COMPOUND TRANSFER AND DEVELOPMENT AGREEMENT
Exhibit
10.85a
Certain
confidential information contained in this document, marked by brackets and the
word “Redacted” ([REDACTED]), has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 promulgated under the
Securities Exchange Act of 1934, as amended.
This
COMPOUND TRANSFER AND DEVELOPMENT AGREEMENT (the “Agreement”) is entered into
and effective as of July 26, 2006 (the “Effective Date”), by and
between Gene Logic Inc. (“GLGC”), a Delaware corporation
with a principal address at 000 Xxxxxxxxxxxx Xxxxx, Xxxxxxxxxxxx, XX 00000, and
Millennium Pharmaceuticals, Inc., (“MLNM”), a Delaware corporation
with a principal address at 00 Xxxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 (each a
“Party” and
collectively, the “Parties” to this
Agreement).
A. GLGC
and MLNM have entered into that certain Amended and Restated Compound
Development Agreement (the “Evaluation Agreement”) dated
as of July 13, 2005, under which GLGC agreed and has performed an evaluation to
assess disease indications for “MLN 4760” (as defined
below).
B. The
Parties desire to enter into an arrangement on the terms and conditions set
forth in this Agreement, whereby MLNM agrees to license rights to the
Development Candidate (as defined below) to GLGC, and GLGC agrees to pursue
commercial development of the Development Candidate.
In
consideration of the undertakings of the Parties in the Evaluation Agreement,
and the mutual covenants and promises of the Parties set forth herein, and other
good and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties agree as follows, intending to be legally
bound:
1. DEFINITIONS. Whenever
used in this Agreement, the terms defined in this Section 1 will have the
meanings specified below.
1.1 “Affiliate” means any
corporation or other legal entity owning, directly or indirectly, fifty percent
(50%) or more of the voting capital shares or similar voting securities of MLNM
or GLGC; any corporation or other legal entity fifty percent (50%) or more of
the voting capital shares or similar voting rights of which is owned, directly
or indirectly, by MLNM or GLGC or any corporation or other legal entity fifty
percent (50%) or more of the voting capital shares or similar voting rights of
which is owned, directly or indirectly, by a corporation or other legal entity
which owns, directly or indirectly, fifty percent (50%) or more of the voting
capital shares or similar voting securities of MLNM or GLGC.
1.2 “Biotherapeutic Compound” means
any molecule that has a molecular weight in excess of 1500 Daltons and that is
covered by, or is developed through activities covered by, MLNM Research Tool
Patents.
1.3 “Biotherapeutic Rights” means
the rights to research, develop and/or commercialize a Biotherapeutic
Compound.
1.4 “Compound” means (a) MLN 4760;
(b) any other compound covered by a Valid Claim under MLNM Patent Rights; (c)
any compound made under GLGC’s development hereunder; (d) any metabolite, ester,
salt, hydrate, solvate, polymorph, stereoisomer, prodrug, or formulation of the
foregoing described in (a), (b), or (c); and (e) any product that has as an
active ingredient (a), (b), (c), or (d).
1.5 “Development Arrangement” means
an arrangement, memorialized by written agreement, between GLGC and a third
party related to the development and/or commercialization of a Development
Candidate in which such third party owns a material interest in the success of
such Development Candidate.
1.6 “Development Candidate” means
any Compound or Biotherapeutic Compound that is developed by GLGC alone or by a
third party (with or without the participation of GLGC) under a Development
Arrangement.
1
1.7 “Development Product” means a
Development Candidate that has received Marketing Approval in any country or
region.
1.8 “End of Regulatory Exclusivity”
means the day after marketing approval could be granted by the FDA in the
relevant country to a company other than GLGC, its Affiliate, a party to a
Development Arrangement, or a sublicense or successor thereof on a product that
has the same active ingredient as the Development Product.
1.9 “FDA” means the United States
Food and Drug Administration, any successor agency thereof, or any equivalent
agency in a foreign country/region (e.g. EMEA in Europe).
1.10 “First Commercial Sale” means
the first sale for use in consumption by the general public of a Development
Product in a country after its regulatory approval.
1.11 “GLGC Development Field” means the prevention,
diagnosis, and treatment of any human disease other than Oncology Diseases (as
that term is defined below). Notwithstanding the previous sentence,
it is understood that GLGC will be restricted from developing a Development
Candidate for the treatment of Type 1 Diabetes, Type 2 Diabetes and Obesity as
specified in the existing Separation Agreement between MLNM and Xxxxxx
Laboratories, dated August 8, 2003, which restriction shall expire and be
inapplicable and unenforceable hereunder as of September 29, 2008.
1.12 “IND” means an Investigational
New Drug application filed with the FDA in conformance with applicable laws and
regulations in the United States, and the equivalent thereof in jurisdictions
outside the United States.
1.13 “Marketing Approval” means the
final approval received from the United States FDA or equivalent regulatory
authority for a Development Candidate in the applicable country or region,
immediately following which such Development Candidate may be subject to the
First Commercial Sale in such country or region.
1.14 “MLN 4760” means the chemical
compound known as MLN 4760 and more fully described as
(S,S)-2-[1-carboxy-2-[3-(3,5-dichlorobenzyl)-3H-imidazol-4-yl]-ethylamino]-4-methylpentanoic
acid.
1.15 “MLN 4760 Program Documents”
means the documents listed on Schedule
1.15.
1.16 “MLNM Patent Rights” means U.S.
Patent 6,632,830 and U.S. Patent 7,045,532 and any related foreign patents and
patent applications related thereto, including (a) any continuation,
continuation-in-part, divisional, resissue, reexamination or extension thereof,
(b) any patent issued from any such applications, and (c) all inventions claimed
in any of the foregoing.
1.17 “MLNM Research Tool Patents”
means the U.S. Patents listed in Schedule 1.17 and any
related foreign patents and patent applications related thereto, including (a)
any continuation, continuation-in-part, divisional, resissue, reexamination or
extension thereof, (b) any patent issued from any such applications, and (c) all
inventions claimed in any of the foregoing.
1.18 “Net Sales” means the gross
invoiced sales by GLGC or its Affiliates or sublicensee for sales or other
commercial disposition of a Development Product to a third party customer
(including Recognized Agents), less the following deductions with respect to
such sales: (a) any rebates, quantity, trade and cash discounts, and other usual
and customary discounts to customers actually allowed or taken; (b) compulsory
payments and rebates, actually paid or deducted; (c) retroactive price
reductions, credits or allowances actually granted upon rejections or returns of
sold Development Products, including for recalls or damaged goods; (d)
deductions for actual bad debts to the extent relating to the Development
Product; (e) freight, postage, shipping and insurance charges actually allowed
or paid for delivery of Development Products, to the extent included in the
gross sales price; and (f) sales taxes, excise taxes, consumption taxes, use
taxes, withholding taxes, import/export duties or other governmental charges
actually due or incurred with respect to sales of Development Product including
without limitation value-added taxes; (g) charge-back payments and rebates
granted to managed health care organizations or to federal, state and local
governments, their respective agencies, purchasers or reimbursers; all of the
deductions in the foregoing clauses (a)-(g) as incurred in the ordinary course
of business in type and amount consistent with good industry practice and
determined in accordance with generally accepted accounting principles on a
basis consistent with GLGC’s audited consolidated financial
statements. For sake of clarity and avoidance of doubt, sales by
GLGC, its Affiliates or sublicensees of a Development Product to Recognized
Agents of such Development Product in a given country shall be considered a sale
to a third party customer.
