LICENSE AGREEMENT Between IMMTECH PHARMACEUTICALS, INC. AND BIOALLIANCE PHARMA SA
Exhibit
10.50
Between
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.
TABLE
OF CONTENTS
Page
ARTICLE I |
DEFINITIONS
|
1 |
|
1.1
|
Definitions
|
1
|
|
1.2
|
Certain
Rules of Construction
|
6
|
ARTICLE II |
MANAGEMENT
OF THE COLLABORATION
|
7 |
|
2.1
|
Steering
Committee
|
7
|
|
2.2
|
Development
Committee
|
8
|
|
2.3
|
Commercialization
Committee
|
9
|
|
2.4
|
Expenses
|
9
|
|
2.5
|
Nondisclosure
Agreement
|
9
|
ARTICLE III |
DEVELOPMENT
PROGRAM
|
9 |
|
3.1
|
Immtech
Responsibility and Control
|
9
|
|
3.2
|
Development
Program
|
10
|
|
3.3
|
Clinical
and Regulatory Approval
|
10
|
|
3.4
|
Development
Program Funding
|
11
|
3.5 |
Development
Program Reporting
|
ARTICLE IV |
LICENSE
|
11 |
|
4.1
|
Grant
to BioAlliance
|
11
|
|
4.2
|
Information
Transfer
|
12
|
|
4.3
|
Agreement
Not to Genericize
|
12
|
|
4.4
|
New
Indication Rights
|
13
|
ARTICLE V |
PAYMENTS
|
14 |
|
5.1
|
Upfront
Payment
|
14
|
|
5.2
|
Subsequent
Payments
|
14
|
|
5.3
|
Reduction
of Royalty
|
15
|
|
5.4
|
Payment
Procedures
|
16
|
ARTICLE VI |
MANUFACTURE
AND SUPPLY; COMMERCIALIZATION
|
16 |
|
6.1
|
Supplies
|
16
|
|
6.2
|
Commercialization
|
17
|
ARTICLE VII |
CONFIDENTIAL
AND TECHNICAL INFORMATION
|
17 |
|
7.1
|
Treatment
of Confidential Information
|
17
|
|
7.2
|
Release
from Restrictions
|
18
|
|
7.3
|
No
Implied Rights
|
18
|
|
7.4
|
Survival
of Confidentiality Obligations
|
19
|
|
7.5
|
Superseding
Prior Confidentiality Agreement
|
19
|
ARTICLE VIII |
PATENT
PROSECUTION AND ENFORCEMENT
|
19 |
|
8.1
|
Inventions
|
19
|
|
8.2
|
Patent
Prosecution and Maintenance
|
19
|
-i-
TABLE
OF CONTENTS
(continued)
Page
|
8.3
|
Infringement
|
19
|
ARTICLE IX |
ADVERSE
EXPERIENCES
|
22 |
|
9.1
|
Notification
|
22
|
|
9.2
|
Reporting
|
23
|
|
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 |
|
12.1
|
Term
|
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
|
|
12.6
|
Surviving
Rights
|
28
|
|
12.7
|
Accrued
Rights and Surviving Obligations
|
28
|
ARTICLE XIII |
MISCELLANEOUS
|
29 |
|
13.1
|
Entire
Agreement; Modification
|
29
|
|
13.2
|
Assignment
|
29
|
|
13.3
|
Performance
by Affiliates
|
29
|
|
13.4
|
Notices
|
29
|
|
13.5
|
Dispute
Resolution
|
30
|
|
13.6
|
Governing
Law
|
30
|
|
13.7
|
Force
Majeure
|
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 |
-ii-
TABLE
OF CONTENTS
(continued)
Page
EXHIBIT A
|
SUPPLY
AGREEMENT
|
EXHIBIT B
|
OPTION
TO LICENSE MALARIA PREVENTION
|
EXHIBIT
I
|
SPECIFICATIONS
|
-iii-
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 000 Xxxxxxx Xxxxx, Xxxxxx Xxxxx, XX 00000 (“Immtech”), and BioAlliance
Pharma SA, a French société anonyme having a principal place of business
at 00, xxxxxxxxx xx Xxxxxxx Martial Xxxxx, 0xx Xxxxx 00000 Xxxxx, Xxxxxx (“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.
1
“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.
2
“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.
3
“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.
4
“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.
5
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
6
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.
7
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.
8
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
9
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.
10
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
11
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
12
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:
|
(i)
|
Upon
[****];
|
|
(ii)
|
Upon
[****];
|
****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
13
Sales
Milestones:
|
(i)
|
Upon
first achieving [****] in annual sales of the Product in the Territory,
[****];
|
|
(ii)
|
Upon
first achieving [****] in annual sales of the Product in the Territory,
[****];
|
(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:
|
(i)
|
[****];
|
|
(ii)
|
[****];
|
|
(iii)
|
[****];
|
(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.
14
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.
15
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 may be offered thereto, including decisions
relating to customer allowances and credits.
16
ARTICLE
VII
CONFIDENTIAL
INFORMATION
7.1 Treatment
of Confidential Information. Each Party agrees to retain in
strict confidence and not to disclose, divulge or otherwise communicate to any
other person or entity any Confidential Information of the other Party, whether
received prior to or after the Effective Date, and further agrees not to use any
such Confidential Information for any purpose, except pursuant to, and in order
to carry out, the terms and objectives of this Agreement, except that each Party
may disclose Confidential Information of the other Party to the officers,
directors, employees, agents, accountants, attorneys, consultants,
subcontractors or other representatives of the receiving Party or its Affiliates
(the “Representatives”),
who, in each case, (a) need to know such Confidential Information for
purposes of the implementation and performance by the receiving Party of this
Agreement and (b) will use the Confidential Information only for such
limited purposes. Each Party hereby agrees to use at least the same
standard of care in complying with its confidentiality obligations hereunder as
it uses to protect its own Confidential Information of comparable sensitivity
(but no less than reasonable care) and to exercise reasonable precautions to
prevent and restrain the unauthorized disclosure of such Confidential
Information by any of its Representatives. Each Party warrants that
each of its Representatives to whom any Confidential Information is revealed
shall previously have been informed of the confidential nature of the
Confidential Information and shall have agreed to maintain its confidentiality
under terms no less restrictive than those set forth in this
Article VII. Without limiting the generality of any of the
foregoing, each Party agrees not to make any disclosure of Confidential
Information of the other Party that would be reasonably likely to impair such
other Party’s ability to obtain U.S. or foreign patents on any patentable
invention or discovery described or otherwise embodied in such Confidential
Information. The Confidential Information of each Party includes
information from Third Parties disclosed by one Party to this Agreement to the
other Party to this Agreement.
7.2 Release
from Restrictions.
(a) The
provisions of Section 7.1 shall not apply to any Confidential Information
disclosed hereunder to the extent that such Confidential Information is required
to be disclosed by the receiving Party to defend or prosecute litigation or to
comply with applicable laws or regulations, including filing an Information
Disclosure Statement with the U.S. Patent and Trademark Office or any other
patent office, or pursuant to an order of a court or regulatory agency, provided
that the receiving Party shall provide prior written notice of such disclosure
to the other Party and shall take actions as are reasonable and lawful to avoid
and/or minimize the degree of such disclosure, including assisting the other
Party in seeking a protective order or other means for preventing disclosure or
use. To the extent, if any, that a Party concludes in good faith that
it is required by applicable laws or regulations to file or register this
Agreement or a notification thereof with any governmental authority, including
the U.S. Securities and Exchange Commission, such Party may do so, and the other
Party shall cooperate in such filing or notification and shall execute all
documents reasonably required in connection therewith. In such
situation, the filing Party shall request confidential treatment of sensitive
provisions of the Agreement to the extent permitted by law. The
Parties shall promptly inform each other as to the
17
activities
or inquiries of any such governmental authority relating to this Agreement, and
shall cooperate to respond to any request for further information
therefrom.
(b) A
Party may disclose this Agreement to a Third Party in connection with or in
conjunction with a proposed merger, consolidation, sale of assets that include
those related to this Agreement, an assignment of this Agreement or loan
financing, raising of capital, or sale of securities, provided that the
disclosing Party obtains an agreement for confidential treatment thereof, except
in the case where after reasonable efforts such Party is unable to obtain such
agreement.
7.3 No
Implied Rights. Except as
otherwise set forth in this Agreement, nothing herein shall be construed as
giving either Party any right, title, interest in or ownership of the
Confidential Information of the other Party. For the purposes of this
Agreement, specific information disclosed as part of Confidential Information
shall not be deemed to be in the public domain or in the prior possession of the
receiving Party merely because it is embraced by more general information in the
public domain or by more general information in the prior possession of the
receiving Party.
