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INTELLECTUAL PROPERTY AGREEMENT

Intellectual Property IP Rights Security Agreement

INTELLECTUAL PROPERTY AGREEMENT | Document Parties: EPIX PHARMACEUTICALS, INC. | EPIX Medical, Inc You are currently viewing:
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EPIX PHARMACEUTICALS, INC. | EPIX Medical, Inc

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Title: INTELLECTUAL PROPERTY AGREEMENT
Governing Law: New York     Date: 3/13/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

INTELLECTUAL PROPERTY AGREEMENT, Parties: epix pharmaceuticals  inc. , epix medical  inc
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EXHIBIT 10.9

 

CONFIDENTIAL TREATMENT

EPIX Medical, Inc. has requested that the marked portions of this document be accorded confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.

 

EXECUTION COPY

 

INTELLECTUAL PROPERTY AGREEMENT

 

This “Agreement” made this 17th day of November, 2003 by and between Dr. Martin R. Prince (hereinafter, “Prince”), an individual residing at *****, and EPIX Medical, Inc., a corporation duly organized under the laws of the State of Delaware and having a principal place of business at 71 Rogers Street, Cambridge, Massachusetts USA (hereinafter “EPIX”).

 

RECITALS

 

Prince is recognized for his expertise in clinical magnetic resonance imaging and magnetic resonance angiography and as the inventor of contrast-enhanced magnetic resonance angiography techniques.

 

Prince and Dr. James F.M. Meaney (hereinafter “Meaney”), an individual residing at *****, are the inventors of certain inventions relating to bolus chase magnetic resonance angiography.

 

Prince represents that he is the owner of, and has the right to grant the discharges, releases, promises and covenants not to sue under intellectual property pertaining to magnetic resonance imaging and magnetic resonance angiography that is the subject of this Agreement.

 

EPIX, by itself and/or through its Affiliates, desires to obtain discharges, releases, promises and covenants not to sue under the above-described intellectual property rights to enable them to develop and commercialize contrast agents used in magnetic resonance imaging and magnetic resonance angiography on the terms set forth herein.

 

Prince desires to grant such discharges, releases, promises and covenants not to sue on the terms set forth herein.

 

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AGREEMENT

 

NOW, THEREFORE, in consideration of the promises and mutual covenants set forth herein, the parties agree as follows:

 

ARTICLE 1

DEFINITIONS

 

1.1                                  “Effective Date” means the date first set forth above.

 

1.2                                  “Royalty Start Date” means the date of the first Sale of an MR Contrast Agent Product.

 

1.3                                  “Affiliate(s)” means any entity which is or becomes directly or indirectly controlled by EPIX, control being defined as (i) the direct or indirect ownership of at least 50% of the stock entitled to vote upon election of directors or persons performing similar functions, or (ii) direct or indirect ownership of the maximum percentage of such stock permitted by local laws or regulations in those countries where fifty percent (50%) ownership by a foreign entity is not permitted.

 

1.4                                  “CE-MRA” means contrast-enhanced MR angiography.

 

1.5                                  “MR” means magnetic resonance imaging and magnetic resonance angiography.

 

1.6                                  “MR Contrast Agent(s)” means any contrast agent used in, or capable of use in CE-MRA procedures.

 

1.7                                  “MR Imaging System(s)” means any magnetic resonance transmission/receiving system, inclusive of all hardware (for example, without limitation, imaging coils) and software components, that is capable of performing CE-MRA procedures.

 

1.8                                  “MR Injection Product(s)” means any pump, tubing set, or like apparatus that is designed for or advertised to be used in CE-MRA procedures to administer, inject or infuse contrast agent(s) to a patient.  Notwithstanding the foregoing, a syringe that is pre-filled with the MR Contrast Agent Product is not an MR Injection Product.

 

1.9                                  “MR Contrast Agent Product” means a product containing the MR Contrast Agent currently designated by EPIX as MS-325.  Expressly excluded from this definition are all other MR Contrast Agents, and MR Imaging Systems or any MR Injection Products, no matter how Sold, provided, used or disposed of.

 

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1.10                            “Prince MR Intellectual Property” means any invention, improvement, trade secret, patent, patent application, copyright and other intellectual property rights to which Prince is able to grant the discharge, release, promise and covenant not to sue herein as of the Effective Date or thereafter during the term of this Agreement, which relate to the manufacture, use, importation, advertisement, offer to Sell, or Sale of any MR Contrast Agent Product.

