LICENSE AGREEMENT
EXHIBIT
10.31
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This
License Agreement (the
“Agreement”)
is
made and entered into as of January 14, 2008 (the “Effective
Date”),
between Alfacell
Corporation,
a
Delaware corporation with its principal place of business at 000 Xxxxxx Xxxxx,
Xxxxxxxx, Xxx Xxxxxx 00000 (“Alfacell”),
and
Par
Pharmaceutical, Inc.,
a
Delaware corporation with its principal place of business at 000 Xxxx
Xxxxxxxxx, Xxxxxxxxx Xxxx, Xxx Xxxxxx 00000 (“Par”).
Alfacell and Par may be referred to herein individually as a “Party”,
or
together as the “Parties”.
Recitals
Whereas,
Alfacell
has expertise developing pharmaceutical products 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) in the Field;
and
Whereas,
Par has
expertise in developing, manufacturing and marketing certain pharmaceutical
products and wishes to develop and market the Product in the Field in the
Territory as further described herein, and Alfacell 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:
“Accelerated
Approval”
means
approval of a Product NDA pursuant to 21 C.F.R. Part 314 Subpart H (a) in which
the FDA evaluation of the NDA is performed on the basis of a surrogate marker
(a
measurement intended to be a substitute for the clinical measurement of
interest) that is considered likely to predict patient benefit and (b) that
may
be a provisional approval, with a required written commitment to complete
clinical studies that formally demonstrate patient benefit.
“Affiliate”
means,
with respect to a Party and for so long as the relationship exists, any other
entity that directly or indirectly controls, is controlled by, or is under
common control with, such Party. An entity shall be regarded as in control
of
another entity if it owns, or directly or indirectly controls, greater than
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.
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“AG
Product”
means
a
generically-labeled version of the Product (i.e.,
such
Product does not bear the Trade Name) supplied by Alfacell and sold by Par
and/or its Sub-distributors or permitted sublicensees.
“Agreement”
has
the
meaning set forth in the introductory paragraph.
“Alfacell”
has
the
meaning set forth in the introductory paragraph.
“Alfacell
Indemnitee”
has
the
meaning set forth in Section 12.2.
“Alfacell
Information”
means
any Product-related information Owned or Controlled by Alfacell as of the
Effective Date or Owned or Controlled by Alfacell after the Effective Date
that,
with respect to a Product in the Field in the Territory, (a) is directly related
to use or sale of the Commercialized Product, (b) is included in an Alfacell
NDA
filing for the Product within the scope of this Agreement, (c) is otherwise
reasonably requested by Par and provided by Alfacell in its sole discretion,
or
(d) is lawfully obtained by Alfacell from a Third Party without restriction
on
disclosure to Par, but only to the extent that such Product-related information
is necessary or useful for, and is specific to use, utilization, or sale of
the
Product, and is disclosed to Par by Alfacell pursuant to this Agreement. Program
Developments Owned or Controlled by Alfacell that are not Alfacell Patents,
shall be Alfacell Information. For the avoidance of doubt, Alfacell shall have
no obligation to disclose to Par any Ranpirnase or Product manufacturing
Know-How Owned or Controlled by Alfacell, except in connection with Section
4.2
of this Agreement.
“Alfacell
Patents”
means
any United States patents and patent applications Owned or Controlled by
Alfacell as of the Effective Date or Owned or Controlled by Alfacell after
the
Effective Date that cover Ranpirnase or Product, the importation, use or making
of Ranpirnase or Product, or any part of the foregoing or that in Par’s opinion
may cover Competing Products, the importation, use or making of Competing
Product, or any part thereof. Such Alfacell patents and patent applications
as
of the Effective Date are set forth on Schedule
1.1,
which
is attached hereto and made part of this Agreement. Schedule
1.1
shall be
amended from time to time during the Term to reflect any such patents Owned
or
Controlled by Alfacell after the Effective Date. The term “Alfacell Patents”
shall include continuations, divisions, provisionals or any substitute
applications of the patents and patent applications set forth on Schedule
1.1,
any
patent issued with respect to any such patent applications, and any reissue,
reexamination, renewal or extension (whether by patent law or regulation, or
any
other law or regulation, for example FDA related extensions) of any such
patent.
“Alfacell
Technology”
means
Alfacell Patents and Alfacell Information.
“Amphinase(s)”
means
all pharmaceutical agents disclosed or claimed in one or more of the
following:
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Patent
No. US 7,229,824 B1
U.S.
Patent Application No. 11/759,247 filed 7 JUN 2007
U.S.
Patent Application No. 11/759,249 filed 7 JUN 2007
U.S.
Patent Application No. 11/759,250 filed 7 JUN 2007
U.S.
Patent Application No. 11/759,251 filed 7 JUN 2007
U.S.
Patent Application No. 11/759,952 filed 8 JUN 2007
U.S.
Patent Application No. 11/759,953 filed 8 JUN 2007
U.S.
Patent Application No. 11/759,954 filed 8 JUN 2007
U.S.
Patent Application No. 11/759,955 filed 8 JUN 2007
The
term
“Amphinase” also means and includes all pharmaceutical agents disclosed or
claimed in any patents issuing on any of the above-referenced patent
applications, and all pharmaceutical agents disclosed or claimed in any
continuation, division, reexamination, or reissue thereof.
“cGMP”
means
the regulatory requirements for current good manufacturing practices promulgated
by the FDA under authority of the U.S. Food, Drug and Cosmetic Act, particularly
21 C.F.R. Section 210 et seq., as the same may be amended from
time to time.
“Change
of Control” means,
in
respect of either Party, an event in which: (a) any other person or group of
persons (as the term “person” is used for purposes of Section 13(d) or 14(d) of
the Exchange Act) not then beneficially owning more than fifty percent (50%)
of
the voting power of the outstanding securities of such Party acquires or
otherwise becomes the beneficial owner (within the meaning of Rule 13d-3
promulgated under the Exchange Act) of securities of such Party representing
more than fifty percent (50%) of the voting power of the then outstanding
securities of such Party with respect to the election of directors of such
Party; or (b) such Party (i) consummates a merger, consolidation or similar
transaction with another person where the voting securities of such Party
outstanding immediately preceding such transaction (or the voting securities
issued with respect to the voting securities of such Party outstanding
immediately preceding such transaction) represent less than fifty percent (50%)
of the voting power of such Party or surviving entity, as the case may be,
immediately following such transaction, or (ii) disposes by sale, assignment,
exclusive license or otherwise of all or substantially all of its intellectual
property rights, except for licenses under such intellectual property rights
in
the ordinary course of business and any isolated sale or assignment of specific
items of intellectual property.
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“Clinical Supplies”
means
supplies of the Product, manufactured, packaged and labeled in compliance with
cGMP and applicable law, in such form and dosage as is determined by Alfacell
pursuant to the Development Program, and suitable for use in the conduct of
pre-clinical and/or human clinical trials of the Product in the United States
pursuant to the Development Program.
“CMC
Section”
means
the Chemistry, Manufacturing and Controls section of an NDA
submission.
“Code”
has
the
meaning set forth in Section 13.3.
“Commercialization”
means
the marketing, promotion, advertising, selling and/or distribution of the
Product in the Field in the Territory after Regulatory Approval has been
obtained; and the term “Commercialize”
has
a
corresponding meaning.
“Commercialization
Committee”
has
the
meaning set forth in Section 2.2.
“Commercially
Reasonable Efforts”
means,
with respect to each Party, the continuous and diligent efforts and commitment
of resources of a degree and kind in accordance with such Party’s reasonable
business, legal, medical and scientific judgment that are consistent with the
efforts and resources such Party uses for other products owned by it or to
which
it has similar rights, which are of similar market potential and at a similar
stage in their life cycle, taking into account the competitiveness of the
marketplace, the regulatory structure involved and other relevant factors;
and
the term “Commercially
Reasonable”
has
a
corresponding meaning. For a Product other than an AG Product, Par’s efforts and
commitments for purposes of this definition will be determined by comparison
to
Par’s branded products; for an AG Product, Par’s efforts and commitments for
purposes of this definition will be determined by comparison to Par’s other
authorized generic products.
“Competing
Product”
means
any pharmaceutical product containing (a) Ranpirnase or (b) any compound or
moiety that includes Ranpirnase or is derived from, or substantially similar
to,
Ranpirnase or its nucleic acid sequences as a starting material, intermediate
or
base material and, in either case (i) for parenteral administration or (ii)
in
the Field; provided,
however,
that
(x) no Amphinase shall be considered a Competing Product, and (y) on and after
the date that a Third Party sells or offers for sale a generically-labeled
version of the Product, the definition of the term “Competing Product” will be
limited to a pharmaceutical product containing Ranpirnase and any generic
equivalent thereof (as determined by the FDA).
“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, which
information 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; provided,
however,
that
Confidential Information shall not include information that a Party can
demonstrate by written evidence: (a) is in the public domain other than as
a result of a breach by such Party (or any of its Sub-distributors) of its
obligations of confidentiality contained herein; (b) was known by the
receiving Party prior to receipt from the disclosing Party; (c) has been
developed by the receiving Party independent of any Confidential Information
of
the disclosing Party; or (d) 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 shall constitute “Confidential
Information” of both Parties hereunder.
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“Contract
Year”
means
(a) if the Initial Commercial Sale occurs during the first 45 days of a
calendar quarter, a twelve (12) month period starting on the first day of
the calendar quarter in which the Initial Commercial Sale (or an anniversary
thereof, as the case may be) occurs or (b) if the Initial Commercial Sale
occurs other than during the first 45 days of a calendar quarter, a
twelve (12) month period starting on the first day of the calendar quarter
immediately following the calendar quarter in which the Initial Commercial
Sale
(or an anniversary thereof, as the case may be) occurs;
provided, however,
that if
a Contract Year is triggered pursuant to the foregoing clause (b), then, for
purposes of computing Net Sales during the initial Contract Year, the Parties
will include the Net Sales during the forty-five (45) days immediately prior
to
thereto.
“CPR”
has
the
meaning set forth in Section 14.5.
“Damages”
has
the
meaning set forth in Section 9.3(e).
“Detail”
means,
with respect to the Product, a face-to-face contact between a sales
representative and a physician or other medical professional licensed in the
Territory to prescribe drugs, during which a First Position Detail or Secondary
Position Detail is made to such person, in each case as measured by each Party’s
internal recording of such activity; provided,
that
such meeting is consistent with and in accordance with the requirements of
applicable laws and this Agreement.
“Development
Committee”
has
the
meaning set forth Section 2.1(a).
“Development Costs”
means
all direct and indirect costs and expenses incurred by Alfacell in connection
with the Development Program, which may include (a) costs associated with
designing, planning and conducting Phase III Clinical Trials and/or the Phase
IIB studies for the Product and all subsequent clinical testing and trials,
including all third-party costs and expenses of any and all Phase IIIB and
Phase
IV studies with respect to the Product that are required by the FDA, and
including all costs associated with meeting with the ODAC and/or completion
of
any studies as a result of such meetings, (b) costs in connection with seeking,
obtaining and maintaining Regulatory Approval, including all FDA filing fees,
(c) payments made to Third Parties in connection with the Development
Program, (d) materials and supplies, and (e) license or acquisition
fees and other costs and expenses associated with Alfacell’s obtaining from a
Third Party any trademarks, tradenames, logos, trade dress or similar
intellectual property rights licensed or acquired by Alfacell after the
Effective Date for use in connection with Commercialization of the Product
in
the Field in the Territory.
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“Development
Program”
means
Alfacell’s activities associated with Alfacell’s development of the Product in
the Field for sale in the Territory by Par pursuant to this Agreement, including
(a) research and development of a recombinant version of Ranpirnase; (b)
manufacture and formulation of the Product for preclinical and clinical studies;
(c) planning, implementation, evaluation and administration of human clinical
trials of the Product in the Field in the Territory; (d) manufacturing process
development and scale-up for the manufacture of the Product; (e) preparation
and
submission of applications for Regulatory Approval in the Field in the
Territory; and (f) post-market surveillance of approved Product
Indications.
“Direct
Cost”
means
the actual costs and expenses paid by Alfacell to Third Party manufacturers
for
Product in finished form, filled, labeled and packaged for commercial sale,
such
costs and expenses not to exceed $*** per
1 mg
vial except with the prior written consent of Par, which consent shall not
be
unreasonably withheld; provided,
however,
that if
the Parties determine to launch a Product where Ranpirnase has been obtained
from a recombinant source, then the Direct Cost shall be amended as the Parties
mutually agree.
“Effective
Date”
means
the date set forth in the introductory paragraph.
“Ex-U.S.
Shipping Costs”
means,
if Alfacell’s manufacturing facility or that of its Third Party Manufacturer (as
defined in the Supply Agreement) as designated by Alfacell pursuant to Section
5.1 of the Supply Agreement is located outside of the continental United States,
all charges and fees for freight, shipping, customs, duties, and insurance
incurred by Par for shipment of Product from such facility.
“Fair
Market Value”
means,
when determined on an annual basis, the total annual cost per sales
representative including salary, commission, benefits, car allowance and
legitimate reimbursable travel and/or home office expenses,
divided by the number of annual Details delivered by the sales representative,
multiplied by the percentage of Product presentation time per Detail (based
on
the Product presentation position in the Detail, e.g.,
60% for
First Position Details, 40% for Secondary Position Details). The Fair Market
Value may also be determined on a calendar quarter basis, as
applicable.
“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.
“Field”
means
all uses for cancer in humans.
“First
Position Detail”
means
a
Detail in which no more than three (3) products are presented, in which key
attributes of the Product are verbally presented consistent with the terms
of
this Agreement and applicable laws, and where the Product receives *** percent
(***%) or more of the total call time and is given primary emphasis
(i.e.,
an
emphasis that is more important than the emphasis given to any other product
presented).
“Force
Majeure Event”
has
the
meaning set forth in Section 14.7.
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“Future
Indication”
means
an Indication of the Product for the treatment of *** any other specific disease
or condition in the Field to which the Parties mutually agree in
writing.
“Full
Approval”
means,
in respect of the Product for the Primary UMM Indication, Secondary UMM
Indication or any Future Indication, Regulatory Approval upon which the FDA
has
granted full approval (i.e.,
any FDA
approval that is not Accelerated Approval) to market the Product for such
Indication in the United States.