7.4 Survival
of Confidentiality Obligations. The confidentiality
obligations of the Parties contained in this Article VII shall remain
binding on both Parties during the Term and for a period of five (5) years after
the termination of this Agreement, regardless of the cause of such
termination. The Parties acknowledge that any breach of this
Article VII will constitute irreparable harm, and that the non-breaching
Party shall be entitled to specific performance or injunctive relief to enforce
this Article VII in addition to whatever remedies such Party may otherwise
be entitled to at law or in equity.
7.5 Superseding
Prior Confidentiality Agreement. The provisions of this
Article VII shall supersede the Confidentiality Agreement between the
Parties dated October 26, 2006, with respect to the subject matter hereof, and
shall establish the sole obligations of confidentiality and nonuse of
Confidential Information received by a Party prior to or after the Effective
Date.
ARTICLE
VIII
PATENT
PROSECUTION AND ENFORCEMENT
8.1 Inventions. All
Inventions shall be the sole and exclusive property of
Immtech. BioAlliance, including BioAlliance’s Affiliates and
sublicensees, shall disclose in writing to Immtech any Invention made by one or
more employees or contractors of BioAlliance including BioAlliance’s Affiliates
and sublicensees, within thirty (30) days of BioAlliance’s written receipt of a
disclosure for such Invention. All subject inventors of such
Inventions shall cooperate to the extent necessary to assist Immtech in the
preparation, filing and prosecution of any patent, copyright, or other
applications related to any Invention, including the filing of all papers
necessary to perfect Immtech’s ownership of said Invention. All
resulting patent applications and patents that claims any Invention will
immediately, and without further action of the Parties, (i) be deemed to be
Immtech Patents and listed in Schedule 1.1 and (ii)
be exclusively licensed to BioAlliance in accordance with the terms of this
Agreement; provided, however, that in no event
18
will
BioAlliance owe any additional Royalty with respect to any Invention made by one
or more employees or contractors of BioAlliance or any Patents that claim such
Invention.
8.2 Patent
Prosecution and Maintenance. All Patents shall be controlled
and maintained by Immtech, at Immtech’s expense.
8.3 Infringement.
(a) BioAlliance
and Immtech shall inform each other promptly in writing of any alleged or
suspected infringement by a Third Party of any of Immtech Technology or Program
Developments related to the Product, and of any available evidence
thereof.
(b) Subject
to Sections 8.3(c), 8.3(d), and 8.3(e), BioAlliance may, at its sole option and
expense, prosecute the infringement of any Immtech Technology or Program
Developments related to the Product in the Territory.
(c) In
the event that a Third Party infringes or constructively infringes Immtech
Technology or Program Developments relating to the Product in the Territory (a
“Product Infringement”),
then the Parties shall discuss whether or not to institute an infringement
action with respect to such Product Infringement. Subject to Section
8.3(d), BioAlliance shall have the right to institute such a suit and control
the prosecution, settlement or compromise thereof. At Immtech’s
option, Immtech may request to be joined as a Party in such Product Infringement
action and BioAlliance shall execute all papers and perform such acts as may be
reasonably required in respect thereof. Immtech shall, at the request
and expense of BioAlliance, be joined as a party in such Product Infringement
action, provide reasonable cooperation and, to the extent possible, Immtech
shall have its employees testify when requested and make available relevant
records, papers, information, samples, specimens and the like regardless of
whether Immtech has joined such suit. BioAlliance shall bear all the
costs of such a suit. If BioAlliance initiates litigation of such
Product Infringement pursuant to this Section 8.3(c), Immtech shall not make any
admission to invalidity or unenforceability in respect thereof without the prior
consent of BioAlliance.
(d) If
a Third Party infringes or constructively infringes Immtech Technology or
Program Developments relating to indications for pafuramidine that are not
within the scope of the Product, Immtech shall have the right to institute a
suit and control the prosecution, settlement or compromise
thereof. Immtech shall bear all the costs of such a
suit. At BioAlliance’s option, BioAlliance may request to be joined
as a Party in such litigation, provided, however, that
BioAlliance’s joining of such action shall not affect Immtech’s control
thereof. BioAlliance shall, at the request of Immtech, provide
reasonable cooperation and, to the extent possible, BioAlliance shall have its
employees testify when requested and make available relevant records, papers,
information, samples, specimens and the like regardless of whether BioAlliance
has joined such suit. BioAlliance shall have the right to select, at
BioAlliance’s expense, separate counsel to participate in such suits on
BioAlliance’s behalf. If Immtech fails to bring any such suit
relating to infringement of Immtech Technology or Program Developments relating
to non-PCP indications for pafuramidine in the Territory within (a) ninety
(90) days following the notice of alleged infringement or (b) ten (10) days
before the time limit, if any, set forth in the appropriate laws and regulations
for the filing of such suit, whichever
19
comes
first, and such failure may adversely affect the rights granted to BioAlliance
hereunder, BioAlliance shall have the right to bring and control any such suit
at its own expense and by counsel of its own choice, and Immtech shall have the
right, at its own expense, to be represented in any such suit by counsel of its
own choice.
(e) Within
thirty (30) days of being notified of alleged or suspected Product Infringement
(but in any event no later than twenty (25) days before the time limit, if any,
set forth in the appropriate laws and regulations for the filing of such suit),
BioAlliance shall either (i) institute a suit for Product Infringement pursuant
to Section 8.3(c) or (ii) notify Immtech that (A) it has a legally relevant
belief that it is in the Parties’ interest to not institute such suit within
such time and (B) it intends to institute such a suit in the
future. If Immtech agrees with BioAlliance’s assessment and intent to
bring such suit in the future, BioAlliance shall have the right to institute
such suit in accordance with Section 8.3(c). If Immtech provides
BioAlliance with written notice within five (5) days of receipt of the notice
from BioAlliance in accordance with the foregoing clause (ii) that it does not
reasonably agree with such assessment, then BioAlliance may institute such suit
within ten (10) days of receipt of such notice from Immtech and such suit shall
be governed by Section 8.3(c); provided, however, that if
BioAlliance determines not to institute such suit within ten (10) days of
receipt of such notice from Immtech, then Immtech may, at its option and
expense, institute and litigate such Product Infringement. In any
such infringement suit Immtech may institute to enforce Immtech Technology or
Program Developments, BioAlliance shall provide reasonable cooperation and, to
the extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples, specimens and the
like. If Immtech initiates litigation of such Product Infringement
pursuant to this Section 8.3(e), BioAlliance shall not make any admission to
invalidity or unenforceability in respect thereof without the prior consent of
Immtech. BioAlliance may join Immtech as a Party, and Immtech shall
execute all papers and perform such acts as may be reasonably required, at the
expense of BioAlliance.
(f) Neither
Party shall have the right to settle any patent infringement suit under this
Section 8.3 in a manner that diminishes the rights or interests of the
other Party without the prior written consent of the other party, which shall
not be unreasonably withheld. Any royalties, payments, damages,
expenses, fees or other awards (collectively “Damages”), received by
BioAlliance and/or Immtech as a result of an infringement suit contemplated by
this Section 8.3, whether through judgment or settlement, shall first be
used to reimburse each Party for its expenses associated with such infringement
suit. Thereafter, (i) [****] , (ii) if Immtech shall have been in
control of such suit pursuant to Section 8.3(e), Immtech shall be entitled to
[****] of the remainder, unless BioAlliance has chosen, after the
initiation of such suit, to join as a Party to such suit, in which case any
remainder shall be shared by the Parties [****] and (iii) if Immtech shall have
been in control of such suit pursuant to Section 8.3(d), any remainder shall be
shared according
****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
20
to each
Party’s harm as indicated by the ratio of sales of the Product as compared to
the sales of the products of the other Party or Parties. The
appropriate share of the Damages shall be paid to the other Party (or Parties),
as applicable, as soon as practicable following receipt of the
Damages.
(g) In
the event that a declaratory judgment action alleging invalidity or
non-infringement of any Immtech Technology or Program Developments related to
the Product shall be brought by a Third Party in the Territory against
BioAlliance or against Immtech and BioAlliance, BioAlliance, at its option,
shall have the right, within thirty (30) days after commencement of such
action (but in any event no later than ten (10) days before the time limit, if
any, set forth in the appropriate laws and regulations for responding to such
action), as applicable, to take over the defense of the action at its own
expense. Immtech will have the option of joining in such suit. In the
event the declaratory judgment action states a count specifically against
Immtech, Immtech, at its option, shall have the right to direct and control
litigation related to such count. In the event that BioAlliance does
not so elect to take over the defense of the action at its own expense, Immtech
shall be free to proceed and solely control such defense. Neither
Party shall have the right to settle any action under this Section 8.3(g)
in a manner that diminishes the rights or interests of the other Party without
the prior written consent of the other party, which shall not be unreasonably
withheld. To the extent that any Damages become payable to any Third
Party as a result of such action, whether through judgment or settlement, the
Parties shall bear such Damages according to each Party’s share of the liability
in causing such Damages, and shall contribute such share as promptly as
practicable. Any Damages received by Immtech and/or BioAlliance as a
result of such action, whether through judgment or settlement, shall first be
used to reimburse each Party for its expenses associated with such infringement
suit not otherwise reimbursed, and then any remainder shall belong to the Party
that brought and controlled such action, subject to payment to Immtech of the
then-applicable Royalty provided in Section 5.2(c) with respect to any such
remainder belonging to BioAlliance, which shall be counted as part of the Net
Annual Sales.