2
If a
Development Product is sold in any country in a form which physically or
chemically combines one or more therapeutically active ingredients to the
Compound component of a Development Product (“Combination Products”), the
Net Sales will be calculated by multiplying the actual Net Sales of the
Combination Product by the fraction A/(A+B), where A is the average invoice
price in the applicable country of the Development Product when comprising the
Compound component only in a comparable formulation, and B is the sum of the
average invoice prices in the applicable country of all other therapeutically or
prophylactically (non-Compound) active ingredients or products in the
Combination Product sold separately in a comparable formulation, during the
applicable calendar year. If A or B cannot be determined because
values for the Development Product or the other active ingredients sold alone
are not available in a particular country, then A or B, as the case may be,
shall be the weighted average of the prices (in effect with respect to the
period for which royalties are being calculated hereunder) at which the
Development Product (when comprising the Compound component only) or the other
(non-Compound) active ingredients are sold alone in the dosage included in the
Combination Product in comparable markets. In the event that no
Development Products (when comprising the Compound component only) or other
(non-Compound) active ingredients are sold alone in any country, the Parties
shall negotiate in good faith an allocation of the fair market value of the
Compound component of Development Product in the Combination
Product. If the Parties are unable to reach agreement then the matter
shall be referred to a person suitably qualified to determine the matter (as
appointed by agreement of the Parties). Such person shall act as an
expert and not as an arbitrator and his or her decision shall be binding on the
Parties (save in the case of negligence or manifest error) including as to the
proportions in which the Parties should pay the expert’s fees.
1.19 “Obesity” means the condition
of excess body fat (adipose tissue), in accordance with the National Institutes
of Health Federal Obesity Clinical Guidelines for adults, whereby body mass
index calculated by dividing body mass in kilograms by height in meters squared
is equal to or greater than twenty-five (25) (for purposes of this definition,
Obesity shall include an overweight condition in accordance with the above
guidelines and comparable obesity and overweight condition in
children).
1.20 “Oncology Diseases” means the
prevention, diagnosis, and treatment of oncological diseases (including
modulation of tumor angiogenesis).
1.21 “Phase IIA Clinical Trial”
means a pilot clinical trial in human beings to evaluate efficacy in selected
populations of patients with the disease or condition to be treated, diagnosed
or prevented, with a focus on demonstrating absorption, metabolic effect and
potential pharmacodynamic of such pharmaceutical product.
1.22 “Phase III Clinical Trial”
means a clinical trial in human beings that is conducted after preliminary
evidence suggesting effectiveness of a pharmaceutical product has been obtained,
is of appropriate size and design to establish that such pharmaceutical product
is safe and effective for its intended use, to define warnings, precautions and
adverse reactions that are associated with such pharmaceutical product in the
dosage range to be prescribed, and to support Marketing Approval of such
pharmaceutical product.
1.23 “Program Materials” means those
materials listed on Schedule
1.23.
1.24 “Proprietary Information of Gene
Logic” means all information about any element of GLGC’s business or
technology disclosed by GLGC to MLNM and designated “Proprietary” or
“Confidential” in writing by GLGC at the time of disclosure to MLNM or within 30
days thereafter.
1.25 “Proprietary Information of
MLNM” means all information about any element of MLNM’s business or
technology disclosed by MLNM to GLGC and designated “Proprietary” or
“Confidential” in writing by MLNM at the time of disclosure to GLGC or within 30
days thereafter.
3
1.26 “Recognized Agent” means any
third party that is engaged by GLGC, its Affiliates, a party to a Development
Arrangement, and/or a sublicensee or successor thereof, to market and/or
distribute in the normal course of business a Development Product in a
particular country in the world on a commission or non-commission
basis.
1.27 “Specific Compound” means a
Compound whose a) chemical structure is specifically disclosed in the MLNM
Patent Rights and b) any metabolite, ester, salt, hydrate, solvate, polymorph,
stereoisomer, prodrug, or formulation of (a) and any product that has as an
active ingredient (a) or (b). Specific Compound refers to a
particular chemical entity (by a formula or a diagram) and does not mean a
compound that is described in the MLNM Patent Rights only by a generic chemical
name or formula.
1.28 “Type 1 Diabetes” means
insulin-dependent diabetes mellitus as diagnosed according to criteria published
in the Report of the Expert Committee on the Diagnosis and Classification of
Diabetes Mellitus (Diabetes Care, Vol. 24, Supp. 1, January 2001) whereby
fasting plasma glucose level is greater than or equal to 126 milligrams per
deciliter and for which the primary cause is beta-cell destruction.
1.29 “Type 2 Diabetes”
non-insulin-dependent diabetes mellitus as diagnosed according to criteria
published in the Report of the Expert Committee on the Diagnosis and
Classification of Diabetes Mellitus (Diabetes Care, Vol. 24, Supp. 1, January
2001) whereby fasting plasma glucose level is greater than or equal to 126
milligrams per deciliter.
1.30 “Upfront Consideration” means
any cash or other consideration paid to GLGC under a Development Arrangement and
that is received by GLGC prior to the occurrence of the first milestone event
set forth in the chart in Section 5.1.1.
1.31 “Valid Claim” means a claim (a) of any
issued, unexpired patent that has not been revoked or held unenforceable or
invalid by a decision of a court or governmental agency of competent
jurisdiction from which no appeal can be taken, or with respect to which an
appeal is not taken within the time allowed for appeal, and that has not been
disclaimed or admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise or (b) of any patent application that has not been
cancelled, withdrawn or abandoned or been pending for more than seven (7)
years.
2.
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TRANSFER;
CONSULTING SERVICES
|
2.1 Transfer of MLN
4760. No later than thirty (30) days after the Effective Date,
MLNM will transfer by shipment to GLGC all of the MLN 4760 supply that MLNM
possesses as of the Effective Date, which is a supply of at least ten (10)
kilograms of MLN 4760, except that MLNM will retain 200 grams of MLN 4760 for
research purposes only. MLNM’s shipment of MLN 4760 will be provided
“as is” without guarantee as to purity and quality. MLNM will, to the
extent known by MLNM, notify GLGC of any applicable handling, storage, use or
disposal requirements and warnings of any safety or health hazards presented by
the possession, storage, handling use or disposal of MLN 4760. MLNM
represents and warrants that: (i) it has the right to provide MLN
4760 under this Agreement; and (ii) it has complied with all applicable laws,
rules and regulations with respect to the use, storage, handling and disposal of
MLN 4760. Upon receipt, GLGC will have full and complete ownership of
all such MLN 4760, and shall be free to use any such MLN 4760 in accordance with
the rights granted under this Agreement.
2.2 Transfer of Program
Materials. No later than thirty (30) days after the Effective
Date, MLNM will transfer by shipment to GLGC the Program Materials in the
amounts specified in Schedule
1.23. MLNM’s shipment of Program Materials will be provided
“as is” without any warranty or guarantee as to purity and
quality. Upon receipt, GLGC will have full and complete ownership of
all such Program Materials, and shall be free to use any such Program Materials
in accordance with the rights granted under this Agreement.
