|
Exhibit 10.50
LICENSE AGREEMENT
Between
IMMTECH PHARMACEUTICALS, INC.
AND
BIOALLIANCE PHARMA SA
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
|
|
1.2
|
Certain
Rules of Construction
|
6
|
| ARTICLE II |
MANAGEMENT OF THE COLLABORATION
|
7 |
|
|
2.2
|
Development
Committee
|
8
|
|
|
2.3
|
Commercialization
Committee
|
9
|
|
|
2.5
|
Nondisclosure
Agreement
|
9
|
| ARTICLE III |
DEVELOPMENT PROGRAM
|
9 |
|
|
3.1
|
Immtech
Responsibility and Control
|
9
|
|
|
3.2
|
Development
Program
|
10
|
|
|
3.3
|
Clinical
and Regulatory Approval
|
10
|
|
|
3.4
|
Development
Program Funding
|
11
|
| |
3.5 |
Development
Program Reporting
|
|
|
|
4.1
|
Grant
to BioAlliance
|
11
|
|
|
4.2
|
Information
Transfer
|
12
|
|
|
4.3
|
Agreement
Not to Genericize
|
12
|
|
|
4.4
|
New
Indication Rights
|
13
|
|
|
5.2
|
Subsequent
Payments
|
14
|
|
|
5.3
|
Reduction
of Royalty
|
15
|
|
|
5.4
|
Payment
Procedures
|
16
|
| ARTICLE VI |
MANUFACTURE AND SUPPLY; COMMERCIALIZATION
|
16 |
| ARTICLE VII |
CONFIDENTIAL AND TECHNICAL INFORMATION
|
17 |
|
|
7.1
|
Treatment
of Confidential Information
|
17
|
|
|
7.2
|
Release
from Restrictions
|
18
|
|
|
7.4
|
Survival
of Confidentiality Obligations
|
19
|
|
|
7.5
|
Superseding
Prior Confidentiality Agreement
|
19
|
| ARTICLE
VIII |
PATENT PROSECUTION AND ENFORCEMENT
|
19 |
|
|
8.2
|
Patent
Prosecution and Maintenance
|
19
|
TABLE OF CONTENTS
(continued)
Page
| ARTICLE IX |
ADVERSE EXPERIENCES
|
22 |
|
|
9.3
|
Literature
Reports
|
23
|
| ARTICLE X |
REPRESENTATIONS AND WARRANTIES
|
23 |
|
|
10.1
|
Representations
and Warranties
|
23
|
| ARTICLE XI |
INDEMNIFICATION AND LIMITATION ON LIABILITY
|
26 |
|
|
11.1
|
Indemnification
by Immtech
|
26
|
|
|
11.2
|
Indemnification
by BioAlliance
|
26
|
|
|
11.3
|
Notice
and Procedures
|
26
|
|
|
11.4
|
Limitation
of Liability
|
27
|
| ARTICLE XII |
TERM AND TERMINATION
|
27 |
|
|
12.2
|
Termination
for Breach
|
27
|
|
|
12.3
|
Termination
for Bankruptcy
|
27
|
|
|
12.4
|
Termination
by BioAlliance
|
27
|
|
|
12.5
|
Effect
of Termination
|
28
|
|
|
12.7
|
Accrued
Rights and Surviving Obligations
|
28
|
| ARTICLE
XIII |
MISCELLANEOUS
|
29 |
|
|
13.1
|
Entire
Agreement; Modification
|
29
|
|
|
13.3
|
Performance
by Affiliates
|
29
|
|
|
13.5
|
Dispute
Resolution
|
30
|
|
|
13.8
|
Independent
Contractors
|
31
|
| |
13.9 |
Severability;
Waiver |
31 |
| |
13.10 |
Further
Actions |
31 |
| |
13.11 |
Cumulative
Rights |
31 |
| |
13.12 |
Counterparts |
31 |
TABLE OF CONTENTS
(continued)
Page
|
EXHIBIT A
|
SUPPLY AGREEMENT
|
|
EXHIBIT B
|
OPTION TO LICENSE MALARIA PREVENTION
|
LICENSE AGREEMENT
This License Agreement (the “ Agreement ”) is
made and entered into as of December 3, 2007 (the
“ Effective
Date ”), by and between Immtech
Pharmaceuticals, Inc ., a Delaware corporation with its
principal place of business at 150 Fairway Drive, Vernon Hills, IL
60061 (“ Immtech ”), and
BioAlliance
Pharma SA , a French société anonyme having a
principal place of business at 59, boulevard du
Général Martial Valin, 4th Floor 75015 Paris, France
(“ BioAlliance
”). Immtech and BioAlliance may be referred to
herein individually as a “ Party ”, or
collectively as the “ Parties
”.
Recitals
Whereas, Immtech has expertise developing and
commercializing pharmaceutical products for infectious diseases and
has developed and owns certain proprietary technology and know-how
relating to the design and manufacture of the Product (as defined
in Section 1.1); and
Whereas , BioAlliance has expertise in licensing,
developing, marketing and distributing certain pharmaceutical
products in Europe and wishes to develop and market the Product as
further described herein, and Immtech agrees to grant BioAlliance
the rights to do so pursuant to the terms of this
Agreement.
Now , Therefore
, in consideration of the foregoing and the covenants and promises
contained herein, the Parties hereby agree as follows:
ARTICLE I
DEFINITIONS
1.1
Definitions
. For the purposes of this Agreement, the following
defined terms have the respective meanings set forth
below:
“
Affiliate ”
means with respect to a Party, any other entity that directly
or indirectly controls, is controlled by, or is under common
control with, such Party. An entity or Party shall
be regarded as in control of another entity if it owns, or
directly or indirectly controls, at least fifty
percent (50%) of the voting stock or other ownership
interest of such entity, or if it directly or indirectly
possesses the power to direct or cause the direction of the
management and policies of the other entity by any means
whatsoever.
