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22
131331
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22
131701
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22
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22
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22
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22
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22
133941
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22
134391
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22
134841
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[ "of", "a", "suspected", "unexpected", "serious", "adverse", "event", "reaction", "in", "a", "patient", "with", "multiple", "myeloma", "participating", "in", "an", "exploratory", "clinical", "trial", ".", "In", "June", "2010", ",", "we", "announced", "that", "the", "U.S.", "Food", "and", "Drug", "Administration", ",", "or", "FDA", ",", "lifted", "the", "clinical", "hold", "it", "had", "placed", "on", "the", "Phase", "3", "clinical", "trials", "in", "NSCLC", ".", "Merck", "KGaA", "has", "resumed", "the", "treatment", "and", "enrollment", "in", "these", "trials", "for", "Stimuvax", "in", "NSCLC", ".", "The", "clinical", "hold", "on", "the", "Stimuvax", "trial", "in", "breast", "cancer", "remains", "in", "effect", "and", "Merck", "KGaA", "has", "discontinued", "the", "Phase", "3", "trial", "in", "breast", "cancer", ".", "Stimuvax", "will", "require", "the", "successful", "completion", "of", "the", "ongoing", "NSCLC", "trials", "and", "possibly", "other", "clinical", "trials", "before", "submission", "of", "a", "biologic", "license", "application", ",", "or", "BLA", ",", "or", "its", "foreign", "equivalent", "for", "approval", ".", "This", "process", "can", "take", "many", "years", "and", "require", "the", "expenditure", "of", "substantial", "resources", ".", "Pursuant", "to", "our", "agreement", "with", "Merck", "KGaA", ",", "Merck", "KGaA", "is", "responsible", "for", "the", "development", "and", "the", "regulatory", "approval", "process", "and", "any", "subsequent", "commercialization", "of", "Stimuvax", ".", "We", "can", "not", "assure", "you", "that", "Merck", "KGaA", "will", "continue", "to", "advance", "the", "development", "and", "commercialization", "of", "Stimuvax", "as", "quickly", "as", "would", "be", "optimal", "for", "our", "stockholders", ".", "In", "addition", ",", "Merck", "KGaA", "has", "the", "right", "to", "terminate", "the", "2008", "license", "agreement", "upon", "30", "days", "prior", "written", "notice", "if", ",", "in", "its", "reasonable", "judgment", ",", "it", "determines", "there", "are", "issues", "concerning", "the", "safety", "or", "efficacy", "of", "Stimuvax", "that", "would", "materially", "and", "adversely", "affect", "Stimuvax", "s", "medical", ",", "economic", "or", "competitive", "viability", ".", "Clinical", "trials", "involving", "the", "number", "of", "sites", "and", "patients", "required", "for", "FDA", "approval", "of", "Stimuvax", "may", "not", "be", "successfully", "completed", ".", "If", "these", "clinical", "trials", "fail", "to", "demonstrate", "that", "Stimuvax", "is", "safe", "and", "effective", ",", "it", "will", "not", "receive", "regulatory", "approval", ".", "Even", "if", "Stimuvax", "receives", "regulatory", "approval", ",", "it", "may", "never", "be", "successfully", "commercialized", ".", "If", "Stimuvax", "does", "not", "receive", "regulatory", "approval", "or", "is", "not", "successfully", "commercialized", ",", "or", "if", "Merck", "were", "to", "terminate", "the", "2008", "license", "agreement", ",", "we", "may", "not", "be", "able", "to", "generate", "revenue", ",", "become", "profitable", "or", "continue", "our", "operations", ".", "Any", "failure", "of", "Stimuvax", "to", "receive", "regulatory", "approval", "or", "be", "successfully", "commercialized", "would", "have", "a", "material", "adverse", "effect", "on", "our", "business", ",", "operating", "results", ",", "and", "financial", "condition", "and", "could", "result", "in", "a", "substantial", "decline", "in", "the", "price", "of", "our", "common", "stock", ".", "We", "understand", "that", "Merck", "KGaA", "intends", "to", "submit", "for", "regulatory", "approval", "of", "Stimuvax", "for", "the", "treatment", "of", "NSCLC", "based", "on", "the", "results", "of", "a", "single", "Phase", "3", "trial", ",", "the", "START", "study", ".", "If", "the", "FDA", "determines", "that", "the", "results", "of", "this", "single", "study", "do", "not", "demonstrate", "the" ]
22
135261
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22
135701
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[ "future", ".", "The", "occurrence", "of", "this", "serious", "adverse", "event", ",", "or", "other", "such", "serious", "adverse", "events", ",", "could", "result", "in", "a", "prolonged", "delay", ",", "including", "the", "need", "to", "enroll", "more", "patients", "or", "collect", "more", "data", ",", "or", "the", "termination", "of", "the", "clinical", "development", "program", "for", "Stimuvax", ".", "For", "example", ",", "we", "have", "been", "informed", "that", "Merck", "KGaA", "plans", "to", "increase", "the", "size", "of", "the", "START", "trial", "of", "Stimuvax®", "in", "NSCLC", "from", "an", "estimated", "number", "of", "1322", "to", "1476", "patients", "as", "part", "of", "a", "plan", "to", "maintain", "the", "statistical", "power", "of", "the", "trial", ".", "This", "change", "was", "agreed", "in", "consultation", "with", "the", "U.S.", "Food", "and", "Drug", "Administration", "(", "the", "FDA", ")", ",", "and", "the", "Special", "Protocol", "Agreement", "(", "SPA", ")", "for", "START", "has", "been", "amended", "to", "reflect", "the", "change", ".", "Another", "unexpected", "serious", "adverse", "event", "reaction", "could", "cause", "a", "similar", "suspension", "of", "clinical", "trials", "in", "the", "future", ".", "Any", "of", "these", "foregoing", "risks", "could", "materially", "and", "adversely", "affect", "our", "business", ",", "results", "of", "operations", "and", "the", "trading", "price", "of", "our", "common", "stock", ".", "The", "terms", "of", "our", "secured", "debt", "facility", "may", "restrict", "our", "current", "and", "future", "operations", ",", "particularly", "our", "ability", "to", "respond", "to", "changes", "or", "to", "take", "some", "actions", ",", "and", "our", "failure", "to", "comply", "with", "such", "covenants", ",", "whether", "due", "to", "events", "beyond", "our", "control", "or", "otherwise", ",", "could", "result", "in", "an", "event", "of", "default", "which", "could", "materially", "and", "adversely", "affect", "our", "operating", "results", "and", "our", "financial", "condition", ".", "In", "February", "2011", "we", "borrowed", "$", "5.0", "million", "pursuant", "to", "the", "terms", "of", "a", "loan", "and", "security", "agreement", ",", "or", "the", "loan", "agreement", ",", "with", "General", "Electric", "Capital", "Corporation", ",", "or", "GECC", ".", "In", "addition", ",", "at", "any", "time", "before", "November", "1", ",", "2011", "we", "may", ",", "at", "our", "sole", "option", ",", "borrow", "from", "GECC", "an", "additional", "$", "7.5", "million", ",", "subject", "to", "our", "satisfaction", "of", "specified", "conditions", "precedent", ".", "make", "distributions", ",", "or", "repurchase", "stock", ".", "The", "loan", "agreement", "also", "requires", "that", "we", "have", "12", "months", "of", "unrestricted", "cash", "and", "cash", "equivalents", "(", "as", "calculated", "in", "the", "loan", "agreement", ")", "as", "of", "each", "December", "31", "during", "the", "term", "of", "the", "loan", "agreement", ".", "A", "breach", "of", "any", "of", "these", "covenants", "or", "the", "occurrence", "of", "certain", "other", "events", "of", "default", ",", "which", "are", "customary", "in", "similar", "loan", "facilities", ",", "would", "result", "in", "a", "default", "under", "the", "loan", "agreement", ".", "If", "there", "was", "an", "uncured", "event", "of", "default", ",", "GECC", "could", "cause", "all", "amounts", "outstanding", "under", "the", "loan", "agreement", "to", "become", "due", "and", "payable", "immediately", "and", "could", "proceed", "against", "the", "collateral", "securing", "the", "indebtedness", ",", "including", "our", "cash", ",", "cash", "equivalents", "and", "short-term", "investments", ".", "We", "can", "not", "be", "certain", "that", "our", "assets", "would", "be", "sufficient", "to", "fully", "repay", "borrowings", "under", "the", "loan", "agreement", ",", "either", "upon", "maturity", "or", "acceleration", "upon", "an", "uncured", "event", "of", "default", ".", "Our", "ability", "to", "continue", "with", "our", "planned", "operations", "is", "dependent", "on", "our", "success", "at" ]
