OBI. If neither Vatea Fund nor OBI elects to purchase any portion of the shares listed in the holder’s sale notice, the holder is free to sell the shares during the 40-day period following the date notice of the proposed sale is given to Vatea Fund and OBI. If the holder does not sell the shares within that time period, then the option given to Vatea Fund and OBI is reinstated and the shares cannot be sold until first offered to Vatea Fund and OBI as described above.
The shares of OBI common stock issued in the exchange will not be registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
In April 2009, OBI filed an application with the United States Food and Drug Administration (FDA) to obtain orphan drug designation for Oxycyte for the treatment of patients with severe, closed-head traumatic brain injury (TBI). If granted, orphan drug status would entitle Oxycyte to seven years of marketing exclusivity for the orphan TBI indication after FDA approval. The orphan drug designation in cases of severe, closed-head TBI would be in addition to Oxycyte use in treating other injuries and conditions.
In May 2009, OBI filed a Cosmetic Product Ingredient Statement (CPIS) with the FDA for Dermacyte™ Gel, its new Oxycyte-based cosmetic product. The gel is an oxygen-rich formulation of Oxycyte, which OBI believes will promote skin health and other desirable cosmetic benefits when applied to the skin. A CPIS is a voluntary registration with the FDA recommended for a cosmetic product’s proposed commercial introduction. We are now evaluating the market opportunities for this product, so we have not entered into any agreements for the manufacture and marketing of Dermacyte.
In March 2009, OBI reached a development and commercial supply agreement with Hospira Worldwide, Inc., to participate in advancement and manufacture clinical-grade Oxycyte. During the development phase of the agreement, which is expected to last at least through the end of 2009, Hospira will provide services in connection with establishing Oxycyte commercial production formulation, manufacturing processes, testing protocols, validation procedures, and regulatory approvals for commercial production. For these services, OBI will pay to Hospira a total of $876,000 upon achieving specified milestones in the development phase. Following successful completion of the development phase, OBI has agreed to purchase all of its requirements for commercial distribution of Oxycyte from Hospira at prices to be negotiated by the parties for an initial term of seven years, which is automatically renewed at the end of the initial and each renewal term for an additional two years, unless terminated after the initial term by either party on not less than 36 months advance notice. Hospira will formulate, fill, finish and label Oxycyte in accordance with good manufacturing practice standards required by applicable regulations for the production of drugs. OBI believes Hospira will have sufficient manufacturing capacity to supply the amount of Oxycyte OBI may need for commercial distribution in the foreseeable future.
On February 23, 2009, OBI and Virginia Commonwealth University (VCU) signed a memorandum of understanding (MOU) to establish a federal defense appropriation-funded joint venture focusing on developing new treatments for military battlefield injuries. The joint venture intends to establish an entity to be known as the Purple Heart Injury Laboratories (PHIL) in Richmond, VA, as jointly managed and operated research laboratories focusing on healing battlefield injuries with new therapies and concepts. This facility will be a segment of Virginia Commonwealth University Reanimation Engineering Shock Center (VCURES). The initial $15 million funding for the joint venture will be sought through an appropriation request in the 2009/2010 federal defense budget.
In February 2009, OBI engaged PFC Pharma Focus AG, a Swiss contract research organization (CRO) to supervise a proposed Phase II Oxycyte dose escalation clinical trial in Switzerland for TBI. OBI has initiated the filing process for the clinical trial protocol in Switzerland with the relevant cantonal ethic committees and Swissmedic.
In May 2009, OBI signed a limited purpose cooperative research and development agreement (LP-CRADA) for equipment/material transfer (from non-NAVY provider to NAVY recipient) with the Naval Medical Research Center and Walter Reed Army Institute of Research for an IND to use Oxycyte in Decompression sickness.
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