“
cGMP
” means the regulatory requirements for current good
manufacturing practices promulgated by the FDA under the U.S.
Food, Drug and Cosmetic Act and the regulations promulgated
thereunder, particularly 21 C.F.R. Section 210
et seq., as the same may be amended from time to
time.
“
Clinical
Supplies ”
means supplies of the Product, manufactured, packaged and
labeled in compliance with cGMP, in such form and dosage as is
determined by Immtech pursuant to the Development Program, and
suitable for use in the conduct of pre-clinical and/or human
clinical trials of the Product by the Parties pursuant to the
Development Program.
“
Commercialization
” means the marketing, promotion, advertising, selling
and/or distribution of the Product in the Territory after
Regulatory Approval has been obtained; and the term “
Commercialize
” has a corresponding meaning.
“
Commercially
Reasonable Efforts ” means the efforts and
resources that would reasonably be used (including the
promptness with which such efforts and resources would be
applied) in the pharmaceutical industry for the diligent
development, manufacture or commercialization of a
pharmaceutical product of similar market and profit potential
and at a similar stage in development or product life as
compared to the Product; and the term “ Commercially
Reasonable ” has a corresponding
meaning.
“Confidential Information ” means information of
a Party that is disclosed to or obtained by the other Party
(including information obtained by a Party as a result of access to
the facilities of the other Party) either prior to or during the
Term, 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 of a Party
that the receiving Party can demonstrate by written
evidence: (i) is in the public domain other than as
a result of a breach by such receiving Party (or any of its
Affiliates) of its obligations of confidentiality contained herein;
(ii) was known by the receiving Party prior to receipt from
the disclosing Party; (iii) has been developed by the
receiving Party independent of any Confidential Information of the
other Party; or (iv) was subsequently, lawfully and in good
faith obtained by the receiving Party on a non-confidential basis
from a Third Party that was not under an obligation to treat such
information in a confidential manner and had a lawful right to make
such disclosure. Without limiting the foregoing, the
terms of this Agreement, including the Development Program, shall
constitute “Confidential Information” of both Parties
hereunder.
“
COGS
” means cost of goods, defined as Transfer Price
multiplied by the units sold by BioAlliance in a calendar
quarter.
“
Development
Committee ” has the meaning set forth Section
2.2.
“
Development
Costs
” means [****].
“
Development
Program ” means the activities associated with
development of the Product, including, but not limited to,
(a) manufacture and formulation of the Product for
preclinical and clinical studies; (b) planning,
implementation, evaluation and administration of human
clinical trials; (c) manufacturing process development
and scale-up for the manufacture of the Product; (d)
preparation and submission of applications for Regulatory
Approval; and (e) post-market surveillance of approved
drug Indications.
“
Direct
Cost ” means [****].
“
Effective
Date ” means the date set forth in the
introductory paragraph.
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
“ Exclusivity Period
” means the period during which the applicable
regulatory agency in the Territory prohibits reference,
without the consent of the owner of an application for
Marketing Approval, to the clinical and other data that is
contained in such application for Marketing Approval, and that
is not published or publicly available outside of such
application for Marketing Approval.
“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.
“
Floor
Price ” means [****].
“
Immtech
Know-How ” means all Know-How Owned or Controlled
by Immtech or any of its Affiliates as of the Effective Date
or during the Term that is useful or necessary for the
development, manufacture, use, sale, offer for sale,
distribution or import of the Product (or pafuramidine as the
active ingredient in the Product) in the Territory, including,
without limitation, any replication or any part of such
Information.
“
Immtech
Patents ” means any Patents Owned or Controlled
by Immtech or any of its Affiliates as of the Effective Date
or during the Term that are useful or necessary for the
development, manufacture, use, sale, offer for sale,
distribution or import of the Product (or pafuramidine as the
active ingredient in the Product) in the Territory, including,
without limitation, all Patents in the Territory that claim
any Invention. A list of the Immtech Patents
existing as of the Effective Date is appended hereto as
Schedule
1.1 , and such list will be updated periodically by
Immtech to reflect additions thereto.
“
Immtech
Technology ” means all Immtech Patents and all
Immtech Know-How.
“
Indication ”
means any of the approved therapeutic uses for the
Product.
“
Initial
Commercial Sale ” means the first sale of the
Product by BioAlliance or its Affiliate in the Territory
following Regulatory Approval of the Product in the
Territory.
“Invention” means any new invention or discovery
related to pafuramidine that is learned, conceived and/or reduced
to practice by one or more employees or contractors of BioAlliance
or its Affiliates or sublicensees, by one or more employees or
contractors of Immtech, or jointly by one or more employees or
contractors of BioAlliance, any BioAlliance Affiliate or
BioAlliance sublicensee and one or more employees of
Immtech.
“
Know-How ”
means all tangible and intangible ideas, inventions (whether
patentable or not), instructions, techniques, technology,
practices, trade secrets, knowledge, know-how, skill,
experience, processes, methods, products, materials,
compositions, models, data, results, formulas, expert opinions
and information, including, without limitation, biological,
chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical, clinical, safety, manufacturing and
quality control data and information.
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
“
Major EU
Market ” means any of the United Kingdom, France,
Germany, Italy, and Spain.
“
Marketing
Approval ” means any and all Regulatory Approvals
of a Product, but excluding Pricing Approval.
“
Net
Sales ” means [****].
