CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.*** COLLABORATION AGREEMENT
EXHIBIT
10.38.1
CONFIDENTIAL
TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS
DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED
WITH THE COMMISSION.***
THIS
COLLABORATION AGREEMENT
(this
“Agreement”)
is
entered into and effective as of this 8th day of September, 2005 (the
“Effective
Date”),
by
and between KING PHARMACEUTICALS, INC., a Tennessee corporation (“King”),
and
INYX, INC., a Nevada corporation (“Inyx”).
WHEREAS,
King
owns certain technology and proprietary materials related to the drugs Intal
and
Tilade;
WHEREAS,
Inyx is
a developer and manufacturer of pharmaceutical aerosol products; and
WHEREAS,
the
parties desire to enter into a collaboration for the purpose of developing,
marketing, and promoting Products (as defined herein);
NOW,
THEREFORE,
in
consideration of the mutual covenants and agreements set forth in this
Agreement, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto agree as
follows:
1.
|
DEFINITIONS
|
1.1
|
Definitions.
In
addition to the terms defined elsewhere herein, as used in this
Agreement,
the following terms have the meanings specified below when used
in this
Agreement:
|
***
***
“AAA”
has the
meaning set forth in Section 2.7(d).
“Act”
means
the United States Federal Food, Drug and Cosmetic Act, as amended.
“Affiliate(s)”
means,
with respect to any Person, any other Person that directly, or indirectly
through one or more intermediaries, controls, is controlled by, or is under
common control with, such Person. A Person will be regarded as in control
of
another Person if such Person owns, or directly or indirectly controls, more
than fifty percent (50%) of the voting securities (or comparable equity
interests) or other ownership interests of the other Person, or if such Person
directly or indirectly possesses the power to direct or cause the direction
of
the management or policies of the other Person, whether through the ownership
of
voting securities, by contract, or any other means whatsoever, provided,
however, that, for purposes of this Agreement, the term “Affiliate” will not
include subsidiaries in which a party or its Affiliates owns a majority of
the
ordinary voting power to elect a majority of the Board of Directors, but
is
restricted from electing such majority by contract or otherwise, until such
time
as such restrictions are no longer in effect.
CONFIDENTIAL
TREATMENT
“Agreement”
means
this Agreement, together with all appendices, exhibits, and schedules referenced
herein or attached hereto, and as the same may be amended or supplemented
from
time to time hereafter pursuant to the provisions hereof.
“Alliance
Management Committee”
or
“AMC”
has the
meaning set forth in Section 2.1.
“Approved
New Product”
has the
meaning assigned to it in the Development Agreement.
“Assignors”
has the
meaning set forth in Section 5.3.
“Audited
Party”
has the
meaning set forth in Section 10.2(a).
“Auditing
Party”
has the
meaning set forth in Section 10.2(a).
“Calendar
Quarter”
means,
with respect to the first such Calendar Quarter, the period beginning on
the
Effective Date and ending on the last day of the calendar quarter within
which
the Effective Date falls and, thereafter, each successive period of three
(3)
consecutive calendar months ending on March 31, June 30, September 30, or
December 31.
“Calendar
Year”
means,
(a) with respect to the first Calendar Year, the period beginning on the
Effective Date and ending on December 31, 2005 and, (b) with respect to the
second Calendar Year and Calendar Year thereafter, the period commencing
on
January 1 and ending on December 31.
“Change
of Control”
means
any sale of voting securities or sale of assets (whether by sale, merger,
consolidation, share exchange, or otherwise in one transaction or a series
of
transactions) in or by a party hereto that, directly or indirectly, results
in
any Third Party becoming the beneficial owner, directly or indirectly, of
securities or assets of such first party representing over fifty percent
(50%)
of the combined voting power of such Person's then outstanding securities
or
over fifty percent (50%) of such first party's total assets.
“Change
of Control Notice”
has the
meaning set forth in Section 11.3(b).
“COGS”
means
the fully absorbed manufacturing costs, which includes direct costs and
allocated costs, but not indirect and overhead costs, attributable to and
directly in connection with the manufacture of a Product and includes the
costs
of all direct material (excluding the Initial Bulk Form), direct labor, direct
services costs, and any other direct or allocated costs of all goods
manufactured; provided that such costs, together with any ***, will in no
event
be more than *** of Net Sales. All reports submitted pursuant to Section
3.2(b)
will include a detailed description of all COGS incurred by each party, and,
in
addition to the audit rights set forth in Article 10, King may audit Inyx's
books and records with respect to such COGS from time to time upon request.
CONFIDENTIAL
TREATMENT
2
“Collaboration
Costs”
means,
to the extent approved by the AMC, the sum of (a) for so long as the Marketing
and Promotion Agreement is in effect, ***, (b) ***, (c) ***, (d) ***,
(e)
***, as contemplated by the Manufacturing and Supply Agreement, (f) any other
cost or expense expressly stated to be a Collaboration Cost in the Collaboration
Documents or under a Marketing Plan and Budget, (g) quantity, trade, or cash
discounts, chargebacks, returns, allowances, rebates (including any and all
federal, state, or local government rebates, such as Medicaid rebates), costs
incurred in connection with processing the foregoing, and price adjustments,
to
the extent actually allowed in any invoice relating to Products (to the extent
not already deducted as part of the calculation of Net Sales), (h) sales
and
other excise taxes and duties or similar governmental charges directly related
to the sale of Products (to the extent not already deducted as part of the
calculation of Net Sales), and (i) any other direct and allocable internal
costs
and direct and allocable external costs incurred in conducting the Collaboration
Program, all calculated in accordance with GAAP and all approved by the AMC.
Notwithstanding anything to the contrary contained herein, Collaboration
Costs
will not include (i) indirect costs, overhead, general, and administrative
costs
and other similar costs, (ii) any costs that relate to the business of a
party
as a whole without specifically referencing a Product, (iii) * * * , or (iv)
any
Excluded New Product Costs. In calculating the Collaboration Costs, the
following principles will apply: (x) there will be no double counting of
any
costs or expenses or of any revenues, and (A) to the extent a cost or expense
has been included in one category or sub-category, it will not be included
in
another, (B) to the extent any revenue has been taken into account in one
category or sub-category, it will not be taken into account in another, and
* *
*
“Collaboration
Documents”
means,
collectively, this Agreement, the Quality Agreement, the Technology Transfer
Agreement, the Manufacturing and Supply Agreement, the Marketing and Promotion
Agreement, and the Development Agreement.
“Collaboration
Program”
means
the association of King and Inyx established pursuant to this Agreement and
the
other Collaboration Documents.
“Competitor
Product”
means
any product for the treatment of asthma or any other product that is targeted
for an indication covered by any Product.
“Confidential
Information”
has the
meaning set forth in Section 12.1(a).
“Consultant”
means a
Third Party who has entered into or hereafter enters into a written agreement
with King or Inyx or both to provide consulting services with respect to
the
Collaboration Program, as determined by the AMC, which written agreement
(a)
includes an assignment of all right, title, and interest in and to all work
product and all inventions arising from the performance of such services,
and
all intellectual property rights attaching thereto, to Inyx or King, as
applicable, and (b) binds the relevant Third Party by obligations of
confidentiality and non-use with respect to all such work product, inventions,
Confidential Information, and intellectual property rights that are at least
as
stringent as those set forth herein.
CONFIDENTIAL
TREATMENT
3
“Development
Agreement”
has the
meaning set forth in Section 3.4(d).
“Discretionary
Funding”
has the
meaning set forth in Section 3.3(b).
“Effective
Date”
has the
meaning set forth in the recitals.
“Excluded
New Product”
means a
New Product excluded from the Collaboration Program pursuant to Section 4.2
of
the Development Agreement.
“Excluded
New Product Costs”
has the
meaning assigned to it in the Development Agreement.
“Excluded
Patent Costs”
has the
meaning assigned to it in the Development Agreement.
“FDA”
means
the United States Food and Drug Administration or any successor organization
and
all agencies under their direct control.
“GAAP”
means
United States generally accepted accounting principles.
“Improvement(s)”
means
any inventions, discoveries, improvements, trade secrets, know-how, and
proprietary methods and materials that are conceived, made, or developed
in the
course of carrying out the Collaboration Program, in each case (a) whether
or
not patentable and (b) whether developed or conceived by employees of, or
Consultants to, King or Inyx, alone or jointly with each other or with permitted
Third Parties, including permitted sublicensees. The term “Improvements” will
include the following: (i) any modification of, improvement to, or derivative
work of a Product or Excluded New Product or then-existing Patent Rights
or
Technology, (ii) any integration of a Product or Excluded New Product into
other
products, (iii) any information, materials, records, or reports developed
in
connection with, or related to, the items in clauses (i) and (ii), and (iv)
any
trade secrets, know-how, or intellectual property rights with respect to
the
items in clauses (i) through (iii). The term “Improvements” will not include any
Inyx Respiratory Products.
