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Answers - Financial Directive - Advanced Estate Tax Planning, Power of Attorney Issues
I recently wrote about the absolute need for a Medical Directive granting the “exclusive power” to your Agent for the purpose of communicating your healthcare wishes and to instruct those in charge of your medical care and to respond to the actual facts and variables known when an actual healthcare decision needs to be made. Your Medical Directive becomes effec
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
tive, when:
1. You cannot communicate your own wishes for your medical care:
A. Orally, B. In writing, or C. Through gestures, and
2. You are diagnosed to be close to death from a terminal condition, or to be permanently comatose, and
3. The medical personnel attending to your care are notified of your written directions.
WHAT IS A FINANCIAL DIRECTIVE?
1. You cannot communicate your own wishes for your medical care:
A. Orally, B. In writing, or C. Through gestures, and
2. You are diagnosed to be close to death from a terminal condition, or to be permanently comatose, and
3. The medical personnel attending to your care are notified of your written directions.
WHAT IS A FINANCIAL DIRECTIVE?
; 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
To summarize, a “Medical” Directive is a legal Instrument addressing the issue(s) of your healthcare and a “Financial” Directive is legal financial Instrument that empowers your Agent over all your financial matters and to exercise or perform any act under a recognized “Principal / Agent” relationship, with power, duty or right of any obligation whatsoever ove
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
r everything that you now presently have or may thereafter acquire in the future, relating to any person, matter, transaction or property, real or personal, tangible or intangible, now owned by you or thereafter acquired by you, including, without limitation, general powers and specifically enumerated powers as to each possible event or circumstances.
In order
In order
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
for your Financial Directive to be legally binding on all third parties, the third parties so notified of your Principal/Agent relationship, your instrument must be in writing, properly witnessed or notarized with power to indemnify all those who accepted it in good faith.
Your Financial Directive should grant your Agent full power and authority to do everyth
Your Financial Directive should grant your Agent full power and authority to do everyth
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ng necessary in exercising any of the powers as fully as you might or you could do if you were personally present, with full power of substitution or revocation, ratifying and confirming all that your Agent may lawfully do or cause to be done by virtue of your Financial Directive.
ESSENTIAL ESTATE TAX PLANNING: THE FINANCIAL DIRECTIVE
A Financial Directive sh
ESSENTIAL ESTATE TAX PLANNING: THE FINANCIAL DIRECTIVE
A Financial Directive sh
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
ould be part of your estate tax planning.
Your Financial Directive Instrument should address the following general powers and specifically enumerate those powers as to each possible event or circumstance:
1. Demand, receive, and obtain by litigation or otherwise, money or other thing of value to which the Principal is, may become, or claims to be entitled, an
Your Financial Directive Instrument should address the following general powers and specifically enumerate those powers as to each possible event or circumstance:
1. Demand, receive, and obtain by litigation or otherwise, money or other thing of value to which the Principal is, may become, or claims to be entitled, an
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
d conserve, invest, disburse, or use anything so received for the purposes intended.
2. Contract in any manner with any person, on terms agreeable to the Agent, to accomplish a purpose of a transaction, and perform, rescind, reform, release, or modify the contract or another contract made by or on behalf of the Principal.
3. Execute, acknowledge, seal, and de
2. Contract in any manner with any person, on terms agreeable to the Agent, to accomplish a purpose of a transaction, and perform, rescind, reform, release, or modify the contract or another contract made by or on behalf of the Principal.
3. Execute, acknowledge, seal, and de
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
liver a deed, revocation, mortgage, lease, notice, check, release, or other instrument the Agent considers desirable to accomplish a purpose of a transaction.
4. Prosecute, defend, submit to arbitration, settle, and propose or accept a compromise with respect to a claim existing in favor of or against the Principal or intervene in litigation relating to the cl
4. Prosecute, defend, submit to arbitration, settle, and propose or accept a compromise with respect to a claim existing in favor of or against the Principal or intervene in litigation relating to the cl
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
aim.
5. Seek on the Principal's behalf the assistance of a court to carry out an act authorized by your Financial Directive Instrument.
6. Engage, compensate, and discharge an attorney, accountant, expert witness, or other assistant as it becomes necessary or relevant to principal objective(s).
7. Keep appropriate records of each transaction, including an ac
5. Seek on the Principal's behalf the assistance of a court to carry out an act authorized by your Financial Directive Instrument.
6. Engage, compensate, and discharge an attorney, accountant, expert witness, or other assistant as it becomes necessary or relevant to principal objective(s).
7. Keep appropriate records of each transaction, including an ac
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ounting of receipts and disbursements.
8. Prepare, execute, and file a record, report, or other document the Agent considers desirable to safeguard or promote the Principal' s interest under a government statute or governmental regulation.
