Delaware
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94-3134940
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(State or other jurisdiction of
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(IRS Employer
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incorporation)
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Identification No.)
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Information to be included in the report
Bayer will fund all clinical development of the Amikacin product following the completion of the ongoing Phase II clinical studies currently being conducted by Nektar (other than $10 million of Phase III clinical trial costs to be reimbursed by Nektar as described above), all activities to support world-wide regulatory filings, approvals and related activities, further development of formulated Amikacin, and final product packaging. Nektar will fund the ongoing clinical development of the Amikacin product through the completion of ongoing Phase II clinical studies and the further development of the nebulizer device included in the Amikacin product through the completion of the Phase III clinical trials and scale-up for commercialization.
Bayer and Nektar will share profits (or losses) on sales of the Amikacin product in the United States such that Bayer receives 52% of product profits (or losses) and Nektar receives 48% of product profits (or losses), subject to certain adjustments. This profit sharing and co-promotion arrangement in the United States will include, among other things, Bayer and Nektar collaborating on the commercial plan, commercial launch, and the shared deployment of sales and marketing personnel and related support activities. In addition, Bayer will pay Nektar a royalty based on annual net sales of the Amikacin product made in any country outside the United States. The royalty rate varies based on the level of annual net sales of the Amikacin product, ranging from a minimum of 14% to a maximum of 30%. Nektar's right to receive the foregoing royalties will expire on a country by country basis upon the later of (a) ten years after the date of first commercial sale of the Amikacin product in that country and (b) the expiration of the last-to-expire of certain patent rights related to the Amikacin product in that country, subject to certain exceptions. Nektar retains responsibility for paying third-party royalties under intellectual property that is practiced in the development, manufacture or commercialization of the Amikacin product as of the date of the agreement.
Nektar will perform clinical manufacturing and supply Bayer with the nebulizer device and formulated Amikacin for use in clinical trials at Nektar's fully burdened manufacturing cost. For commercial manufacturing and supply of the Amikacin product, the parties will enter into a manufacturing and commercial supply agreement pursuant to which Nektar will supply Bayer with all of its requirements for the nebulizer device for the Amikacin product at 130% of Nektar's fully burdened manufacturing cost.
The term of the agreement continues on a country-by-country basis until all royalty and payment obligations expire between the parties. Bayer has termination for convenience rights upon payment of a termination fee and has a termination right that could trigger certain reimbursement obligations by Nektar. In addition, each party has certain termination rights in circumstances where product safety is a concern, the product's failure to meet certain minimum commercial profile requirements, or uncured material breach of terms and conditions of the agreement.
The information in Item 7.01 of this report, including the Exhibit 99.1 hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by Nektar Therapeutics, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
This Current Report on Form 8-K contains forward-looking statements regarding the Amikacin product and Nektar's agreement with Bayer. These forward-looking statements involve risks and uncertainties, including but not limited to: (i) clinical trials are long, expensive and uncertain processes and the successful completion of future clinical development milestones will be required in order for Nektar to realize future development milestone payments under the agreement with Bayer, (ii) the risk of failure of any product that is in clinical development and prior to regulatory approval such as the Amikacin product remains high and can occur at any stage due to efficacy, safety or other factors, (iii) any such failure would likely result in reduced or no further payments to Nektar from Bayer, (iv) competing alternative therapies that are currently on the market or under development could impact the commercial potential of the Amikacin product which could materially and negatively impact Nektar's profit (or loss) share, royalty revenue, and sales milestones under the agreement with Bayer, (v) the agreement could be terminated by Bayer at any time with 90 days notice by Bayer and its payment of a specified termination fee, or under certain circumstances, by Bayer with a termination fee due to Bayer from Nektar, (vi) Bayer and Nektar may not be successful in obtaining regulatory approval of the Amikacin product, (vii) the Amikacin product may not achieve a minimally acceptable commercial profile based on results of clinical trials or competing therapies that target one or more of the same indications, (viii) Nektar's patent applications for the Amikacin product may not issue, or even if such patents issue, the claims contained in such patents may not provide sufficient market exclusivity, (ix) current patents and future patents that may issue may not be valid or enforceable, (x) intellectual property licenses from third parties may be required in the future and such licensing fees may be borne solely by Nektar in certain circumstances, and (xi) potential future disputes with current or future licensees of intellectual property required for the commercialization of the Amikacin product. Other important risks and uncertainties are detailed in Nektar's reports and other filings with the SEC including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Actual results could differ materially from the forward-looking statements contained in this press release. Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events, or otherwise.
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Nektar Therapeutics
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Date: August 06, 2007
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By:
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/s/ Gil M. Labrucherie
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Gil M. Labrucherie
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Senior Vice President and General Counsel
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Exhibit No.
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Description
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EX-99.1
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Press Release Titled "Bayer HealthCare and Nektar Therapeutics Launch Global Development and Commercialization Agreement to Fight Gram-Negative Pneumonias."
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