EXHIBIT
10.38.1
CONFIDENTIAL TREATMENT
REQUESTED. CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN
REDACTED AND HAVE BEEN SEPARATELY
FILED WITH THE
COMMISSION.***
COLLABORATION
AGREEMENT
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:
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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:
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“ 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.
“ 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.
“ 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.
“ 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).
“ 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.
“ 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.
“ 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.
“ 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.
“ 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.
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ADMINISTRATION OF THE
COLLABORATION
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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.
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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.
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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.
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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:
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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);
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definition,
review, and approval of and changes to the strategy and objectives
(but not the actual conduct) of the Collaboration
Program;
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management and
allocation of resources of the Collaboration Program;
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proposal of all
budgets for the Collaboration Program, including as described in
Article 3;
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review and
approval of all agreements required or entered into in connection
with the Collaboration Program, and any and all amendments thereto;
and
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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.
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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.
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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.
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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.
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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:
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For Inyx: Dr. Jack Kachkar, Chairman &
CEO
For King: Brian Markison, President &
CEO
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In the event
such designated officers are unable to resolve such dispute within
such 15-day period, then
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to the extent
the dispute relates to a clinical or development activity or issue,
then such matter will be finally decided by King,
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to the extent
the dispute relates to a regulatory activity or issue, then such
matter will be finally decided by King,
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to the extent
the dispute relates to a marketing activity or issue, then such
matter will be finally decided by King, or
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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.
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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).
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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.
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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.
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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.
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3.
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Budget;
Collaboration Costs; Collaboration Documents
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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.
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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.
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Allocation . All Collaboration Costs incurred by a party on
and after the Effective Date through the Term
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