AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT\ By and Between ** and FIDOPHARM, INC.
Portions
herein identified by ** have
been
omitted pursuant to a request for
confidential
treatment and have been
filed
separately with the Commission
pursuant
to Rule 24b-2 of the Exchange
Act
of
1934, as amended.
AMENDED
& RESTATED LICENSE AND DEVELOPMENT AGREEMENT\
By
and
Between
**
and
FIDOPHARM,
INC.
TABLE
OF CONTENTS
Page
|
||||
INDEX
|
||||
DEFINITIONS
|
1
|
|||
2.
|
LICENSE
GRANT AND OTHER RIGHTS
|
3
|
||
2.1
|
Exclusive
License
|
3
|
||
2.2
|
Right
of Reference
|
4 | ||
2.3
|
Copyrighted
Materials
|
4
|
||
2.4
|
Exclusive
Right of First Negotiation
|
4
|
||
3.
|
CONSIDERATION
|
4
|
||
3.1
|
Upfront
Payment
|
4
|
||
3.2
|
Supply
Agreement
|
4 | ||
3.3
|
No
Additional Consideration
|
5
|
||
4.
|
DEVELOPMENT
|
5 | ||
4.1
|
Overview
|
5
|
||
4.2
|
Development
Plan
|
5
|
||
4.3
|
Diligence
|
5
|
||
4.4
|
Reporting
and Data
|
5
|
||
4.5
|
Compliance
with Laws
|
5
|
||
4.6
|
Access
to Records and Facilities
|
6
|
||
4.7
|
Territory
Specific Development
|
6
|
||
5.
|
PRODUCT
REGISTRATION AND COMMERCIALIZATION
|
6
|
||
5.1
|
Product
Registration
|
6
|
||
5.2
|
Registration
and Commercialization Plans
|
6
|
||
5.3
|
Trademarks
|
6
|
||
5.4
|
Cooperation
|
7
|
||
5.5
|
Reporting
|
7
|
||
6.
|
SUPPLY
OF PRODUCTS
|
7
|
||
6.1
|
Supply
Agreement
|
7
|
||
6.2
|
Technology
Transfer
|
7
|
||
7.
|
PATENTS
|
7 | ||
7.1
|
Prosecution
and Maintenance of Patents
|
7
|
||
7.2
|
Notification
of Infringement
|
7
|
||
7.3
|
Enforcement
Against Third Parties
|
8
|
||
7.4
|
Alleged
Infringement of Third Party’s Patents
|
8
|
||
8.
|
REPRESENTATIONS,
WARRANTIES AND COVENANTS
|
8
|
||
8.1
|
**
Representations, Warranties and Covenants
|
8
|
||
8.2
|
Fidopharm
Representations and Warranties
|
10
|
TABLE
OF CONTENTS
(continued)
Page
|
||||
8.3
|
Regulatory
Cooperation
|
10
|
||
8.4
|
Compliance
with Laws
|
11
|
||
9.
|
CONFIDENTIALITY
|
11
|
||
9.1
|
Confidentiality;
Nondisclosure; Nonuse
|
11
|
||
9.2
|
Exception
to Confidential Information
|
11
|
||
9.3
|
Notification
of Mandatory Disclosure
|
12
|
||
9.4
|
Patent
Application Filing
|
12
|
||
9.5
|
Permitted
Disclosure to Third Parties
|
12
|
||
10.
|
INDEMNIFICATION
AND INSURANCE
|
12
|
||
10.1
|
**
Indemnification Obligations
|
12
|
||
10.2
|
Fidopharm’s
Indemnification Obligations
|
12
|
||
10.3
|
Indemnification
Procedure
|
13
|
||
10.4
|
Insurance
|
13
|
||
11.
|
TERM
AND TERMINATION
|
13
|
||
11.1
|
Term
|
13
|
||
11.2
|
Termination
by Fidopharm
|
13
|
||
11.3
|
Termination
for Breach
|
14
|
||
11.4
|
Termination
for Bankruptcy, etc
|
14
|
||
11.5
|
Termination
for Failure
|
14
|
||
11.6
|
Effect
of Expiration or Termination.
|
15
|
||
12.
|
INJUNCTIVE
RELIEF AND DISPUTE RESOLUTION
|
15
|
||
12.1
|
Equitable
Relief
|
15
|
||
12.2
|
Dispute
Resolution
|
15
|
||
13.
|
MISCELLANEOUS
|
16
|
||
13.1
|
Force
Majeure
|
16
|
||
13.2
|
Further
Assurances
|
16
|
||
13.3
|
Assignment
|
16
|
||
13.4
|
Choice
of Law
|
16
|
||
13.5
|
Notices
|
16
|
||
13.6
|
Entire
Agreement
|
17
|
||
13.7
|
Amendments;
Waivers
|
17
|
||
13.8
|
Severability
|
17
|
||
13.9
|
Independent
Contractors
|
17
|
||
13.10
|
Counterparts
|
17
|
||
13.11
|
Headings
|
17
|
ii
AMENDED
& RESTATED LICENSE AND DEVELOPMENT AGREEMENT
THIS
AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT (“Agreement”)
is
made as of this 22nd day of April 2008 (“Effective
Date”),
by and
between: **, a company having offices at **(“**”),
and Fidopharm,
Inc., a company having offices 000 Xxxxxxxx Xxxx Xxxx, Xxxxx 000, Xxxxxxx,
Xxxxxxxxxxxx 00000 (“Fidopharm”).
Fidopharm and **are together referred to as “Parties”
and
individually as a “Party”.
RECITALS
WHEREAS,
**is
developing ACI-based products for manufacture and commercialization for
veterinary or animal application uses.
WHEREAS, the
largest market in the world for ACI-based products for veterinary or animal
application uses is the United States.
WHEREAS, the
Parties agree that Fidopharm has the requisite expertise and infrastructure
to
register and commercialize veterinary products in the United States.
WHEREAS,
**desires to grant Fidopharm an exclusive license to use its know-how and under
its patent rights to, use, make, have made, market, offer for sale, import
or
export and sell ACI-based products for veterinary or animal application use
in
the United States, and Fidopharm desires to obtain such license.
AND
WHEREAS,
**shall
cause the JV to execute a supply agreement contemporaneously with the execution
of this Agreement providing for the exclusive supply of Products to Fidopharm
for sale and distribution in the Territory.
NOW,
THEREFORE,
in
consideration of the mutual promises set forth herein, the Parties, intending
to
be legally bound, hereby agree as follows:
1. DEFINITIONS
As
used
herein, the following terms shall have the respective meanings set forth
below:
1.1 “ACI”
means
(a)
Active A and/or (b) Active B.
1.2 “Active
A”
shall
have the meaning on Schedule
1.
1.3 “Active
B”
shall
have the meaning on Schedule
1.
1.4 “Affiliate”
means
any individual, corporation, company, partnership, trust, limited liability
company, association or other business entity (“Person”)
which
directly or indirectly controls, is controlled by or is under common control
with the Party in question. As used in this definition of “Affiliate,” the term
“control” shall mean, as to any Person, (a) direct or indirect ownership of
fifty percent (50%) or more of the voting interests or other ownership interests
in the Person in question (or such lesser percentage which is the maximum
allowed to be owned by such Person in a particular jurisdiction); (b) direct
or
indirect ownership of fifty percent (50%) or more of the interest in the income
of the Person in question; or (c) possession, directly or indirectly, of the
power to direct or cause the direction of management or policies of the Person
in question (whether through ownership of securities or other ownership
interests, by contract or otherwise). Notwithstanding the foregoing, the owners
of preferred stock (or common stock issued upon conversion thereof) of a Party
such as financial institutions, venture capital funds and private equity
investors will not be its “Affiliates” for purposes of this
Agreement.
