LICENSING AGREEMENT Between IMMTECH PHARMACEUTICALS, INC. AND PAR PHARMACEUTICAL, INC.
Exhibit
10.48
EXECUTION VERSION
EXECUTION VERSION
Between
AND
PAR
PHARMACEUTICAL, INC.
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the Securities
and Exchange Commission.
TABLE
OF CONTENTS
Page
| ARTICLE I |
DEFINITIONS
|
1
|
|
|
1.1
|
Definitions
|
1
|
|
|
1.2
|
Certain
Rules of Construction
|
6
|
| ARTICLE II | MANAGEMENT OF THE COLLABORATION |
6
|
|
|
2.1
|
Steering
Committee
|
6
|
|
|
2.2
|
Development
Committee
|
8
|
|
|
2.3
|
Commercialization
Committee
|
8
|
|
|
2.4
|
Expenses
|
9
|
|
|
2.5
|
Nondisclosure
Agreement
|
9
|
| ARTICLE III |
DEVELOPMENT
PROGRAM
|
9
|
|
|
3.1
|
Immtech
Responsibility and Control
|
9
|
|
|
3.2
|
Development
Program
|
9
|
|
|
3.3
|
Clinical
and Regulatory Approval
|
9
|
|
|
3.4
|
Development
Program Funding
|
10
|
|
|
3.5
|
Development
Program Reporting
|
10
|
|
|
3.6
|
Post
Regulatory Approval
|
10
|
|
|
3.7
|
Future
Development Programs
|
10
|
| ARTICLE IV |
LICENSE
|
11
|
|
|
4.1
|
Grant
to Par
|
11
|
|
|
4.2
|
Information
Transfer
|
11
|
|
|
4.3
|
Agreement
Not to Genericize
|
11
|
|
|
4.4
|
New
Indication Right of First Offer
|
11
|
| ARTICLE V |
PAYMENTS
|
12
|
|
|
5.1
|
Upfront
Payment
|
12
|
|
|
5.2
|
Milestone
Payments
|
12
|
|
|
5.3
|
Termination
or Adjustment of Royalty
|
14
|
|
|
5.4
|
Payment
Procedures
|
14
|
| ARTICLE VI | MANUFACTURE AND SUPPLY; COMMERCIALIZATION |
14
|
|
|
6.1
|
Clinical
Supplies
|
14
|
|
|
6.2
|
Commercial
Supplies
|
15
|
| ARTICLE VII |
CONFIDENTIAL
AND TECHNICAL INFORMATION
|
15
|
|
|
7.1
|
Treatment
of Confidential Information
|
15
|
|
|
7.2
|
Release
from Restrictions
|
16
|
|
|
7.3
|
No
Implied Rights
|
16
|
|
|
7.4
|
Survival
of Confidentiality Obligations
|
17
|
|
|
7.5
|
Superseding
Prior Confidentiality Agreement
|
17
|
-i-
TABLE
OF CONTENTS
(continued)
(continued)
Page
| ARTICLE VIII |
PATENT
PROSECUTION AND ENFORCEMENT
|
17
|
|
|
8.1
|
Inventions
|
17
|
|
|
8.2
|
Patent
Prosecution and Maintenance
|
17
|
|
|
8.3
|
Infringement
|
18
|
| ARTICLE IX |
ADVERSE
EXPERIENCES
|
20
|
|
|
9.1
|
Notification
|
20
|
|
|
9.2
|
Reporting
|
20
|
|
|
9.3
|
Literature
Reports
|
20
|
| ARTICLE X |
REPRESENTATIONS
AND WARRANTIES
|
20
|
|
|
10.1
|
Representations
and Warranties
|
20
|
| ARTICLE XI |
INDEMNIFICATION
AND LIMITATION ON LIABILITY
|
22
|
|
|
11.1
|
Indemnification
by Immtech
|
22
|
|
|
11.2
|
Indemnification
by Par
|
22
|
|
|
11.3
|
Notice
and Procedures
|
22
|
|
|
11.4
|
Limitation
of Damages
|
23
|
| ARTICLE XII |
TERM
AND TERMINATION
|
23
|
|
|
12.1
|
Term
|
23
|
|
|
12.2
|
Termination
for Breach
|
23
|
|
|
12.3
|
Termination
for Bankruptcy
|
23
|
|
|
12.4
|
Failure
to Meet Development Milestones
|
24
|
|
|
12.5
|
Effect
of Termination
|
24
|
|
|
12.6
|
Surviving
Rights
|
25
|
|
|
12.7
|
Accrued
Rights and Surviving Obligations
|
25
|
| ARTICLE XIII |
MISCELLANEOUS
|
25
|
|
|
13.1
|
Entire
Agreement; Modification
|
25
|
|
|
13.2
|
Assignment
|
25
|
|
|
13.3
|
Performance
by Affiliates
|
25
|
|
|
13.4
|
Notices
|
25
|
|
|
13.5
|
Dispute
Resolution
|
26
|
|
|
13.6
|
Governing
Law; Waiver of Jury Trial
|
26
|
|
|
13.7
|
Force
Majeure
|
27
|
|
|
13.8
|
Independent
Contractors
|
27
|
|
|
13.9
|
Severability;
Waiver
|
27
|
|
|
13.10
|
Further
Actions
|
27
|
|
|
13.11
|
Cumulative
Rights
|
27
|
|
|
13.12
|
Counterparts
|
28
|
-ii-
LICENSE
AGREEMENT
This
License Agreement (the “Agreement”) is made and
entered into as of June 11, 2007 (the “Effective Date”), by and
between Immtech Pharmaceuticals, Inc., a Delaware corporation
with its principal place of business at 000 Xxxxxxx Xxxxx, Xxxxxx Xxxxx,
XX
00000 (“Immtech”), and Par Pharmaceutical,
Inc., a Delaware corporation having a principal place of business
at
000 Xxxx Xxxxxxxxx, Xxxxxxxxx Xxxx, Xxx Xxxxxx 00000
(“Par”). Immtech and Par may be referred to herein
individually as a “Party”, or collectively as the
“Parties”.
Recitals
Whereas,
Immtech has expertise developing and commercializing pharmaceutical products
for
infectious diseases and has developed and owns certain proprietary technology
and know-how relating to the design and manufacture of the Product (as
defined
in Section 1.1); and
Whereas,
Par has expertise in developing, manufacturing and marketing certain
pharmaceutical products and wishes to develop and market the Product
as further
described herein, and Immtech agrees to grant Par the rights to do so
pursuant
to the terms of this Agreement.
Now,
Therefore, in consideration of the foregoing and the covenants
and promises contained herein, the Parties hereby agree as follows:
ARTICLE
I
DEFINITIONS
1.1 Definitions. For
the purposes of this Agreement, the following defined terms have the
respective
meanings set forth below:
“Affiliate”
means with respect to a Party, any other entity that directly or indirectly
controls, is controlled by, or is under common control with, such
Party. An entity or party shall be regarded as in control of another
entity if it owns, or directly or indirectly controls, at least fifty
percent
(50%) of the voting stock or other ownership interest of such entity,
or if it
directly or indirectly possesses the power to direct or cause the direction
of
the management and policies of the other entity by any means
whatsoever.
“cGMP”
means the regulatory requirements for current good manufacturing practices
promulgated by the FDA under the U.S. Food, Drug and Cosmetic Act and
the
regulations promulgated thereunder, particularly 21 C.F.R. Section 210
et seq.,
as the same may be amended from time to time.
“ClinicalSupplies”
means supplies of the Product, manufactured, packaged and labeled in
compliance
with cGMP, in such form and dosage as is determined by Immtech pursuant
to
the
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
1
Development
Program, and suitable for use in the conduct of pre-clinical and/or human
clinical trials of the Product in the United States by the Parties pursuant
to
the Development Program.
“Commercialization”
means the marketing, promotion, advertising, selling and/or distribution
of the
Product in the United States after Regulatory Approval has been obtained;
and
the term “Commercialize” has a corresponding
meaning.
“Commercially
Reasonable Efforts” means the efforts and resources that would
reasonably be used (including the promptness with which such efforts
and
resources would be applied) in the pharmaceutical industry for the diligent
development, manufacture or commercialization of a pharmaceutical product
of
similar market and profit potential and at a similar stage in development
or
product life as compared to the Product; and the term “Commercially
Reasonable” has a corresponding meaning.
“Confidential
Information” means information of a Party that is disclosed to or
obtained by the other Party (including information obtained by a Party
as a
result of access to the facilities of the other Party) either prior to
or during
the term of this Agreement, which information (a) is non-public, confidential
or
proprietary in nature, including trade secrets, financial data, product
information, manufacturing methods, market research data, marketing plans,
identity of customers, nature and source of raw materials, product formulation
and methods of producing, testing and packaging, and (b) relates to the
disclosing Party’s past, present or future research, development or
Commercialization activities; provided, however, that Confidential
Information shall not include information that a Party can demonstrate
by
written evidence: (i) is in the public domain other than as a result
of a breach by such Party (or any of its Affiliates) of its obligations
of
confidentiality contained herein; (ii) was known by the receiving Party
prior to
receipt from the disclosing Party; (iii) has been developed by the receiving
Party independent of any Confidential Information of the other Party;
or (iv)
was subsequently, lawfully and in good faith obtained by the receiving
Party on
a non-confidential basis from a Third Party that was not under an obligation
to
treat such information in a confidential manner and had a lawful right
to make
such disclosure. Without limiting the foregoing, the terms of this
Agreement, including the Development Program, shall constitute “Confidential
Information” hereunder.
