CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.*** TECHNICAL TRANSFER AGREEMENT
EXHIBIT
10.38.3
CONFIDENTIAL
TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS
DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED
WITH THE COMMISSION.***
THIS
TECHNICAL TRANSFER AGREEMENT is made and entered into this 8th day of September,
2005 (the “Effective
Date”), by
and
between INYX,
INC.,
having
an address at 000 Xxxxx Xxxxxx, 00xx
Xxxxx,
Xxx Xxxx, Xxx Xxxx 00000 (“Inyx”)
and
KING
PHARMACEUTICALS, INC.,
having
an address at 000 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxx 00000 (“King”)
(each
individually a “Party”
and
collectively the “Parties”).
WITNESSETH
THAT
WHEREAS,
Inyx has expertise and experience in conducting development and technical
transfer services related to the formulation and/or finishing of pharmaceutical
products and has both pilot plant and commercial scale facilities to manufacture
and package such products and is interested in providing such development,
technical transfer and manufacturing services to King in the pharmaceutical
area;
WHEREAS,
King has a commercial interest in the manufacture and packaging of certain
pharmaceutical products presently sold under the Intal® and Tilade® trademarks
(hereinafter each individually “Product”
and
collectively referred to as the “Products”),
and,
concurrently herewith, the Parties are executing other Collaboration Documents
(as defined below) including a definitive Manufacturing and Supply Agreement
(the “Supply
Agreement”)
pursuant to which Inyx would be the manufacturer, packager and supplier of
the
Products to King; and
WHEREAS,
the parties have entered into that certain Collaboration Agreement between
King
and Inyx, dated of even date herewith (the “Collaboration
Agreement”),
for
the purpose of pursuing a collaboration relating to the development, marketing
and promotion of Products; and
WHEREAS,
in anticipation of the Supply Agreement and the goods and services that Inyx
will supply thereunder, the Parties desire to enter into a binding agreement
pursuant to which Inyx would undertake certain technical transfer services
for
King in order to validate and scale up King’s technology package and prepare
Inyx’s
facilities for the manufacture and packaging of the Products.
NOW,
THEREFORE, in consideration of the mutual covenants contained herein, Inyx
and
King hereby agree as follows:
ARTICLE
1
DEFINITIONS
Unless
otherwise specifically defined in this Agreement, each capitalized term used
herein will have the meaning assigned to such term in the Collaboration
Agreement. In addition, the following terms, whether used in the singular
or
plural, shall have the meanings assigned to them below for purposes of this
Agreement:
CONFIDENTIAL
TREATMENT
“Agreement”
means this Technical Transfer Agreement, and all schedules and annexes attached
hereto, as it may from time to time be supplemented or modified by written
amendment(s) signed by the parties.
“Assignor”
has the meaning set forth in Section 2.9.
“cGMP
Regulation” means Current Good Manufacturing Practices (i) as promulgated under
the Act, at 21 CFR 210 and 211, as the same may be amended or re-enacted
from
time to time and (ii) as required by Law in Canada, as applicable.
“Chemicals
and Materials” means the chemicals (other than Drug Substance) and other
materials, such as cartons and bottles, required to manufacture the
Product.
“Collaboration
Agreement” has the meaning set forth in the recitals.
“Collaboration
Documents” means, collectively, this Agreement, the Collaboration Agreement, the
Quality Agreement, the Supply Agreement, the Marketing and Promotion Agreement,
and the Development Agreement.
“Confidential
Information” has the meaning set forth in Section 3.1(a).
“Drug
Substance” means with respect to the Products, the active ingredient cromolyn
sodium micronized stage 9 for Intal and nedocromil sodium dried stage 11
for
Tilade in a form intended for further processing into a pharmaceutical
formulation, and which contains at least each active ingredient and may contain
inert ingredients but is not in a final formulation intended for administration
to patients, and shall not include other Chemicals and Materials.
“Effective
Date” has the meaning set forth in the recitals.
“Facility”
means Inyx’s production facility located in Manati, Puerto Rico or other Inyx
facilities as mutually agreed upon, and as approved by the FDA.
“Intal”
means the cromolyn sodium inhaler pharmaceutical product in a
chloro-fluoro-carbon (CFC) propellant driven inhaler and more particularly
identified in NDA# 18-887, and amendments thereto.
“Inyx”
has the meaning set forth in the recitals.
“King”
has the meaning set forth in the recitals.
“Laws”
means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of the United States, any foreign
country, supranational entity or any domestic or foreign state, province,
county, city or other political subdivision of any regulatory
authority.
CONFIDENTIAL
TREATMENT
2
“Manufacturing
Process” means the process for manufacturing the Product which is developed,
adapted, validated and/or confirmed during Inyx’s performance of the Services
hereunder using King’s technology package.
|
“Services”
mean the services described in Exhibit
1.
|
“Specifications”
means the specifications established or otherwise approved by King for the
Products.
“Term”
has the meaning set forth in Section 7.1.