22
136161
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22
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[ "do", "not", "anticipate", "realizing", "net", "income", "again", "for", "the", "foreseeable", "future", ".", "As", "of", "December", "31", ",", "2010", ",", "our", "accumulated", "deficit", "was", "approximately", "$", "347.3", "million", ".", "Our", "losses", "have", "resulted", "primarily", "from", "expenses", "incurred", "in", "research", "and", "development", "of", "our", "product", "candidates", ".", "We", "do", "not", "know", "when", "or", "if", "we", "will", "complete", "our", "product", "development", "efforts", ",", "receive", "regulatory", "approval", "for", "any", "of", "our", "product", "candidates", ",", "or", "successfully", "commercialize", "any", "approved", "products", ".", "As", "a", "result", ",", "it", "is", "difficult", "to", "predict", "the", "extent", "of", "any", "future", "losses", "or", "the", "time", "required", "to", "achieve", "profitability", ",", "if", "at", "all", ".", "Any", "failure", "of", "our", "products", "to", "complete", "successful", "clinical", "trials", "and", "obtain", "regulatory", "approval", "and", "any", "failure", "to", "become", "and", "remain", "profitable", "would", "adversely", "affect", "the", "price", "of", "our", "common", "stock", "and", "our", "ability", "to", "raise", "capital", "and", "continue", "operations", ".", "There", "is", "no", "assurance", "that", "we", "will", "be", "granted", "regulatory", "approval", "for", "any", "of", "our", "product", "candidates", ".", "Merck", "KGaA", "has", "been", "testing", "our", "lead", "product", "candidate", ",", "Stimuvax", ",", "in", "Phase", "3", "clinical", "trials", "for", "the", "treatment", "of", "NSCLC", ".", "We", "have", "initiated", "two", "Phase", "1/2", "trials", "in", "2010", "for", "PX-866", ",", "and", "plan", "to", "initiate", "two", "additional", "Phase", "2", "trials", "in", "the", "first", "half", "of", "2011", ".", "Our", "other", "product", "candidates", "remain", "in", "the", "pre-clinical", "testing", "stages", ".", "The", "results", "from", "pre-clinical", "testing", "and", "clinical", "trials", "that", "we", "have", "completed", "may", "not", "be", "predictive", "of", "results", "in", "future", "pre-clinical", "tests", "and", "clinical", "trials", ",", "and", "there", "can", "be", "no", "assurance", "that", "we", "will", "demonstrate", "sufficient", "safety", "and", "efficacy", "to", "obtain", "the", "requisite", "regulatory", "approvals", ".", "A", "number", "of", "companies", "in", "the", "biotechnology", "and", "pharmaceutical", "industries", ",", "including", "our", "company", ",", "have", "suffered", "significant", "setbacks", "in", "advanced", "clinical", "trials", ",", "even", "after", "promising", "results", "in", "earlier", "trials", ".", "For", "example", ",", "the", "clinical", "trials", "for", "Stimuvax", "were", "suspended", "as", "a", "result", "of", "a", "suspected", "unexpected", "serious", "adverse", "event", "reaction", "in", "a", "patient", ".", "Although", "the", "clinical", "hold", "for", "trials", "in", "NSCLC", "has", "been", "lifted", ",", "it", "remains", "in", "effect", "for", "the", "trial", "in", "breast", "cancer", "and", "Merck", "KGaA", "has", "decided", "to", "discontinue", "the", "Phase", "3", "trial", "in", "breast", "cancer", ".", "Regulatory", "approval", "may", "not", "be", "obtained", "for", "any", "of", "our", "product", "candidates", ".", "If", "our", "product", "candidates", "are", "not", "shown", "to", "be", "safe", "and", "effective", "in", "clinical", "trials", ",", "the", "resulting", "delays", "in", "developing", "other", "product", "candidates", "and", "conducting", "related", "pre-clinical", "testing", "and", "clinical", "trials", ",", "as", "well", "as", "the", "potential", "need", "for", "additional", "financing", ",", "would", "have", "a", "material", "adverse", "effect", "on", "our", "business", ",", "financial", "condition", "and", "results", "of", "operations", ".", "We", "are", "dependent", "upon", "Merck", "KGaA", "to", "develop", "and", "commercialize", "our", "lead", "product", "candidate", ",", "Stimuvax", ".", "Under", "our", "license", "agreement", "with", "Merck", "KGaA", "for", "our", "lead", "product", "candidate", ",", "Stimuvax" ]
22
137091
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22
137501
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22
137931
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[ "control", ",", "quality", "assurance", "and", "the", "maintenance", "of", "records", "and", "documentation", ".", "with", "other", "FDA", ",", "state", "and", "foreign", "regulatory", "requirements", ".", "We", "have", "little", "control", "over", "our", "manufacturers", "compliance", "with", "these", "regulations", "and", "standards", ".", "A", "failure", "to", "comply", "with", "these", "requirements", "may", "result", "in", "fines", "and", "civil", "penalties", ",", "suspension", "of", "production", ",", "suspension", "or", "delay", "in", "product", "approval", ",", "product", "seizure", "or", "recall", ",", "or", "withdrawal", "of", "product", "approval", ".", "If", "the", "safety", "of", "any", "quantities", "supplied", "is", "compromised", "due", "to", "our", "manufacturers", "failure", "to", "adhere", "to", "applicable", "laws", "or", "for", "other", "reasons", ",", "we", "may", "not", "be", "able", "to", "obtain", "regulatory", "approval", "for", "or", "successfully", "commercialize", "our", "products", ".", "Any", "failure", "or", "delay", "in", "commencing", "or", "completing", "clinical", "trials", "for", "our", "product", "candidates", "could", "severely", "harm", "our", "business", ".", "Each", "of", "our", "product", "candidates", "must", "undergo", "extensive", "pre-clinical", "studies", "and", "clinical", "trials", "as", "a", "condition", "to", "regulatory", "approval", ".", "Pre-clinical", "studies", "and", "clinical", "trials", "are", "expensive", "and", "take", "many", "years", "to", "complete", ".", "The", "commencement", "and", "completion", "of", "clinical", "trials", "for", "our", "product", "candidates", "may", "be", "delayed", "by", "many", "factors", ",", "including", ":", "It", "is", "possible", "that", "none", "of", "our", "product", "candidates", "will", "complete", "clinical", "trials", "in", "any", "of", "the", "markets", "in", "which", "we", "and/or", "our", "collaborators", "intend", "to", "sell", "those", "product", "candidates", ".", "Accordingly", ",", "we", "and/or", "our", "collaborators", "may", "not", "receive", "the", "regulatory", "approvals", "necessary", "to", "market", "our", "product", "candidates", ".", "Any", "failure", "or", "delay", "in", "commencing", "or", "completing", "clinical", "trials", "or", "obtaining", "regulatory", "approvals", "for", "product", "candidates", "would", "prevent", "or", "delay", "their", "commercialization", "and", "severely", "harm", "our", "business", "and", "financial", "condition", ".", "For", "example", ",", "although", "the", "suspension", "of", "the", "clinical", "development", "program", "for", "Stimuvax", "in", "March", "2010", "has", "been", "lifted", "for", "trials", "in", "NSCLC", ",", "it", "remains", "in", "effect", "for", "the", "Phase", "3", "breast", "cancer", "trial", "and", ",", "in", "any", "event", ",", "may", "result", "in