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Technology Transfer Agreement

Distribution Agreement

Technology Transfer Agreement | Document Parties: PRESTWICK PHARMACEUTICALS | SCHERING | NeuroBiotec GmbH You are currently viewing:
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PRESTWICK PHARMACEUTICALS | SCHERING | NeuroBiotec GmbH

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Title: Technology Transfer Agreement
Date: 4/22/2005

Technology Transfer Agreement, Parties: prestwick pharmaceuticals , schering , neurobiotec gmbh
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Exhibit 10.11

***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 230.406

Agreement

among

SCHERING Aktiengesellschaft
Müllerstra
b e 178
13342 Berlin

(hereinafter called “SCHERING”)

and

NeuroBiotec GmbH
Tegeler Strai
b e 6
13353 Berlin

(hereinafter called “NEUROBIOTEC”)

and

 

Prestwick Pharmaceuticals, Inc.
1825 K Street
Washington, D.C. 2006

(hereinafter called “PRESTWICK”)

 


 

  2

RECITALS

Whereas SCHERING and NEUROBIOTEC have entered into a Technology Transfer Agreement as amended as of May 30, 2002 (the “ Technology Transfer Agreement ”) concerning the sale and transfer of patents and know-how relating to the development, production and marketing of (1) a ready to use pharmaceutical speciality for trans-dermal use (the “ Patch Product ”) and (2) all other non per-oral ready to use pharmaceutical specialties for sustained release (collectively the “ Other Sustained Release Products ”) in humans containing Lisuride and/or Lisuride hydrogen maleate and/or all other pharmaceutically active salts and esters of Lisuride (the “ Product(s) ”) from SCHERING to NEUROBIOTEC;

Whereas NEUROBIOTEC has identified PRESTWICK as partner for the development and marketing in the United States of America (the “ U.S. ”) and Canada of the Patch Product (the “ U.S./Canada Patch Product ”) and the Other Sustained Release Products (the “ U.S./Canada Other Sustained Release Products ” — collectively with the U.S./Canada Patch Product, the “ U.S./Canada Products ”) and has negotiated with PRESTWICK an exclusive, sublicensable license-, development, commercialisation- and drug supply agreement relating to the development and sale of the U.S./Canada Products (the “ Prestwick Cooperation ”);

Whereas SCHERING under the Technology Transfer Agreement has an option to obtain exclusive, sub-licensable development, production and marketing rights for the “U.S./Canada Patch Product” (the “ U.S./Canada Option ”), and a right of first refusal to take an exclusive, sub-licensable license to develop, produce and market the “U.S./Canada Other Sustained Release Products” (the “ U.S./Canada Right of First Refusal ”);

Whereas PRESTWICK wishes to take over the development and marketing of the U.S./Canada Patch Product without being restricted by SCHERING’s U.S./Canada Option, and the development and marketing of the U.S./Canada Other Sustained Release Products without being restricted by SCHERING’s U.S./Canada Right of First Refusal;

Whereas SCHERING is prepared to waive its U.S./Canada Option and its U.S./Canada Right of First Refusal under the conditions set forth in this Agreement in order to allow NEUROBIOTEC to grant all rights to the U.S./Canada Products to PRESTWICK;

 


 

  3

Whereas the parties agree that this Agreement shall be conditional on the execution of the Prestwick Cooperation;

Whereas the parties have already entered into an agreement concerning the development and marketing of the Products by Prestwick for the U.S. in August/September, 2003 (the “U.S. Agreement”);

Whereas the parties agree that this Agreement shall replace the U.S. Agreement;

Whereas the parties agree that the Prestwick Cooperation is likely to improve considerably the prospects for a timely introduction of the U.S./Canada Products and that the simultaneous and coordinated development activities in Europe and the U.S. and Canada are intended to result in development cost reductions and to generate other synergies for the parties hereof.

The parties, therefore, hereby agree to and amend the Technology Transfer Agreement as follows:

1.   

Definitions

 

   

“Affiliate” has the meaning set forth in Article 1 of the Technology Transfer Agreement.

 

 

 

 

   

“Agreement” means this three-party-agreement by and among SCHERING, NEUROBIOTEC and PRESTWICK.

 

 

 

 

   

“Business Day” means a day which is not a Saturday, a Sunday or other day on which banks are required or authorized by law to be closed in Washington D.C., U.S., or Berlin, Germany.

 

 

 

 

   

“Confidential Information” has the meaning set forth in Section 8.1.

 

 

 

 

   

“Development Cost” has the meaning set forth in Article 1 of the Technology Transfer Agreement.

 

 

 

 

   

“Existing Schering Data” has the meaning set forth for the term “Data” in Article 1 of the Technology Transfer Agreement.

 

 

 

 


 

 

  4

   

“First Commercial Sale” means the date on which the first Product is sold commercially by PRESTWICK or on PRESTWICK’s behalf by any sublicensee of PRESTWICK in the U.S. or Canada.

 

   

“Know-how” means: techniques, data and information relating to the Products, including, but not limited to, inventions, practices, methods, manufacturing processes, knowledge, know-how, skill, trade secrets, experience, test data (including pharmacological, toxicological, pre-clinical and clinical test data); data, records and information derived from pre-clinical development, clinical development or CMC/process development, regulatory submissions, adverse reactions, analytical and quality control data, marketing, pricing, distribution, cost, sales and manufacturing data or descriptions.