2.3 Transfer of MLN 4760 Program
Documents. No later than thirty (30) days after the Effective
Date, MLNM will transfer to GLGC all of the MLN 4760 Program
Documents. The MLN 4760 Program Documents shall include documents
that MLNM possesses and are believed by MLNM to be pertinent to the development
of MLN 4760. MLNM represents that it is not aware of any other
documents that are pertinent to the development of MLN 4760, other than the MLN
4760 Program Documents. Should MLNM become aware, of any additional
documents that it believes are pertinent to the development of MLN 4760, MLNM
will promptly notify GLGC and, if in MLNM’s possession or reasonably available
to it, forward such documents to GLGC. Should GLGC notify MLNM of a
document relating to MLN 4760 that it reasonably expected would be part of the
MLN 4760 Program Documents and that GLGC in good faith believes are pertinent to
its development efforts for one or more Development Candidates but that were not
provided by MLNM under this Section 2.3, MLNM will use reasonable efforts to
promptly investigate GLGC’s notice and, if in MLNM’s possession or reasonably
available to it, forward such document to GLGC.
4
2.4 MLNM
Release; MLNM Consulting Services.
2.4.1 Release. MLNM shall
and hereby does grant permission for certain specified individuals (the “Released Individuals”) to
disclose Proprietary Information of MLNM that may be known to each of them
relating specifically to one or more Development Candidates, provided that such
disclosure shall be to GLGC or entities under obligations of confidentiality to
GLGC where such disclosures will be treated as confidential information of
GLGC. For the purpose of this Section 2.4.1., the Released
Individuals are: [REDACTED]. Any services rendered by the
Released Individuals shall be at GLGC’s expense, as determined by GLGC and such
Released Individuals. MLNM shall have no obligation to obtain any
consent from any Released Individuals to consult with GLGC, however MLNM hereby
agrees to send a written letter to each of the Released Individuals in the
substantive form attached hereto as Exhibit
2.4.1. Furthermore, MLNM shall bear no responsibility (for
misrepresentation, falsity or otherwise) to GLGC or any third party with respect
to any disclosures made by a Released Individual to GLGC or a third party, and
GLGC hereby waives any warranty, express or implied, regarding the
same. GLGC will hold harmless and indemnify MLNM for any harm or
damage resulting from its use of the information provided by the Released
Individuals under this Section 2.4.1.
2.4.2 MLN 4760 Program
Consultation. At GLGC’s prior written request, MLNM shall use
commercially reasonable efforts to provide GLGC up to ten (10) hours of
consultation services related to historical knowledge of the MLN 4760 Program,
with the understanding that such consultation will be based upon MLNM’s specific
experience with or actual knowledge of MLN 4760. Such consultation
shall be performed by [REDACTED]., or such other individual(s) mutually agreed
to by the Parties. Such MLNM consultant(s) will have no direct
contact with any person or company other than GLGC. GLGC shall
request consultation by submitting in advance written questions or
topics. The ten (10) hours will include preparation time and meeting
time. GLGC will pay MLNM for consulting services in support of the
Development Program at a rate of$200/hour, which amounts will be invoiced by
MLNM to GLGC. GLGC will pay all such undisputed invoiced amounts
within thirty (30) days of its receipt of such invoice. GLGC shall
accept the consultation and information provided by MLNM under this Section
2.4.2 “as is” and hereby waives any warranty, express or implied, regarding the
same. GLGC will hold harmless and indemnify MLNM and its employees
for any harm or damage resulting from its use of the consultation and
information provided by MLNM under this Section 2.4.2.
2.4.3 MC4
Consultation. At GLGC’s prior written request, MLNM shall use
commercially reasonable efforts to provide GLGC up to twenty (20) hours of
consultation services related to GLGC’s efforts at developing an MC4 antagonist
program, including historical knowledge of MLNM’s MC4 program. Such
consultation shall be performed by either [REDACTED], or such other
individual(s) mutually agreed to by the Parties. Such MLNM
consultant(s) will have no direct contact with any person or company other than
GLGC. GLGC shall request consultation by submitting in advance
written questions or topics. The twenty (20) hours will include
preparation time and meeting time. GLGC will pay MLNM for consulting
services in support of the Development Program at a rate of$200/hour, which
amounts will be invoiced by MLNM to GLGC. GLGC will pay all such
undisputed invoiced amounts within thirty (30) days of its receipt of such
invoice. GLGC shall accept the consultation and information provided
by MLNM under this Section 2.4.3 “as is” and hereby waives any warranty, express
or implied, regarding the same. GLGC will hold harmless and indemnify
MLNM and its employees for any harm or damage resulting from its use of the
consultation and information provided by MLNM under this Section
2.4.3.
2.4.4 MLNM Contact Person for Arranging
Consultation. Requests for consultation under Sections 2.4.2
and 2.4.3 shall be made through [REDACTED] or such other contact person as may
be designated by MLNM.
5
2.4.5 Employment
Contingency. With respect to any particular consultant, MLNM’s
obligations under Sections 2.4.2 and 2.4.3 are contingent upon the consultant’s
continued employment by MLNM. If the employment of any such
consultant is terminated with MLNM prior to the fulfilment of the applicable
consulting service, then MLNM will designate such employee as a Released
Individual under Section 2.4.1, and further MLNM will release such employee from
any post-employment restrictions to the extent that such restrictions would
prevent such employee from consulting for GLGC as contemplated under this
Agreement.
3.
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PROGRAM
DEVELOPMENT; UPFRONT CONSIDERATION
|
3.1 Diligence. Beginning
on the date thirty (30) months after the Effective Date, GLGC shall use
commercially reasonable efforts to develop and commercialize one or more
Development Candidates, either itself or in conjunction with one or more third
parties as it sees fit. Nothing in the preceding sentence will
restrict GLGC from using commercially reasonable efforts prior to the date
thirty (30) months after the Effective Date.
3.1.1 If
GLGC enters into a Development Arrangement prior to GLGC (or the entity with
whom GLGC entered such Development Arrangement) filing an IND for a Development
Candidate, GLGC will provide MLNM with [REDACTED] percent ([REDACTED]) of any
Upfront Consideration that GLGC obtains from such a transaction, which amount
shall not exceed a total cap of: (a) [REDACTED] if such Development Arrangement
does not include a transfer of Biotherapeutic Rights; or (b) [REDACTED] if such
Development Arrangement does include a transfer of Biotherapeutic
Rights. Such obligation will be in addition to the milestones and
royalties set forth in Sections 5.1 and 5.2.
3.1.2 If
GLGC enters into a Development Arrangement subsequent to GLGC (or the entity
with whom GLGC entered such Development Arrangement) filing an IND for a
Development Candidate, but prior to GLGC completing a Phase IIA Clinical Trial
for such Development Candidate, GLGC will provide MLNM with [REDACTED] percent
([REDACTED]) of any Upfront Consideration that GLGC obtains from such a
transaction, which amount shall not exceed a total cap of: (a) [REDACTED] if
such Development Arrangement does not include a transfer of Biotherapeutic
Rights; or (b) [REDACTED] if such Development Arrangement does include a
transfer of Biotherapeutic Rights. Such obligation will be in
addition to the milestones and royalties set forth in Sections 5.1 and
5.2.
