Friday, July 13, 2007

Senate panel sets generic biotech path

A Senate panel voted Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.

Brand-name manufacturers would receive 12 years of exclusive marketing time before generic competition could start under a bill that cleared the Senate Health, Education, Labor and Pensions Committee by a voice vote.

The House has yet to consider a similar bill. Senate supporters hope both chambers can agree on an approach and include it in a broad Food and Drug Administration bill expected to pass in the coming months.

Biologic medicines are derived from living things. Manufacturers say they are much tougher to produce than traditional, chemical-based medicines and small changes can make the drugs ineffective or potentially harmful.

The costs of biotech medicines often reach tens of thousands of dollars per patient each year. They treat a range of diseases including cancer, multiple sclerosis and rheumatoid arthritis.

Generic competition could save patients and taxpayers billions of dollars, said committee chairman Edward Kennedy.

"The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public," he said.

Kennedy, a Massachusetts Democrat, wrote the bill with Democrat Hillary Clinton of New York and Republicans Mike Enzi of Wyoming and Orrin Hatch of Utah. The senators said both sides compromised, particularly on setting brand-name exclusivity at 12 years.

Sen. Sherrod Brown, an Ohio Democrat, said the period was excessive. He offered but withdrew an amendment to cut it to seven years.

If the measure becomes law, several biotech drugs could be open to generic competition because their patents have expired and they have been sold for at least 12 years, Senate staff said.

They include Amgen (Charts, Fortune 500) anemia drug Epogen and Johnson & Johnson (Charts, Fortune 500) rival Procrit, andBiogen Idec's (Charts) multiple sclerosis treatment, Avonex.

To win FDA approval, a generic company would have to conduct at least one clinical trial to show there were no meaningful differences with the name-brand counterpart. The agency could waive the clinical-trial requirement and rely on animal studies and other data.

The new products "will not be copies of, but rather will be similar to" the original versions, groups representing brand- name makers said in a statement.

The Biotechnology Industry Organization (BIO) and the Massachusetts Biotechnology Council said approval standards were "weakened significantly" by letting clinical-trial requirements be waived.

They also voiced concern the FDA could deem generic versions interchangeable with brand-name products.

"To protect patient safety, Congress should ensure that patients are not given follow-on biologics unless expressly prescribed by a physician," BIO President Jim Greenwood said.

The brand-name companies also said the market exclusivity should extend to 14 years, while generic producers said 12 years was too long.

"Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said in a statement

Thursday, July 12, 2007

UK Regulator Says Akzo Must Bid For ICI By Aug 9

Akzo Nobel NV (AKZOY) must either make an offer for Imperial Chemical Industries PLC (ICI.LN) or declare that it won't by August 9, the UK Takeover panel said Friday.

The UK Takeover Panel, which is Britain's takeover watchdog, issued the ultimatum after discussions with both parties' advisers. In a statement issued to the London Stock Exchange the regulators said the Dutch company must state its intentions regarding U.K. rival ICI by 5pm on 9 August.

In early June, Akzo Nobel, the world's largest coatings company by market share, made an indicative offer for ICI of 600p per share in cash, valued at GBP7.2 billion (EUR10.65 billion), an offer that ICI rejected on grounds that it "significantly undervalues ICI."

The Takeover Panel said in its statement that each party has accepted the watchdog's ruling. Both Akzo Nobel and ICI declined to comment Friday on the matter.

A trader who asked not to be identified said the regulator's "put up or shut up" ruling places Akzo Nobel on the back foot and indicates that Akzo is still interested, otherwise the meeting with the panel would have resulted in Akzo walking away. The trader said he therefore expects a raised bid from Akzo.

Another trader, who also asked not to be identified, noted media reports Friday that ICI had requested the deadline be set. He said the move seems aimed at getting Akzo to bid higher than its initial indication of 600p per share, and that price talk in the market is now over 650p.

Akzo Nobel is well cashed-up, after having agreed the sale of its OrganonBioSciences unit to Schering-Plough (SHP) for $11 billion cash.

Nonetheless, analysts were mixed as to what Akzo Nobel will do next.

Some, like Tom Muller at Gilissen and James Knight at Collins-Stewart, believe Akzo will raise it's offer. Knight reckons the next bid for ICI will be around 650p, while Muller says it could be as high as 700p.

Muller and Knight both said Akzo needs to make a significant acquisition, and that ICI seems the most logical and complementary target. If Akzo doesn't come back with a new offer, it risks becoming a takeover target itself, they added.

Rabo Securities analyst Mark van der Geest thinks Akzo should use the cash from the sale of its pharmaceuticals unit for smaller, less complicated acquisitions targets as well as return cash to shareholders. Van der Geest doesn't think Akzo Nobel will raise it's offer for ICI.

"The indicative offer of 600p, made in early June, was more than enough for ICI and any higher bid, will destroy value for shareholders," said Van der Geest.

Akzo Nobel has long been seen as interested in ICI, which it has said in the past "represent a highly attractive addition to its focused coatings and chemicals business."

After ICI rejected its indicative offer in June, Akzo said there was no certainty it would present a fresh proposal to ICI.

Chinese Regulators Pull Licenses Of 5 Drug Cos -Reports

China's food and drug regulatory agency said it has pulled the production licenses of five drug makers over the last year and penalized 128 others, state media reported Saturday.

The report comes as China faces mounting criticism that the safety of its products is poorly regulated.

The State Food and Drug Administration stripped 128 manufacturers of their Good Manufacturing Practice certificates, a symbol of favorable performance, the China Daily newspaper reported on its Web site Saturday.

High Court In Dublin Rules In Pfizer's Favor In Patent Case

Pfizer Inc. (PFE) said the High Court in Dublin has ruled that the patent covering atorvastatin, the active ingredient in Lipitor, would be infringed by a competitor product from Ranbaxy.

The decision, which is subject to a possible appeal, would prevent Ranbaxy from launching a copycat drug before November 2011.

Thursday, July 05, 2007

Judge Rules Sanofi's Patent For Plavix Is Valid

A federal judge on Tuesday rejected a bid by Canadian drug maker Apotex Inc. to invalidate the key U.S. patent for Sanofi-Aventis' (SNY) popular blood thinner Plavix.

However, Apotex said Tuesday that it plans to immediately appeal the ruling with the U.S. Court of Appeals for the Federal Circuit in Washington, which typically handles appeals involving patent cases.

In an opinion Tuesday, U.S. District Judge Sidney H. Stein in Manhattan upheld that patent and said Sanofi is entitled to a permanent injunction to prevent Apotex from marketing its own generic version of the drug. Plavix is co-marketed by France's Sanofi and Bristol-Myers Squibb Co. (BMY).

The decision essentially prohibits a generic version of the drug from being introduced into the market for another four years.

"This court now finds that Apotex has failed to prove by clear and convincing evidence that the (key Plavix) patent is invalid or unenforceable, and Sanofi is entitled to a permanent injunction prohibiting Apotex from further infringement," the judge said.

Shares of Bristol-Myers set a 52-week high of $32.07 on Tuesday. They recently were up $1.44, or 4.8%, to $31.75, while Sanofi's shares in the U.S. recently traded up 14 cents, or 0.3%, to $41.49.

In his ruling, the judge said he will determine damages in the case at a later date.

"Despite today's decision, we are unwavering in our belief that the (Plavix) patent will ultimately be held invalid, and that the court will find inequitable conduct on the part of Sanofi," Apotex Chief Executive Barry Sherman said in a prepared statement.

Sherman noted that Apotex believes the issues in the Plavix case are similar to those in a patent case involving Pfizer's hypertension drug Norvasc. Apotex began selling a generic version of Norvasc last month after prevailing on appeal.

Sanofi and Bristol-Myers issued a joint statement announcing the Plavix ruling on Tuesday, but didn't make any further comment on the decision.

Dresdner Kleinwort analyst Ben Yeoh said Tuesday that Sanofi's win in the Plavix patent case "is quite a big deal" and he was surprised the shares aren't up more on the news.

"The market may be missing the fact that Sanofi could be due damages worth 50% of net sales, which would add up to hundreds of millions of dollars," Yeoh said.

Last August, Stein halted Apotex from selling its generic version until he could hear the patent case. The Canadian company introduced its generic in early August after state antitrust regulators rejected a proposed settlement in a long-running legal dispute between the companies.

Plavix was the second-biggest-selling drug in the world behind Pfizer Inc.'s (PFE) cholesterol drug Lipitor. The blood thinner generated global sales of $5.9 billion, in 2005, the last full year for which figures are available.