1
1.5 “Commercial
Sale” means
sale of Products by Fidopharm or its Affiliates to a Third Party in the
Territory, other than distribution in connection with clinical trials of
Products conducted by Fidopharm.
1.6 “Confidential
Information”
means
all secret or confidential proprietary information or data of a Party provided
in written, oral, graphic, video, computer, electronic or other form to the
other Party.
1.7 “Controlled”
means,
with respect to any intellectual property right or other intangible property,
the possession by license or ownership by a Party (or by an Affiliate) to grant
to the other Party access or a license or sublicense as provided herein without
violating the terms of any written contract with any Third Party.
1.8 “Development”
means
research and chemical development activities, including without limitation
toxicology, test method development and stability testing, process development,
formulation development, delivery system development, quality assurance and
quality control development, statistical analysis, efficacy studies, product
performance studies, environmental impact studies, manufacturing process
development and scale-up, regulatory affairs, and product approval and
regulatory activities other than filing for and seeking Product
Registrations.
1.9 “Field”
means
any and all veterinary or animal application uses.
1.10 “JV”
means
** Limited, which shall be the entity responsible for supplying Products to
Fidopharm.
1.11 “Know-How”
means
any proprietary technical or other information relating to Products and the
make, use or sale of Products, including technology, experience, formulae,
concepts, discoveries, trade secrets, inventions, modifications, improvements,
data (including all chemical, clinical, toxicological, analytical, and quality
control data), results, designs, ideas, analyses, methods, techniques, assays,
research plans, procedures, tests, processes (including manufacturing processes,
specifications and techniques), laboratory records, reports, summaries, and
information contained in submissions to, and information received from,
regulatory authorities, that are Controlled by **, its Affiliates, JV or
Manufacturer as of the Effective Date or during the Term.
1.12 “Law”
or
“Laws”
means
the laws, statutes, rules, codes, regulations, orders, judgments and/or
ordinances of any governmental authority (including without limitation the
Regulatory Authority).
1.13 “Manufacturer”
shall
have the meaning set forth in Schedule
1,
which
shall be amended upon the mutual agreement of the Parties.
1.14 “Patents”
means
(a) the patents and patent applications listed in Schedule
2,
(b) all
patents and patent applications related to Products that may be obtained,
including the make, use or sale of Products and (c) all patents and patent
applications which are divisions, continuations, continuations-in-part,
reissues, renewals, re-examinations, foreign counterparts, substitutions or
extensions of or to any patent applications or patents described in clauses
(a)
or (b) of this sentence, that are Controlled by **, its Affiliates, JV or
Manufacturer as of the Effective Date or during the Term. The Parties hereby
acknowledge that there are no Patents as of the Effective Date; provided, that
upon the filing of a Patent application ** shall create a Schedule
2
which
shall be updated as necessary.
1.15 “Products”
means
any product containing ACI as its active chemical ingredient and which is
covered by Patents and/or uses Know-How, including, but not limited to the
following Products:
(a) “Product
A”
means a
product Developed by **(including by any Affiliate of **or by any Third Party
(on behalf of **or its Affiliates)) meeting the specifications set forth in
Schedule
1;
and
(b) “Product
B”
means a
product Developed by **(including by any Affiliate of ** or by any Third Party
(on behalf of **or its Affiliates)) meeting the specifications set forth in
Schedule
1.
2
1.16 “Product
Registration”
means,
with respect to a Product in a particular country or territory, the registration
or regulatory approval granted by the applicable governmental authority in
such
country or territory allowing for such Product to be marketed, distributed,
sold
or imported there.
1.17 “Regulatory
Authority”
means
the United State’s agency with jurisdiction over Products.
1.18 “Specifications”
means,
with respect to a Product, the specifications for such Product set forth in
the
Product Registration or as otherwise agreed to by the Parties.
1.19 “Supply
Agreement”
means
that Amended & Restated Manufacture and Supply Agreement entered into with
the JV contemporaneously with this Agreement.
1.20 “Territory”
means
the United States and all of its states, territories and
protectorates.
1.21 “Third
Party” means
any
entity or person other than ** or Fidopharm or their respective
Affiliates.
1.22 “Unit”
means
a
** of Product.
1.23 Additional
Definitions. Each
of
the following definitions is set forth in the Section of this Agreement
indicated below:
Definition
|
Section
|
|
Agreement
|
Preamble
|
|
Copyrighted
Materials
|
2.3
|
|
Costs
|
11.5
|
|
Development
Data
|
4.4(b)
|
|
Development
Plan
|
4.2(a)
|
|
Effective
Date
|
Preamble
|
|
Fidopharm
|
Preamble
|
|
Force
Majeure
|
13.1
|
|
Indemnifying
Party
|
10.3
|
|
Initial
Products
|
4.1
|
|
Initial
Term
|
11.1
|
|
**
|
Preamble
|
|
Parties
|
Preamble
|
|
Party
|
Preamble
|
|
Person
|
1.1
|
|
Registration
and Commercialization Plan
|
5.2
|
|
ROFN
Notice
|
2.4
|
|
Term
|
11.1
|
|
Territory
Development
|
4.7
|
|
Territory
Development Costs
|
4.7
|
|
Third
Party-Patent Infringement Notice
|
7.4
|
|
Trademark
|
|
5.3
|
2. LICENSE
GRANT AND OTHER RIGHTS
2.1 Exclusive
License.
(a) Subject
to the terms and conditions of this Agreement, ** hereby grants Fidopharm an
exclusive license, with a right to sublicense, to use the Know-How and under
the
Patents to, use, make, have made, market, offer for sale and import or export
Products in the Field in the Territory. For clarity, Fidopharm’s right to export
hereunder shall not include the right to export Product to end-users or
commercial distributors outside of the Territory.
3
(b) Notwithstanding
the license grant above, Fidopharm shall not make or have Products made and
supplied (other than through the JV) for Commercial Sale in the Territory unless
there as been a Failure (as defined in the Supply Agreement).
2.2 Right
of Reference. ** hereby
grants Fidopharm the right to access, reference and use all data and regulatory
filings (including all Product Registrations Controlled by **, its Affiliates,
JV and Manufacturer) and regulatory communications associated with any
submissions for the Products to the extent permitted under applicable Laws.
Where required in order for Fidopharm to obtain such access, ** shall or shall
cause the appropriate party to, as soon as reasonably possible (and in any
event
no later than thirty (30) days from the date of Fidopharm’s request), provide
the applicable governmental authority with notice of its consent to such access
by Fidopharm in the appropriate form. In the event that ** grants any Third
Party any rights in Products, (i) ** shall use its best efforts to ensure that
any such Third Party will grant ** a right to access, reference and use any
and
all data and regulatory filings related to Products and (ii) ** hereby grants
Fidopharm a right to access, reference and use any and all data and regulatory
filings related to Products which ** has such a right to access; provided,
that
in any event ** shall ensure that any such Third Party shall be subject to
safety and adverse event reporting obligations no less stringent than the terms
and conditions contained in Section 8.3
and
Fidopharm shall be made aware of any such safety or adverse events within
twenty-four (24) hours of ** being informed of such an event. ** reserves the
right to use such data worldwide in support of any registration held by it
or a
Third Party partner.
2.3 Copyrighted
Materials. To
the
extent that ** develops or has developed any manuals, logos, and other
copyrighted works for use with Products (individually and collectively, the
“Copyrighted
Materials”),
**
hereby grants Fidopharm a royalty-free, non-exclusive license to use and
distribute such Copyrighted Materials in connection with marketing, promoting,
selling or importing Products in the Field in the Territory.