3.1.3 If
GLGC enters into a Development Arrangement subsequent to a Phase IIA clinical
study (or Phase III Clinical Trial if no Phase IIA Clinical Trial is pursued)
for such Development Candidate, GLGC will have no financial obligations other
than the milestones and royalties set forth below.
3.1.4 GLGC
shall pay MLNM the portion of Upfront Consideration that is due under Sections
3.1.1 and 3.1.2 within 30 days after the Upfront Consideration is received by
GLGC, provided that if the Upfront Consideration that GLGC receives is in a form
other than cash, then GLGC shall pay MLNM the portion of Upfront Consideration
as cash in an amount that is equal to the fair market value of such Upfront
Consideration at the time of receipt, which amount shall be mutually agreed to
by the Parties. Accordingly, the Parties will work in good faith for
thirty (30) days to agree on the fair market value of such Upfront Consideration
based on industry comparables. If the Parties cannot successfully
reach agreement in such period, either Party may request in writing that the
Parties select a mutually agreed expert to determine the fair market
value. If the Parties cannot agree on an expert within thirty (30)
days after initiating the selection procedure, either Party may request the
American Arbitration Association (“AAA”) office in New York, NY
to appoint an arbitrator to select such an expert on behalf of the Parties in
accordance with the commercial arbitration rules of AAA.
3.2 Annual
Reports. Within 30 days after each annual anniversary of the
Effective Date, GLGC will provide to MLNM a written progress report, which will
describe in summary GLGC’s activities related to one or more Development
Candidates.
4.
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LICENSES;
PROPRIETARY RIGHTS
|
6
4.1 Exclusive License to
GLGC. MLNM shall and hereby does grant to GLGC an exclusive
worldwide license, with rights to sublicense, under the MLNM Patent Rights and
the MLNM Research Tool Patents to develop, make, use, have made and sell
Development Candidates in the GLGC Development Field, except that the rights
granted under the MLNM Research Tool Patents shall not include rights relating
to targets other than ACE2. The License described in this Section 4.1
is subject to the rights retained by MLNM as described in Section
4.4.
4.2 Representations by
Millennium. MLNM represents and warrants that except for the
MLNM Patent Rights and the MLNM Research Tool Patents, as of the Effective Date,
MLNM does not own any other inventions, patents or patent applications that are
reasonably necessary to develop, make, use, have made, and sell Development
Candidates in the GLGC Development Field. In the event of a breach of
the representation in this Section 4.2 where MLNM knew or should have known as
of the Effective Date that an invention, patent or patent application other than
a MLNM Patent Right or MLNM Research Tool Patent was reasonably necessary for
the purposes described hereunder, without limiting any other rights or remedies
of GLGC, MLNM will and hereby does grant to GLGC a non-exclusive worldwide
license, with the right to sublicense, under MLNM’s interest in such invention,
patent or patent application, to develop, make, use, have made and sell
Development Candidates in the GLGC Development Field.
4.3 Nonexclusive License to GLGC to
Intellectual Property Made by MLNM Consulting
Services. Inventions, discoveries, know-how, and
information generated by MLNM employees under Section 2.3.2 and Section 2.3.3
shall be owned by MLNM (“MLNM
Consulting IP”). MLNM hereby agrees to grant and does grant
GLGC a non-exclusive worldwide license, with rights to sublicense, under any
MLNM Consulting IP, to develop, make, use, have made, and sell Development
Candidates in the GLGC Development Field.
4.4 MLNM Retained Rights and
Restrictions.
4.4.1 MLNM
shall retain the non-exclusive right in the GLGC Development Field under the
MLNM Patent Rights to (a) research, develop, make, use, have made and sell
Compounds made by MLNM other than Specific Compounds and (b) for research
purposes only, make, have made and use Specific Compounds.
4.4.2 MLNM
shall retain the non-exclusive right in the GLGC Development Field under the
MLNM Research Tool Patents to conduct research.
4.4.3 Notwithstanding
Sections 4.4.1 and 4.4.2 above, for the life of the MLNM Patent Rights, MLNM
agrees and hereby represents that it shall not a) in the GLGC Development Field,
use an ACE2 enzyme assay or ACE2 binding assay as a primary screen to select a
Compound for development or commercialization, b) develop, make, use, have made
or sell any Specific Compound, or c) develop, make, use, have made or sell any
Compound with the intent of marketing such Compound solely as an ACE2 inhibitor
provided that any ACE2 inhibition exhibited by such Compound shall have a
lesser, secondary contribution to the efficacy as compared to the Compound’s
primary mechanism of efficacy.
4.5 No Implied
Licenses. Inventions and all other technology made solely by
GLGC in its development of one or more Development Candidates will be owned by
GLGC. MLNM shall not have an implied license to any invention made
solely by GLGC, and nothing in Section 4.4 above is intended to grant or imply
any such license. GLGC shall not have an implied license to any
inventions or other technology made solely by MLNM in the exercise of its rights
described in Section 4.4, which inventions and other technology shall be owned
by MLNM.
4.6 Non-Exclusive License to MLNM to
Jointly-Made Inventions. Inventions and all other technology
made jointly by GLGC and MLNM pertaining to GLGC’s development of one or more
Development Candidates shall be owned by GLGC, and MLNM shall have a
non-exclusive license to use such inventions and technology for any purpose
subject to the restrictions set forth in Section 4.4.
5.
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FEES
AND PAYMENTS
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5.1 Milestones.
7
5.1.1 GLGC
will make the following non-refundable, non-creditable payments in the amounts
set forth below within 30 days of the occurrence of the following
events:
Milestone
Event
|
Milestone
Payment
|
Completion
of Phase IIA Clinical Trial
|
[REDACTED]
|
First
subject enrolled in first Phase III Clinical Trial
|
[REDACTED]
|
Marketing
Approval of Product
|
[REDACTED]
|
GLGC will
only pay a milestone for the first time that a particular milestone event is
achieved for a Development Candidate on an indication by indication
basis. However, and as an example, if GLGC initiates two Phase III
trials for different therapeutic indications for a Development Candidate, GLGC
will be obligated to pay [REDACTED] upon enrollment in each of such trials, for
a total of [REDACTED] to be paid to MLNM.
5.1.2 In
addition to the milestones set forth in Section 5.1.1, GLGC will make the
following non-refundable, non-creditable payments in the amounts set forth below
within 30 days of the occurrence of the following events related to a
Development Candidate that incorporates a Biotherapeutic Compound:
Milestone
Event
|
Milestone
Payment
|
Filing
of an IND
|
[REDACTED]
|
Completion
of Phase I Clinical Trial
|
[REDACTED]
|
GLGC will
only pay such milestone for the first time that a particular milestone event is
achieved for a Development Candidate that incorporates a Biotherapeutic Compound
on an indication by indication basis. However, and as an example, if
GLGC files two INDs for different therapeutic indications for a single
Development Candidate incorporating a Biotherapeutic Compound, GLGC will be
obligated to pay [REDACTED] to MLNM.