Joseph F. Tooley, an A.G. Edwards Inc. (AGE) analyst, said Tuesday that Bristol-Myers investors seem to be anticipating an increased chance the company could be acquired, given the Plavix ruling and the conclusion of other recent legal issues. Tooley noted the company's stock is trading at a roughly 29% premium to group.

"I think the stock-price reaction to today's ruling reflects the higher likelihood of a takeout now that the Plavix decision is in hand," said Tooley, whose firm had cooled to the idea of Bristol-Myers takeout.

Earlier this month, Bristol-Myers pleaded guilty to two counts of making false statements to the Federal Trade Commission regarding the proposed settlement in the Plavix case and agreed to pay a $1 million fine.

The company also recently completed the terms of a two-year deferred prosecution agreement with federal prosecutors in New Jersey in a separate accounting scandal at the drug maker.

Tooley doesn't own the stock; his firm or an affiliate received compensation from Bristol-Myers in the past 12 months for products or services other than investment banking.

In a research note Tuesday, Chris Schott, a Banc of America Securities analyst, said speculation that Bristol-Myers will be acquired is likely to increase as the Plavix ruling removes "a major overhang for both companies."

"We view the news today as refueling takeout speculation that has been part of the Bristol story since early January when the media - La Lettre de L'Expansion - broached news of talks between Sanofi and Bristol," said Schott, who raised his price target for Bristol-Myers by $2 to $29 a share on Tuesday.

Schott doesn't own Bristol-Myers or Sanofi stock; his firm has performed investment-banking services for Bristol-Myers and Sanofi in the past 12 months.

Tooley and Schott both said they believe the patent will be upheld on appeal. "We estimate that an appellate hearing could occur in late 2008, with a ruling during 2009," Schott said.

In reviewing the patent, Tooley said A.G. Edwards doesn't believe the issues in the Norvasc case and the Plavix case are "exactly the same" and there is "sufficient difference" in the cases for Bristol-Myers and Sanofi to prevail on appeal.

At trial earlier this year, Apotex argued that the key patent for Plavix was invalid because it was anticipated in a prior patent held by Sanofi, and that its development would have been obvious to a person of ordinary skill in the field who examined the prior patent.

Sanofi and Bristol-Myers had claimed Apotex's generic version of the drug infringes on Sanofi's key U.S. patent, which runs through November 2011.

A Sanofi lawyer argued at trial that Plavix was an "extraordinary breakthrough" and wasn't an obvious development. It required a good deal of experimentation by Sanofi's scientists, he said.

Ruling On Drug Pricing Faults Three Companies

A federal judge ruled that pharmaceutical companies AstraZeneca Plc, Schering-Plough Corp. and Bristol-Myers Squibb Co. engaged in unfair and deceptive trade practices regarding some of their drug prices.

The decision could make the companies more vulnerable in future cases. The judge ruled that Johnson & Johnson didn't violate the law.

The four companies were defendants in a suit that alleged they inflated the average wholesale prices, or AWP, they reported for certain drugs. The AWP has been used as a benchmark by insurers to calculate drug reimbursements. But it has come under heavy scrutiny in recent years amid allegations that manufacturers inflated that measure artificially to boost profits. In 2003, Medicare ceased using the AWP as a basis for drug reimbursements, but some third-party payers continued to reference it.

In the case, U.S. District Court Judge Patti B. Saris in Boston applied Massachusetts state law. Given her decision in this first stage, it is likely the judge will certify a national class to deal with the claims from other states. She ordered AstraZeneca to pay damages of $4.45 million to non-Medicare third-party payers and Bristol-Myers Squibb to pay damages of $183,000. The ruling affects third-party payers who paid for certain prescription drugs from December 1997 to 2003.

In her opinion, Judge Saris wrote that "Unscrupulously taking advantage of the flawed AWP system . . . by establishing secret mega-spreads far beyond the standard industry markup was unethical and oppressive." She also wrote that such practices, "caused real injuries to the insurers and patients" who paid inflated prices for life-sustaining drugs.

The judge asked for more information before deciding on further restitution to third-party payers for co-payments for some drugs. Plaintiffs' attorney Steve Berman said the decision "positions the litigation very well for us. In our view, the companies are now on the hook." Mr. Berman said the damages could be significant in the next round of the litigation. Plaintiffs will be seeking damages of $500 million from AstraZeneca, which could be doubled or trebled, per individual states' laws.

A spokeswoman for AstraZeneca said the company competed responsibly with respect to pricing its drugs and said the suit was "without merit." The company is considering its appellate options. A Bristol-Myers Squibb spokeswoman said the company intends to appeal the damages and maintained that the company isn't responsible for the wholesale price reimbursement benchmark used by insurance companies, insisting its internal practices are fair and reasonable. A Schering-Plough spokesman said the company was pleased the court had narrowed the scope of the case from the plaintiff's original suit. It is also considering an appeal.

New Vioxx Study May Cast Doubt On Merck Claims

In a new blow to Merck & Co.'s defense in the Vioxx litigation, results from a yet-to-be-published study suggest that increased heart risks associated with the painkiller began immediately after patients started taking the drug.

Since Merck withdrew Vioxx from the market in September 2004, it has argued that patients weren't at any heightened risk of a serious cardiovascular event unless they had taken the medicine for at least 18 months.

The new study, known as Victor, was conducted by researchers at Oxford University in England. A Merck defense attorney sent a copy of the study to New Jersey Superior Court Judge Carol E. Higbee along with a letter saying that it was "our understanding that this manuscript has been accepted" for publication by the New England Journal of Medicine.

The study, which was designed to see whether the drug would curb progression of colon cancer, compared Vioxx, known generically as rofecoxib, with placebo in a total of 2,434 patients who were followed for two years. The study was halted when Merck pulled Vioxx from the market after another study, known as Approve, linked the drug to an increased risk of heart attacks and strokes. The new report includes only information about cardiovascular findings.

According to the manuscript, 16 of the 23 cardiovascular events occurred in the Vioxx patents, and half of those occurred in patients within 12 months of taking the drug. "It would appear . . . that patients do not need to take rofecoxib for 18 months to be at increased risk of a cardiovascular thrombotic event," the authors wrote. The study also suggests that by 14 days after patients stopped taking the drug, the risk of heart and stroke went away.

In the wake of the withdrawal, Merck faces about 28,000 lawsuits. Of those that have gone to trial, the company has won 10 and lost five.

A spokeswoman for the New England Journal of Medicine, citing publication policy, declined to discuss the status of the manuscript. In a statement, Merck's outside counsel Ted Mayer said, "The reported findings with respect to confirmed thrombotic events in short-term use are not supported by the data found in the other available large placebo studies with Vioxx, including Alzheimer's studies, ViP and Approve."

NICE OKs Elan, Biogen MS Treatment Tysabri

Ireland-based Elan Corp. (ELN) and U.S.-based Biogen Idec (BIIB) said Tuesday they welcome the U.K. National Institute for Health and Clinical Excellence recommendation for the use of their drug Tysabri, the first NICE approval for any multiple sclerosis drug.

The companies said Tysabri represents a significant advance in MS treatment, offering hope of delaying the progression of disability and reducing the frequency of relapses.

According to the companies, treatment with Tysabri over two years leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.

As of late May, the treatment was being used in about 12,000 patients in both commercial use and clinical trials in the U.S., Germany, France, Ireland and other countries.

However, said one analyst who follows the sector, a key approval for the drug is still awaited from the U.S. Food and Drug Administration.

"This has to be seen in that context," he said, though he added that approval in the U.K. clearly bodes well for the drug.

Friday, June 22, 2007

Pfizer, Conn. Attorney General Probing Co Security Breach

Pfizer Inc. (PFE) has been investigating a security breach exposing personal information, including social-security numbers, of about 17,000 current and former employees.

The Connecticut Attorney General's office said Monday it is investigating the matter and, in a letter to Pfizer, requested additional information on the issue. Blumenthal said 305 Connecticut residents were affected.

"I remain concerned about the possibility that credit-card fraud and identity theft will arise from the breach of this personally identifying information," Attorney General Richard Blumenthal said in a letter to a Pfizer legal representative.

Blumenthal asked the company to reimburse the affected employees for credit freezes. He also requested Pfizer answer about a dozen questions about the incident.

The breach apparently resulted from an employee installing unauthorized file-sharing software onto a Pfizer laptop computer, according to a letter from a Pfizer legal representative sent to attorneys general on May 30. The letter said that 15,700 employees have definitely had their information accessed, and 1,250 may have had it accessed.

"Keep in mind that Pfizer has no indication that any unauthorized individual has used or is using your personal information," said Lisa Goldman, Pfizer privacy officer, in a letter to employees dated June 1.

