Useful Advices - Business

MEANING

Where the right of ownership in the goods is transferred from the seller to the buyer the contract is called a sale. For example: n 1st August X sells 5 bags of sug

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

ar to Y for a sum of Rs.1000/-. This transaction if called a sale since the ownership of 5 bags of sugar is transferred from X to Y. WHAT IS MEANT BY AN AGREEMENT TO SELL?

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

Examples of combination products may in

Where the transfer of ownership in the goods is to take place at a future time or subject to some conditions there after to be fulfilled the contract is called an agreement t

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

sell. For example: On 1st August X and Y agree that X should sell 5 bags of sugar to Y on 15th August for a sum of Rs.1000/-. It is an agreement to sell, since X agrees 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

transfer ownership of the 5 bags of sugar to Y in future on the 15th. In other words, the date of agreement is 1st August. But actual sale would take place only on 15th Aug

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

Combination pro

st.

ESSENTIAL ELEMENTS OF SALE

Following essential elements are necessary to constitute a sale.

1. Existence of two persons namely buyer and seller – The sale requires the

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

existence of two person namely, the seller and the buyer. The seller is a person who sells or agrees to sell goods. The buyer is a person who buys or agrees to buy foods.

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

Both the seller and the purchaser must be competent to enter into a contract, since the transaction of sale involves two persons namely, a seller and a buyer. It necessarily

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

follows that the same person cannot be both a seller and a purchaser. But it is however definitely stated that a joint owner of goods can sell the same to the other owner.

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

or example – a transistor belongs to A and B jointly. In this case, A is a joint owner and B is another joint owner. Now A can sell his part of ownership to B.

2. Price –

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

he consideration for sale of goods must be money called as price. The term price has been defined as money consideration for a sale of goods. The presence of money consider

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

Following aspects would a

tion is an essential element in a transaction of sale. If goods are exchanged for goods the transaction is not a sale, but it would only be an exchange or barter. Likewise

dd to the challenges in developing combination products:

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

f money is exchanged for money, it is an exchange and not a sale. On the other hand where goods are exchanged partly for goods and partly for money, it is a sale.

3. Subjec

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

matter of sale – The subject matter of sale must only be movable properties and not immovable properties like land and house. Transactions involving purchase and sale of im

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

movable property are regulated by a separate Act called the Transfer of Property Act, 1882.

4. Transfer of ownership – The transfer of ownership from the seller to the buyer

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

is the most important ingredient in contract of sale. It is this element which distinguishes a sale from several other calluses of contract like bailment, lease. Hence in a

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

Professional from academic institutions, pharmaceutical industries, health care indust

sale, ownership must be transferred from the seller to the buyer.

5. Presence of essential elements of a valid contract – All the essential elements of a valid contract must

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

be present.

FORMATION OF A CONTRACT OF SALE

Just as every contract is formed by an offer and acceptance and has to be supported by consideration the contract of sale also,

.

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

s made by an offer to buy or sell goods for money consideration, which is known as the price. In other words it must satisfy all the essentials of a valid contract as laid d

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

Companies that provide selfless information through particip

wn. It may be in oral or in writing.

But in the English law, a contract of sale of goods must be evidenced by a memorandum in writing if the value thereof exceeds 10 pounds

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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