5.2 Royalties. GLGC
will pay to MLNM a royalty based on aggregate, worldwide Net Sales of each
Development Product for each calendar year as follows:
5.2.1 [REDACTED]%
of aggregate, worldwide Net Sales of a Development Product for such calendar
year that are less than or equal to [REDACTED];
5.2.2 [REDACTED]%
of aggregate, worldwide Net Sales of a Development Product for such calendar
year that are greater than [REDACTED] and less than or equal to
[REDACTED];
5.2.3 [REDACTED]%
of aggregate, worldwide Net Sales of a Development Product for such calendar
year that are greater than [REDACTED] and less than or equal to
[REDACTED];
5.2.4 [REDACTED]%
of aggregate, worldwide Net Sales of a Development Product for such calendar
year that are greater than [REDACTED].
5.3 Royalty
Payments. GLGC will pay the royalties under Section 5.2 to
MLNM within 60 days of the end of each calendar quarter. Each such
payment will be accompanied by a detailed calculation of the Net Sales and the
royalties due thereon, including the destination of such sales grouped with
subtotal detail showing the country and state locations. GLGC will
provide any additional documentation to support the royalty calculation as is
reasonably requested by MLNM, subject to confidentiality obligations that may be
owed to third parties with respect to information used in those
calculations. The rate of exchange to be used in computing Net Sales
generated in currency other than U.S. Dollars and the amount of currency
equivalent in U.S. Dollars due to GLGC will be made at the rate of exchange,
calculated as the average of the sales and the purchase exchange rate, quoted
for the close of business on the last day of business of the applicable royalty
period in The Wall Street Journal, Eastern Edition.
8
5.4 Royalty
Term. Royalties on Development Products shall be payable on a
country-by-country and Development Product-by-Development Product basis until
the later of (i) the expiration of the term of Millennium Patent Rights in each
such country to the extent only that a Valid Claim of such Millennium Patent
Rights exists in such country which covers the Development Product or the
manufacture of the Development Candidate or (ii) [REDACTED] years after First
Commercial Sale of the Development Product, provided however a) if the End of
Regulatory Exclusivity for a particular Development Product in a particular
country occurs during the [REDACTED] years after First Commercial Sale of the
Development Product or immediately if regulatory exclusivity is unavailable in
such country, the royalty rates described in Sections 5.2.3 and 5.2.4 above for
such Development Product in such country will thereafter be reduced to
[REDACTED]% of aggregate Net Sales, and b) [REDACTED] years after the First
Commercial Sale of such Development Product in such country the royalty rates
described in Sections 5.2.1 and 5.2.2 above will thereafter be reduced to
[REDACTED]% and the royalty rates described in Sections 5.2.3 and 5.2.4 above
will thereafter be reduced to [REDACTED]% of aggregate Net Sales of such
Development Product in that country.
5.5 Non-Stacking and No Royalty
Offsets. Preexisting MLNM obligations related to a Development
Candidate, including obligations to Xxxxxx Laboratories, will be maintained by
MLNM and will not affect GLGC’s milestone payments or royalty rates described
above. GLGC shall be responsible for any other third party
obligations that may pertain to the development and commercialization of any
Development Candidate, and GLGC shall not be entitled to deduct, for any reason,
any portion of royalties paid to any such third party from royalties due to
Millennium pursuant to this Agreement.
5.6 Taxes. All amounts
payable by GLGC to MLNM under this Agreement will be made, so long as payments
are received in the United States, without deduction or withholding of any
applicable sales, use and other taxes (except as provided in this Section 5.6
below) and all applicable export and import fees, customs, duties and similar
charges. However, in the event that any royalties or payments due to
MLNM are subject to withholding income tax required by United States law to be
paid to the United States government, the amount of such tax may be withheld
from the applicable royalties or payment due MLNM. GLGC shall
promptly pay such tax on behalf of MLNM and shall furnish MLNM with a
certificate of withholding tax as proof of payment that such tax was so
deducted. GLGC may not deduct any other withholding or any other
governmental charges from the payments agreed upon under this
Agreement. GLGC shall maintain official receipts of payment of any
such withholding taxes and shall forward such receipts to MLNM.
5.7 Method of Payment; Late Payments;
Interest. Any payments due to MLNM under this Agreement will be made in
U.S. Dollars by wire transfer to a bank account designated by
MLNM. Any portion of any fee or other amount payable under this
Agreement that is not paid when due will accrue interest at one and one-half
percent (1.5%) per month or the maximum rate permitted by applicable law,
whichever is less, from the due date until paid.
5.8 Bookkeeping and Audit Rights.
GLGC will maintain complete and accurate financial records in accordance with
generally accepted accounting principles during the Term (as defined in Section
9.1) and for a period of one (1) year after the termination or expiration of
this Agreement with respect to matters covered by this
Agreement. MLNM will have the right, at its own expense, upon
reasonable prior notice, no more than once per year to engage an independent,
nationally-recognized accounting firm to inspect and audit the records of GLGC
solely with respect to matters covered by this Agreement, provided that if such
inspection and audit reveals that GLGC has underpaid MLNM with respect to any
amounts due and payable under this Agreement, GLGC will promptly pay such
amounts as are necessary to rectify such underpayment, together with interest in
accordance with Section 5.7. If an inspection and audit reveal that
any such underpayments are greater than [REDACTED] of the amount actually due
for a calendar year, GLGC also will reimburse MLNM all of the costs for such
inspection and audit.
6.
|
TREATMENT
OF PROPRIETARY INFORMATION
|
9
6.1 Ownership of Proprietary
Information. The Parties acknowledge that during the Term,
each Party will have access to certain of the other Party’s Proprietary
Information. Both Parties agree that all items of Proprietary
Information are proprietary to the disclosing Party, and will remain the sole
property of the disclosing Party.
6.2 Mutual Confidentiality
Obligations. Each Party agrees as follows: (a) to use
Proprietary Information disclosed by the other Party only for the purposes
described herein; (b) that such Party will not reproduce Proprietary Information
disclosed by the other Party, and will hold in confidence and protect such
Proprietary Information from dissemination to, and use by, any third party; (c)
that neither Party will create any derivative work from Proprietary Information
disclosed to such Party by the other Party; (d) to restrict access to the
Proprietary Information disclosed by the other Party to such of its personnel,
agents, and/or consultants, if any, who have a need to have access and who have
been advised of and have agreed in writing to treat such information in
accordance with the terms of this Agreement; and (e) to return or destroy all
Proprietary Information disclosed by the other Party, at such other Party’s
request, that is in its possession upon termination or expiration of this
Agreement.
6.3 Exclusions. Notwithstanding
the foregoing, any information of a Party will not be deemed Proprietary
Information with respect to the receiving Party for purposes of this Agreement
if such information:
(a) was
already known or available to the receiving Party or its Affiliates, other than
under an obligation of confidentiality or non-use for the benefit of the
disclosing Party or its Affiliates, 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 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 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 6 by the receiving Party; or
(d) was
disclosed to the receiving Party or its Affiliates, other than under an
obligation of confidentiality or non-use, by a Third Party who had no obligation
to the disclosing Party not to disclose such information to others;
or
(e) was
independently discovered by the receiving Party or its Affiliates, without use
of or reference to the disclosing Party’s Proprietary Information.