“
New Licensing
Agreement ” has the meaning set forth in Section
4.4(a).
“
Owned or
Controlled by ” means the possession of the
unencumbered right to grant the license to BioAlliance as
provided herein.
“
Patents ”
means all existing and future patents and patent applications,
including without limitation any continuations,
continuations-in-part, divisions, provisionals or any
substitute applications, any patent issued with respect to any
such patent applications, any reissue, reexamination, renewal
or extension (including any supplemental patent certificate)
of any such patent, and any confirmation patent or
registration patent or patent of addition based on any such
patent, and all foreign counterparts of any of the
foregoing.
“
PCP
” means pneumocystis carinii pneumonia (also known as
pneumocystis jiroveci pneumonia).
“
Phase III
Clinical Trials ” means that portion of the
Development Program that provides for large scale, pivotal,
clinical studies that (a) are conducted in a number of
patients that is intended to be sufficient to obtain a
definitive evaluation of the therapeutic efficacy and safety
of a Product in patients for a given Indication as required by
21 C.F.R. §312.21(c) and/or (b) that are needed
to evaluate the overall risk-benefit relationship of the
Product and to provide adequate basis for obtaining requisite
Regulatory Approvals.
“
Pricing
Approval ” means any and all price and
reimbursement approvals of any country, federal,
supranational, state or local regulatory agency, department,
bureau or other government entity that are necessary for the
sale of the Product in the Territory.
“
Product ”
means a finished oral dosage form for sale in the Territory,
that (i) contains pafuramidine as the only active ingredient,
(ii) is approved by the requisite regulatory authority in the
Territory for the treatment of PCP and/or human African
trypanosomiasis in patients and (iii) is ready for
administration to the ultimate consumer as a pharmaceutical;
provided, however, that the term Product shall specifically
exclude future Indications of pafuramidine, except those
related to PCP and/or human African trypanosomiasis and except
as otherwise provided in Exhibit B.
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
“
Product
Studies ” means clinical studies, pre-clinical
studies, safety studies, epidemiological studies, modeling and
pharmacoeconomic studies, in each case including any ancillary
or incidental development, investigation or research schemes
pertaining thereto, that are designed (a) to support
Regulatory Approval for the Product or (b) to support
publications, promotional and educational activities, future
labeling changes or new Indications for
pafuramidine.
“
Program
Developments ” means all Inventions and related
discoveries, Know-How, copyrights, works of authorship and
other intellectual property rights that are made, developed,
created, conceived or reduced to practice in connection with
or relating to the Development Program or Commercialization
during the Term.
“
Regulatory
Approval ” means any and all approvals (including
Pricing Approval, if required), licenses, registrations, or
authorizations of any country, federal, supranational, state
or local regulatory agency, department, bureau or other
government entity that are necessary for the use, storage,
import, transport and/or sale of the Product in the
Territory.
“
Representative”
has the meaning set forth in Section 7.1.
“
Royalty” has
the meaning set forth in Section 5.2(b).
“
Royalty
Period ” means, on a country by country basis,
the period of time commencing on the Initial Commercial Sale
of the Product in a country and ending upon the later
of: (a) the expiration of the last to expire
valid claim of the Immtech Patents in such country (subject to
the proviso in the last sentence of Section 8.1),
(b) the expiration of the Product’s Exclusivity
Period in such country, and (c) ten (10) years after the
date of the Initial Commercial Sale of the Product in such
country.
“
Selling
Unit ” means 28 tablets of the Product containing
100 mg of pafuramidine per tablet.
“
Supply
Agreement ” means the supply and distribution
terms attached hereto as Exhibit A,
which is considered to be part of this Agreement
.
“
Territory ”
means Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, and United
Kingdom.
“
Term
” has the meaning set forth in
Section 12.1.
“
Third
Party ” means any person or entity that is not a
Party to this Agreement or an Affiliate of such
Party.
“
Transfer
Price ” means [****].
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
1.2
Certain Rules of
Construction .
(a) As
used in this Agreement, unless the context otherwise
requires: Section, Schedule, Article and Exhibit references
are intended to refer to this Agreement; words describing the
singular number shall include the plural and vice versa;
words denoting any gender shall include all genders; words
denoting natural persons shall include corporations,
partnerships and other entities, and vice versa; the words
"hereof", "herein" and "hereunder", and words of similar
import, shall refer to this Agreement as a whole, and not to
any particular provision of this Agreement; the term
"include" and derivations thereof are not intended to apply
any limitation to the item(s) specified; and terms such as
lessee, lessor, lease, landlord, tenant, licensor, licensee
and license will be interpreted broadly to refer also to
sub-leasing or sub-licensing arrangements and/or the Parties
thereto.
(b) This
Agreement is between financially sophisticated and
knowledgeable Parties and is entered into by the Parties in
reliance upon the economic and legal bargains contained
herein, the language used in this Agreement has been
negotiated by the Parties hereto and shall be interpreted and
construed in a fair and impartial manner without regard to
such factors as the Party who prepared, or caused the
preparation of, this Agreement or the relative bargaining
power of the Parties.
ARTICLE II
MANAGEMENT OF THE COLLABORATION
2.1
Steering
Committee .
(a)
Establishment
. The
Parties hereby establish a Steering Committee consisting of
six (6) members, three (3) of whom shall be BioAlliance
designees and three (3) of whom shall be Immtech
designees. Each of the Steering Committee members shall
have appropriate expertise to oversee the Parties’
performance of this Agreement. The initial Steering
Committee members shall be designated by each Party within one week
after the Effective Date. Each Party shall have the
right at any time and from time to time to designate a replacement,
on a permanent or temporary basis, for any or all of its
previously-designated members of the Steering
Committee. At the beginning of each calendar year during
the Term, each Party shall appoint one of its designees to serve as
a Co-Chair of the Steering Committee. The initial
Co-Chairs shall be designated by each Party within one week after
the Effective Date.