Pfizer is investigating the matter and has already taken steps to aid employees. The company has agreed to fund $25,000 of identity-theft insurance for affected employees with no deductible, the letter said. Pfizer has also paid for a credit-monitoring service with Experian at no cost to employees.

Pfizer also said it contacted the three major U.S. credit agencies to inform them of the incident.

Recently, Pfizer shares were up 20 cents at $26.30 on volume of 37.7 million compared with average daily volume of 35.5 million.

Wednesday, January 17, 2007

House Passes Drug-Price Bill

House passage Friday of legislation taking a swipe at drug companies is just the first front in the new Democratic Congress's battle with the health-care industry. The next target: insurers, who will face demands for cuts in their Medicare subsidies.

On a 255-to-170 vote, the House passed legislation that would require the government to negotiate prescription prices with the pharmaceutical industry. Currently, private insurers handle the negotiations for Medicare and the government is barred from getting involved, an arrangement that critics say leads to higher prices than if the government used its clout. Twenty-four Republicans joined the Democratic majority in backing the measure, but its prospects are less certain in the closely divided Senate, and President Bush has threatened a veto.

The price-negotiation bill is just the new Congress's first maneuver on health care, after many Democrats promised on the campaign trail to lower drug costs in Medicare, the federal health program for the elderly and disabled. Beyond that, key Democrats are attacking another big change Republicans brought to Medicare while they controlled Congress. As part of 2003 Medicare drug-benefit legislation, lawmakers seeking to inject more private-sector involvement in the program dramatically increased federal payments to private insurance plans operating in the Medicare Advantage arm of the program.

In Medicare Advantage, private insurers provide seniors a full range of medical benefits as an alternative to the government-run program. Seniors automatically become eligible for Medicare when they turn 65, but then have the choice to sign up instead for coverage through a private Medicare Advantage plan.

Democrats say the payment increases in the legislation -- projected to be worth as much as $46 billion over the decade beginning in 2004 -- are a waste of taxpayer money, and they view Medicare Advantage as an attempt by Republicans to privatize the traditional program. Now, some Democrats want to reduce payments to the private plans, and budgetary concerns are heightening the pressure on the payments to insurers.

The State Children's Health Insurance Program, a federal block grant, will soon need to be reauthorized, and many Democrats would like to expand it. Congress is also likely to boost Medicare payments to doctors. At a time when Democrats are aiming to be fiscally responsible, such spending would likely have to be offset.

"There are precious few areas where we can save money. Medicare Advantage is a prime target to pick up a few dollars," says Rep. Pete Stark, the California Democrat who heads the House Ways and Means panel's health subcommittee. In the Senate, a Democratic aide predicts Medicare Advantage money will become "the standard pay-for" in lawmakers' legislative proposals.

Following a lobbying and advertising blitz by drug companies to block the Democratic attacks, health insurers are preparing their own counterattack. America's Health Insurance Plans, the industry's Washington-based trade group, is telling lawmakers that cuts in insurer subsidies would be tantamount to cuts in benefits for constituents, and it has readied maps to show the growth of Medicare Advantage plans throughout the country, compared to relatively sparse numbers before government payments increased.

It will tap the Coalition for Medicare Choices, a group for Medicare Advantage beneficiaries that AHIP started and funds, to bring satisfied customers to Congress. And AHIP will highlight research showing that a large portion of Medicare Advantage beneficiaries are minorities or have low incomes -- populations shown to suffer disproportionately from chronic health problems that plans say they can manage better than the government.

Of about 44 million Medicare beneficiaries, 7.6 million, or 17%, were in Medicare Advantage plans as of December 2006. That compares with about 6.1 million, or 14%, who were enrolled in the plans in December 2005.

"This is the ultimate in constituency politics," says Karen Ignagni, AHIP'S president and chief executive.

Beyond their philosophical complaints, many Democrats say Medicare Advantage wastes government money. Former House Democratic aide Brian Biles has done a study concluding that, on average, the government is spending $922 more each year for every beneficiary in Medicare Advantage, compared to what would have been spent if the person had remained in regular Medicare.

In 2005, the "overpayment," as Democrats call it, totaled $5.2 billion, according to a November 2006 report by Mr. Biles and others for the Commonwealth Fund, a private, nonprofit foundation that supports health research. An independent panel that advises Congress on Medicare also documented the payment differential. "It's a problem because it causes us to waste a lot of taxpayer money," Mr. Stark says. "I see no reason to do it."

AHIP disagrees with the methodology used in the study, and it points to Medicare data showing that Medicare Advantage beneficiaries save an average of $82 a month, in reduced out-of-pocket costs and extra benefits, compared to people in the traditional program. Insurers say the program has also succeeded in extending and expanding Medicare Advantage to rural areas, where it was lacking. And that means they can count on rural-state legislators to battle the Democratic attacks.

"We wanted equity in those plans. . . . We've got it now," says Iowa Republican Sen. Charles Grassley. "People in Iowa ought to have the same choices as those in New York, Miami and Los Angeles."

High Court Eases Way For Patent Challenges

The Supreme Court continued to reassert its oversight of patent law yesterday with a ruling that weakens intellectual-property protections by making it easier for legal challenges to patents.

The 8-1 decision put the justices on the side of those who have complained that existing rules stifle innovation, and it is their latest rebuke to the specialized panel that hears patent appeals, the U.S. Court of Appeals for the Federal Circuit, for rulings skewing property rights in favor of patent holders. The high court this term has also heard a separate case appealing obstacles imposed by the Federal Circuit against challenges to a patent on grounds that the invention is "obvious." A decision on that is pending.

Yesterday's opinion, by Justice Antonin Scalia, reversed the Federal Circuit's rule that if a company pays royalties for a patent, it forfeits the right to challenge the patent's validity. That has deterred companies from filing challenges because they would be at risk for treble damages for infringement if the patent were found to be valid.

The decision is a victory for MedImmune Inc., a Gaithersburg, Md., pharmaceuticals company that derives about 80% of its revenue from the respiratory-tract drug at issue, Synagis. Under protest, MedImmune paid a royalty to Genentech Inc., of South San Francisco, Calif., to avoid a patent-infringement suit over a component antibody.

Under a 2004 Federal Circuit ruling, the act of paying a royalty precluded challenging the patent's validity. The Federal Circuit reasoned that since the license payment obviated an infringement suit, there was no controversy between the companies. In general, federal courts may only decide cases and controversies, not rule on theoretical disputes or issue advisory opinions.

Justice Scalia wrote that a party shouldn't have to "bet the farm" to challenge a patent. He cited several prior cases where the court allowed parties to challenge laws as unconstitutional without breaking them -- and thus exposing themselves to criminal punishment. Moreover, he wrote, the Supreme Court in 1943 had decided a similar patent case by ruling that "the fact that royalties were being paid did not" make the dispute "hypothetical or abstract."

The Bush administration supported MedImmune, contending that allowing challenges would help weed out invalid patents that stifle innovation. "Public policy strongly favors ridding the economy of invalid patents, which impede efficient licensing, hinder competition, and undermine incentives for innovation," the government said in a friend-of-the-court brief.

The implications could be greatest for the biotechnology industry, where huge profits can turn on a relatively small number of patents, according to Pamela Samuelson, co-director of the Center for Law and Technology at the University of California, Berkeley. Prof. Samuelson said the Supreme Court is telling the Federal Circuit to be "more balanced and less patent-owner friendly."

"Everybody knows there are a lot of weak patents out there," she said. "A lot of inventors take very substantial risks going out into a field of technology, and sometimes they get their foot blown off when some patent is out there like a land mine."

However, some predicted a chilling effect. "This decision allows companies that have taken out licenses to challenge the validity of a patent while also enjoying the benefits of that very same patent," said Charles Barquist, a patent litigator in Morrison & Foerster LLP's Los Angeles office. "MedImmune turns all fundamental assumptions about the stability and finality of a patent license completely on their head," he added in a statement late yesterday. "The Court has upset the risk/benefit calculation that underlies virtually every patent license."

Genentech issued as statement downplaying the significance of the ruling, saying the Supreme Court "only addressed the threshold jurisdictional issue of whether there need to be further proceedings to finally decide this case. It does not express an opinion concerning the merits of MedImmune's claims against Genentech . . ."

Indeed, MedImmune General Counsel William Bertrand said the victory won't have an immediate impact on his company's bottom line, as it has been paying royalties all along and the ruling doesn't nullify the patent at issue, but it does enable resumption of the challenge.