“Development
Committee” has the meaning set forth Section 2.2.
“Development
Costs” means [****].
“Development
Program” means the activities associated with development of the
Product for sale, including, but not limited to, (a) manufacture and
formulation
of the Product for preclinical and clinical studies; (b) planning,
implementation, evaluation and administration of human clinical trials;
(c)
manufacturing process development and scale-up for the manufacture of
the
Product; (d) preparation and submission of applications for Regulatory
Approval;
and (e) post-market surveillance of approved drug Indications.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
2
“Direct
Cost” means the [****].
“Effective
Date” means the date set forth in the introductory
paragraph.
“FDA”
means The Food and Drug Administration of the United States Department
of Health
and Human Services, or any successor agency(ies) thereof performing similar
functions.
“Immtech
Know-How” means all Know-How Owned or Controlled by Immtech as of the
Effective Date or Owned or Controlled by Immtech after the Effective
Date that
relates to or arises out of Immtech’s proprietary technology that is used in the
development, manufacture, use or sale of the Product.
“Immtech
Patents” means any Patents Owned or Controlled by Immtech or any of its
Affiliates or under which Immtech or any of its Affiliates acquires proprietary
technology that is used in the development, manufacture, use or sale
of the
Product, a list of which is appended hereto as Schedule 1.1 and will be
updated periodically by Immtech to reflect additions thereto.
“Immtech
Patent Right” means all United States and foreign Patents (including
all reissues, extensions, substitutions, confirmations, re-registrations,
re-examinations, revalidations and patents of addition) and patent applications
(including, without limitation, all continuations, continuations-in-part
and
divisions thereof) in each case, claiming an invention which is necessary
or
useful for the design, development, testing, use, manufacture or sale
of the
Product, and which are Owned or Controlled by Immtech.
“Immtech
Technology” means all Immtech Patents, all Immtech Know-How and all
Immtech Patent Rights.
“Indication”
means the approved therapeutic uses for the Product.
“Initial
Commercial Sale” means the first sale of the Product by Par or an
Affiliate in the Territory following Regulatory Approval of the
Product.
“Invention”
means any new invention or discovery learned, conceived and/or
reduced
to practice by Par, its Affiliates or their related employees, or jointly
by
such an individual or individuals with one or more employees of Immtech
or a
Third Party, and that is related to pafuramidine.
“Know-How”
means all ideas, inventions, instructions, techniques, processes, methods,
products, materials, compositions, data, formulas, expert opinions and
information, including, without limitation, biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical,
clinical, safety, manufacturing and quality control data and information,
in
each case, and including any such information lawfully obtained from
a Third
Party without restriction on disclosure to Par, which are necessary or
useful
for, and are specific to use, utilization, or sale of the Product.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
3
“Net
Sales” means [****].
“New
Licensing Agreement” has the meaning set forth in Section
4.4(a).
“NDA”
means the New Drug Application and all amendments and supplements thereto
for
the Product filed by Immtech with the FDA, including all documents, data,
and
other information concerning the Product that are necessary for gaining
Regulatory Approval to market and sell the Product.
“Owned
or Controlled by” means the possession of the unencumbered right to
grant the license to Par as provided herein.
“Patents”
means all existing and future patents and patent applications, including
without
limitation any continuations, continuations-in-part, divisions, provisionals
or
any substitute applications, any patent issued with respect to any such
patent
applications, any reissue, reexamination, renewal or extension (including
any
supplemental patent certificate) of any such patent, and any confirmation
patent
or registration patent or patent of addition based on any such patent,
and all
foreign counterparts of any of the foregoing claiming an invention that
is
necessary or useful for the design, development, testing, use, manufacture
or
sale of the Product.
“PCP”
means pneumocystis carinii pneumonia (also known as pneumocystis jiroveci
pneumonia).
“Phase
III Clinical Trials” means that portion of the Development Program that
provides for large scale, pivotal, clinical studies that (a) are conducted
in a
number of patients that is intended to be sufficient to obtain a definitive
evaluation of the therapeutic efficacy and safety of a Product in patients
for a
given Indication as required by 21 C.F.R. §312.21(c) and (b) that are needed to
evaluate the overall risk-benefit relationship of the Product and to
provide
adequate basis for obtaining requisite Regulatory Approvals.
“Positive
Phase III Clinical Trials” means the full and final analysis of a Phase
III Clinical Trial in which (i) the primary outcome protocol variables
reach
statistical significance to the level defined in the study protocol or
related
statistical analysis plan and (ii) it is determined that there are no safety
issues preventing commercialization of the Product.
“Product”
means a finished dosage form for sale in the Territory, that (i) contains
pafuramidine as the active ingredient, (ii) is approved by the FDA for
the
treatment of PCP in patients with a diagnosis of HIV/AIDs and (iii) is
ready for
administration to the ultimate consumer as a pharmaceutical; provided,
however,
that the term Product shall specifically exclude future indications of
pafuramidine, except those related to PCP.
“Product
Studies” means clinical studies, pre-clinical studies, safety studies,
epidemiological studies, modeling and pharmacoeconomic studies, in each
case
including any ancillary or incidental development, investigation or research
schemes pertaining thereto, that are designed (a) to support Regulatory
Approval
for the Product or (b) to support publications,
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
4
promotional
and educational activities, future labeling changes or new Indications
for
pafuramidine.
“Program
Developments” means all inventions, discoveries, Patent Rights,
Know-How, copyrights and works of authorship that are made, developed,
created,
conceived or reduced to practice in connection with or relating to the
Development Program or Commercialization during the term of this Agreement,
regardless of whether the invention, discovery, Know-How, or work is
patentable
and regardless of whether it was made solely by an employee or agent
of Par,
solely by an employee or agent of Immtech, or jointly by Par and
Immtech.
“Proprietary
Information” means all Know-How and other scientific, clinical,
regulatory, marketing, financial, and commercial information or data,
whether
communicated in writing, verbally, or electronically, which is provided
by one
party to the other party in connection with this Agreement, including
any
information related to Patents.
“Regulatory
Approval” means approval by the FDA to market the Product in the United
States, including the issuance by the FDA of an action letter indicating
the
approval of the NDA and the manufacturing processes and facilities for
commercial supplies of the Product.
“Representative”
has the meaning set forth in Section 7.1.
“Royalty
Period” shall have the meaning set forth in Sections 5.2 and
5.3.
“Selling
Unit” means 28 tablets of the Product.
“Territory”
means the United States of America and all of its territories and
protectorates.
“Term”
means the period commencing from the Effective Date and ending upon termination
of this Agreement under Article XII.
“Third
Party” means any person or entity that is not a party to this
Agreement.
“Transfer
Price” means [****].
1.2 Certain
Rules of Construction.
(a) As
used in this Agreement, unless the context otherwise requires: Section,
Schedule, Article and Exhibit references are intended to refer to this
Agreement; words describing the singular number shall include the plural
and
vice versa; words denoting any gender shall include all genders; words
denoting
natural persons shall include corporations, partnerships and other entities,
and
vice versa; the words "hereof", "herein" and "hereunder", and words of
similar
import, shall refer to this Agreement as a whole, and not to any particular
provision of this Agreement; the term "include" and derivations thereof
are not
intended to apply any limitation to the item(s) specified; and terms
such as
lessee, lessor, lease, landlord, tenant,
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
5
licensor,
licensee and license will be interpreted broadly to refer also to sub-leasing
or
sub-licensing arrangements and/or the parties thereto.
(b) This
Agreement is between financially sophisticated and knowledgeable parties
and is
entered into by the parties in reliance upon the economic and legal bargains
contained herein, the language used in this Agreement has been negotiated
by the
parties hereto and shall be interpreted and construed in a fair and impartial
manner without regard to such factors as the party who prepared, or caused
the
preparation of, this Agreement or the relative bargaining power of the
parties.
ARTICLE
II
MANAGEMENT
OF THE COLLABORATION
2.1 Steering
Committee.
(a) Establishment. The
Parties hereby establish a Steering Committee consisting of six (6) members,
three (3) of whom shall be Par designees and three (3) of whom shall
be Immtech
designees. Each of the Steering Committee members shall have
appropriate expertise to oversee the Parties’ performance of this
Agreement. The initial Steering Committee members shall be designated
by each Party within one week after the Effective Date. Each Party
shall have the right at any time and from time to time to designate a
replacement, on a permanent or temporary basis, for any or all of its
previously-designated members of the Steering Committee. At the
beginning of each calendar year during the Term, each Party shall appoint
one of
its designees to serve as a Co-Chair of the Steering Committee. The
initial Co-Chairs shall be designated by each Party within one week after
the
Effective Date.
(b) Meetings
and Procedures.
