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You may be surprised to know that many companies in the US and UK do not put together a water tight contract when dealing with an overseas software services provide

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

r. Most of the agreements are done via email with little or no regard to important aspects such as dispute resolution, intellectual property rights, confidentiality

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

issues and employee infringement. If you plan to use an offshore provider soon, here are some basic tips on how to draw up a workable contract which safeguards the

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

nterests of both parties:

Define deliverables: Since software development is mostly intellectual work and has many grey areas in its definition, it is advisable to

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

define deliverables in a detailed fashion. This helps in making sure that the understanding of the work is clear on both sides and there is no miscommunication of a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

y kind with the supplier. You can also choose to define the change management process and the number of revisions allowed as it makes the deliverables more structur

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

d.

Mention the acceptance clause: What is good for the goose may not be good for the gander. Though an old saying, there is a huge amount of truth in it. Sometimes

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

the software services provider may consider the work completed whereas you might not accept it. Thus the goal or the premises on which the work will be accepted sho

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ld be clearly mentioned to both parties concerned.

Confidentiality rights on both sides: Sometimes companies get an NDA signed with the service provider and expect

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

it to hold true even when working on the project for a long time. This method is not advisable. A suitable contract must be drawn up in the case of ongoing work so

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

hat issues such as confidentiality of information are maintained by the service provider. Though some customers feel that their projects do not warrant such a claus

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e, the information exchanged may even be about the company, business or related information which has been given out unknowingly.

Employee Infringement: Approachin

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

a service provider's employee directly is one of the cardinal sins which can be committed by a client. Thus as a service provider, it is necessary that this clause

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

is mentioned in a contract. The opposite can also happen where the service provider may approach the client's personnel for indirect or direct gain. An employee inf

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ingement clause keeps a check on such practices and provides a legal route if there is substantial evidence of the infringement.

Force Majeure: The relatively rece

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

t natural calamities of the Tsunami and Hurricane Katrina have made it necessary for many large companies to seriously consider the Force Majeure clause. This is ne

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

essary to protect the interests of both parties.

Last but not least, pricing: This is probably the most common reason for arguments between a supplier and vendor a

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

d is applicable in all industries throughout the world. A clear mention of the total project pricing and milestones at which the charges will be paid should be incl

.

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

ded as an important schedule within the contract.

There might be other specific terms and conditions which may have been agreed by you and the supplier. These shou

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

d all be mentioned in the contract not only for the sake of posterity but also for ensuring continuity of work in case of personnel change in the supplier's company

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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