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Agreement for the Manufacturing of a Liposomal Formulation

Manufacturing Agreement

Agreement for the Manufacturing of a Liposomal Formulation | Document Parties: SIGNPATH PHARMA, INC. You are currently viewing:
This Manufacturing Agreement involves

SIGNPATH PHARMA, INC.

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Title: Agreement for the Manufacturing of a Liposomal Formulation
Date: 4/7/2009

Agreement for the Manufacturing of a Liposomal Formulation, Parties: signpath pharma  inc.
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Exhibit 10.5

 

 

Agreement for the Manufacturing of a Liposomal Formulation

 

 

between

 

 

Sign Path Pharmaceuticals, Inc.

45 Broadway 2nd Floor New York, NY 10006, USA

 

 

- hereinafter called „Principal“ -

 

and

 

Polymun Scientific Immunbiologische Forschung GmbH

Nussdorfer Lände 11, A-1190 Vienna, Austria

 

 

- hereinafter called „Contractor“ -

 

 

 

PREAMBLE

 

1.

Contractor is owner and authorized to dispose of the patents and patent applications listed in Annex 1 of this Agreement (hereinafter referred to as „Polymun liposome technology“).

 

2.

Furthermore, Contractor has technical and operational experience, knowledge, as well as other information and know-how in the field of development and utilization of the liposome technology (hereinafter referred to as „Polymun-know-how“).

 

3.

Principal disposes of a liposomal formulation of the active pharmaceutical ingredient curcumin.

 

4.

Contractor has no existing contractual relationship regarding curcumin to other parties than Principal at the date of signing this Agreement and will not enter into such contractual relationship during the term of this Agreement.

 

5.

The parties intend to apply the Polymun liposome technology and the Polymun-Know-how for the efficient production of a liposomal formulation of curcumin and to co-operate for that purpose.

 

§ 1

DEFINITIONS

 

1.

“Agreement” means the body of this Agreement for the Manufacturing   of a Liposomal Formulation, signed by both parties including all annexes and amendments thereto.

 

2.

“Ingredient” means the active pharmaceutical ingredient curcumin (diferuloyl-methane) that Principal intends to use in the kind of liposomes described in Annex 2 of this Agreement.

 

3.

„Subject Matter of Agreement“ shall mean the development of an efficient production method for a liposomal formulation of the Ingredient and production of GMP-like material as well as GMP-compliant material by Contractor under application and utilization of the Polymun liposome technology and the Polymun-Know-how. For this purpose, Principal will make available the Ingredient and all relevant information about physical and chemical properties and descriptions of according analytical methods. Principal and Contractor will cooperate to issue specifications for the product to be manufactured and Contractor agrees to meet these specifications if possible by commercially reasonable efforts.

 


 

4.

„Contractual Intellectual Property Rights“ shall mean

 

 

a)

all patents and patent applications listed in Annex 1, as well as patents that will be issued following these patent applications;

 

 

b)

all further intellectual property rights including additional patents, process patents, etc., which Contractor will file or acquire during the term of this Agreement in connection with the liposome technology.

 

5.

„Contractual Know-how“ shall mean all technical and operational experience, knowledge, results from development and experiments, especially data and knowledge about production, production procedures, application technologies, reports, modifications, improvements as well as other information and know-how of Contractor regarding the liposome technology that

 

 

a)

exist directly and indirectly at signing of this Agreement at the Contractor and

 

 

b)

are acquired during the term of this Agreement.

 

§ 2

PROPRIETARY RIGHTS

 

1.

All Know-How and Proprietary Rights of Principal existing on September 6, 2007 (thereinafter referred to as “Effective Date”) hereof or arising during the term of this Agreement from the separate and independent efforts of Principal (“Background Rights of Principal”) shall be the sole and exclusive property of Principal. Contractor shall have no right or license to use any such Background Rights of Principal except as may be necessary for performing hereunder.

 

2.