", "a", "prolonged", "delay", "or", "in", "the", "termination", "of", "the", "clinical", "development", "program", "for", "Stimuvax", ".", "For", "example", ",", "Merck", "KGaA", "has", "announced", "that", "it", "has", "decided", "to", "discontinue", "the", "Phase", "3", "trial", "in", "breast", "cancer", ".", "A", "prolonged", "delay", "or", "termination", "of", "the", "clinical", "development", "program", "would", "have", "a", "material", "adverse", "impact", "on", "our", "business", "and", "financial", "condition", ".", "The", "failure", "to", "enroll", "patients", "for", "clinical", "trials", "may", "cause", "delays", "in", "developing", "our", "product", "candidates", ".", "We", "may", "encounter", "delays", "if", "we", ",", "any", "collaboration", "partners", "or", "Merck", "KGaA", "are", "unable", "to", "enroll", "enough", "patients", "to", "complete", "clinical", "trials", ".", "Patient", "enrollment", "depends", "on", "many", "factors", ",", "including", ",", "the", "size", "of", "the", "patient", "population", ",", "the", "nature", "of", "the", "protocol", ",", "the", "proximity", "of", "patients", "to", "clinical", "sites", "and", "the", "eligibility", "criteria", "for", "the", "trial", ".", "simultaneously", ",", "patient", "enrollment", "in", "ongoing", "trials", "can", "be", "adversely", "affected", "by", "negative", "results", "from", "completed", "trials", ".", "Our", "product", "candidates", "are", "focused", "in", "oncology", ",", "which", "can", "be", "a", "difficult", "patient", "population", "to", "recruit", ".", "For", "example", ",", "the" ]
22
138401
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[ "candidates", "are", "focused", "in", "oncology", ",", "which", "can", "be", "a", "difficult", "patient", "population", "to", "recruit", ".", "For", "example", ",", "the", "suspension", "of", "the", "Stimuvax", "trials", "resulted", "in", "Merck", "KGaA", "enrolling", "additional", "patients", "which", "could", "delay", "such", "trials", ".", "We", "rely", "on", "third", "parties", "to", "conduct", "our", "clinical", "trials", ".", "If", "these", "third", "parties", "do", "not", "perform", "as", "contractually", "required", "or", "otherwise", "expected", ",", "we", "may", "not", "be", "able", "to", "obtain", "regulatory", "approval", "for", "or", "be", "able", "to", "commercialize", "our", "product", "candidates", ".", "We", "rely", "on", "third", "parties", ",", "such", "as", "contract", "research", "organizations", ",", "medical", "institutions", ",", "clinical", "investigators", "and", "contract", "laboratories", ",", "to", "assist", "in", "conducting", "our", "clinical", "trials", ".", "We", "have", ",", "in", "the", "ordinary", "course", "of", "business", ",", "entered", "into", "agreements", "with", "these", "third", "parties", ".", "Nonetheless", ",", "we", "are", "responsible", "for", "confirming", "that", "each", "of", "our", "clinical", "trials", "is", "conducted", "in", "accordance", "with", "its", "general", "investigational", "plan", "and", "protocol", ".", "Moreover", ",", "the", "FDA", "and", "foreign", "regulatory", "agencies", "require", "us", "to", "comply", "with", "regulations", "and", "standards", ",", "commonly", "referred", "to", "as", "good", "clinical", "practices", ",", "for", "conducting", ",", "recording", "and", "reporting", "the", "results", "of", "clinical", "trials", "to", "assure", "that", "data", "and", "reported", "results", "are", "credible", "and", "accurate", "and", "that", "the", "trial", "participants", "are", "adequately", "protected", ".", "Our", "reliance", "on", "third", "parties", "does", "not", "relieve", "us", "of", "these", "responsibilities", "and", "requirements", ".", "If", "these", "third", "parties", "do", "not", "successfully", "carry", "out", "their", "contractual", "duties", "or", "regulatory", "obligations", "or", "meet", "expected", "deadlines", ",", "if", "the", "third", "parties", "need", "to", "be", "replaced", "or", "if", "the", "quality", "or", "accuracy", "of", "the", "data", "they", "obtain", "is", "compromised", "due", "to", "the", "failure", "to", "adhere", "to", "our", "clinical", "protocols", "or", "regulatory", "requirements", "or", "for", "other", "reasons", ",", "our", "pre-clinical", "development", "activities", "or", "clinical", "trials", "may", "be", "extended", ",", "delayed", ",", "suspended", "or", "terminated", ",", "and", "we", "may", "not", "be", "able", "to", "obtain", "regulatory", "approval", "for", "our", "product", "candidates", ".", "Even", "if", "regulatory", "approval", "is", "received", "for", "our", "product", "candidates", ",", "the", "later", "discovery", "of", "previously", "unknown", "problems", "with", "a", "product", ",", "manufacturer", "or", "facility", "may", "result", "in", "restrictions", ",", "including", "withdrawal", "of", "the", "product", "from", "the", "market", ".", "Approval", "of", "a", "product", "candidate", "may", "be", "conditioned", "upon", "certain", "limitations", "and", "restrictions", "as", "to", "the", "drug", "s", "use", ",", "or", "upon", "the", "conduct", "of", "further", "studies", ",", "and", "may", "be", "subject", "to", "continuous", "review", ".", "After", "approval", "of", "a", "product", ",", "if", "any", ",", "there", "will", "be", "significant", "ongoing", "regulatory", "compliance", "obligations", ",", "and", "if", "we", "or", "our", "collaborators", "fail", "to", "comply", "with", "these", "requirements", ",", "we", ",", "any", "of", "our", "collaborators", "or", "Merck", "KGaA", "could", "be", "subject", "to", "penalties", ",", "including", ":", "Regulatory", "agencies", "may", "require", "us", ",", "any", "of", "our", "collaborators", "or", "Merck", "KGaA", "to", "delay", ",", "restrict", "or", "discontinue", "clinical", "trials", "on", "various", "grounds", ",", "including", "a", "finding", "that", "the", "subjects", "or", "patients", "are", "being", "exposed", "to", "an", "unacceptable", "health", "risk", ".", "For", "example", ",", "in", "March", "2010", ",", "Merck", "KGaA" ]
22
138871
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22
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[ "product", "candidates", "may", "never", "achieve", "market", "acceptance", "even", "if", "we", "obtain", "regulatory", "approvals", ".", "Even", "if", "we", "receive", "regulatory", "approvals", "for", "the", "commercial", "sale", "of", "our", "product", "candidates", ",", "the", "commercial", "success", "of", "these", "product", "candidates", "will", "depend", "on", ",", "among", "other", "things", ",", "their", "acceptance", "by", "physicians", ",", "patients", ",", "third", "party", "payers", "such", "as", "health", "insurance", "companies", "and", "other", "members", "of", "the", "medical", "community", "as", "a", "therapeutic", "and", "cost-effective", "alternative", "to", "competing", "products", "and", "treatments", ".", "If", "our", "product", "candidates", "fail", "to", "gain", "market", "acceptance", ",", "we", "may", "be", "unable", "to", "earn", "sufficient", "revenue", "to", "continue", "our", "business", ".", "Market", "acceptance", "of", ",", "and", "demand", "for", ",", "any", "product", "that", "we", "may", "develop", "and", "commercialize", "will", "depend", "on", "many", "factors", ",", "including", ":", "If", "our", "product", "candidates", "do", "not", "become", "widely", "accepted", "by", "physicians", ",", "patients", ",", "third", "party", "payors", "and", "other", "members", "of", "the", "medical", "community", ",", "our", "business", ",", "financial", "condition", "and", "results", "of", "operations", "would", "be", "materially", "and", "adversely", "affected", ".", "If", "we", "are", "unable", "to", "obtain", ",", "maintain", "and", "enforce", "our", "proprietary", "rights", ",", "we", "may", "not", "be", "able", "to", "compete", "effectively", "or", "operate", "profitably", ".", "Our", "success", "is", "dependent", "in", "part", "on", "obtaining", ",", "maintaining", "and", "enforcing", "our", "patents", "and", "other", "proprietary", "rights", "and", "will", "depend