Eric Schmidt, a biotech analyst at Cowen and Co., sees modest potential impact on Genentech's future earnings from the decision. An adverse decision, should MedImmune prevail at trial, could have an impact of four cents a share on earnings, he said. Genentech receives royalties from licensees as well as paying some royalties to the City of Hope Hospital, in Duarte, Calif., under the patent, Mr. Schmidt said. The company's annual income from all royalties is approaching $1 billion a year.

MedImmune's Synagis, which racked up $1.24 billion in 2005 sales, is an injectable product containing protective antibodies that help guard infants and young children against respiratory syncytial virus, or RSV, a common childhood infection responsible for about 125,000 hospitalizations a year in the U.S. alone, a spokeswoman said.

US Bipartisan Bill To Allow Drug Imports Unveiled

Republican and Democratic lawmakers of both houses of Congress teamed up Wednesday to announce a bill to allow the importation of federally approved drugs into the U.S. from foreign countries.

The bill is the eighth attempt in as many years to reverse a law passed in 1987 which banned the import of drugs approved by the Food and Drug Administration into the U.S. from other countries.

The Pharmaceutical Market Access and Drug Safety Act has been sponsored by Sens. Byron Dorgan, D-ND, and Olympia Snow, R-ME, and Reps. Jo Ann Emerson, R-MO, and Rahn Emanuel, D-IL, in the House of Representatives.

All four expressed confidence that the proposed law would be successful in votes in both chambers. The Democratic leadership in both the Senate and the House have committed themselves to allowing the bill to be voted on the floor, although not to a particular timetable.

At a press conference in the Senate media gallery, Dorgan pointed to the fact that drugs in Canada and in European countries are commonly much cheaper than the same drugs are in the U.S.

Dorgan held up two jars of the popular cholesterol fighting medicine Lipitor, manufactured by drug major Pfizer Inc. (PFE). The medication in both was made in Ireland and then exported to the U.S. and Canada, where it was priced 65% cheaper than in the U.S.

"We want to put downward pressure on the price of prescription drugs," said Dorgan. "Currently, the big drug manufacturers can monopoly price their medicines here, and as a result, American consumers pay the highest prices in the world for prescription drugs."

The legislation would allow individuals to directly order medication from outside the U.S. when using a Canadian pharmacy that is registered with the FDA. It would also allow U.S. licensed pharmacists and wholesalers to import FDA-approved medications from a number of major industrialized nations.

President George W. Bush has spoken out against similar attempts by Congress in the past. Were the bill to pass both chambers successfully, the White House would be left facing the politically unpopular decision to invoke a veto.

The move has the backing of the powerful lobby group, the AARP.

"It's an embarrassment that the very same medications Americans pay top dollar for in the U.S. cost so much less in Canada and Europe. Americans are getting a raw deal," said Bill Novelli, AARP chief executive, in a statement.

Wednesday, December 13, 2006

Warranty Deed with Vendor's Lien

WARRANTY DEED WITH VENDOR’S LIEN
(Vendor’s Lien Reserved and Assigned to Third Party Lender)

STATE OF _______________
COUNTY OF _____________

KNOW ALL MEN BY THESE PRESENTS:

THAT THE UNDERSIGNED, ______________________________________________________ _____________________________________________________ [full legal name(s) of seller(s)], hereinafter called “Grantor(s)”, whether one or more, for and in consideration of the sum of TEN DOLLARS ($10.00) and other valuable consideration to the undersigned in hand paid by the Grantee herein named, the receipt of which is hereby acknowledged, and the further consideration of the execution and delivery by the Grantee of that one certain promissory note described on Exhibit A attached hereto, the payment of which note is secured by the vendor’s lien herein retained, and is additionally secured by a deed of trust of even date therewith and also described on Exhibit A attached hereto, has GRANTED, SOLD AND CONVEYED, and by these presents does GRANT, SELL AND CONVEY unto _____________________________________ ___________________________________________________ [full legal name(s) of grantee(s)], hereinafter referred to as the “Grantee” whether one or more, all of Grantor’(s) right, title and interest in and to the real property described as follows:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
[insert full legal property description]

This conveyance, however, is made and accepted subject to any and all restrictions, easements, covenants and conditions, if any, relating to the hereinabove described property as the same are filed for record in the real property records of _________________________ County, _________________________ [state].

TO HAVE AND TO HOLD the above described premises, together with all and singular the rights and appurtenances thereto in anywise belonging, unto the said Grantee, Grantee’s heirs, executors, administrators, successors and/or assigns forever; and Grantor(s) do hereby bind Grantor(s)’ heirs, executors, administrators, successors and/or assigns to WARRANT AND FOREVER DEFEND all and singular the said premises unto the said Grantee, Grantee’s heirs, executors, administrators, successors and/or assigns, against every person whomsoever claiming or to claim the same or any part thereof.

But it is expressly agreed: (1) that the Vendor’s Lien, as well as Superior Title in and to the above described premises, is retained against the above described property, premises and improvements until the above described not and all interest thereon are fully paid according to the face, tenor, effect and reading thereof, when this Deed shall become absolute; and (2) that the Lender set forth on Exhibit A, attached hereto, at the instance and request of the Grantee herein, having advanced and paid in cash to the Grantor(s) herein that portion of the purchase price of the herein described property as is evidenced by the hereinabove described Note, the Vendor’s Lien, together with the Superior Title to said property, is retained herein for the benefit of said Lender and the same are hereby TRANSFERRED AND ASSIGNED to said Lender, its successors and assigns.

Current ad valorem taxes on the property having been prorated, the payment thereof is assumed by Grantee.

EXECUTED this ________ day of ____________________, 20_____ but to be effective upon the date this instrument is filed for record in the real property records of _________________________ County, _________________________ [state].

GRANTOR(S):


______________________________ ____________________________
[name of seller] [name of seller]


STATE OF _______________
COUNTY OF _____________

Before me, the undersigned Notary Public, on this day personally appeared _________________ __________________________________________________________________________ known to me (or proved to me on the oath of _____________________________________________, or through Drivers License or _____________________________________________) to be the persons whose names are subscribed to the foregoing instrument and acknowledged to me that they executed in the capacity set forth and for the purpose and consideration therein expressed.

Given under my hand and seal of office this ________ day of ____________________, 20_____.

[Notarial seal, if any]



_______________________________
NOTARY PUBLIC, STATE OF ____________


After recording, return to Grantee, at:

Grantee’s address:

_______________________________
_______________________________
_______________________________

Form: WARRANTY DEED

WARRANTY DEED

For good consideration, we (I) ____________________________________________________________ of _____________________________________, County of _____________________, State of _______________________________, hereby bargain, deed and convey to______________________________ of ____________________________, County of ______________________________, State of _____________________, the following described land in _____________________county, free and clear with WARRANTY COVENANTS; to wit:




Grantor, for itself and its heirs, hereby covenants with Grantee, its heirs, and assigns, that Grantor is lawfully seized in fee simple of the above-described premises; that it has a good right to convey; that the premises are free from all encumbrances; that Grantor and its heirs, and all persons acquiring any interest in the property granted, through or for Grantor, will, on demand of Grantee, or its heirs or assigns, and at the expense of Grantee, its heirs or assigns, execute and instrument necessary for the further assurance of the title to the premises that may be reasonably required; and that Grantor and its heirs will forever warrant and defend all of the property so granted to Grantee, its heirs, against every person lawfully claiming the same or any part thereof.

Being the same property conveyed to the Grantors by deed of ______________________________________, dated ___________________, 20____.

WITNESS the hands and seal of said Grantors this ______ day of _________, 20____.



_______________________________________
Grantor



_______________________________________
Grantee



STATE OF ___________________

COUNTY OF _________________

On____________________before me,______________________, personally appeared _________________________________________, personally known to me (or proved to me on the basis of satisfactory evidence) to be the person(s) whose name(s) is/are subscribed to the within instrument and acknowledged to me that he/she/they executed the same in his/her/their authorized capacity(ies), and that by his/her/their signature(s) on the instrument the person(s), or the entity upon behalf of which the person(s) acted, executed the instrument.

WITNESS my hand and official seal.




Signature______________________________

Affiant _____Known _____Unknown

ID Produced______________________

(Seal)

Form: WARRANTY BILL OF SALE

WARRANTY BILL OF SALE

BE IT KNOWN, that for good consideration, and in payment of the sum of $____________, the receipt and sufficiency of which is acknowledged, the undersigned _______________________ of _______________ (Seller) hereby sells and transfers to ________________________________ of _____________________________________________________________________ (Buyer) and its successors and assigns forever, the following described chattels and personal property:






Seller warrants to Buyer it has good and marketable title to said property, full authority to sell and transfer said property, and that said property is sold free of all liens, encumbrances, liabilities and adverse claims of every nature and description whatsoever.

