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COLLABORATION AGREEMENT

Collaboration Agreement

COLLABORATION AGREEMENT

 | Document Parties: INYX INC | KING PHARMACEUTICALS, INC. You are currently viewing:
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INYX INC | KING PHARMACEUTICALS, INC.

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Title: COLLABORATION AGREEMENT
Governing Law: New York     Date: 11/23/2005
Law Firm: Jones Day; Bennett Jones LLP    

COLLABORATION AGREEMENT

, Parties: inyx inc , king pharmaceuticals  inc.
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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:

 

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.

 

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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.

 

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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).

 

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* * *

 

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.

 

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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.

 

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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.

 

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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.

 

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* * * .

 

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.

 

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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;

 

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(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:

 

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For Inyx: Dr. Jack Kachkar, Chairman & CEO

 

For King: Brian Markison, 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.

 

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(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


 
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