(i) The
Steering Committee shall meet at least once per calendar quarter, and
more
frequently at the request of either Party or as required to resolve disputes,
disagreements or deadlocks, on such dates, and at such places and times,
as the
Parties shall agree; provided, however, that the Parties shall use
their Commercially Reasonable Efforts to cause the first meeting of the
Steering
Committee to occur within thirty (30) days after the Effective
Date. The two Co-Chairs shall cooperate to send a notice and agenda
for each meeting of the Steering Committee to all members of the Steering
Committee reasonably in advance of the meeting. The location of
regularly-scheduled Steering Committee meetings shall alternate between
the
offices of the Parties, unless otherwise agreed. The members of the
Steering Committee also may convene or be polled or consulted from time
to time
by means of telephone conference, video conference, electronic mail or
correspondence and the like, as deemed necessary or appropriate by the
Co-Chairs. The Party hosting any Steering Committee meeting shall
appoint one person (who need not be a member of the Steering Committee)
to
attend the meeting and record the minutes of the meeting in
writing. Such minutes shall be circulated to the members of the
Steering Committee promptly following the meeting for review and
comment.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
6
(ii) All
decisions of the Steering Committee shall be made by unanimous vote or
unanimous
written consent of both Parties, with each Party having, collectively
among its
respective designees, one vote in all decisions. The members of the
Steering Committee shall use Commercially Reasonable Efforts to decide
all
matters assigned to the Steering Committee under this Agreement or otherwise
referred to it by mutual agreement of the Parties; provided,
however, that if the members of the Steering Committee are unable
to come
to a mutual agreement, then (i) Immtech shall have the right to make
any
necessary final determination with respect to decisions related to the
development and manufacture of the Product (e.g., determining which drug
strength to pursue, when to initiate the clinical trial), (ii) Par shall
have
the right to make any necessary final determination with respect to decisions
related to the Commercialization of the Product in the Territory (e.g.,
marketing programs and pricing strategies and designation of product
labels);
and (iii) any other matters shall be subject to resolution by the chief
executive officers of the Parties pursuant to Section 13.5.
(c) Purposes
and Powers. The principal purpose of the Steering
Committee shall be to approve the overall strategy for the Parties’
collaboration hereunder and provide guidance and direction as provided
herein. Subject to the express rights of the Parties as set forth
herein, the functions of the Steering Committee shall include:
(i) Acting
as liaison between the Parties to ensure that they are informed of the
ongoing
progress of the Development Program;
(ii) Reviewing
and approving the division of responsibilities between the Parties as
set forth
herein and as expanded from time to time in furtherance of the goals
of the
Parties’ collaboration;
(iii) Reviewing
and approving any proposed amendments to the Development Program;
(iv) Reviewing,
consulting on and providing input in respect of activities related to
the
manufacturing of the Product and the selection of manufacturer(s) of
the Product
(to the extent not already selected as of the date hereof);
(v) In
accordance with the procedures established below, resolving disputes,
disagreements and deadlocks between the Parties, including the other
Committees
established pursuant to this Agreement; and
(vi) Performing
such other responsibilities as may be assigned to the Steering Committee
pursuant to this Agreement or as may be mutually agreed upon by the Parties
from
time to time.
2.2 Development
Committee. Within thirty (30) days after the Effective
Date, the Parties shall establish a development committee (the
“Development Committee”) with responsibility for (i) reviewing
proposed changes to the Development Program following
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
7
2.3 Commercialization
Committee. Within thirty (30) days after the Effective
Date, the Parties shall establish a Commercialization Committee (the
“Commercialization Committee”) with responsibility for (i)
reviewing and approving medical claims and marketing materials to be
used by any
Party in connection with the Product to ensure that the claims made by
a Party
do not diminish the value of the Product to the other party and (ii)
coordinating the activities of the Parties related to the
Commercialization. Each Party shall appoint two designees
to the Commercialization Committee, each of whom shall have expertise
and
experience in the areas of marketing, promotion, advertising and
sales. Either Party may replace any or all of its designees on the
Commercialization Committee at any time upon written notice to the other
Party,
and any member of the Commercialization Committee may designate a suitable
proxy
to perform the functions of that member at any time. In addition, the
Commercialization Committee shall seek to act with the unanimous consent
of its
members. In the event that all of the Commercialization Committee
members do not reach consensus with respect to a matter that is within
the
purview of the Commercialization Committee, the Commercialization Committee
designees of each Party shall collectively have one vote for purposes
of
decision-making hereunder with respect to such matters, with decisions
made by
unanimous vote of both Parties. If the votes of the Commercialization
Committee are split on any matter, such matter shall be referred to the
Steering
Committee for decision.
2.4 Expenses. Each
Party shall be responsible for all travel and related costs and expenses
for its
members and approved invitees to attend meetings of, and otherwise participate
on, the Steering Committee, Development Committee and/or Commercialization
Committee.
2.5 Nondisclosure
Agreement. All designees of each Party serving on the
Steering Committee, Development Committee and/or the Commercialization
Committee
shall as a condition to such service execute a nondisclosure agreement
in form
and substance reasonably satisfactory to the Parties.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
8
ARTICLE
II
DEVELOPMENT
PROGRAM
3.1 Immtech
Responsibility and Control. Subject to the Development
Program and the other terms and conditions contained in this Agreement,
Immtech
shall have control over and responsibility for executing all aspects
of the
Development Program for which Immtech pays Development Costs, including
planning, strategy, administrative management, and fiscal control;
provided, however, that Immtech shall include Par in such efforts
in a consultative capacity. The Development Program shall be
conducted at and coordinated from the facilities of Immtech. Immtech
shall keep Par apprised of the status of the Development Program through
the
Development Committee and, as appropriate, the Steering
Committee. Immtech shall comply, and shall require all of its Third
Party agents and contractors, if any, to comply, with all applicable
laws in the
conduct of the Development Program.
3.2 Development
Program. Immtech shall use Commercially Reasonable
Efforts to conduct the development activities in accordance with the
Development
Program. Notwithstanding the foregoing or any other provision of this
Agreement, Par acknowledges and agrees that (a) the Development Program
is
experimental in nature; and (b) Immtech does not guaranty that the Development
Program will be successful or that Regulatory Approval will be obtained
for the
Product. During the Term, Immtech may revise the Development Program
at any time and from time to time.
3.3 Clinical
and Regulatory Approval.
(a) Conduct
by Immtech. Under Immtech’s direction and control,
Immtech agrees to use Commercially Reasonable Efforts to (a) conduct
required
clinical trials of the Product and obtain Regulatory Approval in accordance
with
the Development Program and (b) include Par in such efforts in a consultative
capacity.
(b) Regulatory
Submissions. The Parties acknowledge that the Product
has not been reviewed or approved for sale or use for any purpose by
any
governmental or regulatory body. Immtech shall prepare any required
application(s) for Regulatory Approval. Immtech shall own,
in its entirety, all clinical data and reports related to Product Studies
including clinical trials for the Product. At all times both prior to
and following Regulatory Approval, (i) Immtech shall inform Par of all
communications with the FDA and (ii) provide copies of FDA submissions
to the
Development Committee prior to their submission to FDA. The Parties
shall cooperate in good faith with respect to, and Immtech shall use
its
Commercially Reasonable Efforts to enable representatives of Par to attend
all
formal meetings with the FDA relating to, regulatory approval of the
Product. The Parties shall cooperate in good faith with respect to
the conduct of any inspections by any regulatory authority of a Party’s site and
facilities related to the Product. To the extent either Party
receives written or material oral communication from the FDA or any other
regulatory authority relating to any Regulatory Approval process with
respect
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under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
9
to
the
Product, the Party receiving such communication shall notify the other
Party and
provide a copy of any written communication as soon as reasonably
practicable.
3.4 Development
Program Funding. Immtech shall be solely responsible for
payment of all Development Costs incurred prior to Regulatory
Approval. If Par determines to pursue any clinical development in
respect of the Product following Regulatory Approval, including any development
for PCP prophylaxis or any other PCP indication, the development costs
in
respect thereof shall be the responsibility of Par unless the Parties
otherwise
agree.
3.5 Development
Program Reporting. Immtech shall (a) provide Par at
regularly scheduled meetings of the Development Committee with summary
updates
regarding the progress of the Development Program and Regulatory Approval
process, (b) advise Par of any unforeseen material problems or delays
encountered since the date of its last report in connection with the
Development
Program, and (c) provide Par as soon as reasonably practicable with such
other
material information as Par may reasonably request in writing from time
to time
with respect to the status of the Development Program.
3.6 Post
Regulatory Approval. Immtech will be
responsible for conducting any development programs for the Product required
by
the FDA following Regulatory Approval. As mutually agreed by the
Parties, Immtech will be responsible for conducting any development programs
related to clinical trials for the Product.
3.7 Future
Development Programs. Immtech shall promptly notify Par
of any additional development programs, including tests or clinical trials,
in
connection with the Product other than as contemplated by this
Agreement. If Immtech discovers new indications for pafuramidine at
any time during the Term, Immtech shall promptly provide all information
related
to such new indications to the Development Committee.
ARTICLE
IV
LICENSE
4.1 Grant
to Par. Subject to the other provisions of this
Agreement, Immtech hereby grants to Par and its Affiliates, within the
Territory, an exclusive (subject to the co-exclusive rights provided
in the last
sentence of this Section 4.1), royalty-bearing license, without the right
to
sublicense, under Immtech Technology to the extent useful to permit Par
to carry
out its rights and obligations set forth in this Agreement (including
the rights
set forth in Article VIII) to market, sell and have sold the Product
in the
Territory. Immtech retains all rights to Immtech Technology except to
the extent explicitly granted to Par hereunder. Additionally, Immtech
hereby appoints Par Immtech’s authorized distributor of record for the
Product. Notwithstanding the foregoing, Immtech retains the right to
manufacture and co-promote the Product.
4.2 Information
Transfer. Promptly after the Effective Date,
Immtech shall, at its own cost, use good faith reasonable efforts to
disclose to
Par in writing, or via mutually
****
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under Rule
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with the Securities
and Exchange Commission.
