<PAGE>
Exhibit 10.4
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
RESEARCH COLLABORATION AND EXCLUSIVE OPTION AGREEMENT
This
Research Collaboration and Exclusive Option Agreement
("Agreement")
is made as of December 1, 2005 (the "Effective Date") by and
between Bausch &
Lomb Incorporated, a New York corporation with a place of business
at One Bausch
& Lomb Place, Rochester, New York 14604-2701 ("B&L") and
PTC Therapeutics, Inc.,
a Delaware corporation with a place of business at 100 Corporate
Court, South
Plainfield, New Jersey 07080-2449 ("PTC").
RECITALS
WHEREAS,
B&L desires to evaluate certain compounds in the possession
of
PTC for the purpose of identifying potential candidates for
development by B&L
for the treatment of ophthalmic diseases caused by
angiogenesis;
WHEREAS,
PTC is pursuing a subset of these compounds as development
candidates in the area of oncology;
WHEREAS,
PTC desires to grant, and B&L desires to receive, an
exclusive
option to license one or more such compounds selected by B&L
for use in the
treatment, diagnosis and/or prevention of diseases of the eye.
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual
covenants contained herein, PTC and B&L hereby agree as
follows:
1. Definitions. In addition to any terms defined elsewhere in this
Agreement,
the following terms shall have the meanings set forth below.
1.1
"Affiliate" means any corporation, association or other entity,
which
directly or indirectly controls, is controlled by or is under
common control
with the party in question. Solely for purposes of this definition
the term
"control" means direct or indirect beneficial ownership of more
than 50% of the
voting stock in such corporation or other business entity, or such
other
relationship as in fact constitutes actual control.
1.2
"Applicable Know-How" means any technical information, including
all
biological, chemical, pharmacological, toxicological, clinical and
assay
information, data, discoveries, inventions, improvements, know-how,
materials,
processes, formulae and trade secrets, whether patentable or
unpatentable (but
not patented), that at any time during the applicable Term are
Controlled by PTC
and that relate to an Evaluation Compound in the applicable
Field.
<PAGE>
-2-
1.3
"Applicable Laws" means all laws, ordinances, rules and
regulations
applicable to this Agreement or the activities contemplated
hereunder, including
without limitation the U.S. Federal Food, Drug, and Cosmetic Act,
as amended.
1.4 "Applicable
Patents" means all U.S. and international patents and U.S.
and international patent applications that at any time during the
applicable
Term are Controlled by PTC, the claims of which may be infringed,
absent a
license, by the manufacture, use, sale, offer for sale or
importation of an
Evaluation Compound in the applicable Field.
1.5
"Confidential Information" means any information communicated by
one
party hereto to the other, which is identified as proprietary or
confidential by
the disclosing party, or which would be reasonably understood to be
the type of
information which should be treated as proprietary or confidential.
PTC's
Confidential Information shall include the Applicable Know-How.
B&L's
Confidential Information shall include the B&L
Improvements.
1.6
"Controlled" means, with respect to any know-how or
intellectual
property right, possession by a party, directly or through an
Affiliate
controlled by such party, of the ability to grant the right to
access or use, or
to grant a license or a sublicense to, such know-how or
intellectual property
right as provided for herein without violating the terms of the
agreement or
other arrangement with any third party under which such rights to
access or use
are obtained.
1.7 "Evaluation
Compounds" means both the PTC Development Compounds and
the PTC Program Compounds.
1.8
"Field" means (i) with respect to the PTC Program Compounds,
the
treatment, diagnosis or prevention of diseases of the eye, and (ii)
with respect
to the PTC Development Compounds, the treatment, diagnosis or
prevention of
diseases of the eye through local delivery to the eye including
without
limitation intravitreal injection and implantation.
1.9 "PTC
Development Compound" means any chemical compound listed on
Exhibit A-2 to this Agreement as supplemented from time to time
with additional
compounds in related series.
1.10 "PTC
Program Compound" means any chemical compound listed on Exhibit
A-1 to this Agreement.