(h) In
the event that a Third Party institutes any suit against BioAlliance and/or
Immtech for patent infringement related solely to the Product, the Party sued
shall promptly notify the other Party in writing. Immtech shall have
the right to control any defense of any such claim involving alleged
infringement of Third Party rights by Immtech’s activities under this Agreement
at Immtech’s expense and using counsel of Immtech’s
choice. BioAlliance shall have the right, at its own expense, to be
represented in any such action by counsel of its own
choice. BioAlliance shall have the right to control any defense of
any such claim involving alleged infringement of Third Party rights by
BioAlliance’s activities under this Agreement at BioAlliance’s expense and using
counsel of BioAlliance’s choice. Immtech shall have the right, at its
own expense, to be represented in any such action by counsel of its own
choice. Each Party shall, at the other's request, provide to the
other Party reasonable assistance and cooperation with respect to any such
suit. Neither Party shall have the right to settle any action under
this Section 8.3(h) in a manner that diminishes the rights or interests of
the other Party without the prior written consent of the other party, which
shall not be unreasonably withheld. To the extent that any Damages
become payable to any Third Party whether as a result of judgment
21
or
through settlement of such suit, [****].
(i) If
either Party becomes aware of a patent or patent application that, when issued,
might provide a basis for a Third Party’s argument that its valid rights are
being infringed by the manufacture, use or sale of the Product hereunder, then
such Party shall promptly inform the other Party of such patent or patent
application, and the Parties shall cooperate with each other so that each Party
can determine whether valid rights of a Third Party are likely to be infringed
by the manufacture, use or sale of the Product hereunder.
(j) If
either Parties believes that a license from a Third Party is necessary to avoid
infringement of patents of the Third Party, the Steering Committee shall:
1) determine whether or not to seek such a license, 2) appoint a
negotiator to negotiate the terms of such a license, 3) determine whether
or not to enter into such a license as negotiated by the negotiator, and
4) determine how the expenses of such a license shall be borne by the
Parties. If the Steering Committee cannot agree with regard to any
responsibility set forth in the preceding sentence, such issue shall be
determined accordance with Section 13.5.
ARTICLE
IX
ADVERSE
EXPERIENCES
9.1 Notification. The
Parties shall, during the Term, keep each other promptly and fully informed of
all of their pharmacological, toxicological and clinical trials, investigations
and findings relating to the Product. Adverse Drug Events (ADEs) and
Individual Case Safety Reports (ICSRs) may originate from any source, such as
healthcare professionals, regulatory authorities, literature, consumers,
patients, lawyers, clinical studies (including post-marketing surveillance and
epidemiological studies), non-interventional studies, patient support programs,
registries, internet, preclinical studies (e.g. toxicological studies), etc.
Each Party shall use every effort to ensure that all ADE/ICSR or pregnancy
reports meet the minimum regulatory criteria for a valid safety
report. BioAlliance shall forward all ADEs/ISCRs received for the
Product to Immtech within five (5) calendar days of receipt, except in the case
of expedited reports, which BioAlliance will forward to Immtech within two (2)
calendars days of receipt. Format for event reporting from BioAlliance to
Immtech shall be a copy or facsimile of the source documentation. All event
information will be transmitted via fax or secure email. The regulatory
reporting time clock for submitting ADE/ICSR and pregnancy reports to Immtech is
considered to start on the date when any individual within BioAlliance is first
notified of a case report that fulfills the minimum criteria for a case
report.
9.2 Reporting. With
regards to the Product, BioAlliance is responsible for preparing and submitting
aggregate and individual case regulatory safety reports within the Territory as
required by regulatory authorities, and shall submit a copy of all such reports
to Immtech. Immtech shall hold and maintain reports of all adverse events and
adverse drug reactions, both serious and non-serious, and reports of pregnancies
in a database for the Product for preparing and submitting aggregate and single
case reports to the FDA for the Product.
****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
22
9.3 Literature
Reports. Immtech shall be responsible for screening published
scientific and medical literature for ADEs/ICSRs. BioAlliance shall be
responsible for notifying Immtech of any relevant ADEs/ICSR that may come to its
attention in BioAlliance Territory via local scientific or medical journals, or
unpublished scientific or conference papers. A copy of the article
shall be provided at the same time as the report.
ARTICLE
X
REPRESENTATIONS
AND WARRANTIES
10.1 Representations
and Warranties.
(a) Mutual
Representations and Warranties. Each Party hereby represents
and warrants to the other Party that, as of the Effective Date:
(i) it
has full corporate power and authority under the laws of the state and/or
country of its incorporation to enter into this Agreement and to carry out the
provisions hereunder;
(ii) this
Agreement is a legal and valid obligation binding upon it and is enforceable in
accordance with its terms;
(iii) the
execution, delivery and performance of this Agreement by it does not materially
conflict with any agreement, oral or written, to which it is a Party or by which
it may be bound, nor violate any law or regulation of any court, governmental
body or administrative or other agency having authority over it;
and
(iv) to
the knowledge of such Party as of the Effective Date (without undertaking any
special investigation), there is no claim, action, suit, proceeding or
investigation pending or threatened against or affecting the transaction
contemplated hereby.
(b) Representations,
Warranties and Covenants of Immtech. Except as set forth on
Schedule 10.1(b), Immtech represents, warrants and covenants to BioAlliance as
follows:
(i) As
of the Effective Date, neither Immtech nor any of its Affiliates has received
any written notice from any person, or has knowledge, of any actual or
threatened claim or assertion that (i) Immtech’s or its Affiliates’ development
of the Product (including any components of the Product), (ii) any of Immtech’s
or its Affiliates’ activities in the development or acquisition of the Immtech
Technology, or (iii) the manufacture, use, offer for sale, sale or import of the
Product under the Immtech Technology, infringes (or would infringe) or
misappropriates any intellectual property rights of any Third Party (including
the claims, if issued, of pending patent applications); and Immtech will inform
BioAlliance if Immtech receives any such notice during the Term.
23
(ii) As
of the Effective Date, (i) there is no action or proceeding pending or, to
Immtech’s knowledge, threatened, with respect to the Product or the Immtech
Technology, including with respect to the conduct of any clinical trials,
manufacturing activities or other activities involving the Product, or that
questions the validity of this Agreement or any action taken by Immtech in
connection with the effectiveness of this Agreement, and (ii) there are no
unsatisfied judgments or outstanding orders, injunctions, decrees, stipulations
or awards (whether rendered by a court, an administrative agency or by an
arbitrator) against Immtech with respect to the Product, or the Immtech
Technology, including with respect to the conduct of any clinical trials,
manufacturing activities or other activities involving the Product, in either
case that is reasonably likely to have a material adverse effect on the rights
granted to BioAlliance hereunder, and Immtech will inform BioAlliance if any of
the forgoing occurs during the Term;
(iii) As
of the Effective Date, (i) to the knowledge of Immtech, the use of the
Immtech Technology by BioAlliance, Immtech and their respective Affiliates and
any permitted contractors, as contemplated by this Agreement, including in the
development of the Product (including any components of the Product), and in the
manufacture, use, offer for sale, sale or import of the Product including any
components of the Product) does not infringe any claim of any issued patent of
any Third Party, and (ii) Immtech has no knowledge of any pending patent
application, which if issued, would similarly be infringed by the use of the
Immtech Technology as contemplated by this Agreement;
(iv) To
the knowledge of Immtech, Immtech has not and will not violate the trade secrets
or misappropriate the confidential Information or intellectual property of any
third party in connection with the development or manufacturing of the Product
or the development or acquisition of the Immtech Technology;
(v)
Immtech has the right to grant the licenses
granted to BioAlliance herein, and Immtech owns all right, title and interest in
and to, or has a license, sublicense or otherwise permission to use and license,
all of the Immtech Technology;
(vi) Immtech
has not as of the Effective Date, and will not during the Term, grant or place
any liens, security interests and/or other encumbrances in or on the Immtech
Technology that would conflict or interfere (including as due to a default or
breach of a third party obligation of Immtech) with the licenses granted to
BioAlliance herein;
(vii) Schedule 1.1
sets forth a true and complete list of all Patents Owned and Controlled by
Immtech that claim the Product or the manufacture or use of the Product for the
treatment of PCP, human African trypanosomiasis or malaria in the Territory as
of the Effective Date;
(viii) The
Immtech Patents and Immtech Know-How licensed to BioAlliance hereunder
constitute all intellectual property Owned and Controlled by Immtech that is
necessary or useful to develop, use or commercialize the Product for the
treatment of PCP in the Territory;
(ix) As
of the Effective Date, none of the Immtech Patents is currently involved in any
interference, reissue, reexamination, or opposition proceeding, and
neither
24
Immtech
nor any of its Affiliates has received any written notice from any person, or
has knowledge, of such actual or threatened proceeding, and Immtech will inform
BioAlliance if any of the forgoing occurs during the Term;
(x) All
current, former and future employees and consultants of Immtech and its
Affiliates who are, have been or will be substantively involved in the design,
review, evaluation or development of Immtech Technology or the Product have
executed (or with respect to future employees or consults will execute) written
contracts or are otherwise obligated to protect the Confidential Information of
Immtech, and to vest in Immtech or its Affiliates exclusive ownership of the
Immtech Technology that they invent or develop; and
(xi) To
Immtech’s knowledge, as of the Effective Date, there is no unauthorized use,
infringement or misappropriation of any of the Immtech Technology by any Third
Party, including any current or former employee or consultant of Immtech and its
Affiliates, and Immtech will inform BioAlliance if any of the forgoing occurs
during the Term.