10
4.3 Agreement
Not to Genericize. Par recognizes and acknowledges
the value of the Immtech Know-How disclosed under this Agreement and
the Immtech
Technology to which Par is granted a license under this
Agreement. Accordingly, Par agrees that it will not file any ANDAs
related to the Product or any product containing pafuramidine, and that
it will
not attempt to copy or design around, the Product or any product containing
pafuramidine without express written agreement from Immtech. Par and
Immtech will negotiate terms in good faith whereby Par would become the
exclusive authorized generic distributor of the Product.
4.4 New
Indication Right of First Offer .
(a) Right
of First Offer. The Parties acknowledge that Immtech is
currently pursuing new indications for pafuramidine for the treatment
and
prophylaxis of malaria. If, following the Effective Date, Immtech
determines that pafuramidine can be used for the treatment and/or prophylaxis
of
malaria, Immtech shall, prior to instituting any Phase III development
program
in respect thereof, provide Par with a one time written notice of information
reasonably available to Immtech, including an estimate of the cost for
developing and obtaining regulatory approval therefor, that is reasonably
required by Par to determine whether or not to enter into an agreement
with
Immtech with respect to such additional indication. The delivery of
such notice shall automatically grant to Par a one time exclusive option
(the
“Option”) to enter into an agreement with Immtech for a license
to permit Par and its Affiliates to market, sell and have sold pafuramidine
for
such additional indication (the “New License
Agreement”). Par shall have twenty-five (25) days from
receipt of such notice to (i) exercise the Option by sending written
notice to
Immtech of its intent thereof or (ii) reject the Option, in either case
at which
time the following shall occur:
(i) If
Par exercises the Option, the Parties shall have ninety (90) days from
the date
of exercise of the Option to negotiate in good faith a New Licensing
Agreement
with Immtech. If, following such ninety (90)-day period, the parties
have not executed the New Licensing Agreement, Immtech may, but shall
not be
obligated to, offer such license for pafuramidine to a Third Party;
provided, however, that a New Licensing Agreement with any Third
Party shall not provide such Third Party with the right to market, sell
and have
sold the Product in the Territory; and
(ii) If
Par rejects the Option, or does not inform Immtech of its intent to exercise
the
Option within the twenty-five (25)-day period, Immtech may, but shall
not
be
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under Rule
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with the Securities
and Exchange Commission.
11
obligated
to, offer such the New License Agreement to a Third Party; provided,
however, that a New Licensing Agreement with any Third Party
shall not
provide such Third Party with the right to market, sell and have sold
the
Product in the Territory.
(b) Future
Indications. Immtech shall use Commercially Reasonable
Efforts to ensure that any new indications for pafuramidine shall be
in
materially different presentation from the Product (e.g., tradename,
dosage form or reference listed drug). If the presentation is not
materially different, the Parties will negotiate in good faith a payment
to Par
to cover revenues that Par lost in commercial sales of the Product due
to the
new and immaterially different presentations. Neither Immtech nor Par
shall directly encourage use of the Product, nor use of the future indications
of pafuramidine for treatment of conditions other than PCP, for any indication
for which it does not have commercialization rights. For purposes of
clarification, the Parties agree that FDA may require that there be more
than
one indication on the same product label and such additional indication(s)
shall
not be deemed to affect the scope of the license granted herein in respect
of
the Product.
ARTICLE
V
PAYMENTS
5.1 Upfront
Payment. In consideration for the execution and delivery
of this Agreement by Immtech, Par shall pay Immtech a fully earned,
non-refundable, non-creditable license fee in the amount of US$3,000,000
by wire
transfer of immediately available funds upon execution and delivery of
this
Agreement.
5.2 Milestone
Payments
(a) Development
Milestone Payments. Subject to the terms and conditions
of this Agreement, upon the achievement of certain milestones, Par shall
make
fully earned, non-refundable, non-creditable payments to Immtech by wire
transfer of immediately available funds as follows:[****]
(i) Upon
the receipt by Immtech of [****], Par shall Pay to Immtech
[****];
(ii) Upon
the [****], Par shall pay to Immtech [****]; and
(iii) Upon
the [****], Par shall pay to Immtech [****].
(b) Sales
Milestones. In addition to the milestone
payments set forth in Section 5.2(a), Par shall additionally be obligated
as
follows:
(i) Par
will pay to Immtech [****] in the calendar year in which aggregate Net
Sales in
the Territory initially equals or exceeds [****] (i.e., this payment is a
one-time obligation).
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
12
(ii) Subject
to Section 5.2(b)(iii), Par will pay to Immtech the milestone payment
corresponding to the highest level of annual Net Sales achieved in that
year,
from the following schedule:
(a) A
milestone payment of [****] upon annual Net Sales of [****] in
the Territory;
(b) A
milestone payment of [****] upon annual Net Sales of [****] in the
Territory;
(c) A
milestone payment of [****] upon annual Net Sales of [****] in the
Territory;
(d) A
milestone payment of [****] upon annual Net Sales of [****] in the
Territory;
(e) A
milestone payment of [****] upon annual Net Sales of [****] in the
Territory;
(iii) The
milestone payments set forth in this Section 5.2(b) are subject to the
following
disbursement limitations: (A) each such milestone payment is available
to
Immtech on a one-time basis; (B) if more than one milestone is reached
in any
given calendar year, then, subject to the following clause (C), each
of such
milestones shall be deemed to have been met, the highest milestone reached
in
such year shall be payable by Par in such year and Par will remain obligated
to
make payment(s) on the lower achieved milestone payment(s) in the immediately
subsequent year(s); and (C) Par shall not be obligated to make more than
one
sales milestone payment as provided in this Section 5.2(b) in any calendar
year;
provided, however, that the milestone payments in Section
5.2(b)(i) and a single milestone payment in Section 5.2(b)(ii) can be
paid by
Par in the same calendar year.
(c) Royalty
Payment. In addition to the milestone payments set forth
above in Sections 5.2(a) and 5.2(b), following the Initial Commercial
Sale of
the Product, Par shall pay to Immtech an amount equal to [****] (amounts
owed to
Immtech pursuant to this Section 5.2(c), the
“Royalty”).
5.3 Termination
or Adjustment of Royalty. The obligation of Par to pay
Royalties to Immtech pursuant to Section 5.2(c) shall cease on the date
on which
the Parties agree to stop sales of the Product.
5.4 Payment
Procedures.
(a) Manner
of Payment. Remittance of payments under Article V will
be made by means of wire or electronic transfer to Immtech’s account in a bank
in the United States to be designated by Immtech.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with
the Securities
and Exchange Commission.
13
(b) Payments
and Reports. All amounts payable to Immtech under this
Agreement shall be paid in U.S. Dollars. The Royalty shall accrue at
the time of sale of the Product to a Third Party. Royalty obligations
that accrue during a calendar quarter shall be paid within forty-five
(45) days
after the end of such calendar quarter, and other payments owing shall
be made
as specified herein. Each payment of Royalties due to Immtech shall
be accompanied by a report listing the gross invoiced sales of the Product
sold
during such period and the calculation of Net Sales based on such sales,
including all other information necessary to determine the appropriate
amount of
such Royalty payments, and any additional information or reports required
under
this Agreement.
(c) Records
and Audit. For a period of three (3) years after the
Royalty period to which the records relate, Par shall keep complete and
accurate
records pertaining to the sale or other disposition of the Product in
sufficient
detail to permit Immtech to confirm the accuracy of all payments due
hereunder. Immtech shall have the right to cause an independent,
certified public accountant to audit such records to confirm the Net
Sales and
Royalty payments; provided, however, that such auditor shall not
disclose Par’s Confidential Information to Immtech, except to the extent such
disclosure is necessary to verify the amount of Royalties and other payments
due
under this Agreement. Such audits may be exercised once a year,
within three (3) years after the Royalty period to which such records
relate,
upon notice to Par and during normal business hours. Any amounts
shown to be owing by such audits shall be paid promptly. Immtech
shall bear the full cost of such audit unless such audit discloses a
variance in
the amounts paid by Par of more than five percent (5%) from the amount
of
Royalties and/or other payments actually owed for the period
audited. In such case, Par shall bear the full cost of such
audit. The terms of this Section 5.4(c) shall survive any termination
or expiration of this Agreement for a period of three (3) years.
ARTICLE
VI
MANUFACTURE
AND SUPPLY; COMMERCIALIZATION
6.1 Clinical
Supplies. Immtech shall manufacture or cause to be
manufactured all Clinical Supplies of Product for the Development Program,
including the completion of pre-clinical work and human clinical
trials. Immtech’s choice of such Third Party contract manufacturer(s)
for the Product, and the terms and conditions of such manufacturing and
supply
agreement(s) for the Product, shall be subject to reasonable prior review
by the
Development Committee (which includes the reasonable input of
Par).
6.2 Commercial
Supplies. Immtech has established a commercial
manufacturing process and for manufacturing or causing to be manufactured
Commercial Supplies of the Product at the scale and in the amounts required
to
meet Par’s sales forecast.
(a) Commercialization. Subject
to the rights and input of the Commercialization Committee, Par shall
have
responsibility for all Commercialization activities, including developing
strategies and tactics related to the advertising, promotion, marketing
and
****
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under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
14
selling
the Product. Par shall, at all times during the term of the
Agreement, use efforts equal to those committed to products of similar
size and
expected value to seek to commercialize the Product in the
Territory for those formulations and indications for which Par is
commercializing the Product without Immtech.
