PRODUCT DEVELOPMENT
AGREEMENT
KING PHARMACEUTICALS,
INC.
KING PHARMACEUTICALS RESEARCH AND
DEVELOPMENT, INC.
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
THIS PRODUCT
DEVELOPMENT AGREEMENT (“ Agreement ”) is
made on June 18, 2008 (the “ Effective Date
”) by and between COREPHARMA LLC , a limited liability
company, incorporated under the laws of New Jersey (“
Core ”), and KING PHARMACEUTICALS, INC. , a
corporation incorporated under the laws of Tennessee (“
KPI ”), and KING PHARMACEUTICALS RESEARCH AND
DEVELOPMENT, INC. , a Delaware corporation and wholly owned
subsidiary of KPI (“ King R&D ”, and
together with KPI, “ King ”).
WHEREAS ,
King and Core are in the business of researching, developing,
formulating and manufacturing pharmaceutical products;
and
WHEREAS ,
Core has certain expertise in formulating, manufacturing, and
developing new formulations of metaxalone that present
bioavailability profile that is higher than the Reference Product
(as defined herein);
WHEREAS ,
King possesses rights in certain intellectual property pertaining
to product formulations of the active pharmaceutical ingredient
metaxalone;
WHEREAS ,
King desires to research, develop, and seek marketing approval for
[***] improved formulations of metaxalone (as further described
herein) [***];
WHEREAS ,
King seeks Core’s services in formulating, manufacturing, and
development of [***] improved formulations of metaxalone (as
further described herein) for human use and Core seeks to provide
such services to King; and
WHEREAS ,
KPI and Core shall, simultaneously with the execution of this
Agreement, execute an Amended and Restated Skelaxin Manufacturing
and Supply Agreement (the “ Amended and Restated Skelaxin
Manufacturing and Supply Agreement ”) to modify
provisions of the Skelaxin Manufacturing and Supply Agreement dated
as of May 11, 2006, between KPI and Core, as amended, to
provide for the transactions contemplated herein and amend pricing
relating to the Improved Product (as defined therein).
NOW,
THEREFORE, THE PARTIES HERETO, INTENDING TO BE LEGALLY BOUND,
HEREBY AGREE AS FOLLOWS:
In this Agreement
unless the context otherwise requires, the following terms shall
have the following meanings:
1.1 “
Affiliate(s) ” means, with respect to any Person, any
other Person that directly, or indirectly through one or more
intermediaries, controls, is controlled by, or is under common
control with, such Person. A Person will be regarded as in control
of another Person if such Person owns, or directly or indirectly
controls, more than 50% of the voting securities (or comparable
equity interests) or other ownership interests of the other Person,
or if such Person
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
directly or
indirectly possesses the power to direct or cause the direction of
the management or policies of the other Person, whether through the
ownership of voting securities, by contract, or any other means
whatsoever, provided, however, that, for purposes of this
Agreement, the term “Affiliate” will not include
subsidiaries in which a party or its Affiliates owns a majority of
the ordinary voting power to elect a majority of the board of
directors, but is restricted from electing such majority by
contract or otherwise, until such time as such restrictions are no
longer in effect.
1.2 “
Agreement ” shall have the meaning set forth in the
preamble hereto.
1.3 “
Amended and Restated Skelaxin Manufacturing and Supply
Agreement ” shall have the meaning set forth in the
preamble hereto.
1.4 “
API ” shall mean the active pharmaceutical ingredient
metaxalone polymorph 1.
1.5 “
Background IP ” shall mean, with respect to a Party,
the Intellectual Property of such Party that is (a) reasonably
useful or necessary for the performance of the Development Services
or the development, manufacture, importation, use, marketing,
distribution, and sale of Target Formulations in and for the
Territory, and (b) Controlled by such Party on the Effective
Date, or that comes within such Party’s Control during the
Term (other than a Party’s rights in any Inventions);
provided, however, that any Intellectual Property created in the
process of the execution of the matters set forth on
Schedule A prior to the Effective Date shall be deemed to be
King Background IP.
1.6 “
Completion of Development Activities for Target [***]
” shall have the meaning assigned to such term in
Section 3.1(a) .