(c) No
Debarment. Immtech has not
employed, contracted with or retained, and neither Party shall employ, contract
with or retain, any person directly or indirectly to perform any Product Studies
or to perform work under the Supply Agreement if such a person (i) is under
investigation by the FDA for debarment or is presently debarred by the FDA
pursuant to 21 U.S.C. § 335a or its successor provisions, or (ii) has a
disqualification hearing pending or has been disqualified by the FDA pursuant to
21 C.F.R. § 312.70 or its successor provisions; and if, during the Term, either
Party or any person employed or retained by it to perform Product Studies
(x) comes under investigation by the FDA for a debarment action or
disqualification, (y) is debarred or disqualified, or (z) engages in
any conduct or activity that could lead to any of the above-mentioned
disqualification or debarment actions, such Party shall immediately notify the
other Party of same.
10.2 Disclaimer. Except as
expressly set forth herein, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, AND IN ALL CASES
WITH RESPECT THERETO. Without limiting the generality of the
foregoing, each party expressly does not warrant (a) the success of the
Product or (b) the safety or usefulness for any purpose of the technology
provided hereunder.
ARTICLE
XI
INDEMNIFICATION
AND LIMITATION ON LIABILITY
11.1 Indemnification
by Immtech. Subject to Section 11.3, Immtech shall
defend, indemnify and hold harmless each of BioAlliance and its Affiliates and
its and their respective directors, officers and employees and the successors
and assigns of any of the foregoing (each a “BioAlliance Indemnitee”) from
and against any and all liabilities, damages, settlements, penalties, fines,
costs or expenses (including, without limitation, reasonable attorneys’ fees and
other expenses of litigation) (collectively, “Liabilities”) arising,
directly or indirectly, out of or
25
in
connection with Third Party claims, suits, actions, demands or judgments to the
extent relating to or based on Immtech’s gross negligence, willful misconduct,
or breach of its representations, warranties or obligations under this
Agreement, except, in each case, to the extent BioAlliance has an obligation to
indemnify Immtech under Section 11.2.
11.2 Indemnification
by BioAlliance. Subject to Section 11.3, BioAlliance
shall defend, indemnify and hold harmless each of Immtech and its Affiliates and
its and their respective directors, officers and employees and the successors
and assigns of any of the foregoing (each an “Immtech Indemnitee”) from and
against any and all Liabilities arising, directly or indirectly, out of or in
connection with Third Party claims, suits, actions, demands or judgments to the
extent relating to or based upon BioAlliance’s gross negligence, willful
misconduct, or breach of its representations, warranties or obligations under
this Agreement, except, in each case, to the extent Immtech has an obligation to
indemnify BioAlliance under Section 11.1.
11.3 Notice
and Procedures. If an Immtech Indemnitee or a BioAlliance
Indemnitee (the “Indemnitee”) intends to claim
indemnification under this Article XI, it shall promptly notify the other
Party (the “Indemnitor”)
in writing of any such alleged Liabilities. The Indemnitor shall have
the right to control the defense thereof with counsel of its choice, provided
that such counsel is reasonably acceptable to Indemnitee; and, provided, further, that any
Indemnitee shall have the right to retain its own counsel at its own expense,
for any reason, including if representation of any Indemnitee by the counsel
retained by the Indemnitor would be inappropriate due to actual or potential
differing interests between such Indemnitee and any other Party reasonably
represented by such counsel in such proceeding. The Indemnitee, its
employees and agents, shall reasonably cooperate with the Indemnitor and its
legal representatives in the investigation of any Liabilities covered by this
Article XI. The obligations of this Section 11.3 shall not
apply to amounts paid in settlement of any claim, demand, action or other
proceeding if such settlement is effected without the consent of the Indemnitor,
which consent shall not be withheld or delayed unreasonably. The
failure to deliver written notice to the Indemnitor within a reasonable time
after the commencement of any such action, if prejudicial to its ability to
defend such action, shall relieve the Indemnitor of any obligation to the
Indemnitee under this Section 11.3. It is understood that only
Immtech or BioAlliance may claim indemnity under this Article XI (on its
own behalf or on behalf of its Indemnitees), and other Indemnitees may not
directly claim indemnity hereunder.
11.4 Limitation
of Liability. EXCEPT FOR
LIABILITY FOR BREACH OF ARTICLE VII, NEITHER PARTY SHALL BE ENTITLED TO
RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER;
provided however, that
this Section 11.4 shall not be construed to limit either party’s
indemnification obligations under Article XI.
26
ARTICLE
XII
TERM
AND TERMINATION
12.1 Term. The
term of this Agreement shall commence on the Effective Date and shall expire,
unless earlier terminated as provided under Sections 12.2, 12.3 or 12.4, upon
the expiration of the last to expire Royalty Period (the “Term”).
12.2 Termination
for Breach. If
either Party commits a breach or default in the performance or observance of any
of its material obligations under this Agreement, and such breach or default
continues for a period of ninety (90) days after delivery by the other Party of
written notice reasonably detailing such breach or default, then the
non-breaching or non-defaulting Party shall have the right to terminate this
Agreement, with immediate effect, by giving written notice to the breaching or
defaulting Party; provided, however that if such breach (other than failure to
make any payment when due) is capable of being cured but cannot be cured within
such ninety (90) day period and the breaching Party initiates actions to cure
such breach within such period and thereafter diligently pursues such actions,
the breaching Party shall have such additional period as is reasonable in the
circumstances to cure such breach not to exceed an additional ninety (90) day
period, provided, however, that in the
event of a good faith dispute with respect to the existence of a material
breach, the cure period shall be tolled until such time as the dispute is
resolved pursuant to Section 13.5 hereof. The Parties shall
retain all rights and remedies (at law or in equity) in respect of any breach
hereof.
12.3 Termination
for Bankruptcy.
This Agreement shall automatically terminate upon the initiation of any
proceeding in bankruptcy, reorganization, dissolution, liquidation or
arrangement for the appointment of a receiver or trustee to take possession of
the assets of either Party or similar proceeding under the law for release of
creditors by or against a Party hereto or if a Party hereto shall make a general
assignment for the benefit of its creditors.
12.4 Termination
by BioAlliance.
(a) BioAlliance
may terminate this Agreement upon thirty (30) days prior written notice to
Immtech in the event that the results of the Phase III Clinical Trial of
the Product do not demonstrate that tolerance of the Product is superior to the
comparator drug used in such trial.
(b) BioAlliance
reserves the right to terminate this Agreement in its entirety at any time
effective upon ninety (90) days prior written notice to Immtech in the event
BioAlliance reasonably believes issues of safety or efficacy (which arise or
become more significant following the Effective Date) are reasonably likely to
prevent or materially delay regulatory approval of the Product in the
Territory. Prior to any notice of termination under this
Section 12.4, the Parties will discuss such issues for a period of up to
thirty (30) days, which discussions shall include a face-to-face meeting of the
Chief Executive Officer of Immtech and the Chief Executive Officer of
BioAlliance if requested by either Party. BioAlliance shall have no
obligation to develop, promote or sell the Product during either such thirty
(30)-day discussion period or ninety (90)-day notice period, if BioAlliance’s
intent to terminate is based upon safety issues. BioAlliance shall
have no obligation to pay to Immtech any milestone
27
payment
under Section 5.2(a) with respect to a milestone event achieved during such
discussion period or notice period; provided that
BioAlliance actually terminates the Agreement effective at the end of the ninety
(90)-day notice period.
12.5 Effect of
Termination.
