsimile: x00 (0)0000 000000
If to Micromet, to:
Micromet AG
Xxxxxxxxxxxxxxxxx 0
X-00000Xxxxxx, Xxxxxxx
Attention: Chief Business Officer
Facsimile: x00 00 000-000-000
Xxxxxxxxxxxxxxxxx 0
X-00000Xxxxxx, Xxxxxxx
Attention: Chief Business Officer
Facsimile: x00 00 000-000-000
with a copy to:
Xxxxxx Godward LLP
One Freedom Square
Reston Town Center
00000 Xxxxxxx Xxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxx Xxxxx, Esq.
Facsimile: x0 (000) 000-0000
One Freedom Square
Reston Town Center
00000 Xxxxxxx Xxxxx
Xxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxx Xxxxx, Esq.
Facsimile: x0 (000) 000-0000
or to such other address as the Party to whom notice is to be given may have furnished to the other
Party in writing in accordance herewith. Any such communication will be deemed to have been given
(i) when delivered, if personally delivered or sent by facsimile on a Business Day,
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
29
and (ii) on the
second Business Day after dispatch, if sent by internationally-recognized overnight courier. It is
understood and agreed that this Section 13.4 is not intended to govern the day-to-day business
communications necessary between the Parties in performing their duties, in due course, under the
terms of this Agreement.
13.5 Entire Agreement; Modifications. This Agreement, together with any schedules
attached hereto (each of which is hereby incorporated herein by reference), sets forth and
constitutes the entire agreement and understanding between the Parties with respect to the subject
matter hereof and all prior agreements, understanding, promises and representations, whether
written or oral, with respect thereto are hereby superceded and of no further force and effect.
Each Party confirms that it is not relying on any representations or warranties of the other Party
except as specifically set forth herein. For the avoidance of doubt, nothing in this Agreement is
intended to or shall be construed to provide that (a) a representation, covenant or obligation
under this Agreement shall be a representation, covenant or obligation under any other agreement or
instrument executed by the Parties, except as expressly provided otherwise herein, or (b) a default
under this Agreement shall constitute a default under any other agreement or instrument executed by
the Parties, except as expressly provided otherwise herein. No amendment or modification of this
Agreement will be binding upon the Parties unless made in writing and duly executed by authorized
representatives of both Parties.
13.6 Relationship of the Parties. It is expressly agreed that the Parties’
relationship under this Agreement is strictly one of licensor-licensee, and that this Agreement
does not create or constitute a partnership, joint venture, or agency. Neither Party will have the
authority to make any statements, representations or commitments of any kind, or to take any
action, which will be binding (or purport to be binding) on the other. All persons employed by a
Party will be employees of such Party and not of the other Party and all costs and obligations
incurred by reason of any such employment will be for the account and expense of such Party.
13.7 Waiver. Any term or condition of this Agreement may be waived at any time by
the Party that is entitled to the benefit thereof, but no such waiver will be effective unless set
forth in a written instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party of any right hereunder or of claims based on the failure to
perform or a breach by the other Party will not be deemed a waiver of any other right hereunder or
of any other breach or failure by said other Party whether of a similar nature or otherwise.
13.8 Counterparts. This Agreement may be executed in two (2) or more counterparts,
each of which will be deemed an original, but all of which together will constitute one and the
same instrument.
13.9 No Benefit to Third Parties. The representations, warranties, covenants and
agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their
successors and permitted assigns, and they will not be construed as conferring any rights on any
other parties.
13.10 Further Assurance. Each Party will duly execute and deliver, or cause to be
duly executed and delivered, such further instruments and do and cause to be done such further acts
and things, including the filing of such assignments, agreements, documents and
30
instruments, as may
be necessary or
as the other Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes, or to better assure and confirm unto such other Party
its rights and remedies under this Agreement.
13.11 English Language. This Agreement has been written and executed in the English
language. Any translation into any other language will not be an official version thereof, and in
the event of any conflict in interpretation between the English version and such translation, the
English version will control.