1.7 “
Confidentiality Agreement ” shall be that
Confidentiality Agreement between Core and KPI, dated
August 18, 2005 attached hereto as Schedule B
.
1.8 “
Control ” or “ Controlled ” shall
mean, with respect to any Intellectual Property, the possession
(whether by ownership or license), or the ability of a Party to
assign, transfer, grant access to, or grant a license or sublicense
of, such item or right as provided for herein.
1.9 “
Core Indemnitees ” shall have the meaning ascribed to
such term in Section 6.1(a) .
1.10 “
Covering ” means, with respect to a product or with
respect to technology, that, in the absence of a license granted
under a Valid Claim, the making, use, offering for sale, or
importation of such product or the practice of such technology
would infringe such Valid Claim.
1.11 “
Development Expense Cap ” shall have the meaning
ascribed to such term in Section 3.1(b) .
1.12 “
Development Expenses ” shall have the meaning ascribed
to such term in Section 3.1(b) .
1.13 “
Development Fees ” shall have the meaning ascribed to
such term in Section 3.1(a) .
1.14 “
Development Plan ” shall mean the workplan, projected
timetable and budget described in Schedule A attached
hereto (as amended by King and Core from time to time pursuant to
Section 2.2 ) for the performance of (i) the
Development Services, (ii) the
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
development of
Target [***], (iii) the achievement of Successful Proof of
Concept for Target [***], and (iv) the development of Target
[***] following achievement of Successful Proof of Concept for
Target [***].
1.15 “
Development Services ” shall mean the services related
to the research, development, and regulatory approval of Target
[***] and Target [***] (after Successful Proof of Concept for
Target [***] has been demonstrated to King) as described and to be
performed by Core under this Agreement, including all research,
preclinical, pharmaceutical, regulatory and other activities
undertaken by Core pursuant to Section 2.3 , including
without limitation all [***] and any other regulatory filings
required for the successful commercialization of Target [***] in
accordance with Section 2.3 and with the assistance of
King, assisting King in its compilation, filing and obtaining
approval of the NDA and any other regulatory filings required for
the successful commercialization of Target [***] in accordance with
Section 2.3 , such other activities as are more fully
described in and in accordance with the Development Plan, and all
technology transfer activities and assistance provided by Core
pursuant to Section 2.6 . The Development Services
shall also include services by Core to achieve Successful Proof of
Concept for Target [***].
1.16 “
Discount ” means, with respect to Target [***], the
following as they relate to the sales of Target [***], and with
respect to Target [***], the following as they relate to the sales
of Target [***]:
(a) all documented
and verifiable applicable sales credits accrued in accordance with
GAAP and customary discounts (such as cash discounts, volume
discounts, chargebacks, promotional, shelf stock and other
allowances, government mandated rebates (whether in existence now
or enacted at any time hereafter) and other rebates, credits, and
returns), and
(b) sales, use or
excise taxes.
1.17 “
FDA ” shall mean the United States Food and Drug
Administration and any successor entity.
1.18 “
First Commercial Sale ” (i) with respect to
branded Target [***] shall mean the first arm’s-length sale
by King, its Affiliates, or any King licensee to a Third Party of
Target [***] for end-use of consumption, including any sale to a
wholesaler or distributor, of such product in a country after the
applicable Regulatory Authority has granted regulatory approval for
such product; and (ii) with respect to branded Target [***]
shall mean the first arm’s-length sale by King, its
Affiliates, or any King licensee to a Third Party of Target [***]
for end-use of consumption, including any sale to a wholesaler or
distributor, of such product in a country after the applicable
Regulatory Authority has granted regulatory approval for such
product. For purposes of this definition, any sale to an Affiliate
or King licensee will not constitute a First Commercial
Sale.
1.19 “
Good Clinical Practices ” shall mean the then-current
standard for the design, conduct, performance, monitoring,
auditing, recording, analysis, and reporting of trials that involve
the participation of human subjects to support or are intended to
support applications for research or marketing permits for products
regulated by the FDA. Good Clinical Practices are established
through FDA regulations (including 21 CFR Parts 11, 50, 54, 312,
and 314), FDA guidance, FDA current review and inspection
standards, and current industry standards.