(a) Upon
the termination of the Agreement by Immtech in accordance with Section 12.2, (i)
all rights and obligations of the Parties under this Agreement, including all
rights and licenses granted to BioAlliance pursuant to this Agreement, shall
automatically and immediately terminate, except as provided in this
Section 12.5, and BioAlliance immediately shall discontinue
Commercialization of Product and all use of the Immtech Technology; and (ii)
BioAlliance shall pay within thirty (30) days after such termination all accrued
and unpaid amounts due to Immtech in accordance with the terms of this Agreement
(including, if such termination shall occur following the grant of Regulatory
Approval, any Sales Milestone payments that have been achieved but not yet paid
by BioAlliance, any unpaid Royalty payments and Transfer Price for Product
delivered to BioAlliance. Notwithstanding the foregoing, BioAlliance may
continue to sell inventory of Product then on hand for an additional period not
to exceed six (6) months, and the sale of such Product shall be subject to the
terms and conditions of this Agreement.
(b) Upon
the termination or expiration of this Agreement each Party shall return to the
other Party, or destroy, at the other Party's request, all Confidential
Information of the other Party.
12.6 Surviving
Rights. The obligations and rights of the Parties under
Sections 5.2(d) (last sentence), 5.4(c), 8.1, 10.2, 12.5 and 12.6, and
Articles I, VII, IX, XI and XIII shall survive termination or expiration of
this Agreement.
12.7 Accrued
Rights and Surviving Obligations. The termination or
expiration of this Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit of either Party prior to such
termination or expiration, including any damages arising from any breach
hereunder. Such termination or expiration shall not relieve either
Party from obligations which are expressly indicated to survive termination or
expiration of this Agreement.
ARTICLE
XIII
MISCELLANEOUS
13.1 Entire
Agreement; Modification. This Agreement, together with the
schedules and exhibits attached hereto and incorporated herein, constitutes the
entire understanding and agreement of the Parties with respect to the subject
matter hereof and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether verbal or written,
between the Parties with respect to the subject matter hereof. No
modification or amendment of any provision of this Agreement shall be valid or
effective unless made in writing and signed by a duly authorized officer of each
Party.
28
13.2 Assignment. This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their permitted successors and assigns; provided, however, that neither
Party shall assign any of its rights and obligations hereunder without the prior
written consent of the other Party except to an Affiliate or as incident to the
transfer or sale of all or substantially all of the business of such Party
relating to the Product to a Third Party, whether by merger, consolidation,
reorganization or acquisition of stock or assets or otherwise. Any
assignment or attempted assignment by either Party in violation of the terms of
this Section 13.2 shall be null and void.
13.3 Performance
by Affiliates. The Parties recognize that each Party may
perform some or all of its obligations under this Agreement through one (1)
or more of its Affiliates; provided, however, that each
Party shall remain responsible for and shall guarantee such performance by its
Affiliates and shall cause its Affiliates to comply with the provisions of this
Agreement in connection with such performance. Each Party hereby
expressly waives any requirement that the other Party exhaust any right, power
or remedy, or proceed against an Affiliate, for any obligation or performance
hereunder prior to proceeding directly against such Party.
13.4 Notices. Any
notices given under this Agreement shall be in writing, addressed to the Parties
at the following addresses, and delivered by person, by facsimile, or by FedEx
or other reputable international courier service. Any such notice
shall be deemed to have been given as of the day of personal delivery,
one (1) day after the date sent by facsimile service or on the day of
attempted or successful delivery to the other Party confirmed by the courier
service.
In
the case of Immtech:
|
Xxx
Xxxxx Xxx Xxxxxx
Xxx
Xxxx, XX 00000
Attn:
Xxxx X. Xxxxxx, CEO
Fax: (000)
000-0000
|
with
a copy to:
|
Paul,
Hastings, Xxxxxxxx & Xxxxxx LLP
00
X. 00xx Xxxxxx
Xxx
Xxxx, XX 00000
Attn:
Xxxxx Xxxxxx, Esq.
Fax:
000-000-0000
|
In
the case of BioAlliance:
|
BioAlliance
Pharma SA
00,
xxxxxxxxx xx Xxxxxxx Martial Xxxxx, 0xx Xxxxx
00000
Xxxxx, Xxxxx
Attention:
Chief Executive Officer
Telephone: x00
000 00 00 00
Facsimile: x00
000 00 00 00
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with
a copy to:
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BioAlliance
Pharma SA
00,
xxxxxxxxx xx Xxxxxxx Martial Xxxxx, 0xx Xxxxx
00000
Xxxxx, Xxxxxx
Attention:
General Counsel
|
29
|
Telephone:
x00 000 00 00 00
Facsimile:
x00 000 00 00 00
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Either
Party may change its address for communications by a notice to the other Party
in accordance with this Section 13.4.
13.5 Dispute
Resolution. The Parties recognize that a bona fide dispute as to
certain matters may, from time to time, arise during the Term that relates to a
Party’s rights and/or obligations hereunder. In the event of the
occurrence of such a dispute, either Party may, by written notice to the other
Party, have such dispute referred to the respective officers designated below,
or their successors, for attempted resolution by good faith negotiation within
thirty (30) days after such notice is received. Such designated
officers are as follows:
For
Immtech: Xxxx X. Xxxxxx, CEO, Xxxx Xxxxx, CFO
For
BioAlliance: Xxxxxxxxx Xxxxxxxxxx, M.D., CEO; Xxxxxxx Xxxxxxx,
CFO
In the
event that the designated officers are not able to resolve the dispute within
such thirty (30)-day period, or such other period of time as the Parties
may mutually agree to in writing, each Parties shall have the right to pursue
any and all remedies available at law or in equity.
13.6 Governing
Law. This Agreement shall be governed by, and construed
in accordance with, the laws of the State of New York without reference to any
rules of conflicts of laws. The Parties hereby consent to the
exclusive jurisdiction of the Federal and State courts of New York and hereby
waive any objection to venue or forum laid therein. The Parties
hereby agree that service of process by certified mail, return receipt
requested, shall constitute personal service for all purposes
hereof.
13.7 Force
Majeure. A Party hereto shall be excused and shall not be held
liable or responsible for failure or delay in fulfilling or performing any of
its obligations under this Agreement if such failure or delay is
caused by acts of God, acts of the public enemy, fire, explosion, flood,
drought, war, terrorists, riot, unavailability of raw material, sabotage,
embargo, strikes or other labor disputes, intervention of governmental
authority, or by any other event or circumstance of like or different character
to the foregoing beyond the reasonable control and without the fault or
negligence of the affected Party (a “Force Majeure
Event”). Such excuse shall continue as long as the Force
Majeure Event continues. Upon cessation of such Force Majeure Event,
such Party shall promptly resume performance hereunder. Each Party
agrees to give the other Party prompt written notice of the occurrence of any
Force Majeure Event, the nature thereof and the extent to which the affected
Party will be unable to perform its obligations hereunder. Each Party
further agrees to use reasonable efforts to correct or otherwise address the
Force Majeure Event as soon as practicable and to give the other Party prompt
written notice when it is again fully able to perform such
obligations.
13.8 Independent
Contractors. In making and performing this Agreement,
BioAlliance and Immtech act and shall act at all times as independent
contractors and nothing contained in this Agreement shall be construed or
implied to create an agency, partnership or
30
employer
and employee relationship between Immtech and BioAlliance. At no time
shall one Party make commitments or incur any charges or expenses for or in the
name of the other Party.
13.9 Severability;
Waiver. If one (1) or more of the provisions of this
Agreement are held by any court or authority having jurisdiction over this
Agreement or either of the Parties to be invalid, illegal or unenforceable, such
provision or provisions shall be validly reformed to as nearly as possible
approximate the intent of the Parties and, if unreformable, shall be divisible
and deleted in such jurisdiction; elsewhere, this Agreement shall not be
affected so long as the Parties are still able to realize the principal benefits
bargained for in this Agreement. The failure of a Party to insist
upon strict performance of any provision of this Agreement or to exercise any
right arising out of this Agreement shall neither impair that provision or right
nor constitute a waiver of that provision or right, in whole or in part, in that
instance or in any other instance. Any waiver by a Party of a
particular provision or right shall be in writing, shall be as to a particular
matter and, if applicable, for a particular period of time and shall be signed
by such Parties.
13.10
Further
Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this
Agreement.
13.11
Cumulative
Rights. The rights, powers and remedies hereunder shall be in
addition to, and not in limitation of, all rights, powers and remedies provided
at law or in equity, or under any other agreement between the
Parties. All of such rights, powers and remedies shall be cumulative,
and may be exercised successively or cumulatively.
13.12
Counterparts. This
Agreement may be executed in two (2) or more counterparts, each of which
shall be an original and all of which shall constitute together the same
document. Counterparts may be signed and delivered by facsimile, each
of which shall be binding when sent.
[Signature
Page Follows]
31
IN
WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by
their duly authorized representatives as of the day and year first above
written.