(b) Distribution. Immtech
hereby appoints Par as the sole and exclusive distributor of the Product
in the
Territory and Par shall use its Commercially Reasonable Efforts to
distribute the Product following Regulatory Approval in the Territory
during the
Term. It shall be Par’s sole right and responsibility, in
coordination with Immtech, to (a) determine the commercially reasonable
launch
dates for the Product, (b) develop advertising and promotional materials
related
to the Product, (c) book sales for the Product, (d) handle all returns
of the
Product, (e) handle all aspects of order processing, invoicing and collection
of
receivables for the Product, (f) collect data regarding sales to hospitals
and
other end users of the Product, (g) monitor inventory levels of the Product,
(g)
provide first line customer support and pharmacovigilance (and after
such
initial support, pharmacovigilance support shall be handled in accordance
with
Section 9), and (h) warehouse the Product.
(c) Pricing. Subject
to the reasonable input of Immtech, Par shall have the sole right and
responsibility to determine the prices for the Product and any discounts
and
rebates that may be offered thereto, including decisions relating to
customer
allowances and credits. Par shall acquire the Product from Immtech at
the Transfer Price as provided in the Supply Agreement between Par and
Immtech
in substantially the form attached hereto as Exhibit A; provided,
however, that, with respect to any quantities of Product Par
distributes
as samples to persons in the medical profession, Par shall acquire such
quantities from Immtech at the Direct Cost.
ARTICLE
VII
CONFIDENTIAL
AND TECHNICAL INFORMATION
7.1 Treatment
of Confidential Information. Each Party agrees to retain
in strict confidence and not to disclose, divulge or otherwise communicate
to
any other person or entity any Confidential Information of the other
Party,
whether received prior to or after the date hereof, and further agrees
not to
use any such Confidential Information for any purpose, except pursuant
to, and
in order to carry out, the terms and objectives of this Agreement, except
that
each Party may disclose Confidential Information of the other Party to
the
officers, directors, employees, agents, accountants, attorneys, consultants,
subcontractors or other representatives of the receiving Party or its
Affiliates
(the “Representatives”), who, in each case, (a) need to know
such Confidential Information for purposes of the implementation and
performance
by the receiving Party of this Agreement and (b) will use the Confidential
Information only for such limited purposes. Each Party hereby agrees
to use at least the same standard of care in complying with its confidentiality
obligations hereunder as it uses to protect its own Confidential Information
of
comparable sensitivity and to exercise reasonable precautions to prevent
and
restrain the unauthorized disclosure of such Confidential Information
by any of
its
****
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under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
15
Representatives. Each
Party warrants that each of its Representatives to whom any Confidential
Information is revealed shall previously have been informed of the confidential
nature of the Confidential Information and shall have agreed to maintain
its
confidentiality under terms no less restrictive than those set forth
in this
Article VII. Without limiting the generality of any of the foregoing,
the parties agree not to make any disclosure of Confidential Information
that
would be reasonably likely to impair the Parties’ ability to obtain U.S. or
foreign patents on any patentable invention or discovery described or
otherwise
embodied in such Confidential Information. The Confidential
Information of each Party includes information from Third Parties disclosed
by
one Party to this Agreement to the other Party to this
Agreement.
7.2 Release
from Restrictions.
(a) The
provisions of Section 7.1 shall not apply to any Confidential Information
disclosed hereunder to the extent that such Confidential Information
is required
to be disclosed by the receiving Party to defend or prosecute litigation
or to
comply with applicable laws or regulations, including filing an Information
Disclosure Statement with the U.S. Patent and Trademark Office or any
other
patent office, or pursuant to an order of a court or regulatory agency,
provided
that the receiving Party shall provide prior written notice of such disclosure
to the other Party and shall take actions as are reasonable and lawful
to avoid
and/or minimize the degree of such disclosure, including assisting the
other
Party in seeking a protective order or other means for preventing disclosure
or
use. To the extent, if any, that a Party concludes in good faith that
it is required by applicable laws or regulations to file or register
this
Agreement or a notification thereof with any governmental authority,
including
the U.S. Securities and Exchange Commission, such Party may do so, and
the other
Party shall cooperate in such filing or notification and shall execute
all
documents reasonably required in connection therewith. In such
situation, the filing Party shall request confidential treatment of sensitive
provisions of the Agreement to the extent permitted by law. The
Parties shall promptly inform each other as to the activities or inquiries
of
any such governmental authority relating to this Agreement, and shall
cooperate
to respond to any request for further information therefrom.
(b) A
Party may disclose this Agreement to a Third Party in connection with
or in
conjunction with a proposed merger, consolidation, sale of assets that
include
those related to this Agreement, an assignment of this Agreement or loan
financing, raising of capital, or sale of securities, provided that the
disclosing Party obtains an agreement for confidential treatment thereof,
except
in the case where after reasonable efforts such Party is unable to obtain
such
agreement.
7.3 No
Implied Rights. Except as otherwise set
forth in this Agreement, nothing herein shall be construed as giving
either
Party any right, title, interest in or ownership of the Confidential
Information
of the other Party. For the purposes of this Agreement, specific
information disclosed as part of Confidential Information shall not be
deemed to
be in the public domain or in the prior possession of the receiving Party
merely
because it is embraced by more general information in the public domain
or by
more general information in the prior possession of the receiving
Party.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
16
7.4 Survival
of Confidentiality Obligations. The confidentiality
obligations of the Parties contained in this Article VII shall remain
binding on
both Parties during the Term and for a period of five (5) years after
the
termination of this Agreement, regardless of the cause of such
termination. The Parties acknowledge that any breach of this Article
VII will constitute irreparable harm, and that the non-breaching Party
shall be
entitled to specific performance or injunctive relief to enforce this
Article
VII in addition to whatever remedies such Party may otherwise be entitled
to at
law or in equity.
7.5 Superseding
Prior Confidentiality Agreement. The provisions of this
Article VII shall supersede the Confidentiality Agreement between the
Parties
dated March 27, 2007, with respect to the subject matter hereof, and
shall
establish the sole obligations of confidentiality and nonuse of Confidential
Information received by a Party prior to or after the Effective
Date.
ARTICLE
VIII
PATENT
PROSECUTION AND ENFORCEMENT
8.1 Inventions. All
Inventions shall be the sole and exclusive property of Immtech. Par
shall disclose in writing to Immtech any Invention within thirty (30)
days of
Par’s written receipt of a disclosure for such Invention. All subject
inventors shall cooperate to the extent necessary to assist Immtech in
the
preparation, filing and prosecution of any patent, copyright, or other
applications related to any Invention, including the filing of all papers
necessary to perfect Immtech’s ownership of said Invention. All
resulting patent applications and patents related to the Product will
immediately, and without further action of the Parties, (i) be deemed
to be
Immtech Patents and listed in Schedule 1.1 and (ii) be exclusively
licensed to Par in accordance with the terms of this Agreement.
8.2 Patent
Prosecution and Maintenance. The Parties shall cooperate
in good faith to determine whether to seek or continue to seek or to
maintain
patent protection in the Territory with respect to any Immtech Patent
Rights,
Immtech Know-How and Program Developments Owned or Controlled by Immtech
and
related to the Product, and whether to file for, procure and maintain
Patent
Rights in the Territory with respect to any Immtech Patent Rights and
Program
Developments Owned or Controlled by Immtech and related to the
Product. In connection with obtaining Patent claims that cover the
making, using or selling of the Product, Immtech shall promptly provide
to Par
copies of all correspondence to and from the U.S. Patent and Trademark
Office
and shall promptly forward to Par copies of any non-confidential external
publications or public presentations by Immtech relating to the Product
for
which Immtech has not received or applied for Patent Rights, as well
as demands,
notices and summonses related thereto. Additionally, Immtech shall
accommodate all reasonable suggestions of Par and its counsel in connection
with
obtaining such Patent claims. The expenses of any such protection of
Immtech Patent Rights, Immtech Know-How and Program Developments, including
the
filing of any Patent term extensions and maintenance of Patents, shall
be borne
by Immtech. Immtech will timely file for any Patent term
extensions.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
17
8.3 Infringement.
(a) Par
and Immtech shall inform each other promptly in writing of any alleged
or
suspected infringement by a Third Party of any of Immtech Technology
or Program
Developments related to the Product, and of any available evidence
thereof.
(b) Subject
to Sections 8.3(c), 8.3(d), and 8.3(e), Par may, at its sole option and
expense,
prosecute the infringement of any Immtech Technology or Program Developments
related to the Product.
(c) In
the event that a Third Party infringes or constructively infringes Immtech
Technology or Program Developments Owned or Controlled by Immtech relating
to
the Product in the Territory (a “Product Infringement”), then
the Parties shall discuss whether or not to institute an infringement
action
with respect to such Product Infringement. Subject to Section 8.3(d),
Par shall have the right to institute such a suit and control the prosecution,
settlement or compromise thereof. At Immtech’s option, Immtech may
request to be joined as a party in such Product Infringement action and
Par
shall execute all papers and perform such acts as may be reasonably required
in
respect thereof; provided, however, that Immtech’s joining of such
action shall not affect Par’s control thereof. Immtech shall, at the
request of Par, provide reasonable cooperation and, to the extent possible,
Immtech shall have its employees testify when requested and make available
relevant records, papers, information, samples, specimens and the like
regardless of whether Immtech has joined such suit. Par shall bear
all the costs of such a suit.