2.4 Exclusive
Right of First Negotiation. Prior
to
** granting to a Third Party a license or similar right (including a
co-promotion right or an option to acquire such license or right) to market,
offer for sale, import or export one (1) or more products containing ACI (other
than Products) in the Field in the Territory, it shall so advise Fidopharm
in
writing (an “ROFN
Notice”).
Upon
request by Fidopharm within thirty (30) days after its receipt of the ROFN
Notice, ** and Fidopharm shall discuss the terms and conditions under which
**
would grant to Fidopharm rights to market, offer for sale, import or export
such
products in the Field in the Territory. If the Parties agree to grant such
rights to Fidopharm, including the terms and conditions of such grant, the
Parties shall prepare and execute an amendment to this Agreement incorporating
such additional rights and terms. If Fidopharm does not so request within the
thirty (30) day period after its receipt of the ROFN Notice, or if the Parties
do not agree in writing on the terms of such additional grant of rights to
Fidopharm within ninety (90) days after the date of the ROFN Notice to
Fidopharm, ** shall be free to grant to one or more Third Parties the right
to
market, offer for sale, import or export such products in the Field in the
Territory, on such terms as ** considers appropriate.
3. CONSIDERATION
3.1 Upfront
Payment. In
partial consideration of the grant of rights under this Agreement and **’s
obligations to conduct the Development activities provided hereunder, Fidopharm
shall pay ** an upfront payment of five hundred thousand dollars (US$500,000)
within fourteen (14) days of the Effective Date.
3.2 Supply
Agreement. As
further consideration of the grant of rights under this Agreement and its
obligations to conduct the Development activities provided hereunder, Fidopharm
shall contemporaneously with this Agreement enter into the Supply
Agreement.
4
3.3 No
Additional Consideration.
** shall
be entitled to no additional consideration for the grant of rights to Fidopharm
under this Agreement and **’s obligations to conduct the Development activities
other than as provided under this Article 3
and
Section 4.7
below.
4. DEVELOPMENT
4.1 Overview.
**
shall be
primarily responsible, at its sole cost except as otherwise specifically
provided herein, for designing and conducting all Development activities
necessary to receive Product Registrations for the Product A and Product B
(together, the “Initial
Products”)
in
accordance with the Development Plan.
Fidopharm shall be responsible, at its sole cost, for submitting the Product
Registrations to the Regulatory Authority.
4.2 Development
Plan.
(a) The
Development of the Initial Products shall be governed by a development plan
(the
“Development
Plan”).
The
initial Development Plan shall be attached hereto as Schedule
4.2.
The
Development Plan shall include options for ‘essentially similar’ and complete
clinical package registration data routes with costings, timelines, stage
payments, ** and other elements to be set forth in the Development
Plan.
(b) The
Development Plan, together with any updates thereto, shall be prepared and
approved as follows from time to time during the Term, each Party shall have
the
right to propose amendments to and amend the existing Development Plan;
provided, that in any event ** shall present Fidopharm an updated Development
Plan at least once per calendar year for its review and approval, not to be
unreasonably withheld or delayed. Fidopharm shall have a period of twenty-one
(21) days from the date that the updated Development Plan is received to provide
its approval. If approval or rejection is not provided to ** within such
twenty-one (21)-day period, then the Development Plan shall be deemed approved.
For purposes of clarity, no change to the Development Plan shall be made without
the prior written approval of both Parties.
4.3 Diligence.
** shall
carry out the Development activities, in strict accordance with the Development
Plan and the timelines set forth therein, necessary for obtaining the Product
Registrations as set forth in this Agreement, including generating any
additional data necessary to obtain Product Registration specifically for the
Territory at Fidopharm’s instruction. Fidopharm shall file the Product
Registrations in accordance with the Registration and Commercialization Plan
based on the data provided by **.
4.4 Reporting
and Data.
(a) Upon
request, ** shall promptly, but in no event later than thirty (30) days after
such request provide Fidopharm with (i) a summary in reasonable detail of all
data generated or obtained from each discrete Development activity performed
under the Development Plan, such as any toxicology study, pharmacokinetics
study
or stability study, (ii) a summary of the Development progress against the
projected Development progress set forth in the current Development Plan and
(iii) a final report of the results of each Development activity, together
with
all material supporting data.
(b) **
shall
provide Fidopharm copies of all substantive or material information with respect
to the Development of Products, including clinical data compiled with respect
to
Products and all information and data filed with any governmental authority
with
respect to Products outside of the Territory, as soon as reasonably practicable
after such information, data or results become available to or compiled by
**,
including any drafts and final versions of any study reports (the “Development
Data”).
Subject to the terms and conditions of this Agreement, Fidopharm shall have
the
right to use the Development Data or any portion thereof for the purpose of
obtaining Product Registrations and commercializing Products in the
Territory.
4.5 Compliance
with Laws. **
or its
agents shall perform its responsibilities under this Article 4, including those
set forth in the Development Plan, in accordance with all applicable
Laws.
5
4.6 Access
to Records and Facilities.
** shall
maintain scientific records, in sufficient detail and in good scientific manner
appropriate for obtaining Patents and regulatory purposes, which shall fully
and
properly reflect all work done and results achieved in the performance of
Development under this Agreement. Fidopharm shall be entitled to have access
during regular business hours and upon reasonable advance notice, to **’s
records and facilities relating to the Development of Products for the purpose
of monitoring compliance with all applicable Laws and other applicable
regulatory requirements. In all Third Party agreements involving the Development
of Products, ** shall require that the Third Parties thereto provide ** with
access to such Third Party facilities and all such data
generated by Third Parties.
Fidopharm shall have the right to inspect such facilities on behalf of ** in
the
event that:
(a) a
specific concern is raised regarding Product by any governmental authority
(including the Regulatory Authority);
(b) a
routine
inspection/audit for Regulatory Authority purposes;
(c) a
routine
inspection to confirm compliance with the terms of this Agreement, including
without limitation, the progress of Product Development; or
(d) a
routine
inspection/audit for a Fidopharm customer.
For
clarity, inspection and audits pursuant to Section 4.6(d) shall be limited
to
two (2) separate visits in any twelve (12) month period for each specific Third
Party; provided, that additional reasonable inspections/audits shall be
permitted upon Fidopharm obtaining **’s prior consent, which shall not be
unreasonably withheld, conditioned or delayed. All inspection/audit costs shall
be borne by the Party incurring such costs.
4.7 Territory
Specific Development. To
the
extent that additional Development is necessary solely to obtain the Product
Registration in the Territory (“Territory
Development”),
**
shall supplement the current Development Plan with a budget setting forth the
reasonable costs for conducting the Territory Development specific activities
(“Territory
Development Costs”)
and
shall submit such supplement to Fidopharm for its consent and upon approval
of
such Territory Development Costs by Fidopharm, Fidopharm shall reimburse such
costs as they are incurred.
5. PRODUCT
REGISTRATION AND COMMERCIALIZATION
5.1 Product
Registration. Fidopharm
shall, at its sole expense, use commercially reasonable efforts to obtain and
maintain Product Registrations in accordance with the Registration and
Commercialization Plan. Fidopharm shall be the sole owner of all Product
Registrations in the Territory. For clarity, Fidopharm shall have the sole
right
in determining whether or not to obtain and/or maintain any specific Product
Registration in the Territory.
5.2 Registration
and Commercialization Plans.
No less
than thirty (30) days prior to first Commercial Sale Fidopharm shall provide
an
annual development plan for its activities in order to obtain Product
Registrations and after first Commercial Sale Fidopharm shall provide an annual
commercialization plan for its efforts to commercialize Products (the
“Registration
and Commercialization Plan”).