“Tilade”
means the nedocromil sodium pharmaceutical product in a chloro-fluoro-carbon
(CFC) propellant driven inhaler and more particularly identified in NDA#
19-660,
and any amendments thereto.
ARTICLE
2
SERVICES
2.1 Description
of Services.
Inyx
shall perform the Services (as outlined in Exhibit
1
hereto)
including any modifications and additions thereto agreed upon by the Parties
to
develop and confirm the Manufacturing Process, and to establish Specifications
for manufacturing and packaging Tilade and packaging Intal. Inyx shall use
its
commercially reasonable efforts to complete the Services in a timely fashion
in
accordance with a schedule agreed upon by the Parties.
2.2 *
*
*
2.3 King’s
Responsibilities.
To
assist Inyx in its performance of this Agreement, King shall provide Inyx,
in a
timely fashion, with all relevant information, documentation and data (including
without limitation information, any documentation and data relating to product
safety and information, documentation and data, including NDA numbers, NDC
codes, etc., necessary for Inyx to drug list the product) necessary or
appropriate for Inyx’s performance hereunder. If requested by Inyx to provide
support or information, King shall provide such reasonable and necessary
support
or information in order to perform the Services under this Agreement (or
an
explanation of the legitimate reason for any delay and a projected date by
which
such support or information will be provided) within five (5) business days
of
Inyx’s request. In the event King is to review or approve any information,
documentation, data or samples prepared or supplied by or on behalf of Inyx,
it
shall complete such review and approval process within five (5) business
days.
Inyx shall cooperate with King in the performance of this Agreement and shall
deal honestly and in good faith with King. It is understood and acknowledged
by
the Parties that King shall retain ownership of the NDA to the Products and
any
supplements thereto, and is responsible for the NDA submission documents
and all
correspondence with the FDA.
CONFIDENTIAL
TREATMENT
3
2.4 Inyx
Responsibilities.
Inyx
shall ensure that any and all Drug Substance, components, and materials supplied
by Inyx are suitable for use under this Agreement, comply with all applicable
Laws and regulations (including without limitation those relating to the
import
of such materials) and receive all required governmental and regulatory
approvals, including without limitation customs and FDA approvals. Furthermore,
Inyx shall provide to King all documentation necessary to support King’s
submissions to the FDA, or any responses to questions raised by the FDA,
which
are necessary for FDA approval of Inyx’s Manati, Puerto Rico site as the
manufacturing, testing and packaging site for King’s Products. Inyx shall notify
King promptly if an authorized agent of a regulatory agency visits its
manufacturing and packaging facility where the Products are being manufactured,
packaged or quality tested. Inyx shall provide copies of all regulatory
correspondence related to the Products to King within forty-eight (48) hours
of
receipt. King shall have fifteen (15) days to review such correspondence
and to
provide comments to Inyx. Should Inyx choose not to include or address King’s
comments when responding to the regulatory agency, then Inyx shall provide
King
a reason in writing as to why King’s comments were not included or addressed.
2.5 Reporting/Transfer
of Results / Project Managers.
Inyx
shall respond to King’s inquiries regarding the status of the Services on an
ongoing basis, and Inyx shall endeavor to keep King informed of interim results.
Inyx shall provide copies of all analytical, cleaning, and process validation
protocols and summaries for King’s review, comments and approval prior to
implementation and execution. Once such protocols and summaries have been
approved and executed, copies shall be provided to King. Upon request, Inyx
shall provide to King an Intal and Tilade development report which summarizes
the implementation efforts of the Services at the Facility. Inyx and King
will
each appoint a Project Manager, who will meet as needed to resolve any issues
or
problems associated with the Services. Upon reasonable request by King and
without unduly interfering with Inyx’s business operations, King shall have the
right to visit the Inyx manufacturing, packaging and testing site for the
Products.
2.6 Dispute
Resolution.
(a) The
Parties recognize that disputes may arise from time to time during the term
of
this Agreement that relate to either Party’s rights and/or obligations
hereunder. It is the objective of the Parties to establish procedures to
facilitate the resolution of disputes arising under this Agreement in an
expedient manner by mutual cooperation. To accomplish this objective, the
parties agree to follow the procedures set forth in this Section
2.6
if and
when a dispute arises under this Agreement.
(b) Unless
otherwise specifically recited in the Agreement, disputes between the Parties
under this Agreement shall be first referred to the AMC by either Party as
soon
as reasonably possible after such dispute has arisen. If the AMC is unable
to
resolve such a dispute within fifteen (15) days of being requested by a Party
to
resolve such dispute, either Party may, by written notice to the other, have
such dispute referred to their respective executive officers designated below
or
their designees, for attempted resolution by negotiations within fifteen
(15)
days after such notice is received. The designated officers are as
follows:
CONFIDENTIAL
TREATMENT
4
For
King: Xxxxx
Xxxxxxxx, President & CEO
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Facsimile:
(000) 000-0000
For
Inyx:
Dr.
