SHPGY » Topics » ARTICLE I DEFINITIONS

This excerpt taken from the SHPGY 8-K filed Feb 23, 2007.

Definitions

The following definitions apply throughout this announcement unless the context otherwise requires:

“Deutsche Bank” means Deutsche Bank AG, London Branch;
“Goldman Sachs” means Goldman Sachs International;
“Morgan Stanley” means Morgan Stanley & Co. International Limited;
“New River” means New River Pharmaceuticals, Inc.;
“Shire” means Shire plc, a public limited company incorporated under the laws of England and Wales;
“US GAAP” means generally accepted accounting principles in the United States;
“United States” means the United States of America, its territories and possessions, any state of the United States and the District of Columbia;
References to “$” are to the lawful currency of the United States of America.

 

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These excerpts taken from the SHPGY 10-Q filed Nov 7, 2006.

ARTICLE I
DEFINITIONS

     Affiliate” means, with respect to a Party, any entity that directly or indirectly controls, is control led by, or is under common control with, such Party, but only for so long as such control continues. For purposes of this definition, “control” means the power to direct the management and affairs of an entity, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of fifty percent (50%) or more of its outstanding voting shares shall in any case be deemed to confer control, provided that, the direct or indirect ownership of a lower percentage of such securities shall not necessarily preclude the existence of control.

     API Cost” for a Shire Product means the actual cost paid by Duramed on a pass-through basis for the active pharmaceutical ingredient in such Shire Product. For the avoidance of doubt, all raw material and manufacturing costs of cervical and vaginal rings in a Shire Product shall not be included in the API Cost.

     Changeover Plan” has the meaning set forth in Section 8.2.






     Effective Date” means the date on which the Parties have attached mutually agreed Exhibits to this Agreement for the supply of a particular Collaboration Product in accordance with Section 2.1.

     Force Majeure Event” has the meaning set forth in Section 9.1.

     Fully Allocated Manufacturing Cost” means the actual cost incurred by Duramed for Manufacturing Shire Product, calculated in accordance with GAAP and using normal standard cost accounting and allocation methods and procedures of Duramed consistently applied and maintained, including, but not limited to, API Cost, all raw material and manufacturing costs of cervical and vaginal rings, and all costs of active and inactive ingredients therein; provided that, for purposes of this Agreement, Fully Allocated Manufacturing Cost shall not include overhead absorption related to significant idle or excess capacity in connection with (i) expansion of an existing facility; or (ii) the construction or validation of any new manufacturing facility of Duramed or any of its Affiliates that may be constructed after the date of this Agreement first written above.

     Losses” means any and all liabilities, damages, fines, penalties, deficiencies, losses and expenses (including interest, court costs, amounts paid in settlement, reasonable fees of attorneys, accountants and other experts or other reasonable expenses of litigation or other proceedings or of any claim, default or assessment); provided, however, that the term “Losses” shall not include any special, consequential, indirect, punitive or similar damages, except to the extent actually paid by a Party pursuant to any Third Party Claim.

     Manufacturing” shall mean all activities related to the manufacturing of a Shire Product or any component or ingredient thereof, including packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing.

     Net Sales Price” shall mean, [*]

     Packaging Specifications” means the packaging and labeling specifications for Shire Product set forth on Exhibit B, as amended or supplemented from time-to-time in accordance with Section 3.13.

     Product Specifications” means the specifications for Shire Product set forth on Exhibit A, as amended or supplemented from time-to-time on mutual agreement of the Parties.

     Purchase Order” has the meaning set forth in Section 3.2.

     Rolling Forecast” has the meaning set forth in Section 3.1.

     Shire Product” means a Collaboration Product to be manufactured hereunder as set forth in Section 2.1.

     Term” has the meaning set forth in Section 7.1.

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     Termination Assistance Services” has the meaning set forth in Section 8.1.

ARTICLE I
DEFINITIONS

     Affiliate” means, with respect to a Party, any entity that directly or indirectly controls, is control led by, or is under common control with, such Party, but only for so long as such control continues. For purposes of this definition, “control” means the power to direct the management and affairs of an entity, directly or indirectly, whether through the ownership of voting securities, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of fifty percent (50%) or more of its outstanding voting shares shall in any case be deemed to confer control, provided that, the direct or indirect ownership of a lower percentage of such securities shall not necessarily preclude the existence of control.

     API Cost” for a Product means the actual cost paid by Shire on a pass-through basis for the active pharmaceutical ingredient in such Product.

     Changeover Plan” has the meaning set forth in Section 8.2.

     Effective Date” shall mean the Closing Date, as such term is defined in the Product Acquisition Agreement.






     Force Majeure Event” has the meaning set forth in Section 9.1.

     Losses” means any and all liabilities, damages, fines, penalties, deficiencies, losses and expenses (including interest, court costs, amounts paid in settlement, reasonable fees of attorneys, accountants and other experts or other reasonable expenses of litigation or other proceedings or of any claim, default or assessment); provided, however, that the term “Losses” shall not include any special, consequential, indirect, punitive or similar damages, except to the extent actually paid by a Party pursuant to any Third Party Claim.

     Manufacturing” shall mean all activities related to the manufacturing of a Product or any component or ingredient thereof, including packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing.

     Packaging Specifications” means the existing packaging and labeling specifications for Product, other than changes resulting from a new NDC Number and replacement of the Shire name with Duramed’s name, as amended or supplemented from time to time in accordance with Section 3.13.

     Product Specifications” means the specifications for Product set forth in the Product NDA.

     Purchase Order” has the meaning set forth in Section 3.2.

     Rolling Forecast” has the meaning set forth in Section 3.1.

     Product” has the meaning set forth in the Product Acquisition Agreement.

     Supply Price” means (a) with respect to Products included in the Initial Order, [*]

     Term” has the meaning set forth in Section 7.1.

     Termination Assistance Services” has the meaning set forth in Section 8.1.

These excerpts taken from the SHPGY 10-Q filed May 9, 2005.

ARTICLE 1
DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

     

DEFINITIONS

      The following terms shall have the following meanings as used in this Agreement:

     

ARTICLE 1
DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

     

This excerpt taken from the SHPGY 8-K filed Apr 25, 2005.
Definitions

The following definitions apply throughout this announcement unless the context otherwise requires:

“EBITDA”   means earnings before interest, taxation, depreciation and amortization;
   
“Goldman Sachs”   means Goldman Sachs International;
“Shire”   means Shire Pharmaceuticals Group plc, a public limited company incorporated under the laws of England and Wales;
   
“SG Cowen”   means SG Cowen & Co. LLC;
     
“TKT”   means Transkaryotic Therapies, Inc.
     
“UK GAAP”   means generally accepted accounting principles in the United Kingdom;
   
“US GAAP”   means generally accepted accounting principles in the United States;
   

References to “$” are to the lawful currency of the United States of America.


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