“GAAP”
means
generally accepted accounting principles in the United States, as in effect
from
time to time.
“Governmental
Authority”
means
any court, tribunal, arbitrator, agency, legislative body, commission, official
or other instrumentality of (a) any government of any country, (b) a federal,
state, province, county, city or other political subdivision thereof or (c)
any
supranational body. The term “Governmental Authority” includes the
FDA.
“Indemnitor”
has
the
meaning set forth in Section 12.3.
“Indication”
means
any approved human therapeutic use(s) for the Product in the Field.
“Initial
Commercial Sale”
means
the first sale of the Product by Par or a Sub-distributor to a Third Party
in
the Field in the Territory following Regulatory Approval for the Primary UMM
Indication, the Secondary UMM Indication or a Future Indication (whichever
Indication is approved for the first Product sale in the
Territory).
“Insolvent
Party”
has
the
meaning set forth in Section 13.3.
“Knowledge”
of
Alfacell means the actual knowledge of Kuslima Shogen, Xxxxxxxx X. Xxxxxx,
Xxxxxx X. Xxxxxxxx and/or Xxxxx Xxxxxxxx, in each case after due and reasonable
inquiry.
“Losses”
has
the
meaning set forth in Section 12.1.
“Material
Commercialization Decision”
has
the
meaning set forth in Section 2.2(d).
“Material
Development Decision”
has
the
meaning set forth in Section 2.1(b)(iii).
“Modified
Targeted Ranpirnase”
means
Targeted Ranpirnase other than for UMM or any Future Indication.
“Net
Margin”
means
Net Sales minus Ex-U.S. Shipping Costs (if applicable).
“Net
Sales”
means,
***.
“NDA”
means
the New Drug Application and all amendments and supplements thereto for the
Product submitted by Alfacell to the FDA, including all documents, data and
other information included in an accepted NDA submission for Regulatory Approval
to market and sell the Product in the Field in the Territory.
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“ODAC”
has
the
meaning set forth in Section 3.1.
“Owned
or Controlled by”
means,
with respect to any patent or other intellectual property right, the possession
of the ability, whether directly or indirectly, and whether by ownership,
license or otherwise, to grant a license, sublicense or other right to or under
such Patent or right as provided for herein without violating the terms of
any
agreement or other arrangement with any Third Party (and in the case of United
States Patent Nos. 6,649,392 and 6,649,393, subject to the interests of the
U.S.
Government therein).
“Par”
has
the
meaning set forth in the introductory paragraph.
“Par Indemnitee”
has
the
meaning set forth in Section 12.1.
“Par
Promoted Products”
means
all FDA-approved branded products that Par is promoting or co-promoting in
the
Territory for their approved indications.
“Party”
and
“Parties”
have
the meaning set forth in the introductory paragraph.
“Phase
III Clinical Trials”
means
that portion of the Development Program that provides for human clinical studies
in the Field 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) are needed to evaluate the overall
risk-benefit relationship of the Product and to provide adequate basis for
obtaining requisite Regulatory Approvals.
“Primary
UMM Indication”
means
the Indication of the Product for the treatment of patients with UMM whose
disease is either unresectable or who are otherwise not candidates for surgery,
wherein (a) the labeling for such Indication recites “ONCONASE® (ranpirnase) in
combination with doxorubicin is indicated for the treatment of patients with
malignant pleural mesothelioma whose disease is unresectable or who are
otherwise not candidates for curative surgery” or a substantially equivalent or
broader label for such Indication, (b) neither the indication nor clinical
pharmacology section of the label is limited to use only in patients who have
first used and/or failed Altima, and (c) such Indication is supported by data
from a pivotal study that demonstrates a statistically significant survival
benefit of at least two months.
“Product”
means
any pharmaceutical product containing Ranpirnase for parenteral administration
that has been developed by Alfacell or is developed by Alfacell pursuant to
this
Agreement, including as the Product may be modified to obtain Regulatory
Approval thereof, including the AG Product.
“Product Infringement”
has
the
meaning set forth in 9.3(c).
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“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 pertaining thereto, that
are
designed (a) to support Regulatory Approval for the Product in the Field in
the
Territory, or (b) to support publications, promotional and educational
activities, future labeling changes or new Indications for Ranpirnase. Unless
otherwise expressly provided herein or agreed to by the Parties, all “Product
Studies” shall be owned by Alfacell.
“Program
Developments”
means
all inventions, discoveries, patents, patent applications, know-how, copyrights
and works of authorship and other intellectual property that are related to
Ranpirnase in the Field and are made, developed, created, conceived or reduced
to practice during the Term of this Agreement by Alfacell in connection with
its
work in the Development Program, regardless of whether the invention, discovery,
patent application, know-how, or work is patentable.
“Ranpirnase”
means
the active pharmaceutical ingredient described in Exhibit
A,
which
may be obtained from natural sources or a recombinant source. For the sake
of
clarity, sequence variants, and fusion proteins and conjugates that incorporate
Ranpirnase, are expressly excluded, but various formulations of the active
pharmaceutical ingredient described in Exhibit
A
are
included.
“Regulatory
Approval”
means
all approvals (including, where applicable, pricing and reimbursement approval
and schedule classifications), product and/or establishment licenses,
registrations or authorizations of any Governmental Authority, necessary for
the
commercialization, use, storage, import, export, transport, offer for sale,
or
sale of a pharmaceutical product for human use in a regulatory jurisdiction
within the Territory, including, if and as applicable, the issuance by the
FDA
of an action letter indicating approval of the NDA; provided,
however,
that
Regulatory Approval for the Product in any Future Indication can occur following
issuance by the FDA of an action letter indicating Accelerated Approval of
the
NDA.
“Representatives” has
the
meaning set forth in Section 8.1.
“Royalty”
has
the
meaning set forth in Section 6.3(a).
“SEC”
has
the
meaning set forth in Section 14.13.
“Secondary
Position Detail”
shall
mean a Detail in which no more than three products are presented, in which
key
attributes of the Product are verbally presented consistent with the terms
of
this Agreement and applicable laws, and where the Product is given significant
emphasis (i.e.,
an
emphasis that is more important than the emphasis given to any other product
presented (other than the product that is presented as the First Position
Detail)).
“Secondary
UMM Indication”
means
an Indication of the Product for the treatment of UMM,
other
than the Primary UMM Indication.
“Solvent Party”
has
the
meaning set forth in Section 13.3.
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“Sub-distributor”
has
the
meaning set forth in Section 4.3.
“Supply Agreement”
has
the
meaning set forth in Section 2.4.
“Targeted
Ranpirnase”
means
any Competing Product that is designed to act, and does act, or is reasonably
understood to act, only in a specific manner on only a particular cell, tissue
or organ system, for an indication in the Field.
“Territory”
means
the United States of America, including its territories, possessions,
protectorates and the Commonwealth of Puerto Rico and any United States military
base or installation located outside of the United States of
America.
“Term”
has
the
meaning set forth in Section 13.1.
“Third
Party”
means
any person or entity other than Alfacell or Par or an Affiliate of Alfacell
or
Par.
“Third Party Product Event”
has
the
meaning set forth in Section 7.4.
“Trademark”
means
the trademark under which the Product may be sold in the Field in the Territory,
including as set forth in Exhibit
B,
as may
be amended by the Parties from time to time.
“Trade
Name”
means
each trade name (i.e., Trademark) established for the Product under this
Agreement.
“Transfer
Price”
means
***.
“UMM”
means
unresectable malignant mesothelioma or mesothelioma presented in a patient
who
otherwise is not a candidate for surgery.
“Valid
Claim” means
(a) an unexpired claim of an issued patent within the Alfacell Patents that
has not been held to be unpatentable, invalid or unenforceable by a United
States court, the United States Patent and Trademark Office, or other authority
in the United States, from which decision no appeal is taken or can be taken;
and (b) a claim of a pending application within the Alfacell
Patents.
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 licensor, licensee
and license will be interpreted broadly to refer also to sub-licensing
arrangements and/or the Parties thereto.
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(b) This
Agreement is between financially sophisticated and knowledgeable entities 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 Development
Committee.
(a) Establishment.
The
Parties hereby establish a committee consisting of such even number as shall
be
agreed by the Parties, fifty percent (50%) of whom shall be Par designees and
fifty percent (50%) of whom shall be Alfacell designees (the “Development
Committee”).
Each
of the Development Committee members shall have appropriate expertise to perform
the functions assigned to the Development Committee pursuant to this Agreement.
The initial Development Committee shall consist of a total of six (6) members
who shall be designated by each Party within ten (10) business days 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 Development 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 Development Committee. The initial
Co-Chairs shall be designated by each Party within ten (10) business days after
the Effective Date.
(b) Meetings
and Procedures.
(i) The
Development Committee shall meet at least once per calendar quarter, and more
frequently at the reasonable request of either Party or as required to discuss
and make efforts to resolve disputes, disagreements or deadlocks of the
Development Committee, 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 Development 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 Development Committee to all members of the
Development Committee reasonably in advance of the meeting. The location of
regularly-scheduled Development Committee meetings shall alternate between
the
offices of the Parties, unless otherwise agreed. The members of the Development
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 Development Committee meeting shall appoint one person (who need not be
a
member of the Development Committee) to attend the meeting and record the
minutes of the meeting in writing. Such minutes shall be circulated to the
members of the Development Committee promptly following the meeting for review
and comment.
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(ii) Alfacell
agrees to keep the Development Committee reasonably informed in respect of
its
conduct of the Development Program pursuant to its authority and responsibility
set forth in Section 3.1, and in particular Alfacell shall provide the
Development Committee with information related to the overall progress of the
Development Program. Upon the request of Par’s members, Alfacell shall provide
copies and updates of its development plans to the Development Committee. Par’s
members shall provide advice, suggestions and constructive feedback on the
Development Program. Additionally, Alfacell shall promptly notify the
Development Committee if, during the Term, it discovers any new, reproducible
uses for Ranpirnase in the Field which have been confirmed by Alfacell and/or
are the subject of an invention disclosure or draft patent application, and
relevant information related thereto (as such information provided by Alfacell
shall be deemed Alfacell Information hereunder).
(iii) The
Development Committee has no decision-making authority except as expressly
set
forth herein. Subject to Section 3.7, the final protocol design for any Phase
III Clinical Trials for any Future Indication, including any material
modification thereof (the “Material
Development Decision”),
shall
be determined by a vote of the Development Committee. All decisions of the
Development 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 Development
Committee shall use Commercially Reasonable Efforts to decide all matters
assigned to the Development Committee under this Agreement or otherwise referred
to it by mutual agreement of the Parties; provided,
however,
that if
the members of the Development Committee are unable to make a decision by
unanimous vote or unanimous written consent within ten (10) days after
commencing discussions regarding such decision, or if Development Program timing
constraints make submission of any matter to the Development Committee
impracticable, then Alfacell shall have the final decision-making authority
with
respect to such decision, except (A) in respect of the Material Development
Decision, and/or (B) in respect of the Development Committee’s recommendation
that Alfacell should not pursue a recombinant source of Ranpirnase, wherein
any
final decision not to pursue a recombinant source of Ranpirnase shall require
the written approval of both Parties.
(c) Purposes
and Powers.
The
principal purpose of the Development Committee shall be to provide a forum
for
open communication between the Parties with respect to development and
manufacturing of the Product in general, and for Par to act in an advisory
and
consultative capacity with respect to the Development Program. The Development
Committee shall make recommendations regarding the overall strategy for the
Development Program, and shall provide advice, guidance, direction and other
recommendations with respect to the Development Program. Subject to the express
rights of the Parties as set forth herein, the functions of the Development
Committee shall include:
(i) Acting
as
liaison between the Parties to ensure open and regular communication channels,
and more particularly to ensure that the Parties are informed of, and have
a
forum to discuss, the ongoing progress of the Development Program;
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(ii) Reviewing
and recommending (or declining to recommend) proposed amendments to the
Development Program;
(iii) 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
(provided that Alfacell shall not be required to renegotiate any previously
negotiated terms and conditions with any such Product manufacturer(s), and
further provided that such consultation and input shall not unreasonably delay
Alfacell’s negotiation and completion of its Product contract manufacturing
arrangements, wherein the reasonableness of any delay shall be determined by
Alfacell in good faith after consultation with Par);
(iv) Reviewing
and recommending (or declining to recommend), in consultation with the
Commercialization Committee, activities (A) related to the publication and/or
dissemination of the clinical data and reports related to Product Studies,
including publications, posters, abstracts and presentations, and (B) with
respect to other matters that intersect or overlap with Commercialization
activities; and
(v) Performing
such other activities and discharging such other responsibilities as may be
assigned to the Development Committee by the Parties pursuant to this Agreement
or as may be mutually agreed upon by the Parties from time to time.
2.2 Commercialization
Committee.
(a) The
Parties hereby establish a committee, separate from the Development Committee,
which shall provide a forum for open communication between the Parties regarding
Product Commercialization activities in the Field, and which shall be
responsible for such matters related to Commercialization of the Products in
the
Field in the Territory as may be described below. The Commercialization
Committee shall consist of such even number as shall be agreed by the Parties,
fifty percent (50%) of whom shall be Par designees and fifty percent (50%)
of
whom shall be Alfacell designees (the “Commercialization
Committee”).
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 Commercialization 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 Commercialization Committee. The
initial Commercialization Committee shall consist of six (6) members (including
the Co-Chairs of such Committee), who shall be designated by each Party within
ten (10) business days after the Effective Date. For the sake of clarity, an
individual may serve on both the Development Committee and the Commercialization
Committee. The Commercialization Committee shall meet at least once per calendar
quarter, and more frequently as mutually agreed by the Parties, on such dates,
and at such places and times, as the Parties shall agree.
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(b) Par
agrees to keep the Commercialization Committee reasonably informed in respect
of
its Commercialization of Products in the Field in the Territory pursuant to
its
authority and responsibility set forth in Section 5.1, and in particular Par
shall (a) provide the Commercialization Committee at its regularly scheduled
meetings with copies of Par’s annual Product marketing plans, information
regarding Par’s Commercialization strategy, and updates regarding the foregoing
and the progress of Par’s Commercialization activities, (b) promptly advise the
Commercialization Committee of any unforeseen material problems or delays
encountered since the date of its last report in connection with the
Commercialization activities, and (c) provide Alfacell as soon as reasonably
practicable with such other material information as Alfacell’s Commercialization
Committee members may reasonably request in writing from time to time with
respect to the status of the Commercialization activities and progress.