Xxxx
Xxxxxxx, Chairman & CEO
Inyx,
Inc.
000
Xxxxx
Xxxxxx, 00xx
Xxxxx
Xxx
Xxxx,
XX 00000
Telephone:
(000) 000-0000
Facsimile:
(000) 000-0000
Email:
xxxxxxxx@xxxxxxx.xxx
In
the
event such designated officers are unable to resolve such dispute, the decision
of King, with respect to regulatory and manufacturing matters relating to
the
Product(s) shall be binding on the parties, as long as Inyx’s cGMP status as to
regulatory and manufacturing matters is not compromised by such decision.
Notwithstanding the foregoing, this Paragraph shall not apply to determinations
as to whether either Party is in breach of any of its obligations under this
Agreement.
2.7 Ownership
of Tangible Materials.
King
shall retain ownership of all information, documents and materials which
King
provides to Inyx in connection with the performance of the Services hereunder,
and King shall have the right to use, all reports, documents and other tangible
materials which Inyx provides to King in the performance of the Services.
Any
such Confidential Information, documents, and materials shall be subject
to
Article
3.
Furthermore, King will have sole and exclusive ownership of all right, title,
and interest on a worldwide basis, with full rights to license or sublicense,
subject to the licenses granted Inyx in the Collaboration Documents, in and
to
any and all
(a) the
Products and New Products,
(b) Technology
transferred to Inyx’s facilities pursuant to this Agreement,
(c) Technology
and Patent Rights as they exist as of the Effective Date, and
(d) any
Improvements to the Technology and all associated Patent Rights, developed
after
the Effective Date during the Term, whether developed by King or Inyx or
jointly
by King and Inyx and any permitted Third Parties, including all rights to
any
Technology and Patent Rights related to Excluded New Products;
provided
that such ownership of right, title, and interest does not extend to the
Inyx
Respiratory Products.
2.8 Inventions
Disclosure and Generally.
Each
Party will promptly provide the AMC with written notice concerning all
Improvements that are conceived, made, or developed by employees or Consultants
of either of them or their Affiliates, whether alone or jointly with the
other
Party or its Affiliates or with permitted Third Parties. Such notice will
be
treated as the Confidential Information of King hereunder. The provisions
of
Section
2.7 and 2.8 and 2.9
will
apply to rights in Improvements conceived, made, or developed by King or
Inyx,
or both, during the course of carrying out the Collaboration
Program.
CONFIDENTIAL
TREATMENT
5
2.9 Assignment.
Inyx
agrees to, and hereby does, and will cause each of its employees, Consultants,
Affiliates, and permitted sublicensees (collectively with Inyx, the “Assignors”)
to, transfer, assign, and convey exclusively to King, its successors and
assigns, forever, the entire right, title, and interest in and to all
Improvements developed by each such Assignor, alone or jointly with each
other
or King, including all intellectual property rights associated therewith.
Inyx
further agrees, and will cause the other Assignors, (i) to promptly provide
King
with written notice, in sufficient detail, of any Improvements such Assignor
makes pursuant to the Collaboration Documents and (ii) to provide King with
such
additional information and to execute and deliver, and to cause the other
Assignors to execute and deliver, any documents or take any other actions
or
otherwise cooperate with King as may reasonably be necessary, or as King
may
reasonably request, to document, enforce, protect, or otherwise perfect King’s
rights in any Improvement, including filing any applicable patent
applications.
2.10 Employees.
Inyx
agrees to have each employee enter into a written agreement with Inyx that
includes an assignment to Inyx, or directly to King with respect to all
Improvements, of all right, title, and interest in and to all work product
and
all inventions arising during the course of his or her employment with Inyx
in
connection with such Improvements or the Collaboration Program, and all
intellectual property rights attaching thereto.
2.11 Non-Compete.
Inyx
acknowledges and agrees that it is subject to the non-competition provisions
of
Section 7.1 of the Collaboration Agreement, which provisions will continue
throughout the term of the Collaboration Agreement notwithstanding the
termination or expiration of this Agreement.
ARTICLE
3
CONFIDENTIALITY
3.1 Nondisclosure
Obligations.