Fidopharm shall update the Registration and Commercialization Plan annually
and
shall provide such updated plan to ** not later than thirty (30) days before
start of each year. The Registration and Commercialization Plan description
shall be agreed between the Parties.
5.3 Trademarks.
Fidopharm shall have the sole right to determine the trademark(s) or trade
name(s) that Fidopharm shall adopt for use with Products (the “Trademark”).
All
goodwill generated through the use of Trademarks by Fidopharm shall inure to
the
benefit of Fidopharm. Fidopharm shall own all Trademarks and shall register
and
maintain such Trademarks at its sole cost and discretion.
6
5.4 Cooperation.
** shall
provide (a) reasonable cooperation and support to Fidopharm in connection with
maintenance of the Product Registration and (b) all information (including
Confidential Information) that is reasonably required for the Development and/or
commercialization of Products. Subject to Article 9,
Fidopharm may use such Confidential Information solely for the purpose of
Developing and commercializing Products.
5.5 Reporting.
Each
Party shall keep the other Party informed of developments known by it that
would
reasonably be expected to have a material adverse effect on any Product or
Product Registration, including, but not limited to, the general regulatory
strategy for Products in the Territory.
6. SUPPLY
OF PRODUCTS.
6.1 Supply
Agreement. Contemporaneously
with the execution of this Agreement Fidopharm shall enter into the Supply
Agreement with the JV. Pursuant to the terms of the Supply Agreement, the JV
shall supply Fidopharm’s requirements of Products. Notwithstanding the
foregoing, as between Fidopharm and **, in the event of a conflict between
the
Supply Agreement and this Agreement, Fidopharm’s rights in regards to the
licenses (and any other intellectual property related to the Products) and
Product Registrations related to the Products shall be governed solely by the
terms of this Agreement.
6.2 Technology
Transfer. In
the
event that there is a Failure (as defined in the Supply Agreement) or if this
Agreement is terminated pursuant to Section 11.2(b), 11.3 or 11.4, (a) the
restrictions set forth in Section 2.1(b)
of this
Agreement shall no longer be applicable (which for clarity, means that Fidopharm
shall have the right to manufacture, or have manufactured, Product itself or
by
a Third Party) and (b) ** shall undertake, and/or, as necessary, cause the
JV
and Manufacturer to undertake, an immediate transfer to Fidopharm or its
designee of all technology and Know-How necessary, useful or used to manufacture
Products. ** shall also make available, or cause to be made available any
individuals who may be useful implementing the manufacturing processes related
to Products.
7. PATENTS
7.1 Prosecution
and Maintenance of Patents.
** will
prosecute and maintain the Patents at its sole cost in the Territory, using
counsel of its choice reasonably acceptable to Fidopharm and shall not abandon
any Patent without the prior written consent of Fidopharm. During the Term,
**
pursuant to this Section 7.1 shall copy Fidopharm, or have Fidopharm copied,
on
all material or substantive documents regarding Patents, which are received
from
or to be filed in any patent office in the Territory, promptly following receipt
from the patent office and within a reasonable time prior to filing with the
patent office (but not less than thirty (30) days), as applicable, including
copies of each patent application, office action, response to office action,
declaration, information disclosure statement, request for terminal disclaimer,
request for patent term extension and request for reexamination. Fidopharm
shall
have the right to comment on the prosecution of such Patents and provide such
comments to **’s patent counsel, and ** shall consider all such comments in good
faith. For the purposes of this Section 7.1, “prosecute
and maintain”
means,
with respect to a patent, the preparing, filing, prosecuting and maintenance
of
such patent, as well as re-examinations, reissues and requests for patent term
extensions and the like with respect to such patent, together with the conduct
of interferences, the defense of oppositions and other similar proceedings
and
appeals thereof with respect to a patent, but shall not include enforcement
litigation or the defense of declaratory judgment actions. Also, as used in
this
Section 7.1, to “abandon” particular Patent shall include deciding not to defend
against an opposition, not to defend an interference or similar proceeding,
not
to pursue an appeal of an adverse decision or not to pursue particular claims,
in each case with respect to such Patent in the United States Patent &
Trademark Office.
7.2 Notification
of Infringement.
The
Parties shall promptly inform each other of any information that comes to their
attention involving (a) actual or apparent infringements or misappropriations
of
the Patents, by any Third Party in the Territory, or (b) claims of alleged
infringement made by any Third Party against either Party or its respective
Affiliates or sub-licensees resulting from the Development, manufacture, import,
offer for sale, sale or use of Products.
7
7.3 Enforcement
Against Third Parties.
(a) Notice.
If
either Party reasonably believes that a Third Party is conducting any activities
in the Territory that may constitute actual or potential infringement of the
Patents, such Party shall promptly notify the other Party of such activities.
(b) Fidopharm’s
First Right to Enforce.
Except
as otherwise agreed, Fidopharm shall have the first right to bring and control
any action or proceeding under such Patents in respect to an alleged
infringement occurring in the Territory. If Fidopharm fails to bring an action
or proceeding with respect to an alleged infringement occurring in the Territory
within one-hundred-twenty (120) days following a request by ** to do so, **
shall have the right to bring and control any such action or proceeding with
respect to such Patents.
(c) Cooperation.
The
Parties shall reasonably cooperate with each other in all actions or proceedings
described in this Section 7.3,
to the
extent pertaining to an alleged infringement. The non-controlling Party agrees
to be joined as a party plaintiff if necessary to prosecute the action or
proceeding and shall provide all reasonable cooperation (including any necessary
use of its name) required to prosecute such litigation; provided that the
controlling Party shall reimburse the non-controlling Party for out-of-pocket
expenses reasonably incurred in providing such cooperation at the controlling
Party’s request. The non-controlling Party will be entitled to be represented by
counsel of its own choice at its own expense.
(d) Recoveries.
Any
recovery obtained by any Party as a result of any proceeding described in this
Section 7.3,
by
settlement or otherwise, shall be applied in the following order of priority:
(i) first, to reimburse each Party for all litigation costs in connection with
such proceeding paid by that Party and not otherwise recovered (on a pro rata
basis based on each Party’s respective litigation costs, to the extent the
recovery was less than all such litigation costs); and (ii) second, the
remainder shall be kept by the controlling Party.
7.4 Alleged
Infringement of Third Party’s Patents.
In the
event that either Party is named as a defendant in any legal or other action
or
proceeding, including any settlement or negotiation, or learns of any threatened
action or proceeding with respect to any alleged infringement of a Third Party
patent or other proprietary right as a result of Developing, manufacturing,
importing, offering for sale, selling or using Products such Party will promptly
notify the other Party in writing (a “Third
Party-Patent Infringement Notice”).
The
Parties will closely coordinate regarding any infringement, or alleged
infringement, of Third Party rights related to Products; provided, that in
the
Territory, Fidopharm shall have the first right but not the obligation to defend
any action brought by, or negotiate a settlement with, a Third Party claiming
any infringement or potential infringement by Products of such Third Party’s
rights. In the event that Fidopharm elects not to, or fails to, initiate any
defense or settlement within one-hundred-twenty (120) days following its receipt
of a Third Party-Patent Infringement Notice, ** shall have the right to take
such steps as may be considered necessary or appropriate by ** to defend such
infringement claim. Each Party shall render such reasonable assistance as may
be
requested by the defending Party in connection with such infringement actions.
If one Party requests the other Party’s reasonable assistance in connection with
such infringement claims or actions, the requesting Party shall reimburse the
other Party for such direct, out-of-pocket expenses as are reasonably incurred
during the course of its providing such requested assistance.
8. REPRESENTATIONS,
WARRANTIES AND COVENANTS.
8.1 **
Representations, Warranties and Covenants.