9. Reimburse the Agent for expenditures properly made by the Agent in exercising the powers granted by this Instrument.
8. Prepare, execute, and file a record, report, or other document the Agent considers desirable to safeguard or promote the Principal' s interest under a government statute or governmental regulation.
9. Reimburse the Agent for expenditures properly made by the Agent in exercising the powers granted by this Instrument.
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
10. In general, do any other lawful act with respect to the subject at hand.
WHEN DOES YOUR FINANCIAL DIRECTIVE BECOME EFFECTIVE?
Your Financial Directive becomes effective when you are considered disabled or incapacitated.
For purposes of your Financial Directive Instrument, "disabled or incapacitated" means when a physician certifies in writing at a date l
WHEN DOES YOUR FINANCIAL DIRECTIVE BECOME EFFECTIVE?
Your Financial Directive becomes effective when you are considered disabled or incapacitated.
For purposes of your Financial Directive Instrument, "disabled or incapacitated" means when a physician certifies in writing at a date l
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
ater than the date of your Instrument was executed that, based on your physician's medical examination of you, your doctor declares you mentally incapable of managing your financial affairs.
Your Financial Directive should have a paragraph to “legally authorize your/the physician” who examines you to disclose your physical or mental condition to another person
Your Financial Directive should have a paragraph to “legally authorize your/the physician” who examines you to disclose your physical or mental condition to another person
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
for validation. You may even authorize a second physician for a second opinion. Subsequent to this verification and disclosure of your incapacitated condition, a third party that accepts your Financial Directive is fully protected from any action taken.
FINANCIAL DIRECTIVE COMPARED TO GENERAL POWER OF ATTORNEY
I am reminded of cases where the spouse is precl
FINANCIAL DIRECTIVE COMPARED TO GENERAL POWER OF ATTORNEY
I am reminded of cases where the spouse is precl
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
uded to sit in important business meetings of which her temporarily incapacitated husband was a member, and decisions were being made affecting her husband’s interest in the business. While a general power of attorney may have been sufficient, but more likely would have required further court action. The Financial Directive is a significantly stronger Instrumen
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
then a general power of attorney, and would have specifically addressed issues concerning the spouse’s ability to sit and vote with the Agent, in decisions affecting the business, and more specifically her ownership interest in the business, with ability to bring in professional assistance to consult with her on such important matters.
CAUTIONARY PROVISIONS W
CAUTIONARY PROVISIONS W
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
ITHIN YOUR FINANCIAL DIRECTIVE YOU WOULD NOT WANT YOUR AGENT TO HAVE
While we have enumerated the specifics of the powers to your Agent, there are some powers you would not want your Agent to have:
1. Your Agent cannot execute a will or codicil on your behalf.
2. Your Agent cannot execute any trust on your behalf; however, your Agent can enter into a custodi
While we have enumerated the specifics of the powers to your Agent, there are some powers you would not want your Agent to have:
1. Your Agent cannot execute a will or codicil on your behalf.
2. Your Agent cannot execute any trust on your behalf; however, your Agent can enter into a custodi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
al agreement with another “independent” individual or bank with trust powers.
3. Your Agent cannot divert your assets to himself [or herself], his [or her] creditors or his [or her] estate.
4. Your Agent shall not exercise, and shall not be vested with any incidents of ownership as to insurance policies insuring your life and shall have no power and no author
3. Your Agent cannot divert your assets to himself [or herself], his [or her] creditors or his [or her] estate.
4. Your Agent shall not exercise, and shall not be vested with any incidents of ownership as to insurance policies insuring your life and shall have no power and no author
.
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
ity over life insurance policies you may own on your Agent's life.
5. Your Agent is your FIDUCIARY, possessing no general or limited power of appointment.
6. Your Agent shall not exercise any powers which you received from your Agent in a fiduciary capacity, and your Agent shall have no authority to exercise any powers, the exercise of which would cause any o
5. Your Agent is your FIDUCIARY, possessing no general or limited power of appointment.
6. Your Agent shall not exercise any powers which you received from your Agent in a fiduciary capacity, and your Agent shall have no authority to exercise any powers, the exercise of which would cause any o
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
f your assets to be considered as taxable in your Agent's estate for the purposes of the federal estate tax or the inheritance tax.
Your Agent shall have NO Power to void or modify any portion of your Financial Directive in any way whatsoever. Only the Principal may revoke or amend by written notice to all parties and only by certified mail with return receipt
Your Agent shall have NO Power to void or modify any portion of your Financial Directive in any way whatsoever. Only the Principal may revoke or amend by written notice to all parties and only by certified mail with return receipt
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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