Alfacell’s members shall provide advice, suggestions and constructive feedback
on such Commercialization strategy, plans and activities (especially in view
of
Alfacell’s retained rights regarding Product commercialization outside of the
Field and outside of the Territory, and Alfacell’s desire to achieve (to the
extent appropriate) global harmonization of Product commercialization (including
branding) worldwide). Par will reasonably and in good faith consider any
comments and recommendations that the Commercialization Committee may have
with
respect to the Commercialization of the Product.
(c) The
Commercialization Committee shall (i) review and recommend (or decline to
recommend), in consultation with the Development Committee, (A) activities
related to the publication and/or dissemination of the clinical data and reports
related to Product Studies, including publications, posters, abstracts and
presentations and (B) matters that intersect or overlap with Product development
and/or manufacturing activities, (ii) support Par’s strategy and plans regarding
Commercialization (to the extent that such strategy and plans have been provided
to the Commercialization Committee), and (iii) perform such other activities
and
discharge such other responsibilities as may be assigned to the
Commercialization Committee by the Parties pursuant to this Agreement or as
may
be mutually agreed upon by the Parties from time to time. Par will reasonably
and in good faith consider any comments and recommendations that the
Commercialization Committee may have with respect to the Commercialization
of
the Product.
(d) The
Commercialization Committee has no decision-making authority except as expressly
set forth herein. All Commercialization issues related to the initial medical
claims for the core launch materials for the Product that will be submitted
to
the FDA for pre-clearance review (the “Material
Commercialization Decision”)
shall
be determined by a vote of the Commercialization Committee. If the
Commercialization Committee is unable to agree on the Material Commercialization
Decision, such dispute or disagreement shall be referred to the CEO of Alfacell
and the CEO of Par for resolution, and the CEOs shall resolve the matter
(without resort to Section 14.5). All decisions of the Commercialization
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 Commercialization Committee shall
use Commercially Reasonable Efforts to decide all matters assigned to the
Commercialization Committee under this Agreement or otherwise referred to it
by
mutual agreement of the Parties; provided,
however,
that if
the members of the Commercialization Committee are unable to make a decision
by
unanimous vote or unanimous written consent within ten (10) days after
commencing discussions regarding such decision, then, except in respect of
any
Material Commercialization Decision, Par shall have the final decision-making
authority with respect to such decision (subject to any limitations on such
authority expressly set forth herein); provided,
however,
that if
Commercialization timing constraints make submission of the matter to the
Commercialization Committee impracticable, then Par shall have the discretion
to
make such determination.
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2.3 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 Development Committee and/or Commercialization Committee.
2.4 Ancillary
Agreements.
All
designees of each Party serving on the 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. Additionally (i) as of the Effective Date, the Parties shall enter
into
a Supply Agreement which is attached hereto as Exhibit
C
(the
“Supply
Agreement”),
and
(ii) within sixty (60) days of the date that the first NDA is submitted to
the
FDA by Alfacell, the Parties shall enter into a Quality Agreement on mutually
agreeable and customary terms, and (iii) within sixty (60) days after Alfacell’s
election to co-promote Product pursuant to Section 5.3 or 5.4, the Parties
shall
enter into a definitive, written Co-Promotion Agreement on mutually agreeable
terms in accordance with Section 5.4.
ARTICLE
III
DEVELOPMENT
PROGRAM
3.1 Alfacell
Responsibility and Control.
Subject
to Sections 2.1(b)(iii) and 3.7, Alfacell shall have final decision-making
authority and primary responsibility for the Development Program and all
non-Commercialization strategies, plans and activities regarding the Product.
Alfacell shall use its Commercially Reasonable Efforts to conduct the
Development Program, to obtain Regulatory Approval for the Product, and to
manufacture the Product, all in accordance with this Agreement. More
specifically, Alfacell shall use its Commercially Reasonable Efforts to (a)
develop the Product for the Primary UMM Indication and, subject to Section
3.7,
at least one Future Indication, (b) prepare and submit all required
application(s) for Regulatory Approval in the Field in the Territory in respect
of the Product for such Indications, including the applicable NDA(s), and (c)
if
necessary, and subject to Section 6.2(a)(ii), work in consultation with the
Development Committee to prepare for any meeting before, and comply with any
action plans negotiated by Alfacell and the FDA in response to requests of,
the
Oncologic
Drugs Advisory Committee to the FDA (the “ODAC”).
Subject
to Section 3.7, Alfacell has the sole right to develop the Product for Future
Indications. Subject to the terms and conditions contained in this Agreement,
Alfacell shall have sole responsibility and control over development and
manufacture of the Product for use in the Field for the Territory and, subject
to Section 3.3(b), all regulatory matters related thereto, including control
over and responsibility for executing all aspects of the Development Program,
including planning, strategy, administrative management, and fiscal control;
provided,
however,
that,
subject to Section 6.2(a)(ii), Alfacell shall include Par (through the
Development Committee) in such efforts in an advisory and consultative capacity.
As of the Effective Date, the Parties anticipate that the Development Program
shall be conducted at and coordinated from the facilities of Alfacell. Alfacell
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.
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3.2 Development
Program.
Subject
to the provisions of this Agreement, Alfacell shall determine the development
plan(s) and the Development Program, and the execution thereof shall be within
Alfacell’s decision-making authority and control (subject to Section
2.1(b)(iii)). 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) Alfacell does not guarantee that the
Development Program will be successful or that Regulatory Approval will be
obtained for the Product in the Field in the Territory. During the Term, subject
to the other provisions of this Agreement, Alfacell may revise the development
plan(s) and/or the Development Program at any time and from time to time,
provided that (y) Alfacell provides the Development Committee with a reasonable
opportunity to review and comment on any proposed revision to the development
plan(s) and/or the Development Program, and (z) Alfacell shall consider in
good
faith any such comments prior to the adoption and implementation of such
revisions.
3.3 Clinical
and Regulatory Approval.
(a) Conduct
by Alfacell.
The
Parties acknowledge that Alfacell has initiated Phase III Clinical Trials in
the
Territory in respect of the Product for the Primary UMM Indication. Alfacell
shall use Commercially Reasonable Efforts to (i) conduct required clinical
trials of the Product for the Primary UMM Indication in the Territory and,
subject to Section 3.7, for the Future Indications in the Territory agreed
to be
pursued by the Parties, and undertake steps to obtain Regulatory Approval in
accordance with this Agreement and in a manner consistent with the Development
Program; and (ii) through the Development Committee, include Par in such efforts
in an advisory and consultative capacity. Alfacell acknowledges that certain
Product-related activities undertaken by Alfacell outside of the Territory
may
trigger material reporting obligations to the FDA and may materially affect
the
Commercialization of the Product by Par in the Territory, and with respect
to
such activities that Alfacell determines in good faith are likely to trigger
such materially reporting obligations and/or are likely to materially affect
such Commercialization by Par, Alfacell shall disclose such Product-related
activities outside of the Territory to Par and permit Par to promptly review
them and provide comments and suggestions that would enable both Parties to
achieve their objectives under this Agreement. If the Parties are unable to
reach mutual agreement regarding a fair and reasonable approach that would
avoid
or minimize any material reporting obligations and material effects on
Commercialization of the Product by Par, such dispute or disagreement regarding
such fair and reasonable approach shall be referred to the CEO of Alfacell
and
the CEO of Par for resolution, and the CEOs shall resolve the matter (without
resort to Section 14.5); provided,
however,
that
this dispute resolution provision shall not empower Par’s CEO with any
decision-making authority regarding Alfacell’s Product-related activities
outside the Territory, including the right to veto any such
activities.
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(b) Regulatory
Submissions.
(i) The
Parties acknowledge that no Product has been reviewed or approved for sale
or
use as a human therapeutic product by any Governmental Authority. Subject to
Section 3.1, Alfacell shall prepare any required application(s) for Regulatory
Approval in the Field in the Territory. Unless otherwise agreed by the Parties,
Alfacell shall own, in its entirety, all clinical data and reports related
to
Product Studies including clinical trials for the Product; provided,
however,
that,
during the Term, Par shall have the right to (i) obtain copies of, and to use,
Alfacell Information that is included in Alfacell’s NDA for the Product for an
Indication, as Par reasonably determines is necessary or desirable to further
the Commercialization of the Product in the Field in the Territory, and (ii)
request copies of, and to use, Alfacell Information that is not included in
Alfacell’s NDA for the Product for an Indication, with Alfacell’s consent (such
consent not to be unreasonably withheld) as Par reasonably determines is
necessary or desirable to further the Commercialization of the Product in the
Field in the Territory. At all times both prior to and following Regulatory
Approval of the Product in the Field in the Territory, Alfacell shall
(A) inform Par of all substantive communications from the FDA concerning
the NDA and any other material communications from the FDA concerning the
Product in the Field within forty-eight (48) hours of receipt thereof, such
substantiality and materiality to be solely based on Alfacell’s reasonable
evaluation, and (B) provide copies of proposed material FDA communications
and submissions concerning the Product to the Development Committee and Par
prior to their submission to the FDA, subject to the extent practicable, as
described below. Except to the extent that Alfacell must respond to the FDA
or
make a submission to the FDA before receipt of the Development Committee’s
and/or Par’s comments, Alfacell will not respond substantively in writing to any
FDA communication or otherwise make any written submissions to the FDA
concerning, in either case, the Product in the Field without first giving Par
a
reasonable opportunity to review and comment thereon. Such opportunity shall
not
exceed ten (10) days, unless otherwise required by the FDA, in which case
Alfacell shall use Commercially Reasonable Efforts to provide Par with an
opportunity to review and comment to the extent practicable, but Par agrees
that
Alfacell shall be entitled to respond in any manner as Alfacell determines
in
its reasonable discretion is appropriate given the timing of the FDA regulatory
review process. Alfacell shall review and consider in good faith any comments
received from Par related to such FDA communications or submissions related
to
the Product in the Field, and any comments or suggestions timely received from
Par that are otherwise related to Regulatory Approvals for the Product in the
Field in the Territory. For the sake of clarity, the Parties recognize that
the
FDA regulatory review process may involve both non-Commercialization
(i.e.,
development and/or manufacturing) and Commercialization aspects of the Product
in the Field in the Territory (for example, proposed labeling of the Product
for
a given Indication). If any such intersection or overlap of Alfacell’s final
decision-making authority regarding development and manufacturing and Par’s
final decision-making authority regarding Commercialization results in a dispute
or disagreement, such dispute or disagreement shall be referred to the CEO
of
Alfacell and the CEO of Par for resolution, and the CEOs shall resolve the
matter (without resort to Section 14.5).
(ii) The
Parties shall cooperate in good faith with respect to obtaining, and Alfacell
shall use Commercially Reasonable Efforts to enable representatives of Par
to
attend, if and as requested by Par and as permitted by the FDA, formal meetings
with the FDA relating to Regulatory Approval of the Product in the Field in
the
Territory. The Parties shall cooperate in good faith with respect to the conduct
of any inspections by the FDA or equivalent foreign regulatory authority of
a
Party’s site and facilities related to the Product. To the extent either Party
receives any material written or oral communication from the FDA or equivalent
foreign regulatory authority relating to the Regulatory Approval process with
respect to the Product in the Field in the Territory, the Party receiving such
communication shall promptly notify the other Party and provide a copy of such
written communication and/or a written summary of such oral communication as
soon as reasonably practicable.
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(iii) If
“ONCONASE®”
is
not
approved by the FDA as the Product Trade Name, Alfacell shall not submit any
other Trade Name(s) for the Product for approval by the FDA unless such other
Trade Name(s) has (have) been mutually agreed by the Parties. Subject to the
license rights granted herein, Alfacell shall own all right, title, and interest
to ONCONASE and all such Trade Names and intellectual property rights related
thereto (including trademark and copyright), and Par shall (A) assign any
right, title, and interest it has in any Trade Names (including intellectual
property rights related thereto (including trademark and copyright)) to
Alfacell, free and clear of all liens, claims, and encumbrances, and
(B) take any and all actions reasonably requested by Alfacell in
furtherance of the foregoing. *** related to the choosing of any new Trade
Name
for the Product in the Field in the Territory, including any market research
studies conducted by Par pertaining to ONCONASE or any new proposed Trade
Name(s) for the Product.
3.4 Development
Program Funding.
Except
as otherwise expressly provided herein or as otherwise expressly agreed by
the
Parties in writing, Alfacell shall be solely responsible for payment of all
Development Costs.
3.5 Development
Program Reporting.
Alfacell 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) promptly 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. Alfacell
shall, at its sole cost and expense and under its control and responsibility,
(a) maintain Regulatory Approval(s) of the Product in the Field in the
Territory at all times during the Term following receipt of the same, subject
to
Par’s cooperation with such efforts as may be required to maintain such
Regulatory Approval(s) and (b) conduct any post-Regulatory Approval
development programs for the Product that are required by or negotiated with
the
FDA as a condition to obtaining or maintaining Regulatory Approval of the
Product. If mutually determined by the Parties to be beneficial to the
development and/or Commercialization of Product in the Field in the Territory,
the Parties shall collaborate and cooperate in conducting any post-Regulatory
Approval development programs for the Product in the Field in the Territory
that
are not required by or negotiated with the FDA, ***. Such post-Regulatory
Approval development programs shall be conducted in accordance with a written
agreement and budget which are accepted in writing by both Parties.
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3.7 Future
Indications Programs.