6.4 Permitted
Disclosures. Notwithstanding the foregoing, each Party may
disclose Proprietary Information to the limited extent necessary (a) to comply
with the order of a court of competent jurisdiction or other governmental body
having authority over such Party, provided that the Party making the disclosure
pursuant to the order will first have given notice to the other Party and made a
reasonable effort to obtain a protective order; (b) to comply with applicable
law or regulation requiring such disclosure; or (c) to establish a Party’s
rights under this Agreement, including to make such court filings as it may be
required to do.
6.5 Publicity. Neither
Party shall have the right to originate any publicity, news release or other
public announcement, written or oral, relating to this Agreement or the
transactions contemplated hereunder, without the prior written consent of the
other Party, such consent not to be unreasonably withheld. Such
consent or the withholding of consent shall be communicated in writing to the
requesting Party within a specified review period (“Review Period”) that is five
(5) business days, with the exception that for an oral disclosure by a Party
based on scripted material (such as a conference script) and the publicly
disclosable facts set forth in the attached Exhibit 6.5 the
Review Period shall be forty-eight (48) hours, and either Party may disclose the
publicly disclosable facts in Exhibit 6.5 to
respond to questions from analysts, investors, the media or other third parties
without further review by the other Party (provided the other Party has
previously reviewed and consented to scripted material that led to such
questions), or as otherwise required by law. The other Party’s
failure to communicate in writing within the applicable Review Period shall be
deemed that Party’s consent. Either Party may publicly disclose
without regard to the preceding requirements of this Section 6.5 information
that was previously disclosed in a public disclosure that was in compliance with
such requirements. Nothing in this Section 6.5 shall be deemed to
prevent GLGC from announcing publicly a) that it has entered into a Development
Arrangement or achieved a development milestone on one or more Development
Candidates or Development Products, or b) the status or strategy of its
development efforts, including information related to disease indications being
pursued.
10
7.
|
PROSECUTION
AND MAINTENANCE OF PATENT RIGHTS; PATENT
COSTS
|
7.1 Inventions Made Solely by
GLGC. GLGC shall be responsible, in its sole discretion and at
its own expense, for the filing, prosecution and maintenance of all patents and
patent applications made solely by GLGC.
7.2 Inventions Made Solely by
MLNM. MLNM shall have the first right and option to file and
prosecute, at its own expense, patent applications claiming inventions made
solely by MLNM as a result of the services MLNM provides under Sections 2.3.2
and 2.3.3 and other assistance provided under this Agreement. If MLNM
elects not to undertake the filing, prosecution and/or maintenance of any patent
or patent application claiming such an invention, then MLNM shall notify GLGC of
such election and GLGC shall be entitled to file, prosecute and/or maintain, at
GLGC’s expense, such patent or patent application in the name of
MLNM.
7.3 Inventions Made Jointly by GLGC and
MLNM. GLGC shall have the first right and option to file and
prosecute, at its own expense, patent applications claiming inventions made
jointly by GLGC and MLNM as a result of the development activities performed
under this Agreement. If GLGC elects not to undertake the filing,
prosecution and/or maintenance of any patent or patent application claiming a
jointly-made invention, then GLGC shall notify MLNM of such election and MLNM
shall be entitled to file, prosecute and/or maintain, at MLNM’s expense, such
patent or patent application.
7.4 MLNM
Research Tool Patents.
7.4.1 At
its sole cost and expense, GLGC shall prosecute and maintain the MLNM Research
Tool Patents (including, at GLGC’s option, through the use of outside
counsel). The Parties will cooperate to ensure transfer of such
prosecution and maintenance efforts to GLGC promptly following the Effective
Date. In addition, no later than thirty days following the Effective
Date of the Agreement, MLNM shall execute a Power of Attorney in favor of one or
more patent attorneys or agents designated by GLGC for the purpose of
prosecuting the MLNM Research Tool Patents. Once the Power of
Attorney has been assigned to GLGC, GLGC thereafter shall promptly upon receipt
forward to MLNM copies of any material correspondence received from the
U.S. or foreign patent offices with respect to the MLNM Research Tool
Patents. MLNM shall have the right to comment on and to discuss
prosecution and maintenance activities with GLGC, and, if such comments and
advice are timely offered by MLNM, GLGC shall consider the same in good faith,
but shall not be obligated to implement any comments and advice so offered by
MLNM.
7.4.2 If
GLGC elects not to undertake the prosecution and/or maintenance of any patent or
patent application within MLNM Research Tool Patents, then GLGC shall notify
MLNM of such election and MLNM shall be entitled to prosecute and/or maintain,
at MLNM’s expense, such patent or patent application. Upon such
election by GLGC not to prosecute or maintain such patent or patent application,
the exclusive license granted to GLGC under Section 4.1 with respect to such
patent or patent application shall convert to a non-exclusive license and MLNM
shall have the right to use such patent or patent application for any purpose
subject to the restrictions set forth in Section 4.4.3.
7.5 Cooperation. Pursuant
to Sections 7.2, 7.3 and 7.4, each party agrees to cooperate with the other with
respect to the preparation, filing, prosecution and/or maintenance of patents
and patent applications. The party responsible for the preparation,
filing, prosecution and/or maintenance of such patents and patent applications
shall provide the other with copies of all material filings and material
correspondences from the relevant patent office, and shall consider in good
faith all comments from the other party pertaining to such filings and
correspondences.
8.
|
THIRD
PARTY INFRINGEMENT
|
8.1 Notice. Each Party
shall promptly notify in writing to the other Party during the term of this
Agreement any suspected infringement of the MLNM Patent Rights or MLNM Research
Tool Patents of which it becomes aware, and shall provide the other Party with
all available evidence supporting such suspected infringement or unauthorized
use.
11
8.2 Initial Right to
Enforce. Subject to Section 8.3 below, GLGC shall have the
first right to initiate a suit or take other appropriate action that it believes
is reasonably required to protect its interests in the GLGC Development Field
and MLNM shall have the first right to initiate a suit or take other appropriate
action that it believes is reasonably required to protect its interests outside
the GLGC Development Field.
8.3 Step-In Right. If a
first party fails to initiate a suit or take other appropriate action that it
has the first right to initiate pursuant to Section 8.2 above within 90 days
after becoming aware of the basis for such suit or action, then the other party
may, in its discretion, provide the first party with written notice of its
intent to initiate suit or take action. If the other party provides
such notice and the first party fails to initiate suit or take other appropriate
action within 30 days after receipt of such notice (which period may be extended
an additional 30 days at the request of the first party provided such extension
does not materially prejudice the rights of the other party), then the other
party has the right to initiate suit or take other appropriate action that it
believes is reasonably necessary to protect its interests.