**
hereby represents, warrants and covenants to Fidopharm as follows:
8
(a) The
execution and delivery by ** of this Agreement and the performance by ** of
its
obligations hereunder have been duly authorized by all necessary corporate
action on the part of **, and do not conflict with the terms of any other
contract, agreement, arrangement or understanding to which ** is a
party.
(b) Except
as
set forth herein, no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or filing with, any
federal, state or local governmental authority is required on the part of **
in
connection with the valid execution, delivery and performance of this
Agreement.
(c) **
is and
will be in compliance through the term of this Agreement in all material
respects with all Laws applicable to its performance under this
Agreement.
(d) There
is
no action or proceeding pending or threatened against ** that questions the
validity of this Agreement or any action taken by ** in connection with the
execution of this Agreement.
(e) In
regards to intellectual property:
(i) **
has
not knowingly infringed any Third Party patent rights in developing Products.
In
the event that ** becomes aware of any Third Party patents rights being
infringed, or potentially being infringed, by the development, manufacture
or
commercialization of a Product, ** shall notify Fidopharm of such infringement
or potential infringement within twenty-four (24) hours of gaining such
knowledge.
(ii) as
of the
Effective Date, there are no pending proceedings in any court or arbitration,
administrative or other tribunal which are concerned with the validity or
ownership of any of the Patents or Know-How. Without derogation from the
foregoing, there are no oppositions, revocation, cancellation, invalidation
or
rectification proceedings pending in relation to any of the Patents or Know-How
in any court. No Third Party has notified ** or any ** Affiliate of its
intention to bring any such proceedings.
(iii) **
has
not and no ** Affiliate has received any written complaints or threats and
there
are no pending proceedings or claims, alleging that the exploitation of the
Patents or Know-How infringe or would infringe the intellectual property rights
of any Person;
(iv) Details
of the Patents are set out in Schedule
2
and all
the details are correct. Without derogation from the generality of the
foregoing, the Patents are subsisting and all applications for Patents indicated
in Schedule
2
as
pending are pending. The legal and beneficial owner or applicant for
registration of each of the Patents specified in Schedule
2
is
correctly stated;
(v) The
Patents and Know-How are the only intellectual property rights owned by,
licensed to or used by ** or its Affiliates in relation to Products and to
the
best of **’s knowledge no intellectual property rights other than the Patents or
Know-How are required in order to Develop, manufacture, use, import and/or
sell
or commercialize Products in the Territory;
(vi) All
actions required to be taken before the Effective Date for the prosecution
and
maintenance of the Patents (including all applicable fees due and payable before
such date) have been taken or paid; and
(vii) The
Patents are not and, during the Term, will not become subject to any encumbrance
or lien in favor of any Third Party that is inconsistent with or otherwise
restricts the rights and sublicenses granted to Fidopharm
hereunder.
(f) In
regards to Development:
(i) **
**
9
(ii) All
trials related to Products have been carried out and will be carried out in
accordance with all relevant Laws;
(iii) Neither
** nor any ** Affiliate is engaged in any litigation, opposition or arbitration
proceedings affecting or relating to Products, the Patents, Know-How (including
but not limited to claims relating to product liability) as plaintiff or
defendant and there are no such proceedings pending or threatened by or against
** or any ** Affiliate and ** is not aware of facts or circumstances likely
to
give rise to any such proceedings; and
(iv) No
injunction has been granted against ** or its Affiliates in connection with
Products, the Patents or Know-How.
(g) Neither
** or any ** Affiliate has nor will provide (directly or indirectly) any Third
Party access or rights to use its Know-How (including, without limitation,
use
of any data or under any Patents) for Development, regulatory approval or
commercialization of any product containing Active A at a concentration range
between **and **weight/volume.
(h) As
of the
Effective Date, neither it nor its Affiliates has been debarred or is subject
to
debarment and neither ** nor any of its Affiliates will use in any capacity,
in
connection with the Development or commercialization of Products, any Person
who
has been debarred pursuant to Section 306 of the United States Federal Food,
Drug and Cosmetic Act, or who is subject of a conviction described in such
section. Further, ** agrees to inform Fidopharm in writing immediately if it
or
any Person who is performing services hereunder is debarred or is the subject
of
a conviction described in Section 306, or if any action, suit, claim,
investigation or legal administrative proceeding is pending or, to the best
of
**’s knowledge, is threatened, relating to the debarment of **, its Affiliates
or any Person used in any capacity by ** or its Affiliates in connection with
the Development or commercialization of Products.
8.2 Fidopharm
Representations and Warranties.
Fidopharm hereby represents and warrants to ** as follows:
(a) The
execution and delivery by Fidopharm of this Agreement and the performance by
Fidopharm of its obligations hereunder have been duly authorized by all
necessary corporate action on the part of Fidopharm, and do not conflict with
the terms of any other contract, agreement, arrangement or understanding to
which Fidopharm is a Party.
(b) Except
as
set forth herein, no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or filing with, any
federal, state or local governmental authority is required on the part of
Fidopharm in connection with the valid execution, delivery and performance
of
this Agreement, where the failure to obtain any of the foregoing would not
have
a material adverse impact on the ability of Fidopharm to meet its obligations
hereunder.
(c) Fidopharm
is and will be in material compliance throughout the Term with all of the
applicable Laws relating to Products in the Territory.
8.3 Regulatory
Cooperation.
(a) The
Parties shall disclose to each other all reports or other knowledge they receive
with respect to adverse experiences, and reports of mislabeling, stability
failures or microbiological contamination.
(b) In
addition to and without limiting the requirements of Section 8.3(a)
above,
Fidopharm and ** agree, throughout the duration of this Agreement, to notify
the
other Party immediately of any information concerning any serious or unexpected
side effect, injury, toxicity or sensitivity reaction, or any unexpected
incidents, and the severity thereof, associated with the clinical uses, studies,
investigations, tests and marketing of Products, whether or not determined
to be
attributable to Products. Each Party shall cooperate with the other to resolve
any complaints received by either Party with respect to Products.
10
(c) Each
of
Fidopharm and ** shall promptly deliver to the other all material correspondence
that such Party may receive, directly or indirectly, from regulatory authorities
in jurisdictions where such Party (or its sublicensees, distributors, or
sub-distributors) has rights to market Products, except for procedural,
nonsubstantive communications which do not relate to the safety or efficacy
of
Products. Fidopharm and ** shall also immediately notify the other Party about
any information such Party receives regarding any threatened or pending action
by a governmental agency that may affect the safety and efficacy claims of
Products or the continued marketing, promotion, distribution, sale or
manufacture of Products. Upon receipt of any such information, the Parties
shall
consult in an effort to arrive at a mutually acceptable procedure for taking
appropriate action, provided
that
nothing contained herein shall be construed as restricting either Party’s right
to make a timely report of such matter to any governmental or regulatory agency
or take other action that it deems to be appropriate or required by applicable
law or regulation. It is Fidopharm’s responsibility to report adverse events in
accordance with local Laws and requirements to governmental or regulatory
agencies in the Territory.
(d) Without
limiting the foregoing, it is also understood that each Party may notify any
of
its Affiliates, licensees, distributors or sub-licensees of any incident or
event reported by either Party under this Section 8.3.
In
addition, each Party shall, and shall require its respective Affiliates to:
(i)
to the extent permissible under time constraints and reporting requirements,
provide to the other Party in advance of initial or periodic submission to
the
applicable regulatory authorities any and all adverse event reports from
clinical trials and commercial experiences with Products; (ii) provide such
adverse event reports to the other Party contemporaneously with the provision
of
such reports to the applicable regulatory authority; and (iii) adhere to all
requirements of applicable Laws which relate to the reporting and investigation
of adverse events and keep the other Party informed of such events. If a Party
contracts with a Third Party for any research to be performed by such Third
Party on Products, that Party shall require such Third Party to report to the
contracting Party the information set forth above.
