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As a secured lender, once you decide to foreclose on a business borrower’s loan collateral, you must provide certain information and documentation to your lawyer so he or she can file suit. The

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

more quickly you send this data, and the more thorough the data is, the more efficient your attorney can be in initiating the action.

Care Package. I recommend that lenders develop a practice

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

Examples of combination products may in

of compiling a “care package” for their lawyers when assigning a non-performing loan for collection. The package should include:

1. Loan documents. Each and every piece of paper documenting

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

he loan needs to be forwarded. This would include all promissory notes, mortgages, security agreements, amendments, modifications, assignments, etc. Not only will the law firm need these mater

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

ials to analyze the case, but Indiana Trial Rule 9.2(A) requires written instruments, upon which a cause of action is based, to be filed as exhibits to the Complaint.

2. Defaults. Although mo

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

Combination pro

t defaults will be for non-payment, there may be other breaches of the loan documents. All such defaults need to be identified in the Complaint. To give your attorney a jump start on the defau

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

t analysis, a listing of any and all contract breaches, with the operative dates and citations to loan document sections, will be useful.

3. Debt figures. Even though the loss amount may chan

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

ge (increase) over time, the standard practice in Indiana is to specify the debt (damages) as of the filing of the Complaint. These figures will include any losses recoverable under the loan do

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

uments, mainly the entire unpaid principal (assuming the debt is being accelerated), accrued interest and late fees. A brief calculation of the figures should be explained, including relevant d

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

tes, interest rates, etc.

4. Notice letter. A copy of the notice and cure letter to the borrower should be provided, assuming that the loan documents required one and that you sent one. Not

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

nly will your counsel need to evaluate the notice and cure element of the case, but it’s good practice to attach the letter as an exhibit to the Complaint.

5. Title/UCC searches. If you have

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

Following aspects would a

a prior title insurance policy and/or UCC search, those materials should be sent with the care package. Lenders could save some expense simply by ordering an update to the title policy from the

dd to the challenges in developing combination products:

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

same company. Or, a separate title insurance company may provide a new commitment faster and more cheaply based on a prior policy.

6. Environmental analysis. If an environmental liability an

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

lysis has been performed, the report should be included in what you send to your counsel.

7. Appraisals. If the you had any collateral appraised in the weeks leading up to the decision to for

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

eclose, the appraisal reports should be provided. Knowing the present value of the collateral may be helpful in work-out negotiations or decisions regarding the disposition of the collateral.

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

. Contact information. Current contact information for the borrower or, if applicable, the borrower’s counsel should be supplied. It’s also a good idea to provide a copy of all correspondence

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

Professional from academic institutions, pharmaceutical industries, health care indust

between the lender and the borrower (or the borrower’s lawyer) related to pre-suit/work-out discussions. This information will enable your counsel to understand better the nature of the dispute

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

, and to hit the ground running with future communications.

Efficiency. Two things are saved when lenders and their counsel are efficient: time and expense. If, at the beginning of an assign

.

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

ent, your staff provides outside counsel with the care package I propose, law firms (at least mine) will initiate the foreclosure action quicker and for less money. Delays and attorney’s fees c

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

Companies that provide selfless information through particip

n be avoided by bypassing the follow-up that usually is required in obtaining data from the lender – things that can be provided at the outset, even before the lender first contacts its attorney

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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