(d) If
a Third Party files an ANDA targeting both the Product and non-PCP indications
for pafuramidine, Immtech shall have the right to institute a suit and
control
the prosecution, settlement or compromise thereof; provided, however,
that
Immtech shall not, without Par’s consent, take any action in the prosecution,
settlement or compromise of such suit that would adversely affect Par’s rights
hereunder or otherwise economically adversely affect the commercialization
of
the Product. Immtech shall bear all the costs of such a
suit. At Par’s option, Par may request to be joined as a party in
such litigation, provided, however, that Par’s joining of such
action shall not affect Immtech’s control thereof. Par shall, at the
request of Immtech, provide reasonable cooperation and, to the extent
possible,
Par shall have its employees testify when requested and make available
relevant
records, papers, information, samples, specimens and the like regardless
of
whether Par has joined such suit. Par shall have the right to select,
at Par’s expense, separate counsel to participate in such suits on Par’s
behalf.
(e) Within
ten (10) days of being notified of alleged or suspected Product Infringement,
Par shall either (i) institute a suit for Product Infringement pursuant
to
Section 8.3(c) or (ii) notify Immtech that (A) it has a legally relevant
belief
that it is in the Parties’ interest to not institute such suit within such time
and (B) it intends to institute such a suit in the future. If Immtech
agrees with Par’s assessment and intent to bring such suit in the future, Par
shall have the right to institute such suit in accordance with Section
8.3(c). If Immtech provides Par with written notice within five (5)
days of receipt of the notice from Par in accordance with
****
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under Rule
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and Exchange Commission.
18
the
foregoing clause (ii) that it does not reasonably agree with such assessment,
then Par may immediately institute such suit and such suit shall be governed
by
Section 8.3(c); provided, however, that if Par determines not to
institute such suit within five (5) days of receipt of such notice from
Immtech,
then Immtech may, at its option and expense, institute and litigate such
Product
Infringement. In any such infringement suit Immtech may institute to
enforce Immtech Technology or Program Developments Owned or Controlled
by
Immtech, Par shall, provide reasonable cooperation and, to the extent
possible,
have its employees testify when requested and make available relevant
records,
papers, information, samples, specimens and the like. If Immtech
initiates litigation of such Product Infringement pursuant to this Section
8.3(e), Par shall not make any admission to invalidity or unenforceability
in
respect thereof without the prior consent of Immtech. Par may join
Immtech as a party, and Immtech shall execute all papers and perform
such acts
as may be reasonably required, at the expense of Par.
(f) Any
Royalties, payments, damages, expenses, fees or other awards (collectively
“Damages”), received by Par and/or Immtech as a result of an
infringement suit, whether through judgment or settlement, shall first
be used
to reimburse each Party for its expenses associated with such infringement
suit. Thereafter, (i) if Par shall have been in control of such suit
pursuant to Section 8.3(c), any remainder shall be shared by the Parties
in
accordance with the then-applicable Royalties provided in Section 5.2(c)
(e.g., if the Net Sales have exceeded [****], Par shall be entitled
to
[****], and Immtech shall be entitled to [****], of the remainder), (ii)
if
Immtech shall have been in control of such suit pursuant to Section 8.3(e),
Immtech shall be entitled to 100% of the remainder, unless Par has
chosen, after the initiation of such suit, to join as a party to such
suit, in
which case any remainder shall be shared by the Parties equally and (iii)
if
Immtech shall have been in control of such suit pursuant to Section 8.3(d),
any
remainder shall be shared according to each Party’s harm as indicated by the
ratio of sales of the Product as compared to the sales of the products
of the
other Party or Parties. The appropriate share of the Damages shall be
paid to the other Party (or Parties), as applicable, as soon as practicable
following receipt of the Damages.
(g) In
the event that a declaratory judgment action alleging invalidity or
non-infringement of any Immtech Technology or Program Developments related
to
the Product shall be brought by a Third Party in the Territory against
Par or
against Immtech and Par, or a Citizen’s Petition shall have been filed with the
USFDA, Par, at its option, shall have the right, within ten (10) days
after
commencement of such action or the filing of such Petition, as applicable,
to
take over the defense of the action at its own expense. Immtech will
have the
option of joining in such suit. In the event the declaratory judgment
action states a count specifically against Immtech, Immtech, at its option,
shall have the right to direct and control litigation related to such
count. In the event that Par does not so elect to take over the
defense of the action at its own expense, Immtech shall be free to proceed
and
solely control such defense. To the extent that any Damages become
payable to any Third Party as a result of such action, whether through
judgment
or settlement, the Parties shall bear such Damages according to each
Party’s
share of the liability in causing such Damages, and shall contribute
such share
as promptly as practicable. Any Damages received by Immtech and/or
Par as a result of such action,
whether through judgment or settlement, shall first be used to reimburse
each
Party for its
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
19
expenses
associated with such infringement suit not otherwise reimbursed, and
then any
remainder shall be shared by the Parties equally, with such share of
the Damages
to be paid to the other party, as applicable, as soon as practicable
upon
receipt of the Damages.
(h) In
the event that a Third Party institutes any suit against Par and/or Immtech
for
patent infringement related solely to the Product, the Party sued shall
promptly
notify the other Party in writing. Immtech shall assume the defense
of such suit at Immtech’s expense; provided, however, that if Par
is also a defendant in such action and Par shall have reasonably concluded
that
there may be legal defenses available to it that are different from or
additional to those available to Immtech, Par shall have the right to
select, at
Par’s expense, separate counsel to participate in such legal defenses on
Par’s
behalf. Each Party shall, at the other's request, provide to the
other Party reasonable assistance and cooperation with respect to any
such
suit. To the extent that any Damages become payable to any Third
Party whether as a result of judgment or through settlement of such suit,
[****].
(i) If
either Party becomes aware of a patent or patent application that, when
issued,
might provide a basis for a Third Party argument that its valid rights
are being
infringed by the manufacture, use or sale of the Product hereunder, then
such
Party shall promptly inform the other Party of such patent or patent
application, and the Parties shall cooperate with each other so that
each Party
can determine whether valid rights of a Third Party are likely to be
infringed
by the manufacture, use or sale of the Product hereunder.
(j) Par
shall have the sole and exclusive right to institute a Citizen’s Petition in
order to protect the Immtech Patent Rights related to the Product and,
to the
extent it exercises its right in respect thereof, shall control all aspects
of
such Petition, including correspondence and/or negotiations with the
FDA;
provided, however, that Par shall include Immtech in such efforts
in a consultative capacity. Immtech shall maintain the sole and
exclusive right to institute a Citizen’s Petition in order to protect the
Immtech Patent Rights related to all other indications for
pafuramidine
(k) If
either Party believes that a license from a Third Party is necessary
to avoid
infringement of patents of the Third Party, the Steering Committee shall:
1)
determine whether or not to seek such a license, 2) appoint a negotiator
to
negotiate the terms of such a license, 3) determine whether or not to
enter into
such a license as negotiated by the negotiator, and 4) determine how
the
expenses of such a license shall be borne by the Parties. If the
Steering Committee cannot agree with regard to any responsibility set
forth in
the preceding sentence, such issue shall be determined accordance with
Section
13.5.
ARTICLE
IX
ADVERSE
EXPERIENCES
9.1 Notification. The
parties shall, during the term of this Agreement, keep each other promptly
and
fully informed of all of their pharmacological, toxicological and clinical
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
20
trials,
investigations and findings relating to the Product.
Adverse Drug Events (ADEs) and Individual Case Safety Reports (ICSRs)
may
originate from any source, such as healthcare professionals, regulatory
authorities, literature, consumers, patients, lawyers, clinical studies
(including post-marketing surveillance and epidemiological studies),
non-interventional studies, patient support programs, registries, internet,
preclinical studies (e.g. toxicological studies), etc. Each Party shall
use
every effort to ensure that all ADE/ICSR or pregnancy reports meet
the minimum
regulatory criteria for a valid safety report. Par shall forward all
ADEs/ISCRs received for the Product to Immtech within five calendar
days of
receipt. Format for event reporting from Par to Immtech shall be a
copy or
facsimile of the source documentation. All event information will be
transmitted
via fax or secure email. The regulatory reporting time clock for submitting
ADE/ICSR and pregnancy reports to Immtech is considered to start on
the date
when any individual within Par is first notified of a case report that
fulfills
the minimum criteria for a case report.
9.2 Reporting. With
regards to the Product, Immtech is responsible for preparing and submitting
aggregate and individual case regulatory safety reports within the Territory
as
required by regulatory authorities. Immtech shall also hold and maintain
reports
of all adverse events and adverse drug reactions, both serious and non-serious,
and reports of pregnancies in a database for the Product for preparing
and
submitting aggregate and single case reports to the FDA for the
Product.
9.3 Literature
Reports. Immtech shall be responsible for screening
published scientific and medical literature for ADEs/ICSRs. Par shall
be
responsible for notifying Immtech of any relevant ADEs/ICSR that may
come to its
attention in Par Territory via local scientific or medical journals,
or
unpublished scientific or conference papers. A copy of the article
shall be provided at the same time as the report.
ARTICLE
X
REPRESENTATIONS
AND WARRANTIES
10.1 Representations
and Warranties.
(a) Mutual
Representations and Warranties. Each Party hereby
represents and warrants to the other Party that:
(i) it
has full corporate power and authority under the laws of the state of
its
incorporation to enter into this Agreement and to carry out the provisions
hereunder;
(ii) to
the knowledge of such Party as of the Effective Date (without undertaking
any
special investigation), the performance by either Party of the activities
under
this Agreement will not infringe, nor cause such Party to unlawfully
or wrongly
use, any existing patent, trademark, trade secret, confidential or proprietary
right or other rights owned or claimed by a Third Party;
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
21
(iii) this
Agreement is a legal and valid obligation binding upon it and is enforceable
in
accordance with its terms;
(iv) the
execution, delivery and performance of this Agreement by it does not
materially
conflict with any agreement, oral or written, to which it is a party
or by which
it may be bound, nor violate any law or regulation of any court, governmental
body or administrative or other agency having authority over it;
and
(v) to
the knowledge of such Party as of the Effective Date (without undertaking
any
special investigation), there is no claim, action, suit, proceeding or
investigation pending or threatened against or affecting the transaction
contemplated hereby.
