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Processing Agreement

 

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Title:

Processing Agreement

Entities:

Akorn, Inc.; NeoPharm, Inc.; Ross & Hardies

Date:

2002

Size:

Preview shows 7KB of 39KB total

Price:

$47

ID:

#282544

 

 

► Business ► Processing Agreements
► Services ► Legal
► Biotech & Drugs ► Pharmaceutical Preparations
► Biotech & Drugs ► Biological Products

 

 

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                              PROCESSING AGREEMENT


THIS PROCESSING AGREEMENT (the "Agreement") is made and entered into
this 20th day of December, 2001, between Akorn, Inc., a Louisiana Corporation
("Akorn") and NeoPharm, Inc., a Delaware Corporation ("NeoPharm").

WHEREAS, NeoPharm is a pharmaceutical company which has developed
certain chemotherapeutic agents (the "Products");

WHEREAS, Akorn owns and operates a lyophilization facility located at
1222 West Grand Avenue, Decatur, Illinois (the "Facility") and has the ability
and capacity to process and finish pharmaceutical products; and

WHEREAS, NeoPharm desires to contract with Akorn to process and finish
the Products at the Facility, and Akorn desires to provide such services, on the
terms and conditions set forth herein

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


ARTICLE I
PROCESSING ESTIMATE/DELIVERY OF PRODUCTS

Section 1.1. PROCESSING ESTIMATE. At least thirty (30) days prior to
the Effective Date (as defined herein), and at least thirty (30) days prior to
the commencement of each twelve (12) month period thereafter, NeoPharm shall
deliver to Akorn its good faith estimate (the "Estimate") of the quantity of
Products to be Processed (as defined herein) by Akorn hereunder for the upcoming
twelve (12) month period. Such estimate shall be non-binding, and NeoPharm shall
update the Estimate quarterly based upon its expected Processing needs. Akorn
agrees to allocate to the Processing of NeoPharm's Products no less than fifteen
percent (15%) of the Facility's Processing capacity during every twelve (12)
month period during the Term of this Agreement; the actual allocation of the
Facility's capacity to NeoPharm for such period shall be agreed upon by the
parties and is referred to herein as the "Processing Maximum". Processing
Capacity shall be measured in terms of hours usage of the Facility. NeoPharm
shall have the right to audit Akorn's books and records to ascertain compliance
with this Section 1.1.

Section 1.2. PURCHASE ORDERS. From time to time, NeoPharm shall provide
Akorn with a purchase order (the "Purchase Order") which shall set forth the
Product to be Processed and the quantity of Bulk Product to be Processed by
Akorn (the "Batch"). Akorn shall provide NeoPharm with written acceptance of the
Purchase Order, which acceptance shall set forth the date the Processing Run (as
defined herein) for the Batch covered by such Purchase Order shall commence (the
"Processing Run Commencement Date"). Akorn agrees that the Pocessing Run
Commencement Date shall be no later than fourteen (14) days after Akorn's
receipt of the
{Page}

Purchase Order. Akorn shall use its best efforts to accommodate NeoPharm's
request to amend a Purchase order to modify the size of a Batch to be Processed.

Section 1.3. ESTIMATED YIELD. Upon Akorn's acceptance of a Purchase
Order, Akorn shall calculate the estimated Final Product to be manufactured
(the "Estimated Yield") from the Batch that is the subject of the Purchase
Order. The Estimated Yield factor to be applied to each Purchase Order shall
be based upon the optimum yield determined from the first (3) Processing Runs
of a particular Product. Such determination and each such Processing Run
shall be performed and conducted in the presence of a NeoPharm
representative. In the event NeoPharm disagrees with Akorn's Estimated Yield,
the Parties shall in good faith agree upon a third party to review the data
Akorn utilized to calculate the Estimated Yield. The findings of such third
party shall be binding on both parties. In the event that the actual yield of
any Batch is less than ninety-five percent (95%) of the Estimated Yield,
NeoPharm shall be entitled to an investigation of the reason(s) for the
reduced yield of the Batch, and NeoPharm shall be entitled to an equitable
reduction (the "Yield Credit") in the Processing Fee (as defined herein).

Section 1.4. DELIVERY OF BULK PRODUCTS. At least fifteen (15)
business days prior to each Processing Run Commencement Date, NeoPharm shall
deliver to Akorn sufficient amounts of Bulk Product for such Processing Run
along with any applicable vial labeling materials. For purposes of this
Agreement, Bulk Product shall mean formulated solutions of the Products.
NeoPharm warrants that all Bulk Product provided hereunder shall meet all
applicable specifications and shall have been produced in compliance with
applicable federal, state and local laws and regulations, including, without
limitation, the Good Manufacturing Practices Regulations ("GMPs") of the
United States Food and Drug Administration ("FDA"), 21 C.F.R. part 211, in
effect at the time of Processing. In connection with the delivery of Bulk
Product, NeoPharm shall provide Akorn with written certification of the
sterility of Bulk Product.

Section 1.5. OWNERSHIP/RISK OF LOSS. NeoPharm shall own all Bulk
Product delivered by NeoPharm and all Finished Product (as defined herein)
Processed by Akorn and, except in a case giving rise to Akorn's
indemnification responsibilities hereunder, NeoPharm shall bear the risk of
loss with respect to such materials.

ARTICLE II
PROCESSING OF BULK PRODUCTS

Section 2.1. PROCESSING OBLIGATIONS. Commencing with each Processing
Run Commencement Date, Akorn shall Process the Bulk Product corresponding to
the applicable Purchase Order in accordance with the terms of this Article II
(each a "Processing Run"). For purposes of this Agreement, "Processing" shall
mean filling into vials, lyophilizing, inspecting and packaging the Bulk
Product in order to produce finished pharmaceutical dosage forms of the
Products (the "Finished Product"). The parameters (the "Processing
Parameters") under which Akorn shall Process the Bulk Product shall be

 

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