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
1.20 “
Good Laboratory Practices ” shall mean the
then-current standards for conducting nonclinical laboratory
studies that support or are intended to support applications for
research or marketing permits for products regulated by the FDA.
Good Laboratory Practices are established through FDA regulations
(including 21 CFR Part 58), FDA guidance, FDA current review
and inspection standards, and current industry
standards.
1.21 “
Good Manufacturing Practices ” shall mean the
then-current Good Manufacturing Practices as defined in the U.S.
Code of Federal Regulations that are applicable to each Target
Formulation as amended from time to time. Good Manufacturing
Practices are established through FDA regulations (including 21 CFR
Parts 210 and 211), FDA guidance, FDA current review and inspection
standards, and current industry standards.
1.22 “
Intellectual Property ” shall mean (a) all
compounds, formulations, materials, methods, techniques, trade
secrets, copyrights, know-how, data, documentation, regulatory
submissions, specifications, and other intellectual property of any
kind (whether or not protectable under patent, trademark,
copyright, or similar laws) and (b) for clarity, all patents
and patent applications claiming the foregoing, as applicable, and
all divisions, continuations and continuations-in-part of such
patent applications, all patents issuing thereon and all reissues,
reexaminations and extensions of any of the foregoing
patents.
1.23 “
Inventions ” shall mean all Intellectual Property and
discoveries, inventions, developments, modifications, innovations,
updates, enhancements, improvements, writings, or rights (whether
or not protectable under patent, trademark, copyright, or similar
laws) that are conceived, discovered, invented, developed, created,
made, or reduced to practice solely by a Party, or jointly by the
Parties, in the course of performing their obligations under the
Development Plan.
1.24 “
King Indemnitees ” shall have the meaning ascribed to
such term in Section 6.1(b) .
1.25 “
King Inventions ” shall have the meaning ascribed to
such term in Section 4.2 .
1.26 “
Launch Quantity ” shall have the meaning ascribed to
such term in Section 2.5(c) .
1.27 “
Loss of Market Exclusivity ” means, with respect to
Target [***], the date of the first FDA approved sale of a product
under an ANDA referencing the NDA for Target [***], and with
respect to Target [***], the date of the first FDA approved sale of
a product under an ANDA referencing the NDA for Target
[***].
1.28 “
Losses ” shall have the meaning ascribed to such term
in Section 6.1(a) .
1.29 “
NDA ” shall mean a New Drug Application or similar
application or submission filed with a Regulatory Authority in a
country or group of countries to obtain marketing approval for a
Target Formulation in that country or in that group of
countries.
1.30 “
Net Sales ” (i) in the case of Target [***],
means [***]; and (ii) in the case of Target [***], means
[***].
1.31 “
Party ” shall mean Core or King; and “
Parties ” shall mean Core and King.
1.32 “
Person ” shall mean an individual, sole
proprietorship, partnership, limited partnership, limited liability
partnership, corporation, limited liability company, business
trust,
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
joint stock
company, trust, unincorporated association, joint venture, or other
similar entity or organization including a government or political
subdivision, department, or agency of a government.
1.33 “
Project Team ” shall have the meaning ascribed to such
term in Section 2.2(c) .
1.34 “
Project Technology ” shall mean all data generated and
everything discovered, developed, made, perfected, improved,
designed, engineered, devised, produced, conceived, or first
reduced to practice by Core or any of its employees or consultants,
subcontractors, or development and/or collaborative partners in the
course of providing the Development Services, whether tangible or
intangible, including without limitation each and every Invention,
work of authorship, trade secret, formula, process, routine,
subroutine, technique, concept, method, idea, and algorithm, and
all software and related documentation in any source of development
(including but not limited to source code, object code, flow
charts, diagrams and other materials of any type whatsoever) and
all rights of any kind in or to any of the foregoing (including
without limitation patents, trade secrets, know-how and copyrights)
regardless of whether any or all of the foregoing constitutes
copyrightable or patentable subject matter.
1.35 “
Proof of Concept ” shall mean the formulation
experiments and other activities set forth in the Development Plan
for the achievement of Successful Proof of Concept for Target
[***].
1.36 “
Reference Product ” shall mean that drug product
containing a dosage of [***] of metaxalone as described in NDA
#13-217.