(b)
Meetings
and Procedures .
(i)
The
Steering Committee shall meet at least once every six (6) months,
and more frequently at the request of either Party or as required
to resolve disputes, disagreements or deadlocks, on such dates, and
at such places and times, as the Parties shall agree; provided ,
however , that
the Parties shall use their Commercially Reasonable Efforts to
cause the first meeting of the Steering Committee to occur within
thirty (30) days after the Effective Date. The two
(2) Co-Chairs shall cooperate to send a notice and agenda for each
meeting of the Steering Committee to all members of the Steering
Committee reasonably in advance of the meeting. The
location of regularly-scheduled Steering Committee meetings
shall
alternate
between the offices of the Parties, unless otherwise
agreed. The members of the Steering Committee also
may convene or be polled or consulted from time to time by
means of telephone conference, video conference, electronic
mail or correspondence and the like, as deemed necessary or
appropriate by the Co-Chairs. The Party hosting any
Steering Committee meeting shall appoint one (1) person (who
need not be a member of the Steering Committee) to attend the
meeting and record the minutes of the meeting in
writing. Such minutes shall be circulated to the
members of the Steering Committee promptly following the
meeting for review and comment.
(ii)
All
decisions of the Steering Committee shall be made by unanimous vote
or unanimous written consent of both Parties, with each Party
having, collectively among its respective designees, one (1) vote
in all decisions. The members of the Steering Committee
shall use Commercially Reasonable Efforts to decide all matters
assigned to the Steering Committee under this Agreement or
otherwise referred to it by mutual agreement of the Parties;
provided ,
however , that
if the members of the Steering Committee are unable to come to a
mutual agreement, then (1) Immtech shall have the
right to make any necessary final determination with respect to
decisions related to the development and manufacture of the Product
( e.g. ,
determining which drug strength to pursue, when to initiate the
clinical trial), subject to Exhibit B
, and (2) BioAlliance shall have the right to make any necessary
final determination with respect to decisions related to the
Commercialization of the Product in the Territory ( e.g. ,
marketing programs and pricing strategies and designation of
product labels).
(c)
Purposes
and Powers . The principal purpose of the
Steering Committee shall be to approve the overall strategy for the
Parties’ collaboration hereunder and provide guidance and
direction as provided herein. Subject to the express
rights of the Parties as set forth herein, the functions of the
Steering Committee shall include:
(i)
Acting
as liaison between the Parties to ensure that they are informed of
the ongoing progress of the Development Program;
(ii)
Reviewing
and approving the division of responsibilities between the Parties
as set forth herein and as expanded from time to time in
furtherance of the goals of the Parties’
collaboration;
(iii)
Reviewing
and approving any proposed amendments to the Development
Program;
(iv)
Reviewing,
consulting on and providing input in respect of activities related
to the manufacturing of the Product and the selection of
manufacturer(s) of the Product (to the extent not already selected
as of the date hereof);
(v)
In
accordance with the procedures established above, resolving
disputes, disagreements and deadlocks between the Parties,
including the other Committees established pursuant to this
Agreement; and
(vi)
Performing
such other responsibilities as may be assigned to the Steering
Committee pursuant to this Agreement or as may be mutually agreed
upon by the Parties from time to time.
2.2
Development
Committee . Within thirty (30) days after
the Effective Date, the Parties shall establish a development
committee (the “ Development Committee
”) with responsibility for (i) reviewing proposed
changes to the Development Program following Regulatory Approval;
and (ii) performing such other duties as may be assigned under
this Agreement or as may be delegated to the Development Committee
by the Steering Committee. Each Party shall appoint two
(2) designees to the Development Committee each of whom shall have
expertise and experience in the areas of pharmaceutical development
and manufacturing. Either Party may replace any or all
of its designees on the Development Committee at any time upon
written notice to the other Party, and any member of the
Development Committee may designate a suitable proxy to perform the
functions of that member at any time. The Development
Committee shall meet at least once every calendar quarter during
the Development Program, and more frequently at the request of
either Party or as required to resolve disputes, disagreements or
deadlocks, on such dates, and at such places and times, as the
Parties shall agree. The Development Committee shall
seek to act with the unanimous consent of all members of the
Development Committee. In the event that the Development
Committee members do not reach consensus with respect to a matter
that is within the purview of the Development Committee, the
Development Committee designees of each Party shall collectively
have one (1) vote for purposes of decision-making hereunder with
respect to such matters, with decisions made by unanimous vote of
both Parties. If the votes of the Development Committee
are split on any matter, such matter shall be referred to the
Steering Committee for
decision.
2.3
Commercialization
Committee . Within thirty (30) days after
the Effective Date, the Parties shall establish a Commercialization
Committee (the “ Commercialization
Committee ”) with responsibility for (i)
reviewing and approving medical claims and marketing materials to
be used by any Parties in connection with the Product to ensure
that the claims made by a Party do not diminish the value of the
Product to the other Party and (ii) coordinating the activities of
the Parties related to the Commercialization. Each Party
shall appoint two (2) designees to the Commercialization Committee,
each of whom shall have expertise and experience in the areas of
marketing, promotion, advertising and sales. Either
Party may replace any or all of its designees on the
Commercialization Committee at any time upon written notice to the
other Party, and any member of the Commercialization Committee may
designate a suitable proxy to perform the functions of that member
at any time. The Commercialization Committee shall meet
at least once every six (6) months, and more frequently upon the
mutual agreement of the Parties if necessary to resolve disputes,
disagreements or deadlocks. The Commercialization
Committee shall seek to act with the unanimous consent of its
members. In the event that all of the Commercialization
Committee members do not reach consensus with respect to a matter
that is within the purview of the Commercialization Committee, the
Commercialization Committee designees of each Parties shall
collectively have one (1) vote for purposes of decision-making
hereunder with respect to such matters, with decisions made by
unanimous vote of both Parties. If the votes of the
Commercialization Committee are split on any matter, such matter
shall be referred to the Steering Committee for
decision.
