Показаны сообщения с ярлыком licensing. Показать все сообщения
Показаны сообщения с ярлыком licensing. Показать все сообщения

суббота, 21 марта 2015 г.

Starting a Business in New York: The Licensing Requirements

Starting your own business can be a fulfilling and rewarding endeavor, but it also comes with administrative and legal hassles. Apart from correctly incorporating your business, hiring employees, protecting intellectual property and developing marketing, there are a number of logistical considerations you must also address to begin conducting business.
Starting_a_Business_in_New_York_The_Licensing_Requirements2

5 Licenses and Permits You Need to Conduct Business in New York

One of these is obtaining the necessary licenses and permits. If State or Federal Authorities require documentation to conduct your business operations, failure to comply with such regulations presents exposure to heavy fines.
This post covers the five licenses and permits you will most likely need to conduct business in New York.

Permit to Conduct Business

Starting_a_Business_in_New_York_The_Licensing_Requirements1In New York, as in any other state, you will need to register with the State in order to legitimately conduct business. Registering your business requires you to make several long-term decisions impacting your business, and therefore requires significant consideration. For example, at the time of registration you must decide on your name (affecting future possible trademark disputes) and the structure of your entity (affecting taxation and future investment potential). Depending on the structure of your entity, you will need to register with either the NY Secretary of State (Corporations, Limited Partnerships and Limited Liability Companies), or the County Clerk’s Office (Sole Proprietorships and General Partnerships). If your corporation is incorporated elsewhere, say Delaware, to conduct business in New York, you will need to file for a foreign (out-of-state) business license with the New York State Department of State.

Employment associated filing requirements

Starting_a_Business_in_New_York_The_Licensing_Requirements3Before you hire your first employee, you will need to acquire an Employer Identification Number (EIN) from the Internal Revenue Service (IRS). The EIN is a 9-digit number that lets the IRS keep track of tax accounts of various business entities. If you form a corporation, partnership, or intend to hire employees other than yourself, then an EIN number is a requirement. Your corporate attorney can help determine whether or not you need an EIN and when and how to apply for one.

Sales Tax License

If your business is selling certain specified goods and services in New York State, you will be required to register with the Tax Department to obtain a Certificate of Authority from the State. The Certificate of Authority permits you to collect sales tax from your customers on each sale.
The requirements to pay sales tax depend on the kind of activity your business conducts. While different states vary on sales tax regulations, generally, you must collect sales tax on most tangible goods and services delivered to consumers in a state where you have a physical presence. Some typical exceptions to the general rule include: products for re-sale, wholesale products, prescription drugs, raw materials, and agricultural products.
In New York, the physical presence requirement includes having “affiliated persons” who solicit business, make deliveries, or have an interest in the business. This so-called “Amazon tax" is being implemented on a state-by-state basis in order to require e-commerce companies to collect sales tax. The divided state approaches make it difficult for e-commerce companies to navigate the patchwork of regulation, so make sure to consult a lawyer to ensure compliance.
 You must register with the New York Tax Department at least 20 days before you begin business. It is important to note that conducting business without registering could result in a fine of up to $10,000.

Local zoning requirements

Starting_a_Business_in_New_York_The_Licensing_Requirements4Local zoning requirements are important when it comes to purchasing property for your business or altering the use of a pre-existing property. New York has three zoning districts: Residential, Commercial and Manufacturing. Depending on the nature of your business, you must ensure that the space you work out of falls under the relevant zoning district. Typically, the person constructing a building will need prior approval from the Department of Buildings, so you should ideally confirm with the Seller or Lessor of the property that it is compliant.

Federal Licenses and Permits

When a small business’s product or service is regulated by a federal agency, it will be required to obtain a federal license or permit. Your business will need a federal permit or license to operate within these sectors. A few examples include: Alcoholic beverages, Agriculture, Transportation and Logistics, and Radio and Television. A different regulator controls each sector, and therefore the application process also varies by sector.
It is important to manage, comply with and maintain your licenses. As a best practice, keep copies of all your permits and mark dates for renewals. Many licenses and permits may have accompanying rules and obligations.

пятница, 13 июня 2014 г.

LARGE AND IN CHARGE VS. SMALL BUT MIGHTY – WHO MAKES A BETTER LIFE SCIENCES LICENSING PARTNER?



Given deal-making’s importance in this market environment, and the diverse roles of the panel members, the topic of who makes the better deal partner was bound to lead to a very spirited and informative discussion during the Allicense 2014 conference, last month in San Francisco. With more and more deals getting done in order to fill gaps in pipelines, create therapeutic franchises, and form new companies, the importance of picking the correct partner has never been more important.

