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Title: |
Agreement |
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Entities: |
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Date: |
2007 |
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Preview shows 11KB of 54KB total |
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Price: |
$41 |
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ID: |
#2848648 |
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AGREEMENT
effective as of this 22nd day of January, 2007 (the "Effective Date")
by and between
Novartis Pharma AG
Lichtstrasse 35 CH 4056, Base1 Switzerland
(hereinafter "Novartis" )
and
Unigene Laboratories, Inc.
110 Little Falls Road, Fairfield, NJ 07004 USA
(hereinafter "Supplier")
WHEREAS Novartis is engaged in the manufacture, marketing and sales of pharmaceutical drug substances;
WHEREAS Supplier is a company engaged in the processing and supply of certain pharmaceutical substances, including the *** terminal fragments of *** made via a recombinant technology;
WHEREAS Novartis desires a supply of *** for the purposes of *** and Supplier confirms being able to properly supply *** to Novartis on the terms and conditions set forth in this Agreement;
NOW THEREFORE, the parties agree as follows:
| 1. | Definitions |
"Affiliates" shall mean any corporation or business entity controlling, controlled by or under common control with a party to this Agreement. For such purposes, "control" shall mean the direct or indirect ownership of at least fifty percent (50%) of the voting interest in such corporation or other entity or the power in fact to control the management decisions of such entity.
"cGMP" shall mean current and future good manufacturing practices and standards specified by the EUIPIC and FDA guidelines.
"Drug Substance" shall mean *** with the chemical structure:
***
"Drug Substance Information" shall mean yield data, quality measurements, safety information and such other information as Novartis reasonably requests relating to the Drug Substance, as further described in Annex 3.
"Effective Date" shall have the meaning attributed thereto in the preamble of this Agreement.
"Final Summary Report" shall mean the final summary report to be provided by Supplier as detailed in Annex 2.
"QA Agreement" shall mean the QA agreement to be attached to this Agreement at Annex 4.
"Specifications" shall mean the current specifications for the Drug Substance set forth in Annex 1.
"Technical Grade" shall mean Drug Substance prepared according to the non optimized Supplier process.
| 2. | Supply of Drug Substance |
| 2.1 | Supplier agrees to supply Novartis with Drug Substance which complies with the Specifications in the following amounts: |
| ***. |
In addition, Supplier shall supply Novartis with such additional amounts of Drug Substance as Novartis reasonably requires as notified by Novartis to Supplier in writing during the term of this Agreement, at the prices set out in Annex 2.
| 2.2 | At all times during the term of this Agreement, Supplier undertakes to hold and maintain in good standing all required and advisable authorizations and permits to manufacture and supply the Drug Substance hereunder, from the authorities of the country in which production is performed. Supplier shall inform Novartis promptly in the event any such authorization or permit is not obtained in a timely manner or is withdrawn or is threatened to be withdrawn. |
| 3. | Quality |
| 3.1 | Quality of Drug Substance supplied hereunder shall meet the Specifications and shall be in accordance with the QA Agreements. ***. |
2
| 3.2 | The Supplier warrants that it shall manufacture and supply the Drug Substance and carry on operations at its facility where the Drug Substance is manufactured in full compliance with (i) regulatory guidelines and requirements as applicable, including in the case of cGMP compliant Drug Substance, cGMP and (ii) the prevailing laws and regulations on health, safety and environmental protection. |
| 3.3 | Each time Supplier ships Drug Substance to Novartis, it shall provide Novartis with a certificate of analysis. |
| 3.4 | ***. |
| 3.5 | Novartis shall treat all confidential information subject to review under this Article 3 in accordance with the confidentiality provisions of this Agreement, and shall cause its accounting firm to enter into a confidentiality agreement with Supplier obligating it to retain all such financial information in confidence pursuant to such confidentiality agreement. |
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