Notwithstanding the scope of Alfacell’s decision-making authority set forth
herein (including in Section 3.1), (a) without the prior consent of the
Development Committee, Alfacell will not initiate a Phase III Clinical Trial
on
the Product for any Future Indication in the Territory unless the Development
Committee has agreed to the design of such trial, and (b) even with such prior
consent by the Development Committee, without the prior written consent of
Par,
(i) in any consecutive twenty-four (24) month period Alfacell shall not initiate
first Phase III Clinical Trials on, and Par shall have no financial obligations
in Section 6.2(b) (Future Indication Milestones) for, more than two (2) ongoing
Future Indications in the Territory (where the initiation of a first Phase
III
Clinical Trial in a Future Indication in the Territory shall be deemed to occur
on the date of administration of the first dose of the Product to the first
patient in such first Phase III Clinical Trial), and (ii) Alfacell shall not
initiate, in the aggregate, first Phase III Clinical Trials on more than three
(3) Future Indications in the Territory. As of the Effective Date, the
Indications recited in clauses (a)-(c) of the definition of “Future Indications”
have been mutually agreed by the Parties to be Indications eligible for study
by
Alfacell pursuant to this Section 3.7. Upon the determination of the design
of
the Phase III Clinical Trials for any Future Indication in the Territory by
the
Development Committee, Alfacell shall use Commercially Reasonable Efforts to
develop the Product for such Future Indication in the Territory. In the event
that the Development Committee is unable to agree as to the design of such
trial
described in clause (a) above, such dispute or disagreement shall be referred
to
the CEO of Alfacell and the CEO of Par for resolution, and the CEOs shall use
their best efforts to resolve the matter in good faith within thirty (30) days
after such referral, subject to Section 14.5.
3.8 Recombinant
Source.
Unless
otherwise agreed by the Parties, during the Term, Alfacell shall use its
Commercially Reasonable Efforts to pursue a recombinant source of Ranpirnase.
As
of the Effective Date, the Parties agree that obtaining such recombinant source
would be advantageous and would further the objectives of both Parties under
this Agreement. Notwithstanding the foregoing or any other provision of this
Agreement, (i) Par acknowledges and agrees that Alfacell does not guarantee
that
such pursuit will be successful or that Regulatory Approval in the Field in
the
Territory will be obtained for any Product containing recombinant Ranpirnase
and
(ii) Alfacell shall not use in the manufacturer of the Product Ranpirnase that
has been obtained from a recombinant source without Par’s prior written
consent.
ARTICLE
IV
LICENSE
4.1 Grant
to Par.
(a) License
Generally; Appointment as Exclusive Distributor.
Alfacell
hereby grants to Par the following rights and licenses:
(i) an
exclusive (even as to Alfacell, but subject to the co-exclusive rights provided
for or referred to in Section 4.1(c)(iii) and 5.4), royalty-bearing license
under the Alfacell Patents and under any and all applicable Regulatory Approvals
in the Field to
promote, market, have marketed, distribute, sell, offer for sale and otherwise
Commercialize Product in the Field in the Territory and to do such other things
necessary to comply with Par’s obligations under this Agreement.
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(ii) as
further provided in, and subject to Article IX, in order to protect the Product
in the Field, an exclusive (even as to Alfacell but subject to Alfacell’s rights
in Article IX) license to enforce the Alfacell Patents against any potential
Third Party infringement that could reasonably be expected to adversely affect
the Commercialization or value of the Product in the Territory.
(b) Restriction
on Right to Sublicense.
Notwithstanding the license grants provided in Section 4.1(a), Par (i) shall
have the right to market, sell, offer for sale, and have sold AG Product only
beginning (a) on the date on or, with Alfacell’s prior written consent,
immediately prior to the anticipated date that a Third Party sells or offers
for
sale a generically-labeled version of the Product or (b) if applicable, upon
(or
as part of) settlement of a litigation under Section 9.3 that allows a Third
Party to sell or offer for sale a generically-labeled version of the Product
and
(ii) shall not have a general right to sublicense, but shall have the limited
right to grant sublicenses only under its rights to market, sell, offer for
sale, and have sold AG Product and only in connection with settlement of a
litigation under Section 9.3 that allows a Third Party to sell or offer for
sale
a generically-labeled version of the Product, provided, that Par has obtained
the consent of Alfacell to such settlement to the extent required under Section
9.3. Par will at all times remain responsible to Alfacell for all of its
obligations under this Agreement and shall be responsible for the acts or
omissions of its sublicensees in exercising rights granted hereunder. Each
sublicense granted by Par shall be consistent with the terms of this Agreement,
and Par shall furnish Alfacell a copy of any such sublicense it grants.
(c) Reservation
of Rights.
(i)
Alfacell hereby retains any and all rights which are not expressly granted
to
Par hereunder.
(ii)
Nothing in Section 4.1(a) limits Alfacell from exercising its co-promote rights
under Section 5.4.
(iii)
Nothing in Section 4.1(a) limits Alfacell’s ability to perform its obligations
under this Agreement, the Supply Agreement, the Quality Agreement and the
Co-Promotion Agreement (if Alfacell exercises its co-promote right).
(iv)
For
purposes of clarity and without limitation, Alfacell has exclusively retained
(even as to Par) the right to perform (alone or with Third Parties) any and
all
activities related to the use, research, manufacture and development of Products
within and outside the Field and the Territory, and to Commercialize the
Products outside the Field in the Territory and in all fields outside the
Territory.
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(v)
Alfacell has retained the right to enforce the Alfacell Patents as it sees
fit
against any potential Third Party infringement that could not reasonably be
expected to adversely affect the Commercialization or value of the Product
under
this Agreement, including any patent rights not related to Ranpirnase, Product
or Competing Product. For purposes of clarity, Par shall not have any right
to
enforce, and Alfacell shall exclusively have the right to enforce, each patent
claim covering one or more Amphinases. Similarly, with respect to each Modified
Targeted Ranpirnase that becomes subject to an Option granted to Par under
Section 4.5, if Par rejects its Option under Section 4.5, or if Par does not
inform Alfacell of its exercise of the Option within the required time period,
or if the Parties have not executed a New License Agreement within the
prescribed period under Section 4.5(b) after Par’s exercise of the Option, then
thereafter Par shall not have any right to enforce, and Alfacell shall
exclusively have the right to enforce, patent claims covering the particular
Modified Targeted Ranpirnase that was subject to the Option. In all events,
prior to the enforcement of any Alfacell Patent against any Third Party in
the
Territory, Par and Alfacell shall confer in good faith regarding such
enforcement.
(d) Trademark
and Trade Name License.
(i) Alfacell
hereby grants to Par an exclusive (even as to Alfacell, subject to the
co-promote right provided to Alfacell in Section 5.4), royalty-bearing (but
at no additional consideration except as expressly provided herein) license
in
the Field in the Territory, without the right to sublicense, under the Trademark
and each Trade Name that has obtained or hereafter obtains Regulatory Approval
for use in connection with the Product, to promote, market, offer for sale,
sell
and have sold Product in the Field in the Territory; provided,
however,
that
Alfacell retains the right to exercise the foregoing rights only as and to
the
extent required to permit Alfacell to exercise its co-promote right under
Section 5.4 and to perform its obligations under this Agreement. To the
extent required by applicable law in the Territory, Alfacell shall make
applications to the applicable Governmental Authority for the registration
of
Par as a registered user of the Trademark and each Trade Name that has obtained
or hereafter obtains Regulatory Approval for use in connection with the Product,
respectively, in respect of each respective registration of the Trademark or
such Trade Name(s), and Par shall cooperate with Alfacell in making such
applications. For the avoidance of doubt, Alfacell retains all rights to the
Trademark and each Trade Name except to the extent explicitly granted to Par
hereunder, and all goodwill associated with the use of the Trademark and each
Trade Name will inure exclusively to the benefit of Alfacell.
(ii) Par
shall
comply with the guidelines attached hereto (or to be attached hereto after
the
Effective Date by Alfacell, subject to Par's consent, not to be unreasonably
withheld) as Schedule
4.1(d)
in
respect of the size, form, and manner of the use of the Alfacell name and logo,
and the Trademark and Trade Name(s) in the Commercialization of the Product
in
the Field in the Territory, subject to any reasonable future revisions thereto
requested by Alfacell in writing, provided that any such material revisions
thereto shall not be effective unless and until consented to by Par, such
consent not to be unreasonably withheld (however, if Par does not so consent,
such dispute shall be resolved by the CEO of Alfacell and the CEO of Par
(without resort to Section 14.5)). All packaging, inserts, labels, promotional
or other materials for the Product sold or to be sold by Par and its
Sub-distributors in the Territory shall display the name and Trademark of
Alfacell and each such Trade Name (except in respect of the AG Product), and
shall identify Alfacell as licensor and manufacturer of the Product.
Any
failure by Par or its Sub-distributors to comply with this Section 4.1(d) shall
be a material breach of this Agreement.
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(e) Challenge.
If Par
or any of its Affiliates or Sub-distributors directly challenges, or directly
assists any Third Party in challenging, in any forum the validity,
enforceability, scope or any other elements of the Alfacell Patents, then
Alfacell may terminate this Agreement on thirty (30) days’ notice to Par if Par
or any of its Affiliates or Sub-distributors shall not cease such challenge
within such 30-day period. Without limiting the generality of the foregoing,
Par
specifically agrees that filing a request for reexamination, attempting to
institute an interference, or filing an opposition with respect to any Alfacell
Patent(s) or foreign counterparts thereof will be deemed a “challenge” under
this Section 4.1(e).
4.2 Information
Transfer.
(a) Promptly
after the Effective Date, Alfacell shall, at its own cost, disclose to Par
in
writing, or via mutually acceptable electronic media, copies or reproductions
of
all Alfacell Information, but only to the extent not previously disclosed to
Par, that are reasonably necessary or useful for Par and its Sub-distributors
to
market, sell or have sold the Product in the Field in the Territory. In
addition, during the Term of this Agreement, Alfacell shall promptly disclose
to
Par in writing, or via mutually acceptable electronic media, on an ongoing
basis, copies or reproductions of all new Alfacell Information that is
reasonably necessary for Par and its Sub-distributors to market, sell or have
sold the Product in the Field in the Territory. Such disclosed Alfacell
Information shall be automatically deemed to be within the scope of the licenses
granted to Par under Section 4.1 without payment of any additional
compensation.
(b) During
the Term of this Agreement, (i) when either Party becomes aware of a potential
infringement of the Alfacell Patents by a Third Party in the Field in the
Territory, (ii) during the course of a Third Party infringement action brought
by or against the Parties as a result of the Party’s (Parties’) activities
pursuant to this Agreement, or (iii) on Par’s reasonable request, Alfacell shall
promptly disclose to Par in writing, or via mutually acceptable electronic
media, copies or reproductions of all new Alfacell Information described in
Section 4.2(a) which has not been previously disclosed to Par and which is
reasonably necessary for Par to exploit its rights under Article IX. Such
disclosed Alfacell Information shall be automatically deemed to be within the
scope of the licenses granted to Par under Section 4.1 without payment of any
additional compensation.
4.3 Appointment
of Sub-distributors.
Par may,
with the prior written consent of Alfacell in its sole discretion (such consent
not to be withheld for any potential sub-distributor that is an Affiliate of
Par), appoint sub-distributors (which may be Par’s Affiliates or non-Affiliates;
each a “Sub-distributor”)
to
distribute Product for use in the Field in the Territory, subject to the
following clauses (a-e) and the other terms and conditions of this
Agreement:
(a) each
agreement with a Sub-distributor shall be in writing and shall state that the
Sub-distributor’s rights under such agreement are subject to all relevant terms
and conditions of this Agreement, including (without limitation) provisions
and
restrictions relating to Field, Territory, price, payment, reporting, audit
of
books and records, promotional materials, trade name, and
termination;
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(b) if
this
Agreement terminates, in whole or in part, the rights of any Sub-distributors
shall automatically be terminated in accordance therewith;
(c) Par
shall
promptly notify Alfacell in writing of any breaches of this Agreement that
are
due to any act or omission by any Sub-distributor(s), and shall report to
Alfacell the full details of such breach and the actions to be taken by Par
to
cure such breach;
(d) Par
shall
ensure that each Sub-distributor complies with all applicable terms and
conditions of this Agreement, and shall be liable to Alfacell for any failure
of
any Sub-distributor to do so; and
(e) Par
shall
provide Alfacell with the names and primary business addresses of all
Sub-distributors and, within fifteen (15) days of the effective date of each
agreement with a Sub-distributor, Par shall provide a copy of each such
agreement to Alfacell.
For
the
avoidance of doubt, (i) any act or omission of a Sub-distributor that would
be a
breach of this Agreement if performed by Par will be deemed to be a breach
by
Par of this Agreement, and (ii) Par’s customers (e.g., wholesalers) shall not be
considered Sub-distributors for purposes of this Agreement.
4.4 Exclusivity.
(a) Alfacell
agrees that, during the Term, it will not, and it will not enable or contract
with any Third Party to, (i) market, sell or distribute the Product in the
Field
in the Territory or develop or supply the Product for sale in the Field in
the
Territory, except in accordance with Section 5.4 and/or for the development
and
supply of the Product in the Field in the Territory pursuant to this Agreement,
(ii) market, sell or distribute any Competing Product in the Territory or
develop or supply any Competing Product for sale in the Territory; or (iii)
use
the Trademark in connection with any product in the Territory other than the
Product pursuant to this Agreement; provided,
however,
that,
subject to Section 4.5, the foregoing restrictions provided in this Section
4.4(a) shall not restrict Alfacell, directly or through a Third Party, from
developing, manufacturing, importing, marketing, selling or distributing
Modified Targeted Ranpirnase.
(b) Par
agrees that, and shall cause its Sub-distributors to agree that, during the
Term, Par and its Sub-distributors will not, and will not enable or contract
with any Third Party to manufacture, import, market, sell or distribute any
Competing Product in the Territory.
To
the
fullest extent permitted by applicable law, Par is prohibited from selling
(and
Par shall not permit its Sub-distributors to sell), and Par and its
Sub-distributors shall not sell, Product (i) outside the Territory, (ii) to
customers in the Territory that Par or its Sub-distributors know, or have reason
to know, plan to resell or in the past have resold the Product for use outside
the Territory, and Par shall not during the Term actively approach, or accept
or
fill orders from, customers outside the Territory. This prohibition includes
detailing, visiting, calling, mailing, or marketing Product to such customers.