(b) Immtech
Representations and Warranties. Immtech hereby
represents and warrants to Par that:
(i) Immtech
has granted to Par under this Agreement a license under all Immtech Technology,
that are Owned or Controlled by Immtech or its Affiliates and are necessary
or
useful to Par’s conduct of its activities and exercise of its rights under this
Agreement;
(ii) Immtech
has the full right and authority to grant to Par all the license rights
under
the Immtech Technology that Immtech grants under this Agreement, and
neither
Immtech nor any of its Affiliates have granted to any Third Party any
rights
under the Immtech Technology (or any part thereof), or any rights that
would
conflict with or prevent the grant of the rights purported to be granted
in this
Agreement;
(iii) Immtech
is the owner of the entire right, title and interest in the Immtech Technology
and that it has the right and authority to enter into this Agreement
and to
grant the license under Section 2.1(a) hereof,
(iv) to
Immtech’s knowledge and belief, neither the use, manufacture or sale of the
Product, the practice of any inventions included in the Immtech Patents,
nor the
use of the Immtech Know-How infringes upon any Third Party patent, know-how
or
other intellectual property rights in the Territory;
(v) all
Immtech Patents are Owned or Controlled by Immtech and may be licensed
as
provided hereunder by Immtech without violating Immtech’s contractual
obligations to a Third Party and there is no claim, action, suit, proceeding
or
investigation
(vi) pending
or, to Immtech’s knowledge, threatened against or affecting the Immtech Patents
licensed hereunder; and
(vii) to
Immtech’s best knowledge and belief, the Product will be granted orphan drug
exclusivity by the FDA under the Orphan Drug Act, as amended.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
22
ARTICLE
XI
INDEMNIFICATION
AND LIMITATION ON LIABILITY
11.1 Indemnification
by Immtech. Subject to Section 11.3, Immtech shall
defend, indemnify and hold harmless each of Par and its directors, officers
and
employees and the successors and assigns of any of the foregoing (each
a
“Par Indemnitee”) from and against any and all liabilities,
damages, settlements, penalties, fines, costs or expenses (including,
without
limitation, reasonable attorneys’ fees and other expenses of litigation)
(collectively, “Liabilities”) arising, directly or indirectly,
out of or in connection with Third Party claims, suits, actions, demands
or
judgments to the extent relating to or based on Immtech’s gross negligence,
willful misconduct, or breach of its representations, warranties or obligations
under this Agreement, except, in each case, to the extent Par has an
obligation
to indemnify Immtech under Section 11.2.
11.2 Indemnification
by Par. Subject to Section 11.3, Par shall defend,
indemnify and hold harmless each of Immtech and its directors, officers
and
employees and the successors and assigns of any of the foregoing (each
an
“Immtech Indemnitee”) from and against any and all Liabilities
arising, directly or indirectly, out of or in connection with Third Party
claims, suits, actions, demands or judgments to the extent relating to
or based
upon Par’s gross negligence, willful misconduct, or breach of its
representations, warranties or obligations under this Agreement, except,
in each
case, to the extent Immtech has an obligation to indemnify Par under
Section
11.1.
11.3 Notice
and Procedures. If an Immtech Indemnitee or a Par
Indemnitee (the “Indemnitee”) intends to claim indemnification
under this Article XI, it shall promptly notify the other Party (the
“Indemnitor”) in writing of any such alleged
Liabilities. The Indemnitor shall have the right to control the
defense thereof with counsel of its choice, provided that such counsel
is
reasonably acceptable to Indemnitee; and, provided, further, that
any Indemnitee shall have the right to retain its own counsel at its
own
expense, for any reason, including if representation of any Indemnitee
by the
counsel retained by the Indemnitor would be inappropriate due to actual
or
potential differing interests between such Indemnitee and any other Party
reasonably represented by such counsel in such proceeding. The
Indemnitee, its employees and agents, shall reasonably cooperate with
the
Indemnitor and its legal representatives in the investigation of any
Liabilities
covered by this Article XI. The obligations of this Section 11.3
shall not apply to amounts paid in settlement of any claim, demand, action
or
other proceeding if such settlement is effected without the consent of
the
Indemnitor, which consent shall not be withheld or delayed
unreasonably. The failure to deliver written notice to the
Indemnitor within a reasonable time after the commencement of any such
action,
if prejudicial to its ability to defend such action, shall relieve the
Indemnitor of any obligation to the Indemnitee under this Section
11.3. It is understood that only Immtech or Par may claim indemnity
under this Article XI (on its own behalf or on behalf of its Indemnitees),
and
other Indemnitees may not directly claim indemnity hereunder.
****
Material omitted pursuant to a request for confidential treatment
under Rule
24b-2 of the Exchange Act of 1934. Material filed separately
with the Securities
and Exchange Commission.
23
11.5 Limitation
of Damages. EXCEPT AS PROVIDED IN SECTION 4.4(b)
OF THIS AGREEMENT AND IN RESPECT OF THIRD PARTY CLAIMS UNDER ARTICLE
XI, NEITHER
PARTY NOR ANY OF ITS REPRESENTATIVES OR AFFILIATES SHALL BE LIABLE TO
THE OTHER
PARTY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING
ECONOMIC
DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS (EXCEPT TO THE EXTENT OF
ACCRUED
COLLABORATION PAYMENTS), REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED,
SHALL HAVE OTHER REASON TO KNOW OR IN FACT SHALL KNOW OF THE POSSIBILITY
OF THE
FOREGOING.
ARTICLE
XII
TERM
AND TERMINATION
12.1 Term. The
term of this Agreement shall commence on the Effective Date and shall
expire,
unless earlier terminated as provided under Sections 12.2, 12.3 or 12.4,
on the
date on which any Royalty and other payment obligations of Par under
this
Agreement cease.
12.2 Termination
for Breach. If either party commits a material
breach or material default in the performance or observance of any of
its
obligations under this Agreement, and such breach or default continues
for a
period of sixty (60) days after delivery by the other Party of written
notice
reasonably detailing such breach or default, then the non-breaching or
non-defaulting Party shall have the right to terminate this Agreement,
with
immediate effect, by giving written notice to the breaching or defaulting
Party. The Parties shall retain all rights and remedies (at law or in
equity) in respect of any breach hereof.
12.3 Termination for Bankruptcy. This Agreement shall automatically terminate upon the initiation of any proceeding in bankruptcy, reorganization, dissolution, liquidation or arrangement for the appointment of a receiver or trustee to take possession of the assets of either Party or similar proceeding under the law for release of creditors by or against a party hereto or if a party hereto shall make a general assignment for the benefit of its creditors. All licenses and rights to licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. Par, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code, and upon commencement of a bankruptcy proceeding by or against Immtech under the Code, shall be entitled to a complete duplicate of, or complete access to (as Par deems appropriate), any such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly delivered to Par (a) upon any such commencement of a bankruptcy proceeding upon written request therefor by Par, unless Immtech elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of Immtech upon written request therefor by Par, and each Party hereby acknowledges and agrees that the foregoing shall serve as its consent to such transfer of the
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities
and Exchange Commission.
24
intellectual
property and all embodiments thereof. The
foregoing provisions of this Section 12.3 are without prejudice to any rights
Par may have arising under the Code or other applicable law.
12.5 Failure
to Meet Development Milestones. If either (i) Immtech
fails to obtain Positive Phase III Clinical Trials in respect of the current
Phase III Clinical Trials or (ii) the FDA rejects the NDA, then, Par shall
have
the right to immediately terminate this Agreement by providing a written notice
of termination to Immtech.
12.6 Effect
of Termination.
(a) Upon
the termination of the Agreement by Par in accordance with Section 12.2, (i)
Par
and its Affiliates shall have a non-exclusive, royalty-free, fully-paid up,
perpetual, worldwide license to the Immtech Technology to make, sell and have
sold the Product in the Territory.
(b) Upon
the termination of the Agreement by Immtech in accordance with Section 12.2,
(i)
all rights and licenses granted to Par pursuant to this Agreement shall
automatically and immediately terminate and Par immediately shall discontinue
Commercialization of Product and all use of the Product trademarks (and any
word
or design confusingly similar thereto) and the Immtech Technology; and (ii)
Par
shall pay within thirty (30) days after such termination: (x) all accrued and
unpaid amounts due to Immtech in accordance with the terms of this Agreement
(including, if such termination shall occur following the grant of Regulatory
Approval, any Sales Milestone payments that have been achieved but not yet
paid
by Par, any unpaid Royalties and transfer costs for Product manufactured
pursuant to Par’s sales forecast but not yet delivered to Par, but only to the
extent that Immtech is unable to sell such Product; (y) any other amounts that
will become due to Immtech through or after the effective date of such
termination in accordance with the terms hereof; and (z) if such termination
shall occur prior to the grant of Regulatory Approval, the Development
Milestones if and when they are achieved. The remedies set forth in
this Section 12.5(b) constitute Immtech’s sole and exclusive rights and remedies
for a termination of the Agreement by Immtech in accordance with Section 12.2
at
law or in equity in respect of thereof.