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By:
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/s/ Xxxx X. Xxxxxx | ||
Name:
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Xxxx X. Xxxxxx | |||
Title:
|
Chairman and Chief Executive Officer |
BIOALLIANCE PHARMA SA | ||||
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By:
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/s/ Xxxxxxxxx Xxxxxxxxxxx | ||
Name:
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Xxxxxxxxx Xxxxxxxxxxx | |||
Title:
|
Chairman and CEO |
EXHIBIT
A
SUPPLY
AGREEMENT
Between
AND
BIOALLIANCE
PHARMA
ARTICLE
I - DEFINITIONS
Section
1 Definitions. All capitalized terms
used in this Supply Agreement shall have the meaning ascribed to them in the
License Agreement to which this Supply Agreement is attached as an
exhibit. Capitalized terms used in this Supply Agreement that are not
defined in the License Agreement, whether used in the singular or plural, shall
have the following meanings:
1.1 "Administrative
Costs" means all costs related to conducting a recall, withdrawal or correction
in accordance with Applicable Laws.
1.2 "Applicable
Laws" means all laws, ordinances, rules and regulations within the Territory
applicable to the Manufacturing and Packaging of the Product or any aspect
thereof and the obligations of Immtech or BioAlliance, as the context requires
under this Agreement, including, without limitation, (i) all applicable federal,
state and local laws and regulations of each Territory; (ii) the U.S. Federal
Food, Drug and Cosmetic Act, and (iii) the cGMPs.
1.3 "Batch"
means defined quantity of finished Product which has been Manufactured and
Packaged for BioAlliance in accordance with the Specifications.
1.4 "Calendar
Quarter" means a period of three (3) consecutive months commencing on January 1,
April 1, July 1 or October 1 of any calendar year.
1.5 “COA”
means Certificate of Analysis.
1.6 "Commencement
Date" means the first date upon which a European regulatory authority provides
Marketing Approval of the Product.
1.7 "Contract
Year" means each consecutive twelve (12) month period beginning on the
Commencement Date.
1.8 "Defective
Product" means Product that is not releasable due to Nonconformity.
1.9 "Delivery
Date" shall mean the date on which Immtech shall tender the relevant Batch(es)
to BioAlliance. Each Delivery Date shall be specified by BioAlliance on the
relevant Purchase Order and confirmed by Immtech as set forth in Section
3.4.
1.10 "Firm
Commitment" shall mean a binding commitment in writing made by BioAlliance to
purchase Product in accordance with section 3.1.
1.11 "Manufacture"
means all operations of receipt of materials, production, packaging, labeling,
quality control, release of Product.
1.12 “Manufacture
Date” means the date that pafuramidine first comes into contact with another
ingredient during the manufacturing process of Product.
1.13 “Manufacturing
Release Record(s)” (“MRR”) means a) all completed production/Batch records; b)
all quality control test/request forms (result worksheets) and associated
summary data; c) dynamic monitoring performed during processing; d) any
alert/action notifications generated during processing; e) any planned or
unplanned deviations associated with the Product; f) any out of Specification
result investigations associated with the Product; g) the COA for the Batch
comparing testing to Specifications; h) the appropriate disposition notification
for the Batch.
1.14 “Nonconformity”
means a deficiency in characteristic, documentation or procedure, which renders
the Product not in conformity with the Specifications or the other warranties
set forth in Section 6.1.
1.15 “Packaging”
means Primary Packaging and Secondary Packaging.
1.16 “Primary
Packag(ing)” means material intended to contain and protect Product during
handling, storage and transport.
1.17 "Purchase
Order" shall have the meaning set forth in Section 3.2.
1.18 "Rolling
Forecast" shall have the meaning set forth in Section 3.1.
1.19 “Secondary
Packag(ing)” means packaging material that is not Primary
Packaging.
1.20 “Specification”
means the specifications for the regulatory, manufacturing, quality control and
quality assurance procedures, processes, practices, standards, instructions and
any other attributes that the parties agree upon, or that are otherwise
required, with respect to the Product which will be attached hereto as Exhibit I
in draft form until the Commencement Date, and made a part of hereof, as
determined in accordance with the analytical methodology set forth therein, as
such specifications may be amended from time to time in accordance with this
Supply Agreement.
1.21 "Unit"
means each individually packaged unit of Product.
ARTICLE
II – EFFECTIVE DATE; CONTROLLING TERMS
Section
2.1 Effective
Date
This
Supply Agreement shall automatically become effective as of the Effective
Date.
2
Section
2.2 Controlling
Terms
This
Agreement is governed by the License Agreement to which this Agreement is
attached as an Exhibit. All of the terms of the License Agreement
apply to and control this Supply Agreement and for any terms that may be
interpreted to conflict between the two agreements, the terms of the License
Agreement shall control.
ARTICLE III – COMMERCIAL
SUPPLY
Section
3.1 Forecasts
Immtech
shall notify BioAlliance in writing of the Commencement Date. On or
before the first (1st) day of each calendar month following the Commencement
Date, BioAlliance shall furnish to Immtech a written twelve (12) month rolling
forecast of the commercial quantities of Product that BioAlliance intends to
order from Immtech during such period ("Rolling Forecast"). BioAlliance shall
provide the first Rolling Forecast to Immtech at least four (4) months prior to
the first Delivery Date. The first three (3) months of such Rolling
Forecast shall constitute a binding commitment for the quantities of Product
specified therein ("Firm Commitment") and the following nine (9) months of the
Rolling Forecast shall be non-binding, good faith estimates.
Section
3.2 Purchase
Orders
At least
quarterly, BioAlliance shall submit purchase orders for the period covered by
the Firm Commitment portion of the Rolling Forecast, which shall include the
information specified in Section 3.4 ("Purchase Order"). Product
shall be ordered by BioAlliance only in writing. Immtech will not accept verbal
orders of any kind for the production of Product. BioAlliance shall submit each
Purchase Order to Immtech at least one-hundred twenty (120) days in advance of
the earliest Delivery Date requested in the Purchase Order. Immtech
will confirm such Delivery Dates within fifteen (15) business days of receipt of
the Purchase Order. If Immtech indicates within such fifteen (15) day
period that it is unable to meet any such Delivery Date, the parties will work
together in good faith to set an amended Delivery Date or
Dates. [****] In the event of a conflict between the terms
of any Purchase Order and this Supply Agreement, this Supply Agreement shall
control. Notwithstanding the foregoing, Immtech shall supply BioAlliance with
quantities of Product which exceed by not more than 25% the quantities specified
in the Firm Commitment portion of the Rolling Forecast, and shall use
Commercially Reasonable Efforts to supply additional excess quantities requested
by BioAlliance.
Prior to
the Commencement Date, BioAlliance may purchase clinical supplies of the Product
by submitting Purchase Orders in accordance with this
Section 3.2.
****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
3
Section
3.3 Product
Supply
All
Product supplied hereunder shall be manufactured by Immtech in accordance with
the Specifications and cGMPs and in compliance with all Applicable
Laws. Immtech shall be responsible for obtaining, and shall store at
no cost to BioAlliance, any materials required for the manufacture of Product,
in reasonable quantities consistent with the Rolling Forecast and Purchase
Orders. Immtech shall use and rotate all stock of materials on a
first-in, first-out basis. Immtech shall be responsible for all
payments to Third Parties for any materials purchased from, or other products or
services provided by, Third Parties in connection with the Manufacture and
Packaging of the Product. Immtech will utilize a documented system of
procedures for the control of changes to the Specifications. The
parties acknowledge that the Specifications may need to be refined and modified
as the parties gain experience with the manufacture, testing and use of the
Product. Accordingly, Immtech and BioAlliance agree to negotiate in
good faith to modify the Specifications from time to time as the parties’
experience with the manufacture, testing and use of the Product warrants; and
Immtech further agrees that it will facilitate changes to the Specifications
that are necessary or appropriate in light of regulatory
requirements. The parties agree to allocate on an equitable basis any
special costs of developing and implementing revised
procedures. Immtech will be responsible for labeling and Packaging of
Product for final distribution, utilizing trademarks and artwork developed
jointly by BioAlliance and Immtech. Immtech will test each Batch of
Product and supply BioAlliance with a COA confirming that such Batch meets the
Specifications applicable to such Product. BioAlliance may then
retest the Batch of Product as more fully set forth in Section 4.4 to confirm
that it meets such Specifications.
Section
3.4 Product
Delivery
All
Purchase Orders will contain the following information: (i) the precise quantity
of Product desired and required Delivery Dates, (ii) desired Packaging and
quantities by package (e.g., bottles of 00, xxxxxxx xx 000, xxxxxx xxxxxxxx xx
00), (xxx) the anticipated shipping destination for Product (which may be
modified as provided below) and (iv) such other information as BioAlliance
wishes to provide or that Immtech might find necessary or useful in completing a
specific Purchase Order. Immtech shall make each shipment of Product
in the quantity and on the Delivery Date specified for it on the applicable
Purchase Order, via the mode(s) of transportation and to the destination
specified on such Purchase Order. Product shall be delivered F.C.A.