13.12 Force Majeure. Neither Party will be deemed to be in breach of this Agreement
as a result of default, delay or failure to perform by such Party that results from any cause
beyond the reasonable control of such Party that could not reasonably be foreseen by such Party,
including without limitation, fire, earthquake, acts of God, acts of war, strikes, lockouts, or
other labor disputes, riots, civil disturbances, actions or inactions of governmental authorities
(except actions in response to a breach of applicable laws by such Party), or epidemics. This
Section 13.12 will not operate to excuse payment by a Party of any amounts due to any other Party
under this Agreement. In the event of any such force majeure, the Party affected will promptly
notify the other Party, will use commercially reasonable efforts to overcome such force majeure,
and will keep the other Party informed with respect thereto. If the event of force majeure
continues for a period greater than one hundred and eighty (180) days, then the unaffected Party
may terminate this Agreement immediately by notice in writing to the affected Party.
13.13 Construction. Except where the context otherwise requires, wherever used, the
singular will include the plural, the plural the singular, the use of any gender will be applicable
to all genders and the word “or” is used in the inclusive sense (and/or). The captions of this
Agreement are for convenience of reference only and in no way define, describe, extend or limit the
scope or intent of this Agreement or the intent of any provision contained in this Agreement. The
term “including” as used herein means including, without limiting the generality of any description
preceding such term. No rule of strict construction will be applied against either Party.
[Remainder of this page is left blank intentionally. Signature page follows.]
31
In Witness Whereof, the Parties have executed this Agreement by their respective
authorized representatives as of the date first written above.
Cambridge Antibody Technology Limited | ||||||
By: | /s/ Xxxxx Xxxxxxx | |||||
Name: | Xxxxx Xxxxxxx | |||||
Title: | General Counsel | |||||
Micromet AG | ||||||
By: | /s/ Xxxxxxxxx Xxxx | |||||
Xxxxxxxxx Xxxx, Ph.D | ||||||
Chief Business Officer | ||||||
By: | /s/ Xxxxxx X. Xxxxx | |||||
Name: Title: |
Xxxxxx X. Xxxxx
|
[Signature Page to the MT-201 Non-Exclusive Product License Agreement]
Schedule I
CAT Licensed Patents
[***] | [***] | [***] | [***] | |||||||||
PUBLISHED PCT |
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
US |
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
EUROPE |
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
AUSTRALIA |
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
JAPAN |
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
CANADA |
[***] | [***] | [***] | [***] | [***] | [***] | ||||||
SOUTH KOREA |
[***] | [***] | [***] | [***] | [***] | [***] |
* | Patents in opposition proceedings. | |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Schedule II
CAT Background Know-How
[***]:[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Schedule III
EpCAM Target
The EpCAM Target sequences are:
[***]
EpCAM nucleotide sequence
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Schedule IV
Excluded Field
“Excluded Field” means:
the discovery, isolation, characterization, research, development, and/or commercialization of an
Antibody useful for the diagnosis, treatment and/or prevention of one or more of the following
disease conditions wherein the primary scientific rationale or activity is [***]:
i. | [***]); | ||
ii. | [***]; | ||
iii. | [***], | ||
iv. | [***]; | ||
v. | [***]; and/or | ||
vi. | [***], |
provided, however, that for the purpose of this Agreement the term “Excluded Field”
will not include the diagnosis, treatment and/or prevention of the above disease conditions caused
by [***].