(c) With
the exception of any breach of Article VII of this Agreement, the parties agree
that the provisions of this Section 12.5 are intended to limit the claims that
the parties may have against each other in the circumstances described herein,
and the liquidated damages provided herein bear a reasonable relationship to
the
anticipated harm that would be caused by the relevant breaches. The
parties further acknowledge and agree that, with the exception
of any breach of Article VII of this Agreement, the amount of actual loss caused
by such breaches of this Agreement as provided in Section 12.2 is difficult
to
estimate with precision and that the parties would not have a convenient and
adequate alternative to liquidated damages hereunder.
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities
and Exchange Commission.
25
(d) Upon
the termination or expiration of this Agreement each Party shall return to
the
other Party, or destroy, at the other Party's request, all Confidential
Information of the other Party.
12.7 Surviving
Rights. The obligations and rights of the Parties under
Sections 4.3, 5.4(c), 8.1, 10.2, 12.1, 12.3, 12.5, 12.7 and 12.8 and Articles
VII, IX, XI and XIII shall survive termination or expiration of this
Agreement.
12.8 Accrued
Rights and Surviving Obligations. The termination or
expiration of this Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit of either Party prior to such
termination or expiration, including any damages arising from any breach
hereunder. Such termination or expiration shall not relieve either
Party from obligations which are expressly indicated to survive termination
or
expiration of this Agreement.
ARTICLE
XIII
MISCELLANEOUS
13.1 Entire
Agreement; Modification. This Agreement, together with
the Schedules attached hereto and incorporated herein, constitutes the entire
understanding and agreement of the Parties with respect to the subject matter
hereof and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether verbal or written,
between the Parties with respect to the subject matter hereof. No
modification or amendment of any provision of this Agreement shall be valid
or
effective unless made in writing and signed by a duly authorized officer of
each
Party.
13.2 Assignment. This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their permitted successors and assigns; provided, however,
that neither Party shall assign any of its rights and obligations hereunder
without the prior written consent of the other Party except to an Affiliate
or
as incident to the merger, consolidation, reorganization or acquisition of
stock
or assets affecting substantially all of the assets or actual voting control
of
the assigning Party. Any assignment or attempted assignment by either
Party in violation of the terms of this Section 13.2 shall be null and
void.
13.3 Performance
by Affiliates. The Parties recognize that each Party may
perform some or all of its obligations under this Agreement through one (1)
or
more of its Affiliates; provided, however, that each Party shall
remain responsible for and shall guarantee such performance by its Affiliates
and shall cause its Affiliates to comply with the provisions of this
Agreement
in connection with such performance. Each Party hereby expressly
waives any requirement that the other Party exhaust any right, power or remedy,
or proceed against an Affiliate, for any obligation or performance hereunder
prior to proceeding directly against such Party.
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities
and Exchange Commission.
26
13.4 Notices. Any
notices given under this Agreement shall be in writing, addressed to the Parties
at the following addresses, and delivered by person, by facsimile, or by FedEx
or other reputable international courier service. Any such notice
shall be deemed to have been given as of the day of personal delivery, one
(1)
day after the date sent by facsimile service or on the day of attempted or
successful delivery to the other Party confirmed by the courier
service.
|
In
the case of Immtech:
|
Xxx
Xxxxx Xxx Xxxxxx
Xxx
Xxxx, XX 00000
Attn:
Xxxx X. Xxxxxx, CEO
Fax: (000)
000-0000
|
|
with
a copy to:
|
Paul,
Hastings, Xxxxxxxx & Xxxxxx LLP
00
X. 00xx Xxxxxx
Xxx
Xxxx, XX 00000
Attn: Xxxxx
Xxxxxx, Esq.
Fax: 000-000-0000
|
|
In
the case of Par:
|
Par
Pharmaceuticals, Inc.
000
Xxxx Xxxxxxxxx
Xxxxxxxxx
Xxxx, XX 00000
Attn: General
Counsel’s Office
Fax: (000)
000-0000
|
|
with
a copy to:
|
Xxxxxx,
Xxxxxxxxxx & Xxxxxxxxx LLP
000
Xxxxx Xxxxxx
Xxx
Xxxx, XX 00000-0000
Attn:
X. Xxxx Milling, Jr., Esq.
Fax:
(000) 000-0000
|
13.5 Either
Party may change its address for communications by a notice to the other Party
in accordance with this Section 13.4.
13.6 Dispute
Resolution. The parties recognize that a
bonafide dispute as to certain matters may, from time
to time,
arise during the Term that relates to a party’s rights and/or obligations
hereunder. In the event of the occurrence of such a dispute, either
party may, by written notice to the other party, have such dispute referred
to
the respective officers designated below,
or
their successors, for attempted resolution by good faith negotiation within
thirty (30) days after such notice is received. Such designated
officers are as follows:
For
Immtech: Xxxx X. Xxxxxx, CEO, Xxxx Xxxxx, CFO
For
Par: Xxxx
XxxXxxx, President, Branded Division
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities
and Exchange Commission.
27
In
the
event that the designated officers are not able to resolve the dispute within
such thirty (30)-day period, or such other period of time as the parties may
mutually agree to in writing, each party shall have the right to pursue any
and
all remedies available at law or in equity.
13.7 Governing
Law; Waiver of Jury Trial. This Agreement shall be
governed by, and construed in accordance with, the laws of the State of New
York
without reference to any rules of conflicts of laws. The parties
hereby consent to the exclusive jurisdiction of the Federal and State courts
of
New York and hereby waive any objection to venue or forum laid
therein. The parties hereby agree that service of process by
certified mail, return receipt requested, shall constitute personal service
for
all purposes hereof. The parties expressly reject the application of
the United Nations Convention on Contracts for the International Sale of Goods
and all implementing legislation thereunder. EACH PARTY HEREBY WAIVES
ITS RIGHT TO A TRIAL BY JURY OF ANY CLAIM OR CAUSE OF ACTION BASED UPON, ARISING
OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY,
IN
ANY ACTION, PROCEEDING OR OTHER LITIGATION OF ANY TYPE BROUGHT BY ANY PARTY
AGAINST THE OTHER, WHETHER WITH RESPECT TO CONTRACT CLAIMS, TORT CLAIMS OR
OTHERWISE. THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS,
RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS
AGREEMENT.
13.8 Force
Majeure. A party hereto shall be excused and shall not
be held liable or responsible for failure or delay in fulfilling or performing
any of its obligations under this Agreement if such failure or delay
is caused by acts of God, acts of the public enemy, fire, explosion, flood,
drought, war, terrorists, riot, unavailability of raw material, sabotage,
embargo, strikes or other labor disputes, intervention of governmental
authority, or by any other event or circumstance of like or different character
to the foregoing beyond the reasonable control and without the fault or
negligence of the affected party (a “Force Majeure
Event”). Such excuse shall continue as long as the Force Majeure
Event continues. Upon cessation of such Force Majeure Event, such
party shall promptly resume performance hereunder. Each party agrees
to give the other party prompt written notice of the occurrence of any Force
Majeure Event, the nature thereof and the extent to which the affected party
will be unable to perform its obligations hereunder. Each party
further agrees to use reasonable efforts to correct or otherwise address the
Force Majeure Event as soon as practicable and to give the other party prompt
written notice when it is again fully able to perform such
obligations.
13.9 Independent
Contractors. In making and performing this Agreement,
Par and Immtech act and shall act at all times as independent contractors and
nothing contained in this Agreement
shall be construed or implied to create an agency, partnership or employer
and
employee relationship between Immtech and Par. At no time shall one
Party make commitments or incur any charges or expenses for or in the name
of
the other Party.
13.10 Severability;
Waiver. If one (1) or more of the provisions of this
Agreement are held by any court or authority having jurisdiction over this
Agreement or either of the Parties to be invalid, illegal or unenforceable,
such
provision or provisions shall be validly reformed to as
nearly as
possible approximate the intent of the Parties and, if unreformable, shall
be
divisible and deleted in such jurisdiction; elsewhere, this Agreement shall
not
be affected so long as the Parties are still able to realize the principal
benefits bargained for in this Agreement. The failure of a Party to
insist upon strict performance of any provision of this Agreement or to exercise
any right arising out of this Agreement shall neither impair that provision
or
right nor constitute a waiver of that provision or right, in whole or in
part,
in that instance or in any other instance. Any waiver by a Party of a
particular provision or right shall be in writing, shall be as to a particular
matter and, if applicable, for a particular period of time and shall be signed
by such Party.
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities
and Exchange Commission.
28
13.11 Further
Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
13.12 Cumulative
Rights. The rights, powers and remedies hereunder shall
be in addition to, and not in limitation of, all rights, powers and remedies
provided at law or in equity, or under any other agreement between the
Parties. All of such rights, powers and remedies shall be cumulative,
and may be exercised successively or cumulatively.
13.13
Counterparts. This
Agreement may be executed in two (2) or more counterparts, each of which shall
be an original and all of which shall constitute together the same
document. Counterparts may be signed and delivered by facsimile, each
of which shall be binding when sent.
[Signature
Page Follows]
****
Material omitted pursuant to a request for confidential treatment under
Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities
and Exchange Commission.
29
IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by
their duly authorized representatives as of the day and year first above
written.
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By: /s/
Xxxx X.
Xxxxxx
Name: Xxxx X. Xxxxxx Title:
Chairman and Chief Executive Officer
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PAR
PHARMACEUTICAL, INC.
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By:
/s/ Xxxx MacPhee__________________________
Name: Xxxx
XxxXxxx
Title: President,
Branded Products Division
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