• Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property

  You are a new associate at the law firm of Dewey, Chetum, and Howe. John, a former researcher at PharmaCARE, comes to your office. He has concerns about PharmaCARE’s use of AD23, one of the company’s top-selling diabetes drugs. Two (2) years ago, after PharmaCARE’s research indicated that AD23 might also slow the progression of Alzheimer’s disease, John and his team of pharmacists began reformulating the drug to maximize that effect. In order to avoid the Food and Drug Administration’s (FDA) scrutiny, PharmaCARE established a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy to sell the new formulation to individuals on a prescription basis. CompCARE established itself in a suburban office park near its parent’s headquarters. To conserve money and time, CompCARE did a quick, low-cost renovation.

  CompCARE benefited from PharmaCARE’s reputation, databases, networks, and sales and marketing expertise, and within six (6) months had the medical community buzzing about AD23. Demand soared, particularly among Medicare, Medicaid, and Veterans Affairs patients. Seeing the opportunity to realize even more profit, CompCARE began advertising AD23 directly to consumers and marketing the drug directly to hospitals, clinics, and physician offices, even though compounding pharmacies are not permitted to sell drugs in bulk for general use. To circumvent this technicality, CompCARE encouraged doctors to fax lists of fictitious patient names to CompCARE. PharmaCARE sold CompCARE to WellCo, a large drugstore chain, just weeks before AD23 was publicly linked to over 200 cardiac deaths.

  As CompCARE and its new parent company enjoyed record profits and PharmaCARE’s stock price approached $300 per share, reports started surfacing that people who received AD23 seemed to be suffering heart attacks at an alarming rate. The company ignored this data and continued filling large orders and paying huge bonuses to all the executives and managers, including John, whose wife recently died from a heart attack after using AD23.

  John has come to you with an internal company memo describing the potential problems with AD23, and information describing the company’s willingness “roll the dice” and continue to market the drug.

  Your senior partner has asked you to write a memo outlining the following issues for review by the senior partners.

  Write an eight to ten (8-10) page paper in which you:

1.    Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCARE violated any of the issues in question.

2.    Argue for or against Direct-to-Consumer (DTC) marketing by drug companies. Provide support for your response.

3.    Determine the parties responsible for regulating compounding pharmacies under the current regulatory scheme, the actions that either these parties or the FDA could / should have taken in this scenario, and whether PharmaCARE could face legal exposure surrounding its practices. Support your response.

4.    Analyze the manner in which PharmaCARE used U.S. law to protect its own intellectual property and if John has any claim to being the true “inventor” of AD23. Suggest at least three (3) ways the company could compensate John for the use of his intellectual property.

5.    Summarize at least one (1) current example (within the past two [2] years) of intellectual property theft, and examine the effect on that company’s brand.

6.    Analyze the potential issue surrounding the death of John’s wife and other potential litigants against PharmaCARE as a result of AD23.

7.    Specify both the major arguments that John can make to claim that he is a whistleblower and the type of protections that he should be afforded. Justify your response.

8.    Use at least three (3) quality resources in this assignment. Note: Wikipedia is not an acceptable reference and proprietary Websites do not qualify as academic resources.

I will be off line till after 8 PM EST July 9th.  Please review the essay requirements below.  Please provide a short sample of your APA style for section 1 only and then we can discuss price and deadlines.

This course requires the completion of a comprehensive Strategic Plan.

You have a choice to use either an existing company or a fictitious company. In either case, the Project is to complete a written plan that will suggest a practical Strategic Direction for the company.

The Plan will have 7 sections. The 6 sections will reflect each of the 6 TCOs plus a bibliography. Each section will be 2 – 3 pages in standard business proposal format.

The sections are:

1.        Strategy – In this section, you should describe what “SHOULD” be the strategy of a technologically driven company. You should focus specifically on the technology strategy. You should think about all the things we learned in the class that will determine a strategy that will help the company succeed.

Remember that you can use either an existing company or a fictitious company. If you choose to use an existing company, you can visit their web site to see if their strategy is listed. Or you can do a web search on their technology strategy to see if anyone has written any stories about their strategy. For a fictitious company, you should make up a technology strategy that fits that type of company.

Examples of a Technology Strategy:

• Verizon Wireless – Have the best network of all wireless carriers
• Honda – Build the best engines
• Intel – Have the fastest and most powerful CPUs

2.       Core Competencies  – Given an organizational and industry context, identify the core technological competencies of the organization.  Like all subsequent sections of the project, this section is based on the Strategy Section.

Example:  Verizon Wireless Strategy is the having the best Network. Thus, the core competencies will be built around the network. Things like RF Engineers and wireless security experts would be detailed

1. Industry Dynamics  –  Here you should take the strategy identified in Section 1 and describe in detail why that is the right strategy based on what is occurring in the industry. Provide as much detail as possible as to the industry trends and why you think those trends are important

4.       Technology Sourcing and Internal Innovation   –  Given an organizational context, develop a plan to increase the innovative capabilities of the organization both through collaboration strategies and internal innovation.

Here you would offer ideas as to what is the best way to “Source” the technology that supports the strategy. A complete discussion about how best to manage the innovative capabilities of the company being described is required.

5.       Product Development Strategy Given information about a company’s industry, and organization, formulate a technological innovation strategy through its new product development strategy.

Product Development is very important to an organization. This section will describe how the company will structure its product development. Obviously, the kind of structure will be determined directly by the technology strategy stated in Section 1.

6.       Strategy to protect innovations  – Given a company situation be able to determine whether and how to protect its technological innovations.

Using the things learned in the class, describe how you would use patents, trade secrets, copyrights, etc. to protect the Intellectual Property (IP) required to support the strategy.

1. A bibliography listing your references for the project

With the help of your CFO, you have put together the following preliminary budget figures based on last year’s numbers for a planned production and sales level of 4,000 units per year: 

You are planning for the future and working on a report based on data from last year’s actual performance. You are going to use the breakeven formula to determine the businesses breakeven point and to answer some important questions regarding your data. 

Using only the data from last year’s actual performance write a report answering the following questions:

1. Which of these 8 cost categories would be considered variable, and which fixed, and explain why?
2. Which costs would be considered mixed (i.e., semi-variable or semi-fixed)?
3. Ignoring utility costs altogether, compute the contribution margin per unit, in dollars and in percentage and the breakeven level of sales?
4. Ignoring utility costs altogether, if instead of breaking even, the firm wants to make $10,000/month profit, answer the following:
   • How many units must be sold each month?
   • To how many sales dollars is this unit volume equivalent?
5. In year 2, the CEO plans to add $300,000/yr. expense in added administrative salaried headcount. Ignoring utility costs altogether, how many additional units must be sold just to pay for this added expense?

Show ALL calculations.

The following rubric will be used for grading:

Go to this link to download your SAP Gui for your home computer

https://www.dropbox.com/sh/alarbj8qemjnxzz/m84-a2DvNm

Will send login information after handshake agreement

On Assignment 04-02 only half of it has to be done for me to recieve full credit.

PLEASE DO NOT ACCEPT ASSIGNMENT IF YOU CANNOT COMPLETE IT……