“IND”
means
(a) an Investigational New Drug Application (as defined in 21 CFR § 312.3) that
is required to be filed with the FDA before beginning clinical testing of
a
product in human subjects, or any successor application or procedure, or
(b) any
counterpart of a U.S. Investigational New Drug Application that is required
in
any other country or region in the Territory before beginning clinical testing
of a product in human subjects in such country or region.
“indemnitee”
has the
meaning set forth in Section 13.3.
“indemnitor”
has the
meaning set forth in Section 13.3.
“Infringement”
has the
meaning set forth in Section 6.3(a)(i).
“Infringement
Notice”
has the
meaning set forth in Section 6.3(a)(i).
CONFIDENTIAL
TREATMENT
4
*
* *
“Intal”
means
(a) the cromolyn sodium inhaler pharmaceutical product in a chloro-fluoro-carbon
(CFC) propellant driven inhaler and more particularly identified as NDA No.
18-887 and (b) the cromolyn sodium inhaler pharmaceutical product in a
hydro-fluoro-alkane (HFA) propellant driven inhaler and more particularly
identified as pending NDA 20-957, and amendments thereto (the product described
in this clause (b), “Intal
HFA”).
“Inyx”
has the
meaning set forth in the recitals.
“Inyx
Respiratory Products”
has the
meaning set forth in Section 7.2.
“King”
has the
meaning set forth in the recitals.
“King
Respiratory Product”
has the
meaning set forth in Section 8.3.
“Manufacturing
and Supply Agreement”
has the
meaning set forth in Section 3.4(b).
“Manufacturing
Offer Notice”
has the
meaning set forth in Section 8.3.
“market”
or
“marketing”
means
any and all activities directed to the marketing and promotion of a product
for
commercial sale and will include pre-launch and post-launch marketing,
promoting, distributing, offering to sell, and selling a product, importing
a
product for sale, and any and all clinical and marketing studies conducted
after
obtaining marketing approval for any product (but not including any preclinical
studies), and interacting with Regulatory Authorities regarding the foregoing.
“Marketing
and Promotion Agreement”
has the
meaning set forth in Section 3.4(c).
“Marketing
Costs”
means
the sum of (a) all reasonable out-of-pocket costs and expenses incurred by
a
party directly attributable to the following functions for the sale, promotion,
and marketing of a Product in the Territory: (i) market research on such
Product
or relevant indications, (ii) marketing communications and Product advertising,
(iii) corporate accounts, (iv) managed care, (v) sales force training, (vi)
product hotlines, (vii) reimbursement support, (viii) contracting, (ix) pricing,
(x) telemarketing services, (xi) distribution costs, including freight,
insurance, warehousing, order entry, and billing, (xii) the cost of Product
detailing of a party's sales force plus reasonable out-of-pocket costs and
expenses paid to Third Parties for product details provided by such Third
Parties, (xiii) patient registries, if required, (xiv) the cost of Product
samples, and (xv) all reasonable out-of-pocket costs and expenses incurred
by a
party and directly attributable to the promotion of a Product in the Territory
and (b) Personnel Costs incurred by a party directly attributable to marketing
personnel and support staff working (either full time or part of the time)
on
the marketing of Products in the Territory. Examples of functions that would
be
included in the marketing headcount cost are: marketing, marketing
communications, clinical research and educational managers, clinical support
managers, corporate accounts, managed care, product hotlines, sales forecasting,
reimbursement support (government economic managers), marketing research,
contracting, and pricing.
CONFIDENTIAL
TREATMENT
5
“Marketing
Plan and Budget”
has the
meaning set forth in Section 3.1(a).
“NDA”
means a
New Drug Application pursuant to Section 505 of the Act (21 U.S.C. Section
355)
related to a product, including the Products, submitted to the FDA or any
successor application or procedure or any foreign counterpart of a U.S. New
Drug
Application for approval to market, including, where applicable, applications
for pricing and reimbursement approval, and all supplements and amendments
thereto.
“Net
Sales”
means
the gross amount, computed in accordance with GAAP, received
for the Products by a party or its Affiliates from Third Parties in the
Territory, less returns and less the following amounts to the extent deducted
from invoice or absorbed or accrued by the party or its Affiliates:
(a) customary quantity, trade, or cash discounts (including inventory
management agreement fees and discounts), chargebacks, returns, allowances,
rebates (including any and all federal, state, or local government rebates,
e.g., Medicaid rebates), and price adjustments allowed or given (including
retroactive price reductions); (b) sales and other excise taxes, tariffs,
and duties directly related to the sale, to the extent such items are included
in the gross amount received; (c) amounts actually refunded due to rejected,
spoiled, damaged, outdated, or returned Product or for sales that become
the
subject of a subsequent temporary or partial recall by a Regulatory Authority
for safety or efficacy reasons outside the control of the parties; and (d)
freight, shipment, postage, insurance, and other transportation costs actually
incurred in shipping Product to a Third Party purchaser. If any Product is
sold
to a Third Party in a transaction that is not at arm's length between the
buyer
and seller, then the gross amount to be included in the calculation of Net
Sales
for such sale will be the amount that would have been invoiced had the
transaction been conducted at arm's length, which amount will be determined,
whenever possible, by reference to the average selling price of the relevant
Product in arm's-length transactions in the country of sale at the time of
sale.
If any Product is sold to a Third Party for consideration other than cash
or for
consideration that is not readily ascertainable, then the gross amount to
be
included in the calculation of Net Sales for such sale will be determined
based
on the reasonable value of the consideration given, taking into account the
average selling price of the relevant Product in arm's-length transactions
in
the country of sale at the time of sale. Any goods or services provided in
exchange of the supply of Products, disposal of Product, or use of Product
in
clinical or preclinical trials or as free samples (such samples to be in
quantities common in the industry for this sort of Product) will not give
rise
to any deemed sale under this definition. For purposes of Section 4.3(c)
of the
Development Agreement, the foregoing definition will apply to Unmarketed
Excluded New Products.
“New
Product”
means
any new diagnostic or therapeutic compound, formulation, or product that
includes Intal or Tilade and any derivatives of Intal or Tilade, or combinations
thereof, and that treats asthma or any other indication, whether respiratory
or
otherwise, and that are developed under the Collaboration Program.
“Offered
Product”
has the
meaning set forth in Section 8.1.
CONFIDENTIAL
TREATMENT
6
“Patent
Rights”
means
the rights and interests in and to issued patents and pending patent
applications (which for purposes of this Agreement will be deemed to include
certificates of invention and applications for certificates of invention
and
priority rights) in any country in the Territory, including all provisional
applications, substitutions, continuations, continuations-in-part, divisions,
and renewals, all letters patent granted thereon, and all reissues,
reexaminations and extensions thereof, that in each case relate to (a) any
Product or Excluded New Product or any methods of using and making a Product
or
Excluded New Product or (b) any Improvement.
“Person”
means
an individual, corporation, partnership, limited liability company, trust,
business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental
authority, or any other form of entity not specifically listed
herein.
“Personnel
Costs”
means
the reasonable costs of employment of personnel employed by or under contract
to
a party, including salaries, benefits (including the costs of cars or allowances
therefor), travel, lodging, meals, and office and computing
supplies.
“Product(s)”
means
any pharmaceutical product containing Intal or Tilade, and will include any
Approved New Product but will not include an Excluded New Product.
“Product
Offer Notice”
has the
meaning set forth in Section 8.1.
“Program
Plans”
means
any written plans (which may include a detailed strategy and proposed timelines)
describing the activities to be carried out by each party during each Calendar
Year pursuant to this Agreement or any other Collaboration Document that
are
approved by the AMC, or a committee thereof, during the Term.
“Quality
Agreement”
has the
meaning set forth in Section 3.4(e).
“Regulatory
and IP Costs”
means
Personnel Costs, reasonable out-of-pocket costs and expenses (e.g., filing
fees,
user fees, annual product and facility registration fees, permit fees, and
the
like) incurred by a party directly attributable (a) to obtaining or maintaining
Regulatory Approvals for a Product (including any device incorporating the
Product) (including, for example, communications and meetings with Regulatory
Authorities) and satisfying all registration and other requirements of
Regulatory Authorities within the Territory (including, for example, adverse
event reporting and Product pricing approvals) in connection with each party's
activities under the Collaboration Program and (b) to preparing, filing,
prosecuting, maintaining, enforcing, and defending Patent Rights or Technology
with respect to Products as contemplated in Article 6 hereof.
“Regulatory
Approval”
means
the technical, medical, and scientific licenses, registrations, authorizations,
and approvals (including approvals of NDAs, supplements and amendments, pre-
and
post- approvals, pricing and third party reimbursement approvals, and labeling
approvals) of any Regulatory Authority necessary for the development (including
the conduct of clinical trials), manufacture, distribution, marketing,
promotion, offer for sale, use, import, export, or sale of a Product in a
regulatory jurisdiction in the Territory.