2.4
Expenses
. Each Party shall be responsible for all travel and
related costs and expenses for its members and approved invitees to
attend meetings of, and otherwise participate on, the Steering
Committee, Development Committee and/or Commercialization
Committee.
2.5
Nondisclosure
Agreement . All designees of each Party serving
on the Steering Committee, Development Committee and/or the
Commercialization Committee shall as a condition to such service
execute a nondisclosure agreement in form and substance reasonably
satisfactory to the Parties.
ARTICLE III
DEVELOPMENT PROGRAM
3.1
Immtech
Responsibility and Control . Subject to the
Development Program and the other terms and conditions contained in
this Agreement, Immtech shall have control over all aspects of the
Development Program, including planning, strategy, administrative
management, and fiscal control; provided ,
however , that
Immtech shall include BioAlliance in such efforts as expressly
provided in this Agreement and otherwise in at least a consultative
capacity. The Development Program shall be coordinated
from the facilities of Immtech. Immtech shall keep
BioAlliance apprised of the status of the Development Program
through the Development Committee and, as appropriate, the Steering
Committee. Immtech shall comply, and shall require all
of its Third Party agents and contractors, if any, to comply, with
all applicable laws in the conduct of the Development
Program. BioAlliance shall have the right, through the
Development Committee and the Steering Committee, to actively
participate in planning, strategy, evaluation and management with
respect to clinical trials of the Product in the United States
conducted under the Development Program, including input regarding
patient recruitment, and Immtech shall discuss, consider and, as
appropriate, implement the reasonable suggestions and
recommendations of BioAlliance with regard to such clinical trials
of the Product. Immtech shall reimburse BioAlliance on a
quarterly basis for direct and indirect costs and expenses incurred
by BioAlliance in accordance with the budget set forth in the
Development Program for costs associated with planning, strategy,
evaluation and management with respect to the Phase III
Clinical Trials of the Product for the treatment of PCP in the
United States. BioAlliance will provide a written
invoice to Immtech for such costs and expenses on a quarterly
basis, and Immtech will reimburse BioAlliance for such costs and
expenses incurred during the quarter within sixty (60) days after
receipt of invoice.
3.2
Development
Program . Immtech shall use Commercially
Reasonable Efforts to conduct the development and regulatory
activities with respect to the Product in accordance with the
Development Program. Notwithstanding the foregoing or
any other provision of this Agreement, the Parties acknowledge and
agree that (a) the Development Program is experimental in
nature; and (b) neither Party provides any guaranty that the
Development Program will be successful or that Regulatory Approval
will be obtained for the Product. During the Term,
Immtech may revise the Development Program at any time and from
time to time, subject to Section 2.1 and Exhibit
B.
3.3
Clinical
Activities and Regulatory Approval in the
Territory.
(a)
Conduct
. Under Immtech’s direction and control,
BioAlliance agrees to use Commercially Reasonable Efforts to
conduct required clinical trials of the Product and obtain
Regulatory Approval in accordance with the Development Program in
the Territory. Specifically, BioAlliance will fund all
clinical development required to obtain Regulatory
Approval
of the Product in the Major EU Markets. The amount
of Royalty owed by BioAlliance to Immtech under
Section 5.2(b) will be reduced in an amount not to exceed
50% per period, until BioAlliance has recouped 50% of the
expenses (including Third Party costs) reasonably incurred by
BioAlliance in connection with the clinical development of the
Product or obtaining Regulatory Approval of the Product in the
Territory. For clarification, once the Parties have
agreed to development and regulatory activities to be
conducted by BioAlliance in the Territory, BioAlliance shall
have control over any decisions relating to implementation of
such activities, including any such matters that involve
patient safety.
(b)
Regulatory
Submissions . The Parties acknowledge that the
Product has not been reviewed or approved for sale or use for any
purpose by any governmental or regulatory body. With
Immtech’s input and approval (not to be unreasonably withheld
or delayed), BioAlliance shall prepare any required application(s)
for Regulatory Approval in the Territory, and BioAlliance shall
bear the costs of the registration of the Product in the
Territory. Immtech shall own, in its entirety, all
clinical data and reports related to Product Studies including
clinical trials for the Product, which shall be included in the
Immtech Technology. At all times both prior to and
following Regulatory Approval, (i) BioAlliance shall inform Immtech
of all communications with the required regulatory agencies in the
Territory with respect to the Product, and (ii) provide copies of
all proposed regulatory agency submissions for the Product to the
Development Committee prior to their submission. The
Parties shall cooperate in good faith with respect to, and
BioAlliance shall use its Commercially Reasonable Efforts to enable
representatives of Immtech to attend all formal meetings with the
regulatory agencies relating to, Regulatory Approval of the
Product. The Parties shall cooperate in good faith with
respect to the conduct of any inspections by any regulatory
authority of a Party’s site and facilities related to the
Product. To the extent either Party receives written or
material oral communication from any regulatory authority relating
to any Regulatory Approval process with respect to the Product, the
Party receiving such communication shall notify the other Party and
provide a copy of any written communication as soon as reasonably
practicable.