Seller further warrants to Buyer that it will full defend, protect, indemnify and hold harmless the Buyer and its lawful successors and assigns from any adverse claim thereto.

SAID ASSETS ARE OTHERWISE SOLD IN "AS IS" CONDITION AND WHERE PRESENTLY LOCATED.

Signed this _____ day of________________, 20____.

In the presence of:



______________________________ _______________________________
Witness Seller



_______________________________ _______________________________
Address Address




Other Forms You May Need

Form: Sale of Goods Agreement

Sale of Goods Agreement

Agreement made _____________ (date), between _________________________, of _________________________________ (address), _____________________ (city), ______________ (county), ________________ (state), in this agreement referred to as seller, and ___________________, of ____________________________ (address), __________________ (city), __________________ (county), _____________ (state), in this agreement referred to as buyer.

SECTION ONE: SALE OF GOODS
Seller shall sell, transfer and deliver to buyer on or before ____________________ (date), the following personal property: ____________________________________________________________
____________________________________________________________
____________________________________________________________ (description of goods).


SECTION TWO: CONSIDERATION
Buyer shall accept the goods and pay ________________________________________ Dollars ($ ________ ) for the goods.

SECTION THREE: IDENTIFICATION OF GOODS
Identification of the goods to this agreement shall not be deemed to have been made until both buyer and seller have specified that the goods in question are to be appropriated to the performance of this agreement.

SECTION FOUR: PAYMENT ON RECEIPT
Buyer shall make payment for the goods at the time when, and at the place where, the goods are received by buyer.

SECTION FIVE: RECEIPT CONSTRUED AS DELIVERY
Goods shall be deemed received by buyer when delivered to buyer at ________________________________________ (address), __________ (city), __________ (county), __________ (state).

SECTION SIX: RISK OF LOSS
The risk of loss from any casualty to the goods, regardless of the cause, shall be the responsibility of the seller until the goods have been accepted by the buyer.

SECTION SEVEN: WARRANTY OF NO ENCUMBRANCES
Seller warrants that the goods are now free, and that at the time of delivery shall be free from any security interest or other lien or encumbrance.

SECTION EIGHT: WARRANTY OF TITLE
Furthermore, seller warrants that at the time of signing this agreement, seller neither knows nor has reason to know of the existence of any outstanding title or claim of title hostile to the rights of seller in the goods.

SECTION NINE: RIGHT OF INSPECTION
Buyer shall have the right to inspect the goods on arrival and, within _______ business days after delivery, buyer must give notice to seller of any claim for damages on account of condition, quality or grade of the goods, and buyer must specify the basis of the claim of buyer in detail. The failure of buyer to comply with these conditions shall constitute irrevocable acceptance of the goods by buyer.

In witness whereof, the parties have executed this agreement at ________________________________________ (designate place of execution) the day and year first above written.



_________________________
Signature



_________________________
Signature

Form: Quitclaim Deed

QUITCLAIM DEED

THIS QUITCLAIM DEED, Executed this ____ day of __________________, 20____, by first party_________________________________________________ whose post office address is___________________________________________ to second party,_______________________________________________________ whose post office address is___________________________________________.

WITNESSETH, That the said first party, for good consideration and for the sum of $_______________ paid by the said second party, the receipt whereof is hereby acknowledged, does hereby remise, release and quitclaim unto the said second party forever, all the right, title, interest and claim which the said first party has in and to the following described parcel of land, and improvements and appurtenances thereto in the County of_____________________, State of_______________, to wit:




IN WITNESS WHEREOF, The said first party has signed and sealed these presents the day and year first above written.

Signed, sealed and delivered in presence of:



____________________________ ______________________________
Witness First Party



____________________________ ______________________________
Witness Second Party

STATE OF }
COUNTY OF }

On________________________________before me,__________________________, personally appeared___________________________________________________, personally known to me (or proved to me on the basis of satisfactory evidence) to be the person(s) whose name(s) is/are subscribed to the within instrument and acknowledged to me that he/she/they executed the same in his/her/their authorized capacity(ies), and that by his/her/their signature(s) on the instrument the person(s), or the entity upon behalf of which the person(s) acted, executed the instrument.

WITNESS my hand and official seal.




_____________________________
Signature


Affiant: _____Known _____Unknown

ID Produced: __________________________


[Seal]

Form: QUITCLAIM BILL OF SALE

BE IT KNOWN, for good consideration, and in consideration of the payment of _____________________________, the receipt and sufficiency of which is acknowledged, the undersigned _____________________(Seller) hereby sells, transfers, assigns and conveys unto _____________________ and its successors and assigns forever with quitclaim covenants only, the following described property:




Seller hereby sells and transfers only such right, title and interest as it may hold and that said chattels sold herein are sold subject to such prior liens, encumbrances and adverse claims, if any, that may exist, and Seller disclaims any and all warranties thereto.

Said assets are further sold in "AS IS" condition and where presently located.


Signed this _____ day of __________________, 20____.



In the presence of:



______________________________
Seller



_______________________________
Witness

Form: OPEN LISTING REALTY AGREEMENT

1. This agreement signed on the ____day of________________ 20____, by and between _________________________(Owner) and _____________________(Real Estate Broker) who agree as follows:

2. Listing term. Owner lists the property described in Paragraph 3, with the Real Estate Broker for a period of _____days, from date hereof.

3. Description of Property. The property listed is located at:




4. Commission. The Owner agrees to pay the Real Estate Broker a commission of _____% of the sale price should the Broker find a purchaser ready, willing, and able to pay at least $___________ for the property or such other sum as may be accepted by Owner. Said commissions are payable upon closing.

5. Non-Exclusive. The Owner retains the right to sell the property directly on his or her own behalf with no sales commission to broker, so long as the Broker did not find this purchaser. The Owner further has the right to list the property with other brokers. If a sale is made within months after this agreement terminates to parties found by the Real Estate Agent during the term of this agreement, and wherein the buyer has been disclosed to the Owner, the Owner shall pay the commission specified above.

6. Forfeit of Deposit. If a deposit of money is forfeited by a purchaser produced by Broker, one half shall be retained by the Broker, providing that this amount does not exceed the commission, and one half shall be paid to the Owner.


Witnessed:



_______________________________ ______________________________
Witness Owner



_______________________________ ______________________________
Witness Broker

Form: Installment Sale and Security Agreement

This contract is made this _________[date] between the seller and the buyer, designated below by their signatures and seals.

1. Payment. Seller sells buyer the articles described above (goods) upon the terms set forth below. Buyer, given the choice of paying the net price set forth below or the time price in any installments as set forth below, agrees to pay same to seller or its assigns at its offices at the address shown above or at any other address which seller may direct in writing delivered to buyer. It is agreed that the contracts, whether one or more, existing between seller and buyer, having an unpaid balance of $_____(old balance), shall remain in full force and effect, that seller's security interest in the goods sold under them shall remain perfected, and that as to the contract evidenced by this instrument, buyer shall make payments in the amount and for the period set forth below until the total time balance as set forth has been paid. Upon a default in the contract evidenced by this instrument, the existing contract shall also be deemed to be in default:

Payable in _________ consecutive installments of $_____ each, except the last installment shall be the balance due.

First installment due _________[date].

2. Warranties. No representation or statements have been made by seller concerning the goods except as stated in this agreement, and no warranty, express or implied, by seller, arises apart from this writing. Buyer warrants that any property offered in trade for the goods is free from any lien, claim, incumbrance or security interest.

3. Fees. Buyer will pay all costs of filing this contract or any financing or termination statement with respect to the goods, and appoints seller buyer's attorney-in-fact to do whatever seller may deem necessary to perfect or continue perfected its security interest in the goods.

4. Retention of security interest. Until all installment payments, and all other amounts due under this agreement, have been paid, seller shall retain a security interest in the goods and any and all equipment, parts, accessories, attachments, additions and other goods, and all replacements of them, installed in, affixed to or used in connection with the goods and, if buyer sells or otherwise disposes of the goods in violation of the terms of this agreement, in the proceeds of such sale or disposition.

5. Insurance. Buyer will insure the goods against all hazards in form and amounts and with an insurer satisfactory to seller. If buyer fails to obtain insurance seller shall have the right to obtain it at buyer's expense (without waiver of any other remedy) and buyer assigns to seller all right to receive proceeds of insurance not exceeding the unpaid balance (including any costs of collection, attorney's fees or other costs actually incurred in connection with it) and directs any insurer to pay all proceeds directly to seller and authorizes seller to endorse any draft for proceeds. In the event of damage to the goods and payment of insurance, seller shall have the option of replacing the goods or applying the proceeds on any obligation secured by this agreement. Seller may upon default under this agreement, or default in the payment or performance of any obligation secured by this agreement, cancel any insurance on goods after repossession of them, or on that portion of the goods repossessed if less than all.