CONFIDENTIAL
TREATMENT
7
“Regulatory
Authority”
means
the FDA or any counterpart of the FDA outside the United States, or other
national, supra-national, regional, state, or local regulatory agency,
department, bureau, commission, council, or other governmental entity with
authority over the distribution, importation, exportation, manufacture,
production, use, storage, transport, or clinical testing, pricing, or sale
of a
product (including a Product), including any device incorporating the product.
“Regulatory
Filings”
means,
collectively, any and all INDs and drug master files (DMFs), NDAs, applications
for any device incorporating a product (including a Product), applications
for
designation of a product as an “Orphan Product(s)” under the Orphan Drug Act or
any other similar filings (including any foreign equivalents and further
including any related correspondence and discussions), and all data contained
therein, as may be required by or submitted to any Regulatory Authority for
the
Regulatory Approval.
“Requested
Party”
has the
meaning set forth in Section 10.3(a).
“Requesting
Party”
has the
meaning set forth in Section 10.3(a).
“Respiratory
Offer Notice”
has the
meaning set forth in Section 7.2.
“Technology”
means
and includes all inventions, discoveries, improvements, trade secrets, know-how,
and proprietary methods and materials, whether or not patentable, relating
to
the Products or Excluded New Products (including (a) samples of, methods
of
production, or use of, and structural and functional information pertaining
to,
chemical compounds, proteins, or other biological substances, and (b) data,
formulations, techniques, and know-how), in each case that (i) are useful
with
respect to the Collaboration Program and (ii) (A) are controlled by King
as of
the Effective Date or (B) developed or conceived by employees of, or Consultants
to, King or Inyx, alone or jointly with each other or with permitted Third
Parties, in the conduct of the Collaboration Program, including all
Improvements.
“Technology
Transfer Agreement”
has the
meaning set forth in Section 3.4(a).
“Term”
has the
meaning set forth in Section 11.1.
“Terminated
Agreement”
has the
meaning set forth in Section 11.8.
“Territory”
means
the United States and Canada, including any of their states, provinces,
territories, possessions, and protectorates, the District of Columbia, and
the
Commonwealth of Puerto Rico.
“Third
Party”
means
any Person other than King and Inyx and their respective
Affiliates.
CONFIDENTIAL
TREATMENT
8
*
* *
.
“Tilade”
means
(a) the nedocromil sodium inhaler pharmaceutical product in a
chloro-fluoro-carbon (CFC) propellant driven inhaler and more particularly
identified in NDA No. 19-660 and (b) a nedocromicl sodium inhaler pharmaceutical
product in a hydro-fluoro-alkane (HFA) propellant driven inhaler (the product
described in this clause (b), “Tilade
HFA”).
“Trademark”
will
have the meaning assigned to it in the Marketing and Promotion
Agreement.
*
* *
.
1.2 Interpretation.
When a
reference is made in this Agreement to Articles, Sections, Exhibits, or
Schedules, such reference will be to an Article or Section of or Exhibit
or
Schedule to this Agreement unless otherwise indicated. 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. Whenever the words
“include,”“includes,” or “including” are used in this Agreement, they will be
deemed to be followed by the words “without limitation.” Unless the context
otherwise requires, (i) ”or” is disjunctive but not necessarily exclusive,
(ii) words in the singular include the plural and vice versa, and
(iii) the use in this Agreement of a pronoun in reference to a party
hereto
includes the masculine, feminine, or neuter, as the context may require.
The
Schedules and Exhibits hereto will be deemed part of this Agreement and included
in any reference to this Agreement. This Agreement will not be interpreted
or
construed to require any Person to take any action, or fail to take any action,
if to do so would violate any applicable law.
2.
|
ADMINISTRATION
OF THE COLLABORATION
|
2.1
|
Establishment
and Function of AMC.
Inyx and King will establish an alliance management committee (the
“Alliance
Management Committee”
or “AMC”)
within thirty (30) days of the Effective Date to plan, administer,
and
monitor the activities of the parties under the Collaboration Program,
including all activities set forth in the Program Plans, if any.
In
particular, the AMC will review and approve, or recommend revisions
to,
any Program Plans, review and monitor the progress of the Collaboration
Program, and recommend necessary adjustments to the Collaboration
Program.
In planning, administering, and monitoring the Collaboration Program,
the
AMC will allocate tasks and responsibilities, taking into account
each
party's respective specific capacities and expertise in order to
avoid
duplication and to enhance synergies, as well as comply with the
requirements of this Agreement and the other Collaboration
Documents.
|
2.2
|
Membership
of the AMC.
Each party will appoint three (3) representatives of such party
to the
AMC. One of King's senior representatives will chair the AMC, but
such
chair shall not have a casting or tie-breaking vote. Both parties
will
have the right from time to time to substitute individuals, on
a permanent
or temporary basis, for any of its previously designated members
of the
AMC. The members appointed by each party will be vested with appropriate
decision-making authority and power by such party. Members of the
AMC will
be senior executives of the parties (or their Affiliates), respectively,
and will not be outside consultants, independent contractors, or
outside
legal counsel, but such Persons are permitted to attend meetings
of the
AMC. Each party will bear its own costs associated with its participation
on the AMC.
|
CONFIDENTIAL
TREATMENT
9
2.3
|
Committees.
The AMC will have the right and power to appoint and delegate its
responsibilities to committees as reasonably needed to accomplish
its work
and the composition and eligibility requirements for the same will
be
agreed by the members of the AMC. Such committees may include regulatory,
clinical/development, sales and marketing, and manufacturing committees.
Except as otherwise mandated by the AMC in its minutes, each committee
established by the AMC will be governed by the rules and guidelines
applicable to the AMC set forth in this Agreement. The AMC will
set forth
clearly each such committee's decision making responsibilities
that have
been delegated to it by the AMC. Any member of a committee may
send a
designee to observe a committee if such member is unable to attend,
but
such observer will not vote in such member's place unless given
a written
proxy from such member of the committee. Each party will have the
right at
any time to substitute individuals, on a permanent or temporary
basis, for
any of its previously designated representatives to any committee,
by
giving written notice thereof to the other party. If an issue to
be
addressed by a committee appears to fall within the oversight and
administration of more than one committee, such committees will
confer
with each other to determine which committee will oversee and administer
such issue.
|
2.4
|
Responsibilities
of the AMC.
The AMC will be solely responsible for making all decisions not
specifically reserved to either party hereunder, including decisions
with
respect to the following matters:
|
(i)
|
the
definition, review, approval, and amendment (not less than annually)
of
the Program Plans, if any, and all related strategy and objectives
(but
not the actual conduct of such
plans);
|
(ii)
|
definition,
review, and approval of and changes to the strategy and objectives
(but
not the actual conduct) of the Collaboration
Program;
|
(iii)
|
management
and allocation of resources of the Collaboration
Program;
|
(iv)
|
proposal
of all budgets for the Collaboration Program, including as described
in
Article 3;
|
CONFIDENTIAL
TREATMENT
10
(v)
|
review
and approval of all agreements required or entered into in connection
with
the Collaboration Program, and any and all amendments thereto;
and
|
(vi)
|
performance
of such other functions as appropriate to further the purposes
of this
Agreement and the Collaboration Program as determined from time
to time by
the parties.
|
2.5
|
AMC
Meetings.
During the Term of this Agreement, the AMC will meet: (a) at
least
once each Calendar Quarter on a date and at a location to be agreed
to by
the AMC in advance, and (b) upon written notice by either
party to
the other that a meeting is required or requested, in which case
a meeting
will be held within thirty (30) calendar days of such notice on
a date and
at a location to be agreed to by the parties, or sooner if warranted
by
circumstances. Notice requesting a meeting will include adequate
information describing the activity to be reviewed. Any meetings
of the
AMC may be held in person at a location to be agreed to by the
parties, or
by videoconference or teleconference. Other representatives of
the parties
may attend AMC meetings as participants. At least one week prior
to any
meeting of the AMC, each of the parties will provide the other
party with
a proposed agenda of the matters to be discussed at such meeting.
The
parties will agree, at the first meeting of the AMC, upon procedures
for
maintaining meeting minutes.
|
2.6
|
Vote
and Approval.
The AMC may take action on a matter at a meeting only if a quorum
exists
with respect to that matter. The attendance of at least two (2)
members of
the AMC of each party at a meeting will constitute a quorum for
the
transaction of business. Each member of the AMC will be entitled
to cast
one (1) vote on any matter to be acted upon at any meeting of the
AMC. All
decisions made by the AMC will require *** by the members of the
AMC
present at the meeting. Any action required or permitted to be
taken at
any meeting of the AMC may be taken without a meeting if the action
is
taken by all members of the AMC. The action must be evidenced by
one or
more written consents describing the action taken and signed by
each
member of the AMC.
|
2.7
|
Dispute
Resolution.