8.4 Compliance
with Laws.
Both
Parties shall comply in all material respects with all applicable Laws with
respect to the supply, Development, testing, marketing, promotion, storage,
import, distribution and sale of Products.
9. CONFIDENTIALITY
9.1 Confidentiality;
Nondisclosure; Nonuse.
During
the Term, and for ten (10) years after the termination of this Agreement, each
Party shall keep confidential the other Party’s Confidential Information and,
except as expressly permitted herein, shall not disclose such Confidential
Information to any Third Party in any manner whatsoever, in whole or in part,
without first obtaining the other Party’s prior written consent to such
disclosure. The standard of care required of each Party in protecting the
confidentiality of the other Party’s Confidential Information shall be at least
as strict as the same standard of care that the receiving Party uses in
protecting its own Confidential Information, but in no event shall either Party
use less than a reasonable standard of care. Neither Party shall use any
Confidential Information of the other Party for any purpose other than to
perform its obligations under this Agreement or as otherwise authorized under
this Agreement. The receiving Party shall ensure that its employees,
representatives, and agents comply with this provision, and shall be responsible
for any breach by such employees, representatives, or agents.
9.2 Exception
to Confidential Information.
The
foregoing obligations of confidentiality, nondisclosure and nonuse shall not
apply to any Confidential Information (a) which is now public knowledge or
which
hereafter becomes public knowledge through no breach of this Agreement by the
receiving Party; (b) which the receiving Party received without restriction
from
an independent Third Party; (c) which the receiving Party can demonstrate was
already in its possession at the time of receipt from the disclosing Party
and
not subject to another agreement between the Parties; or (d) which the receiving
Party can demonstrate was independently developed by the receiving Party in
the
course of work by the officers, directors, employees, consultants or agents
of
itself or of its Affiliates, subsidiaries or related companies without the
aid,
use or application of Confidential Information of the disclosing
Party.
11
9.3 Notification
of Mandatory Disclosure.
Each
Party may use or disclose Confidential Information of the other Party to the
extent such use or disclosure is reasonably necessary in complying with
applicable Laws or required by governmental authorities or pursuant to a court
order or otherwise submitting information to governmental authorities in
connection with clinical trials or applying for Product Registrations,
negotiating or making a permitted sublicense or otherwise exercising its rights
hereunder; provided that if a Party is required under applicable Laws or court
order to make any such disclosure of the other Party’s Confidential Information,
it shall (i) give prompt written notice to the disclosing Party of the proposed
disclosure, and allow the disclosing Party at least fourteen (14) business
days
to object to all or any portion of the disclosure before it is disclosed; (ii)
provide written notice of disclosure immediately thereafter, if advance notice
is not possible; (iii) minimize the extent of such disclosure, to the extent
possible; and (iv) seek confidential treatment of such information prior to
its
disclosure, it being understood that any information so disclosed shall
otherwise remain subject to the limitations on use and disclosure
hereunder.
9.4 Patent
Application Filing.
Notwithstanding anything to the contrary, if a disclosing Party has not filed
a
necessary Patent application with respect to any applicable Confidential
Information, it may require the receiving Party to delay the proposed authorized
or required disclosure (to the extent the disclosing Party may legally do so),
for up to ninety (90) days, to allow for the filing of such an
application.
9.5 Permitted
Disclosure to Third Parties. Except
as
expressly permitted in this Agreement, neither Party shall disclose this
Agreement or any terms of this Agreement to any Third Party without the prior
written consent of the other Party; except that such consent shall not be
required for disclosure to actual or prospective investors, collaboration
partners or the other party in a proposed investment, merger, acquisition or
a
similar transaction, or to a Party’s accountants, attorneys and other
professional advisors (provided that such disclosures shall be subject to
continued confidentiality obligations at least as strict as is set forth
herein). To the extent that either Party determines that it or the other Party
is required to file or register this Agreement or a notification thereof to
comply with the requirements of an applicable stock exchange or NASDAQ
regulation or any governmental authority, including without limitation the
U.S.
Securities and Exchange Commission, such Party shall promptly inform the other
Party thereof. Prior to making any such filing, registration or notification,
the Parties shall agree on the provisions of this Agreement for which the
Parties shall seek confidential treatment, it being understood that if one
Party
determines to seek confidential treatment for a provision for which the other
Party does not, then the Parties will use reasonable efforts in connection
with
such filing to seek the confidential treatment of any such provision. The
Parties shall cooperate, each at its own expense, in such filing, registration
or notification, including without limitation such confidential treatment
request, and shall execute all documents reasonably required in connection
therewith.
10. INDEMNIFICATION
AND INSURANCE
10.1 **’s
Indemnification Obligations.
** shall
indemnify and hold Fidopharm harmless from and against any direct costs,
expenses (including, without limitation, reasonable attorneys’ fees) or damages
which arise from breach by ** of any of its representations, covenants,
warranties or obligations set forth herein, including, without limitation,
any
claims in connection with (i) failure of Products supplied by ** to meet the
Specifications, or (ii) any breach of its representations, warranties or
covenants hereunder, except to the extent such damages are caused by or arise
from (x) the gross negligence or willful misconduct of Fidopharm; or (y) any
matter as to which Fidopharm has agreed to indemnify ** hereunder.
10.2 Fidopharm’s
Indemnification Obligations.
Fidopharm shall indemnify and hold ** harmless from and against any direct
costs, expenses (including, without limitation, reasonable attorneys’ fees) or
damages which arise from the breach by Fidopharm of any of its representations,
covenants, warranties or obligations set forth herein or from the marketing,
sale or distribution of Products by Fidopharm and its Affiliates, distributors
and permitted sublicensees, except to the extent such damages were caused by
or
arise from (i) the gross negligence or willful misconduct of **; or (ii) any
matter as to which ** has agreed to indemnify Fidopharm hereunder.
12
10.3 Indemnification
Procedure.
(a) Promptly
after the receipt by any Party hereto of notice of (a) any claim or (b) the
commencement of any action or proceeding, such Party shall, if a claim with
respect thereto is to be made against any Party obligated to provide
indemnification pursuant to Section 10.1
or
10.2
hereof
(the “Indemnifying
Party”),
give
such Indemnifying Party written notice of such claim or the commencement of
such
action or proceeding. Such Indemnifying Party shall have the right, at its
option, to compromise or defend, subject to Section 10.3(c)
below,
at its own expense and by its own counsel, any such matter involving the
asserted liability of the Party seeking such indemnification. Such notice,
and
the opportunity to compromise or defend, shall be a condition precedent to
any
liability of the Indemnifying Party under the indemnification provisions of
Section 10.1 or
10.2.
In the
event that any Indemnifying Party shall undertake to compromise or defend any
such asserted liability, it shall promptly notify the Party seeking
indemnification of its intention to do so, and the Party seeking indemnification
agrees to cooperate fully with the Indemnifying Party and its counsel in the
compromise of, or defense against, any such asserted liability. In any event,
the indemnified Party shall have the right, at its own expense, to participate
in the defense of such asserted liability, provided,
that
the Indemnifying Party’s counsel shall make all final decisions concerning the
defense or, subject to Section 10.3(c)
below,
compromise or settlement of such litigation.
(b) Each
of
the Parties hereto shall be entitled to be represented at any proceedings
brought against the other Party under this Article 10
by its
own counsel, at its own expense, and shall cooperate fully with the other Party
in any such proceeding, provided
it is
adequately reimbursed for its out-of-pocket costs and expenses, excluding
attorneys’ fees.