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Schedule V
Excluded Technologies
“Excluded Technology” means:
1. | “[***],” meaning the technology claimed in the following [***] to which CAT has sole right, title and interest: [***]” |
2. | “[***],” meaning the technology claimed in the following Patents to which CAT has sole right, title and interest: [***]; |
3. | “[***],” meaning solely Antibodies which [***] and in which [***]; |
4. | “Research Products,” meaning those certain research products for which CAT has granted certain exclusive rights to a Third Party under the [***] License Agreement, as may then be in effect. |
5. | “[***],” meaning any Antibody [***] for the purpose of simultaneously detecting and/or measuring Antigens whereby such product: |
(a) | Contains or comprises: |
(i) | an [***] of [***] Antibodies of different [***] [***] (excluding Antibodies serving a purpose as controls), or | ||
(ii) | an [***] of [***] Antibodies of the same [***] [***], provided that such Antibody is used to [***] [***] [***] data points for the purpose of [***] (excluding Antibodies serving a purpose as controls), and |
(b) | contains or comprises an array of Antibodies [***], and | ||
(c) | is in a format where the [***], and | ||
(d) | employs any type of [***], and | ||
(e) | may be used [***] or [***] (as appropriate), and | ||
(f) | is not, by way of example, (i) any type of [***] technology; (ii) any type of [***] technology; (iii) any type of [***] assay. |
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Schedule VI
CAT Third Party Claims
[***]
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Table of Contents
Page | ||||||||
1. | DEFINITIONS | 1 | ||||||
2. | GRANT OF LICENSES | 7 | ||||||
2.1 | Research License | 7 | ||||||
2.2 | Commercialization License | 8 | ||||||
2.3 | Reservation of Rights | 8 | ||||||
2.4 | Excluded Technology | 8 | ||||||
2.5 | Know-How Transfer | 9 | ||||||
3. | IDENTIFICATION OF LICENSED PRODUCTS AND REPORTING | 9 | ||||||
3.1 | Identification of Licensed Products | 9 | ||||||
3.2 | Abandonment of a Licensed Product | 9 | ||||||
3.3 | Dossier Updates | 9 | ||||||
4. | GATEKEEPING AND THE EXCLUDED FIELD | 10 | ||||||
4.1 | EpCAM Target | 10 | ||||||
4.2 | Micromet Representations | 10 | ||||||
4.3 | Limitation | 10 | ||||||
5. | PAYMENTS | 10 | ||||||
5.1 | Initial License Fee | 10 | ||||||
5.2 | Therapeutic Licensed Product Milestone Payments and Royalty Rates | 10 | ||||||
5.3 | Diagnostic Licensed Product Milestone Payments and Royalty Rates | 11 | ||||||
5.4 | Payment | 12 | ||||||
5.5 | Records; Audits | 14 | ||||||
5.6 | Payment of Additional Amounts | 14 | ||||||
5.7 | Confidentiality | 14 | ||||||
5.8 | Withholdings | 14 | ||||||
6. | REPRESENTATION AND WARRANTIES; COVENANTS | 15 | ||||||
6.1 | Representations of CAT | 16 | ||||||
6.2 | Reciprocal Representations and Warranties | 16 | ||||||
6.3 | Additional Covenants | 16 | ||||||
6.4 | DISCLAIMER OF WARRANTY | 16 | ||||||
7. | CONFIDENTIALITY | 16 |
-i-
Table of Contents
(continued)
(continued)
Page | ||||||||
7.1 | Definition | 16 | ||||||
7.2 | Exclusions | 17 | ||||||
7.3 | Disclosure and Use Restriction | 17 | ||||||
7.4 | Authorized Disclosure | 18 | ||||||
7.5 | Use of Name | 18 | ||||||
7.6 | Terms of Agreement to be Maintained in Confidence | 18 | ||||||
7.7 | Press Release | 19 | ||||||
8. | FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS | 19 | ||||||
8.1 | Prosecution and Maintenance | 20 | ||||||
8.2 | Costs | 20 | ||||||
8.3 | No Challenge | 20 | ||||||
8.4 | Notice | 20 | ||||||
8.5 | Enforcement | 20 | ||||||
8.6 | Release | 20 | ||||||
9. | IMPROVEMENTS; OWNERSHIP | 21 | ||||||
9.1 | Phage Display Improvements | 21 | ||||||