(a)
The parties recognize that disputes as to certain matters may from
time to
time arise during the Term of this Agreement that relate to either
party's
rights or obligations hereunder. It is the objective of the parties
to
establish procedures to facilitate the resolution of disputes arising
under this Agreement or any other Collaboration Document in an
expedient
manner by mutual cooperation and without resort to litigation.
To
accomplish this objective, the parties agree to follow the procedures
set
forth in this Section 2.7 if and when a dispute arises under any
Collaboration Document.
|
(b)
|
Unless
otherwise specifically recited in a particular Collaboration Document,
disputes between the parties under such Collaboration Document
will 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
11
For
Inyx:
Dr. Xxxx Xxxxxxx, Chairman & CEO
For
King:
Xxxxx Xxxxxxxx, President & CEO
(c)
|
In
the event such designated officers are unable to resolve such dispute
within such 15-day period, then
|
(i)
|
to
the extent the dispute relates to a clinical or development activity
or
issue, then such matter will be finally decided by
King,
|
(ii)
|
to
the extent the dispute relates to a regulatory activity or issue,
then
such matter will be finally decided by
King,
|
(iii)
|
to
the extent the dispute relates to a marketing activity or issue,
then such
matter will be finally decided by King,
or
|
(iv)
|
***
|
Notwithstanding
the foregoing, this subsection (c) will not apply to determinations as to
whether either party is in breach of any of its obligations under this
Agreement.
(d)
|
Disputes
not subject to the final decision-making authority of either party,
as
described in Section 2.7(c)(iv) above, will be resolved by binding
arbitration in accordance with the rules of the American Arbitration
Association (the “AAA”)
and the provisions of this Section
2.7(d).
|
(i)
|
The
party desiring to initiate an arbitration proceeding will send
a written
notice to the other party requesting the commencement of the arbitration
proceeding and specifying the issue to be resolved. Within fifteen
(15)
days from the date such notice is sent, each party will designate
one
neutral arbitrator. Within fifteen (15) days thereafter, the first
two
arbitrators will designate a third. Each arbitrator will by training,
education, or experience have knowledge of the subject matter of
the
dispute. If either party fails to choose an arbitrator within the
foregoing time period, the AAA will choose an arbitrator on behalf
of that
party. Disputes about arbitration procedure will be resolved by
the
arbitrators or, failing agreement, by the AAA in New York, New
York.
Unless otherwise agreed by the parties, the arbitration proceedings
will
be conducted in New York, New York.
|
CONFIDENTIAL
TREATMENT
12
(ii)
|
Within
5 days of the selection of the final arbitrator, the parties will
deliver
to the arbitrators a joint letter (A) stating each of the issues
that is
the subject of the dispute, (B) setting forth each party's final
position
with respect to each such issue, and (C) directing the arbitrators
to
resolve the dispute by selecting the final position of one of the
parties;
provided that, if the parties cannot agree on a joint letter, each
party
will submit a letter setting forth its position on each issue,
and the
failure of any party to submit such a joint letter will not prevent
the
arbitration from proceeding. In addition, each party may submit
with the
joint letter supporting documentation for such party's final position.
In
resolving the dispute, the arbitrators will have no authority to
make a
decision on any issue other than by selecting the final position
of one of
the parties.
|
(iii)
|
An
arbitration decision will be rendered in writing within 30 days
of the
submission of the letter described above, which award will be final
and
binding on the parties and will be deemed enforceable in any court
having
concurrent jurisdiction of the subject matter hereof and the parties.
In
selecting the final position of one of the Parties, the arbitrators
will
have the authority to grant specific performance and allocate costs
between the parties (excluding attorneys' fees, which each party
must bear
itself); provided that the arbitrators will have no authority to
award
punitive damages or any damages in excess of the limitations contained
in
this Agreement.
|
3.
|
Budget;
Collaboration Costs; Collaboration
Documents
|
3.1
|
Marketing
Plan and Budget.
(a)
On
or prior to October 1 of each year during the Term of this Agreement,
the
AMC will agree upon expense contributions to the Collaboration
Program to
be made by each party and will approve a marketing plan and budget
for the
following Calendar Year (each a “Marketing
Plan and Budget”);
provided that the Marketing Plan and Budget for the period between
the
Effective Date and December 31, 2005 will be approved by the AMC
within
one month of the Effective Date. If the parties are unable to agree
on a
Marketing Plan and Budget prior to October 1, the Marketing Plan
and
Budget applicable to the current Calendar Year will apply to the
following
Calendar Year until such time as the parties are able to agree
on a new
Marketing Plan and Budget. The initial draft of the Marketing Plan
and
Budget will be developed by King and Inyx for final approval by
the AMC,
with King developing the portions of the Marketing Plan and Budget
relating to clauses (i) through (v) and (xi) in Section 3.1(b)
below, and
Inyx developing the portions relating to clauses (vi) through (x)
below.
|
CONFIDENTIAL
TREATMENT
13
(b)
|
Each
Marketing Plan and Budget will set forth the manner in which the
Products
are to be promoted during the period to which the Marketing Plan
and
Budget relates and will include, at a minimum: (i) the Collaboration
Costs
to be incurred in connection with the Collaboration Program; (ii)
Products
positioning, strategy, and tactics with supporting advertising
and
promotional activity to be undertaken; (iii) any training or sampling
programs to be conducted; (iv) medical and education programs to
be
conducted; (v) public relations activities; (vi) the minimum number
of
quarterly and annual details to be provided by each party and targets
therefor that will be allocated in a professionally equitable manner;
(vii) the number of sales representatives to Detail the Products;
(viii)
identification of physician targets; (ix) determination of data
and
materials required to assess sales representatives; (x) Product
weighting;
and (xi) such other information relating to the marketing of the
Products
as deemed advisable by the AMC. Neither party will make any material
change in any previously approved Marketing Plan and Budget without
the
prior written approval of the AMC.
|
3.2
|
Collaboration
Costs.
|
(a)
|
Allocation.
All Collaboration Costs incurred by a party on and after the Effective
Date through the Term of this Agreement ***.
|
(b)
|
Accounting.
Within fifteen (15) days following the end of each Calendar Quarter,
Inyx
and King will submit to the AMC, or any finance committee thereof,
an
accounting of all Collaboration Costs incurred by it with respect
to all
Products and the Collaboration Program in the relevant time period.
Within
fifteen (15) days thereafter, the AMC will produce a report setting
forth
the calculation of Collaboration Costs and their allocation between
the
parties in accordance with Section 3.2(a) above. The report will
also set
forth the amount of any payments that a party must make to the
other party
in order to achieve *** of the Collaboration Costs as provided
in Section
3.2(a) above. All such payments will be made within sixty (60)
days
following the end of the applicable Calendar Quarter. Within thirty
(30)
days after the end of the Calendar Year relevant to such Calendar
Quarters, the AMC will produce a report setting forth the calculation
of
aggregate Collaboration Costs incurred over the relevant Calendar
Year and
the allocation between the parties in accordance with Section 3.2(a)
above. The report will also set forth the amount of any payments
that a
party must make to the other party in order to achieve *** of the
Collaboration Costs as provided in Section 3.2(a) above. All such
payments
will be made within sixty (60) days following the end of the applicable
Calendar Year.
|
CONFIDENTIAL
TREATMENT
14
(c)
|
Advance
Payments and Offset.
Each of the parties will fund projected Collaboration Costs on
a monthly,
prospective basis, such that all anticipated Collaboration Costs
identified in the Marketing Plan and Budget for a given month,
or that are
otherwise determined by the AMC to be reasonably likely to be incurred
in
such month, will be allocated between the parties *** in accordance
with
Section 3.2(a). At the end of each Calendar Quarter, the parties
will
reconcile their respective funding payments pursuant to Section
3.2(b)
hereof, and, at the discretion of the party who has funded an amount
greater than the Collaboration Costs allocable to such party for
the
relevant Calendar Quarter, such party will be reimbursed by the
other
party within ten (10) days after the end of such Calendar Quarter
or, at
its discretion, will receive a credit against Collaboration Costs
payable
by that party in the subsequent Calendar Quarter(s), which credit
amount
will be carried forward until fully
credited.
|
(d)
|
Currency
Conversion.
All Collaboration Costs incurred in currencies other than U.S.
Dollars
will be converted to U.S. Dollars based on the exchange rate quoted
in The
Wall Street Journal, NY Edition on the last business day of the
applicable
Calendar Quarter.
|
3.3
|
Collaboration
Costs Overruns and Additional Expenditures.