", "in", "large", "part", "on", "our", "ability", "to", ":", "As", "of", "December", "31", ",", "2010", ",", "we", "owned", "approximately", "16", "U.S.", "patents", "and", "21", "U.S.", "patent", "applications", ",", "as", "well", "as", "the", "corresponding", "foreign", "patents", "and", "patent", "applications", ",", "and", "held", "exclusive", "or", "partially", "exclusive", "licenses", "to", "approximately", "eight", "U.S.", "patents", "and", "two", "U.S.", "patent", "applications", ",", "as", "well", "as", "the", "corresponding", "foreign", "patents", "and", "patent", "applications", ".", "The", "degree", "of", "future", "protection", "for", "our", "proprietary", "rights", "is", "uncertain", ".", "The", "patent", "position", "of", "biotechnology", "and", "pharmaceutical", "firms", "is", "highly", "uncertain", "and", "involves", "many", "complex", "legal", "and", "technical", "issues", ".", "There", "is", "no", "clear", "policy", "involving", "the", "breadth", "of", "claims", "allowed", "in", "patents", "or", "the", "degree", "of", "protection", "afforded", "under", "patents", ".", "Although", "we", "believe", "our", "potential", "rights", "under", "patent", "applications", "provide", "a", "competitive", "advantage", ",", "it", "is", "possible", "that", "patent", "applications", "owned", "by", "or", "licensed", "to", "us", "will", "not", "result", "in", "patents", "being", "issued", ",", "or", "that", ",", "if", "issued", ",", "the", "patents", "will", "not", "give", "us", "an", "advantage", "over", "competitors", "with", "similar", "products", "or", "technology", ",", "nor", "can", "we", "assure", "you", "that", "we", "can", "obtain", ",", "maintain", "and", "enforce", "all", "ownership", "and", "other", "proprietary", "rights", "necessary", "to", "develop", "and", "commercialize", "our", "product", "candidates", ".", "Even", "if", "any", "or", "all", "of", "our", "patent", "applications", "issue", "as", "patents", ",", "others", "may", "challenge", "the", "validity", ",", "inventorship", ",", "ownership", ",", "enforceability", "or", "scope", "of", "our", "patents", "or", "other", "technology", "used", "in", "or", "otherwise", "necessary", "for", "the", "development", "and", "commercialization", "of", "our", "product", "candidates", ".", "We", "may", "not", "be", "successful", "in", "defending", "against", "any", "such", "challenges", ".", "Moreover", ",", "the", "cost", "of", "litigation", "to", "uphold", "the", "validity", "of", "patents", "to" ]
22
139801
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[ "in", "defending", "against", "any", "such", "challenges", ".", "Moreover", ",", "the", "cost", "of", "litigation", "to", "uphold", "the", "validity", "of", "patents", "to", "prevent", "infringement", "or", "to", "otherwise", "protect", "our", "proprietary", "rights", "can", "be", "substantial", ".", "If", "the", "outcome", "of", "litigation", "is", "adverse", "to", "us", ",", "third", "parties", "may", "be", "able", "to", "use", "the", "challenged", "technologies", "without", "payment", "to", "us", ".", "There", "is", "no", "assurance", "that", "our", "patents", ",", "if", "issued", ",", "will", "not", "be", "infringed", "or", "successfully", "avoided", "through", "design", "innovation", ".", "Intellectual", "property", "lawsuits", "are", "expensive", "and", "would", "consume", "time", "and", "other", "resources", ",", "even", "if", "the", "outcome", "were", "successful", ".", "In", "addition", ",", "there", "is", "a", "risk", "that", "a", "court", "would", "decide", "that", "our", "patents", ",", "if", "issued", ",", "are", "not", "valid", "and", "that", "we", "do", "not", "have", "the", "right", "to", "stop", "the", "other", "party", "from", "using", "the", "inventions", ".", "There", "is", "also", "the", "risk", "that", ",", "even", "if", "the", "validity", "of", "a", "patent", "were", "upheld", ",", "a", "court", "would", "refuse", "to", "stop", "the", "other", "party", "from", "using", "the", "inventions", ",", "including", "on", "the", "ground", "that", "its", "activities", "do", "not", "infringe", "that", "patent", ".", "If", "any", "of", "these", "events", "were", "to", "occur", ",", "our", "business", ",", "financial", "condition", "and", "results", "of", "operations", "would", "be", "materially", "and", "adversely", "effected", ".", "In", "addition", "to", "the", "intellectual", "property", "and", "other", "rights", "described", "above", ",", "we", "also", "rely", "on", "unpatented", "technology", ",", "trade", "secrets", ",", "trademarks", "and", "confidential", "information", ",", "particularly", "when", "we", "do", "not", "believe", "that", "patent", "protection", "is", "appropriate", "or", "available", ".", "However", ",", "trade", "secrets", "are", "difficult", "to", "protect", "and", "it", "is", "possible", "that", "others", "will", "independently", "develop", "substantially", "equivalent", "information", "and", "techniques", "or", "otherwise", "gain", "access", "to", "or", "disclose", "our", "unpatented", "technology", ",", "trade", "secrets", "and", "confidential", "information", ".", "We", "require", "each", "of", "our", "employees", ",", "consultants", "and", "advisors", "to", "execute", "a", "confidentiality", "and", "invention", "assignment", "agreement", "at", "the", "commencement", "of", "an", "employment", "or", "consulting", "relationship", "with", "us", ".", "However", ",", "it", "is", "possible", "that", "these", "agreements", "will", "not", "provide", "effective", "protection", "of", "our", "confidential", "information", "or", ",", "in", "the", "event", "of", "unauthorized", "use", "of", "our", "intellectual", "property", "or", "the", "intellectual", "property", "of", "third", "parties", ",", "provide", "adequate", "or", "effective", "remedies", "or", "protection", ".", "If", "our", "vaccine", "technology", "or", "our", "product", "candidates", ",", "including", "Stimuvax", ",", "conflict", "with", "the", "rights", "of", "others", ",", "we", "may", "not", "be", "able", "to", "manufacture", "or", "market", "our", "product", "candidates", ",", "which", "could", "have", "a", "material", "and", "adverse", "effect", "on", "us", "and", "on", "our", "collaboration", "with", "Merck", "KGaA", ".", "Issued", "patents", "held", "by", "others", "may", "limit", "our", "ability", "to", "develop", "commercial", "products", ".", "All", "issued", "patents", "are", "entitled", "to", "a", "presumption", "of", "validity", "under", "the", "laws", "of", "the", "United", "States", ".", "If", "we", "need", "licenses", "to", "such", "patents", "to", "permit", "us", "to", "develop", "or", "market", "our", "product", "candidates", ",", "we", "may", "be", "required", "to", "pay", "significant", "fees", "or", "royalties", ",", "and", "we", "can", "not", "be", "certain", "that", "we", "would", "be", "able", "to", "obtain", "such", "licenses", "on", "commercially", "reasonable", "terms", ",", "if", "at", "all", ".", "Competitors" ]
22
140281
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22
140771
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22
141261
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22
141721
