Essay on Accounting Case 09-3

• In-licensing. One issue was whether to in-license compounds from a biotech company to diversify Sirtris’s drug development platform beyond its narrow focus on SIRT1, one of seven sirtuin variants in the human body. Several members of the Sirtris executive team were advocating a more balanced risk portfolio as the company started to increase investment in its drug development efforts. Partnership with Pharma. As is almost always the case in biotech, the team was in discussions about a partnership with a few large pharmaceutical firms. They were considering (a) what it would mean for the organization to become tied to a pharmaceutical company at this stage of its development and (b) whether to postpone a deal until Sirtris had more clinical data. Was this the right point in the company’s history to do a deal? Nutraceuticals. Sinclair received a near-constant stream of emails and phone calls from the public requesting Sirtris’s proprietary version of resveratrol, SRT501. For some time, he had contemplated selling SRT501 as a nutraceutical, an off-the-shelf health supplement that would not require FDA approval. This idea raised many questions about market opportunity, commercialization strategies, and the potential impact of a nutraceuticals offering on the Sirtris brand and

To balance these competing interests, Harvard agreed to receive an equity stake in the company, and Syndexa would pay Harvard a small up-front fee to license the patents that Hotamisligil had developed. For Syndexa one of the key parts of negotiations was centered on the research that the start-up intended to fund in Hotamisligil’s lab at Harvard. Harvard had major concerns with how the Syndexa-sponsored research will be separated from the other funds (government- or foundation-funded projects) that Hotamisligil receives. Harvard cannot funnel federally funded inventions to companies, however at the same time Syndexa was looking for assurance that they would have first crack at intellectual property for a technology that they funded. Another major issue extending negotiations was the conditions under which Syndexa would make royalty payments to Harvard for products that were not covered under Harvard patents, but discovered using Harvard technologies. To ensure that Harvard would receive a reasonable return on the patents it was licensing, Syndexa agreed to pay a small royalty rate if they developed a new therapeutic cure for diabetes using its Harvard license. Both parties agreed to the concept of an ‘identified product’, essentially a drug discovered through the use of patents, targets and assays being licensed from Harvard. Negotiations over what constituted an ‘identified product’ continued through the rest

In this case study, we deal with two separate agreements between SolvGen and Careway Pharma that are being audited for the possible sale of SolvGen to Direct Drugs, Inc. First, is the research and development agreement between SolvGen and Careway. And second, is the license and distribution agreement between the aforementioned. These agreements are both written and contractually binding and are within the scope of Multiple Deliverable Arrangements.

There are four components of Administrative Simplification Subsection/HIPAA (Gartee, 2011). The four identified components under “Title 2, subsection f” include: Transactions and Code Sets, Uniform Identifiers, Privacy, and Security (Gartee, 2011, pg. 71). “Health plans, clearinghouses, and healthcare providers” that are regulated in those four areas by HIPAA’s Administrative Simplification Subsection are considered to be covered entities (Gartee, 2011, pg. 71). Business associate agreements apply to the privacy and security components of the Administrative Simplification Subsection under HIPAA (Gartee, 2011). Most covered entities rely on other individuals or businesses for certain functions. These other businesses and individuals are referred

state where the suit is filed to warrant a jurisdiction. Since there is a non FDA approved chemical

1. The IASB proposes clarifying that the classification of liabilities as either current or non-current should be based on the entity’s rights at the end of the reporting period which are

Most health care providers such as doctors, psychologist, chiropractors, dentists, pharmacies, clinics, hospitals, health insurance companies, government programs such as Medicare and Medicaid, health care clearinghouses are all required to follow the HIPPA regulations and are referred to as covered entities. Business associates of the covered entity must also comply with the HIPPA regulation as they would have access to health

Due to the information, 20 acres of land equal 80 sheep according to the exchange rate of last year, a one-room cabin equal 3 acres of land and equal 12 sheep finally, a plow equals 2 goat and equal 2/3 sheep according to last year’s exchange rate and 2 carts which were traded with a poor acre of land equals 8 sheep plus 400 sheep. So Deyonne’s total assets are 500(2/3) sheep. Deyonne’s liabilities and assets deduction are 35 sheep plus 3 sheep, which will come to 38 sheep,

LAB Pharmaceuticals does not have enough capital to finance the testing of Davanrik, an antidepressant drugs that has potential side effects relating to obesity. LAB approaches Merck & Co., Inc. (Merck) and asks the company to license Davanrik, as well as funding the clinical testing. Merck must decide whether or not to bid to license Davanrik and if so, at what price.

Every organization has the opportunity to maximize their return by how they strategically fit themselves in their respective market place and by how they manage the internal assets to maximize their utilization. InVentiv Health is a Contract Research Organization (CRO) that provides support for commercialization, preclinical research, clinical research and clinical trials management within the pharmaceutical industry. InVentiv Health specializes in clinical trial services and offers their clients the expertise of moving an asset, drug or device through the FDA approval process, from conception to

Alien Gear could also go the route of licensing by allowing a host country to use their patient and make their product in that country. They would receive a portion of the sales and it would save them on production and transportation

to the NIMH, drug companies were not going to fund and test this drug unless there

Disco is obligated, via a “Development Agreement,” to engage Pharmco to perform all of Disco’s research, development, & clinical testing activities related to products under development.

Identification of device, drug, biologics, or combination product status and the appropriate regulatory classification and pre-market submission pathway in jurisdictions where the product will be marketed

This rule gives pharmaceutical companies the ability to create and define diseases in order to