2. Evaluation Activities.
2.1
Provision of Information regarding Evaluation Compounds. PTC
shall
provide the following information to B&L to the extent
available for each
Evaluation Compound promptly following B&L's request with
respect to the first
group of Evaluation Compounds to be evaluated and then within [**]
following
B&L's request with regard to subsequent groups of Evaluation
Compounds to be
evaluated, provided that such requests with regard to subsequent
groups of
Evaluation Compounds may occur no more often than [**] and no more
often than
[**] during the Initial Term and [**] during the Extension
Term:
(a) PTC Compound Number ([**]);
<PAGE>
-3-
(b) molecular weight;
(c) chemical name and structure, including calculated 2D and 3D
molecular features; provided, however, that (i) chemical names and
structures
for PTC Program Compounds shall only be provided for inspection at
PTC's offices
until such time as specific compounds are selected for evaluation
by B&L, at
which time the names and structures of only those compounds
selected will be
provided, and (ii) chemical names and structures for PTC
Development Compounds
shall not be provided until after the in vitro screening proposed
by B&L is
complete, and then only for those PTC Development Compounds
actually screened
and for which B&L submits a written notice of continued
interest;
(d) [**];
(e) [**];
(f) [**];
(g) [**];
(h) a summary
description of the government grants received by PTC
in support of its research and development efforts relating to any
Evaluation
Compounds;
(i) any additional Applicable Know-How that would reasonably be
expected to be material to B&L's evaluation of the Evaluation
Compounds;
provided, however, that such additional Applicable Know-How shall
only be
provided for inspection at PTC's offices until such time as
specific Evaluation
Compounds are selected for evaluation by B&L; and
(j) information regarding any of the following of which PTC
becomes
aware following the Effective Date: (i) patent or other
intellectual property
rights owned or controlled by any third party that would be
infringed by such
Evaluation Compound or B&L's exercise of the evaluation license
granted under
Section 4.1 in accordance with this Agreement; (ii) any claims made
against PTC
asserting the invalidity, unenforceability, abuse or misuse of any
of the
Applicable Know-How or Applicable Patents; (iii) any claim made by
PTC of any
violation or infringement or misappropriation by others of PTC's
rights in an
Evaluation Compound, or the Applicable Know-How or Applicable
Patents; (iv) any
claim made that PTC is in conflict with or infringing upon the
asserted rights
of others in connection with the Applicable Compound, or the
Applicable Know-How
or Applicable Patents within the Field; (v) any patent or other
intellectual
property rights owned or controlled by any third party that would
be infringed
by the composition of matter of an Evaluation Compound or use of an
Evaluation
Compound in the applicable Field; and (vi) any licenses or
covenants not to sue
granted by PTC under the Applicable Know-How or Applicable Patents
in the
applicable Field; provided that PTC shall have no liability for any
Third Party
Claims under any provision of this Agreement based on any failure
to disclose
any information described in this Section 2.1(l); and further
provided that
PTC's obligation to provide the information described in this
Section 2.1(l)
shall only commence once B&L intends to engage [**].
2.2
Restrictions on Use of Information. B&L shall limit access to
the
information disclosed pursuant to Section 2.1 above to those
individuals under
its control who are involved in the evaluation process. In
particular, B&L shall
not store such information on any computer system or in any
database that is
either generally available to B&L scientific personnel or third
party
consultants or advisers, unless B&L implements reasonable
technological
measures (e.g.,
<PAGE>
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two-factor authentication employing unique userids and passwords)
to prevent
such information from being accessed by individuals other than
individuals who
are involved in the evaluation process. B&L shall not combine
or aggregate such
information within any database containing information not
developed pursuant to
the activities contemplated under this Agreement or a License
Agreement.
2.3
Provision of Evaluation Compounds. Subject to the limitation set
forth
in Sections 2.6 and 2.7, PTC shall, upon request by B&L, make
available to B&L
in such quantities as B&L may reasonably request any Evaluation
Compound
selected by B&L for evaluation, screening, testing and
formulation. Such
Evaluation Compounds shall be made available at PTC's facilities or
shall be, at
B&L's request and expense, provided to B&L at B&L's
facilities.
2.4
Evaluation of PTC Development Compounds by B&L. B&L agrees
that it
shall select the PTC Development Compounds as the first of the
Evaluation
Compounds to be evaluated and shall, promptly following the
Effective Date,
begin evaluation, screening, testing and formulation activities
with regard to
the PTC Development Compounds. If the evaluation, screening,
testing and/or
formulation done by B&L fails, B&L shall promptly notify
PTC in writing whether
B&L intends to continue evaluation, screening, testing or
formulation activities
with regard to the PTC Development Compounds.
2.5
Support of Evaluation Activities. Subject to the limitation set
forth
in Sections 2.6 and 2.7, PTC shall support B&L's evaluation
activities under
this Agreement as reasonably requested by B&L, including
without limitation, (i)
providing reasonable access to PTC's facilities and equipment
required to
conduct such activities, (ii) procuring reagents, assays and other
chemicals and
materials required to conduct such activities, (iii) making
available one or
more qualified employees to conduct or assist in the conduct of
such activities,
and (iv) otherwise reasonably cooperating with B&L.
2.6
Payment for PTC Obligations. B&L shall pay PTC $[**] during
the
Initial Term for PTC's obligations pursuant to Sections 2.3 and 2.5
(the "PTC
Obligations"), invoiced by PTC and paid by B&L in four
installments of $[**] on
a quarterly basis (with quarters, for this purpose, deemed to be
the four
consecutive three-calendar-month periods commencing with the
Effective Date),
representing the equivalent of [**] Absent any additional payments
by B&L
pursuant to Section 2.7, PTC's provision of [**] support during the
Initial Term
shall represent an upper limit on the amount of support that PTC is
required to
provide to fulfill the PTC Obligations.