If Par or its Sub-distributors knowingly sell the Product outside of the
Territory, Par shall provide full details of such Product sale to Alfacell
and
pay Alfacell, at Alfacell’s option, in addition to any other remedies available
to Alfacell, for each Product thus sold, ***. In addition, Alfacell may
terminate this Agreement on sixty (60) days’ notice to Par if Par does not cease
such sales, and cause its Sub-distributors to cease such sales, outside the
Territory within such 60-day period. Additionally, Par agrees that, and shall
cause its Sub-distributors to agree that, during the Term, Par and its
Sub-distributors will not, and will not enable or contract with any Third Party
to, promote, market, have marketed, distribute, offer for sale, sell or have
sold the Product outside of the Field.
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4.5 Right
of First Negotiation.
(a) If,
following the Effective Date, Alfacell determines that a particular Modified
Targeted Ranpirnase compound demonstrates activity across one or more tumor
cell
types and has commercial viability (and such determination is reasonably
supported by reasonable non-clinical or pre-clinical data in respect of such
cell type(s)), Alfacell shall, prior to instituting any Phase III development
program in respect thereof, provide Par with a one time written notice of
information that Alfacell possesses or that Alfacell has a contractual right
with any Third Party to obtain, subject to any corresponding contractual
obligation, including copies of such data, and 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 negotiations for
a
license agreement with Alfacell with respect to such Modified Targeted
Ranpirnase. The delivery of such notice shall automatically grant to Par an
exclusive option (the “Option”)
to
enter into an agreement with Alfacell for an exclusive license to permit Par
to
market, sell and have sold such Modified Targeted Ranpirnase in respect of
the
applicable indications (the “New
License Agreement”).
Par
shall determine and notify Alfacell of its determination in writing, as soon
as
practicable, and in any event no more than *** days after the grant of such
Option by Alfacell, to (i) exercise the Option by delivery of written notice
to
Alfacell of its exercise of such Option, or (ii) reject the Option. The
exercise, or determination not to exercise, by Par of its rights under this
Section 4.5(a) in respect of any granted Option shall not affect its rights
in
respect of any other Modified Targeted Ranpirnase compound that was not subject
to such Option. Any data or other information provided by Alfacell to Par
pursuant to this Section 4.5(a) shall be deemed and treated as Confidential
Information in accordance with and subject to Section 8.1. If Par fails to
exercise its Option within such *** period, or if Par rejects its Option,
or if the Parties do not execute a New License Agreement despite their good
faith efforts during the *** described in subsection (b) below, then within
ten
(10) business days after such failure, rejection or absence of execution (as
applicable), Par shall return to Alfacell all documentation containing
Confidential Information of Alfacell that was received by Par pursuant to this
Section 4.5(a).
(b) If
Par
exercises its Option, the Parties shall, during the *** from the date of
exercise of the Option, negotiate exclusively a New License Agreement with
one
another in good faith. If, following such ***, the Parties have not executed
the
New License Agreement despite their good faith efforts, Alfacell may, but shall
not be obligated to, offer such license for Modified Targeted Ranpirnase for
the
applicable indication(s) to a Third Party. If Par rejects the Option, or does
not inform Alfacell of its exercise of the Option within the *** after the
grant
of such Option by Alfacell, (i) Alfacell may, but shall not be obligated to,
negotiate and enter into a license agreement with a Third Party, and (ii)
thereafter the particular Modified Targeted Ranpirnase that had been subject
to
such Option shall be deemed to no longer be a “Competing Product” for purposes
of this Agreement.
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ARTICLE
V
COMMERCIALIZATION
5.1 Par
Responsibility and Control.
Except
as otherwise expressly set forth herein, subject to the input of the
Commercialization Committee, Par shall have responsibility for all
Commercialization activities in the Field in the Territory, including developing
strategies and tactics related to the advertising, promotion, pricing, marketing
and selling the Product. Par shall have final decision-making authority and
primary responsibility for all Commercialization strategies, plans and
activities regarding the Product in the Field in the Territory. Par shall use
its Commercially Reasonable Efforts to Commercialize the Product in the Primary
UMM Indication, the Secondary UMM Indication and any Future Indications that
have obtained Regulatory Approval in the Territory. Par shall include Alfacell
in such efforts in an advisory and consultative capacity. Par shall comply,
shall cause its Sub-distributors to comply, and shall require all of its Third
Party agents and contractors, if any, to comply, with all applicable laws in
Commercializing the Product in accordance with this Agreement.
5.2 Certain
Present Intentions and General Obligations of Par.
As of
the Effective Date, Par intends on or before the Initial Commercial Sale to
assign a dedicated product manager for Commercialization of the Product. In
addition, following the Initial Commercial Sale, Par shall (if it has not
theretofore) employ or engage a sales training manager (such position may be
filled by an employee or a consultant experienced in oncology) and a
reimbursement specialist (who shall be knowledgeable about Part B).
5.3 Specific
Commercialization Rights and Obligations of Par.
(a) Following
Regulatory Approval for the Product for the Primary UMM Indication, Secondary
UMM Indication and any Future Indication, Par shall use Commercially Reasonable
Efforts to Commercialize the Product for each such applicable Indication in
accordance with this Agreement and in a manner consistent with the then-current
Commercialization plan(s), and shall include Alfacell in such efforts in an
advisory and consultative capacity. Subject to any conditions or limitations
set
forth herein, it shall be Par’s sole right and responsibility 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, (h) provide
first line customer support and pharmacovigilance (and after such initial
support, pharmacovigilance support shall be handled in accordance with Article
X), (i) warehouse the Product, and (j) 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 determine the
Commercialization plan(s) and Commercialization activities, and the execution
thereof shall be within Par’s decision-making authority and control. Par shall
use Commercially Reasonable Efforts to achieve an Initial Commercial Sale within
*** after Alfacell obtains Regulatory Approval for the Primary UMM Indication,
Secondary UMM Indication and/or any Future Indication (as applicable). Par
shall
utilize proactive and continuous Product Commercialization efforts (which may
be
subject to factors that are beyond the reasonable control of Par) by Par during
the first ***
after
Initial Commercial Sale to advance the objectives and optimize the financial
returns of both Parties under this Agreement (i.e., during such ***, Par shall
not cease Commercializing, or engage in di minimis Commercialization of, the
Product).
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(b) On
no
less than ninety (90) days’ written notice to Par given on or after the *** of
the Initial Commercial Sale, Alfacell may elect to add up to *** sales
representatives under Alfacell’s control, at Alfacell’s expense, to co-promote
the Product for the approved Indication(s), subject to a mutually agreeable
co-promote agreement. If Alfacell so elects, then such co-promotion by Alfacell
of the Product for the approved Indication(s) (including UMM Indications) shall
be deemed to be an accelerated exercise by Alfacell of its co-promote right
pursuant to Section 5.4; provided,
however,
that
Alfacell shall continue to pay for such additional sales representatives only
until such time as its co-promote right could have otherwise been exercised
pursuant to Section 5.4
(subject
to Section 5.4(a)(z)).
5.4 Co-promote.
(a) Subject
to Section 5.4(b) and Alfacell’s right to elect an accelerated exercise of
Alfacell’s co-promote right with respect to all approved Indications pursuant to
Section 5.3(b), Alfacell shall have the right to co-promote the Product on
the
approval of any Future Indication in the Territory (i) by providing written
notice to Par at least *** in advance of Alfacell’s planned commencement of
such co-promote activities and (ii) by entering into a mutually agreeable,
definitive, written co-promotion agreement with Par setting forth the
particulars of the Parties’ rights and obligations concerning co-promotion of
the Product. The Parties shall use good faith to enter into, prior to the
Initial Commercial Sale, such co-promotion agreement, which shall, among other
things, include (x) an obligation of Par to pay Alfacell only the Fair Market
Value per Detail for Alfacell’s sales representatives for such co-promotion,
which Details provided by Alfacell’s sales representatives shall not exceed ***
percent (***%) of all of the Details for the Product for the applicable Future
Indication, (y) if Alfacell intends use such Alfacell sales representatives
to
promote or co-promote a pharmaceutical product (other than the Product) that
shares an FDA-approved, labeled indication with any Par Promoted Product,
Alfacell shall be entitled to promote or co-promote such pharmaceutical product
if, and only if, Alfacell provides written notice of such intention to Par,
and
(z) if Alfacell provides such written notice indicating its intent to promote
or
co-promote such pharmaceutical product, or if Alfacell in fact promotes or
co-promotes such pharmaceutical product, then Par shall no longer be obligated
to pay to Alfacell the Fair Market Value per Detail for co-promotion by Alfacell
of the Product, and such co-promotion by Alfacell of the Product shall
thereafter be at Alfacell’s sole cost and expense (until such time as Alfacell
no longer promotes or co-promotes such pharmaceutical product, which shall
not
occur prior to 60 days following the delivery by Alfacell of written notice
to
Par in respect thereof). Alfacell shall not be entitled to initiate any
co-promotion activities for the Product unless and until the Parties enter
into
such co-promotion agreement.
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(b) If
the
Product obtains Regulatory Approval for a Future Indication prior to the
Regulatory Approval of the Product for the Primary UMM Indication or Secondary
UMM Indication, and if the Parties do not waive the pre-condition related
thereto set forth in Section 6.2(b), then, subject to Section 5.3, Alfacell’s
right to co-promote the Product may not be exercised by Alfacell until the
later
of (i) *** following the initial commercial sale of
the
Product for such Future Indication and (ii) the earlier to occur of (a)
Regulatory Approval of the Product for the Primary UMM Indication or Secondary
UMM Indication, or (b) the *** of Regulatory Approval related to the Product
for
such Future Indication.
ARTICLE
VI
PAYMENTS
6.1 Upfront
Payment.
In
consideration for the execution and delivery of this Agreement by Alfacell,
Par
shall pay Alfacell a fully earned, non-refundable, non-creditable license fee
in
the amount of US$5,000,000 by wire transfer of immediately available funds
upon
execution and delivery of this Agreement.
6.2 Milestone
Payments.
(a) UMM
Indication Milestone Payments.
(i) Subject
to the terms and conditions of this Agreement, including Section
6.2(a)(ii):
(1) if
Alfacell obtains Full Approval for the Product for the Primary UMM Indication
on
or before July 31, 2010, Par shall pay to Alfacell US$30,000,000;
(2) if Alfacell
obtains Full Approval for the Product for the Primary UMM Indication after
July
31, 2010, then in lieu of the milestone payment provided in Section
6.2(a)(i)(1), Par shall instead pay to Alfacell US$***; and
(3) if
Alfacell has not obtained Full Approval for the Product for the Primary UMM
Indication at the time that it obtains Full Approval for the Product for a
Secondary UMM Indication, then, in lieu of any milestone payment provided in
Section 6.2(a)(i)(1) or 6.2(a)(i)(2), Par shall pay to Alfacell US$***;
provided,
however,
that if
Alfacell subsequently obtains Full Approval for the Product for the Primary
UMM
Indication, then Par shall pay to Alfacell either US$*** (if such Full Approval
for the Product for the Primary UMM Indication is obtained on or before July
31,
2010) or US$*** (if such Full Approval for the Product for the Primary UMM
Indication is obtained after July 31, 2010), as applicable.
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(ii) If
a meeting with the ODAC is called for by the FDA or if Par reasonably believes
that the FDA will have outstanding review issues and/or questions relevant
to
the CMC Section, then Par may, in its sole discretion, make a partial prepayment
of the amounts provided in Section 6.2(a)(i) in an amount not to exceed US$***;
provided, however, that (A) any such prepayment amount shall be used
exclusively in the preparation of the CMC Section or, as applicable, preparation
for the meeting with, or in compliance with any requests of, the ODAC, and
(B)
in consideration of such prepayment, Par and Alfacell shall be entitled to
jointly control, subject to Section 14.5, the preparation for any meeting with
the ODAC or preparation of the CMC Section, as applicable, the compliance with
any requests of the ODAC and the allocation of funds related
thereto.
(b) Future
Indication Milestones.
Provided
Alfacell shall have received Full Approval for either the Primary UMM Indication
or the Secondary UMM Indication, or provided that each of the Parties agrees
in
writing, in its sole discretion, to waive the foregoing pre-condition due to
unexpected and/or unavoidable delays in receipt of such Full Approval for a
UMM
Indication despite Alfacell’s Commercially Reasonable Efforts to obtain such
receipt, then and in addition to the milestones payments set forth in Section
6.2(a) and subject to Section 3.7, upon the achievement of certain milestones,
Par shall make fully earned, non-refundable, non-creditable payments to Alfacell
by wire transfer of immediately available funds as follows:
(i) Upon
the
administration of the first dose of the Product to the first patient in a first
Phase III Clinical Trial for each Future Indication, Par shall pay to Alfacell
US$***;
(ii) Upon
the
acceptance for filing by the FDA of Alfacell’s NDA subject to a Special Protocol
Assessment (as described as of the Effective Date at
xxxx://xxx.xxx.xxx/xxxx/xxxxx/xxxxxxxx.xxx#x) for each Future Indication, Par
shall pay to Alfacell US$***; provided,
however,
that in
the event a Special Protocol Assessment is not used, then, prior to filing
of
the applicable Alfacell NDA with the FDA, up to two (2) experts shall be
retained by each Party (for a total of four (4) experts), and if such experts
reasonably agree that the Phase III Clinical Trial data package is unlikely
to
support FDA approval for such Future Indication, then Par shall not be obligated
to pay to Alfacell such amount; and
(iii) Upon
a
Regulatory Approval of each Future Indication, Par shall pay to Alfacell
US$***.
(c) Sales
Milestone Payments.
In
addition to the milestone payments set forth above, following the Initial
Commercial Sale, on the terms and subject to the conditions contained herein,
Par shall additionally be obligated as follows:
(i) Subject
to Section 6.2(c)(ii), Par will pay to Alfacell the following one-time only
milestone payments:
***
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(ii) The
milestone payments set forth in Section 6.2(c)(i) (“Sales
Milestone Payments”)
are
subject to the following: (A) each such Sales Milestone Payment is
available to Alfacell on a one-time basis, such that once achieved and paid,
such Sales Milestone Payment shall not be payable again regardless of the amount
of Net Sales in any future Contract Year; (B) if more than one milestone is
achieved for the first time in any given Contract Year, then Par shall make
each
Sales Milestone Payment, and each such achieved milestone shall be forever
satisfied hereunder; and (C) the aggregate of all Sales Milestone Payments
under this Section 6.2(c) during the Term shall not exceed an amount equal
to US$***.
