Partnering with Impax
At Impax Laboratories our aim is to contribute to the global body of knowledge in our key areas of research, to the quality of life of patients everywhere and to the success of our partners, customers and shareholders.
To that end, Impax works in a community of global and national partners within the research and pharmaceutical industries. This includes marketing partnerships to leverage the company’s technology platform, distribution partnerships, research collaborations and agreements with other pharmaceutical industry companies.
Strategic Alliances
Where strategically appropriate, we have developed marketing partnerships to leverage our technology platform in order to maximize product revenues and profitability. We will depend on our strategic alliances to achieve market penetration and generate revenues for those products covered by the alliances. We intend to seek additional partnerships for the expanded marketing and distribution of our products.
Teva Pharmaceuticals
In June 2001 we entered into a Strategic Alliance Agreement with Teva Pharmaceutical Industries for controlled-release generic pharmaceutical branded and OTC products. The agreement granted Teva exclusive US marketing rights.
In July 2010, the Teva Agreement was amended to terminate the provisions of the Teva Agreement with respect to the Omeprazole 10mg, 20mg and 40mg products. Additionally, the Company agreed to pay to Teva a profit share on future sales of the fexofenadine HCI/pseudoephedrine product, if any, but in no event will such profit share payments exceed an aggregate amount of $3,000,000.
Pfizer (formerly Wyeth)
In June 2002 we signed a semi-exclusive Development, License and Supply Agreement with Wyeth (now a part of Pfizer) relating to our Loratadine/Pseudoephedrine Sulfate 5mg/120mg 12-Hour Extended Release Tablets and Loratadine/Pseudoephedrine Sulfate 10mg/240mg 24-hour Extended Release Tablets under the Alavert™ brand. Impax is responsible for developing and manufacturing the products, while Wyeth is responsible for their marketing and sale. Wyeth launched the first product as Alavert™ D-12 in May 2003.
In 2008 we entered into a three-year co-promotion agreement with Wyeth under which we began performing physician detailing sales calls for a Wyeth-branded product to neurologists effective July 1, 2009. In March 2010 we entered into the First Amendment to the Co-Promotion Agreement with Wyeth, a wholly owned subsidiary of Pfizer. Under the terms of the Amendment, we began to perform physician detailing sales calls services for Pfizer’s Lyrica product to neurologists, effective April 1, 2010. We will receive a fixed fee, subject to annual cost adjustment, for providing physician detailing sales calls within a contractually defined range of an aggregate number of physician detailing sales calls rendered on a quarterly basis.
Merck (formerly Schering-Plough)
In June 2002 we signed a non-exclusive Licensing, Contract Manufacturing and Supply Agreement with Schering-Plough (now a part of Merck) relating to our Loratadine and Pseudoephedrine Sulfate 5mg/120 mg 12-hour Extended Release Tablets under the Claritin-D® 12-hour brand. Schering-Plough launched the product as Claritin-D® 12-Hour in March 2003.
Shire
In January 2006 Impax entered into a License and Distribution Agreement with an affiliate of Shire Laboratories, Inc. (“License and Distribution Agreement”), under which the Company received a non-exclusive license to market and sell an authorized generic of Shire’s Adderall XR product. Impax commenced sales of the AG Product in October 2009. Under the terms of the License and Distribution Agreement with Shire, Shire is responsible for manufacturing the AG Product, and Impax is responsible for marketing and sales of the AG Product.
Putney
On July 31, 2007 we entered into an exclusive license, development and supply agreement with Putney under which the parties agreed to collaborate on the development and commercialization of a generic equivalent of the drug Rimadyl (chewable tablets in 25, 75 and/or 100 mg dosage strengths).
The term of the agreement is a period of six years from the date of first commercial sale. At this time, we estimate a March 2011 FDA ANDA approval and product launch.
Medicis
In November 2008 we entered into a Joint Development Agreement with Medicis Pharmaceutical Corporation providing for collaboration in the development of five dermatological products, including an advanced form SOLODYN» product.To the extent the products are commercialized, Medicis will pay us royalties based on its sales of the advanced form SOLODYN» product and we will share equally in the profits on the sales of the four additional products.
Endo Pharmaceuticals
In June 2010 we entered into a Development and Co-Promotion Agreement under which Endo will pay us certain milestones related to the development of an Impax-branded pipeline product and obtain right to co-promote the product outside of the field of neurology in the US.
GlaxoSmithKline
In December 2010, we entered into a License, Development and Commercialization Agreement and a related Supply Agreement with Glaxo Group Limited. Under the terms of the License Agreement, we granted GSK exclusive development and commercial licenses to our lead-branded-product candidate known as IPX066, and certain follow-on products at the option of GSK, for all worldwide jurisdictions, except those in the United States of America and Taiwan, R.O.C. Under the Supply Agreement, we are required to manufacture IPX066 for GSK's use in its development and commercial activities, for which GSK will pay a transfer price computed under the terms of the Supply Agreement. Under the License Agreement, we received an initial $11.5 million up-front payment in December 2010. The Company has the potential to receive up to $175 million of additional contingent payments upon the achievement of certain specified development, clinical, regulatory, and /or commercialization milestones
