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Useful Advices - The Simple but Powerful Reasons for Corporate Minutes
Every year, many business owners choose to incorporate their companies. They may make this decision at the outset, or may arrive at it later because their business is growing and they want to shield themselves from the risks that growing businesses face. Either way, the business owners want to limit the extent to which
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
their personal assets are at risk, should something damaging (usually, a lawsuit) arise. It's a wise move.
What entrepreneurs often don't focus on, though, is the fact that, by incorporating, they have brought a new entity into the world. Much like giving birth to a child. The company now has an independent existenc
What entrepreneurs often don't focus on, though, is the fact that, by incorporating, they have brought a new entity into the world. Much like giving birth to a child. The company now has an independent existenc
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e that can, literally, outlive you. The company has needs separate and apart from yours (such as a need to be able to pay its own bills, in addition to paying you). And if you do not treat the corporation properly as an independent "being," the privilege of shielding yourself and limiting your personal liability can be tak
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
en away from you (as children, in certain extreme situations, can be taken away from their parents).
In order for a corporation - any corporation, no matter how large or small -- to preserve its special, limited liability status, it needs to observe certain formalities and take certain actions. These "formalitie
In order for a corporation - any corporation, no matter how large or small -- to preserve its special, limited liability status, it needs to observe certain formalities and take certain actions. These "formalitie
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s" include (among other things) issuing stock, electing officers and directors, keeping corporate records, adequately capitalizing the corporation, and clearly keeping personal and corporate funds separate. When a corporation doesn't do these things, its limited liability status is open and vulnerable to attack from cre
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ditors who may claim wrongdoing or fraud. In legalese, this is called "piercing the corporate veil."
Whew! Sounds like a lot, especially for a one-person corporation. At first, it seems a bit awkward and artificial. But it's not difficult. Think of keeping corporate records, having minutes of your "meetings" as merely the cor
Whew! Sounds like a lot, especially for a one-person corporation. At first, it seems a bit awkward and artificial. But it's not difficult. Think of keeping corporate records, having minutes of your "meetings" as merely the cor
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
porate form of "covering your @#%!" Minutes are also helpful when there is more than one owner of a company, so that there is a written summary of the discussion, the actions taken, and how the owners voted. In order to maintain your limited liability shield, it must be clear that the corporation has officially authorized i
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ts officers and directors to take significant actions on its behalf. How do you know when a corporation has done so? Because there are written minutes of a meeting (or ratifications of these actions), kept in the corporation's books!
What's Major? What's Ordinary?
So written records of major decisions are vital. B
What's Major? What's Ordinary?
So written records of major decisions are vital. B
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ut what kinds of issues are considered major? Celine moaned, "Does this mean I have to make a written record every time I go to Staples for pencils? Or take a potential client out to lunch?" Certainly not! Here's a general rule: if the transaction is the kind of transaction that your business engages in over and over as
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
its core business, then that transaction is "in the ordinary course of business" ("OCB", is the legalese acronym), and does not need to be documented. So Celine, who is a life coach, does not need to document each time she signs an agreement with a new client. Or Bob, a bookstore owner, does not need to write up minute
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s for each sale of a book off his shelves.
But there's a second part to the general rule. If the corporation's doing what it does is in the ordinary course of business, actions that enable the business to do what it does are not (in the ordinary course). These, by contrast, involve the major decisions that do need to b
But there's a second part to the general rule. If the corporation's doing what it does is in the ordinary course of business, actions that enable the business to do what it does are not (in the ordinary course). These, by contrast, involve the major decisions that do need to b
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e documented. They are often one-time (or only occasional) transactions. So Celine's paying $10,000 to create a website for her coaching business is not OCB. Yes, she may need to update the website periodically; she may even choose to completely overhaul it more than once; but once it's up, it's done. The website is not Celine
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
's core business: coaching is. The website is just an ancillary marketing tool. Similarly, Bob's hiring a contractor to renovate the store and put up bookshelves is not OCB. Once they're up, they're up.
What are other examples of major decisions or transactions that should be documented?
-Leases for, or subleas
What are other examples of major decisions or transactions that should be documented?
-Leases for, or subleas
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
es of, the business premises
-Significant contracts (often that involve an unusually large commitment of funds)
-Electing officers and directors of a corporation
-Taking out loans, obtaining credit lines, or getting other forms of financing for the business
-Joint ventures
-De
-Significant contracts (often that involve an unusually large commitment of funds)
-Electing officers and directors of a corporation
-Taking out loans, obtaining credit lines, or getting other forms of financing for the business
-Joint ventures
-De
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
signating corporate bank accounts, choosing your bank location and who is authorized to sign on the account
-Mergers, reorganizations, or transactions involving a bulk sale of much of the corporation's assets
-Providing benefits to employees
Where's the fun in all this?
First, learning to wri
-Mergers, reorganizations, or transactions involving a bulk sale of much of the corporation's assets
-Providing benefits to employees
Where's the fun in all this?
First, learning to wri
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
te good minutes is a terrific exercise in learning how to "get to the point." And that's the hallmark of a true professional. Minutes are not meant to be a painstaking transcript of every syllable uttered (indeed many comments are eminently forgettable)! Rather, distill the essence of each matter. What were the issues d
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
iscussed (1 to 2 sentences)? The significant points raised? Actions taken?
Second, meetings, and the minutes that result, are a wonderful occasion for you and your co-owners (if you have them) to relish your company's development. It's a time to get together, ideally, in a spirit of camaraderie, to hash out the important issu
Second, meetings, and the minutes that result, are a wonderful occasion for you and your co-owners (if you have them) to relish your company's development. It's a time to get together, ideally, in a spirit of camaraderie, to hash out the important issu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
es. If you're a sole owner, you can simply "ratify" the decisions that you make. But the very process of recording these items can give you a deeper understanding of the issues faced by your company along with the ability to focus on what's important.
Finally, meeting minutes are like a (summary) diary. And who doesn't
Finally, meeting minutes are like a (summary) diary. And who doesn't
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
enjoy the memories that leafing back over diary pages of the past bring up? Memories can be of challenging learning experiences - like the strategic alliance (or other relationship) that didn't quite pan out as planned. Or they can provide markers to your company's change and growth over time. In one year, you may see minutes
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
authorizing a loan for a significant equipment purchase. In the next year, you may have ratified a major contract, which you never could have contemplated had it not been for that equipment. Far from being a deadly chore, minutes can give you that very boost of encouragement you need to keep moving your company forward
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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