8.4 Conduct of Certain Actions;
Costs. The party initiating suit shall have the sole and
exclusive right to select counsel for any suit initiated by it pursuant to
Sections 8.2 or 8.3. If required under applicable law in order for
the initiating party to initiate and/or maintain such suit, the other party
shall join as a party to the suit. The initiating party shall assume
and pay all of its out-of-pocket costs incurred in connection with any
litigation or proceedings initiated by it, as well as the other party’s expenses
unless the other party elects to retain its own counsel. The other
party will have the right to participate and be represented by its own counsel
at its own expense. Regardless of whether a party is joined in a suit
or other proceeding, neither party shall enter into any settlement, consent
judgment or other voluntary final disposition of any infringement action under
this paragraph that would be materially prejudicial to the other party without
the other party’s prior written consent which shall not be unreasonably withheld
or delayed. The proceeds of any such settlement, consent judgment or
other voluntary final disposition under this paragraph will be applied in
accordance with the principals set forth in Section 8.5 below.
8.5 Recoveries. With
respect to any suit or action referred to in Sections 8.2 and 8.3, any recovery
obtained as a result of any proceeding, by settlement or otherwise, shall be
applied in the following order of priority:
(a) first,
the Parties shall be reimbursed for all costs incurred in connection with such
proceeding paid by the Parties and not otherwise recovered;
(b) second,
any recovery for infringing activities in the GLGC Development Field shall be
retained by GLGC;
(c) third,
any recovery for infringing activities relating to Oncology Diseases shall be
retained by MLNM;
(d) fourth,
only if recovered in a suit initiated prior to September 30, 2008, any recovery
for infringing activities relating to Obesity, Type 1 Diabetes or Type 2
Diabetes shall be retained by MLNM; and
(e) fifth,
any remainder shall be paid 75% to the party initiating the suit or action and
25% to the other party.
9.
|
TERM
AND TERMINATION
|
9.1 Term. Unless
terminated earlier in accordance with the following provisions of this clause,
this Agreement shall commence on the Effective Date and shall continue in effect
until the later of (a) ten (10) years after the Effective Date, or (b) the last
to expire claim in the MLNM Patent Rights, or (c) the end of the Royalty Term
set forth in Section 5.4 (the “Term”).
12
9.2 Termination for
Breach. Any failure by a Party to comply with any of its
material obligations contained in this Agreement shall entitle the Party not in
default to give to the Party in default written notice specifying the nature of
the default and requiring the defaulting Party to make good or otherwise cure
such default. If, after a Party’s receipt of notice pursuant to this
Section 9.2, such default has not been cured within sixty (60) days (unless such
Party can demonstrate good faith efforts to cure, in which case the default
period shall be extended an additional 30 days) then the Party not in default
shall be entitled, on written notice to the other Party and without prejudice to
any other rights available to it by law or in equity, to terminate this
Agreement with immediate effect.
9.3 Effect of Termination.
Termination shall be without prejudice to the rights, remedies, obligations, and
liabilities of either Party which may have accrued on or at any time up to the
date of termination. Breach or termination of this Agreement or of
any right hereunder shall not give rise to a right by either Party to seek
rescission of or to void or unwind under any theory the transactions
contemplated under the Purchase Agreement, and shall have available to it the
remedies provided by law other than those remedies.
9.4 Survival. The
provisions of Articles 6, 10, 11, 12, and 13 along with Sections 4.5, 5.8, and
this Section 9.4, together with any definitions used or exhibits, schedules, or
appendices referenced therein, shall survive any termination or expiration of
this Agreement.
10.
|
INDEMNIFICATION;
PROCEDURES
|
10.1 Indemnification. Each
Party hereby covenants and agrees to defend, indemnify and hold harmless the
other Party, the other Party's affiliates, and their respective directors,
officers, employees, successors and assigns (collectively, the “Indemnified Parties”) from and
against all claims, suits, actions, liabilities, losses, costs, reasonable
attorneys’ fees, expenses, judgments and damages incurred by any of them as a
result of any claims by third parties in tort, contract or otherwise arising in
any way out of (a) a breach of the Indemnifying Party's (defined below)
representations and warranties hereunder, or (b) any gross negligence or wilful
misconduct by or on behalf of the Indemnifying Party or its sublicensees; but
excluding any such claim to the extent arising out of either the breach of a
representation and warranty made by the Indemnified Party or the gross
negligence of or wilful misconduct by any Indemnified Party.
10.2 Indemnification
Procedures. In the case of any claim asserted by a third party
against an Indemnified Party, notice will be given by the Indemnified Party to
the Party obligated to provide indemnification under Section 10.1 (the “Indemnifying Party”) promptly
after such Indemnified Party has actual knowledge of any claim as to which
indemnity may be sought, and the Indemnified Party will permit the Indemnifying
Party (at its expense) to assume the defense of any claim or any litigation
resulting therefrom; provided that (a) the counsel for Indemnifying Party who
will conduct the defense of such claim or litigation will be reasonably
satisfactory to the Indemnified Party, (b) the Indemnified Party may participate
(but not control) in such defense at such Indemnified Party’s expense, and (c)
the omission by any Indemnified Party to give notice as provided herein will not
relieve the Indemnifying Party of its indemnification obligation under this
Agreement except to the extent that such omission results in a failure of actual
notice to the Indemnifying Party and the Indemnifying Party is materially
prejudiced by such failure to give notice. Except with the prior
written consent of the Indemnified Party, the Indemnifying Party, in the defense
of any such claim or litigation, will not consent to entry of any judgment or
enter into any settlement that provides for injunctive or other non-monetary
relief affecting the Indemnified Party or that does not completely release the
Indemnified Party. The Indemnified Party will not settle or
compromise any claim by a third party for which the Indemnified Party is
entitled to indemnification hereunder without the prior written consent of the
Indemnifying Party if the Indemnifying Party elects to assume the defense of
such claim in accordance with this Section 10.2. In the event that
the Indemnifying Party does not promptly accept the defense of any matter as
above provided and thereafter diligently conduct such defense, the Indemnified
Party will have the full right to defend against any such claim or demand and
will be entitled to settle or agree to pay in full such claim or demand and to
recover any amounts paid plus all reasonable expenses (including attorneys'
fees) from the Indemnifying Party. In any event, if the Indemnifying
Party promptly undertakes the defense of any claim and thereafter diligently
conducts such defense, the Indemnifying Party and the Indemnified Party will
cooperate in the defense of any claim or litigation subject to this Section 10.2
and the records of each will be available to the other with respect to such
defense.
13
11.
|
LIMITATION
OF LIABILITY; INSURANCE
|
11.1 Limitation of
Liability. 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 6 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 ANY OTHER PARTY UNDER THIS
AGREEMENT.
11.2 Essential Basis of Agreement.
The Parties acknowledge and agree that the disclaimers, exclusions and
limitations of liability set forth in this Section 11 form an essential basis of
this Agreement, and that, absent any of such disclaimers, exclusions or
limitations of liability, the terms of this Agreement, including, without
limitation, the economic terms, would be substantially different.
11.3 Insurance. For its
development and commercialization activities, GLGC will be responsible for
providing adequate insurance coverage in such amounts and subject to such
deductibles as are prevailing in the industry from time to time, and provided
that it is reasonably available at reasonable rates, GLGC shall maintain a
minimum of an aggregate of [REDACTED] in general compensation liability
insurance, an aggregate of [REDACTED] in product liability insurance prior to
the start of a Phase III trial of a Development Candidate and an aggregate of
[REDACTED] in product liability insurance as of the start of a Phase III trial
of a Development Candidate. GLGC will name MLNM as an additional
insured on any such policies.