1.37 “
Regulatory Authority ” shall mean any governmental
regulatory authority which regulates any aspect of the manufacture,
development, market approval, sale, distribution or use of any
Target Formulation, including without limitation, FDA.
1.38 “
Skelaxin Manufacturing Agreement ” shall mean the
Amended and Restated Manufacturing and Supply Agreement between KPI
and Core, dated the date hereof, as such agreement may be amended,
modified or supplemented from time to time.
1.39 “
Successful Proof of Concept ” shall have the meaning
assigned to such term in Section 3.1(a) .
1.40 “
Target A Royalty Rate ” means [***].
1.41 “
Target Formulations ” shall mean either Target [***]
and/or Target [***].
1.42 “
Target [***] ” shall mean [***].
1.43 “
Target [***] Patent Right ” means any patents and
patent applications Covering Target [***] conceived or reduced to
practice by Core, issued patents resulting from such applications,
and all divisions, continuations, substitutions, reissues,
extensions, registrations, patent term extensions and renewals of
the foregoing.
1.44 “
Target [***] Royalty Period ” shall have the meaning
assigned to such term in Section 3.1(d)(i) .
1.45 “
Target [***] ” shall mean [***].
1.46 “
Target [***] Patent Right ” means any patents and
patent applications Covering Target [***] conceived or reduced to
practice by Core, issued patents resulting from such
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
applications,
and all divisions, continuations, substitutions, reissues,
extensions, registrations, patent term extensions and renewals of
the foregoing.
1.47 “
Target [***] Royalty Period ” shall have the meaning
assigned to such term in Section 3.1(d)(ii)
.
1.48 “
Term ” shall have the meaning ascribed to such term in
Section 5.1 .
1.49 “
Termination Notice Period ” shall have the meaning
ascribed to such term in Section 2.2(b) .
1.50 “
Territory ” shall mean all countries of the
world.
1.51 “
Third Party ” shall mean any person or entity other
than Core or King or their respective Affiliates.
1.52 “
Valid Claim ” means, as to Target [***], a claim in a
Target [***] Patent Right, and as to Target [***], a claim in a
Target [***] Patent Right, with respect to which none of the
following ((i), (ii) or (iii)) apply: (i) has been held
permanently revoked, unenforceable or invalid in the country in the
Territory by a final unappealable decision of a court or government
agency of competent jurisdiction over such claim, (ii) has
been admitted to be invalid or unenforceable through agreement,
disclaimers, consent decrees or otherwise, or (iii) in the
case of a patent application, has been pending for more than five
(5) years after the filing of its first priority
application.
ARTICLE 2 DEVELOPMENT OF
PRODUCTS
2.1 General
. King hereby retains Core and Core hereby agrees (i) to
collaborate with King in, and to perform, the Development Services
for Target [***], (ii) to collaborate with King in, and to
perform the Development Services to achieve Successful Proof of
Concept for Target [***], (iii) upon achievement of Successful
Proof of Concept for Target [***], to collaborate with King to
establish a target product profile that will become Target [***]
and a Development Plan to achieve such target product profile, and
(iv) to collaborate with King in, and to perform the
Development Services established in connection with the Development
Plan described in Section 2.1(iii) above. Core and King will
perform their respective research and development responsibilities
hereunder with respect to the Target Formulations in accordance
with the Development Plan and will perform all their respective
obligations and exercise their respective rights under this
Agreement in compliance with all applicable laws and regulations.
King will have final decision-making authority with respect to the
establishment and execution of a target product profile for Target
[***]and the Development Plan to achieve such target product
profile for Target [***].
2.2 Target
Formulations and Development Plan .
(a) Core
and King have agreed upon the Development Plan attached hereto as
Schedule A . From time to time King and Core may, in
writing, agree to modify and revise the Development Plan pursuant
to and subject to the terms of Section 2.1 (including,
for the avoidance of doubt, the last sentence of
Section 2.1 ), to add the Development Plan to achieve
Target [***] following Successful Proof of Concept for Target
[***].
