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Advice Pool - NDAs - Review Checklist
NDAs (“non-disclosure” and “confidentiality” agreements) are documents commonly used to prevent unauthorized use of business information.
Disclosing important information to prospective customers, suppliers or investors is a common business dilemma, becaus
Disclosing important information to prospective customers, suppliers or investors is a common business dilemma, becaus
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
e:
- The “disclosing party” fears being “ripped off” - that the information will be used without compensation.
- The “receiving party” fears that it may have similar work underway and does not want to be accused of pirating someone's ideas.
What should y
- The “disclosing party” fears being “ripped off” - that the information will be used without compensation.
- The “receiving party” fears that it may have similar work underway and does not want to be accused of pirating someone's ideas.
What should y
; 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
u look for before signing a NDA?
1. Who are the parties?
The agreement should clearly identify the name, entity, address, and jurisdiction of the parties.
2. Is the agreement mutual?
Does the agreement cover both parties or does it only cover disclosure
1. Who are the parties?
The agreement should clearly identify the name, entity, address, and jurisdiction of the parties.
2. Is the agreement mutual?
Does the agreement cover both parties or does it only cover disclosure
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s by one party?
3. What is the purpose of the agreement?
The agreement should specify the purpose of the disclosure. Is it background information for the purpose of developing a business relationship? Is it part of another agreement?
4. What information
3. What is the purpose of the agreement?
The agreement should specify the purpose of the disclosure. Is it background information for the purpose of developing a business relationship? Is it part of another agreement?
4. What information
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 covered?
Confidential information is usually broadly defined to include “any and all information … whether oral or in writing.” It is important that information be marked “confidential” and that oral disclosures are reduced to writing and marked confiden
Confidential information is usually broadly defined to include “any and all information … whether oral or in writing.” It is important that information be marked “confidential” and that oral disclosures are reduced to writing and marked confiden
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tial in a timely manner.
5. What information is excluded?
NDAs exclude information that was already known prior to the date of the agreement if documented in written records; in the public domain; rightfully received from another source; or developed inde
5. What information is excluded?
NDAs exclude information that was already known prior to the date of the agreement if documented in written records; in the public domain; rightfully received from another source; or developed inde
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
endent of this disclosure as evidenced by written records.
6. What safeguards are required?
The agreement should specify procedures for protecting the confidential information. It should state under what circumstances it can be disclosed to employees or o
6. What safeguards are required?
The agreement should specify procedures for protecting the confidential information. It should state under what circumstances it can be disclosed to employees or o
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
ther parties.
7. What is the term of the agreement?
How long is the agreement effective? Is it one year? Three years? Or, is it of indefinite duration?
8. What are the termination provisions?
How is the agreement terminated? How is the confidential info
7. What is the term of the agreement?
How long is the agreement effective? Is it one year? Three years? Or, is it of indefinite duration?
8. What are the termination provisions?
How is the agreement terminated? How is the confidential info
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mation handled in the event of termination? Is it destroyed? Returned? How will it be accounted for?
9. What does it say about intellectual property rights?
Usually, NDAs specify that neither party acquires any intellectual property rights under the agree
9. What does it say about intellectual property rights?
Usually, NDAs specify that neither party acquires any intellectual property rights under the agree
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
ment, other than the limited rights to carry out the specified purpose. The agreement should say, “No right or license, express or implied, is granted in connection with any Confidential Information disclosed pursuant to this Agreement” and “No commercial u
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e is allowed without prior written consent.”
10. Does it address similar work in progress?
Sometimes NDAs say that each party acknowledges that the other is developing and acquiring similar technology and that “nothing in this agreement precludes the rece
10. Does it address similar work in progress?
Sometimes NDAs say that each party acknowledges that the other is developing and acquiring similar technology and that “nothing in this agreement precludes the rece
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
ving party from developing similar technology without obligation to the discloser provided it does not use the discloser’s confidential information.”
11. Does it address derivative work?
Sometimes NDAs say that in the event that either party develops new
11. Does it address derivative work?
Sometimes NDAs say that in the event that either party develops new
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
information or data as a result of the work carried out, “that party shall have the right to use or publish that new information, with the prior written consent of the other party.”
12. Is the existence of the agreement confidential?
Sometimes the agreeme
12. Is the existence of the agreement confidential?
Sometimes the agreeme
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
t specifies that neither party shall make any public announcement or disclosure of this agreement without the prior written consent of the other party.
13. Are there any warranties?
Usually a NDA says that the disclosing party is authorized to make the di
13. Are there any warranties?
Usually a NDA says that the disclosing party is authorized to make the di
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
sclosure, but that there are no other warranties.
14. What happens in the event of breach?
NDAs frequently call for “injunctive relief” in addition to any and all remedies at law. This means that a party can seek a court order prohibiting use of its infor
14. What happens in the event of breach?
NDAs frequently call for “injunctive relief” in addition to any and all remedies at law. This means that a party can seek a court order prohibiting use of its infor
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
ation in violation of the agreement. Unfortunately, for most business disputes, going to court is not an effective remedy because it is costly and the outcome is unpredictable. For business disputes, mediation and arbitration before a neutral party experien
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
ced in business matters is a faster and more cost effective way to resolve disputes.
15. Governing laws and jurisdiction?
If both parties are located in the same state, the choice of law and the location for the dispute resolution proceeding is easy. Freq
15. Governing laws and jurisdiction?
If both parties are located in the same state, the choice of law and the location for the dispute resolution proceeding is easy. Freq
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ently, however, the parties are located in difference states or countries and hence it can be contentious which law applies. To prevent one party from having the “home court advantage,” I recommend a “mutually inconvenient” location that is business friendl
.
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
y such as Delaware or the Netherlands.
In conclusion, how confidential information is disclosed is important. Sufficient information needs to be disclosed to persuade the other party to proceed. Disclosing too much information without protection is risky.
In conclusion, how confidential information is disclosed is important. Sufficient information needs to be disclosed to persuade the other party to proceed. Disclosing too much information without protection is risky.
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
isclosing too little information precludes the business relationship from progressing. Used effectively, NDAs protect information and facilitate business transactions. Used ineffectively, NDAs can confuse ownership rights and restrict business opportunities
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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