(Incoterms 2000) BioAlliance’s facility in Paris, France (with the specific
destination to be determined by BioAlliance no earlier than fourteen (14) days
prior to the requested Delivery date, and no later than the Delivery Date. Each
shipment of the Product shall be accompanied by relevant COA and an
invoice. BioAlliance will then own such Batch. BioAlliance
will assume all operational and financial responsibility for processing and
handling returned inventories of Product due to Product expiry.
Section
3.5 Payment
For the
quantities of Product to be supplied by Immtech, BioAlliance shall pay Immtech
the Transfer Price, except that, with respect to any quantities of Product that
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, such quantities shall be supplied at the Direct Cost.
4
Payment
of the Product delivered shall be made by BioAlliance within sixty (60)
days of the date of invoice or receipt of the Product, whichever shall last
occur, unless such shipment of Product is rejected in accordance with the
provisions of Section 4.4. [****] .
ARTICLE
IV – PRODUCT QUALITY AND REGULATORY MATTERS
Section
4.1 Specification(s) of
Product
Product
will be packaged, labeled and handled according to written specification(s) and
procedures mutually agreed upon between the parties.
Section
4.2 Product
Quality
Immtech
warrants that the Product delivered under this Agreement to BioAlliance shall
conform to the Specifications and shall be manufactured according to Applicable
Laws and cGMPs.
Immtech
warrants that neither it, nor its vendors, will engage in any act which causes
any Product produced for BioAlliance to become adulterated, and agrees that such
Product will not be adulterated, within the meaning of the federal Food, Drug
and Cosmetic Act, as amended, when Product is delivered to
BioAlliance.
Section
4.3(b) Quality
Control
Immtech
will take all steps reasonably necessary to ensure that it has contracted with
Third Party manufacturers with the facilities, equipment, instrumentation,
resources and trained personnel to provide all raw materials, in-process and
product assays, analysis and other testing, as compliance with cGMP may require
in connection with Immtech's supply of Product. Immtech shall provide
a COA for each lot of Product supplied hereunder at the time of
shipment.
Immtech
shall maintain complete and accurate documentation of all validation data,
stability testing data, batch records, quality control and laboratory testing
and any other data required under cGMP in connection with the supply of Product
hereunder.
Immtech
shall notify BioAlliance if it makes any changes in any of the materials,
equipment, facilities, process or procedures used to manufacture the Product if
such changes would impact the Product’s ability to meet applicable
Specifications.
Immtech
shall investigate, and cooperate fully with BioAlliance in investigating any
Batch of Product that fails to meet the applicable Specifications or any the
requirements of any governmental or regulatory agency with jurisdiction over the
manufacture of the Product. Immtech shall keep BioAlliance informed
of the status of any investigation and, upon completion of the investigation,
shall provide BioAlliance with a final written report describing the cause of
the failure and summarizing the results of the investigation.
**** Material omitted pursuant to a request for confidential treatment
under Rule 24b-2 of the Exchange Act of 1934. Material filed
separately with the Securities and Exchange Commission.
5
Immtech
agrees to cooperate with any inspection by the FDA or other regulatory agency in
connection with BioAlliance’s activities under the Agreement, including but not
limited to any inspection prior to Regulatory Approval in the
Territory.
Section
4.4 Defective
Product
Within at
most thirty (30) days of delivery of Batches of the Product, BioAlliance may
reject such Batches by informing Immtech of any Nonconformity of the delivered
Batches. Any Product received by BioAlliance from Immtech that has not been
rejected by BioAlliance within thirty (30) days after receipt shall be deemed to
have been accepted; provided,
however, that in the case of any Nonconformity of any Product provided by
Immtech hereunder, which Nonconformity is not discoverable upon reasonable
physical inspection and testing but is discovered at a later time, BioAlliance
may reject such Product by giving written notice to Immtech of BioAlliance’s
rejection of such Product within twenty (20) days after discovery of such latent
defect(s).
In the
event of a disagreement between the parties as to whether the Product meets the
Specifications, the parties shall cause a mutually acceptable independent
laboratory to review records, test data and to perform the tests and/or analyses
set forth in the Specifications on samples of the alleged Defective
Product. The independent laboratory shall determine whether the
Product met the Specifications, and such independent laboratory's results shall
be final and binding. Unless otherwise agreed to by the parties in
writing, the costs associated with such testing and review shall be borne by the
party which was incorrect about whether the Product meets the
Specifications. Whether or not Immtech accepts BioAlliance’s basis
for rejection, promptly on receipt of a notice of rejection of a Batch of
Product, Immtech shall replace such rejected Product, at its cost, within sixty
(60) days. If the independent laboratory rules that the original
Batch met the applicable Specifications and warranties provided by Immtech
hereunder, BioAlliance shall purchase that Batch at the agreed-upon price,
irrespective of whether Immtech has already replaced it.
Section
4.5 Facility
Access
Upon
written request and permission from Immtech, BioAlliance, through its employees,
consultants or other representatives will have the right during normal business
hours and at a time mutually agreed to inspect Immtech's or its affiliates’
manufacturing operations to determine whether or not Immtech is complying in all
respects with its obligations hereunder. BioAlliance agrees that all
such inspections and audits shall be carried out in a manner calculated not to
unreasonably interfere with Immtech's and its Affiliates’ conduct of business
and to insure the continued confidentiality of Immtech's business and technical
information. Further, BioAlliance agrees to comply with all of Immtech's safety
and security requirements during any visits to the Immtech and affiliates’
facilities. BioAlliance agrees to make promptly available to Immtech
any associated reports from such facility visit(s).
Section
4.6 MRR Documents and
Data
Following
the Manufacture of each Batch of Product, and upon written request as required,
Immtech shall provide BioAlliance with properly completed copies of all
MRR
6
Documents,
including Manufacturing and Packaging Batch records prepared in accordance with
the Specifications.
Section
4.7 Recordkeeping
Immtech
shall maintain true and accurate books, records, test and laboratory data,
reports and all other information relating to Manufacturing and Packaging under
this Agreement, including all information required to be maintained by the
Specifications and all Applicable Laws. Such information shall be maintained in
forms, notebooks and records for a period of at least two (2) years from the
relevant finished Product expiration date or longer if required under Applicable
Laws. BioAlliance may inspect the foregoing once per calendar year
upon reasonable advance written request to Immtech.
Section
4.8 Finished Product
Compliance
Upon
Product release by Immtech and acceptance of the Product in accordance with this
Supply Agreement and pursuant to the License Agreement, BioAlliance shall be
solely responsible for compliance with all Applicable Laws related to any
subsequent labeling, packaging, and any required testing of
Product.
Section
4.9 Governmental Inspections and
Requests
Immtech
shall immediately advise BioAlliance if an authorized agent of any regulatory
authority visits either Immtech or any facility related to the Manufacturing or
Packaging of the Product. Immtech shall furnish to BioAlliance a copy
of the portions of the report relevant to the Product by such regulatory
authority, if any, within ten (10) days of Immtech's receipt of such
report. Further, upon receipt of a regulatory authority request to
inspect the facilities or audit Immtech's books and records with respect to
Manufacturing and testing under this Supply Agreement, Immtech shall immediately
notify BioAlliance, and shall provide BioAlliance with a copy of any written
document received from such regulatory authority related to the Product. To the
extent related to Manufacturing or Packaging hereunder, Immtech shall provide to
BioAlliance a copy of any proposed written response to any such inspection
related to the Product prior to its submission and a reasonable opportunity for
BioAlliance to review and comment on such response, as well as a copy of the
final response submitted to the regulatory authority.
Section
4.10 Product
Complaints
BioAlliance
will notify Immtech within 2 working days of any customer complaints that relate
to the Manufacture or Packaging of the Product. Immtech as requested
by BioAlliance will conduct internal investigations to determine the validity of
the complaint. Immtech will use commercially reasonable efforts to
report the findings of such investigation to BioAlliance within 10 working days
of notification. BioAlliance will be responsible for customer
response communications and will submit a copy of such communications to Immtech
at least one week prior to issuing such response for Immtech’s review and
comment. Any complaint received by Immtech for the Product will be
forwarded to BioAlliance within 2 working days.