6.3 Royalty.
(a) Royalty
Payment.
In
addition to the milestone payments set forth above in Section 6.2, following
the
Initial Commercial Sale of the Product, in respect of any Contract Year, Par
shall pay to Alfacell an amount equal to (i) *** (amounts owed to Alfacell
pursuant to this Section 6.3(a), the “Royalty”).
(b) Royalty
Step Down.
Upon
expiration of the last to expire Valid Claim within the Patents licensed to
Par
during the Term pursuant to Section 4.1, each of the royalty rates set forth
in
Section 6.3(a) shall be reduced as follows ***;
and
further provided, in
the
event that, after such expiration of the last to expire Valid Claim, a
subsequent Valid Claim should come into existence during the Term, then the
royalty rates set forth in Section 6.3(a) shall again apply without reduction
pursuant to this Section 6.3(b).
(c) Termination
of Royalty.
Unless
otherwise expressly provided herein, the obligation of Par to pay Royalties
to
Alfacell pursuant to Section 6.3(a) shall cease upon expiration or termination
of this Agreement.
6.4 Other
Payment Obligations of Par.
Par
shall pay to Alfacell the amounts set forth in Section 5.4 (Co-promote) and
Section 7.2 (Pricing), in each case subject to the terms set forth
therein.
6.5 Payment
Procedures.
(a) Manner
of Payment.
Remittance of payments to Alfacell hereunder will be made in immediately
available funds by means of wire or electronic transfer to an Alfacell account
in a bank in the United States to be designated by Alfacell.
(b) Payments
and Reports.
All
amounts payable to Alfacell under this Agreement shall be paid in U.S. Dollars.
Milestone Payments under Section 6.2 shall be made no later than ten (10) days
after the satisfaction of the milestone giving rise to the applicable payment.
The Royalty shall accrue at the time of sale of the Product by Par or a
Sub-distributor 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 Alfacell shall be accompanied by a
report listing the number of units of Product sold, the gross invoiced sales
amounts of the Product sold during such period, the calculation of Net Sales
based on such sales, the applicable royalty rate, the Royalties payable, all
other information necessary to determine the appropriate amount of such Royalty
payments, and any additional information or reports required under this
Agreement or reasonably requested by Alfacell.
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(c) Records
and Audit.
(i) For
a
period of three (3) years after the calendar year to which the records
relate, Par shall keep, and shall cause its Sub-distributors to keep, complete
and accurate records pertaining to the sale or other disposition of the Product
in sufficient detail to permit Alfacell to confirm the accuracy of all payments
due hereunder. Alfacell shall have the right to cause an independent, certified
public accountant to which Par has no reasonably, well-founded objection
to
audit such records to confirm the gross invoiced sales amounts, the Net Sales,
Net Margin and Royalty payments; provided,
however,
that
such auditor shall not disclose Par’s Confidential Information to Alfacell,
except to the extent such disclosure is necessary to verify the amount of
Royalties and other payments due under this Agreement, and such auditor shall
enter into a non-disclosure agreement reasonably acceptable to Par. Such
audits
may be exercised once a year on reasonable advance notice to Par and during
normal business hours, within three (3) years after the Royalty period to
which such records relate. Any amounts shown to be owing by such audits shall
be
paid promptly. Alfacell shall bear the 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 to Alfacell for the period audited. In such case, Par shall bear the
reasonable cost of such audit.
(ii) For
a
period of three (3) years after the calendar year to which the records
relate or such longer period as may be required by applicable law, Alfacell
shall keep records pertaining to calculation of Direct Cost in sufficient
detail
to permit Par to confirm the accuracy of Direct Cost (and thus accuracy of
the
Transfer Price), as well as records pertaining to any other amounts charged
to
or reimbursed by Par hereunder. Par shall have the right to cause an
independent, certified public accountant to which Alfacell has no reasonably,
well-founded objection to audit such records to confirm Direct Cost and any
such
other amounts charged to or reimbursed by Par pursuant to the terms hereof;
provided,
however,
that
such auditor shall not disclose Alfacell’s Confidential Information to Par,
except to the extent such disclosure is necessary to verify the amount of
any
overpayments made by Par to Alfacell, and such auditor shall enter into a
non-disclosure agreement reasonably acceptable to Alfacell. Such audits may
be
exercised once a year on reasonable advance notice and during normal business
hours, within three (3) years after the date of payment to which such
records relate, upon notice to Alfacell and during normal business hours.
Any
amounts shown to be owing by such audits shall be paid promptly. Par shall
bear
the cost of such audit unless such audit discloses an overpayment by Par
of more
than five percent (5%) as compared to the amount of payments and/or
reimbursements actually owed to Alfacell for the period audited. In such
case,
Alfacell shall bear the reasonable cost of such audit.
(iii) The
terms
of this Section 6.5(c) shall survive any termination or expiration of this
Agreement for a period of three (3) years following the calendar year in
which
the relevant payment obligation hereunder expires or terminates.
(d) Withholding
of Taxes.
Par may
withhold from milestones, royalties or other amounts due to Alfacell under
this
Agreement such amounts for payment of any withholding tax that is required
by
law to be paid to any taxing authority with respect to such amounts payable
to
Alfacell; provided,
however,
that in
regard to any such tax withholding, Par shall give Alfacell such documents
and
provide any other cooperation or assistance on a reasonable basis as may
reasonably be requested by Alfacell by to enable Alfacell to claim exemption
therefrom, to receive a full refund of such withholding tax or to claim a
foreign tax credit and shall, upon Alfacell’s request, give proper evidence from
time to time as to the payment of such tax.
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(e) Late
Payment and Interest.
Any
payments due under this Agreement by either Party that are not paid by the
date
such payments are due shall bear interest at one
percent (1%) per month from the date such payments are due. The foregoing
interest shall be due from the Party owing the payment amount without any
special notice and shall be in addition to any other remedies that the Party
entitled to such payment may have pursuant to this Agreement.
ARTICLE
VII
MANUFACTURE
AND SUPPLY
7.1 Clinical
and Commercial Supplies.
Alfacell shall manufacture or cause to be manufactured all Clinical Supplies
of
the Product for the Development Program, including the completion of
pre-clinical work and human clinical trials. Subject to the terms of the
Supply
Agreement, Alfacell will establish a commercial manufacturing process 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, and
Alfacell will exclusively supply Par with Par’s requirements of commercial
supplies of the Product pursuant to the Supply Agreement.
7.2 Pricing.
Subject
to the terms and conditions of this Agreement and the Supply Agreement, Par
shall acquire the Product from Alfacell at the Transfer Price, as provided
in
the Supply Agreement. The Parties acknowledge and agree that both would benefit
from any commercially reasonably, achievable reduction in the Direct Cost,
but
only if the corresponding cost reduction does not negatively impact Product
yields, output, quality, purity and the like.
7.3 Par
Labeling and Packaging.
The
Parties agree that the label for the Product in the Field in the Territory
shall
be, and all packaging and presentations concerning such Product shall display,
a
Par label in accordance with Par’s customary practices, subject to Section
4.1(b), and the Parties shall use Commercially Reasonable Efforts to cooperate
in gaining Regulatory Approval to sell Products in the Field in the Territory
under the Par label.
7.4 Citizen’s
Petitions.
Each
Party shall notify the other in writing if it becomes aware of a Third Party
product under development, or a regulatory filing by a Third Party with respect
to a product, that in either case incorporates Ranpirnase, including, with
respect to any such regulatory filing, any 505(j) filing, 505(b)(2) filing
or
other form of application for approval (such development or filing, a
“Third
Party Product Event”).
Par
shall, following Regulatory Approval of the Product, have the first right
to
institute a citizen’s petition addressing the safety and/or efficacy of such
Third Party Product Event, and, to the extent Par exercises its right in
respect
thereof, shall reasonably control all aspects of such citizen’s petition in a
commercially reasonable manner, including correspondence and/or negotiations
with the FDA; provided,
however,
that Par
shall include Alfacell in such efforts in a consultative capacity. In the
event
Par does not exercise its rights above with respect to such a Third Party
Product Event within three (3) months of the notice referenced above, then
Alfacell shall have the exclusive right to institute a citizen’s petition
addressing the safety and/or efficacy of such Third Party Product Event,
and, to
the extent Alfacell exercises its right in respect thereof, shall control
all
aspects of such citizen’s petition in a Commercially Reasonable fashion,
including correspondence and/or negotiations with the FDA, provided,
however,
that
Alfacell shall include Par in such efforts in a consultative capacity.
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ARTICLE
VIII
CONFIDENTIAL
AND TECHNICAL INFORMATION
8.1 Treatment
of Confidential Information.
Each
Party agrees to retain in strict confidence and not to disclose, divulge
or
otherwise communicate to any Third Party any Confidential Information of
the
other Party, whether received prior to or after the Effective Date, 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 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 VIII.
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.
8.2 Release
from Restrictions.
(a) The
provisions of Section 8.1 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,
however,
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.
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(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,
however,
that the
disclosing Party obtains an agreement for confidential treatment
thereof.
8.3 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.
8.4 Survival
of Confidentiality Obligations.
The
confidentiality obligations of the Parties contained in this Article VIII
shall remain binding on both Parties during the Term and for a period of
five
(5) years after the expiration or termination of this Agreement, regardless
of
the cause of such termination. The Parties acknowledge that breach of this
Article VIII may constitute irreparable harm, and that the non-breaching
Party shall be entitled to seek specific performance or injunctive relief
to
enforce this Article VIII in addition to whatever remedies such Party may
otherwise be entitled to at law or in equity.
8.5 Superseding
Prior Confidentiality Agreement.
The
provisions of this Article VIII shall supersede the Confidentiality
Agreement between the Parties dated September 17, 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
IX
PATENT
PROSECUTION AND ENFORCEMENT
9.1 Program
Developments.
All
Program Developments shall be the sole and exclusive property of Alfacell.
All
United States patent applications covering Program Developments and all United
States patents issuing thereon will immediately, and without further action
of
the Parties, (a) be deemed to be Alfacell Patents and listed in Schedule
1.1
and (b)
be exclusively licensed to Par in accordance with the terms of this
Agreement.
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9.2 Patent
Prosecution and Maintenance.
(a) 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
Alfacell Patent, Alfacell Information and any Program Development or such
other
things that that could reasonably be expected to affect the Commercialization
or
value of the Product in the Territory. In connection therewith, Alfacell
shall
promptly provide Par with copies of all correspondence to and from the U.S.
Patent and Trademark Office, as well as any related demand, notice and summons,
that relates to such Alfacell Patent or Program Development. Each Party,
and its
employees and agents, shall provide the other Party and its legal
representatives with reasonable assistance and cooperation with respect to
such
Patent prosecution, including entering into any joint defense and/or joint
privilege agreement that may be reasonably requested by such Party and Alfacell
shall consider in good faith all reasonable suggestions of Par and its patent
counsel related thereto. Alfacell’s patent prosecution and maintenance expenses
associated with Alfacell Patents including the filing of any patent term
extensions, shall be borne by Alfacell; prosecution- and maintenance-related
expenses incurred by Par in connection with its review and consultation
concerning any Alfacell Patents, including Alfacell’s filing of any patent term
extensions, shall be borne by Par. Alfacell will timely apply for any applicable
patent term extensions.
(b) Par
agrees to cooperate fully in the preparation, filing, prosecution and
maintenance of any Alfacell Patents in the Territory under this Agreement,
and
in the obtaining and maintenance of any patent extensions and the like with
respect to any Alfacell Patent.
(c) If
Alfacell elects (i) to abandon the prosecution or maintenance of any Alfacell
Patent under which Par has a license hereunder, or (ii) elects not to file
a
patent application in the Territory for any invention within Program
Developments that could reasonably be expected to affect the Commercialization
or value of the Product in the Territory under this Agreement, then Alfacell
shall promptly notify Par in writing at least sixty (60) days before the
abandonment or applicable filing deadline therefore, and Par shall have the
right, upon providing written notice to Alfacell of Par’s election to do so, at
Par’s expense, to file, prosecute, continue prosecution and/or maintenance, as
applicable, of such Alfacell Patent or Patent within Program Developments.
In
such case, Par shall keep Alfacell reasonably informed on matters regarding
such
filing, prosecution and maintenance, including by providing Alfacell with
a copy
of any and all correspondence between Par and the U.S. Patent and Trademark
Office, providing Alfacell with sufficient time to review and comment on
such
communications (excluding any non-substantive correspondence or communications),
and Par shall consider in good faith the requests and suggestions of Alfacell
with respect to such communications with the U.S. Patent and Trademark Office.
With respect to the activities set forth in this Section 9.2 that are continued
by Par, Alfacell shall provide a power of attorney and relevant files and
other
information Owned or Controlled by Alfacell pertaining to such Alfacell Patents
or Program Developments, as soon as reasonably practical after receiving
such
written election by Par.
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9.3 Infringement
by a Third Party.
(a) Par
and
Alfacell shall inform each other promptly in writing of any alleged or suspected
infringement by a Third Party in the Territory of any of Alfacell Patent
that
could reasonably be expected to have an adverse effect on the Commercialization
or value of the Product in the Territory,
and of
any available evidence thereof.
(b) Subject
to Sections 9.3(c), 9.3(d), and 9.3(e), Par shall have the first right, but
not
the obligation, at its sole option and expense, to prosecute the infringement
by
a Third Party in the Territory of any Alfacell Patent that could reasonably
be
expected to have an adverse effect on the Commercialization or value of the
Product in the Territory.