(a)
Each party will use commercially reasonable efforts to complete
all tasks
assigned to it pursuant to the Collaboration Program in accordance
with
the funding allocated to such tasks in the Marketing Plan and Budget.
In
the event either party anticipates or becomes aware that the actual
costs
of any given task assigned to it may or will likely exceed the
funds
allocated to such task, such party will promptly notify the AMC.
The AMC
and any committee charged with primary oversight responsibility
for the
task in question will work together in good faith for up to thirty
(30)
days to determine whether to readjust the Marketing Plan and Budget
to
allocate additional funds to such task, to revise the scope of
such task
to permit satisfactory completion at the then-budgeted funding
level, or
both.
|
(b)
|
Notwithstanding
the foregoing, either party may, in its discretion, spend additional
amounts above and beyond those allocated in the Marketing Plan
and Budget
(“Discretionary
Funding”)
on any task assigned to such party pursuant to the Collaboration
Program
or on any other task the AMC has approved. In such event, the party
wishing to expend Discretionary Funding will first inform the other
party
of its intent to do so. If such other party consents to such Discretionary
Funding being deemed a Collaboration Cost, such Discretionary Funding
will
constitute a Collaboration Cost, and the rights and obligations
of the
parties with respect to such Collaboration Costs will be determined
in
accordance with the terms and conditions of the Collaboration Documents
as
they apply to the Collaboration Program. If such other party does
not
consent, then such Discretionary Funding will not constitute a
Collaboration Cost but will be borne solely by the party undertaking
the
Discretionary Funding, and the parties will negotiate in good faith,
prior
to the expenditure of the Discretionary Funding, the rights and
obligations of the parties with respect to such Discretionary
Funding.
|
CONFIDENTIAL
TREATMENT
15
(c)
|
Notwithstanding
Section 2.7(c), except to the extent this Agreement or any other
Collaboration Document expressly provides for payments that do
not require
AMC approval, and except to the extent the AMC has approved any
payment
hereunder, neither party will (i) be obligated to incur any costs
or
expend any funds that have not been approved by such party or (ii)
have
the authority to cause the other party to incur any costs or expend
any
funds that have not been approved by such other
party.
|
3.4
|
Collaboration
Documents.
In furtherance of the Collaboration Program, concurrently herewith,
the
parties are executing the following
agreements:
|
(a)
|
a
Technology Transfer Agreement, in the form attached hereto as Exhibit
A
(the “Technology
Transfer Agreement”);
|
(b)
|
a
Manufacturing and Supply Agreement, in the form attached hereto
as Exhibit
B (the “Manufacturing
and Supply Agreement”);
|
(c)
|
a
Marketing and Promotion Agreement, in the form attached hereto
as Exhibit
C (the “Marketing
and Promotion Agreement”);
|
(d)
|
a
Development Agreement, in the form attached hereto as Exhibit D
(the
“Development
Agreement”);
and
|
(e)
|
a
Quality Agreement, in the form attached hereto as Exhibit E (the
“Quality
Agreement”).
|
4.
|
Licenses
|
4.1
|
License
Grant.
Subject to the terms and conditions of this Agreement, beginning
on the
Effective Date and thereafter during the Term, King hereby grants
to Inyx
a non-exclusive limited license (without a right to sublicense
except as
provided in Section 4.2) under the Technology and Patent Rights
to make,
use, sell, offer for sale, and import Products in the Territory,
which
license will be exercisable by Inyx only as part of the Collaboration
Program and only for the conduct of the activities required in
the
performance of its obligations or exercise of its rights under
the
Collaboration Documents.
|
CONFIDENTIAL
TREATMENT
16
4.2
|
Sublicenses.
Inyx may not sublicense any of the rights granted to it pursuant
to this
Agreement or the other Collaboration Documents, or utilize subcontractors
in the performance thereof, except to wholly owned subsidiaries
of Inyx.
In the event of a grant of a sublicense to any such subsidiary
(or any
other Person with King's consent), Inyx acknowledges and agrees
that it
will remain liable for all obligations, including obligations to
perform,
under the Collaboration Documents and for all actions of such subsidiaries
(or other sublicensee) under any such sublicense. All such sublicensees
must agree, in writing, to be bound by the terms of the Collaboration
Documents, including the confidentiality and assignment provisions
thereof. Inyx will notify King, in writing, of any such subsidiary
sublicense promptly upon granting of such
sublicense.
|
4.3
|
Consultants.
Inyx, with the prior written consent of the AMC, may use individual
Consultants in connection with the performance of its duties and
the
exercise of its rights under this Agreement and the other Collaboration
Documents. Inyx acknowledges and agrees that it will remain liable
for all
obligations, including obligations to perform, under the Collaboration
Documents and for all actions of such Consultants pursuant thereto,
and
Inyx will indemnify and hold King harmless from and against any
and all
other claims or liabilities for costs and expenses incurred by
reason of
any action of any Consultants.
|
4.4
|
Termination
of Collaboration Documents.
Inyx understands and agrees that the scope of the license granted
in
Section 4.1 will be reduced from time to time as each of the Collaboration
Documents expires or terminates.
|
5.
|
Intellectual
Property Rights
|
5.1
|
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 such party or its 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.
|
5.2
|
Ownership.
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 the Technology Transfer
Agreement;
|
(c)
|
Technology
and Patent Rights as they exist as of the Effective Date;
and
|
CONFIDENTIAL
TREATMENT
17
(d)
|
any
Improvements to the Technology and all associated Patent Rights,
developed
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.
5.3
|
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
Improvements, including filing any applicable patent applications.
|
5.4
|
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.
|
6.
|
FILING,
PROSECUTION, AND MAINTENANCE OF PATENT RIGHTS
|
6.1
|
Patent
Filing, Prosecution, and Maintenance.
During the Term of this Agreement, with respect to any Patent Rights
arising hereunder:
|
(a)
|
King,
acting through patent attorneys or agents of its choice, will be
responsible for the preparation, filing, prosecution, and maintenance
of
all patents and patent applications, whether related to Technology
or
Patent Rights. At King's request, Inyx will reasonably cooperate
with and
assist King in connection with such
activities.
|
(b)
|
Except
as expressly provided herein, King makes no warranty with respect
to the
validity, perfection, or dominance of any patent or other proprietary
right or with respect to the absence of rights in Third Parties
that may
be infringed by the manufacture or sale of any Product. Each party
agrees
to bring to the attention of the AMC any patent or patent application
it
discovers that relates to the Collaboration
Program.
|
CONFIDENTIAL
TREATMENT
18
(c)
|
Except
as provided in the Development Agreement with respect to Excluded
Patent
Costs, all reasonable fees and expenses of counsel and other reasonable
costs and expenses of each party attributable to the filing, prosecution,
and maintenance of Patent Rights or Technology used or reasonably
expected, in the judgment of the AMC, to be used or useful in the
Collaboration Program will be deemed Regulatory and IP
Costs.
|
6.2
|
Information
and Cooperation.
King will keep the AMC regularly informed of the status of the
Patent
Rights and will provide to Inyx's legal counsel, subject to appropriate
confidentiality or common interest agreements, with (a) copies
of all
filings and correspondence with the patent offices, administrative
boards,
or courts that King sends or receives in connection with filing,
prosecution, maintenance, and defense of the Patent Rights, and
(b) copies
of filings and correspondence under clause (a) sufficiently in
advance of
the due date so as to give Inyx's legal counsel sufficient time
to
comment; provided nothing herein will limit King's sole right to
file,
prosecute, maintain, and defend the Patent Rights in its sole
discretion.
|
6.3
|
Legal
Action.
|
(a)
|
Actual
or Threatened Infringement.
|
(i)
|
In
the event either party becomes aware of any possible infringement
or
unauthorized possession, knowledge, or use of any Patent Right,
Technology, or any Trademarks (collectively, an “Infringement”),
that party will promptly notify the AMC and the other party and
provide
them with full details (an “Infringement
Notice”).