(a)
Each
party acknowledges that it may receive confidential or proprietary information
(the “Confidential
Information”)
of the
other party in the performance of the Collaboration Documents, including
information obtained or reviewed in connection with any audits or investigations
performed pursuant to this Agreement. Each party will hold confidential and
will
not, directly or indirectly, disclose, publish, or use for the benefit of
any
Third Party or itself, except in carrying out its duties under the Collaboration
Documents, any confidential or proprietary information of the other party
or
confidential or proprietary information jointly developed by the parties,
without first having obtained the furnishing party’s written consent to such
disclosure or use. “Confidential Information” will include know-how, scientific
information, clinical data, efficacy and safety data, adverse event information,
formulas, methods and processes, specifications, pricing information (including
discounts, rebates, and other price adjustments), and other terms and conditions
of sales, customer information, business plans, and all other intellectual
property. The Patent Rights and Technology will be deemed the Confidential
Information of King. The restrictions in this Article 3 will not apply
to
any information that:
CONFIDENTIAL
TREATMENT
6
(i) is
or
becomes part of the public domain other than by unauthorized acts of the
receiving party or its Affiliates, sublicensees, Consultants, and contractors,
as applicable;
(ii) can
be
shown by written documentation to have been disclosed to the receiving party
or
its Affiliates or sublicensees by a Third Party who was not otherwise prohibited
from transmitting the information to the receiving party by a contractual,
legal, or fiduciary obligation of confidence to the disclosing
party;
(iii) prior
to
disclosure under this Agreement, was already in the possession of the receiving
party or its Affiliates or sublicensees, provided such information was not
obtained directly or indirectly from the other party hereto pursuant to a
confidentiality agreement;
(iv) can
be
shown by written documentation to have been independently developed by the
receiving party or its Affiliates without breach of any of the provisions of
this Agreement, including without reference to the Confidential Information
of
the disclosing party;
(v) is
disclosed by the receiving party pursuant to oral questions, interrogatories,
requests for information or documents, subpoena, or a civil investigative demand
of a court or governmental agency; provided, however, that the receiving party
notifies the other party promptly following receipt thereof so that the other
may seek a protective order or other appropriate remedy to prevent or limit
such
disclosure; and provided further that the receiving party furnishes only that
portion of the information that it is advised by counsel is legally required
and
imposes such obligations of secrecy as are possible in that regard;
(vi) is
required or permitted to be disclosed by the receiving party under any
statutory, regulatory, or similar legislative requirement or any rule of any
stock exchange to which it or any Affiliate is subject; provided, however,
that
the other party will be allowed to review the proposed disclosure and the
receiving party agrees to consider in good faith any proposed revisions thereof
provided to the receiving party within two (2) business days of the other
party’s receipt of the proposed disclosure, and the parties will seek
confidential treatment for such disclosure as permitted by applicable law;
or
(vii) is
required by authorities to obtain Regulatory Approval.
(b) The
receiving party agrees that it will disclose the Confidential Information only
to its employees and Consultants who need to know such Confidential Information
for such party to perform its obligations hereunder. The receiving party agrees
(i) to inform all of its employees and Consultants who receive Confidential
Information of the confidential nature thereof and to direct all such employees
and Consultants to treat the Confidential Information confidentially in
accordance with this Agreement; (ii) to be responsible for any breach of the
Agreement by any of its employees and Consultants; and (iii) to make all
reasonable, necessary, and appropriate efforts to safeguard the Confidential
Information from disclosure other than as permitted hereby, which will include
requiring all employees and Consultants who have access to Confidential
Information of the disclosing party to execute written obligations to maintain
the same in confidence and not to use such information except as expressly
permitted under the Collaboration Documents. Each party agrees to enforce
confidentiality obligations to which its employees and Consultants are
obligated.
CONFIDENTIAL
TREATMENT
7
(c) Upon
the
expiration or termination of this Agreement or upon request of the disclosing
party, the receiving party will return to the disclosing party any and all
Confidential Information of the disclosing party and any reproductions
thereof.
(d) The
obligations set forth in this Article 3 will survive the termination or
expiration of this Agreement for a period of five (5) years
(or, in
the case of any Confidential Information identified as a trade secret by the
disclosing party at the time of disclosure, for so long as such trade secret
Confidential Information is susceptible of remaining a trade
secret).
3.2 Terms
of this Agreement.
The
Parties agree not to disclose any terms or conditions of this Agreement to
any
Third Party without the prior consent of the other Party, except as required
by
applicable Laws.
3.3 Injunctive
Relief.
The
Parties hereto understand and agree that remedies at law may be inadequate
to
protect against any breach of any of the provisions of this Article 3 and
Sections 2.8 through 2.10 by either Party or their employees, agents, officers
or directors or any other person acting in concert with it or on its behalf.
Accordingly, each Party may be entitled to the granting of injunctive relief
by
a court of competent jurisdiction against any action that constitutes any such
breach of this Article 3 and Sections 2.8 through 2.10.
ARTICLE
4
INYX’S
REPRESENTATIONS,
WARRANTIES
AND COVENANTS
Inyx
represents, warrants and covenants to King as follows:
4.1 Commercially
Reasonable Efforts.
Inyx
shall use its commercially reasonable efforts to perform the Services in
accordance with the agreed upon timeline, which is attached as Exhibit
2
(the
“Timeline”).
In
the event Inyx is not able to meet the Timeline, Inyx will provide written
notice to King of such inability as soon as practical, but in any event, within
seventy-two (72) hours of discovering such inability.
4.2 Qualified
Personnel and Services.