Beginning with the hypothesis that smaller, specialty pharma players are actively doing more deals, and as a result, beginning to take significant “market share” away from big pharma, two macro discussions began to take shape: Who makes the better partner for getting a deal done vs. after a deal gets done, and overall reasons for doing a deal, financial engineering vs. innovative science.

In picking a partner, efficiency of being able to complete a deal was a major topic of discussion. Jeff Jonker, Senior Vice President at Theravance, believes that the smaller the company, the quicker it is able to act, and the more likely it is to move on an opportunity on which big pharma might pass. He also attributes specialty pharma’s ability to act quicker than their counterparts, due in part to a lack of imagination in big pharma companies. Contrarily, Graham Brazier, VP of Business Development at Bristol-Myers Squibb, and George Golumbeski, SVP of Business Development at Celgene, took similar positions on the other side of the aisle, each summarizing that they come across so many inbound opportunities, day in and day out, that even if they didn’t perform any outreach, they still wouldn’t miss a potential deal. However, Brazier did concede that, while they would not miss any opportunities, in specific cases, they may come to the table later than a potential specialty competitor. Natalie Holles, SVP of Business Development of Hyperion Therapeutics, agreed with both camps, commenting that big pharma can move quickly when there is an internal champion who wants to get a specific deal done, but absent of that internal champion, a ton of opportunities are created for specialty pharma buyers.

Once the ink dries, and a deal is done, the new partner must be able to execute on the potential value and collaboration created between the two parties. It is vital to pick a partner that you believe can best help realize the contingent value, especially given the increasing number of deals structured with downstream economics. Once again, two differing positions emerged between the panelists. James Mackay, President & COO, Ardea Biosciences and Global Product Vice President of AstraZeneca, Lesinurad, believes partnering with the correct big pharma company is the best of both worlds. Mackay commented that allowing the smaller partner to operate as it always has, but with big pharma’s influence and resources, makes for a perfect marriage. Jonker shared his own company’s model as a point of agreement with Mackay, saying that Theravance is attempting to get bigger by getting smaller. Theravance is splitting into two arms, one taking over their assets obtained through a GSK alliance, and the other controlling assets discovered through internal R&D efforts. Perhaps the best example of the big/”small” alliance is Roche’s acquisition of Genentech. This monster acquisition still allowed both sides to maintain their autonomy, and is widely seen as one of the most successful biopharma acquisitions of all times.

Making an argument for the specialty player, Natalie Holles debated that if specialty pharma truly believes in the science behind a deal, this class of players is more willing to focus on making the deal work. Often times specialty companies have fewer products, and are thus forced to fully back an idea in order to survive. Gary Phillips, SVP and Chief Strategy Officer of Mallinckrodt Pharma, argued that it is harder for larger companies to realize value created in future activities/milestones, because of their slower, more conservative nature.

The second debate emerged from the topic of motivation behind completing an acquisition. The specialty side of the aisle claims that big pharma is currently only acquiring companies for the sake of financial engineering, not for exciting science, while big pharma stands strong in saying that breakthrough science is still the driver for doing deals.

This is an especially hot topic, due to Pfizer’s desire to purchase AstraZeneca, which many believe is for the tax benefits from an inversion into a foreign parent, and has nothing to do with pipeline value. Gary Phillips hypothesized that the current state of the market is the main driver behind the trend towards financially engineered deals, and that this trend is here to stay. Cheap debt and tax domiciles are creating opportunities to leverage lower tax rates in foreign countries and minimize G & A expenses. While this is good for the financial well-being of pharma companies, many worry that this motivation is not healthy for the long-term outlook of drug development. George Golumbeski mentioned that investing in innovation is the most defining consideration, but this is harder to do in large pharma, where there is currently so much emphasis on financial wizardry. With the focus away from innovative science, this leaves the door wide open for specialty pharma to take advantage of opportunities that otherwise would not be available. Overall, it may not be the intent of big pharma to focus on cost cutting, but with smart leaders at the helm and advantageous financial opportunities across the globe, the market is forcing their hand.

Like so many other “whom is better than whom” debates, the final answer to the question of who makes the best partner in deal-making really comes down to “it depends”. If the market for a specific drug or company is so complex and large that only big pharma has the scale to accommodate it, then maybe they make more sense. On the flip side, if a specialty, single product company has extensive knowledge in a therapeutic area, with natural synergies, and their survival depends on putting the full efforts of the company behind a deal being successful, they may be the correct partner. One thing is certain, in an industry that relies so heavily on completing deals, selecting the correct partner can be the difference between a drug making it to market and collecting dust on the shelf.

Check out the video that kickstarted the Allicense 2014 conference:

https://www.youtube.com/watch?v=c706k-JKntw#t=74