2.7
Additional Resources. By mutual agreement, PTC may provide
additional
support for the B&L's evaluation activities beyond the PTC
Obligations, for
which B&L shall reimburse PTC at a rate of $[**] for PTC
resources (whether
internal or outsourced), or in the case of any out-of-pocket
purchase of
materials or equipment, for the actual cost to PTC of such
materials or
equipment.
2.8
Payment Terms. Subject to Section 2.6 (which specifies the
payment
amount for PTC's performance of the PTC Obligations), PTC shall
invoice B&L at
the end of each quarter for activities during the quarter then
ended specifying
the work performed, the man hours expended and the out of pocket
expenses
incurred, and B&L shall pay such invoices within [**]
<PAGE>
-5-
following receipt of invoice. If B&L disputes any amounts in an
invoice, it
shall notify PTC in writing of the reasons for such dispute within
[**] of
receipt of such invoice. B&L's failure to pay such disputed
amounts after
written notice is given to PTC shall not constitute a material
breach of this
Agreement for such time period as the parties are working together
in good faith
to resolve the dispute.
3. Option.
3.1 Fee
for Option Grant. Within fifteen (15) days following the
Effective
Date, B&L shall pay to PTC the sum of Three Hundred Thousand
Dollars ($300,000)
via check or wire transfer to a bank account designated by PTC.
3.2 Option
to PTC Program Compounds.
(a) Grant of Option. Subject to the terms and conditions set
forth
in this Agreement, PTC hereby grants to B&L, and B&L hereby
accepts, an
exclusive option (the "PTC Program Compounds Option") to obtain,
from time to
time during the Term, one or more exclusive, worldwide licenses to
develop and
commercialize one or more of the PTC Program Compounds in the
applicable Field
pursuant to the terms and conditions set forth in Exhibit B (each
such license,
a "License Agreement").
(b) Exercise of PTC Program Compounds Option. B&L may exercise
the
PTC Program Compounds Option at any time and as often during the
Term as B&L, in
its sole discretion, may determine, by providing written notice of
such exercise
to PTC specifying the PTC Program Compound that is the subject of
such exercise.
Following exercise of the PTC Program Compounds Option, the parties
shall
memorialize the license granted to B&L by executing a written
License Agreement
for such PTC Program Compound in the form attached hereto as
Exhibit B, and such
PTC Program Compound shall be deemed a "Licensed Compound".
(c) Exercise Fee. Within [**] following execution of the first
such
License Agreement for a Licensed Compound under Section 3.2(b),
B&L shall pay to
PTC the sum of [**] Dollars ($[**]), and within [**] following
execution of each
subsequent License Agreement for a Licensed Compound under Section
3.2(b), B&L
shall pay to PTC the sum of [**] Dollars ($[**]). Such amounts
shall be paid via
check or wire transfer to a bank account designated by PTC at the
time of
execution of each such License Agreement.
3.3 Option
to PTC Development Compounds.
(a) Grant of Option. Subject to the terms and conditions set
forth
in this Agreement, PTC hereby grants to B&L, and B&L hereby
accepts, an
exclusive option (the "PTC Development Compounds Option") to obtain
a worldwide
license to develop and commercialize the PTC Development Compounds
in the
applicable Field as further described in this Section.
(b) Exercise of Option. B&L may exercise the PTC
Development
Compounds Option at any time during the DC Term that B&L, in
its sole
discretion, may determine, by providing written notice of such
exercise to PTC.
<PAGE>
-6-
(c) Negotiation of License Agreement. Following the Effective
Date
the parties shall negotiate the terms and conditions of an
exclusive, worldwide
license to develop and commercialize the PTC Development Compounds
in the
applicable Field. Following exercise of the PTC Development
Compounds Option and
execution of a license agreement with respect thereto, the PTC
Development
Compounds shall be deemed "Licensed Compounds". Notwithstanding the
foregoing,
if after B&L exercises the PTC Development Compounds Option the
parties do not
reach agreement on the terms of such license agreement and enter
into such
license agreement prior to the date [**] following the expiration
of the DC
Term, B&L's rights under this Agreement with respect to the PTC
Development
Compounds shall expire and be of no further force or effect;
provided that the
parties shall extend their negotiations for an additional [**]
beyond the
expiration of such negotiation period if, by mutual agreement, the
parties
determine that such negotiations then remain active and viable.