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[ ",", "and", "Alimta", "(", "pemetrexed", ")", ",", "a", "chemotherapeutic", "from", "Eli", "Lilly", "and", "Company", ".", "Stimuvax", "has", "not", "been", "tested", "in", "combination", "with", "or", "in", "comparison", "to", "these", "products", ".", "It", "is", "possible", "that", "other", "existing", "or", "new", "agents", "will", "be", "approved", "for", "this", "indication", ".", "In", "addition", ",", "there", "are", "at", "least", "three", "vaccines", "in", "development", "for", "the", "treatment", "of", "NSCLC", ",", "including", "GSK", "s", "MAGE", "A3", "vaccine", "in", "Phase", "3", ",", "NovaRx", "Corporation", "s", "Lucanix", "in", "Phase", "3", "and", "Transgene", "s", "TG-4010", "in", "Phase", "2", ".", "TG-4010", "also", "targets", "MUC1", ",", "although", "using", "technology", "different", "from", "Stimuvax", ".", "To", "our", "knowledge", ",", "these", "vaccines", "are", "not", "currently", "being", "developed", "in", "the", "same", "indications", "as", "Stimuvax", ".", "However", ",", "subsequent", "development", "of", "these", "vaccines", ",", "including", "Stimuvax", ",", "may", "result", "in", "direct", "competition", ".", "Small", "Molecule", "Products", ".", "PX-866", "is", "an", "inhibitor", "of", "phosphoinositide", "3-kinase", "(", "PI3K", ")", ".", "We", "are", "aware", "of", "several", "companies", "that", "have", "entered", "clinical", "trials", "with", "competing", "compounds", "targeting", "the", "same", "protein", ".", "Among", "those", "are", "compounds", "being", "developed", "by", "Novartis", "(", "Phase", "1/2", ")", ",", "Roche/Genentech", "(", "Phase", "1", ")", ",", "Bayer", "(", "Phase", "1", ")", ",", "Semafore", "(", "Phase", "1", ")", ",", "Sanofi-Aventis", "(", "Phase", "2", ")", ",", "Pfizer", "(", "Phase", "1", ")", "and", "Calistoga", "(", "Phase", "2", ")", ".", "There", "are", "also", "several", "approved", "targeted", "therapies", "for", "cancer", "and", "in", "development", "against", "which", "PX-866", "might", "compete", ".", "Many", "of", "our", "potential", "competitors", "have", "substantially", "greater", "financial", ",", "technical", "and", "personnel", "resources", "than", "we", "have", ".", "In", "addition", ",", "many", "of", "these", "competitors", "have", "significantly", "greater", "commercial", "infrastructures", "than", "we", "have", ".", "Our", "ability", "to", "compete", "successfully", "will", "depend", "largely", "on", "our", "ability", "to", ":", "Established", "competitors", "may", "invest", "heavily", "to", "quickly", "discover", "and", "develop", "novel", "compounds", "that", "could", "make", "our", "product", "candidates", "obsolete", ".", "In", "addition", ",", "any", "new", "product", "that", "competes", "with", "a", "generic", "market-leading", "product", "must", "demonstrate", "compelling", "advantages", "in", "efficacy", ",", "convenience", ",", "tolerability", "and", "safety", "in", "order", "to", "overcome", "severe", "price", "competition", "and", "to", "be", "commercially", "successful", ".", "If", "we", "are", "not", "able", "to", "compete", "effectively", "against", "our", "current", "and", "future", "competitors", ",", "our", "business", "will", "not", "grow", "and", "our", "financial", "condition", "and", "operations", "will", "suffer", ".", "If", "we", "are", "unable", "to", "enter", "into", "agreements", "with", "partners", "to", "perform", "sales", "and", "marketing", "functions", ",", "or", "build", "these", "functions", "ourselves", ",", "we", "will", "not", "be", "able", "to", "commercialize", "our", "product", "candidates", ".", "We", "currently", "do", "not", "have", "any", "internal", "sales", ",", "marketing", "or", "distribution", "capabilities", ".", "In", "order", "to", "commercialize", "any", "of", "our", "product", "candidates", ",", "we", "must", "either", "acquire", "or", "internally", "develop", "a", "sales", ",", "marketing", "and" ]
22
142141
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[ "to", "commercialize", "any", "of", "our", "product", "candidates", ",", "we", "must", "either", "acquire", "or", "internally", "develop", "a", "sales", ",", "marketing", "and", "distribution", "infrastructure", "or", "enter", "into", "agreements", "with", "partners", "to", "perform", "these", "services", "for", "us", ".", "Under", "our", "agreements", "with", "Merck", "KGaA", ",", "Merck", "KGaA", "is", "responsible", "for", "developing", "and", "commercializing", "Stimuvax", ",", "and", "any", "problems", "with", "that", "relationship", "could", "delay", "the", "development", "and", "commercialization", "of", "Stimuvax", ".", "Additionally", ",", "we", "may", "not", "be", "able", "to", "enter", "into", "arrangements", "with", "respect", "to", "our", "product", "candidates", "not", "covered", "by", "the", "Merck", "KGaA", "agreements", "on", "commercially", "acceptable", "terms", ",", "if", "at", "all", ".", "Factors", "that", "may", "inhibit", "our", "efforts", "to", "commercialize", "our", "product", "candidates", "without", "entering", "into", "arrangements", "with", "third", "parties", "include", ":", "If", "we", "are", "not", "able", "to", "partner", "with", "a", "third", "party", "and", "are", "not", "successful", "in", "recruiting", "sales", "and", "marketing", "personnel", "or", "in", "building", "a", "sales", "and", "marketing", "and", "distribution", "infrastructure", ",", "we", "will", "have", "difficulty", "commercializing", "our", "product", "candidates", ",", "which", "would", "adversely", "affect", "our", "business", "and", "financial", "condition", ".", "If", "we", "lose", "key", "personnel", ",", "or", "we", "are", "unable", "to", "attract", "and", "retain", "highly-qualified", "personnel", "on", "a", "cost-effective", "basis", ",", "it", "would", "be", "more", "difficult", "for", "us", "to", "manage", "our", "existing", "business", "operations", "and", "to", "identify", "and", "pursue", "new", "growth", "opportunities", ".", "Our", "success", "depends", "in", "large", "part", "upon", "our", "ability", "to", "attract", "and", "retain", "highly", "qualified", "scientific", ",", "clinical", ",", "manufacturing", ",", "and", "management", "personnel", ".", "In", "addition", ",", "any", "difficulties", "retaining", "key", "personnel", "or", "managing", "this", "growth", "could", "disrupt", "our", "operations", ".", "Future", "growth", "will", "require", "us", "to", "continue", "to", "implement", "and", "improve", "our", "managerial", ",", "operational", "and", "financial", "systems", ",", "and", "continue", "to", "retain", ",", "recruit", "and", "train", "additional", "qualified", "personnel", ",", "which", "may", "impose", "a", "strain", "on", "our", "administrative", "and", "operational", "infrastructure", ".", "The", "competition", "for", "qualified", "personnel", "in", "the", "biopharmaceutical", "field", "is", "intense", ".", "We", "are", "highly", "dependent", "on", "our", "continued", "ability", "to", "attract", ",", "retain", "and", "motivate", "highly-qualified", "management", ",", "clinical", "and", "scientific", "personnel", ".", "Due", "to", "our", "limited", "resources", ",", "we", "may", "not", "be", "able", "to", "effectively", "recruit", ",", "train", "and", "retain", "additional", "qualified", "personnel", ".", "If", "we", "are", "unable", "to", "retain", "key", "personnel", "or", "manage", "our", "growth", "effectively", ",", "we", "may", "not", "be", "able", "to", "implement", "our", "business", "plan", ".", "Furthermore", ",", "we", "have", "not", "entered", "into", "non-competition", "agreements", "with", "all", "of", "our", "key", "employees", ".", "In", "addition", ",", "we", "do", "not", "maintain", "key", "person", "life", "insurance", "on", "any", "of", "our", "officers", ",", "employees", "or", "consultants", ".", "The", "loss", "of", "the", "services", "of", "existing", "personnel", ",", "the", "failure", "to", "recruit", "additional", "key", "scientific", ",", "technical", "and", "managerial", "personnel", "in", "a", "timely", "manner", ",", "and", "the", "loss", "of", "our", "employees", "to", "our", "competitors", "would", "harm", "our", "research", "and", "development", "programs", "and", "our", "business", ".", "Our", "business", "is", "subject", "to", "increasingly", "complex", "environmental", "legislation", "that", "has", "increased", "both", "our", "costs", "and", "the", "risk", "of", "noncompliance", ".", "Our", "business", "may", "involve", "the", "use" ]
22
142611
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22
143091
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22
143561
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22
144011