 

1.11                            “Prince Patents” means the patents and patent applications included within the Prince MR Intellectual Property, including, without limitation, the patents and patent applications listed in Exhibit A and any and all applications, continuation applications, continuation-in-part applications, divisional applications, reissue applications, reexamination applications, foreign counterparts or other statutory rights arising from or based on such applications, anywhere in the world.

 

1.12                            “Third Party(ies)” means any entity which is neither a party to this Agreement nor an Affiliate of such a party.

 

1.13                            “EPIX Licensee(s)” means any entity that is authorized by EPIX to Sell the MR Contrast Agent Product to a customer/user in any country of the world.  Currently, the only EPIX Licensees are Berlex Laboratories, Inc. (hereinafter “Berlex”), a company having its principal place of business at 340 Changebridge Road, Montville, New Jersey, and Schering AG (hereinafter “Schering”), a company having its principal place of business at Müllerstrasse 178, D-13342 Berlin, Germany.

 

1.14                            “Sell” means to sell, lease, or otherwise transfer or convey an MR Contrast Agent Product.  A commercially reasonable number of units of MR Contrast Agent Product that are provided, free of charge, to Third Parties as samples for promotional purposes shall be deemed not to have been Sold for purposes of determining the royalty payable hereunder.  “Sold”, “Sale”, and other forms of “Sell” shall have the same meaning.

 

1.15                            “Net Sales” means the gross amount invoiced or otherwise charged a customer by EPIX (or its Affiliates) or EPIX Licensees for a MR Contrast Agent Product Sold by EPIX (or its Affiliates) or EPIX Licensees in any country of the world, less the following amounts: (a) insurance, transportation, taxes, customs brokers fees and customs duties provided such deductions are paid by EPIX (or its Affiliates) or EPIX Licensees and listed on the invoice; (b) allowances or credits to customers in the ordinary course of business in connection with the sale of an MR Contrast Agent Product on account of outdating, recall, market withdrawal, rejection, or return of such MR Contrast Agent Product, (c) credited allowances to such independent

 

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customers for such MR Contrast Agent Product which were spoiled, damaged, out-dated or returned; (d) freight and insurance costs charged to such customers; (e) quantity and promotional discounts actually allowed and taken; (f) sales, use, value added, and other taxes or governmental charges (such as customs duties) incurred in connection with the sale, exportation or importation of the MR Contrast Agent Product in finished packaged form; (g) charge back payments and/or rebates or other fees provided to distributors, wholesalers, or other purchasers and managed health care organizations or federal, state and local governments, their agencies, purchasers and reimbursers, including reimbursements to social security organizations; and (h) volume-related customer program costs which are required by the customer and which are independent of marketing initiatives.

 

The parties recognize that (a) customers may include persons in the chain of commerce, who enter into agreements with a seller as to price even though title to the MR Contrast Agent Product does not pass directly from the seller to such customers, and even though payment for such MR Contrast Agent Product is not made by such customers directly to the seller; and (b) in such cases chargebacks paid by EPIX (or its Affiliates) or EPIX Licensees to or through a Third Party (such as a wholesaler) can be deducted by EPIX (or its Affiliates) or EPIX Licensees  from gross revenue in order to calculate Net Sales.  Any deductions listed above which involve a payment by EPIX (or its Affiliates) or EPIX Licensees shall be taken as a deduction against aggregate sales for the quarter in which the payment is made.

 

Net Sales will be accounted for in accordance with international accounting standards consistently applied. In any instance where the calculation of Net Sales according to international accounting standards differs materially from GAAP such that the result of such calculation under international accounting standards would cause EPIX (or its Affiliates) or EPIX Licensees to improperly account for such revenue under GAAP, EPIX will provide Prince with any and all information requested by Prince regarding the calculation of Net Sales to enable Prince to comply with GAAP in recognizing revenue from such Net Sales.

 

Where a MR Contrast Agent Product is transferred by EPIX (or its Affiliates), through one or more Affiliates or EPIX Licensees for Sale to a customer/user, only the Sale to such customer/user shall be included in the Net Sales.  For example, where a MR Contrast Agent Product is transferred by (i) EPIX to Berlex or Schering (whether through one or more Affiliates of EPIX) for Sale to a customer/user, or (ii) Mallinckrodt to EPIX or Berlex or Schering for Sale to a customer/user, only the Sale to such customer/user shall be included in the Net Sales.