Inyx
shall engage and employ professionally qualified personnel to perform the
Services contemplated hereunder. Inyx represents and warrants that there is
no
claim, suit, proceeding, or other investigation pending, or to the actual
knowledge of Inyx, overtly threatened against Inyx which is likely to prevent
or
materially adversely affect the rights and interests of King hereunder. Inyx
represents and warrants that neither it nor any member of its staff has been
disqualified or debarred by the FDA for any purpose. If during the Term of
this
Agreement, Inyx becomes aware that Inyx or any member of its staff is or is
about to become disqualified or debarred, Inyx will provided immediate written
notice of same to King. Inyx represents and warrants, to the best of its
knowledge, that neither it nor any member of its staff has been charged with
or
convicted under federal law for conduct relating to the development or approval
of any NDA or Abbreviated New Drug Application (“ANDA”),
or
otherwise relating to the regulation of any drug product under any relevant
statute, law, or regulation. If at any time Inyx or any member of its staff
is
charged with or convicted under federal law for conduct relating to the
development or approval of any NDA or ANDA, or otherwise relating to the
regulation of any drug product under any relevant statute, law, or regulation,
Inyx will provide immediate written notice of same to King. Inyx represents
and
warrants that it shall comply in all material respects with all Laws applicable
to the conduct of its business pursuant to this Agreement, including, but not
limited to, the Act. Inyx hereby warrants that the Services provided for herein
will be performed in accordance with the cGMP Regulations and applicable
Laws.
CONFIDENTIAL
TREATMENT
8
4.3 Disclaimer.
THE
FORGOING EXPRESS WARRANTIES AND THOSE IN ARTICLE 5 ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY
OF
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE, OR AGAINST INFRINGEMENTS,
AND ALL OTHER WARRANTIES ARE HEREBY DISCLAIMED AND EXCLUDED BY EACH PARTY.
ARTICLE
5
GENERAL
REPRESENTATION AND WARRANTIES
Each
Party represents, warrants and covenants to the other as follows:
5.1 Power
and Authorization.
It has
all requisite power and authority (corporate and otherwise) to enter into this
Agreement and has duly authorized by all necessary action the execution and
delivery hereof by the officer or individual whose name is signed on its behalf
below.
5.2 No
Conflict.
Its
execution and delivery of this Agreement and the performance of its obligations
hereunder do not and will not conflict with or result in a breach of or a
default under its organizational instruments or any other agreement, instrument,
order, Laws or regulations applicable to it or by which it may be
bound.
5.3 Enforceability.
This
Agreement has been duly and validly executed and delivered by it and constitutes
its valid and legally binding obligation, enforceable in accordance with its
terms, except as enforcement may be limited by bankruptcy, insolvency or other
laws of general application relating to or affecting the enforcement of
creditors’ rights and except as enforcement is subject to general equitable
principles.
CONFIDENTIAL
TREATMENT
9
5.4 Compliance
with Applicable Laws.
Each
Party shall comply with all applicable Laws in connection with the performance
of this Agreement.
ARTICLE
6
INDEMNIFICATION
6.1 Indemnification
by King.
Except
as otherwise provided in Section
6.2
below,
King shall indemnify, defend and hold Inyx, its Affiliates and their respective
directors, officers, employees, agents, successors and assigns harmless from
and
against any Third Party damages, judgments, claims, suits, actions, liabilities,
costs and expenses (including, but not limited to, reasonable attorneys’ fees)
arising out of or connected with (a) King’s negligent acts or omissions or
willful misconduct in connection with King’s activities in support of Inyx’s
performance of the Services hereunder, (b) King’s material breach of any of
its warranties, representations, or covenants hereunder, or (c) a claim that
the
Services or the manufacture or handling of the Product infringes a United States
patent or any other proprietary rights, if it is a claim related to the use
of
King’s technology and know-how.
6.2 Indemnification
by Inyx.
Except
as otherwise provided in Section 6.1
above,
Inyx shall indemnify, defend and hold King, its Affiliates and their respective
directors, officers, employees, agents, successors and assigns harmless from
and
against any Third Party damages, judgments, claims, suits, actions, liabilities,
costs and expenses (including, but not limited to, reasonable attorneys’ fees)
resulting from any Third Party claims or suits arising solely out of (a) the
Services or the handling of the Products; (b) Inyx’s material breach of any
of its warranties, representations, or covenants hereunder; (c) Inyx’s
negligent acts or omissions or willful misconduct in its performance of the
Services or the manufacture, packaging, labeling, or storing of the Product;
or
(d) a claim that the Services or the manufacturing or handling of the Products
infringes a United States patent or any other proprietary rights as the claim
relates to the use of Inyx technology and know-how.
6.3 Indemnification
Procedures.