4. Intellectual Property.
4.1
Evaluation License. PTC hereby grants to B&L, and B&L
hereby accepts,
an exclusive license under the Applicable Know-How and the
Applicable Patents to
evaluate, screen, test and formulate the Evaluation Compounds for
utility in the
applicable Field. With the consent of PTC, not to be unreasonably
withheld, B&L
may transfer the Evaluation Compounds to, and have such evaluation,
screening,
testing and formulation performed for it by, a third-party service
provider,
provided that B&L shall be responsible for compliance with the
terms of this
Agreement by any such third-party service provider.
4.2
Exclusivity. PTC agrees that, during the applicable Term, it shall
not
evaluate, screen or test for any third party, or permit any third
party to
evaluate, screen, or test (i) any of the Evaluation Compounds for
utility in the
applicable Field, (ii) disclose any Applicable Know-How to any
third party for
use in the applicable Field, or (iii) grant or have granted, within
the
applicable Field, any license, option to license or covenant not to
sue under
any of the Applicable Patents to any third party.
4.3
B&L Improvements. B&L shall own all right, title and
interest in and
to, any new process, manufacture, compound, composition of matter,
improvement,
discovery, claim, formula, process, trade secret, technology or
know-how
relating to any Evaluation Compound that is conceived or first
reduced to
practice solely by B&L employees, agents and/or third party
contractors during
the applicable Term as a result of the activities contemplated
under this
Agreement, including all patent and other intellectual property
rights thereto
(collectively, "B&L Improvements").
4.4 Joint
Improvements. The parties shall jointly own all right, title
and
interest in and to, any new process, manufacture, compound,
composition of
matter, improvement, discovery, claim, formula, process, trade
secret,
technology or know-how relating to any Evaluation Compound that is
conceived or
first reduced to practice jointly by one or more B&L employees,
agents and/or
third party contractors, on the one hand, and one or more PTC
employees, agents
and/or third party contractors, on the other hand, during the
applicable Term as
a result of the activities contemplated under this Agreement,
including all
patent and other intellectual property rights thereto
(collectively, "Joint
Improvements"). Subject to Section 4.5, each party may freely
license or assign
its interest in Joint Improvements without the consent of
<PAGE>
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the other party and without any duty to account to the other party.
B&L and PTC
shall be jointly responsible, using outside patent counsel mutually
agreed upon
by the parties and free of ethical conflict, for the preparation,
filing,
prosecution and maintenance of Joint Improvement patents and patent
applications
and the parties shall share equally the responsibility for all
documented
external costs associated therewith. Should either party elect to
discontinue
its payment obligations under this Section 4.4 for costs incurred
for the
filing, prosecution and maintenance of a Joint Improvement patent
or patent
application in one or more countries, at the request of the other
party such
party will assign its full right, title and interest in and to such
particular
patent or patent application to such other party
4.5
License to B&L Improvements and Joint Improvements. B&L
hereby grants
to PTC, and PTC hereby accepts, a non-exclusive, royalty-free,
worldwide
license, with the right to sublicense, to B&L Improvements for
use outside of
the applicable Field. At the request of PTC, B&L shall
negotiate terms,
including the payment of fees and royalties, under which (i) such
non-exclusive
licenses may be converted to exclusive licenses, and (ii) B&L
will grant an
exclusive license to B&L's interest in the Joint Improvements
for use outside of
the applicable Field.
4.6
Restriction on Practice and Use of Applicable Know-How and
Applicable
Patents. Notwithstanding the license rights granted herein, B&L
shall not
practice or use any Applicable Know-How or Applicable Patents to
synthesize or
discover any compound other than Evaluation Compounds, nor to
determine the
structure of any PTC Development Compound in advance of a
disclosure of such
compound's structure pursuant to Section 2.1(b). Breach of this
Section 4.6
shall constitute material breach of this Agreement under Section
5.3, remedies
for which shall not be limited by Section 8.
5. Term and Termination.
5.1
Initial Term. The term of this Agreement shall commence as of
the
Effective Date and, unless extended or earlier terminated as
forth
below, shall continue:
(i) with
respect to the PTC Program Compounds, for a period of one (1)
year
following the Effective Date (the "Initial Term"); and
(ii) with
respect to the PTC Development Compounds, until the earlier of
(a) the
date, if any, on which B&L has notified PTC in writing pursuant
to
Section
2.4 that B&L does not intend to continue evaluation,
screening,
testing or
formulation activities with regard to the PTC Development
Compounds;
(b) the date, if any, of the execution of a license agreement
pursuant
to Section 3.3; or (c) one (1) year following the Effective
Date
(the "DC
Term").
