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EXHIBIT 10.31
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WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
LICENSE AGREEMENT
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 300
Atrium Drive, Somerset, New Jersey 08873 (“
Alfacell ”),
and
Par Pharmaceutical, Inc .,
a Delaware corporation with its principal place of business at
300 Tice Boulevard, Woodcliff Lake, New Jersey 07677
(“
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, Lawrence
A. Kenyon, Andrew P. Aromando and/or Diane Scudiery, 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 here
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