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Manufacture and Supply Agreement

 

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Title:

Manufacture and Supply Agreement

Entities:

aaiPharma Inc.; Orapharma Inc; Dechert LLP

Date:

2001

Size:

Preview shows 5KB of 68KB total

Price:

$52

ID:

#1259417

 

 

► Business ► Supply ► Manufacture & Supply Agreements
► Biotechnology & Drugs
► Services ► Legal

 

 

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                       MANUFACTURE AND SUPPLY AGREEMENT


This Manufacture and Supply Agreement (the "Agreement") is entered into as
of February 16, 2001 (hereinafter "Effective Date") by and between aaiPharma
Inc., a Delaware corporation with principal corporate offices located at 2320
Scientific Park Drive, Wilmington, North Carolina 28405 ("AAI") and OraPharma,
Inc., a Delaware corporation with principal corporate offices located at 732
Louis Drive, Warminster, Pennsylvania 18974 ("OraPharma").

RECITALS

OraPharma and AAI propose to enter into a manufacturing and supply
agreement in order to commercialize Arestin(TM) ("Arestin") (previously referred
to as minocycline periodontal therapeutic system or MPTS), a drug product
consisting of minocycline hydrochloride encapsulated in a bioresorbable polymer,
poly(glycolide-co-dl-lactide). OraPharma has completed phase 3 clinical trials
for Arestin and filed a new drug application ("NDA") for the product on February
17, 2000 and OraPharma received approval of the NDA from the Food and Drug
Administration to launch the product on February 16, 2001. AAI was the
manufacturer of clinical trial materials used in the Phase 3 clinical trials.
AAI and OraPharma agree that the most cost-effective commercialization of
Arestin is to scale-up the clinical manufacturing process at the AAI Wilmington
plant .

NOW THEREFORE, the parties hereby agree as follows:

ARTICLE 1 - DEFINITIONS

For purposes of this Agreement, the following terms shall have the
respective meanings set forth below:

1.01. "Act" shall mean the United States Food, Drug and Cosmetic Act, as
amended from time to time, and the regulations promulgated thereunder.

1.02. "Affiliate" shall mean a corporation or any other entity that
directly, or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with, the designated party, but only
for so long as the relationship exists. "Control" shall mean ownership of
shares of stock having at least fifty percent (50%) of the voting power entitled
to vote for the election of directors in the case of a corporation.

1.03. "Batch" shall mean the manufactured Product (i) having uniform
characteristics, (ii) manufactured during a single, continuous, homogeneous
processing run, and (iii) bearing the same lot number.
<PAGE>

1.04. "cGMP" shall mean those current Good Manufacturing Practices
required by the FDA to be followed in connection with the manufacture of
pharmaceutical products, as defined from time to time by the Act and related
regulations, or any successor laws or regulations governing the manufacture,
handling, storage, and control of the Product in the United States.

1.05. "Commercialize" shall mean the activities undertaken to market,
promote, and sell a pharmaceutical product.

1.06. "Diligent Efforts" shall mean the commercially reasonable efforts
that a prudent business person or company would expend in the normal course of
business to accomplish an important objective, but shall not mean efforts that
could, if carried out, have a significant negative impact on the party's
relevant business unit as a whole.

1.07. "FDA" shall mean the United States Food and Drug Administration or
any successor United States governmental agency performing similar functions
with respect to pharmaceutical products.

1.08. "Initial Manufacturing Cost" shall mean the Manufacturing Cost for
the initial [*] commercial Batches of Product.

1.09. "Manufacturing Cost" shall mean the price charged to OraPharma for
AAI to manufacture the Product for any calendar year, and expressed on a per
Batch basis.

1.10. "NDA" shall mean a New Drug Application submitted to the FDA for the
Product which OraPharma intends to Commercialize under the name Arestin(TM).

1.11. "Product" shall mean microencapsulated minocycline hydrochloride
(also known as minocycline PTS microspheres) manufactured according to the
Product Specifications (defined below).

1.12. "Product Specifications" shall mean the manufacturing, testing,
storage, and quality control specifications for Product as set forth
in the NDA as approved by the FDA (or any supplements thereto), plus
any additional specifications agreed upon in writing by the parties
and attached hereto as Appendix A.

1.13 "Production Capacity" shall mean the ability to manufacture [*]
Batches in a four-week period; provided, however, that the number of
Batches will be amended to reflect the final equipment installed and

 

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