The AMC will make a recommendation as to which actions should be
taken
with respect to such matters; provided that King will have the
final
decision as to whether to follow such recommendation. King will
be under
no obligation to prosecute or prevent the Infringement of or relating
to
Patent Rights, Technology, or Trademarks.
|
(ii)
|
If
the matter relates to an Excluded New Product and if King does
not
commence an action to prosecute, or otherwise take steps to prevent
or
terminate, the Infringement within one hundred eighty (180) days
from any
Infringement Notice, expressly excluding any immaterial infringement,
then
Inyx will have the right and option to take such action as Inyx
will
consider appropriate to prosecute or prevent such Infringement,
but only
if such Infringement is in the Territory. No suit instituted by
Inyx
pursuant to this clause (ii) may be settled without the approval
of the
AMC.
|
CONFIDENTIAL
TREATMENT
19
(iii)
|
All
reasonable costs and expenses expended by a party in connection
herewith
will be deemed Collaboration Costs to the extent the same are related
to a
Product. All monies or other assets recovered by a party pursuant
hereto
will be allocated first to offset all costs and expenses of such
suit, and
all remaining amounts will be retained by
King.
|
(iv)
|
If
either party determines that it is necessary or desirable for the
other to
join any such suit, action, or proceeding, the other party will,
upon
written notice from the prosecuting party, execute all papers and
perform
such other acts as may be reasonably required in the
circumstances.
|
(v)
|
Each
party will always have the right to be represented by counsel of
its own
selection in any suit instituted under this Section 6.3 by the
other party
for Infringement. If either party lacks standing and the other
party has
standing to bring any such suit, action, or proceeding, then such
other
party will bring such suit at the request of the first party.
|
(vi)
|
In
any action under this Section 6.3, the parties will fully cooperate
with
and assist each other.
|
(b)
|
Defense
of Claims.
|
(i)
|
In
the event that any action, suit, or proceeding is brought against
King or
Inyx or any Affiliate of either party alleging the infringement
of the
technology or intellectual property rights of a Third Party by
reason of
any party's activities performed pursuant to the Collaboration
Documents,
the AMC will determine how the parties will defend themselves in
such
action. All costs related to the same will be deemed Regulatory
and IP
Costs. Each party will have the right to separate counsel in any
such
action or proceeding. The parties will cooperate with each other
in the
defense of any such suit, action, or proceeding; provided, however,
that
King will have the option to assume control of the defense of any
action,
suit, or proceeding. The parties will give each other prompt written
notice of the commencement of any such suit, action, or proceeding
or
claim of infringement and will furnish each other a copy of each
communication relating to the alleged infringement. King, in its
sole
discretion, may compromise, litigate, settle, or otherwise dispose
of any
such suit, action, or proceeding. If the defending party agrees
that the
other party should institute or join any suit, action, or proceeding
pursuant to this Section 6.3, the defending party may join the
other party
as a party to the suit, action, or proceeding, and the party so
joined
will execute all documents and take all other actions, including
giving
testimony, that may reasonably be required in connection with the
prosecution of such suit, action, or
proceeding.
|
CONFIDENTIAL
TREATMENT
20
(ii)
|
If
as a consequence of such action, suit, or proceeding by a Third
Party
claiming that the discovery, development, manufacture, use, or
sale of a
Product or Excluded New Product infringes such Third Party's intellectual
property rights, the parties will examine and discuss in good faith
the
consequences of such prohibition or restriction or other conditions
on
this Agreement and the other Collaboration Documents and on possible
modifications thereto.
|
6.4
|
Trademark
Prosecution.
King will be responsible for the filing, prosecution, defense,
and
maintenance before all trademark offices of any Trademarks applicable
to
the Products and the Excluded New Products, and all related and
reasonable
costs and expenses will be deemed Regulatory and IP
Costs.
|
7.
|
Obligations
OF INYX
|
7.1
|
*
*
*
|
7.2
|
*
* *
|
8.
|
Obligations
OF KING
|
8.1
|
*
* *
|
8.2
|
*
* *
|
8.3
|
Manufacturing
Right of First Negotiation.
Subject to the terms and conditions of this Section 8.3, during
the Term,
King grants to Inyx a right of first negotiation with respect to
the
manufacture of any products of King in the respiratory field not
already
manufactured pursuant to the Manufacturing and Supply Agreement
(a
“King
Respiratory Product”).
In the event that King elects to have a party other than King or
its
Affiliates manufacture a King Respiratory Product, King will deliver
to
Inyx a written notice (the “Manufacturing
Offer Notice”)
identifying the King Respiratory Product and the price and terms,
if any,
upon which King proposes to have such King Respiratory Product
manufactured. Inyx will have fifteen (15) business days following
the
receipt of any such Manufacturing Offer Notice to notify King in
writing
of Inyx's election to negotiate with King. Upon receipt of Inyx's
election, King will negotiate exclusively with Inyx for a period
of
forty-five (45) days with respect to the manufacture of such King
Respiratory Product, based on the price and terms, if any, set
out in the
Manufacturing Offer Notice. In the event the parties fail to come
to terms
regarding the manufacture of the King Respiratory Product within
the
aforesaid period, or, if having agreed to terms, the parties are
unable to
enter definitive agreements within thirty (30) days following such
agreement, then King will be free to enter into an agreement with
a Third
Party to manufacture such King Respiratory Product on terms and
conditions
agreed to by King and such Third
Party.
|
CONFIDENTIAL
TREATMENT
21
8.4
|
***
|
9.
|
CERTAIN
REGULATORY MATTERS
|
9.1
|
Regulatory
Filings.
King will be responsible for filing, obtaining, and maintaining
Regulatory
Approvals in connection with the Collaboration Program, including
all
Excluded New Products and including making all Regulatory Filings;
and all
such approvals, including any NDAs and INDs, will be owned by and
held in
the name of King.
|
9.2
|
AMC
Oversight.
King will provide the AMC with reports on the progress of all Regulatory
Filings and communications with Regulatory Authorities in the Territory
and, if requested by the AMC, with (i) copies of all Regulatory
Filings
relating to the Territory and (ii) copies of all correspondence
with
Regulatory Authorities in the Territory. To the extent practicable
and
consistent with applicable laws, King will afford Inyx a reasonable
opportunity to comment on such Regulatory Filings; provided that
nothing
herein will limit King's sole right to oversee such Regulatory
Filings.
|
9.3
|
Inyx's
Responsibilities.
Inyx agrees to cooperate with King with respect to the activities
hereunder, including as follows:
|
(a)
|
to
make Inyx's personnel reasonably available, upon reasonable notice
of
King, at such personnel's place of employment to consult with King
on
issues arising related to the activities conducted in accordance
with this
Article 9 or otherwise relating to regulatory matters involving
the
Products or Excluded New Products, including any request from any
Regulatory Authority, including regulatory, scientific, technical,
and
clinical testing issues, or
otherwise;
|
(b)
|
to
cooperate with King, at King's request, to comply with specific
requests
of a Regulatory Authority with respect to data supplied or to be
supplied
for filing with such Regulatory Authority, or with respect to Products
supplied by King; and
|
(c)
|
from
time to time, or upon reasonable request, during the term of this
Agreement, to transfer to King all previously undisclosed data
relating to
the Products and Excluded New Products that is in Inyx's possession
or
control.
|
CONFIDENTIAL
TREATMENT
22
9.4
|
Regulatory
Costs.
All costs and expenses associated with filing, obtaining, and maintaining
Regulatory Approvals in connection with the Collaboration Program
will be
deemed Regulatory and IP Costs.
|
9.5
|
Licenses.
Each party hereto will, at its sole cost and expense, maintain
in full
force and effect all necessary licenses, permits, and other authorizations
required by law, regulation, ordinance, or statute to carry out
its duties
and obligations under the Collaboration
Documents.
|
10.
|
RECORDKEEPING
AND AUDITS
|
10.1
|
Maintenance
of Books and Records.
Each party will maintain complete and accurate books and records
in
sufficient detail, in accordance with GAAP and all applicable laws,
rules,
ordinances, and regulations, to enable verification of the performance
of
such party's obligations under the Collaboration Documents and
verification of the Collaboration Costs incurred by such party.
Such
records will be maintained for a period of twenty-four (24) months
after
the end of the Term or longer if required by applicable law.
|
10.2
|
Payment
Audits.
(a)
Either party (herein, the “Auditing
Party”)
may demand, no more than once during any Calendar Year from the
Effective
Date until two (2) years following the end of the Term, an audit
of the
relevant books and records of the other party (herein, the “Audited
Party”)
in order to verify the Audited Party's reports with respect to
Collaboration Costs and any payments required under the Collaboration
Documents. Upon no less than fifteen (15) days' prior written notice
to
the Audited Party, the Audited Party will grant access to the relevant
books and records of the Audited Party to members of a nationally
recognized independent public accounting firm selected by the Auditing
Party in order to conduct a review or audit thereof. Such access
will be
available during normal business hours. The accountants will report
their
conclusions and calculations to the Auditing Party and the Audited
Party;
provided that in no event will the accountants disclose any information
of
the Audited Party except to the extent necessary to verify the
Audited
Party's reporting and other compliance with the terms of this Agreement,
and, at the request of the Audited Party, such accountants will
execute
appropriate non-disclosure agreements. Except as hereinafter set
forth,
the Auditing Party will bear the full cost of the performance of
any such
audit.
|
(b)
|
If,
as a result of any audit of the books and records of Audited Party,
it is
shown that the payments from one party to the other under this
Agreement
with respect to the period of time audited were less than or more
than the
amount that should have been paid, or it is shown that the Collaboration
Costs claimed by the Audited Party were overstated, then the parties
will
reconcile the amounts owed by each party to the other. In addition,
if
such audit demonstrates that Collaboration Costs were overstated
or
revenue underreported by more than *** for the period audited,
then the
Audited Party will also reimburse the Auditing Party for its documented
reasonable out-of-pocket costs and expenses incurred in connection
with
the audit.
|
CONFIDENTIAL
TREATMENT
23
10.3
|
Compliance
Audits. (a)
In
addition to the access and audit rights of the parties set forth
in
Section 10.2, no more than once during any Calendar Year during
the Term,
upon reasonable prior notice, each party (the “Requested
Party”)
will, and will cause its Affiliates to, afford to the other party
(the
“Requesting
Party”)
reasonable access during normal business hours (and at such other
times as
the parties may mutually agree) to such of the Requested Party's
relevant
books, records, and other information as the Requesting Party may
reasonably request in order to monitor the Requested Party's compliance
with such party's obligations under the Collaboration Program.