3.4
Development
Program Funding . If BioAlliance determines to
pursue any clinical development in respect of the Product following
Regulatory Approval, including any development for PCP prophylaxis
or any other PCP indication, the development costs in respect
thereof shall be the responsibility of BioAlliance, subject to the
royalty reduction for such costs provided in
Section 3.3(b).
3.5
Development
Program Reporting . Each Party shall (a) provide
the other Party at regularly scheduled meetings of the Development
Committee with summary updates regarding the progress of the
Development Program and Regulatory Approval process activities
being conducted by the reporting Party, (b) advise the other Party
of any unforeseen material problems or delays encountered since the
date of its last report in connection with the Development Program,
and (c) provide the other Party as soon as reasonably practicable
with such other material information as such other Party may
reasonably request in writing from time to time with respect to the
status of the Development Program.
ARTICLE IV
LICENSE
4.1
Grant
to BioAlliance. Subject to the other provisions
of this Agreement, Immtech hereby grants to BioAlliance and its
Affiliates an exclusive (subject to the co-exclusive rights
provided in the last sentence of this Section 4.1), royalty-bearing
license, under Immtech Technology to carry out its rights and
obligations set forth in this Agreement to develop, use, market,
offer for sale, sell, have sold, distribute and import the Product
in the Territory. BioAlliance may sublicense its rights under this
Agreement without the prior written consent of Immtech; provided
that any such sublicense is (i) not to a person or entity directly
competing with Immtech, The Consortium consisting of The
University of North Carolina at Chapel Hill, Auburn University,
Duke University or Georgia State University Research Foundation,
Inc. in the discovery, development, or commercialization of
anti-parasitic and anti-infective drugs, and (ii) in accordance
with the terms and conditions of this Agreement, including, without
limitation, Articles VII, VIII and XI. BioAlliance shall
provide Immtech with a copy of any such sublicense agreement within
thirty (30) days of the full execution and delivery by the
sublicensee of such sublicense agreement to
BioAlliance. BioAlliance shall use Commercially
Reasonable Efforts to enforce its rights under each such sublicense
agreement. In the event that there are one or more
sublicense agreements still in force upon the termination or
expiration of this Agreement, other than a termination due to a
breach of such sublicense agreement by the sublicensee, Immtech
will negotiate with such sublicensee in good faith regarding the
grant of a license by Immtech directly to such sublicensee under a
new agreement. Immtech retains all rights to Immtech
Technology except to the extent explicitly granted to BioAlliance
hereunder. Notwithstanding the foregoing, Immtech retains the right
to manufacture the Product. BioAlliance will use
Commercially Reasonable Efforts to commercialize the Product in the
Major EU Markets within twenty-four (24) months of initial European
Union registration (or such longer period as the Parties may agree
in light of the requirements of any regulatory authority in the
Territory, such agreement not to be unreasonably withheld). If
commercial sales do not occur in each of the Major EU Markets
within such time period, at Immtech’s option, license rights
within such country will revert to Immtech and this Agreement shall
remain in full force effect in all other countries in the
Territory.
4.2
Information
Transfer. Promptly after
the Effective Date, Immtech shall disclose to BioAlliance in
writing, or via mutually acceptable electronic media, copies or
reproductions of all Immtech Know-How, not previously disclosed to
BioAlliance, reasonably necessary in order to enable BioAlliance to
exploit its rights granted under Section 4.1. In
addition, during the Term, Immtech shall promptly disclose to
BioAlliance in writing, or via mutually acceptable electronic
media, on an ongoing basis, copies or reproductions of all new
Immtech Know-How that is reasonably necessary in order to enable
BioAlliance to exploit its rights granted under
Section 4.1. Such Immtech Know-How and other
information shall be automatically deemed to be within the scope of
the licenses granted herein without payment of any additional
compensation.
4.3
Agreement
Not to Genericize . BioAlliance
recognizes and acknowledges the value of the Immtech Know-How
disclosed under this Agreement and the Immtech Technology to which
BioAlliance is granted a license under this
Agreement. Accordingly, BioAlliance
agrees
that (i) it will not attempt to copy or design around the
Product or any product containing pafuramidine during the
Term, and if this Agreement is terminated early by Immtech
under Sections 12.2 or 12.3 or by BioAlliance under
Section 12.4, for two years immediately following such
termination if the Product is still commercially available by
Immtech, or any of Immtech’s Affiliates or sublicensees,
and (ii) it will not during the Term attempt to sell any
product containing pafuramidine outside the confines of this
Agreement, without express written agreement from
Immtech.
4.4
Sales
in the Territory . To the extent not
otherwise prohibited by law, neither Immtech nor its Affiliates or
licensees (other than BioAlliance) will sell the Product to
customers inside the Territory or to any Third Party that Immtech
has reasonable grounds to believe are likely to import the Product
into the Territory. If Immtech becomes aware that a
Third Party outside the Territory is exporting the Product acquired
from Immtech or any Affiliate or licensee (other than BioAlliance)
to a country within the Territory, then Immtech shall use
Commercially Reasonable Efforts within its legal rights and the
remedies afforded by applicable laws to deter such Third Party from
continuing such exportation. All inquiries or orders
received by Immtech for the Products to be distributed within the
Territory shall be referred to BioAlliance.
4.5
New
Indication Rights .
(a)
Notice
.
