CERS » Topics » DEFINITIONS

These excerpts taken from the CERS 10-K filed Mar 13, 2009.

Definitions:

As used herein the following terms have the meanings set forth below:

“Baxter” has the meaning set forth in the Recitals.

“Bill of Materials” means the structured list of materials required to assemble the Product.

“Capital Equipment” has the meaning set forth in Section 4.3.

“Cerus” has the meaning set forth in the Introduction.

“Cerus Confidential Information” has the meaning set forth in Section 18.1.

“Change Control” has the meaning set forth in Section 8.

“Device History Files” has the meaning set forth in Section 20.

“DMR” has the meaning set forth in Section 1.

“Effective Date” has the meaning set forth in the Introduction.

“FDA QSR” means Food and Drug Administration Quality Systems Regulation.

“FDA” means the Food and Drug Administration and any successor agency.

“Initial Term” has the meaning set forth in the Term section.

“INTERCEPT Blood System” has the meaning set forth in the Recitals.

“Inventions” has the meaning set forth in Section 21.6.

“Laws” has the meaning set forth in Section 2.2(c).

“Losses” has the meaning set forth in Section 16.1.

 

   Confidential    9-24-2008

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


Cerus/NOVA Biomedical Manufacturing Agreement

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“Non-Conforming Material Requests (NCMRs)” means request to authorize use of Product that does not meet specification.

“Manufacturing Agreement” has the meaning set forth in the Introduction.

“Manufacturing Documentation” has the meaning set forth in Section 20.

“NOVA” has the meaning set forth in the Introduction.

“NOVA Confidential Information” has the meaning set forth in Section 18.1.

“Parties” has the meaning set forth in the Introduction.

“Pricing Schedule” means the pricing method as set forth in Attachment 3.

“Product Line Quality Committee (PLQC)” has the meaning set forth in Attachment 1.

“Product” has the meaning set forth in the Recitals.

“Purchase Order” means a formal, binding request by Cerus to NOVA to procure materials and/or services that Cerus deems necessary or desirable for the procurement of Product, or the procurement of Product itself, at a cost to be mutually agreed upon by Cerus and NOVA.

“Quality Plan” has the meaning set forth in Section 3.1 in Attachment 1.

“Renewal Term” has the meaning set forth in the Term section.

“Services Agreement” has the meaning set forth in the Recitals.

“Specifications” means the detailed plans, requirements, and instructions developed for the production of Product provided by Cerus to NOVA pursuant to Section 2.1(b) of this Agreement.

“Supply Agreement” has the meaning set forth in the Recitals.

“Term” has the meaning set forth in the Term section.

“Unit” means a single Product.

Section 10.3 Definitions.

As used herein, a “Breach” shall mean a breach of a covenant, obligation or other provision of this Agreement, and such breach will be deemed to have occurred if there is or has been one or more misstatements or inaccuracies in, or one or more failures to perform or comply with, any representation, warranty, covenant, obligation or other provision of this Agreement.

As used herein, “Damages” shall mean all Liabilities, obligations, losses, damages, deficiencies, assessments, judgments, costs, expenses (including, without limitation, reasonable attorneys’ fees and costs and expenses incurred in investigating, preparing, defending against or prosecuting any Proceeding).

As used herein, “Liabilities” means any debts, obligations, duties or liabilities of any nature, whether known or unknown, and whether accrued, contingent or otherwise.

As used herein, “Proceeding” means any third-party action, arbitration, audit, hearing, investigation, litigation or suit (whether civil, criminal, administrative, investigative or informal) commenced, brought, conducted or heard by or before, or otherwise involving, any governmental body or arbitrator.

Section 10.4 Fenwal Insurance. Fenwal shall carry appropriate levels of insurance coverage consistent with its commercially reasonable business practices.

Section 10.5 Cerus Insurance. Cerus shall carry appropriate levels of insurance coverage consistent with its commercially reasonable business practices.

Section 10.6 Limitation on Liability. In no event shall any Party be liable for incidental or consequential damages regardless of whether such Party shall be advised, shall have other reason to know, or in fact shall know of the foregoing, in excess of [*] U.S. dollars (U.S. $[*]) in the aggregate under this Agreement.

This excerpt taken from the CERS 10-K filed Feb 27, 2008.

DEFINITIONS

As used in this Supply Agreement, capitalized terms not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement, and the following capitalized terms shall have the following meanings:

1.1 “Cost of Goods Sold” or “COGS” means, (a) with respect to a Supply Deliverable manufactured by [ * ] Supply Deliverable calculated in accordance with U.S. generally accepted accounting principles consistently applied, and (b) with respect to a Supply Deliverable manufactured by [ * ], not to exceed the greater of (A) [ * ] percent ([ * ]%) of the COGS of such Supply Deliverable or (B) in the case of S-59 Psoralen, $[ * ] for orders supplied pursuant to Section 2.1(b)(i) or $[ * ] for orders supplied pursuant to Section 2.1(b)(ii).

1.2 “Disposable Kits” shall mean the Intercept Platelet and Plasma disposable kits manufactured by Cerus or on behalf of Cerus by a Third Party supplier.

1.3 “Good Manufacturing Practice” or “GMP” means the most current version of the good manufacturing practice standards promulgated by the United Stated Food and Drug Administration and the ICH.

1.4 “Light Devices” shall mean the UVA light devices that are used for Cerus’ Intercept blood system and are manufactured and supplied to Cerus by a Third Party supplier.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.5 “Research and Development Activities” shall mean the research, pre-clinical and clinical activities conducted by or on behalf of Anza or its Affiliate or Licensee with respect to any product.

1.6 “S-59 Psoralen” shall mean quantities of Cerus’ proprietary compound that is known as amotosalen (or “S-59”) and is manufactured by Cerus or on behalf of Cerus by a Third Party supplier.

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