A Party
which intends to claim indemnification under this Article 6
(the
“Indemnitee”)
shall
promptly notify the other Party (the “Indemnitor”)
in
writing of any action, claim or other matter in respect of which the Indemnitee
or any of its Affiliates, or any of their respective directors, officers,
employees or agents intend to claim such indemnification; provided,
however,
the
failure to provide such notice within a reasonable period of time shall not
relieve the Indemnitor of any of its obligations hereunder except to the extent
the Indemnitor is prejudiced by such failure. The Indemnitee, its Affiliates,
and their respective directors, officers, employees and agents shall cooperate
fully with the Indemnitor and its legal representatives in the investigation,
negotiation, compromise, settlement and defense of any action, claim or other
matter covered by this indemnification. The Indemnitor shall be in charge of
and
control of any such investigation, negotiation, compromise, settlement and
defense and shall have the right to select counsel with respect thereto,
provided that the Indemnitor shall promptly notify the Indemnitee of all
developments in the matter. In no event shall the Indemnitor or Indemnitee
compromise or settle any such matter without the prior written consent of the
other Party, who shall not be bound by any such compromise or settlement absent
such prior consent, which shall not be unreasonably withheld or delayed;
provided that the Indemnitee will have no right to withhold its consent to
any
settlement if the settlement involves only the payment of money by the
Indemnitor or its insurer. The Indemnitee shall have the right, but not the
obligation, to be represented by counsel of its own selection and at its own
expense.
CONFIDENTIAL
TREATMENT
10
6.4 Survival
of Indemnification Obligations.
The
provisions of this Article 6
shall
survive the expiration or termination of this Agreement.
6.5 Disclaimer
of Consequential Damages.
In no
event shall either Party be liable to the other Party for incidental, special,
or consequential damages, including, but not limited to, any claims for damages
based upon lost profits.
ARTICLE
7
TERM
AND TERMINATION
7.1 Term.
Subject
to Section
2.2
and the
provisions of this Article
7,
this
Agreement shall remain in full force and effect unless and until terminated
or
expired in accordance with the provisions of this Article (the “Term”).
7.2 Termination
by Mutual Agreement.
This
Agreement may be terminated at any time upon mutual written agreement between
the Parties.
7.3 Termination
for Default.
Each
Party will have the right to terminate this Agreement at any time upon written
notice to the other Party, if such other Party breaches in a material way any
of
the representations, warranties, covenants, or agreements set forth in this
Agreement or otherwise materially defaults in the performance of any of its
duties or obligations under this Agreement, which breach or default is not
cured
or, if the breach or default is not capable of being cured within sixty days,
commenced to be cured and diligently pursued, in each case, within sixty (60)
days after written notice is given to the breaching Party specifying the breach
or default.
7.4 Bankruptcy;
Insolvency.
To the
extent permitted by law, each Party will have the right to terminate this
Agreement immediately upon notice to the other Party, if such other Party is
declared bankrupt or insolvent, if there is an assignment for the benefit of
creditors, or if a receiver is appointed or proceedings commenced (and not
dismissed within sixty (60) days), voluntarily or involuntarily, under any
bankruptcy or similar law.
7.5 Termination
by King.
(a)
Subject to the terms of Section 7.5(b) below, King will have the right to
terminate this Agreement immediately upon written notice to Inyx if there is
a
Change of Control of Inyx.
(b) Notwithstanding
Section 7.5(a) above, if, at least thirty (30) days prior to any Change of
Control of Inyx, Inyx notifies King of a contemplated Change of Control and
provides King with a Change of Control Notice, King shall not have the right
to
terminate this Agreement upon occurrence of such Change of Control unless it
notifies Inyx in writing within fifteen (15) days of its receipt of such Change
of Control Notice of its decision to terminate this Agreement. In the event
that
King does notify Inyx, as provided herein, of King’s intent to terminate this
Agreement upon a Change of Control of Inyx, Inyx shall have seven (7) days
from
such notice to terminate the contemplated Change of Control prior to its
completion and have this Agreement remain in full force and effect; provided
that any such termination of a Change of Control will not be deemed a waiver
of
King’s ability to exercise its rights under this Section 7.5 with respect to any
future Change of Control of Inyx.
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7.6 Effects
of Termination of this Agreement.
Should
either King or Inyx exercise their right to terminate this Agreement (but not
in
the event of an expiration of this Agreement as set forth in Section 7.9),
then
all other Collaboration Documents will concurrently terminate.
7.7 No
Release.
Neither
the termination nor expiration of this Agreement will release or operate to
discharge either Party from any liability or obligation that may have accrued
prior to such termination or expiration. Any termination of this Agreement
as
provided herein will not be an exclusive remedy but will be in addition to
any
remedies whatsoever that may be available to the terminating Party.
7.8 Obligations.
Notwithstanding the giving of any notice of termination pursuant to this
Article
7,
each
Party will continue to fulfill its obligations under this Agreement at all
times
until the effective date of any such termination or expiration.
7.9 Expiration.
This
Agreement shall expire and the Supply Agreement shall become effective upon
King’s approval and release of *** validation lots of the Products for
commercial sale, and technical transfer shall be considered complete at such
time. The technical transfer must occur within *** of King’s initial purchase
order for Products.
7.10 Rights
and Duties Upon Termination.