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[ "of", "an", "acquired", "company", "or", "business", "or", "in-licensed", "product", "candidate", ".", "In", "addition", ",", "our", "future", "success", "would", "depend", "in", "part", "on", "our", "ability", "to", "manage", "the", "rapid", "growth", "associated", "with", "some", "of", "these", "acquisitions", "and", "in-licenses", ".", "We", "can", "not", "assure", "you", "that", "we", "would", "be", "able", "to", "make", "the", "combination", "of", "our", "business", "with", "that", "of", "acquired", "businesses", "or", "companies", "or", "in-licensed", "product", "candidates", "work", "or", "be", "successful", ".", "Furthermore", ",", "the", "development", "or", "expansion", "of", "our", "business", "or", "any", "acquired", "business", "or", "company", "or", "in-licensed", "product", "candidate", "may", "require", "a", "substantial", "capital", "investment", "by", "us", ".", "We", "may", "not", "have", "these", "necessary", "funds", "or", "they", "might", "not", "be", "available", "to", "us", "on", "acceptable", "terms", "or", "at", "all", ".", "We", "may", "also", "seek", "to", "raise", "funds", "by", "selling", "shares", "of", "our", "capital", "stock", ",", "which", "could", "dilute", "our", "current", "stockholders", "ownership", "interest", ",", "or", "securities", "convertible", "into", "our", "capital", "stock", ",", "which", "could", "dilute", "current", "stockholders", "ownership", "interest", "upon", "conversion", ".", "Our", "common", "stock", "may", "become", "ineligible", "for", "listing", "on", "The", "NASDAQ", "Stock", "Market", ",", "which", "would", "materially", "adversely", "affect", "the", "liquidity", "and", "price", "of", "our", "common", "stock", ".", "Our", "common", "stock", "is", "currently", "listed", "for", "trading", "in", "the", "United", "States", "on", "The", "NASDAQ", "Global", "Market", ".", "As", "a", "result", "of", "our", "failure", "to", "timely", "file", "our", "Annual", "Report", "on", "Form", "10-K", "for", "the", "year", "ended", "December", "31", ",", "2009", ",", "we", "received", "a", "letter", "from", "The", "NASDAQ", "Stock", "Market", "informing", "us", "that", "we", "did", "not", "comply", "with", "continued", "listing", "requirements", ".", "Although", "the", "filing", "of", "our", "Annual", "Report", "on", "Form", "10-K", "for", "the", "year", "ended", "December", "31", ",", "2009", "allowed", "us", "to", "regain", "full", "compliance", "with", "SEC", "reporting", "requirements", "and", "The", "NASDAQ", "Stock", "Market", "continued", "listing", "requirements", ",", "we", "have", "in", "the", "past", "and", "could", "in", "the", "future", "be", "unable", "to", "meet", "The", "NASDAQ", "Global", "Market", "continued", "listing", "requirements", ".", "For", "example", ",", "on", "August", "20", ",", "2008", "we", "disclosed", "that", "we", "had", "received", "a", "letter", "from", "The", "NASDAQ", "Stock", "Market", "indicating", "that", "we", "did", "not", "comply", "with", "the", "requirements", "for", "continued", "listing", "on", "The", "NASDAQ", "Global", "Market", "because", "we", "did", "not", "meet", "the", "maintenance", "standard", "in", "Marketplace", "Rule", "4450", "(", "b", ")", "(", "1", ")", "(", "A", ")", "(", "recodified", "as", "Marketplace", "Rule", "5450", "(", "b", ")", ")", "that", "specifies", ",", "among", "other", "things", ",", "that", "the", "market", "value", "of", "our", "common", "stock", "be", "at", "least", "$", "50", "million", "or", "that", "our", "stockholders", "equity", "was", "at", "least", "$", "10", "million", ".", "Although", "we", "regained", "compliance", "with", "the", "stockholders", "equity", "standard", ",", "we", "have", "a", "history", "of", "losses", "and", "would", "expect", "that", ",", "absent", "the", "completion", "of", "a", "financing", "or", "other", "event", "that", "would", "have", "a", "positive", "impact", "on", "our", "stockholders", "equity", ",", "our", "stockholders", "equity", "would", "decline", "over", "time", ".", "Further", ",", "in", "the", "past", "our", "stock", "price", "has", "traded", "near", ",", "and", "at", "times", "below" ]
22
144471
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22
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22
145411
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22
145871
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22
146331
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22
146781
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22
147261
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22
147721
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22
148191
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22
148631
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22
149081
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22
149521
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22
149971
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22
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22
150871
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22
151331
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22
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22
153161
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[ "common", "stock", ",", "$", "0.0001", "par", "value", "per", "share", "(", "the", "Common", "Stock", ")", ",", "issued", "or", "issuable", "to", "the", "selling", "stockholder", "(", "the", "Selling", "Stockholder", ")", "named", "in", "the", "prospectus", "that", "forms", "a", "part", "of", "the", "Company", "s", "Registration", "Statement", "on", "Form", "S-3", "filed", "on", "the", "date", "hereof", "(", "the", "Registration", "Statement", ")", ".", "The", "Shares", "include", "(", "i", ")", "59,921", "shares", "of", "Common", "Stock", "(", "the", "Commitment", "Shares", ")", "issued", "to", "the", "Selling", "Stockholder", "pursuant", "to", "that", "certain", "Common", "Stock", "Purchase", "Agreement", ",", "dated", "as", "of", "July", "6", ",", "2010", ",", "by", "and", "between", "the", "Company", "and", "Small", "Cap", "Biotech", "Value", ",", "Ltd.", "(", "the", "Purchase", "Agreement", ")", ",", "and", "(", "ii", ")", "up", "to", "5,090,759", "shares", "of", "Common", "Stock", "(", "the", "Agreement", "Shares", ")", "that", "may", "be", "issued", "upon", "the", "terms", "and", "subject", "to", "the", "conditions", "set", "forth", "in", "the", "Purchase", "Agreement", ".", "We", "have", "examined", "copies", "of", "the", "Purchase", "Agreement", ",", "the", "Registration", "Rights", "Agreement", ",", "dated", "as", "of", "July", "6", ",", "2010", ",", "by", "and", "between", "the", "Company", "and", "the", "Selling", "Stockholder", ",", "the", "Registration", "Statement", ",", "and", "the", "prospectus", "that", "forms", "a", "part", "thereof", ".", "We", "have", "also", "examined", "instruments", ",", "documents", "and", "records", "which", "we", "deemed", "relevant", "and", "necessary", "for", "the", "basis", "of", "our", "opinions", "hereinafter", "expressed", ".", "In", "such", "examination", ",", "we", "have", "assumed", "(", "i", ")", "the", "authenticity", "of", "original", "documents", "and", "the", "genuineness", "of", "all", "signatures", ",", "(", "ii", ")", "the", "conformity", "to", "the", "originals", "of", "all", "documents", "submitted", "to", "us", "as", "copies", ",", "and", "(", "iii", ")", "the", "truth", ",", "accuracy", ",", "and", "completeness", "of", "the", "information", ",", "representations", "and", "warranties", "contained", "in", "the", "records", ",", "documents", ",", "instruments", "and", "certificates", "we", "have", "reviewed", ".", "Based", "on", "and", "subject", "to", "the", "foregoing", ",", "we", "are", "of", "the", "opinion", "that", ":", "We", "express", "no", "opinion", "as", "to", "the", "laws", "of", "any", "other", "jurisdiction", "other", "than", "the", "federal", "laws", "of", "the", "United", "States", "of", "America", "and", "the", "General", "Corporation", "Law", "of", "the", "State", "of", "Delaware", ".", "We", "consent", "to", "the", "use", "of", "this", "opinion", "as", "an", "exhibit", "to", "the", "Registration", "Statement", ",", "and", "we", "consent", "to", "the", "reference", "of", "our", "name", "under", "the", "caption", "Legal", "Matters", "in", "the", "prospectus", "that", "forms", "a", "part", "of", "the", "Registration", "Statement", ".", "In", "giving", "such", "consent", ",", "we", "do", "not", "thereby", "admit", "that", "we", "are", "in", "the", "category", "of", "persons", "whose", "consent", "is", "required", "under", "Section", "7", "of", "the", "Securities", "Act", ".", "/s/", "Wilson", "Sonsini", "Goodrich", "&", "Rosati", ",", "P.C", ".", "We", "consent", "to", "the", "reference", "to", "our", "firm", "under", "the", "caption", "Experts", "in", "the", "Registration", "Statement", "(", "Form", "S-3", ")", "and", "related", "Prospectus", "of", "Oncothyreon", "Inc.", "for", "the", "registration", "of", "5,150,680", "shares", "of", "its", "common", "stock", "and", "to", "the", "incorporation", "by", "reference", "therein", "of", "our", "reports", "dated", "March", "14", ",", "2011", ",", "with", "respect" ]