6. Maintenance. Buyer will keep the goods in good condition and free from liens and other security interests, will pay promptly all taxes and assessments upon them or with respect to their use, will not use the goods illegally or dispose of or incumber them, will not remove the goods from the premises to which they are delivered as stated on the face of this contract, without the prior written consent of seller and will not permit the goods to be fixtures, or to become accessions to other goods unless on the front page of this agreement it is indicated that the goods are to be attached to real estate in which case buyer agrees to furnish seller with a disclaimer or disclaimers, in form satisfactory to seller, signed by all persons having an interest in the real estate, of any interest in the goods which is prior to seller's interest.

7. Events of default. The occurrence of any of the following shall constitute a default under this agreement: (1) failure of buyer to perform any obligation or agreement specified in this agreement, or if any warranty or representation made under this agreement by buyer should prove to be materially incorrect; (2) the death of buyer, any cosigner or guarantor on any obligation secured by this agreement, or the dissolution, merger, consolidation or reorganization of any corporate buyer or corporate obligor on such obligation; (3) the institution of any proceeding in bankruptcy, receivership or insolvency against buyer; or against any obligor on any secured obligation or the institution by any party of action for attachment or similar process; (4) the issuance of execution process against any property of buyer or any such coobligor, or the entry of any judgment against buyer or any such coobligor, or any assignment for benefit of creditors or similar action adversely involving any such party; (5) any condemnation, levy, forfeiture or similar action against the goods or any part of them; (6) when seller shall in good faith and upon reasonable grounds believe that the prospect of performance of any obligation of buyer under this agreement, or of performance or payment of any obligation secured by this agreement, by buyer or any other obligor on them, is materially diminished; (7) the default by buyer under any other contract obligations, or installment sale security agreement between the parties to this security agreement.

8. Remedies on default. In the event of a default, or if seller or seller's assignee shall consider the payment of the balance of the installment payments insecure, seller shall have the right to: (1) obtain judgment for the amount of the installments delinquent under the contract plus interest at six % on such delinquent payments from due date and reasonable attorney's fees without prejudicing seller's right to subsequently obtain judgment for additional, or the balance of, the installments or to exercise other rights contained in this agreement or at its option, declare all unpaid installments and other moneys due or to become due under this contract immediately due and payable and to obtain judgment for the total amount of unpaid installments due plus interest of 6% on delinquent payments from due date and reasonable attorney's fees; (2) enter any premises and without breach of the peace take possession of the goods; and (3) exercise the rights on default of a secured party under the Uniform Commercial Code. Seller may require buyer to assemble the goods and make them available to seller at a place to be designated by seller which is reasonably convenient to seller and buyer. Seller shall have the right to take immediate possession of the goods wherever found, with or without legal process, and to sell or otherwise dispose of the goods. Unless the goods are perishable or threaten to decline speedily in value or are of a type customarily sold on a recognized market, seller will give buyer reasonable notice of the time and place of any public sale of the goods or the time after which any private sale or other intended disposition is to be made. The requirements of reasonable notice shall be met if such notice is mailed, postage prepaid, to the address of the buyer shown at the beginning of this contract or such other address of buyer as may from time to time be shown on seller's records, at least five days prior to such action. Buyer will pay any deficiency that may remain after exercise of such rights plus expenses of retaking, holding, preparing for sale, selling or the like, including seller's reasonable attorney's fees. All of seller's rights under this agreement are cumulative and no waiver of any default shall affect any later default.

9. Miscellaneous terms and provisions. (1) Loss or damage to the goods will not release buyer. (2) Repairs to the goods and equipment or accessories placed on the goods shall be at buyer's expense and shall constitute component parts of the goods, subject to the terms of this contract. (3) If any part of this contract is adjudged invalid, the remainder will not be invalidated by this. (4) Seller may assign this contract but buyer shall not. Seller's assignee shall have all of the rights, powers and remedies of seller but shall be subject to none of seller's obligations, and any right, remedy or authority conferred upon seller under this agreement shall upon assignment be deemed to be conferred upon seller's assignee, even though the term "seller" only is used in this agreement, and any notice to which seller is entitled shall be given to seller's assignee if buyer has notice of an assignment. (5) Buyer will not assert against any assignee of this contract any defense which buyer may have against seller. (6) If there be more than one signer of this contract, their obligations shall be joint and several and each specifically waive presentment or demand and agree that any extension or extensions of time of payment of this contract or any installment or part installment may be made before, at or after maturity by agreement with any one or more of the parties, and they waive any right which they may have to require the holder to proceed against any person. (7) This agreement will be governed by the laws of the State of _________, and all obligations of buyer shall bind h� heirs, executor, administrator or successors.

10. Warranty as to use. Buyer warrants that the goods are purchased for use primarily for personal, family or household purposes. If any of the goods described are now or are to become fixtures, the same are or will be affixed to the following described real estate: _________.

11. Exclusive statement of contract. This writing contains the full, final and exclusive statement of the contract between the parties and no agreement or warranty shall be binding on the seller unless expressly contained in it.

Executed in triplicate by buyer on the date written above, until the seller executes this contract it shall be considered an offer binding on buyer but not on seller. Upon execution of this contract by the seller by signature of the seller or seller's authorized representative this contract will be considered accepted by the seller. Buyer acknowledges receipt of a copy of this contract.

Witness the following signatures and seals:



Buyer _________









Buyer _________

Witness my hand and seal: _________ Company







By ________

Form: EXCLUSIVE RIGHT TO SELL

For and in consideration of your services to be rendered in listing for sale and in
undertaking to sell or find a purchaser for the property hereinafter described, the parties
understand and agree that this is an exclusive listing to sell the real estate located at:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________

together with the following improvements and fixtures:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________


The minimum selling price of the property shall be________________
dollars ($_______), to be payable on the following terms:
_______________________________________________________________
_______________________________________________________________


You are authorized to accept and hold a deposit in the amount of
______________________________________ dollars ($_______) as a deposit and to apply such deposit on the purchase price.

If said property is sold, traded or in any other way disposed of either by us or by
anyone else within the time specified in this listing, it is agreed to and understood that
you shall receive from the sale or trade of said property as your commission
____________________________ percent ( %) of the purchase price. Should said property be sold or traded within____ days
after expiration of this listing agreement to a purchaser with whom you have been
negotiating for the sale or trade of the property, the said commission shall be due and
payable on demand.

We agree to furnish a certificate of title showing a good and merchantable title of
record, and further agree to convey by good and sufficient warranty deed or guaranteed
title on payment in full.

The listing contract shall continue until midnight of ___________,
20____.




Date:___________________________________


_______________________________
Owner

_______________________________
Owner






I accept this listing and agree to act promptly and diligently to procure a buyer for
said property.



Date:________________________


_______________________________
Agent/Broker

Form: BILL OF SALE OF BUSINESS

For good and sufficient consideration, receipt of which is hereby acknowledged, the undersigned ___________________________ ("Seller") hereby sells, transfers and conveys to ___________________________("Buyer"):

1. All and singular, the goods and chattels, property and effects, listed in Schedule A annexed hereto, which is incorporated herein and made a part hereof; and

2. The whole of the good will of the ______________ business formerly operated by the undersigned which is the subject of this sale.

The undersigned warrants that said goods and chattels are free and clear of all encumbrances, that it has full right and title to sell the same, and that it will warrant and defend the same against the claims and demands of all persons. The undersigned hereby warrants and covenants that I shall not within _______ years of the date of this instrument engage in the business of ________________ within __________________.

Dated: ____________________________





_______________________________
Witness



_______________________________
Seller

Form: AGREEMENT TO SELL PERSONAL PROPERTY

AGREEMENT TO SELL PERSONAL PROPERTY

Purchase and Sell Agreement made by and between __________________ of _______________________(Seller), and _______________________________ of _______________________(Buyer).

Whereas, for good consideration the parties mutually agree that:

1. Seller agrees to sell, and Buyer agrees to buy the following described property:



2. Buyer agrees to pay to Seller and Seller agrees to accept as total purchase price the sum of $__________, payable as follows:

$________deposit herewith paid
$________balance payable on delivery by cash
$________bank per certified check

3. Seller warrants it has good and legal title to said property, full authority to sell said property, and that said property shall be sold by warranty bill of sale free and clear of all liens, encumbrances, liabilities and adverse claims of every nature and description whatsoever.