Upon
termination of this Agreement and in accordance with Sections
7.2, 7.3, 7.4, 7.5, and 7.6
Inyx
shall, as promptly as practicable, (i) cease work on the Services, and (ii)
turn
over to King all results and information obtained during the Services (whether
in written or electronic form) which are then in Inyx’s possession and which are
the property of King in accordance with Article
2
of this
Agreement.
7.11 Payments
Upon Termination.
The
expiration or termination of this Agreement pursuant to this Article
7
will not
release either Party from any obligation to pay to the other Party any amounts
accrued under this Agreement with respect to the period prior to the effective
date of such expiration or termination.
ARTICLE
8
FORCE
MAJEURE
8.1 Effect
of Force Majeure.
Neither
Party will be liable to the other Party for any failure to perform as required
by this Agreement if the failure to perform is due to circumstances reasonably
beyond such Party’s control including acts of God, civil disorders or
commotions, acts of aggression, fire, explosions, floods, drought, war,
sabotage, embargo, utility failures, material shortages, a national health
emergency, or appropriations of property. A Party whose performance is affected
by a force majeure event will take prompt action using its reasonable best
efforts to remedy the effects of the force majeure event.
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8.2 Termination.
If, as
a result of force majuere, Inyx is unable to fully perform its obligations
hereunder for any consecutive period of one hundred eighty (180) days, King
shall have the right to terminate this Agreement, upon providing written notice
to Inyx, such termination to be effective thirty (30) days from the date of
such
notice.
ARTICLE
9
NOTICES
9.1 Except
as
otherwise specifically provided herein, any notice or other documents to be
given under this Agreement will be in writing and will be deemed to have been
duly given if sent by registered post, nationally recognized overnight courier,
or confirmed facsimile transmission to a Party (followed by hard copy by mail),
or delivered in person to a Party at the address or facsimile number set out
below for such Party or such other address as the Party may from time to time
designate by written notice to the other:
If
to
King:
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Attn:
President
Facsimile:
(000) 000-0000
with
a
copy to:
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Attn:
Executive Vice President and General Counsel
Facsimile:
(000) 000-0000
and
Xxxxx
Day
000
Xxxx
00xx Xxxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Xxxx X. Xxxxxx, Esq.
Facsimile:
(000) 000-0000
CONFIDENTIAL
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If
to
Inyx:
Inyx,
Inc.
000
Xxxxx
Xxxxxx
00xx
Xxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Chairman and CEO
Facsimile:
(000) 000-0000
with
a
copy to:
Xxxxxxx
Xxxxx LLP
10th
Floor, 00000-000 Xxxxxx
Xxxxxxxx,
Xxxxxxx
Xxxxxx
X0X 0X0
Attn:
Xxxx X. Xxxxxxxxxx, Q.C.
Facsimile:
(000) 000-0000
Any
such
notice or other document will be deemed to have been received by the addressee
three (3) business days following the date of dispatch of the notice or other
document by post or, where the notice or other document is sent by overnight
courier, by hand, or is given by facsimile, simultaneously with the transmission
or delivery thereof.
ARTICLE
10
MISCELLANEOUS
10.1 Entire
Agreement.
This
Agreement with the Exhibits and Schedules attached hereto, together with the
other Collaboration Documents, contains all of the terms agreed to by the
Parties regarding the subject matter hereof and thereof and supersede any prior
agreements, understandings, or arrangements between them, whether oral or in
writing. This Agreement may not be amended, modified, altered, or supplemented
except by means of a written agreement or other instrument executed by both
of
the Parties hereto. No course of conduct or dealing between the Parties will
act
as a modification or waiver of any provisions of this Agreement.
10.2 Relationship
of the Parties.
The
Parties hereto are acting and performing as independent contractors, and nothing
in this Agreement creates the relationship of partnership, joint venture, sales
agency, or principal and agent. Neither Party is the agent of the other, and
neither Party may hold itself out as such to any other Party. All financial
obligations associated with each Party’s business will be the sole
responsibility of such Party.
10.3 Publicity.
Any
press release, publicity or other form of public written disclosure related
to
this Agreement prepared by one Party shall be submitted to the other Party
prior
to release for approval, which approval shall not be unreasonably withheld
by
such other Party.
10.4 Use
of
Party’s Name.
Except
as expressly provided or contemplated hereunder and except as otherwise required
by applicable law, no right is granted pursuant to this Agreement to either
Party to use in any manner the trademarks or name of the other Party, or any
other trade name, service xxxx, or trademark owned by or licensed to the other
Party in connection with the performance of the Agreement. Notwithstanding
the
above, either Party shall be permitted to use the other Party’s name and marks,
as may be required under applicable Law, in connection with securities or other
public filings.
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10.5 Severability.
In the
event that any of the provisions or a portion of any provision of this Agreement
is held to be invalid, illegal, or unenforceable by a court of competent
jurisdiction or a governmental authority, such provision or portion of provision
will be construed and enforced as if it had been narrowly drawn so as not to
be
invalid, illegal, or unenforceable, and the validity, legality, and
enforceability of the enforceable portion of any such provision and the
remaining provisions will not be adversely affected thereby.