12.
|
REPRESENTATIONS AND
WARRANTIES.
|
12.1 Mutual
Representations. Each Party represents and warrants that (i)
it has the full right, power, and authority to enter into this Agreement and
(ii) the execution, delivery, and performance of this Agreement by such Party
shall not constitute or result in a violation, breach, or default under the
terms of any indenture, agreement (written or oral), instrument, understanding,
or other obligation or restriction to which each Party is a party or by which
each is bound.
12.2 Disclaimer of
Warranty. THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN
THIS SECTION 12 AND ELSEWHERE IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER
REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL
PROPERTY.
13. NOTICES. All notices, requests,
demands, waivers and other communications required or permitted to be given
under this Agreement will be in writing and will be deemed to have been duly
given if (a) delivered personally, (b) sent by next-day or overnight mail or
delivery (with confirmation of delivery) or (c) sent by fax (with overnight
delivery of copy) as follows:
(i) if
to GLGC:
Gene
Logic, Inc.
000
Xxxxxxxxxxxx Xxxxx
Xxxxxxxxxxxx,
XX 00000
Fax: (000)
000-0000
Attention:
Sr. Vice President/General Counsel
with a
copy to:
Xxxxxx
Godward LLP
One
Freedom Square
Reston Town Center
00000
Xxxxxxx Xxxxx
Xxxxxx,
XX 00000-0000
Fax: (000)
000-0000
Attn: Xxx
Xxxxxx
14
(ii) if
to MLNM:
Millennium
Pharmaceuticals, Inc.
00
Xxxxxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
Attention:
Xxxxx Xxxxxx
with a
copy to:
Millennium
Pharmaceuticals, Inc.
00
Xxxxxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
Fax: (000)
000-0000
Attention:
General Counsel
or, in
each case, at such other address as may be specified in writing to the other
parties hereto. All such notices, requests, demands, waivers and
other communications will be deemed to have been received (x) if by personal
delivery on the day after such delivery, (y) if by next-day or overnight mail or
delivery, on the day delivered, or (z) if by fax, on the next day following the
day on which such fax was sent, provided that a copy is also sent by overnight
(with confirmation receipt) mail.
14.
|
GENERAL
|
14.1 Relationship of
Parties. The Parties hereto expressly understand and agree
that the Parties are not joint venturers, partners or agents of each
other. Neither Party has the authority to bind, enter into contracts
or make representation on behalf of the other Party. Each Party is
responsible for all of its employees and third parties it may use to perform on
its behalf.
14.2 Choice of Law. This
Agreement shall be construed and the respective rights of the parties determined
according to the substantive laws of the State of Delaware notwithstanding the
provisions governing conflicts of laws under such Delaware law to the
contrary.
14.3 Section 365(n) of the Bankruptcy
Code. All rights and licenses granted under or pursuant
to any section of this Agreement are and shall otherwise be deemed to be for
purposes of Section 365(n) of the United States Bankruptcy Code (the “Bankruptcy Code”), licenses of
rights to “intellectual property” as defined in Section 101(35A) of the
Bankruptcy Code. The parties shall retain and may fully exercise all
of their respective rights and elections under the Bankruptcy Code.
14.4 Severability. If
any provision of this Agreement, including any phrase, sentence, clause, section
or subsection is inoperative or unenforceable for any reason, such circumstances
will not have the effect of rendering the provision in question inoperative or
unenforceable in any other case or circumstance, or of rendering any other
provision or provisions herein contained invalid, inoperative, or unenforceable
to any extent whatsoever.
14.5 Binding
Effect. This Agreement will be binding upon and inure to the
benefit of the parties and their respective legal representatives, successors
and permitted assigns.
14.6 Headings. Paragraph
headings are inserted for convenience of reference only and do not form a part
of this Agreement.
15
14.7 Counterparts. This
Agreement may be executed simultaneously in two or more counterparts, each of
which will be deemed an original.
14.8 Amendment,
Waiver. This Agreement may be amended, modified, superseded or
cancelled, and any of the terms may be waived, only by a written instrument
executed by each party or, in the case of waiver, by the party or parties
waiving compliance. The delay or failure of any party at any time or
times to require performance of any provisions will in no manner affect the
rights at a later time to enforce the same. No waiver by any party of
any condition or of the breach of any term contained in this Agreement, whether
by conduct, or otherwise, in any one or more instances, will be deemed to be, or
considered as, a further or continuing waiver of any such condition or of the
breach of such term or any other term of this Agreement.
14.9 No Third Party
Beneficiaries. No third party including any employee of any
Party to this Agreement, will have or acquire any rights by reason of this
Agreement. Nothing contained in this Agreement will be deemed to
constitute the parties partners with each other or any third party.
14.10 Assignment and
Successors. This Agreement may be assigned by either Party to
an Affiliate or in the case of a merger, reorganization or acquisition of all or
substantially all of its assets or (in the case of GLGC) the assets related to
GLGC’s DRS business. Either Party may subcontract or assign part or
all of its rights and obligations under this agreement to a third party with
prior, advance written notice to the other Party. Notwithstanding the
previous sentence, if a Party seeks to subcontract or assign any rights or
obligations related to the Development Candidates, the other Party may seek to
block such subcontract or assignment by reasonably demonstrating, within thirty
(30) days after receipt of notice, a material detrimental impact to the rights
and obligations that are the subject of the proposed subcontract or
assignment.
14.11 Force
Majeure. Neither MLNM nor GLGC will be liable for failure or
delay in performing obligations set forth in this Agreement, and neither will be
deemed in breach of its obligations, if such failure or delay is due to nature
disasters or any causes reasonably beyond the control of MLNM or
GLGC.
14.12 No Partnership. It
is expressly agreed that the relationship between GLGC and MLNM shall not
constitute a partnership, joint venture or agency. Neither GLGC nor
MLNM shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior consent of the other Party to do so.
14.13 Entire
Agreement. This Agreement, including any Schedules and
Exhibits attached hereto (each of which is hereby incorporated herein by
reference), sets forth the entire Agreement and undertaking between the Parties
as to the subject matter hereof and supersedes all prior discussions and
negotiations relating to the subject matter hereof. No variation or
amendment of this agreement shall bind either Party unless made in writing and
agreed to in writing by duly authorized officers of both
Parties. Nothing in this Agreement is intended to amend or supersede
any term of the Asset Purchase Agreement between the parties dated July 22, 2004
as amended June 29, 2006.
IN WITNESS
WHEREOF this Agreement has been executed the day and year first above written,
through their duly authorized representatives.
By: /s/ Xxxx X. Xxxxxxx
Name: Xxxx
X. Xxxxxxx
Title: President
and Chief Executive Officer
|
MILLENNIUM
PHARMACEUTICALS, INC.
By: /s/ Xxxx Xxxxxxxxxx
Name: Xxxx
Xxxxxxxxxx
Title: Senior
V.P., Corporate Development
|
16
Schedule
1.15
MLN
4760 Program Documents
[REDACTED]
17
Schedule
1.17
MLNM
Research Tool Patents
[REDACTED]
18
Schedule
1.23
Program
Materials
[REDACTED]
19