4. Said property is sold in "AS IS" condition, Seller disclaiming any warranty of merchantability, fitness or working order or condition of the property except that it shall be sold in its present condition, reasonable wear and tear expected.

5. The parties agree to transfer title on________________, 20____, at the address of the Seller.

6. This agreement shall be binding upon and inure to the benefit of the parties, their successors, assigns and personal representatives.

Signed this ______day of____________________, 20 ____.




______________________________ ______________________________
Witness Buyer



______________________________ ______________________________
Witness Seller

Form: Agreement to Sell Works of Art

Agreement to Sell Works of Art

The following constitutes the entire agreement with respect to the sale by ________________________________ [Buyer's full name] ("Buyer") of sculptures, drawings and graphics created by ________________________________ [Artist's full name] ("Artist"):

1. For a period of _________ years commencing on the date of this agreement, Buyer shall have the exclusive right, in any part of the world, to offer for sale and to authorize others to offer for sale, all items of art works created and owned by Artist. Artist shall initially deliver each such item of his work to Buyer at such location as may be designated by Buyer.

2. During the period of _________ years, Buyer shall have the exclusive right to arrange, and to authorize others to arrange, for the publication and/or sale, in any part of the world, of books and catalogues containing illustrated reproductions of the art work of Artist.

3. During the period of _________ years, Buyer shall arrange for exhibitions of Artist's works in the Cities of __________________, __________________ and such other places as the parties shall jointly determine. Buyer shall be responsible for all of the expenses of such exhibitions, including advertising and catalogue costs and insurance, and shall bear the entire cost of storing all items of Artist's work delivered to Buyer pursuant to this agreement.

4. The parties acknowledge that Artist has furnished to Buyer photographs of each item of Artist's works owned by Artist on the date of this agreement. The price at which Buyer shall offer each such item for sale shall not be less than the price set forth on the back of such photograph. The parties shall jointly determine the minimum sales price to be charged as to those art works to be created by Artist during the term of this agreement. Minimum prices may be changed from time to time in such manner as shall jointly be determined by the parties.

5. Upon the sale of any of the art works covered by this agreement, Buyer shall be reimbursed, from the actual net proceeds of sale, for any initial shipping cost advanced with respect to such item. In addition and as compensation for Buyer's services in effecting the sale of a particular work, Buyer shall be entitled to retain _____% of the balance of the net proceeds of the particular sale, as and for Buyer's commission for having effected such sale, with the remaining _________ percent of such balance, less any amounts otherwise due to Buyer under this agreement, to be paid to Artist on a quarterly basis.

6. This agreement shall be governed by and construed in accordance with the laws of the State of _________ and shall be binding upon and inure to the benefit of the respective executors, administrators, successors and assigns of the parties.

Dated _________.

Buyer:



________________________________
[Buyer's Signature]

________________________________
[Buyer's Printed Name]


Artist:



________________________________
[Artist's Signature]

________________________________
[Artist's Printed Name]

Form: AGREEMENT TO SELL BUSINESS

AGREEMENT TO SELL BUSINESS

Agreement made this _________day of _________, 20__ by and between ____________________ and _____________________ (doing business as _____________________) of ________________________ ____________________ (hereinafter referred to as "Seller") and _________________________________ (hereinafter referred to as the "Buyer").

Whereas the Seller desires to sell and the Buyer desires to buy the business of a certain _______________________ now being operated at ____________________________ and known as ______________________ and all assets thereof as contained in Schedule "A" attached hereto, the parties hereto agree and covenant as follows:

1. The total purchase price for all fixtures, furnishings and equipment is $___________ Dollars payable as follows: (a) $____________ paid in cash; certified or bank checks, as a deposit upon execution of this Agreement, to be held by ________________________. (b) $___________ additional to be paid in cash, certified or bank checks, at the time of passing papers. (c) $_________ to be paid by a note of the Buyer to the Seller, bearing interest at the rate of _____ percent per annum with an option of the Buyer to prepay the entire outstanding obligation without penalty. Said note shall be secured by a chattel mortgage and financing statement covering the property to be sold hereunder, together with any and all other property acquired during the term of said note and placed in or within the premises known as __________________________ ____________________.

2. The property to be sold hereunder shall be conveyed by a standard form Bill of Sale, duly executed by the Seller.

3. The Seller promises and agrees to convey good, clear, and marketable title to all the property to be sold hereunder, the same to be free and clear of all liens and encumbrances. Full possession of said property will be delivered in the same condition that it is now, reasonable wear and tear expected.

4. Consummation of the sale, with payment by the Buyer of the balance of the down payment and the delivery by the Seller of a Bill of Sale, will take place on or before ______________, 20__.

5. The Seller may use the purchase money, or any portion thereof, to clear any encumbrances on the property transferred and in the event that documents reflecting discharge of said encumbrances are not available at the time of sale, the money needed to effectuate such discharges shall be held by the attorneys of the Buyer and Seller in escrow pending the discharges.

6. Until the delivery of the Bill of Sale, the Seller shall maintain insurance on said property in the amount that is presently insured.

7. Operating expenses of _____________________ including but not limited to rent, taxes, payroll and water shall be apportioned as of the date of the passing of papers and the net amount thereof shall be added to or deducted from, as the case may be, the proceeds due from the Buyer at the time of delivery of the Bill of Sale.

8. If the Buyer fails to fulfill his obligations herein, all deposits made hereunder by the Buyer shall be retained by the Seller as liquidated damages.

9. The Seller promises and agrees not to engage in the same type of business as the one being sold for_______ years from the time of passing, within a __________ radius of ___________________________.

10. A Broker's fee for professional services in the amount of _________________($________) Dollars is due from the Seller to_________, provided and on the conditions that papers pass.

11. The Seller agrees that this Agreement is contingent upon the following conditions: (a) Buyer obtaining a Lease on the said premises or that the existing Lease be assigned in writing to the Buyer. (b) Buyer obtaining the approval from the proper authorities (Town and State) of the transfer of all necessary licenses to the Buyer. (c) The premises shall be in the same condition, reasonable wear and tear expected, on the date of passing as they are currently in.

12. All of the terms, representations and warranties shall survive the closing. This Agreement shall bind and inure to the benefit of the Seller and Buyer and their respective heirs, executors, administrators, successors and assigns.

13. If this Agreement shall contain any term or provision which shall be invalid or against public policy or if the application of same is invalid or against public policy, then, the remainder of this Agreement shall not be affected thereby and shall remain in full force and effect.

IN WITNESS WHEREOF, the parties hereto have caused this instrument to be executed in triplicate on the day and year first above written.

SELLER:



________________________________________________________

BUYER:



________________________________________________________

BROKER:



________________________________________________________

Living Will Declaration

LIVING WILL OF

_____________________________________


I, __________________________________________________, a resident of the City of ___________________, ________________ County, State of _____________, being of sound and disposing mind, memory and understanding, do hereby willfully and voluntarily make, publish and declare this to be my LIVING WILL, making known my desire that my life shall not be artificially prolonged under the circumstances set forth below, and do hereby declare:

l. This instrument is directed to my family, my physician(s), my attorney, my clergyman, any medical facility in whose care I happen to be, and to any individual who may become responsible for my health, welfare or affairs.

2. Death is as much a reality as birth, growth, maturity and old age. It is the one certainty of life. Let this statement stand as an expression of my wishes now that I am still of sound mind, for the time when I may no longer take part in decisions for my own future.

3. If at any time I should have a terminal condition and my attending physician has determined that there can be no recovery from such condition and my death is imminent, where the application of life-prolonging procedures and "heroic measures" would serve only to artificially prolong the dying process, I direct that such procedures be withheld or withdrawn, and that I be permitted to die naturally. I do not fear death itself as much as the indignities of deterioration, dependence and hopeless pain. I therefore ask that medication be mercifully administered to me and that any medical procedures be performed on me which are deemed necessary to provide me with comfort, care or to alleviate pain.

4. In the absence of my ability to give directions regarding the use of such life-prolonging procedures, it is my intention that this declaration shall be honored by my family and physician as the final expression of my legal right to refuse medical or surgical treatment and accept the consequences for such refusal.

5. In the event that I am diagnosed as comatose, incompetent, or otherwise mentally or physically incapable of communication, I appoint ______________________________ to make binding decisions concerning my medical treatment.

6. If I have been diagnosed as pregnant and that diagnosis is known to my physician, this declaration shall have no force or effect during the course of my pregnancy.