(c) If
a
Third Party so infringes (or constructively infringes by filing an application
for regulatory approval with the FDA) an Alfacell Patent, or if a declaratory
judgment action alleging invalidity, unenforceability or non-infringement
of any
Alfacell Patent, shall be brought by a Third Party in the Territory against
Par
or against Alfacell or both of them (applicable to Ranpirnase, Product or
Competing Product), or a Citizen’s Petition in respect of the Product shall have
been filed with the FDA (each of the foregoing, a “Product
Infringement”),
then
the Parties shall discuss whether or not to institute an infringement action
(and/or defend against applicable declaratory judgment actions) with respect
to
such Product Infringement (and any legally or commercially relevant belief
by
Alfacell that it is in the Parties’ interest to not institute such action shall
be considered in good faith by Par). Subject to Sections 9.3(b) and 9.3(d),
Par shall have the first right to institute such a suit and control the
prosecution, settlement or compromise thereof (including defense of applicable
declaratory judgment actions); provided,
however,
that no
such settlement, compromise, consent judgment or other voluntary final
disposition of any Product Infringement action which invalidates or restricts
any Valid Claim(s) Owned or Controlled by Alfacell may be entered into by
Par
without the prior written consent of Alfacell, which consent shall not be
unreasonably withheld. At Par’s option, Alfacell shall agree to be joined as a
party, or otherwise initiate suit if necessary, in such Product Infringement
action and Par and Alfacell shall execute all papers and perform such acts
as
may be reasonably required to accomplish the same, at the sole expense of
Par;
provided,
however,
that
Alfacell’s joining of or participation in such action shall not affect Par’s
control thereof in accordance with this Section 9.3(c). Alfacell shall, at
the
reasonable request of Par, provide reasonable cooperation and use its
Commercially Reasonable Efforts to have its employees testify when requested
and
make available relevant records, papers, information, samples, specimens
and the
like that Alfacell’s counsel agrees should be provided to Par, regardless of
whether Alfacell has joined such suit. Alfacell shall have the right to join
such action and/or select, at Alfacell’s expense, separate counsel to
participate in such suit on Alfacell’s behalf.
(d) Within
ninety (90) days of being notified of alleged or suspected Product Infringement,
Par shall either (i) institute a suit for Product Infringement pursuant to
Section 9.3(c) or (ii) notify Alfacell that it has a good faith belief that
it is in the Parties’ interest to not institute such suit within such time and
Par shall provide to Alfacell a reasoned legal and/or commercial basis for
not
instituting such a suit at that time. If Alfacell disagrees with such reasoned
legal and/or commercial basis, then such dispute or disagreement shall be
referred to the CEO of Alfacell and the CEO of Par for resolution, and the
CEOs
shall resolve the matter (without resort to Section 14.5). If Par takes neither
action provided in the foregoing clause (i) or (ii) above within such ninety
(90)-day period, or if within such ninety (90)-day period Par notifies Alfacell
that it does not intend to institute such a suit, then thereafter Alfacell
shall
have the exclusive right to institute an action and control the prosecution,
settlement or compromise thereof. At Alfacell’s option Par shall agree to be
joined as a party in such litigation; provided,
however,
that
Par’s joining of such action shall not affect Alfacell’s control thereof in
accordance with this Section 9.3(d). Par shall, at the reasonable request
of
Alfacell, provide reasonable cooperation and, to the extent practicable,
Par
shall use its Commercially Reasonable Efforts to have its employees testify
when
requested and make available relevant records, papers, information, samples,
specimens and the like that Par’s counsel agrees should be provided to Alfacell,
regardless of whether Par has joined such suit. Par shall have the right
to join
such action and/or select, at Par’s expense, separate counsel to participate in
such suit on Par’s behalf.
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(e) Any
payments that represent royalties for sales of infringing products, other
payments, damages, expenses, fees or other awards (collectively “Damages”),
received by Par and/or Alfacell as a result of a Product 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 instituted and controlled a suit in accordance with Section
9.3(c), then any remainder *** and (ii) if Alfacell shall have instituted
and
controlled a suit in accordance with Section 9.3(d), then any remainder
***.
9.4 Infringement
of Third Party Rights.
(a) 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 use, offer for sale or sale of the Product in the Territory,
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 so
infringed.
(b) In
the
event that a Third Party institutes any suit against Par and/or Alfacell
for
patent infringement that could reasonably be expected to have an adverse
effect
on the Commercialization or value of the Product in the Territory, the Party
sued shall promptly notify the other Party in writing. Par shall assume the
defense of such suit at Par’s expense;
provided, however,
that if
Alfacell is also a defendant in such action and Alfacell shall have reasonably
concluded that there may be legal defenses available to it that are different
from or additional to those available to Par, Alfacell shall have the right
to
select, at Alfacell’s expense, separate counsel to participate in such legal
defenses on Alfacell’s behalf; provided, further that notwithstanding any such
different or additional legal defenses of Alfacell, Par shall have the first
right to control the defense of any such patent infringement suit pursuant
to
this Section 9.4 and Par may settle or compromise such suit with the prior
written consent of Alfacell, which consent shall not be unreasonably withheld.
To the extent that any Damages become payable to any Third Party whether
as a
result of judgment or through settlement of such suit, ***.
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(c) If
either
Party becomes aware of a patent or patent application of a Third Party that
could reasonably be expected to have an adverse effect on the Commercialization
or value of the Product in the Territory and for which pursuit of a license
would be reasonable in connection with Commercialization of the Product in
the
Territory, the Commercialization Committee shall: (A) determine whether or
not Alfacell should seek such a license, (B) recommend whether or not to
enter into such a license as negotiated by Alfacell, (C) determine how the
expenses of such a license shall be borne by the Parties and (D) insure that
Par
is a beneficiary thereof consistent with the licenses granted herein. If
the
Commercialization Committee cannot agree with regard to any item set forth
in
the preceding sentence, such issue shall be determined by the CEOs of the
Parties.
9.5 Trademark
Infringement.
Alfacell
and Par shall promptly notify the other in writing of any alleged or threatened
infringement or any challenge to the validity of the Trademark or any challenge
to Alfacell’s ownership of or Par’ s right to use the Trademark in the Territory
of which they become aware. Both Parties shall use their reasonable efforts
in
cooperating with each other to terminate such infringement without litigation.
Alfacell shall have the sole right to bring and control any action or proceeding
with respect to infringement of any of the Trademark at its own expense and
by
counsel of its own choice, subject to the following provisions. With respect
to
infringement of any of the Trademark in the Territory, if Alfacell fails
to
bring an action or proceeding within (i) thirty (30) days following the
notice of alleged infringement or (ii) ten (10) days before the time limit,
if any, set forth in the appropriate laws and regulations for the filing
of such
actions, whichever comes first, Par shall have the right to bring and control
any such action at its own expense and by counsel of its own choice, and
Alfacell shall have the right, at its own expense, to be represented in any
such
action by counsel of its own choice. In the event a Party brings an infringement
action, the other Party shall cooperate fully, including if required to bring
such action, the furnishing of a power of attorney or being named as a party.
Neither Party shall have the right to settle any infringement litigation
under
this Section 9.5 relating to the Trademark in
a
manner that diminishes the rights or interests of the other Party without
the prior written consent of the other Party,
which
shall not be unreasonably withheld, delayed or conditioned.
Except
as otherwise agreed to by the Parties as part of a cost-sharing arrangement,
any
recovery realized as a result of such litigation, after reimbursement of
any
litigation expenses of Alfacell and Par, ***.
ARTICLE
X
ADVERSE
EXPERIENCES
10.1 Notification.
The
Parties shall, during the Term, keep each other promptly and fully informed
of
all of their pharmacological, toxicological and clinical trials, investigations
and findings relating to the Product in the Field in the Territory in accordance
with a pharmacovigilance agreement. To the extent required, Alfacell will
notify
appropriate Governmental Authorities in accordance with applicable law with
respect thereto and notify Par promptly after receipt of information with
respect to any adverse reaction directly or indirectly attributable to the
use
or application of the Product in the Field in the Territory. In such a case,
the
Parties shall meet as soon as possible to define, according to applicable
law,
appropriate procedures and actions to address the difficulty. Each Party
also
shall forward to the other Party, on a regular basis, information on adverse
reactions and any material difficulty associated with clinical use, studies,
investigations, tests and prescriptions of the Product in the Field in the
Territory. Par will forward all ADE reports related to the Product in the
Field
in the Territory received by Par or its Sub-distributors to Alfacell within
five
days of receipt of the applicable event. The information forwarded will be
the
initial event information obtained from Par’s call center. Par will not make any
medical evaluation of the event. Alfacell will be responsible for any follow-up
activities with the reporting party and all tracking, trending and signal
detection for the Product. The Parties will use their Commercially Reasonable
Efforts to inform each other without delay of any other governmental action
which may adversely impact, in a direct manner, Commercialization of the
Product
in the Field in the Territory, and will furnish each other copies of any
relevant documents relating thereto.
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10.2 Reporting.
Alfacell, as the NDA holder, is responsible for preparing, processing,
assessment, and submitting aggregate and periodic reports and individual
case
safety reports within the Territory as required by regulatory authorities.
Alfacell 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, periodic,
and
single case reports to the FDA for the Product in the Field in the
Territory.
Par
shall reasonably cooperate at its own expense.
10.3 Literature
Reports.
Alfacell shall be responsible for screening published scientific and medical
literature for ADEs/ICSRs related to the Product in the Field. A copy of
any
such relevant literature reports and/or articles shall be promptly provided
to
the other Party.
To the
extent of additional obligations contained in Section 8.1.3 of the Supply
Agreement, such obligations are hereby incorporated by reference
herein.
ARTICLE
XI
REPRESENTATIONS
AND WARRANTIES
11.1 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)
this Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms; (iii) 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 (iv) 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) Alfacell
Representations, Warranties and Covenants.
Alfacell hereby represents, warrants and covenants to Par that:
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(i) neither
Alfacell nor any of its Affiliates has granted or, during the Term, will
grant
to any Third Party any rights under the Alfacell Patents, or any rights,
that
are in conflict with or prevent the grant of the rights granted by Alfacell
to
Par in this Agreement;
(ii) the
Alfacell Patents constitute all of the patents and patent applications Owned
or
Controlled by Alfacell as of the Effective Date that are necessary or are
useful
to Commercialize the Product in the Field in the Territory (as the Product
is
known to Alfacell as of the Effective Date, and if such Product were to be
Commercialized as of the Effective Date);
(iii) Schedule
1.1
sets
forth a true and complete list of all patents and patent applications Owned
or
Controlled by Alfacell that claim Ranpirnase, the Product or their uses in
the
Field in the Territory as of the Effective Date, which Schedule
1.1
will be
updated periodically during the Term by Alfacell to reflect additions thereto;
(iv) Alfacell
Owns or Controls the Patents listed on Schedule
1.1,
and it
has the right and authority to enter into this Agreement and to grant the
license under Section 4.1(a) hereof;
(v) Alfacell
has received no notice alleging infringement of a Third Party patent in
connection with its development and/or manufacture of the Product in the
Field
in the Territory;
(vi) Alfacell
has provided to Par copies of all material correspondence with the FDA related
to the Product;
(vii) as
of the
Effective Date, the molecule for the Primary UMM Indication has been granted
orphan drug designation by the FDA under the Orphan Drug Act, as
amended;
(viii) as
of the
Effective Date, (A) there is no action or proceeding pending or, to
Alfacell’s Knowledge, threatened in the Territory with respect to use,
development, manufacture or importation of the Product in the Field in the
Territory in accordance with this Agreement, including with respect to
infringement of any Third Party patent in the Field in the Territory, the
conduct of any clinical trials, manufacturing activities or development
activities involving the Product, or that reasonably calls into question
the
validity of this Agreement or any action taken by Alfacell in connection
with
the execution of this Agreement, and (B) there are no unsatisfied judgments
or outstanding orders, injunctions, decrees, stipulations or awards (whether
rendered by a court, an administrative agency or by an arbitrator) against
Alfacell with respect to the Product or the Alfacell Patents in the Field
in the
Territory;
(ix) Alfacell
has not as of the Effective Date, and will not during the Term, grant or
place
any liens, security interests, other encumbrances and/or licenses in or on,
or
otherwise divest, the Alfacell Patents that would conflict or interfere with
the
licenses granted to Par in the Field in the Territory, as set forth herein;
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(x) Alfacell
has not violated and will not, during the Term, violate the trade secrets
and
has not misappropriated, and will not, during the Term, misappropriate, the
confidential information or intellectual property of any Third Party in
connection with the development or manufacturing of the Product for use in
the
Field in the Territory;
(xi) none
of
the Alfacell Patents is currently involved in any interference, reissue,
or
reexamination proceeding, and neither Alfacell nor any of its Affiliates
has
received any written notice from any person of such actual or threatened
proceeding;
(xii) based
on
its calculations as of the Effective Date, Alfacell has in its possession,
or
has access to, a sufficient egg inventory as of the Effective Date to
manufacture enough Product to complete the current Phase III Clinical Trial
for
UMM and to supply *** vials of the Product after anticipated Initial Commercial
Sale in the Field in the Territory and Alfacell shall not, without the prior
consent of Par, utilize such egg inventory other than in respect of the Products
under this Agreement;
(xiii) to
Alfacell’s Knowledge, as of the Effective Date, there is no unauthorized use,
infringement or misappropriation of any of the Alfacell Patents by any Third
Party in the Field in the Territory, including any current or former employee
or
consultant of Alfacell and its Affiliates; and
(xiv) as
of the
Effective Date, any Alfacell research or development programs for potential
follow-on RNase products (including sequence variants of Ranpirnase) are
pre-IND
programs.
ARTICLE
XII
INDEMNIFICATION
AND LIMITATION ON LIABILITY; INSURANCE
12.1 Indemnification
by Alfacell.
Subject
to Section 12.3, Alfacell 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 reasonable attorneys’ fees and other expenses of
litigation) (collectively, “Losses”)
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 Alfacell’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 Alfacell under
Section 12.2.
12.2 Indemnification
by Par.
Subject
to Section 12.3, Par shall defend, indemnify and hold harmless each of
Alfacell and its directors, officers and employees and the successors and
assigns of any of the foregoing (each an “Alfacell
Indemnitee”)
from
and against any and all Losses 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 Par’s gross negligence, willful misconduct,
or breach of its representations, warranties or obligations under this
Agreement, except, in each case, to the extent Alfacell has an obligation
to
indemnify Par under Section 12.1.
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12.3 Notice
and Procedures.
If an
Alfacell Indemnitee or a Par Indemnitee (the “Indemnitee”)
intends to claim indemnification under this Article XII, it shall promptly
notify the other Party (the “Indemnitor”)
in
writing of any such alleged Losses promptly after it becomes aware of the
basis
for such indemnification. The Indemnitor shall have the right to control
the
defense thereof with counsel of its choice, provided,
however,
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 Losses covered by this
Article XII. The obligations of this Section 12.3 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, conditioned or delayed unreasonably. The failure to
deliver prompt written notice to the Indemnitor shall relieve the Indemnitor
of
any obligation to the Indemnitee of liability under this Section 12.3 to
the extent it is prejudiced thereby. It is understood that only Alfacell
or Par
may claim indemnity under this Article XII (on its own behalf or on behalf
of its Indemnitees), and other Indemnitees may not directly claim indemnity
hereunder.