Such access
will be available during normal business hours. Any inspection
conducted
by either party pursuant to this Section 10.3 will be at the sole
cost and
expense of the Requesting Party.
|
11.
|
TERM
AND TERMINATION
|
11.1
|
Term
of Agreement.
The term of this Agreement (the “Term”)
will commence as of the Effective Date hereof and will continue,
unless
terminated sooner or extended as provided below, until the earlier
of (i)
the later of December 31, 2015 and the last date on which any Approved
New
Product is sold and (ii) expiration or termination of the last
of the
other Collaboration Documents.
|
11.2
|
Termination
by Either Party. (a)
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 within sixty (60) days after
written
notice is given to the breaching party specifying the breach or
default.
|
(b)
|
Each
party may, by written notice delivered to the breaching party,
terminate
this Agreement if there are two or more similar or substantially
similar
material breaches of this Agreement by the breaching party within
any
12-month period, which termination will be effective thirty (30)
days
following such written notice; provided, however, that any failure
of a
non-breaching party to exercise this termination right with respect
to
certain breaches will not be deemed a waiver of the ability of
such
non-breaching party to exercise this right upon any subsequent
breach.
|
(c)
|
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.
|
CONFIDENTIAL
TREATMENT
24
11.3
|
Termination
by King. (a)
King will have the right to terminate this Agreement immediately
upon
written notice to Inyx if (i) subject to the terms of Section 11.3(b)
below, there is a Change of Control of Inyx, or (ii) the Manufacturing
and
Supply Agreement terminates.
|
(b)
|
*
*
*
|
11.4
|
Effects
of Termination. (a)
Upon termination or expiration of this Agreement, all other Collaboration
Documents, except the Manufacturing and Supply Agreement and the
Quality
Agreement, and the Development Agreement (to the extent provided
in
Section 7.3 of such agreement), will concurrently
terminate.
|
(b)
|
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.
|
(c)
|
Notwithstanding
the giving of any notice of termination pursuant to this Article
11, each
party will continue to fulfill its obligations under this Agreement
at all
times until the effective date of any such
termination.
|
11.5
|
Actions
Upon Termination.
Upon the termination or expiration of this Agreement for any reason,
|
(a)
|
Except
as provided in a concurrently terminating Collaboration Document,
Inyx
will immediately cease all uses of the license granted hereunder;
|
(b)
|
Inyx
will deliver to King all Improvements and all documents, material,
data,
records, analyses, and information related thereto;
and
|
(c)
|
The
parties will cooperate with each other, including by making their
personnel and other resources reasonably available to each other
as
necessary, for a period of ninety (90) days to effect an orderly
termination of the Collaboration Program and an orderly transition
of
Collaboration Program responsibilities to
King.
|
11.6
|
Survival.
The provisions of Articles 2 (to the extent necessary for the AMC
to
perform the actions assigned to it following termination or expiration
of
this Agreement or any other Collaboration Document), 5, 11, 12,
13, and 15
and Sections 10.1, 10.2, and 14.3 will survive any expiration or
termination of this Agreement.
|
11.7
|
Payments
Upon Termination. (a)
The
expiration or termination of this Agreement pursuant to this Article
11
will not release either party from any obligation to pay to the
other
party any amounts accrued under any of the Collaboration Documents
in
connection with activities completed, Collaboration Costs incurred,
and
revenue realized with respect to the period prior to the effective
date of
such expiration or termination.
|
CONFIDENTIAL
TREATMENT
25
(b)
|
Within
thirty (30) days after the expiration or termination of this Agreement,
each party will provide to the other (i) a reasonably detailed
statement of Collaboration Costs incurred by such party during
the period
of January 1 of the Calendar Year in which such expiration
or
termination occurs through the effective date of such expiration
or
termination; and (ii) any final reports with respect to
revenue or
Net Sales relating to the Products during such period, as required
by any
of the other Collaboration
Documents.
|
(c)
|
Within
thirty (30) days after receipt of such information, the AMC will
determine
the net amounts due and or payable by Inyx and King, and such amounts
will
be paid by the parties within thirty (30) days after such AMC
determination.
|
11.8
|
Effects
of Termination of any Collaboration Document.
Upon termination or expiration of any Collaboration Document (the
“Terminated
Agreement”),
except to the extent of the survival of any provisions thereof,
all
references to Collaboration Documents herein will not include a
reference
to such Terminated Agreement.
|
12.
|
CONFIDENTIALITY;
Announcements
|
12.1
|
Confidential
Information. (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 Section 10.2 or Section
10.3 of
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 12 will not
apply to
any information that:
|
CONFIDENTIAL
TREATMENT
26
(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.
|
CONFIDENTIAL
TREATMENT
27
(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.
|
(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 12 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).
|
12.2
|
Public
Announcements.
The form and content of any public announcement to be made by one
party
regarding this Agreement, any of the other Collaboration Documents,
or the
Collaboration Program, or the subject matter contained in the
Collaboration Documents, will be subject to the prior written consent
of
the other party (which consent will not be unreasonably withheld,
delayed,
or conditioned), except as may be required by applicable law (including
disclosure requirements of the Securities and Exchange Commission,
the New
York Stock Exchange, NASDAQ, or any other stock exchange), in which
event
such party will endeavor to give the other party reasonable advance
notice
and review of any such disclosure.
|
13.
|
INDEMNIFICATION
AND INSURANCE
|
13.1
|
Indemnification
by Inyx.
Inyx will defend, indemnify, and hold King and its Affiliates,
and their
respective officers, directors, employees, agents, successors,
and
assigns, harmless from and against any and all Third Party claims,
liabilities, losses, costs, actions, suits, judgments, damages,
and
expenses (including attorneys' fees and costs) arising out of:
(a) any breach by Inyx of any representation, warranty,
or covenant
contained in the Collaboration Documents; (b) the negligence
or
willful misconduct of Inyx, its Affiliates, or their respective
employees
or agents in the performance of any obligation under the Collaboration
Documents; and (c) any claims relating to the performance or
nonperformance of Inyx's obligations under the Collaboration Documents;
provided, however, that Inyx will not be required to indemnify
King with
respect to any such claim, liability, loss, cost, action, suit,
damage, or
expense hereunder to the extent the same is caused primarily by
any breach
of contract, negligent act or omission or intentional misconduct
by King
or any or its Affiliates or is otherwise covered by King's indemnification
obligation in Section 13.2.
|
CONFIDENTIAL
TREATMENT
28
13.2
|
Indemnification
by King.
King will defend, indemnify, and hold Inyx and its Affiliates,
and their
respective officers, directors, employees, agents, successors,
and
assigns, harmless from and against any and all Third Party claims,
liabilities, losses, costs, actions, suits, judgments, damages,
and
expenses (including attorneys' fees and costs) arising out of:
(a) any breach by King of any representation, warranty,
or covenant
contained in the Collaboration Documents; (b) the negligence
or
willful misconduct of King, its Affiliates, or their respective
employees
or agents in the performance of any obligation under the Collaboration
Documents; and (c) any claims relating to the performance or
nonperformance of King's obligations under the Collaboration Documents;
provided, however, that King will not be required to indemnify
Inyx with
respect to any such claim, liability, loss, cost, action, suit,
damage, or
expense hereunder to the extent the same is caused primarily by
any breach
of contract, negligent act or omission or intentional misconduct
by Inyx
or any or its Affiliates or is otherwise covered by Inyx's indemnification
obligation in Section 13.1.
|
13.3
|
Claims
Procedures.