22
153611
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[ "common", "stock", "and", "to", "the", "incorporation", "by", "reference", "therein", "of", "our", "reports", "dated", "March", "14", ",", "2011", ",", "with", "respect", "to", "the", "consolidated", "financial", "statements", "of", "Oncothyreon", "Inc.", ",", "and", "the", "effectiveness", "of", "internal", "control", "over", "financial", "reporting", "of", "Oncothyreon", "Inc.", ",", "included", "in", "its", "Annual", "Report", "(", "Form", "10-K", ")", "for", "the", "year", "ended", "December", "31", ",", "2010", ",", "filed", "with", "the", "Securities", "and", "Exchange", "Commission", ".", "We", "consent", "to", "the", "incorporation", "by", "reference", "in", "this", "Registration", "Statement", "on", "Form", "S-3", "of", "our", "report", "dated", "May", "5", ",", "2010", ",", "relating", "to", "the", "2008", "and", "2009", "consolidated", "financial", "statements", "of", "Oncothyreon", "Inc.", "and", "subsidiaries", ",", "appearing", "in", "the", "Annual", "Report", "on", "Form", "10-K", "of", "Oncothyreon", "Inc.", "for", "the", "year", "ended", "December", "31", ",", "2010", ",", "and", "to", "the", "reference", "to", "us", "under", "the", "heading", "Experts", "in", "the", "Prospectus", ",", "which", "is", "part", "of", "this", "Registration", "Statement", "." ]
23
153760
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[ "UNITED", "STATES", "SECURITIES", "AND", "EXCHANGE", "COMMISSION", "Washington", ",", "D.C", ".", "Indicate", "by", "check", "mark", "if", "the", "registrant", "is", "a", "well-known", "seasoned", "issuer", ",", "as", "defined", "in", "Rule", "405", "of", "the", "Securities", "Act", ".", "Indicate", "by", "check", "mark", "if", "the", "registrant", "is", "not", "required", "to", "file", "reports", "pursuant", "to", "Section", "13", "or", "Section", "15", "(", "d", ")", "of", "the", "Act", ".", "Indicate", "by", "check", "mark", "whether", "the", "registrant", "(", "1", ")", "has", "filed", "all", "reports", "required", "to", "be", "filed", "by", "Section", "13", "or", "15", "(", "d", ")", "of", "the", "Exchange", "Act", "of", "1934", "during", "the", "past", "12", "months", "(", "or", "for", "such", "shorter", "period", "that", "the", "registrant", "was", "required", "to", "file", "such", "reports", ")", ",", "and", "(", "2", ")", "has", "been", "subject", "to", "such", "filing", "requirements", "for", "the", "past", "90", "days", ".", "Indicate", "by", "check", "mark", "whether", "the", "registrant", "has", "submitted", "electronically", "and", "posted", "on", "its", "corporate", "Web", "site", ",", "if", "any", ",", "every", "Interactive", "Data", "File", "required", "to", "be", "submitted", "and", "posted", "pursuant", "to", "Rule", "405", "of", "Regulation", "S-T", "(", "§", "232.405", "of", "this", "chapter", ")", "during", "the", "preceding", "12", "months", "(", "or", "for", "such", "shorter", "period", "that", "the", "registrant", "was", "required", "to", "submit", "and", "post", "such", "files", ")", ".", "Indicate", "by", "check", "mark", "if", "disclosure", "of", "delinquent", "filers", "pursuant", "to", "Item", "405", "of", "Regulation", "S-K", "(", "§229.405", "of", "this", "chapter", ")", "is", "not", "contained", "herein", ",", "and", "will", "not", "be", "contained", ",", "to", "the", "best", "of", "registrant", "s", "knowledge", ",", "in", "definitive", "proxy", "or", "information", "statement", "incorporated", "by", "reference", "in", "Part", "III", "of", "this", "Form", "10-K", "or", "any", "amendment", "to", "this", "Form", "10-K", ".", "Indicate", "by", "check", "mark", "whether", "the", "registrant", "is", "a", "large", "accelerated", "filer", ",", "an", "accelerated", "filer", ",", "a", "non-accelerated", "filer", ",", "or", "a", "smaller", "reporting", "company", ".", "See", "the", "definitions", "of", "large", "accelerated", "filer", ",", "accelerated", "filer", "and", "smaller", "reporting", "company", "in", "Rule", "12b-2", "of", "the", "Exchange", "Act", ".", "Indicate", "by", "check", "mark", "whether", "the", "registrant", "is", "a", "shell", "company", "(", "as", "defined", "in", "Rule", "12b-2", "of", "the", "Act", ")", ".", "The", "estimated", "aggregate", "market", "value", "of", "the", "Common", "Stock", "held", "by", "non-affiliates", "(", "shareholders", "holding", "less", "than", "5", "%", "of", "an", "outstanding", "class", "of", "stock", ",", "excluding", "directors", "and", "executive", "officers", ")", "of", "the", "Company", "on", "June", "30", ",", "2009", "was", "$", "65,826,720", ".", "This", "calculation", "is", "based", "upon", "an", "estimate", "of", "the", "fair", "market", "value", "of", "the", "Common", "Stock", "of", "$", "20.00", "per", "share", ",", "which", "was", "the", "price", "of", "the", "last", "several", "trades", "of", "which", "management", "is", "aware", "prior", "to", "this", "date", ".", "Because", "there", "is", "not", "an", "active", "trading", "market", "for", "the", "Common", "Stock", ",", "we", "have", "used", "our", "book", "value", "of", "$", "12.41", "as", "of", "June", "30", ",", "2009", "to", "calculate" ]
23
154191
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24
155921
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24
156361
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24
156821
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24
158571
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24
159011
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24
159471
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24
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24
160391
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24
160821
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25
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25
162881
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25
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25
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25
166221