 

 

 

 

   

“Net Sales” means the amount invoiced by PRESTWICK or any sublicensee of PRESTWICK (each a “Seller”) for sales of a Product to unaffiliated third parties less the following deductions applicable to the Products for:

 

 

 

 

 

(i)   

transportation charges and insurance charges paid by the Seller;

 

 

(ii)   

sales and excise taxes or customs duties paid by the Seller or any other governmental charges imposed upon the sale of the Products and paid by the Seller;

 

 

 

 

(iii)   

rebates and premiums granted or allowed in connection with the sale of a Product;

 

 

 

 

(iv)   

allowances or credits to customers on account of governmental requirements, price differences, rejection, outdating, returns or recalls of the Products;

 

 

 

 

(v)   

quantity discounts, cash discounts or chargebacks granted in connection with the sale of the Products,

 

 

 

 

(vi)   

provisions for price reductions.

 

 

 

   

In the event a Product is sold in the form of a combination product containing one or more active ingredients in addition to a Product, Net Sales for such combination product will be adjusted by multiplying actual Net Sales of such combination product by the fraction A / (A+B) where A is the invoice price of the Product, if sold separately, and B is the invoice price of any other active

 


 

 

  5

   

ingredient or ingredients in the combination, if sold separately. If the other active ingredient or ingredients in the combination are not sold separately, Net Sales shall be calculated by multiplying actual Net Sales of such combination product by the fraction A / C where A is the invoice price of the Product if sold separately, and C is the invoice price of the combination product. If neither the Product nor the other active component or components of the combination product is sold separately, Net Sales shall be determined between SCHERING and PRESTWICK in good faith.

 

   

“Other Sustained Release Products” has the meaning set forth in the first paragraph of the Recitals above.

 

 

 

 

   

“Patch Product” has the meaning set forth in the first paragraph of the Recitals above.

 

 

 

 

   

“Prestwick Cooperation” has the meaning set forth in the second paragraph of the Recitals above.

 

 

 

 

   

“Product(s)” has the meaning set forth in the first paragraph of the Recitals above.

 

 

 

 

   

“Step I Milestone” means the fee to be paid by SCHERING to NEUROBIOTEC pursuant to Section 7.1 (ii) of the Technology Transfer Agreement in order to retain its option right pursuant to Section 7.2 of the Technology Transfer Agreement.

 

 

 

 

   

“Technology Transfer Agreement” has the meaning set forth in the first paragraph of the Recitals above.

 

 

 

 

   

“U.S.” has the meaning set forth in the second paragraph of the Recitals above.

 

 

 

 

   

“U.S. Agreement” has the meaning as set forth in the seventh paragraph of the Recitals above;

 

 

 

 

   

“U.S./Canada Option” has the meaning as set forth in the third paragraph of the Recitals above.

 

 

 

 

   

“U.S./Canada Other Sustained Release Product” has the meaning set forth in the second paragraph of the Recitals above.

 

 

 

 


 

 

  6

   

“U.S./Canada Patch Product” has the meaning set forth in the second paragraph of the Recitals above.

 

   

“U.S./Canada Products” has the meaning set forth in the second paragraph of the Recitals) above.

 

 

 

 

   

“U.S./Canada Right of First Refusal” has the meaning set forth in the third paragraph of the Recitals above.

 

 

 

 

2.   

Waiver of Rights

 

   

In consideration of the payment of royalties to SCHERING by PRESTWICK pursuant to Section 3 below and the reduction of the Step I Milestone pursuant to Section 4 below, SCHERING hereby waives its U.S./Canada Option and its U.S./Canada Right of First Refusal vis-à-vis NEUROBIOTEC in favour of PRESTWICK in order to allow NEUROBIOTEC to grant all rights to the U.S./Canada Products to PRESTWICK under the Prestwick Cooperation, and Schering hereby agrees that the execution of the Prestwick Cooperation will not contravene, and shall be permitted under, the Technology Transfer Agreement. Accordingly, Articles 6, 7 and 10 of the Technology Transfer Agreement shall not apply to the U.S./Canada Products. The scope of application of Articles 6, 7 and 10 of the Technology Transfer Agreement is thus reduced to the development, production and marketing of Products outside the U.S. and Canada and/or any Product other than the U.S./Canada Products in the U.S. or Canada.

 

 

 

 

3.   

Royalties

 

 

 

 

3.1   

In consideration of the waiver by SCHERING of its U.S./Canada Option and its U.S./Canada Right of First Refusal in PRESTWICK’s favour pursuant to Section 2 above, PRESTWICK shall pay to SCHERING royalties based on Net Sales of Products in the amount of

 

 

 

 

 

 

 

 

 

 

 

-

 

[...***...] % for the Patch Product; and

 

 

-

 

[...***...] % for Other Sustained Release Products.


* Confidential Treatment Requested

 


 

  7

   

The Parties will meet and discuss in good faith if the marketing of the Products by PRESTWICK becomes economically unviable because of significant generic competition to the U.S./Canada Patch Product marketed by PRESTWICK.

 

3.2   

All royalties shall be calculated on a Product by Product basis and shall be payable on a country-by-country basis from the date of the First Commercial Sale of a Product in the U.S. until ten (10)&


 
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