(b) King
may, at any time during the Term upon no less than fifteen
(15) days’ prior written notice to Core (the period
beginning on the date upon which such notice is
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
given to the
actual date of termination shall be referred to as the “
Termination Notice Period ”), elect to terminate the
development of any Target Formulation by Core and King under the
Development Plan for any or no reason. In the event that at the
time King delivers a termination notice pursuant to this
Section 2.2(b) , Core has completed at least fifty
percent (50%) of the work relating to the achievement of a
milestone relating to the terminated Target Formulation within the
Termination Notice Period, King shall pay Core the corresponding
pro-rated share of the Development Fee(s) set forth under
Section 3.1(a) for those milestone events partially
achieved and those achieved in accordance with
Section 3.1(a) within the Termination Notice Period.
For the avoidance of doubt, such payment by King of the Development
Fees shall be subject to receipt by King of a detailed invoice from
Core and all supporting documentation reasonably requested by King
to determine such partial achievement or achievement of the
milestone(s). On the effective date of such termination of a Target
Formulation, the Parties shall no longer be obligated to perform
any activities under the Development Plan with respect to such
Target Formulation. King shall promptly reimburse Core for
Development Expenses incurred up to the effective date of such
termination but shall not be obligated to reimburse Core for
Development Expenses incurred after the effective date of such
termination (other than Development Expenses in respect of
non-cancelable or non-refundable commitments made prior to the
notice date of such termination). For clarity, the Development Plan
and King’s obligations to reimburse Core for Development
Expenses with respect to the remaining Target Formulation, other
than the terminated Target Formulation, shall be unaffected and
Core and King shall continue their activities under the Development
Plan in relation to such other Target Formulation.
(i) Core
and King will establish a project team (“ Project Team
”) to oversee the Development Services and Core’s and
King’s activities relating to the development of Target
Formulation(s), to monitor the progress of the development of
Target Formulation(s) at all stages of development and according to
the benchmarks and milestones set forth in the Development Plan, to
modify the Development Plan from time to time as provided in
Section 2.2(a) , and to facilitate ongoing
communication between Core and King. The Project Team shall consist
of (i) a Core representative and (ii) a King
representative from its Scientific Operations Department and
(iii) a King representative from its Technical Operations
Department. Core and King may appoint additional development,
regulatory and business personnel to the Project Team as they deem
necessary to accomplish the development of Target Formulation(s).
In planning, administering, and monitoring the Development Services
hereunder, the Project Team will allocate tasks and expertise in
order to avoid duplication and to enhance synergies as well as to
comply with the requirements of this Agreement.
(ii) Subject
to Section 2.1 , the Project Team shall operate by
consensus, with the representatives of each of Core and King having
collectively one (1) vote on behalf of such Party. The Project
Team will meet monthly to review the status of the Development Plan
and assess Core’s progress against the associated budget. For
each meeting of the Project Team, the presence of at least one
(1) representative of each of Core and King shall constitute a
quorum. Action on any Project Team matter may be taken at a
meeting, by teleconference or by videoconference and in each case
documented in written minutes or by
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
other written
agreement. Except as otherwise expressly provided for herein, each
of Core and King shall bear their own expenses for maintaining
their representatives on the Project Team.
(iii) The
Project Team shall attempt to resolve any and all disputes
regarding the Development Plan by consensus. If the Project Team is
unable to reach a consensus with respect to such a dispute, then
such dispute shall be submitted to escalating levels of the senior
management of Core and King for review. If such dispute cannot be
resolved despite escalation, then the Chief Executive Officer of
Core and the Chief Science Officer of King shall attempt to resolve
such dispute. In the event that these Officers cannot reach an
agreement regarding a dispute, then King shall have the right to
decide the matter; provided , however that King may
not amend or modify the Development Plan to require Core to engage
in or perform any Development Services that are not expressly
provided for in the Development Plan or otherwise agreed to by Core
in writing, or require Core to incur Development Expenses in excess
of the Development Expense Cap.