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[ "the", "royalty", "stream", ",", "in", "order", "to", "get", "best", "total", "return", "for", "shareholders", ".", "We", "plan", "to", "raise", "the", "necessary", "capital", "to", "do", "this", "through", "a", "convertible", "debenture", "or", "sale", "of", "shares", ".", "We", "have", "retained", "a", "competent", "and", "experienced", "financial", "firm", "to", "assist", "in", "this", "process", ".", "In", "the", "short", "term", ",", "operations", "will", "continue", "to", "be", "funded", "by", "shareholder", "loans", "and", "in", "the", "longer", "term", "the", "royalty", "payments", "from", "EWT", "are", "expected", "to", "contribute", "strongly", "to", "our", "company", "s", "balance", "sheet", ".", "Cash", "Requirements", "Over", "the", "next", "12", "months", "we", "intend", "to", "operate", "as", "a", "business", "development", "company", ".", "We", "anticipate", "that", "we", "will", "incur", "the", "following", "operating", "expenses", "during", "this", "period", ":", "We", "believe", "that", "we", "will", "require", "additional", "funds", "to", "implement", "our", "growth", "strategy", ".", "These", "funds", "may", "be", "raised", "through", "equity", "financing", ",", "debt", "financing", ",", "or", "other", "sources", ",", "which", "may", "result", "in", "further", "dilution", "in", "the", "equity", "ownership", "of", "our", "shares", ".", "There", "is", "no", "assurance", "that", "we", "will", "be", "able", "to", "maintain", "operations", "at", "a", "level", "sufficient", "for", "an", "investor", "to", "obtain", "a", "return", "on", "their", "investment", "in", "our", "common", "stock", ".", "Further", ",", "we", "may", "continue", "to", "be", "unprofitable", ".", "Purchase", "of", "Significant", "Equipment", "We", "do", "not", "anticipate", "the", "purchase", "or", "sale", "of", "any", "plant", "or", "significant", "equipment", "during", "the", "next", "12", "months", ".", "Trends", "and", "Uncertainties", "Our", "revenues", "are", "dependent", "on", "the", "success", "of", "EWT", "in", "selling", "wind", "turbines", "to", "our", "customer", "list", ".", "Prospects", "look", "good", "in", "the", "current", "political", "environment", "of", "support", "for", "renewables", "but", "results", "can", "not", "be", "assured", ".", "Our", "ability", "to", "develop", "new", "business", "in", "the", "current", "market", "environment", "may", "take", "some", "time", ".", "Employees", "As", "of", "April", "30", ",", "2011", ",", "we", "had", "two", "employees", "consisting", "of", "Harold", "Dickout", ",", "our", "chief", "executive", "officer", ",", "president", "and", "chairman", "and", "Frank", "Pickersgill", ",", "our", "secretary", ".", "We", "plan", "to", "hire", "additional", "employees", "when", "circumstances", "warrant", ".", "Going", "Concern", "We", "anticipate", "that", "additional", "funding", "will", "be", "required", "in", "the", "form", "of", "equity", "financing", "from", "the", "sale", "of", "our", "common", "stock", ".", "At", "this", "time", ",", "we", "can", "not", "provide", "investors", "with", "any", "assurance", "that", "we", "will", "be", "able", "to", "raise", "sufficient", "funding", "from", "the", "sale", "of", "our", "common", "stock", "or", "through", "a", "loan", "from", "our", "directors", "to", "meet", "our", "obligations", "over", "the", "next", "twelve", "months", ".", "We", "do", "not", "have", "any", "arrangements", "in", "place", "for", "any", "future", "debt", "or", "equity", "financing", ".", "Off-Balance", "Sheet", "Arrangements", "We", "have", "no", "off-balance", "sheet", "arrangements", "that", "have", "or", "are", "reasonably", "likely", "to", "have", "a", "current", "or", "future", "effect", "on", "our", "financial", "condition", ",", "changes", "in", "financial", "condition", ",", "revenues", "or", "expenses", ",", "results", "of", "operations", ",", "liquidity", ",", "capital", "expenditures", "or", "capital", "resources", "that", "is", "material", "to", "stockholders", ".", "Expenses", "Our", "operating", "expenses", "for", "the", "three", "and", "nine", "month", "periods", "ended", "April", "30", ",", "2011", "and", "2010", "are", "outlined", "in", "the", "table", "below", ":", "Operating", "expenses", "for", "the", "nine", "months" ]
25
166691
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[ "ended", "April", "30", ",", "2011", "and", "2010", "are", "outlined", "in", "the", "table", "below", ":", "Operating", "expenses", "for", "the", "nine", "months", "ended", "April", "30", ",", "2011", ",", "increased", "by", "32.2", "%", "as", "compared", "to", "the", "comparative", "period", "in", "2010", "primarily", "as", "a", "result", "of", "foreign", "exchange", "differences", ".", "Other", "income", "for", "the", "nine", "months", "ended", "April", "30", ",", "2011", ",", "decreased", "by", "99.9", "%", "as", "compared", "to", "the", "comparative", "period", "in", "2010", ".", "Equity", "Compensation", "We", "currently", "do", "not", "have", "any", "stock", "option", "or", "equity", "compensation", "plans", "or", "arrangements", ".", "As", "of", "April", "30", ",", "2011", ",", "our", "company", "had", "working", "capital", "deficit", "of", "$", "2,189,601", ".", "Contractual", "Obligations", "As", "a", "smaller", "reporting", "company", ",", "we", "are", "not", "required", "to", "provide", "tabular", "disclosure", "obligations", ".", "Critical", "Accounting", "Policies", "Our", "financial", "statements", "and", "accompanying", "notes", "have", "been", "prepared", "in", "conformity", "with", "accounting", "principles", "generally", "accepted", "in", "the", "United", "States", "of", "America", "for", "financial", "statements", ".", "Preparing", "financial", "statements", "requires", "management", "to", "make", "estimates", "and", "assumptions", "that", "affect", "the", "reported", "amounts", "of", "assets", ",", "liabilities", ",", "revenue", ",", "and", "expenses", ".", "These", "estimates", "and", "assumptions", "are", "affected", "by", "management", "s", "application", "of", "accounting", "policies", ".", "We", "believe", "that", "understanding", "the", "basis", "and", "nature", "of", "the", "estimates", "and", "assumptions", "involved", "with", "the", "following", "aspects", "of", "our", "financial", "statements", "is", "critical", "to", "an", "understanding", "of", "our", "financials", ".", "Basis", "of", "Presentation", "The", "condensed", "consolidated", "interim", "financial", "statements", "of", "our", "company", "have", "been", "prepared", "in", "accordance", "with", "accounting", "principles", "generally", "accepted", "in", "the", "United", "States", "of", "America", "(", "``", "US", "GAAP", "''", ")", "for", "interim", "financial", "information", "and", "the", "instructions", "to", "Form", "10-Q", ".", "Accordingly", ",", "they", "do", "not", "include", "all", "of", "the", "information", "and", "footnotes", "required", "by", "US", "GAAP", "for", "complete", "financial", "statements", ".", "In", "the", "opinion", "of", "our", "company", "'s", "management", ",", "all", "adjustments", "(", "consisting", "only", "of", "normal", "recurring", "accruals", ")", "considered", "necessary", "for", "a", "fair", "presentation", "have", "been", "included", ".", "Operating", "results", "for", "the", "nine-month", "period", "ended", "April", "30", ",", "2011", "are", "not", "necessarily", "indicative", "of", "the", "results", "that", "may", "be", "expected", "for", "the", "full", "fiscal", "year", "ending", "July", "31", ",", "2011", ".", "The", "condensed", "consolidated", "interim", "financial", "statements", "should", "be", "read", "in", "conjunction", "with", "the", "audited", "consolidated", "financial", "statements", "of", "our", "company", "for", "the", "fiscal", "year", "ended", "July", "31", ",", "2010", ".", "Quantitative", "Disclosures", "About", "Market", "Risks", "As", "a", "smaller", "reporting", "company", ",", "we", "are", "not", "required", "to", "provide", "the", "information", "required", "by", "this", "Item", ".", "Controls", "and", "Procedures", "Management", "s", "Report", "on", "Disclosure", "Controls", "and", "Procedures", "We", "maintain", "disclosure", "controls", "and", "procedures", "that", "are", "designed", "to", "ensure", "that", "information", "required", "to", "be", "disclosed", "in", "our", "reports", "filed", "under", "the", "Securities", "Exchange", "Act", "of", "1934", ",", "as", "amended", ",", "is", "recorded", ",", "processed", ",", "summarized", "and", "reported", "within", "the", "time", "periods", "specified", "in", "the", "Securities", "and", "Exchange", "Commission", "'s", "rules", "and", "forms", ",", "and", "that", "such", "information", "is", "accumulated", "and", "communicated" ]
25
167151
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25
167641
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25
168131
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25
168581
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25
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26
170821
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26
171271
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27
172951
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