 

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Notwithstanding the foregoing, the Net Sales for any calendar quarter shall be no less than the net sales of MR Contrast Agent Product by EPIX Licensees for the corresponding calendar quarter as reported (i) by EPIX Licensees to EPIX (or its Affiliates) or (ii) by EPIX in publicly available documentation (such as, for example, the Quarterly and/or Annual Reports).

 

Given the worldwide scope of this Agreement, the impracticality of monitoring by EPIX of the movement of the MR Contrast Agent Product through international markets and the impracticality of establishing a value for pro-rata use in CE-MRA (if any), it is agreed and recognized that paying royalties on all Sales of MR Contrast Agent Product, as a whole, is fair and reasonable, representing a balance between the concerns and interests of both parties and resulting in a convenience for EPIX.

 

1.16                            “Third Party Price” means the average amount paid by all Third Parties for the MR Contrast Agent Product in arms-length transactions during the calendar quarter corresponding to the royalty period of any royalty report, provided there are substantial Sales of such MR Contrast Agent Product to Third Parties during the royalty period.  In the event of a dispute regarding whether there have been such substantial Sales, the parties agree to first meet and negotiate in good faith with the expectation of determining a Third Party Price.

 

1.17                            “Confidential Information” means any information disclosed by one party to the other, pursuant to this Agreement, which is in written, graphic, machine readable or other tangible form and is marked “Confidential”, “Proprietary” or in some other manner to indicate its confidential nature.  Confidential Information may also include oral information disclosed by one party to the other provided that such information is designated as confidential at the time of disclosure and reduced to a written summary by the disclosing party, within thirty (30) days after its oral disclosure, which is marked in a manner to indicate its confidential nature and delivered to the receiving party.  Notwithstanding the foregoing limitations, all sales and similar reports and records provided by EPIX to Prince hereunder, or to which Prince or its designee may gain access pursuant to Article 4, are hereby deemed to be Confidential Information of EPIX.

 

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ARTICLE 2

DISCHARGE, RELEASE, AND COVENANT

 

2.1                                  Subject to the terms and conditions of this Agreement, Prince hereby discharges, releases, promises and covenants not to sue, threaten to sue or otherwise disturb EPIX, and its Affiliates, and any EPIX Licensee, subcontractor, supplier, distributor, vendor, reseller, purchaser, or user of the MR Contrast Agent Product, acquired directly or indirectly from EPIX (or its Affiliates) or an EPIX Licensee in any country in the world, for any claim or cause of action based upon (i) the Prince MR Intellectual Property and (ii) the manufacture, use, Sale, advertisement, offer for Sale, importation, lease, or otherwise transfer or disposition of the MR Contrast Agent Product, whether such claim or cause of action is presently known or unknown.  This covenant not to sue is personal in nature and limited to EPIX, its Affiliates, any successor(s) to EPIX, and any EPIX Licensee, subcontractor, supplier, distributor, vendor, reseller, purchaser, or user of the MR Contrast Agent Product.

 

2.2                                  Prince hereby grants to EPIX, and its Affiliates and any EPIX Licensee, a non-exclusive, license, without the right to sublicense, under U.S. Patent ***** to make, have made, use, offer to Sell, Sell, import, export and otherwise transfer the MR Contrast Agent Product during the term of this Agreement.  Nothing in this Agreement shall be construed as expressly, impliedly, or otherwise granting a license, of any kind or type, under the Prince Patents other than U.S. Patent *****.

 

2.3                                  Nothing contained in this Agreement shall be construed as:

 

(a)           a warranty or representation by Prince as to the validity, enforceability, and/or scope of any one of the Prince Patents; or

 

(b)          imposing on Prince any obligation to institute legal action for infringement of any one of the Prince Patents, or to defend a legal action brought by a Third Party in relation to any one of the Prince Patents; or

 

(c)           imposing on Prince any obligation to file application(s) or other intellectual property registration(s) related to the Prince MR Intellectual Property, or to secure or maintain in force any one of the Prince Patents; or

 

(d)          imposing on Prince any obligation to furnish any technical information or know-how.

 

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ARTICLE 3

COMPENSATION AND RELATED OBLIGATIONS

 

3.1                                  In consideration of the license, discharges, releases, promises and covenants not to sue granted herein, EPIX agrees to pay Prince:

 

(a)           ***** ($ *****), the payment being due and payable within two (2) weeks of the Effective Date of the Agreement; and

 

(b)          commencing with the Royalty Start Date, a royalty equal to ***** percent (*****%) of Net Sales.