A
party (the “indemnitee”)
that intends to claim indemnification under this Article 13 will
notify
the other party (the “indemnitor”)
within a reasonable time in writing of any action, claim, or liability
in
respect of which the indemnitee believes it is entitled to claim
indemnification; provided that the failure to give timely notice
to the
indemnitor will not release the indemnitor from any liability to
the
indemnitee except to the extent the indemnitor is actually prejudiced
thereby. The indemnitor will have the right, by notice to the indemnitee,
to assume the defense of any such action or claim within the fifteen
(15)
day period after the indemnitor's receipt of notice of any action
or claim
with counsel of the indemnitor's choice and at the sole cost of
the
indemnitor. If the indemnitor does not so assume the defense of
such Third
Party claim, the indemnitee may assume such defense with counsel
of its
choice and at the sole cost of the indemnitor. If the indemnitor
so
assumes such defense, the indemnitee may participate therein through
counsel of its choice, but at the sole cost of the indemnitee.
The party
not assuming the defense of any such claim will render all reasonable
assistance to the party assuming such defense, and all reasonable
out-of-pocket costs of such assistance will be for the account
of the
indemnitor. No such claim will be settled other than by the party
defending the same, and then only with the consent of the other
party,
which will not be unreasonably withheld; provided that the indemnitee
will
have no obligation to consent to any settlement of any such action
or
claim that imposes on the indemnitee any liability or obligation
that
cannot be assumed and performed in full by the indemnitor, and
the
indemnitee will have no right to withhold its consent to any settlement
of
any such action or claim if the settlement involves only the payment
of
money by the indemnitor or its
insurer.
|
CONFIDENTIAL
TREATMENT
29
13.4
|
Insurance.
During the Term, each party will maintain insurance (either through
purchase of a policy from a nationally recognized Third Party insurer
or
through maintenance of a self-insurance program) against such risks
and
upon such terms (including coverages, deductible limits, and self-insured
retentions) as is customary for the activities to be conducted
by such
party under this Agreement and is appropriate to cover its indemnification
obligations hereunder. Each party will name the other as an additional
insured on such party's relevant insurance policies and will furnish
to
the other party evidence of such insurance, upon
request.
|
13.5
|
Limited
Liability.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT OR ANY
OTHER
COLLABORATION DOCUMENT, NEITHER KING NOR INYX WILL BE LIABLE WITH
RESPECT
TO ANY SUBJECT MATTER OF THE COLLABORATION DOCUMENTS UNDER ANY
CONTRACT,
NEGLIGENCE, STRICT LIABILITY, OR OTHER LEGAL OR EQUITABLE THEORY
FOR (I)
ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES
OR
(II) COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY, OR
SERVICES.
|
14.
|
REPRESENTATIONS
AND WARRANTIES
|
14.1
|
By
Inyx.
Inyx represents and warrants to King
that:
|
(a)
|
the
execution, delivery, and performance of each Collaboration Document
by
Inyx does not conflict with, or constitute a breach of or under,
any
order, judgment, agreement, or instrument to which Inyx is a party;
|
(b)
|
the
execution, delivery, and performance of each Collaboration Document
by
Inyx does not require the consent of any Person or the authorization
of
(by notice or otherwise) any governmental or regulatory authority;
|
(c)
|
each
Collaboration Document is a legal, valid, and binding obligation
of Inyx
enforceable against it in accordance with its terms and conditions,
except
as enforceability may be limited by bankruptcy, insolvency, or
other laws
affecting the enforcement of creditors' rights generally, and except
that
the availability of the remedy of specific performance or other
equitable
relief is subject to the discretion of the court before which any
proceeding therefor may be brought;
and
|
CONFIDENTIAL
TREATMENT
30
(d)
|
As
of the Effective Date, neither Inyx nor any of its employees or
agents, in
their capacity as such, have been disqualified or debarred by the
FDA,
pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted
under United States law for conduct relating to the development
or
approval, or otherwise relating to the regulation of any Product
under the
Generic Drug Enforcement Act of 1992, or any other relevant law,
rule, or
regulation or been disbarred, disqualified, or convicted under
or for any
equivalent or similar applicable foreign law, rule, or regulation.
|
14.2
|
By
King.
King represents and warrants to Inyx
that:
|
(a)
|
the
execution, delivery, and performance of each Collaboration Document
by
King does not conflict with, or constitute a breach of or under,
any
order, judgment, agreement, or instrument to which King is a
party;
|
(b)
|
the
execution, delivery, and performance of each Collaboration Document
by
King does not require the consent of any Person or the authorization
of
(by notice or otherwise) any governmental or regulatory authority;
|
(c)
|
each
Collaboration Document is a legal, valid, and binding obligation
of King
enforceable against it in accordance with its terms and conditions,
except
as enforceability may be limited by bankruptcy, insolvency, or
other laws
affecting the enforcement of creditors' rights generally, and except
that
the availability of the remedy of specific performance or other
equitable
relief is subject to the discretion of the court before which any
proceeding therefor may be brought;
and
|
(d)
|
As
of the Effective Date, neither King nor any of its employees or
agents, in
their capacity as such, have been disqualified or debarred by the
FDA,
pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted
under United States law for conduct relating to the development
or
approval, or otherwise relating to the regulation of any Product
under the
Generic Drug Enforcement Act of 1992, or any other relevant law,
rule, or
regulation or been disbarred, disqualified, or convicted under
or for any
equivalent or similar applicable foreign law, rule, or
regulation.
|
14.3
|
Warranty
Disclaimer.
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER
PARTY
MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES,
RIGHTS, OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
AND
NONINFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE
FOREGOING.
|
CONFIDENTIAL
TREATMENT
31
15.
|
MISCELLANEOUS
PROVISIONS
|
15.1
|
Notices.
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
If
to
Inyx:
Inyx,
Inc.
000
Xxxxx
Xxxxxx
00xx
Xxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Chairman and CEO
Facsimile:
(000) 000-0000
CONFIDENTIAL
TREATMENT
32
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.
15.2
|
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.
|
15.3
|
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.
|
15.4
|
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.
|
15.5
|
Entire
Agreement.
This Agreement, 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.
|
15.6
|
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 15.1 above.
Nothing
in this Section 15.6, however, will affect the right of any party
to serve
legal process in any other manner permitted by law or
equity.
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CONFIDENTIAL
TREATMENT
33
15.7
|
Equitable
Relief.
Each party acknowledges that a breach by it of the provisions of
this
Agreement, including the provisions of Articles 5 and 12 and Section
7.1,
cannot reasonably or adequately be compensated in damages in an
action at
law and that such a breach may cause the other party irreparable
injury
and damage. By reason thereof, each party agrees that the other
party is
entitled to seek, in addition to any other remedies it may have
under this
Agreement or otherwise, preliminary and permanent injunctive and
other
equitable relief to prevent or curtail any breach of this Agreement
by the
other party; provided, however, that no specification in this Agreement
of
a specific legal or equitable remedy will be construed as a waiver
or
prohibition against the pursuing of other legal or equitable remedies
in
the event of such a breach. Each party agrees that the existence
of any
claim, demand, or cause of action of it against the other party,
whether
predicated upon this Agreement, or otherwise, will not constitute
a
defense to the enforcement by the other party, or its successors
or
assigns, of the covenants contained in this
Agreement.
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15.8
|
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.
|
15.9
|
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.
|
15.10
|
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.
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CONFIDENTIAL
TREATMENT
34
15.11
|
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. If, as a result of a force
majeure
event, a party is unable to fully perform its obligations hereunder
for
any consecutive period of one hundred eighty (180) days, the other
party
will have the right to terminate this Agreement, upon providing
written
notice to the nonperforming party, such termination to be effective
thirty
(30) days from the date of such notice.
|
15.12
|
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.
|
15.13
|
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.
|
15.14
|
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.
|
15.15
|
Conflict.
In the event of a conflict between the terms, conditions, and provisions
of this Agreement and any other Collaboration Document, the terms,
conditions, and provisions of this Agreement shall
govern.
|
15.16
|
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.
|
CONFIDENTIAL
TREATMENT
35
15.17
|
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 will 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.
|
IN
WITNESS WHEREOF, the parties have duly executed this Collaboration Agreement
as
of the first date written above.
KING PHARMACEUTICALS, INC. | ||
|
|
|
By: | /s/ Xxxxx Xxxxxxxx | |
Xxxxx Xxxxxxxx |
||
President and CEO |
INYX, INC. | ||
|
|
|
By: | /s/ Xxxx Xxxxxxx | |
Xxxx Xxxxxxx |
||
Chairman and CEO |
CONFIDENTIAL
TREATMENT
36
EXHIBIT
A
TECHNOLOGY
TRANSFER AGREEMENT
CONFIDENTIAL
TREATMENT
EXHIBIT
B
MANUFACTURING
AND SUPPLY AGREEMENT
CONFIDENTIAL
TREATMENT
EXHIBIT
C
MARKETING
AND PROMOTION AGREEMENT
CONFIDENTIAL
TREATMENT
EXHIBIT
D
DEVELOPMENT
AGREEMENT
CONFIDENTIAL
TREATMENT
EXHIBIT
E
QUALITY
AGREEMENT
CONFIDENTIAL
TREATMENT