12.4 Limitation
of Damages.
EXCEPT
IN RESPECT OF (A) ANY CLAIM RELATED TO THE WILLFUL MISCONDUCT OF A PARTY
OR
INTENTIONAL BREACH OF A REPRESENTATION, WARRANTY OR OBLIGATION BY A PARTY
UNDER
THIS AGREEMENT OR (B) ANY THIRD PARTY CLAIMS UNDER ARTICLE XII, NEITHER
PARTY NOR ANY OF ITS REPRESENTATIVES (AS DEFINED IN SECTION 8.1) 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,
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.
12.5 Insurance.
During
the Term and a period of three (3) years thereafter, each Party shall have
and
maintain, at its own expense, with a reputable and financially secure insurance
carrier or carriers, (a) general liability insurance coverage for the
manufacture, supply, use and sale of the Product and such Party's activities
related to this Agreement as is reasonable, normal and customary in the
pharmaceutical industry generally for parties similarly situated and as is
appropriate to such activities, and (b) product liability insurance coverage
as
is reasonable, normal and customary in the pharmaceutical industry generally
for
the manufacture, supply, use and sale of pharmaceutical products of similar
risk
profile to the Product. Subject to the foregoing, each Party shall have in
place prior to the Initial Commercial Sale product liability insurance coverage
in an amount of not less than *** US dollars ($***) per occurrence, and Alfacell
shall have a maximum self-insured retention or deductible of *** US dollars
($***) with respect thereto. Upon the request of the other Party, each
Party shall provide a certificate of insurance evidencing such coverage to
the
other Party.
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ARTICLE
XIII
TERM
AND TERMINATION
13.1 Term.
The
term of this Agreement (the “Term”)
shall
commence on the Effective Date and shall expire, unless earlier terminated
as
provided under Sections 13.2, 13.3, 13.4 or 13.5, on the earlier to occur
of
(a) January
1, 2015, if no Full Approval has been obtained for the Product for the Primary
UMM Indication or Secondary UMM Indication in the Territory by such date;
provided,
however,
that if
Par agrees to waive the precondition in respect thereof pursuant to Section
6.2
and becomes obligated to make a payment to Alfacell of $*** upon the
administration of the first dose of the Product to the first patient in a
first
Phase III Clinical Trial for any Future Indication, then the Term shall
automatically be extended until the seventh (7th) anniversary of such payment;
or
(b) the
latest to occur of the following: (i) in respect of any Indication, the twelfth
(12th) anniversary of the initial commercial sale for the Product with such
Indication, (ii) the date of expiration of the last Valid Claim within the
Alfacell Patents; and (iii) a date later than the foregoing (i) or (ii),
which
shall be mutually agreed by the Parties in writing, if the Parties agree
that
Product sales in the Field in the Territory should be continued; provided,
however,
that if
Par becomes obligated to make a payment to Alfacell of $*** upon the
administration of the first dose of the Product to the first patient in a
first
Phase III Clinical Trial for any Future Indication, then the Term shall
automatically be extended until the seventh (7th) anniversary of such
payment.
13.2 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 and
demanding its cure, 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. In the
event
that Par reasonably believes that Alfacell has materially breached or materially
defaulted under this Agreement and failed to cure such breach or default
as
provided above, and Par does not wish to terminate its license hereunder,
then
Par may, in its discretion, retain its license and seek to have a court or
an
arbitrator (a) determine whether Alfacell has materially breached or defaulted
under this Agreement and failed to timely cure such material breach or default,
and (b) if such court or arbitrator determines that Alfacell has so materially
breached or defaulted and has failed to timely cure such material breach
or
default, and that Par has suffered Losses arising, directly or indirectly,
out
of or in connection with or relating to or based on such uncured material
breach
or default, then such court or arbitrator may either (i) award monetary damages
or (ii) prospectively reduce royalty rates and/or other payments hereunder
(including reduction in milestone payments), where (i) or (ii) would be
objectively determined by such court or arbitrator to be a fair and reasonable
remedy for any actual damages determined to have been suffered by Par by
such
material breach or default by Alfacell.
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13.3 Termination
for Bankruptcy.
Each
Party (the “Insolvent
Party”)
shall
promptly notify the other Party (the “Solvent
Party”)
in
writing 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 the Insolvent Party or similar
proceeding under the law for release of creditors by or against the Insolvent
Party or if the Insolvent Party shall make a general assignment for the benefit
of its creditors. If the applicable circumstance described above shall have
continued for sixty (60) days undismissed, unstayed, unbonded and
undischarged, the Solvent Party may terminate this Agreement upon written
notice
to the Insolvent Party within ninety (90) days of the Insolvent Party
providing the notice referenced above; provided,
however,
if the
Insolvent Party provides for the cure of all of its defaults under this
Agreement (if any) and provides adequate assurance of its future performance
of
its obligations to the Solvent Party’s reasonable satisfaction, then the Solvent
Party shall not have the right to terminate this Agreement pursuant to this
Section 13.3. All licenses and rights to licenses granted under or pursuant
to
this Agreement and the Supply 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. The foregoing provisions of this Section 13.3 are
without prejudice to any rights Par may have arising under the Code or other
applicable law.
13.4 Termination
for Failure to Meet UMM Milestones.
Par
shall have the right to terminate this Agreement on ninety days’ written notice
to Alfacell if (a) the Product for the Primary UMM Indication shall not obtain
Full Approval on or before January 1, 2012, or (b) the Product for the Primary
UMM Indication receives a Not Approvable communication from the
FDA.
13.5 Other
Grounds for Termination.
A Party
may terminate this Agreement pursuant to the terms and conditions of Sections
4.1(e) and/or 4.4(b).
13.6 Effects
of Termination.
(a) If
Par
elects to terminate this Agreement in accordance with Section 13.2, all
rights and licenses granted to Par shall automatically and immediately terminate
and shall revert to Alfacell (unless otherwise expressly set forth
herein).
(b) If
Alfacell elects to terminate this Agreement in accordance with Section 13.2,
(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, Trade
Names
and the Alfacell Technology (without any right to sell inventory pursuant
to
subsection (d) below); and (ii) Par shall pay within thirty (30) days after
such termination: (x) all accrued and unpaid amounts due to Alfacell in
accordance with the terms of this Agreement (including, if such termination
shall occur following the grant of Regulatory Approval, any payments under
Section 6.2 that have been achieved but not yet paid by Par, any unpaid
Royalties and the Transfer Price for Product manufactured or in process pursuant
to Par’s binding sales forecast but not yet delivered to Par, as well as raw
materials purchased therefor, but only to the extent that Alfacell is unable
to
sell such Product); and (y) any other amounts that will become due to Alfacell
through or after the effective date of such termination in accordance with
the
terms hereof. The remedies set forth in this Section 13.6(b) are in addition
to
any rights and remedies otherwise available to Alfacell at law or in
equity.
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(c) Upon
the
termination or expiration of this Agreement each Party shall return to the
other
Party, or destroy, all Confidential Information of the other Party.
(d) Except
in
the case of termination of this Agreement by Alfacell under Section 13.2,
Par may continue to sell inventory of Product then on hand for an additional
period not to exceed six (6) months, and the sale of such Product shall be
subject to the terms and conditions of this Agreement.
13.7 Surviving
Rights.
The
expiration or termination of this Agreement shall not affect the obligations
and
rights of the Parties which from their context are intended to survive such
expiration or termination. Without limiting the foregoing sentence, the
provisions of Section 6.5; Section 10.1 (with respect to Par’s obligation to
forward all ADE reports); Sections 12.1 through 12.4; Sections 13.3 (with
respect to Par’s rights under the Code) and 13.6; this Section 13.7; and Section
13.8; and Articles I, VIII and XIV, shall survive termination or expiration
of this Agreement.
13.8 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
XIV
MISCELLANEOUS
14.1 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.
14.2 Assignment.
This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their successors and permitted 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 14.2 shall be null and void. In the
event of a Change of Control of Par or Alfacell, the surviving entity shall
promptly confirm to Alfacell or Par, as applicable, in writing its obligation
to
abide by the terms and conditions of this Agreement, and shall meet with
Alfacell or Par, as applicable, within thirty (30) days of such Change of
Control to discuss and review continued performance under this
Agreement.
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14.3 Performance
by Sub-distributors.
The
Parties recognize that, subject to Section 4.3, Par may perform some or all
of
its obligations under this Agreement through one (1) or more of its
Sub-distributors, which may or may not be Affiliates of Par; provided,
however,
that Par
shall remain responsible for and shall guarantee such performance by its
Sub-distributors (whether or not Affiliates), and shall cause its
Sub-distributors (whether or not Affiliates) to comply with the provisions
of
this Agreement in connection with such performance.
14.4 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 followed
by
U.S. Mail, return receipt requested, or by FedEx or other reputable national
courier service. Any such notice shall be deemed to have been given as of
the
day of personal delivery, one (1) business day after the date sent by
facsimile service or on the day of delivery to the other Party confirmed
by the
courier service.
In
the case of Alfacell:
|
Alfacell
Corporation
000
Xxxxxx Xxxxx
Xxxxxxxx,
XX 00000
Attention:
Chief Executive Officer
Facsimile:
(000) 000-0000
|
with
a copy (which shall not
constitute
notice) to:
|
Xxxxxx
Xxxxxx LLP
Times
Square Tower
0
Xxxxx Xxxxxx
Xxx
Xxxx, Xxx Xxxx 00000
Attention:
Xxxxx X. Xxxxxxx
Facsimile:
(000) 000-0000
|
In
the case of Par:
|
Par
Pharmaceutical, Inc.
000
Xxxx Xxxxxxxxx
Xxxxxxxxx
Xxxx, XX 00000
Attn:
General Counsel’s Office
Fax:
(000) 000-0000
|
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with
a copy (which
shall not
constitute
notice) to:
|
Xxxxxx,
Xxxxxxxxxx & Xxxxxxxxx LLP
000
Xxxxx Xxxxxx
Xxx
Xxxx, XX 00000-0000
Attn:
X. Xxxx Milling, Jr., Esq.
Fax:
(000) 000-0000
|
Either
Party may change its address for communications by a notice to the other
Party
in accordance with this Section 14.4.
14.5 Dispute
Resolution.
The
Parties recognize that a bona fide
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
Alfacell:
|
Kuslima
Shogen, CEO
|
For
Par:
|
Xxxx
XxxXxxx, President, Strativa Pharmaceuticals (a division of Par
Pharmaceutical, Inc.)
|
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, the Parties shall attempt in good faith
to
resolve such dispute in a voluntary, amicable and expeditious manner
through non-binding mediation in
New
York, New York under the International Institute for Conflict Prevention
and
Resolution (“CPR”)
Mediation Procedure then currently in effect. Unless the Parties agree
otherwise, the mediator will be selected from the JAMS panel of
neutrals and
each Party shall bear its own costs.
If the
dispute is not resolved within sixty (60) days of a Party’s written request for
mediation, there is no further obligation to mediate. If the Parties
are unable to resolve any dispute through mediation as set
forth in this Section 14.5, each Party shall have the right to pursue any
and all remedies available at law or in equity.
14.6 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.
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WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS
DENOTE SUCH OMISSION
14.7 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 (each, 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 affected 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.
14.8 Independent
Contractors.
In
making and performing this Agreement, Par and Alfacell 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 Alfacell 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.
14.9 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.
14.10 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.
14.11 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.
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INFORMATION OMITTED AND FILED SEPARATELY
WITH
SECURITIES AND EXCHANGE COMMISSION
ASTERISKS
DENOTE SUCH OMISSION
14.12 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.
14.13 Publicity
and Press Releases.
Neither
Party shall (a) originate any publicity, news release or other public
announcement, written or oral, whether to the public press, stockholders
or
otherwise, relating to this Agreement, any amendment hereto or performance
hereunder, or (b) use the name of the other Party in any publicity, news
release
or other public announcement, except (i) with the prior written consent of
the
other Party, which consent shall not be unreasonably withheld or delayed,
or
(ii) as required by applicable law or regulation, in which case the originating
Party shall submit to the other Party
(for
review and any proposed modifications, as well as the Parties’ coordination,
prior to such disclosure or use) each such required disclosure, and shall
comply
with the terms of Article VIII;
provided, however,
that if
a Party determines in good faith that it is required to make a public disclosure
with respect to the subject matter of this Agreement pursuant to any applicable
securities laws or the rules of any securities exchange on which its securities
are traded, it shall not be required to obtain the prior written approval
of the
contents of such public disclosure from the other Party, but it shall use
its
reasonable best efforts to provide the other Party with a reasonable opportunity
to review such public disclosure before it is made public and will consider
in
good faith changes to such public disclosure suggested by the other Party.
Public disclosures with respect to the subject matter of this Agreement that
contain only information that is consistent with the information contained
in
prior public disclosures made by one of the Parties in accordance with the
terms
of this Section 14.13 shall not require prior review or approval by the
non-disclosing Party. Par acknowledges that Alfacell will be obligated to
file a
copy of this Agreement with the United States Securities and Exchange Commission
(“SEC”).
Alfacell will seek confidential treatment of those portions of this Agreement
which it deems appropriate under applicable regulations of the SEC.
[Signature
Page Follows]
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INFORMATION OMITTED AND FILED SEPARATELY
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SECURITIES AND EXCHANGE COMMISSION
ASTERISKS
DENOTE SUCH OMISSION
IN
WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by
their duly authorized representatives as of the Effective Date.
ALFACELL
CORPORATION
|
||
By:
|
/s/ Kuslima Shogen | |
Name: | Kuslima Shogen | |
Title:
|
Chairman & CEO | |
PAR
PHARMACEUTICAL, INC.
|
||
By:
|
/s/ Xxxxxxx X. XxXxxx | |
Name: | Xxxxxxx X. XxXxxx | |
Title:
|
CEO & President |
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