7. I understand the full import of this declaration and I am emotionally and mentally competent to make this declaration. I hope you, who care for me, will feel morally bound to follow its mandate. I recognize that this appears to place a heavy responsibility upon you, but it is with the intention of relieving you of such responsibility and of placing it upon myself, in accordance with my strong convictions, that this statement is made.

IN WITNESS WHEREOF, I have hereunto subscribed my name and affixed my seal at _______________, _______________, this _____ day of ____________, 20____, in the presence of the subscribing witnesses whom I have requested to become attesting witnesses hereto.



___________________________
Declarant




The declarant is known to me and I believe him/her to be of sound mind.


____________________________ _____________________________
Witness Address




____________________________ _____________________________
Witness Address




Subscribed and acknowledged, before me by___________________ __________________________, and subscribed and sworn to before the witnesses, on the _______day of ____________________, 20___.




____________________________ (SEAL) NOTARY PUBLIC

State of ___________________

My Commission Expires: ____________________________



Copies of this instrument have been given to:




Receipt and acknowledged & date:

Tuesday, December 12, 2006

How Backdating Helped Executives Cut Taxes

New evidence suggests that corporate executives may have found another way to manipulate their stock options, this time to cheat on their income taxes.

In a paper that began circulating in recent days, a Securities and Exchange Commission economist concludes there is strong statistical evidence that executives manipulated the exercise dates of their options as part of a tax dodge. And a review of corporate filings turns up some companies with startling options-exercise patterns.

The new information could open another front in the options-backdating scandal. Backdating already has sparked the broadest corporate-fraud probe in decades, with more than 130 companies under investigation by federal authorities. So far, attention has focused on the practice of retroactively selecting favorable dates to grant options. The new wrinkle involves rigging the dates on which options are exercised, sometimes years after they're granted.

The tax dodge related to options, however, almost certainly involves fewer executives than are caught up in the furor over the backdating of grants.

The reason it can be tempting to backdate the exercise of options lies in the way the Internal Revenue Service treats different types of income for tax purposes. Options, a common part of executive pay packages, give the recipient the right to buy a company's stock at a fixed price in the future. That price, known as the strike price, is usually the stock's market price on the day the options were granted.

About three-quarters of the time, executives immediately sell the shares they buy when they exercise options. Under IRS rules that typically apply, those executives must pay ordinary income tax, as well as payroll taxes, on the difference between the stock's value on the date the option was exercised and the option's strike price. The highest federal marginal income tax rate is 35%.

But for a variety of reasons, including corporate rules that require top managers to own a certain amount of stock, some executives don't sell immediately. Those who hold the shares for at least a year pay a much lower capital-gains tax -- currently 15% -- on any profit between the time they exercise and when they eventually dispose of the shares. That lower rate gives the executive an incentive to exercise the options at a relative low point for the stock: The move reduces the amount of money that would be owed at the ordinary income tax rate, and shifts the difference so it is potentially taxed at the much-lower capital gains rate.

Consider an executive who holds options on 100,000 shares with a strike price of $10. If he exercises and sells when the price is $20, he realizes $1 million in income and must pay $350,000 in income taxes.

If he instead can claim an exercise price of $16, he lowers his income tax to $210,000. If he then sells a year later and the stock is at the same price of $20, he pays $60,000 in capital-gains levies, for a total tax bite of $270,000. In other words, he has the same $1 million gain but saves $80,000 in taxes. The problem arises if the executive misrepresents when the exercise occurred to claim a lower exercise price.

Determining which executives or companies might be involved is difficult, and it's impossible to know what information they may have included in their tax returns. But some executives have exhibited unusual timing in their options exercises.

At Maxim Integrated Products Inc., a Sunnyvale, Calif., chip maker, chief executive John F. Gifford exercised options and held shares seven times between 1997 and 2002, according to regulatory filings and insider-trading data from Thomson Financial. In all but one case, Mr. Gifford's reported exercise date was the very day the stock reached its lowest closing price of the month. After the Sarbanes-Oxley corporate-reform law took effect in 2002, drastically reducing the opportunity to backdate by tightening reporting requirements, his fortunate timing vanished.

Maxim is facing investigations by the SEC and federal prosecutors in California over its option-granting practices. A special committee of directors is also probing the matter.

Chuck Rigg, a Maxim vice president, said the company is "looking into" questions about Mr. Gifford's options exercises, but said initial data don't indicate any problems. Mr. Rigg added that the company used an outside broker to handle options exercises. "There's not a way you can backdate that," he said. Mr. Gifford didn't respond to requests for comment.

At Royal Gold Inc., a Denver-based mining concern, Chairman Stanley Dempsey exercised options and held shares 12 times between 1997 and 2001, according to regulatory filings and Thomson data. Ten of those trades ostensibly came on a day when the stock was equal to its monthly low. The stock was thinly traded, and in some cases, there were several days each month when the stock closed at the same low price.

Academics have looked before at the issue of option-exercise timing, but studies were largely inconclusive. However, new research by SEC economist David Cicero suggests that some executives may have cut their income-tax burden by pretending their options were exercised on a prior day, when the company's stock was trading at a lower price. That would likely be a fraud under federal tax laws.

"The Cicero paper appears to be very well done," said David Yermack, a finance professor at New York University's Stern School of Business who has studied options issues. "It's strong evidence that executives were manipulating their exercise dates, similar to the way they were manipulating their award dates."

Mr. Cicero, who is also a doctoral candidate at the University of Georgia, examined more than 40,000 transactions between 1996 and 2005, and zeroed in on the subset of exercises in which the executive exercised and held on to the resulting shares.

The patterns he found in that subset are stark: Before the tightening of reporting requirements in 2002, shares on average fell 1.3% in the 20 trading days prior to the reported exercise date. In the next 20 days, they rose 4.8%. In other words, on average, executives were exercising options during a noticeable trough in the market price. After Sarbanes-Oxley, the phenomenon vanished.

Mr. Cicero wrote that the "striking stock price pattern" is "highly suggestive" of some type of timing, and said "backdating is difficult to rule out." Mr. Cicero didn't name any individual executives or companies.

He stressed in the paper, which is in draft form, that the views were his own, not those of the SEC.

An SEC spokesman, John Heine, declined to comment on the Cicero study. But he noted that the agency's enforcement director, Linda Thomsen, testified in a U.S. Senate hearing in September that the SEC is investigating exercise backdating as well as backdating of option grants.

Mr. Yermack said he also has been studying the issue, along with Erik Lie of the University of Iowa and Randall Heron, of the University of Indiana. Messrs. Lie and Heron are widely credited with the first academic research that suggested backdating of option grants could be widespread.

Although preliminary, their new research found that 13% of the exercises by CEOs who followed an "exercise-and-hold" strategy and didn't immediately report the actions to the SEC came at their stock's lowest price of the month. That percentage is nearly three times as great as would be expected if CEOs were exercising on random dates, Mr. Yermack said, and is highly suggestive that some were backdating exercises to avoid taxes.

The team of three professors also found that the phenomenon greatly diminished after Sarbanes-Oxley, which required executives to report option exercises to the SEC within two days. Before that, they had until the 10th day of the next month to report, which critics say provided a wide enough window to allow backdating to occur. The findings of a potential new options-fraud maneuver come even as Sarbanes-Oxley is coming under attack as being too harsh.

The phenomenon of option-exercise manipulation isn't new. An executive of Symbol Technologies Inc. pleaded guilty to tax-fraud charges in 2004 in connection with the practice, and Mercury Interactive Corp. has said former executives engaged in it. But it has largely remained under the radar as the scandal over option-grant backdating has snared headlines.

Alan L. Dye, a securities attorney at Hogan & Hartson LLP in Washington, said there are scant external checks to prevent backdating if an executive exercises an option and doesn't immediately sell the stock in the open market. "All the documentation is internal paperwork," he said. "Like any internal paperwork, unless good controls are in place, they can be misdated."

Michael D. Webb, the former CEO of EPIX Pharmaceuticals Inc., exercised options and held shares on 11 occasions between 1997 and 2002, according to filings and Thomson data. On six of those occasions -- including the last five in a row -- his reported exercise date corresponded to the lowest closing price of the month. The other five dates were also relatively favorable: Two on the second-lowest closing price of the month, and none any worse than the seventh-lowest.

Mr. Webb left EPIX, which is based in Cambridge, Mass., last year. In an interview, he said he wouldn't be able to answer any questions about his options timing without consulting transaction records, which he said he didn't have available. He declined to discuss how EPIX handled option exercises. A spokeswoman for EPIX declined to comment, citing "significant changes in management" that made it difficult to research past events.