2.3 Core
Responsibilities . Core shall use commercially reasonable
efforts, consistent with the Development Plan and within the
Development Expense Cap, to implement the Development Plan with
respect to:
(ii) manufacture,
release, and complete stability analysis of clinical and
registration batches of Target [***];
(iii) conduct
the necessary [***];
(iv) produce
final clinical, pharmaceutical development and stability
reports;
(v) develop,
in conjunction with corresponding documentation in NDA
submission-ready format reasonably acceptable to King, a drug
product, which at a minimum meets the definition of Target [***];
and
(vi) compile,
file, prosecute and obtain approval of the NDA for Target [***],
provided, however, that upon King’s written request Core
shall immediately transfer all right title and interest in and to
the NDA, as well as all documents, studies, work papers, work
product (in any form or format), third party contracts, or other
assets related to the NDA (either prior to filing with the FDA, or
post filing with the FDA), and execute all documents necessary or
requested by FDA to transfer ownership of the NDA and related
matters to King, and to have King designated as the primary contact
for all future communications with FDA related to the NDA for
Target [***].
(i) undertake
an experimental program for Target [***] that constitutes Proof of
Concept;
(ii) upon
achievement of Successful Proof of Concept for Target [***] and in
accordance with and subject to Section 2.1 ,
collaborate with King to establish a target product profile that
will become Target [***] and a Development Plan to achieve such
target
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
product
profile, for Core’s provision of Development Services in
connection with the Development Plan for Target [***];
and
(iii) upon
King’s approval of the Development Plan for Target [***],
provide Development Services to King for Target [***] in accordance
with the Development Plan and within the applicable budget to
develop, in conjunction with corresponding documentation in NDA
submission-ready format reasonably acceptable to King, a drug
product, which at a minimum meets the definition of Target [***].
Such Development Services shall include, but not be limited to,
production of clinical and registration batches of Target [***],
and such reasonable assistance as King may require to successfully
file and prosecute the NDA for Target [***].
(c)
Records, cGLP, cGCP, and cGMP: Core shall maintain records
regarding the Development Services in reasonably sufficient detail
and in accordance with Good Laboratory Practices, Good Clinical
Practices, and Good Manufacturing Practices to properly reflect and
document, in a manner appropriate for purposes of supporting the
filing of potential patent applications and the filing and
obtaining of an NDA, all work done and results achieved in the
performance of the Development Services hereunder. Core will make
such records available to King during normal business hours upon
reasonable notice.
(d)
Validation Protocols. Core shall be responsible for the
preparation and execution of process validation protocols.
Validation protocols shall be reviewed and approved by King prior
to execution, such approval not to be unreasonably withheld. Core
shall prepare the completed validation reports which shall be
reviewed and approved by King, such approval not to be unreasonably
withheld.
2.4 King
Responsibilities .
(a)
Assistance with Implementation and Completion . King shall
use commercially reasonable efforts to provide reasonable
assistance to Core in connection with (a) implementing the
Development Plan for Target [***], (b) completing Target [***]
and, (c) when the Development Plan for Target [***] has been
established in accordance with Section 2.1 ,
implementing such Development Plan and completing Target
[***].
(b)
NDA Filing . Without prejudice to King’s right to
terminate the Development Plan as to Target Formulations pursuant
to Section 2.2(b) , King agrees that it will use
commercially reasonable efforts to assist in the filing of an NDA
for Target [***] and that it will use commercially reasonable
efforts to assure that an NDA for Target [***] is filed as soon as
possible after Core has provided to King, in form mutually
acceptable to King and Core, which acceptance shall not be
unreasonably withheld or delayed, the chemistry, manufacturing and
controls sections for filing and such additional information as is
reasonably necessary for King to file an NDA for Target
[***].
(c)
Reversion of Rights .
(i) Notwithstanding
anything to the contrary contained in this Agreement, in the event
that an NDA for Target [***] has not been filed with the FDA within
thirty (30) months of Completion of Development Activities for
Target [***] (which failure to file was not caused by Core’s
breach of its obligations hereunder or otherwise due to matters
outside King’s control), then all rights relating to Target
[***] granted to King pursuant to this
Note: Certain material has been
redacted from this document and filed separately with the SEC
pursuant to a request for confidential treatment under
Rule 24b-2. The locations of these redactions are indicated
throughout the document by the following marking:
[***].
Agreement
(including any Intellectual Property relating to Target [***]
created in the process of the execution of the matters set forth on
Schedule A prior to the Effective Date) shall revert
automatically to Cor
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