The Parties acknowledge that Immtech is currently
pursuing new indications for pafuramidine. If, following the
Effective Date, Immtech determines that pafuramidine can be used
for the treatment and/or prophylaxis of malaria or any other
indication, Immtech shall, prior to instituting any Phase III
development program in respect thereof, provide BioAlliance with a
one-time written notice of information reasonably available to
Immtech, including an estimate of the cost for developing and
obtaining regulatory approval therefor, that is reasonably required
by BioAlliance to assess its interest in exercising the rights
granted under this Section 4.5 (“Immtech’s Written
Notice”).
(b)
Right
to Include Malaria . If Immtech’s Written Notice
provided pursuant to Section 4.5(a) above relates to the use of
pafuramidine for the treatment and/or prophylaxis of malaria,
Immtech’s Written Notice shall be accompanied by copies of
any minutes of teleconferences or meetings with the FDA and/or EMEA
reflecting direction on the required development of pafuramidine
for prevention of malaria (and, if proposed by Immtech, treatment
of malaria) and all relevant information regarding such proposed
development and the budget therefor. Upon receipt of
Immtech’s Written Notice, BioAlliance shall have sixty (60)
days in which to provide written notice to Immtech that BioAlliance
would like to include the prevention of malaria (and, if proposed
by Immtech, treatment of malaria) within the scope of this
Agreement upon the terms and conditions set forth in the attached
Exhibit B. Upon receipt of BioAlliance’s written notice, the
terms and conditions set forth in Exhibit B shall become effective
and shall be deemed to be incorporated within and made a part of
this Agreement.
(c)
Right of First
Offer for Other Indications . The delivery of
Immtech’s Written Notice pursuant to Section 4.5(a) above
with regard to development of pafuramidine for any indication other
than prevention or treatment of malaria shall automatically grant
to BioAlliance a one-time exclusive option (the “
Option
”) to enter into an agreement with Immtech for a license to
permit BioAlliance and its Affiliates to market, offer for sale,
sell, have sold and
import
pafuramidine for such additional indication in the Territory
(the “ New License
Agreement ”). BioAlliance shall have
ten (10) days from receipt of such notice to (i)
exercise the Option by sending written notice to Immtech of
its intent thereof or (ii) reject the Option, in either case
at which time the following shall occur:
(i)
If
BioAlliance exercises the Option, the Parties shall have sixty (60)
days from the date of exercise of the Option to negotiate in good
faith a New Licensing Agreement. If, following such
sixty (60) day period, the Parties have not executed the New
Licensing Agreement, Immtech may, but shall not be obligated to,
offer such license for pafuramidine to a Third Party; provided
that, if Immtech proposes to offer or enter into a license for
pafuramidine for the same indication with a Third Party on
principal financial terms that in the aggregate are more favorable
to the licensee than those principal financial terms last offered
by BioAlliance when compared using a discounted cash flow of
milestones, royalties, and any other payments utilizing the London
Interbank Offered Rate (LIBOR) rate plus 10%, then
Immtech shall notify BioAlliance of the principal
financial terms offered to such Third Party and BioAlliance shall
have ten (10) days in which to enter into a New Licensing Agreement
on such terms; and
(ii)
If
BioAlliance rejects the Option, or does not inform Immtech of its
intent to exercise the Option within the ten (10)-day period,
Immtech may, but shall not be obligated to, offer such license to a
Third Party.
ARTICLE V
PAYMENTS
5.1
Upfront
Payment . In consideration for the execution and
delivery of this Agreement by Immtech, BioAlliance shall pay
Immtech a fully earned, non-refundable, non-creditable license fee
in the amount of US$3,000,000 by wire transfer of immediately
available funds upon execution and delivery of this
Agreement.
5.2
Subsequent
Payments
(a)
Milestone
Payments . Subject to the terms and conditions of
this Agreement, upon the achievement of certain milestones,
BioAlliance shall make fully earned, non-refundable, non-creditable
payments to Immtech by wire transfer of immediately available funds
as follows:
Regulatory
Milestones:
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
Sales
Milestones:
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(i)
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Upon
first achieving [****] in annual sales of the Product in the
Territory, [****];
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(ii)
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Upon
first achieving [****] in annual sales of the Product in the
Territory, [****];
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(b)
Royalty
. In
addition to the milestone payments set forth in
Section 5.2(a), subject to the terms and conditions of this
Agreement, BioAlliance shall additionally be obligated to make the
following payments based on Net Sales for a calendar year (“
Royalty
”) to Immtech:
(c)
Royalty
Reduction . In addition to
the reduction in the Royalty under Section 3.3(a), in the
event that one or more licenses from one or more Third Parties
(excluding any licensee of Immtech) to any issued patents covering
the composition of matter or use of the Product for a particular
Indication are required by BioAlliance or its Affiliates in order
to use, market, offer to sell, sell, have sold or import the
Product for such Indication under this Agreement (hereinafter
“ Third
Party Patent Licenses ”), then BioAlliance will have
the right upon the approval of Immtech, which approval shall not be
unreasonably withheld, to obtain a license from such Third Party
and offset [****] of any royalty actually paid to such Third Party
by reducing the Royalty due to Immtech by [****] in any calendar
quarter; provided, however, that in no event shall the Royalty owed
to Immtech be reduced by more than [****] in any calendar quarter
as a result of the reductions set forth in Section 3.3(a) and
this Section 5.2(c); provided further that the amount of any
such reduction under Section 3.3(a) or this
Section 5.2(c) that is not applied because of the limitation
in the preceding proviso may be carried forward to future
quarters.
(d)
Royalty
Period . The Royalty
shall be payable upon a country-by-country basis during the Royalty
Period. At the end of the Royalty Period in a given
country, BioAlliance’s licenses pursuant to Section 4.1
shall become a fully paid-up, perpetual license in such
country.