5.2
Extension Term. B&L may elect to extend the term of this
Agreement
solely with respect to the PTC Program Compounds for one (1)
additional period
of six (6) months following the Initial Term (the "Extension Term")
by (i)
notifying PTC in writing of such election at least [**] prior to
the expiration
of the Initial Term, which written notice shall specify the PTC
Program
Compounds that remain the subject of interest by B&L (the
"Extension
Compounds"), and (ii) paying to PTC the non-refundable sum of [**]
Dollars
($[**]) prior to the
<PAGE>
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expiration of the Initial Term. Following such extension, the term
"Evaluation
Compounds" shall refer only to the Extension Compounds. With
respect to PTC
Program Compounds, the Initial Term together with any applicable
Extension Term
shall be referred to herein as the "Term." With respect to PTC
Development
Compounds, any references to the "Initial Term" or the "Term" shall
mean the DC
Term.
5.3
Termination for Breach. Either party may terminate this Agreement
upon
written notice to the other party in the event that the other party
has failed
to perform a material obligation under this Agreement, and has
failed to cure
such non-performance within sixty (60) days following receipt of
written notice
specifying in reasonable detail the nature of such failure.
5.4
Termination by B&L. B&L may terminate this Agreement
without cause in
B&L's sole discretion upon ninety (90) days written notice to
PTC.
5.5 Effect
of Expiration and Termination.
(a) Expiration of DC Term. Subject to Section 3.3(c), upon
expiration of the DC Term, (i) the PTC Development Compound Option
shall expire;
(ii) rights granted to the PTC Development Compounds shall, if they
are not
Licensed Compounds, revert to PTC; (iii) the evaluation license
granted under
Section 4.1 shall terminate with respect to the PTC Development
Compounds; and
(iv) B&L shall disclose to PTC and permit PTC to use all
evaluation, screening,
testing and formulation data and the like generated pursuant to
this Agreement
relating to the PTC Development Compounds, if they are not Licensed
Compounds.
(b) Expiration of the Term. Upon expiration of the Term, (i) the
PTC
Program Compounds Option shall expire; (ii) rights to all PTC
Program Compounds
that are not Licensed Compounds shall revert to PTC; (iii) the
evaluation
license granted under Section 4.1 shall terminate with respect to
the PTC
Program Compounds; and (iv) B&L shall disclose to PTC and
permit PTC to use all
evaluation, screening, testing and formulation data and the like
generated
pursuant to this Agreement relating to all PTC Program Compounds
that are not
Licensed Compounds.
(c) Termination. Upon termination of this Agreement under
Sections
5.3 or 5.4, (i) each of the PTC Development Compounds Option and
the PTC Program
Compounds Option shall expire; (ii) rights to all Evaluation
Compounds that are
not Licensed Compounds shall revert to PTC; (iii) the evaluation
license granted
under Section 4.1 shall terminate; and (iv) B&L shall disclose
to PTC and permit
PTC to use all evaluation, screening, testing, formulation and
similar data (but
not techniques, protocols or methodologies) generated pursuant to
this Agreement
relating to all Evaluation Compounds that are not Licensed
Compounds.
(d) License upon Expiration or Termination. B&L shall, and
hereby
does, grant to PTC a non-exclusive license, effective as of
expiration or
termination of the applicable Term with respect to an Evaluation
Compound that
is not a Licensed Compound, under all know-how and patent rights
that are
conceived or first reduced to practice by B&L employees, agents
and/or third
party contractors prior to such expiration or termination as a
result of the
activities contemplated under this Agreement which know-how and
patent rights
cover the Evaluation Compound or method of use of such Evaluation
Compound in
the applicable Field,
<PAGE>
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with the right to sublicense, to make, have made, use, offer for
sale, sell and
import such Evaluation Compound, and only the Evaluation Compound,
in any
country of the world. At the request of PTC, B&L shall
negotiate terms,
including the payment of fees and royalties, under which such
non-exclusive
license may be converted to an exclusive license, subject to any
non-exclusive
licenses that may have been granted by B&L to any third parties
prior to such
request.
(e) No Effect on Licensed Compounds. Neither termination nor
expiration of this Agreement shall terminate or otherwise affect
licenses
granted with regard to Licensed Compounds prior to the date of such
termination
or expiration, and all such licenses shall survive such termination
or
expiration.
5.6
Survival. Termination or expiration shall not relieve either
party
from any obligations accrued as of the date of such termination or
expiration.
The obligations of the parties under Sections 2.2, 4.3, 4.4, 4.5,
5.5, 5.6, 7,
8, 9, 10 and 11 shall survive termination or expiration of this
Agreement.
6. Warranties, Representations and Covenants.
6.1
Representations, Warranties and Covenants of Each Party.
(a) Authority. Each party represents and warrants that it
possesses
all right, title, interest and authority necessary to enter into
this Agreement,
perform its obligations hereunder and grant the rights embodied
herein and that
it is not aware of any legal impediment that would inhibit its
ability to
perform its obligations under this Agreement.