Section
4.11 Recall
7
In the
event Immtech believes a recall, field alert, Product withdrawal or field
correction may be necessary with respect to any Product provided under this
Supply Agreement, Immtech shall immediately notify BioAlliance in
writing. Immtech will not act to initiate a recall, field alert,
Product withdrawal or field correction without the express prior written
approval of BioAlliance, unless otherwise required by Applicable
Laws. In the event BioAlliance believes a recall, field alert,
Product withdrawal or field correction may be necessary with respect to any
Product provided under this Supply Agreement, BioAlliance shall immediately
notify Immtech in writing and Immtech shall provide all necessary cooperation
and assistance to BioAlliance. The cost of any recall, field alert,
Product withdrawal or field correction shall be borne by BioAlliance except to
the extent such recall, field alert, Product withdrawal or field correction is
caused by Immtech's breach of its warranties, representations or obligations
under this Supply Agreement or Applicable Laws, defects in the Product arising
out of the Manufacture of such Product or its negligence or willful misconduct,
then such cost (limited to reasonable, actual and documented Administrative
Costs incurred by BioAlliance for such recall, withdrawal or correction) shall
be borne by Immtech and Immtech shall, at BioAlliance’s option, either refund
BioAlliance for the Transfer Price paid by BioAlliance for such Product, credit
an amount equal to the Transfer Price paid by BioAlliance for such Product
against future orders of Product submitted by BioAlliance hereunder, or replace
the affected Product with replacement Product manufactured in compliance with
cGMP and other Applicable Laws and regulations and that conform to the
Specifications and the warranties provided by Immtech hereunder, free of charge,
as soon as practicable after the date that BioAlliance notifies Immtech
regarding such event with respect to Product.
Section
4.12 Quality
Agreement
Within
one hundred and eighty (180) days from the Effective Date, the parties will
enter into an agreement that details the quality assurance obligations of each
party with respect to supply of the Product (the “Quality
Agreement”). Notwithstanding the foregoing, failure to enter into a
Quality Agreement shall not mean that Immtech does not have to supply the
Product to BioAlliance. The parties shall amend the Quality Agreement
from time to time as the parties deem necessary. If the parties enter
into a Quality Agreement, all Product supplied to BioAlliance shall be supplied
in accordance with the Quality Agreement.
ARTICLE V – BUFFER STOCK;
MANUFACTURING RIGHTS
Section
5.1 Buffer
Stock
Beginning
on the date that is [****] months prior to the anticipated date of the Initial
Commercial Sale, Immtech shall have available (including as a result of Product
Manufactured by any Second Source Facility, as defined below) a buffer stock of
Product for supply to BioAlliance (the “Buffer Stock”), as determined by mutual
agreement of the parties. The level of Buffer Stock will be expressed
as a number of months of supply of Product and will be determined based upon the
quantities specified in the most recent applicable months of the Rolling
Forecast. The Buffer Stock shall be no less than [****] months supply
of Product at any time.
Section
5.2 Second Source
Facility
**** Material omitted pursuant to a request for confidential
treatment under Rule 24b-2 of the Exchange Act of 1934. Material
filed separately with the Securities and Exchange Commission.
8
If
Immtech: (a) discontinues or permanently ceases to manufacture the Product
(unless otherwise agreed to in advance by BioAlliance); or (b) otherwise
breaches its supply obligations hereunder or is otherwise unable or unwilling to
supply BioAlliance with Product which conforms to the Specifications for a
period in excess of one hundred twenty (120) consecutive days (“Event”), then
effective upon written notice by BioAlliance that an Event has occurred, Immtech
will work with BioAlliance or its sublicensees to identify a Third Party to
manufacture the Product in order to satisfy BioAlliance’s and its Affiliates’
and sublicensees’ requirements of the Product. Immtech will enter
into an agreement with a Third Party manufacturer acceptable to Immtech and will
grant such Third Party manufacturer a license for the Immtech Technology as
necessary for the Third Party Manufacturer to manufacture and supply the Product
to BioAlliance, and its Affiliates and sublicensees. In addition,
Immtech shall provide such technical assistance to such Third Party manufacturer
as reasonably required, at Immtech’s expense, to the extent of any out-of-pocket
expenses incurred by Immtech in connection with providing such technical
assistance.
ARTICLE
VI - REPRESENTATIONS, WARRANTIES AND COVENANTS
Section
6.1 Limited
Warranty
Immtech
represents and warrants to BioAlliance that all of the Product supplied under
this Supply Agreement (a) shall have been Manufactured and Packaged in
conformance with the Specifications and Applicable Laws, (b) shall conform
to the Specifications in effect at the time of delivery, (c) shall not be
adulterated or misbranded within the meaning of the U.S. Federal Food, Drug and
Cosmetic Act when delivered, and (d) at the time of delivery, shall be free
and clear of any lien or encumbrance.
THE
LIMITED WARRANTY SET FORTH IN THIS SECTION 6.1 IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY,
WARRANTY OF NON-INFRINGEMENT AND ANY WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSEDIN THIS SECTION 6.1 OR IN THE
AGREEMENT, IMMTECH MAKES NO OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH
RESPECT TO THE MANUFACTURING, PACKAGING OR THE PRODUCT.
Section
6.2 Release
Responsibility.
Immtech,
as the party responsible for release of the finished Product, warrants that it
will not release any Batch of Product if the required final Product testing
indicates that the Product does not comply with the Specifications and the
warranties set forth in Section 6.1.
Section
6.3 Existence and
Power
Each
party hereby represents and warrants to the other party that such party (i) is
duly organized, validly existing and in good standing under the laws of the
state in which it is organized, (ii) has the power and authority and the legal
right to own and operate its property and assets, and to carry on its business
as it is now being conducted, and (iii) is in compliance with all requirements
of applicable law, except to the extent that any noncompliance would not
materially adversely affect such party's ability to perform its obligations
under the Agreement.
9
Section
6.4 Authorization and
Enforcement of Obligations
Each
party hereby represents and warrants to the other party that such party (i) has
the power and authority and the legal right to enter into this Agreement and to
perform its obligations hereunder and thereunder and (ii) has taken all
necessary action on its part to authorize the execution and delivery of the
Agreement and the performance of its obligations hereunder. The Agreement has
been duly executed and delivered on behalf of such party, and constitutes a
legal, valid, binding obligation, enforceable against such party in accordance
with its terms.
Section
6.5 No
Conflict
Each
party hereby represents and warrants to the other party that the execution and
delivery of this Agreement and the performance of such party's obligations
hereunder (i) to not conflict with or violate any requirement of Applicable Laws
or any material contractual obligation of such party and (ii) do not materially
conflict with, or constitute a material default or require any consent under,
any material contractual obligation of such party.
10
EXHIBIT
B
OPTION
TO LICENSE
MALARIA
PREVENTION
In the
event that BioAlliance provides written notice to Immtech pursuant to Section
4.5(b) within sixty (60) days of its receipt of Immtech’s Written Notice
pursuant to Section 4.5(a) that BioAlliance would like to include the prevention
of malaria (and, if proposed by Immtech, treatment of malaria) within the scope
of this Agreement, the following terms and conditions shall become effective and
be deemed to be incorporated within and made a part of this
Agreement:
1.
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The
term “Product” shall include a finished dosage form for sale in the
Territory that contains pafuramidine as the only active ingredient and is
approved by the requisite regulatory authority in the Territory for the
prevention or treatment of malaria in
patients.
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2.
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BioAlliance
shall [****] for designing, planning and conducting the development of the
Product for the prevention of malaria (and, if proposed by Immtech,
treatment of malaria) incurred by Immtech pursuant to the budget set forth
in the Development Program (the “Malaria Development
Costs”). If Immtech has not entered into an arrangement to develop
the Product for the prevention of malaria in the United States with a
Third Party and intends to commercialize the Product for the prevention of
malaria in the United States, then following Regulatory Approval of the
Product for the prevention of malaria in the Territory, BioAlliance will
[****].
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3.
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Immtech
will provide a written invoice to BioAlliance for the BioAlliance Share of
the Malaria Development Costs on a quarterly basis (which invoice shall
set forth the total Development Costs for such quarter and the BioAlliance
Share thereof), and BioAlliance will reimburse Immtech for the BioAlliance
Share of the Malaria Development Costs within sixty (60) days after
receipt of invoice. In no event shall BioAlliance be
responsible for payment of any Development Costs other than the Malaria
Development Costs or for payment of any part of the Malaria Development
Costs that exceed the budget for the Malaria Development Costs set forth
in Immtech’s Written Notice as provided to BioAlliance pursuant to
Sections 4.5(a) and 4.5(b) or amended by unanimous approval of the
Steering Committee (and if Immtech makes any amendment to the Development
Program that increases the budget for the Malaria Development Costs, which
amendment is not unanimously approved by the Steering Committee, then
Immtech shall [****].
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****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
|
4.
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Section
5.2(a) of the Agreement shall be amended to add the following
provisions:
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Milestones:
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(i)
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Upon
[****]; and
|
|
(ii)
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Upon
[****];
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|
(iii)
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Upon
[****];
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|
(iv)
|
Provided
that Marketing Approval (and, if sought, Pricing Approval) of the Product
for the prevention of malaria is obtained in any Major EU Market,
[****];
|
|
(v)
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Upon
[****];
|
|
(vi)
|
Upon
[****]; and
|
|
(vii)
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Upon
[****].
|
****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
2
EXHIBIT
I
Specifications
Final
product specifications to be defined and updated based on requirements of US
FDA.
3