All Know-How and Proprietary Rights of Contractor existing on the Effective Date hereof or arising during the term of this Agreement from the separate and independent efforts of Contractor (“Background Rights of Contractor”) shall be the sole and exclusive property of Contractor. Principal shall have no right or license to use any such Background Rights of Contractor except as may be necessary for performing hereunder. Notwithstanding the foregoing, Contractor and Principal may negotiate in good faith license terms for Background Rights of Contractor at any further point in time. However, Contractor shall disclose in writing any such Background Rights of Contractor as soon as practicable or prior to use, whichever occurs first, Ingredient so that Principal may have the opportunity to accept its use, provide alternatives or terminate this Agreement at Principal’s sole discretion.

 

3.

All Proprietary Rights arising from Development Activities of Contractor and/or its agents and subcontractors, solely by Contractor or jointly or severally with the assistance activities of Principal regarding the Ingredient (“Ingredient Resulting Proprietary Rights”), shall be the sole and exclusive property of Principal. Principal shall have the right to prepare, file, prosecute, obtain and maintain at its sole expense patent applications and patents relating to Ingredient Resulting Proprietary Rights in countries of its choice. Both parties agree that each will identify and memorialize Ingredient Resulting Proprietary Rights for itself and the other party. Contractor hereby assigns and conveys to Principal all right, title, and interest in and to such Ingredient Resulting Proprietary Rights and agrees to execute any and all legal instruments reasonably requested by Principal to effect, acknowledge, or perfect such assignment and conveyance. Notwithstanding the limitations of existing and disclosed agreements with third parties, Contractor represents and warrants that each and every officer, employee, agent and subcontractor assigned to work for Principal hereunder shall have entered into an agreement with Contractor for the assignment of relevant Ingredient Resulting Proprietary Rights to Contractor. In addition, Contractor, its agents, and subcontractors shall treat such Ingredient Resulting Proprietary Rights confidentially under the provisions of § 8 and shall have no right or license to use such Ingredient Resulting Proprietary Rights for any purpose other than as expressly set forth herein. Principal will name those employees and consultants of Contractor as inventors on patent applications who have substantially contributed to the according invention. However, Principal has no obligation whatsoever to compensate such inventors for their contribution.

 

Page 2 of 7


 

4.

All Proprietary Rights arising from Development Activities of Contractor and/or its agents and subcontractors, solely by Contractor or jointly or severally with the assistance activities of Principal regarding the Polymun liposome technology in general (“PLT Resulting Proprietary Rights”), shall be the sole and exclusive property of Contractor. Contractor shall have the right to prepare, file, prosecute, obtain and maintain at its sole expense patent applications and patents relating to PLT Resulting Proprietary Rights in countries of its choice. Both parties agree that each will identify and memorialize PLT Resulting Proprietary Rights for itself and the other party. Principal hereby assigns and conveys to Contractor all right, title, and interest in and to such PLT Resulting Proprietary Rights and agrees to execute any and all legal instruments reasonably requested by Contractor to effect, acknowledge, or perfect such assignment and conveyance. Notwithstanding the limitations of existing and disclosed agreements with third parties, Principal represents and warrants that each and every officer, employee, agent and subcontractor assigned to work for Principal hereunder shall have entered into an agreement with Principal for the assignment of relevant PLT Resulting Proprietary Rights to Principal. In addition, Principal, its agents, and subcontractors shall treat such PLT Resulting Proprietary Rights confidentially under the provisions of § 8 and shall have no right or license to use such PLT Resulting Proprietary Rights for any purpose other than as expressly set forth herein. Contractor will name those employees and consultants of Principal as inventors on patent applications who have substantially contributed to the according invention. However, Contractor has no obligation whatsoever to compensate such inventors for their contribution. Notwithstanding the foregoing, Contractor and Principal may negotiate in good faith license terms for PLT Resulting Proprietary Rights at any further point in time, for which Principal shall have a right of first refusal for PLT Resulting Proprietary Rights that includes Ingredient Resulting Proprietary Rights. However, Contractor shall disclose in writing any such PLT Resulting Proprietary Rights as soon as practicable or


 
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