(c) Neither
Party may settle a claim described in this Article 10
in a
manner which would impose upon the other Party any monetary obligation or
require such other Party to submit to an injunction or otherwise limit its
rights, in each case, without the prior written consent of such other Party,
which consent shall not be unreasonably withheld, conditioned, or
delayed.
10.4 Insurance. The
Parties shall each maintain insurance in amounts commercially reasonable for
the
veterinary pharmaceutical industry commensurate with their rights and
obligations hereunder.
11. TERM
AND TERMINATION
11.1 Term.
The
initial term of this Agreement shall begin on the Effective Date and shall
continue for ten (10) years after the first Commercial Sale (the “Initial
Term”)
unless
earlier terminated pursuant to this Article 11. At the expiration of the Initial
Term, the term of this Agreement shall automatically renew for successive five
(5) year periods (the Initial Term and all such renewal periods, the
“Term”)
unless
written notice of non-renewal is provided by Fidopharm to ** at least sixty
(60)
days prior to the applicable renewal date.
11.2 Termination
by Fidopharm.
(a) Fidopharm
shall have the right to terminate this Agreement without cause and without
penalty upon ninety (90) days prior written notice to **, provided, that such
period shall be extended for a reasonable period (not to exceed another sixty
(60) days) in order to effect the transfer of Product Registrations pursuant
to
Section 11.6(e).
For
clarity, any early, without
cause
termination by Fidopharm ahead of Product registration deems all fees / costs
paid to ** as not refundable. Should such a termination by Fidopharm occur
during the implementation of the Development Plan, Fidopharm shall be liable
for
all reasonable non-cancelable ongoing costs, solely in regards to the Territory,
necessary to complete the then current Development activities; provided, that
**
shall immediately terminate such ongoing commitments as soon as possible and
shall not incur any non-necessary expenses in effectuating such termination.
13
(b) In
the
event that Fidopharm terminates the Supply Agreement pursuant to Section 12.2
or
12.3 therein, Fidopharm shall have the right to terminate this Agreement
immediately and without penalty upon written notice to **.
11.3 Termination
for Breach.
In the
event of any material default by either Party in the performance of any of
the
terms and conditions of this Agreement, the other Party may terminate this
Agreement upon ninety (90) days’ written notice; provided
that (i)
if during such ninety (90) day period the Party against whom the material
default is claimed cures such default, (ii) if such breach cannot be cured
within such ninety (90) day period, such Party takes reasonable steps to
commence and proceeds diligently thereafter to cure such default and, in fact,
cures such default within a reasonable period of time, or (iii) if such default
is cured in any other manner satisfactory to the other Party as a substitute
for
full performance, then this Agreement will continue in full force and effect
until it expires as provided herein.
11.4 Termination
for Bankruptcy, etc.
Either
Party shall be entitled to terminate this Agreement immediately:
(a) if
any
creditor of the other Party or any other person levies or attempts to levy
any
distress, execution, sequestration or other process over the business assets
of
the other Party or an encumbrancer takes or attempts to take possession of
the
business or assets of the other Party;
(b) if
a
petition shall be presented for the winding up of the other Party or if a
meeting is convened for the purpose of passing a resolution for the winding
up
of the other Party;
(c) if
a
receiver, administrative receiver, manager, trustee or administrator shall
be
appointed over all or any part of the business or assets of the other
Party;
(d) if
the
other Party or any director or creditor of such other Party shall present a
petition to the court for an administrative order in respect of such other
Party;
(e) if
the
other Party shall convene a meeting of its creditors or shall make any proposal
for or enter into any compromise, composition or scheme of arrangement with
its
creditors or make any assignment for the benefit of its creditors;
(f) if
the
other Party shall be deemed to be unable to pay its debts within the meaning
of
any relevant insolvency law or any relevant insolvency decree or regulation
(or
any statutory amendment or reenactment thereof); or
(g) if
any
event analogous to the foregoing shall occur under the laws of any relevant
jurisdiction.
11.5 Termination
for Failure.
In the
event ** fails to provide (a) the necessary technical and regulatory batches
needed for Product Registration in the Territory for the Initial Products within
the agreed to timeline in the Development Plan; or (b) provide by December
31,
2008 (i) shelf life data under accelerated conditions demonstrating **-month
and
**-month accelerated stability for Product A and Product B and (ii) clinical
efficacy of Product B, each from an independent lab reasonably acceptable to
Fidopharm, and reasonable acceptability of **of Product A and Product B **
by
Fidopharm based on commercial viability of Products, Fidopharm shall have the
right to terminate this Agreement immediately and upon such termination **
shall
reimburse any payments made to it under this Agreement and one hundred percent
(100%) of the cost and expenses expended by Fidopharm to Develop, register
and
commercialize Products in the Territory up to five hundred thousand dollars
($500,000), including all costs and expenses for obtaining the Product
Registrations (together with the upfront payment, the “Costs”);
provided, that in the event ** has accomplished (x) subsection (i) of Section
(b) above, the reimbursement shall be reduced by forty percent (40%) of the
Costs, and/or (y) subsection (ii) of Section (b) above, the reimbursement shall
be reduced by another forty percent (40%) of the Costs and/or (z) Section (a)
above, the reimbursement shall be reduced by another twenty (20%) of the
Costs.
14
11.6 Effect
of Expiration or Termination.
(a) No
expiration or termination of this Agreement pursuant to this Article
11
shall
relieve either Party of obligations accrued to such date of expiration or
termination or of obligations which continue by the terms hereof beyond such
expiration or termination, including, but not limited to, any payment
obligations hereunder. Articles 1, 9, 10 and 13 and Sections 2.4, 5.3, 6.2,
8.1,
8.2 and this Section 11.6 shall survive the termination or expiration of this
Agreement
(b) In
the
event that this Agreement expires or is terminated pursuant to Section 11.2(b),
11.3 or 11.4 the licenses granted hereunder to Fidopharm shall become
irrevocable, royalty-free, non-exclusive licenses, with the right to grant
sublicenses, to market, promote and sell Products in the Field in the
Territory.
(c) Within
thirty (30) days following the termination of this Agreement, each Party shall
destroy, delete (as to Confidential Information stored in electronic format)
or
return to the other Party all Confidential Information of the other Party,
and
shall provide the other Party written certification of such destruction or
return.
(d) After
termination of this Agreement, Fidopharm shall cease using or selling Products
pursuant to the license grant herein (for clarity, the preceding shall not
limit
Fidopharm’s rights pursuant to the licenses granted under Section 11.6(b));
provided, however, that Fidopharm may continue to sell in the ordinary course
of
business for a period of twelve (12) months reasonable quantities of Products
which are manufactured and in Fidopharm’s normal inventory at the date of
termination; provided that such Product had been ordered in-line with
Fidopharm’s forecast.
(e) In
the
event of termination of this Agreement by Fidopharm pursuant to Section 11.2(a),
Fidopharm shall (i) transfer to ** all rights, title and interests in and to
the
Product Registration and (ii) take such other steps requested by **, all of
the
foregoing at **’s sole cost and expense, to effect the transfer.
Fidopharm will provide all reasonable support, at **’s reasonable cost, to
facilitate the transfer of such Product Registrations in a timely
manner.
12. INJUNCTIVE
RELIEF AND DISPUTE RESOLUTION
12.1 Equitable
Relief.
Notwithstanding anything to the contrary in this Agreement, either Party will
have the right to seek temporary injunctive relief or the ordering of specific
performance in any court of competent jurisdiction as may be available to such
Party under the laws and rules applicable in such jurisdiction with respect
to
any matters arising out of the other Party’s performance of or failure to
perform its obligations under this Agreement.