(b) No Conflicts. Each party represents and warrants to the
other
that the execution, delivery and performance of this Agreement does
not: (i)
conflict with, or constitute a breach of, any order, judgment,
agreement or
instrument to which such party is a party or is otherwise bound; or
(ii) require
the consent of any person or entity.
6.2
Representations, Warranties and Covenants of PTC.
(a) Compliance with Laws. PTC covenants, represents and
warrants
that it shall comply with all Applicable Laws.
(b) Third Party Intellectual Property. PTC represents and
warrants
that to its knowledge as of the Effective Date there are no patent
or other
intellectual property rights owned or controlled by any third party
that would
be infringed by the Evaluation Compounds or B&L's exercise of
the evaluation
license granted under Section 4.1 in accordance with this
Agreement.
6.3
Representations, Warranties and Covenants of B&L. B&L
covenants,
represents and warrants that it shall comply with all Applicable
Laws.
<PAGE>
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7. Indemnification.
7.1 PTC
Indemnification.
(a) Indemnity. PTC shall indemnify, defend and hold harmless
B&L and
its Affiliates, and their directors, officers, agents and
employees
(collectively, the "B&L Indemnified Parties") from and against
all claims,
demands, losses, liabilities, damages, costs and expenses
(including reasonable
attorneys' fees and any costs of settlement) incurred by the
B&L Indemnified
Parties resulting from or arising in connection with any claim,
suit, action or
proceeding brought by a third party (a "Third Party Claim") against
any such B&L
Indemnified Party based on:
(i) PTC's breach of any of PTC's covenants, representations or
warranties hereunder; or
(ii) any act or omission constituting recklessness, gross
negligence or willful misconduct on the part of PTC.
(b) Limitations on PTC Indemnification. PTC shall have no
obligation
to indemnify, defend or hold harmless the B&L Indemnified
Parties in connection
with any Third Party Claim to the extent such Third Party Claim is
covered by
B&L's obligations under Section 7.2, or arises from: (i) a
B&L Indemnified
Party's breach of any of B&L's covenants, representations or
warranties
hereunder; or (ii) any act or omission constituting recklessness,
gross
negligence or willful misconduct on the part of any of the B&L
Indemnified
Parties.
7.2
B&L Indemnification.
(a) Indemnity. B&L shall indemnify, defend and hold harmless
PTC,
its Affiliates, and their directors, officers, agents and
employees
(collectively, the "PTC Indemnified Parties") against all claims,
demands,
losses, liabilities, damages, costs and expenses (including
reasonable
attorneys' fees and any costs of settlement) incurred by the PTC
Indemnified
Parties resulting from or arising in connection with a Third Party
Claim brought
against any such PTC Indemnified Party based on:
(i) B&L's breach of any of B&L's covenants, representations
or
warranties hereunder; or
(ii) any act or omission constituting recklessness, gross
negligence or willful misconduct on the part of B&L.
(b) Limitations on B&L Indemnification. B&L shall have no
obligation
to indemnify, defend or hold harmless the PTC Indemnified Parties
in connection
with any Third Party Claim to the extent such Third Party Claim is
covered by
PTC's obligations under Section 7.1, or arises from: (i) a PTC
Indemnified
Party's breach of any of PTC's covenants, obligations,
agreements,
representations or warranties hereunder; or (ii) any act or
omission
constituting recklessness, gross negligence or willful misconduct
on the part of
any of the PTC Indemnified Parties.
<PAGE>
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7.3
Indemnification Procedure.
(a) Notification and Cooperation. The party seeking
indemnification
hereunder (the "Indemnified Party") shall: (i) promptly notify in
writing the
party obligated to indemnify (the "Indemnifying Party") of any
claim, action or
proceeding of a third party for which the Indemnified Party
seeks
indemnification; and (ii) cooperate fully with the Indemnifying
Party and its
legal representatives in the investigation of any such claim,
action or
proceeding. The Indemnified Party's failure to comply with its
obligations under
this Section shall not constitute a breach of this Agreement nor
relieve the
Indemnifying Party of its indemnification obligations hereunder,
except to the
extent, if any, that the Indemnifying Party's defense or settlement
of the
affected claim, action or proceeding was actually and materially
impaired
thereby.
(b) Defense. The Indemnifying Party shall conduct, at its own
expense, the defense of any and all such claims, charges, suits or
other actions
by a third party, and the Indemnified Party may, at its own
expense, assist in
such defense if it so chooses, provided that the Indemnifying Party
shall
control such defense and all negotiations relative to the
settlement of any such
claim. Neither party shall settle or admit liability with respect
to any such
claims, charges, suits or other actions which could result in
liability to the
other party without the prior written consent of the other party,
which consent
shall not be unreasonably withheld or delayed.
8. Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS
AGREEMENT TO THE
CONTRARY, NEITHER PTC NOR B&L, NOR THEIR RESPECTIVE AFFILIATES,
DIRECTORS,
OFFICERS, EMPLOYEES OR AGENTS, SHALL HAVE ANY LIABILITY TO THE
OTHER FOR ANY
SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES, IN
CONNECTION WITH OR
ARISING OUT OF THIS AGREEMENT, EVEN IF SUCH DAMAGES WERE
FORESEEABLE, EXCEPT TO
THE EXTENT SUCH DAMAGES ARE OWED TO A THIRD PARTY BY A PARTY
ENTITLED TO
INDEMNIFICATION UNDER THIS AGREEMENT AND EXCEPT FOR ANY DAMAGES
ARISING FROM
BREACH OF A PARTY'S CONFIDENTIALITY OBLIGATIONS UNDER THIS
AGREEMENT.
9. Confidentiality.
9.1
Nondisclosure and Nonuse Obligations. During the Term, and
thereafter
after expiration or termination hereof, each party will maintain
all
Confidential Information of the other party in trust and confidence
and will not
disclose any Confidential Information of the other party to any
third party or
use any Confidential Information of the other party except to the
extent
required to enjoy its rights or comply with its obligations under
this
Agreement. Confidential Information shall be disclosed only to
employees,
agents, Affiliates and consultants who have a need for such
information and who
are bound by obligations of nondisclosure and non-use at least as
restrictive as
those set forth herein. Each party shall be responsible for any
disclosure or
use of the Confidential Information by such employees, agents,
Affiliates and
consultants. Each party shall protect the other party's
Confidential Information
using not less than the same standard of care with which it treats
its own
Confidential Information, but at all times shall use at least
reasonable care.
<PAGE>
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9.2
Exceptions. Confidential Information shall not include any
information
which:
(a) is now, or lawfully becomes, generally known or available to
the
public through no fault of the recipient;
(b) is known by the receiving party at the time of receiving
such
information;
(c) is hereafter lawfully furnished to the receiving party by a
third party, as a matter of right and without restriction on
disclosure;
(d) is independently developed by the receiving party without
any
breach of this Section as evidenced by its written records; or
(e) is the subject of a written permission to disclose provided
by
the disclosing party.
9.3
Authorized Disclosure. Notwithstanding any other provision of
this
Agreement, each party may disclose Confidential Information of the
other party
if such disclosure is required: (i) by an order of a court or other
governmental
body, or any political subdivision thereof or arbitral panel with
jurisdiction
over the disclosing party; or (ii) by law or regulation (including,
without
limitation, to comply with any applicable securities regulation,
stock exchange
or NASDAQ disclosure requirements), but only to the extent that any
such
disclosure is reasonably necessary. With respect to any order of a
court or
other governmental body, the disclosing party shall, if
practicable, first have
given written notice to the other party hereto and shall use
reasonable efforts
to limit the scope and content of such disclosure to the required
scope and
content. With respect to disclosure required by Applicable Laws or
regulations
(including, without limitation, any applicable securities
regulation, stock
exchange or NASDAQ disclosure requirements), the disclosing party
shall, if
practicable, first give written notice to the other party hereto
and allow the
other party a reasonable opportunity to comment on the content of
such
disclosure and shall consult with the other party with respect to
the comments
of such other party.
9.4
Obligations at End of Term. Each party agrees, at the request of
the
other party, upon expiration or termination of this Agreement to
either: (i)
return to the other party all originals and copies of the other
party's
Confidential Information; or (ii) at the other party's option,
destroy all
originals and copies of the other party's Confidential Information
and to
certify in writing such destruction to the other party; provided,
however that
(a) the receiving party may keep one copy of the other party's
Confidential
Information in a secure location, solely for purposes of enforcing
and
determining such party's rights and obligations under this
Agreement; (b) PTC
shall have no obligation to return or destroy any copies embodying
the B&L
Improvements or the Joint Improvements; and (c) B&L shall have
no obligation to
return or destroy any Applicable Know-How relating to any Licensed
Compounds or
the Joint Improvements.
9.5
Injunctive Relief. The parties agree that any breach of the
restrictions contained in this Section or Section 4.6 will cause
irreparable
harm to the non-breaching party entitling the non-breaching party
to injunctive
or other preliminary relief in addition to all other legal
remedies.
<PAGE>
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10. Publicity. All publicity, press releases and other
announcements regarding
this Agreement or the transactions contemplated hereby shall be
reviewed in
advance by, and subject to the written approval of, both
parties.
Notwithstanding the foregoing, either party may, without the
written consent of
the other, disclose the terms of this Agreement insofar as
reasonably required
to comply with applicable securities laws (including, without
limitation, any
applicable stock exchange or NASDAQ disclosure requirements);
provided, however,
that where practicable the disclosing party shall provide advance
notice and a
reasonable opportunity to the other party to provide comments
regarding any
confidential treatment or similar request. The disclosing party
shall if
practicable reasonably consider any such comments from the other
party. In
addition, each party shall have the right to disclose, under
obligations of
confidentiality and as reasonably required, the terms of this
Agreement to
potential acquirers, investors, lenders, licensees, sublicensees,
contractors
and other third parties in connection with acquisition, financing,
product
development or commercialization activities.