10.6 Assignment
Inyx may
not assign or otherwise transfer this Agreement or any interest herein or right
hereunder, without the prior written consent of King, and any such purported
assignment, transfer, or attempt to assign or transfer any interest herein
or
right hereunder will be void and of no effect. King may freely assign and
otherwise transfer this Agreement or any interest herein or right hereunder
without Inyx’s consent. Subject to the foregoing, this Agreement will be binding
upon and inure to the benefit of the Parties hereto and their respective
permitted successors and assigns.
10.7 Governing
Law.
This
Agreement will be construed under and in accordance with, and governed in all
respects by, the laws of the State of New York, without regard to its conflicts
of law principles.
10.8 Consent
to Jurisdiction.
Each of
the Parties hereby submits to the exclusive general jurisdiction of the courts
of the State of New York and the courts of the United States of America for
the
Eastern District of New York in any action or proceeding arising out of or
relating to this Agreement and to the jurisdiction of the appellate courts
to
which appeals are required to be taken from any of the foregoing. Each of the
Parties waives any defense of inconvenient forum to the maintenance of any
such
action or proceeding. Any Party may make service on any other Party by sending
or delivering a copy of the process to the Party to be served at the address
and
in the manner provided for the giving of notices in Section
9.1
above.
Nothing in this Section
10.8,
however, will affect the right of any Party to serve legal process in any other
manner permitted by law or equity.
10.9 Headings.
The
headings contained in this Agreement are for reference purposes only and will
not affect in any way the meaning or interpretation of this
Agreement.
10.10 Continuing
Obligations.
Termination, assignment or expiration of this Agreement shall not relieve either
Party from full performance of any obligations incurred prior
thereto.
10.11 Non-Waiver.
The
failure of either Party to enforce or to exercise, at any time or for any period
of time, any term of or any right arising pursuant to this Agreement does not
constitute, and will not be construed as, a waiver of such term or right, and
will in no way affect that Party’s right later to enforce or exercise such term
or right.
CONFIDENTIAL
TREATMENT
15
10.12 Interpretation.
The
Parties hereto acknowledge and agree that: (a) each Party and its
representatives have reviewed and negotiated the terms and provisions of this
Agreement and have contributed to its revision; and (b) the terms and
provisions of this Agreement will be construed fairly as to each Party hereto
and not in favor of or against either Party regardless of which Party was
generally responsible for the preparation or drafting of this
Agreement.
10.13 Exhibits,
Schedules and Attachments.
Any and
all exhibits, schedules and attachments referred to herein form an integral
part
of this Agreement and are incorporated into this Agreement by such
reference.
10.14 Third
Party Beneficiaries.
This
Agreement is not intended to confer upon any non-party rights or remedies
hereunder, except as may be received or created as part of a valid
assignment.
10.15 Further
Assurances.
Each of
Inyx and King agrees to duly execute and deliver, or cause to be duly executed
and delivered, such further instruments and do and cause to be done such further
acts and things, including the filing of such additional assignments,
agreements, documents, and instruments, that may be necessary or as the other
Party hereto may at any time and from time to time reasonably request in
connection with the Collaboration Documents or to carry out more effectively
the
provisions and purposes of, or to better assure and confirm unto such other
Party its rights and remedies under, the Collaboration Documents.
10.16 Certain
Expenses and Commissions.
Except
as otherwise expressly set forth in this Agreement or the other Collaboration
Documents, the Parties hereto will each pay all their costs and expenses,
including legal and accounting fees, incurred in connection with the
preparation, negotiation, execution, and delivery of the Collaboration Documents
and will indemnify and hold the other harmless from and against any and all
other claims or liabilities for such costs and expenses incurred by reason
of
any action taken by any such Party.
10.17 Counterparts.
This
Agreement will become binding when any one or more counterparts hereof,
individually or taken together, will bear the signatures of each of the Parties
hereto. This Agreement may be executed in any number of counterparts, each
of
which will be deemed an original as against the Party whose signature appears
thereon, but all of which taken together will constitute but one and the same
instrument.
CONFIDENTIAL
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IN
WITNESS WHEREOF, this Agreement has been executed by the Parties hereto as
of
the day and year first written above.
| King Pharmaceuticals, Inc. | Inyx, Inc. | ||
| /s/ Xxxxx Xxxxxxxx | /s/ Xxxx Xxxxxxx | ||
|
Xxxxx Xxxxxxxx
President and CEO
|
Xxxx Xxxxxxx
Chairman and CEO
|
CONFIDENTIAL
TREATMENT
17
EXHIBIT
1
SERVICES
INTAL
CFC 200 & 112 DOSE
***
CONFIDENTIAL
TREATMENT
EXHIBIT
2
TIMELINE
***
CONFIDENTIAL
TREATMENT