(e)
Reduction
in Royalty Rate . If, at any time during the
Royalty Period, BioAlliance notifies Immtech in writing that there
is no valid claim other than a method claim of the Immtech Patents
in a country in the Territory in which the Product is sold by
BioAlliance, including any Affiliate or sublicensee of BioAlliance,
and there is no Exclusivity Period then in effect with respect to
the Product in such country, or that such circumstances are
expected to
****
Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of
1934. Material filed separately with the Securities
and Exchange Commission.
occur
during the twelve (12) months following such notice, and a
generic version of the Product is being marketed and sold in
such country, then the Parties will meet following such notice
to negotiate in good faith a reduction in the Royalty rates
set forth in Section 5.2(b) that is commercially
reasonable under such circumstances, and, if the Parties are
unable to reach agreement on such matter, BioAlliance shall
have the right to discontinue its sales of the Product in such
country and its discontinuation of such sales shall not
constitute a breach of this Agreement.
(f)
Combination
Products . In the
event that Immtech intends to offer the Product as part of a system
or in combination with another product containing one or more of
the active ingredients (the “Combination Product”)
during the Term of this Agreement, Immtech will notify BioAlliance
and the Parties will discuss whether this Agreement will be amended
to allow BioAlliance to distribute such Combination
Product.
5.3
Payment
Procedures .
(a)
Manner
of Payment . Remittance of payments under
Article V will be made by means of wire or electronic transfer
to Immtech’s account in a bank in the United States to be
designated by Immtech.
(b)
Payments
and Reports . All amounts payable to Immtech
under this Agreement shall be paid in U.S. Dollars. The
Royalty shall accrue at the time of sale of the Product to a Third
Party. Royalty obligations that accrue during a calendar
quarter shall be paid within sixty (60) days after the end of
such calendar quarter, and other payments owing shall be made as
specified herein. Each Royalty payment due to Immtech
shall be accompanied by a report listing the gross invoiced sales
of the Product sold during such period and the calculation of Net
Sales based on such sales, including all other information
necessary to determine the appropriate amount of such Royalty
payments, and any additional information or reports required under
this Agreement.
(c)
Records
and Audit . For a period of three (3) years
after the Royalty period to which the records relate, BioAlliance
shall keep complete and accurate records pertaining to the sale or
other disposition of the Product in sufficient detail to permit
Immtech to confirm the accuracy of all payments due
hereunder. Immtech shall have the right to cause an
independent, certified public accountant to audit such records to
confirm the Net Sales and Royalty payments; provided ,
however , that
such auditor shall not disclose BioAlliance’s Confidential
Information to Immtech, except to the extent such disclosure is
necessary to verify the amount of Royalty and other payments due
under this Agreement. Such audits may be exercised once
a year, within three (3) years after the Royalty period to
which such records relate, upon notice to BioAlliance and during
normal business hours. Any amounts shown to be owing by
such audits shall be paid promptly. Immtech shall bear
the full cost of such audit unless such audit discloses a variance
in the amounts paid by BioAlliance of more than five
percent (5%) from the amount of Royalty and/or other payments
actually owed for the period audited. In such case,
BioAlliance shall bear the full cost of such audit. The
terms of this Section 5.4(c) shall survive any termination or
expiration of this Agreement for a period of three (3)
years.
ARTICLE VI
MANUFACTURE AND SUPPLY; COMMERCIALIZATION
6.1
Supplies
.
(a)
Immtech
shall manufacture or cause to be manufactured all Clinical Supplies
of Product for the Development Program, including the completion of
pre-clinical work and human clinical trials necessary for
registration in the Territory, pursuant to the Supply
Agreement.
(b)
Immtech
has established a commercial manufacturing process and for
manufacturing or causing to be manufactured commercial supplies of
the Product at the scale and in the amounts required to meet
BioAlliance’s sales forecast, pursuant to the Supply
Agreement.
(c)
BioAlliance
shall acquire the Product from Immtech at the Transfer Price,
provided ,
however ,
that, with respect to any quantities of Product BioAlliance or its
Affiliates or sublicensees purchases for use in Product Studies in
the Territory or distributes as samples to persons in the medical
profession, BioAlliance shall acquire such quantities from Immtech
at the Direct Cost. BioAlliance shall pay Immtech for
Product within sixty (60) days of receipt of such Product
(unless rejected in accordance with the Supply
Agreement).
6.2
Commercialization
. Subject to the rights and input of the
Commercialization Committee, BioAlliance shall have responsibility
for all Commercialization activities, including developing
strategies and tactics related to the advertising, promotion,
marketing and selling the Product in the
Territory. BioAlliance shall, at all times during the
Term, use Commercially Reasonable Efforts equal to those committed
to products of similar size and expected value to seek to
Commercialize the Product in the Territory for those formulations
and indications for which BioAlliance is commercializing Product
without Immtech.
(a)
BioAlliance
Activities . It shall be BioAlliance’s sole
right and responsibility in the Territory, in consultation with
Immtech, to (i) determine the commercially reasonable launch dates
for the Product, (ii) develop advertising and promotional materials
related to the Product, (iii) book sales for the Product,
(iv) handle all returns of the Product, (v) handle all
aspects of order processing, invoicing and collection of
receivables for the Product, (vi) collect data regarding sales
to hospitals and other end users of the Product, (vii) monitor
inventory levels of the Product, (viii) provide first line customer
support and pharmacovigilance (and after such initial support,
pharmacovigilance support shall be handled in accordance with
Article IX), and (ix) warehouse the Product.
(b)
Pricing
. BioAlliance shall have the right and responsibility to
determine the prices for the Product and any discounts and rebates
that
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