11. Miscellaneous.
11.1 Bankruptcy. All licenses granted under this Agreement by PTC
to
B&L, for all purposes of Section 365(n) of Title XI of the
United States Code
("Title XI"), are licenses of rights to "intellectual property" as
defined in
Title XI. If PTC seeks or involuntarily is placed under Title XI
and the trustee
rejects this Agreement as contemplated under 11 U.S.C. 365(n)(1),
B&L hereby
elects pursuant to Section 365(n) to retain all rights granted to
B&L under this
Agreement to the extent permitted by law.
11.2 Relationship of the Parties. Nothing in this Agreement shall
be
deemed to create any contract or relationship of employment between
B&L and PTC
or any personnel of PTC. PTC shall be responsible for all federal,
state and
local laws pertaining to income taxes, withholding taxes, Social
Security,
unemployment compensation, worker's compensation and any other
rights, benefits,
or obligations relating to such personnel.
11.3 Notices. All notices required or permitted hereunder must be
given
in writing and mailed postage prepaid, certified or registered
mail, return
receipt requested, or sent by a nationally recognized express
courier service,
or hand-delivered at the following addresses:
To PTC:
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, New Jersey 07080-2449
Attn.: Legal Dep't
Email copy to: legal@ptcbio.com
To
B&L:
Bausch & Lomb Incorporated
One Bausch & Lomb Place
Rochester, New York
14604-2701
Attn.: Senior Vice President - Research and
Development and Chief Scientific Officer
<PAGE>
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Copy to:
Bausch & Lomb Incorporated
One Bausch & Lomb Place
Rochester, New York
14604-2701
Attn.: Senior Vice President and General Counsel
All notices shall be deemed made upon receipt by the addressee
as
evidenced by the applicable written receipt.
11.4 Captions and Section References. The titles, headings or
captions
in this Agreement do not define, limit, extend, explain or describe
the scope or
extent of this Agreement or any of its terms or conditions and
therefore shall
not be considered in the interpretations, construction or
application of this
Agreement.
11.5 Severability. If any term or provision of this Agreement shall
be
found to be invalid, illegal or otherwise unenforceable, such
finding shall not
affect the other terms or provisions of this Agreement, or the
whole of this
Agreement, but such term or provision shall be deemed modified to
the extent
necessary to render such term or provision enforceable, and the
rights and
obligations of the parties shall be construed and enforced
accordingly,
preserving to the fullest permissible extent the intent and
agreements of the
parties set forth in this Agreement.
11.6 Amendment. No amendment, change or modification of any of
the
terms, provisions or conditions of this Agreement shall be
effective unless made
in a writing that expressly references this Agreement and is signed
on behalf of
the parties hereto by their duly authorized representatives.
11.7 Waiver. No waiver of any term, provision or condition of
this
Agreement, whether by conduct or otherwise, in any one or more
instances, shall
be deemed to be or construed as a further or continuing waiver of
any such or
other term, provision or condition of this Agreement.
11.8 Force Majeure. Neither party shall be liable hereunder to
the
other party nor shall be in breach for failure to perform its
obligations caused
by circumstances beyond the control of either party, including, but
not limited
to: acts of nature; fires; earthquakes; floods; riots; wars; civil
disturbances;
sabotage; accidents; shortages or government actions. In the case
of any such
event, the affected party shall promptly notify the other party,
and shall keep
the other party informed of the event in writing specifying the
extent to which
its performance will likely be affected. The party affected shall
exert
reasonable diligent efforts to eliminate, cure or overcome any such
cause and
resume performance as soon as practicable.
11.9 Benefits and Binding Nature of Agreement. This Agreement shall
be
binding upon and shall inure to the benefit of the parties hereto
and their
respective successors and assigns permitted under this
Agreement.
11.10 Assignment; Change in Control. The rights under this
Agreement
may not be assigned by either party (the "Assigning Party") without
the written
consent of the other party (the "Non-Assigning Party") except (i)
to any
Affiliate of the Assigning Party or (ii) to any party
<PAGE>
-15-
which acquires substantially all of the assets and business of the
Assigning
Party to which this Agreement relates.
11.11 Entire Agreement. This Agreement, including the Exhibits
attached
hereto, sets forth the entire agreement between the parties hereto
pertaining to
the subject matter hereof and supersedes all negotiations,
preliminary
agreements, memoranda or letters of proposal or intent, discussions
and
understandings of the parties hereto in connection with the subject
matter
he