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Describe how each of the following differs concerning the three common forms of business ownership, (Sole Proprietorship, Partnership, and Incorporation):
Decision making
Raising money for start-up
Distribution of profits (or losses!)
Taxation

Discuss the advantages and disadvantages of doing business as a Sole Proprietorship, Partnership, Corporation and Limited Liability Company.

Indicate whether the following statement best describes a corporation, a sole proprietorship, or a partnership.

a. Liability is limited to the amount invested.

b. Unlimited personal liability.

c. Unlimited liability for oneself and one's partner's actions.

d. Ability to share work and risks of ownership without issuing shares.

e. Direct control by the owner.

f. Most difficult to organize.

g. Greater ability to secure funds from outside investors.

h. Accounts for largest sales receipts in the United States.

i. The most common form of business.

difference between limited and unlimited government

What is an Ivy League school? (p.47). What is the reputation of Ivy League schools and what sort of student is most likely to attend them? (Think about race and cultural background.)

Match the following study types to their definition below: case control study, randomized controlled trial, registry, Investigational Device Exemptions (IDE)

A.

B.

C.

D.

Prospectively comparing the outcomes of patients randomly assigned to be treated with a new device or procedure relative to a control group that may receive no treatment or standard treatment

A.

Case control study

A.

B.

C.

D.

Monitoring outcomes through a collection of cases performed in a real world, which may be accumulated either prospectively or retrospectively after a number of cases have been performed

B.

Registry

A.

B.

C.

D.

Retrospectively comparing the outcomes of a group of patients treated with a new device or procedure to a matched group receiving no treatment or a standard treatment

C.

Investigational Device Exemptions (IDE)

A.

B.

C.

D.

Allows a device to be used in a clinical study in order to collect safety and effectiveness data.

D.

Randomized controlled trial

Match the following terms to their definition below: continuation, evergreening, divisional, picket fence

A.

B.

C.

D.

A new patent application that claims a distinct or independent invention based upon pertinent parts carved out of the specification in the original patent

A.

Divisional

-

A.

B.

C.

D.

An application that is filed to pursue additional claims to an invention using the identical description or specification from the original patent

B.

Evergreening

-

A.

B.

C.

D.

A process of creating a series of secondary patents and claims that serve as a barrier to competitors

C.

Picket fence

A.

B.

C.

D.

A process of introducing modifications to existing inventions and then applying for new patents to protect the invention beyond its original 20-year patent term

D.

Continuation

Clinical trials can be designed to demonstrate that a new technology offers measurable, relevant benefits, in terms of safety, clinical effectiveness, and in some instances, cost-effectiveness

True

Or

False

A user-oriented approach to R&D, with formal mechanisms for incorporating user experience feedback and design input into product development, can directly help reduce clinical trial and commercialization risk.

True

Or

False

When it comes to using clinical data collected outside of the US to support a US regulatory submission, it’s important to understand that:

a. FDA expects clinical trial design and conduct to conform with relevant local regulations and applicable Good Clinical Practices

b. FDA looks critically at data obtained from foreign studies in terms of its applicability to the US patient population

c. FDA reserves the right to audit foreign clinical sites to confirm whether or not the data is valid for the purposes of obtaining an approval to market a device in the U.S

d. All of the above

As described in the textbook, all of the following statements about R&D are true except:

a. The R&D plan is where specific engineering activities are defined, and then matched to the personnel, resources, and timelines necessary to achieve them

b. Each R&D milestone should be broken down into the key technical challenges that must be overcome to achieve it

c. The process of achieving R&D milestones is iterative, not linear

d. R&D planning is one of the few activities within the biodesign innovation process that can be driven within a single function (i.e., engineering) rather than managed with cross-functional involvement

Trade secret protection can be an effective strategy in an environment where patent protection is weak, and it has the additional advantage of being consistently less expensive than patenting in both the short and long term.

True

Or

False

Lesson Obiectives

The paper should be 300-500 words

Conduct research and produce a presentation on a turning point in

American history before 1900.

Conduct historical research.

Explain the research process.

Cite source of where you got your information from.