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Top Articles - Contracts that Work - So Sue Me!
While music to a lawyer’s ears, at least to his wallet, this phrase should make every business person cringe. Litigation absorbs time and money, often astonishing amounts of both. Worse, it signals a major breach in what is presumably a valuable relationship. Wors
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
t of all, it means the business problem the contract was meant to address has not been solved. Instead of one problem and a plan to resolve it, you now have two, neither of which will add to your bottom line. Avoiding such a situation requires time, thought and som
; 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
effort, but all are a worthwhile investment if they produce a transaction that moves forward smoothly and efficiently.
Let’s explore some of the common causes of deal failure:
• The vendor is dishonest. (Customers may also be dishonest, but that raises issues out
Let’s explore some of the common causes of deal failure:
• The vendor is dishonest. (Customers may also be dishonest, but that raises issues out
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
side the scope of this essay.)
In some ways, this situation is the easiest to deal with. The more blatant the vendor’s misconduct, the easier it is to “pull the plug” and look for an alternative vendor. Time and money will still be lost, but the customer who acts
In some ways, this situation is the easiest to deal with. The more blatant the vendor’s misconduct, the easier it is to “pull the plug” and look for an alternative vendor. Time and money will still be lost, but the customer who acts
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
romptly will at least limit his or her losses. If the vendor is dishonest, but conceals it well, is incompetent yet earnest, customer may attempt to nurse the project along, allowing losses to mount. (Of course, a vendor who is honest but in over his head may event
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ally admit the fact and negotiate a buy out, thereby avoiding the need for either side to proclaim “So Sue Me.”)
• Happily, genuine vendor dishonesty is relatively rare. More frequently the parties have almost complete power to avoid contractual disputes simply by
• Happily, genuine vendor dishonesty is relatively rare. More frequently the parties have almost complete power to avoid contractual disputes simply by
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
negotiating and documenting their agreements thoroughly. That requires time and effort, and it requires each side to leave their comfort zone and ask “What will happen if things go wrong.” That question is contrary to the mindset deemed necessary to “do the deal.”
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
Negotiators are trained to be positive, to “get to yes” and NOT to rock the boat. But really making sure that the deal will work requires recognition that things can, and probably will, go wrong.
Problems fall into two general categories: the unforeseen and the unf
Problems fall into two general categories: the unforeseen and the unf
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
oreseeable. A good contract goes to great lengths to eliminate the unforeseen, and provides mechanisms to deal with the unforeseeable. “The unforeseen” is simply a polite name for “the overlooked.” Overlooking a key condition or a vital contingency is not a career
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
enhancing exercise. While there are no sure and certain guarantees against oversights, there are safeguards that can substantially reduce the exposure:
• Take your time.
Easier said than done in a world in which everything is needed yesterday. But which is more d
• Take your time.
Easier said than done in a world in which everything is needed yesterday. But which is more d
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
maging – a delay to get the project right or damage control when the project comes apart? Consider what a commitment to “first at all costs” did for General Custer.
• Do your homework.
o What needs to be done?
o When?
o By whom?
o What contingencies
• Do your homework.
o What needs to be done?
o When?
o By whom?
o What contingencies
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
must be addressed?
o HOW will they be addressed (and by whom)?
o Which project/product features are “must haves”?
o Are there key personnel who need to be identified?
o Are there target dates?
o Which of the targets are guideposts and which
o HOW will they be addressed (and by whom)?
o Which project/product features are “must haves”?
o Are there key personnel who need to be identified?
o Are there target dates?
o Which of the targets are guideposts and which
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
re central to successful completion?
o If there are no target dates, why not? After all, time is money.
o What is the business problem you are attempting to solve?
o What are your standards for success?
If you are not solving a specific and defined b
o If there are no target dates, why not? After all, time is money.
o What is the business problem you are attempting to solve?
o What are your standards for success?
If you are not solving a specific and defined b
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
usiness problem, or meeting a specific need, why are you spending time and money on the project?
If you cannot identify what will constitute success, why are you spending time and money on the project?
This brings us back to “take your time.” If the project is so
If you cannot identify what will constitute success, why are you spending time and money on the project?
This brings us back to “take your time.” If the project is so
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
ushed that its fundamental goals have not been defined, trouble may not be far off.
• Play “Devil’s advocate.”
o WILL this project solve the specified business problem?
o What CAN go wrong?
o How will you respond when things do go wrong?
It is tempting t
• Play “Devil’s advocate.”
o WILL this project solve the specified business problem?
o What CAN go wrong?
o How will you respond when things do go wrong?
It is tempting t
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
cut corners at this time. Planning to respond to problems is hard work. But failing to put in the necessary effort will simply invite one side or the other to proclaim, at the worst possible time: “So sue me!”
Even the most thorough and searching project plan ca
Even the most thorough and searching project plan ca
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
nnot anticipate all problems. Key personnel may leave abruptly. A third party’s product may not arrive on time, or may not work as promised. Management may cut the budget. Business changes may render the project unnecessary, or may require substantial revisions.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Enter the change control provisions, which can serve a number of useful purposes:
• Eliminate time wasted on finger-pointing
• Eliminate (or at least reduce) the possibility of one side taking undue advantage of the other
• Keeping the deal alive.
But did you inc
• Eliminate time wasted on finger-pointing
• Eliminate (or at least reduce) the possibility of one side taking undue advantage of the other
• Keeping the deal alive.
But did you inc
.
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
lude change control provisions in the contract? Did you specify:
• Who will respond when problems arise?
• Who is authorized to amend the agreement?
• A problem escalation procedure?
• A dispute resolution procedure?
• Cost controls?
• Spec
• Who will respond when problems arise?
• Who is authorized to amend the agreement?
• A problem escalation procedure?
• A dispute resolution procedure?
• Cost controls?
• Spec
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
fic buy-out or exit mechanisms?
Hard work? Yes.
Boring work? Sometimes.
Valuable work? Would you rather manage a portfolio of projects that run more or less smoothly and contribute to the bottom line or would you rather spend your days putting out fires
Hard work? Yes.
Boring work? Sometimes.
Valuable work? Would you rather manage a portfolio of projects that run more or less smoothly and contribute to the bottom line or would you rather spend your days putting out fires
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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