 

3.2                                  In the event that the MR Contrast Agent Product is Sold during a calendar quarter under circumstances where the selling price is not established on an arms-length basis, Net Sales shall be calculated using the Third Party Price of such MR Contrast Agent Product.  If there is no Third Party Price for such MR Contrast Agent Product, the parties shall immediately determine an appropriate royalty base for such MR Contrast Agent Product.  In the event that a resolution is not reached, the dispute shall be resolved according to the resolution procedure of paragraph 13.2.

 

3.3                                  In further consideration of the license, discharges, releases, promises and covenants granted herein, EPIX agrees to provide to Prince, or another designated in writing by Prince, ***** Dollars ($*****) worth of MR Contrast Agent Product per year calendar commencing on the earlier of (i) the day that the FDA issues final approval of the use of MR Contrast Agent Product for a CE-MRA procedure or indication, or (ii) the day the MR Contrast Agent Product becomes commercially available, and continuing each calendar year thereafter until expiration or termination of the Agreement.  The number of Doses to be provided for each calendar year will be determined by dividing ***** by the Third Party Price per Dose as of the first day of such year.  EPIX will provide Prince with an invoice promptly after the first day of the year setting forth the number of Doses to be delivered to Prince during such year and the method by which the number of doses was determined, including without limitation, the Third Party Price per Dose.  Such Doses shall be deemed not to have been Sold for purposes of determining the royalty payable under this Agreement.  One (1) dose of MR Contrast Agent Product is equal to the largest commercially available volume of MR Contrast Agent Product, within a container, for administration to one (1) patient.  For example, where the largest commercially available volume of MR Contrast Agent within a container for administration to one (1) patient is a vial or syringe containing one hundred milliliters

 

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(100ml) of MR Contrast Agent Product, one dose of MR Contrast Agent Product is one hundred milliliters (100ml).

 

3.4                                  EPIX shall deliver the MR Contrast Agent Product referenced in paragraph 3.3 of this Agreement to a place in North America as designated by Prince within ninety (90) days of written notice.  Each dose shall be delivered to Prince in accordance with industry “best practices” and shall be packaged in a separate container in the same manner and material(s) (for example, without limitation, vial or syringe) as commercially available to bona fide customers/users.  In the event that the MR Contrast Agent Product is available in more than one type or form of container, Prince shall have the option, at his sole discretion, to designate the type or form of container.  To facilitate storage of such MR Contrast Agent Product, Prince may, at his sole discretion, specify delivery of the MR Contrast Agent Product of paragraph 3.3 in prorated amounts at monthly or quarterly intervals.

 

3.5                                  Notwithstanding paragraph 3.3, in the event that Prince, in any calendar year, requests delivery of fewer Doses than were indicated on the invoice provided to Prince by EPIX for such calendar year, then the difference between the number of Doses indicated on the invoice and the number of Doses actually requested in that calendar year shall be added to the number of Doses available to be requested by Prince in a subsequent year under the conditions of paragraph 3.4.  Further, in the event that the last year of the term of this Agreement is not a full calendar year, EPIX shall deliver to Prince, under the same terms and conditions as set forth in paragraphs 3.3 and 3.4, a pro-rated amount of MR Contrast Agent Product plus any increase based on a carry over of a non-requested amount from previous year(s).

 

3.6                                  Prince shall not Sell directly or indirectly (for example, through another) the MR Contrast Agent Product provided by EPIX to Prince pursuant to paragraphs 3.3 - 3.5 of this Agreement.  Notwithstanding the foregoing, MR Contrast Agent Product of paragraphs 3.3 - 3.7 that is used in a CE-MRA procedure by Prince, or his employers or employees, which is invoiced and/or charged to a Third Party, shall not be considered as Sold to such Third Party for the purposes of this paragraph 3.6 nor for the purposes of determining the royalty payable under this Agreement.

 

3.7                                  Prince agrees to comply with all applicable laws and regulations pertaining to the use, handling, storage, disposal, administration, billing, recordkeeping and sale of the MR Contrast Agent Product provided by EPIX hereunder.  Without limiting the generality of the foregoing, Prince will properly disclose accurate pricing information relating to the MR Contrast A


 
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