12.2 Dispute
Resolution. In
the
event the Parties are unable to resolve any controversy or claim arising from
this Agreement (“Dispute”),
the
Parties will submit such Dispute to arbitration under the rules of the American
Arbitration Association, as the same may be amended by mutual agreement of
the
Parties. The Dispute shall be submitted to an expert panel in the pertinent
field for binding arbitration. Such expert panel may be mutually agreed by
the
Parties, but if no such agreement is reached within ten (10) days after the
written notice from one Party to the other, then each Party shall promptly
select one expert, and those two (2) shall select a third expert, the three
(3)
of whom shall comprise the expert panel. The arbitrator(s) shall determine
what
discovery will be permitted, based on the principle of limiting the cost and
time which the parties must expend on discovery; provided, the arbitrator(s)
shall permit such discovery as they deem necessary to achieve an equitable
resolution of the dispute. Both Parties will cooperate in providing fully to
each other all requested information and documents relating to the arbitration
proceedings, except for information and documents subject to any privilege.
The
place of any arbitration proceedings shall be New York, New York or such other
location as the Parties may mutually agree. During the arbitration proceedings,
except for the matter that is in dispute and under arbitration, this Agreement
shall continue to be implemented by both Parties. Unless the expert panel for
good cause determines otherwise, each Party shall bear one-half of the fees
and
expenses of the experts and shall bear its own costs and attorneys’ fees in
connection with the arbitration proceeding; provided that the arbitrator(s)
may
in their discretion award to the prevailing party the costs and expenses
incurred by the prevailing party in connection with the arbitration proceeding.
The decision and/or award rendered by the arbitrator(s) shall be written, final
and non-appealable and may be entered in any court of competent jurisdiction.
The provisions of this subsection shall not prohibit either Party from seeking
equitable relief to restrain any breach or threatened breach of this Agreement
at any time in any court of competent jurisdiction as may be available to such
Party under the laws and rules applicable in such jurisdiction. The arbitral
proceedings and all pleadings and written evidence shall be in the English
language. Any written evidence originally in a language other than English
shall
be submitted in English translation accompanied by the original or true copy
thereof.
15
13. MISCELLANEOUS
13.1 Force
Majeure. Neither
Party hereto shall be liable for damages, nor shall this Agreement be terminable
or cancelable by reason of any delay or default in such Party’s performance
hereunder (other than the payment of monies due and owing to a Party under
this
Agreement) if such default or delay is caused by acts of God, acts of public
enemies, war or insurrection, civil commotion, destruction of production
facilities or materials by earthquake, fire, flood or storm, epidemics, labor
disputes or strikes, or failure of public utilities (“Force
Majeure”).
Each
Party shall endeavor to resume its performance hereunder as soon as reasonably
possible if such performance is delayed or interrupted by reason of Force
Majeure.
13.2 Further
Assurances.
Each of
the Parties shall, from time to time during the term of this Agreement, upon
request by the other, execute and deliver all such further documents or
instruments as may be required in order to give effect to the purpose and intent
of this Agreement.
13.3 Assignment.
Neither
Party shall assign this Agreement without the prior written consent of the
other
Party, provided, that either Party may assign this Agreement without the prior
written consent of the other Party (a) to an Affiliate or (b) to a party in
connection with the sale or transfer of substantially all of its assets with
respect to the business to which this Agreement is related to such party. Any
permitted assignee shall assume all obligations of its assignor under this
Agreement. Any purported assignment in violation of this Section 13.3
shall be
void. No assignment shall relieve either Party of responsibility for the
performance of any accrued obligation that such Party then has
hereunder.
13.4 Choice
of Law.
This
Agreement shall be governed by, and construed in accordance with, the laws
of
the State of Delaware, USA, without giving effect to its principles of conflicts
of laws. The Parties hereby submit to the exclusive jurisdiction of, and waive
any venue objections against, federal and state courts of competent jurisdiction
in the State of Delaware in any litigation or dispute arising out of this
Agreement. The prevailing party in any dispute or legal action regarding the
subject matter of this Agreement shall be entitled to recover attorney’s fees
and costs.
13.5 Notices.
Any
notice, request or other communication required or permitted by this Agreement
to be given by any Party to another Party shall be in writing and either mailed
by registered or certified mail, return receipt requested, by express delivery
service or by facsimile transmission, addressed to such Party, Attention: the
Managing Director, at its address indicated in the preamble or to such other
address as such Party previously may have designated by like written notice.
Notice shall be deemed to have been given upon receipt. Facsimile transmission
numbers for the Parties are as follows:
16
If
to Fidopharm:
Fidopharm,
Inc.
000
Xxxxxxxx Xxxx Xxxx, Xxxxx 000
Xxxxxxx,
XX 00000
Xxxxxx
Xxxxxx of America
Attn:
**
Tel:
Fax:
|
with
a copy to:
Xxxxxx,
Xxxxx & Xxxxxxx
0000
Xxxxxx Xxxxxx
Xxxxxxxxxxxx
XX, 00000
Xxxxxx
Xxxxxx of America
Attn:
Fahd M.T. Riaz, Esq.
Tel:
(000) 000-0000
Fax:
(000) 000-0000
|
If
to **:
**
**
|
with
a copy to:
**
|
13.6 Entire Agreement.
This
Agreement constitutes the entire agreement between the Parties with respect
to
the subject matter hereof and supersedes all prior written or oral agreements
or
understandings regarding the subject matter hereof or in conflict with its
terms, including but not limited to, the License and Development Agreement
entered into by the Parties on February 15, 2008. This Agreement will be
construed as if it were drafted jointly by the Parties and shall not be strictly
construed against either Party.
13.7 Amendments;
Waivers.
No
modification of any of the terms of this Agreement shall be deemed valid unless
it is in writing and signed by the Party against whom such modification is
sought to be enforced. The failure of either Party to insist upon the strict
performance of any term of this Agreement or the waiver by either Party of
any
breach under this Agreement shall not prevent the subsequent strict enforcement
of such term nor be deemed a waiver of any subsequent breach.
13.8 Severability.
In the
event any court declares illegal or unenforceable, as written or applied, any
provision of this Agreement, such provision shall be severed and the remaining
provisions of this Agreement shall continue in full force and effect as if
such
provision had been deleted or made inapplicable to the situations to which
such
provision cannot be legally applied. The Parties shall use their best efforts
to
agree upon a valid and enforceable provision as a substitute for the severed
provision, taking into account the intent of this Agreement.
13.9 Independent
Contractors.
Each
Party is an independent contractor under this Agreement. Nothing contained
in
this Agreement is intended nor is to be construed so as to constitute ** or
Fidopharm as partners or joint venturers with respect to this Agreement. Neither
Party shall have any express or implied right or authority to assume or create
any obligations on behalf of or in the name of the other Party, or to bind
the
other Party to any other contract, agreement or undertaking with any Third
Party
or Affiliate.
13.10 Counterparts.
This
Agreement may be executed by fax and in one or more counterparts, each of which
shall be deemed to be an original but all of which together shall constitute
one
and the same instrument.
13.11 Headings.
The
headings used in this Agreement have been inserted for convenience of reference
only and do not define or limit the provisions hereof.
***
Remainder of Page Intentionally Left Blank; Signature Page Follows
***
17
IN
WITNESS WHEREOF,
the
Parties hereto have executed this Agreement as of the Effective
Date.
FIDOPHARM,
INC.
|
/s/
**
|
Name:
**
|
Title:
President & CEO
|
/s/
**
|
Name:
**
|
Title:
CEO
|
18
SCHEDULE
1
**
19
SCHEDULE
2
Patents
No
Patents exist as of the Effective Date.
20
SCHEDULE
4.2
**
21