9.2 | CAT Phage Display Improvements | 21 | ||||||
9.3 | Further Assurances | 22 | ||||||
10. | TERM AND TERMINATION | 22 | ||||||
10.1 | Term | 22 | ||||||
10.2 | Termination for Material Breach | 22 | ||||||
10.3 | Amendment or Termination of [***] Agreement | 23 | ||||||
10.4 | Additional Termination Right Regarding the Research License | 23 | ||||||
10.5 | Consequences of Expiration and Xxxxxxxxxxx | 00 | ||||||
00.0 | Xxxxxxxx | 00 | ||||||
00. | INDEMNIFICATION AND INSURANCE | 24 | ||||||
11.1 | Indemnification By Micromet | 24 | ||||||
11.2 | Indemnification Procedure | 24 | ||||||
11.3 | Expenses | 26 | ||||||
11.4 | Insurance | 26 |
-ii-
[***] | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
Table of Contents
(continued)
(continued)
Page | ||||||||
12. | LIMITATION OF LIABILITY | 26 | ||||||
13. | MISCELLANEOUS | 27 | ||||||
13.1 | Assignment | 27 | ||||||
13.2 | Severability | 27 | ||||||
13.3 | Governing Law; Dispute Resolution | 28 | ||||||
13.4 | Notices | 28 | ||||||
13.5 | Entire Agreement; Modifications | 29 | ||||||
13.6 | Relationship of the Parties | 29 | ||||||
13.7 | Waiver | 29 | ||||||
13.8 | Counterparts | 30 | ||||||
13.9 | No Benefit to Third Parties | 30 | ||||||
13.10 | Further Assurance | 30 | ||||||
13.11 | English Language | 30 | ||||||
13.12 | Force Majeure | 30 | ||||||
13.13 | Construction | 30 |
-iii-
Exhibit 10.37
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
This Amendment (the “Amendment”) is made as of this 17th day of March, 2005 by and
between Micromet AG, located at Xxxxxxxxxxxxxxxxx 0, X-00000, Xxxxxx, Xxxxxxx (“Micromet”)
and Cambridge Antibody Technology Limited, located at The Xxxxxxxx Building, Granta Park,
Cambridgeshire CB 1 6GH, England (“CAT”) (each of Micromet, and CAT, a “Party” and, collectively,
the “Parties”).
Recitals
A. The Parties have entered into that certain Non-Exclusive Product License Agreement, dated
as of September 3, 2003 (the “Agreement”), pursuant to which the Parties have granted certain
intellectual property licenses for the MT201 Product and other products in respect of the EpCAM
target and for the purposes described therein. Capitalized terms used herein without definition
shall have the meanings given to such terms in the Agreement.
B. The Parties desire to amend the Agreement to delete the Excluded Field.
Agreement
Now, Therefore, for and in consideration of the mutual promises and covenants set
forth herein and for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties hereby agree as follows:
1. Expiration of Excluded Field. The Parties acknowledge and agree that, effective as of 22
February, 2004, CAT has ceased to be bound by the Excluded Field restriction pursuant to its
agreement with [***] dated [***] and, consequently, pursuant to the terms of Section 2.4
of the Agreement, any restrictions set forth in the Agreement relating to the Excluded Field have
ceased to apply as of 22 February 2004.
2. Counterparts. This Amendment may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument.
3. Effectiveness. This Amendment shall become effective upon the execution hereof by both
Parties.
4. Continuing Effect. Other than as set forth in this Amendment, all of the terms and
conditions of the Agreement shall continue in full force and effect.
*** | Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. |
1.
In Witness Whereof, the parties have executed this Amendment to the Non-Exclusive
Product License Agreement as of the date first written above.
Micromet AG | Cambridge Antibody Technology Limited | |||||||||||
By:
|
/s/ Xxxxxxxxx Xxxx
|
By: | /s/ Xxxxxxxx Xxxxxx
|
|||||||||
Name:
|
Xxxxxxxxx Xxxx
|
Name: | Xxxxxxxx Xxxxxx
|
|||||||||
Title:
|
CEO
|
Title: | Assistant General Counsel
|
|||||||||
2.