There are 4 total questions. Please have complete and clear answers for the ques

There are 4 total questions. Please have complete and clear answers for the questions and support your answers to written questions w/ statutory law and cases. At least 3-5 page long answers is expected for the essay and 2-3 pages for short answer. Please submit the labeled answers with no plagiarism. All answers must be in your own words (ie: no third party text and no common answers). Answers consisting of third party material will not be acceptable (it is OK to reference a case or a regulation, but do not substitute it for the content of your answer). Include the references (in APA format) and regulations used for each question directly beneath the respective answer and not at the end of the document.
Question 1. (Essay) Describe and provide analysis on the outcome of the following case. In your description include the rulings and reasoning of the court, as well as the importance of the case:
Case C-319/05 Commission of the European Communities v/ Federal Republic of Germany [2007]ECLI:EU:C:2007:678 (30 Points)
Question 2. (Short Answer) Please describe the main purpose and importance of the Agreement on Mutual Recognition between the European Community and the United States. (15 Points)
Question 3. (Essay) Please describe, in your own words, the approval process and requirements for the 4U product manufactured by a German company. The medicinal product portion of the 4U product consists of a novel medicinal product that is a new active substance to treat diabetes. The medical device part is co-packaged with the medicinal product part. Each part of the product will be manufactured and sold in Germany. The company also plans to market and sell the product in France, Italy and Spain. The company will manufacture and sell the entire co-packaged product as set forth above. Include all applicable regulations and processes for the relevant types of product approval. (Also, identify all possible medicinal product pathways-even if they may not be applicable for this product). (40 points)
Question 4. (Short Answer) For the EU, please describe (a) the requirements for a product to qualify as an Orphan Medicinal Product; and (b) the incentives provided for Orphan Medicinal Products. Please be sure to include the requirements as well as incentives. (15 points)