Top Adding - Real Estate

Loan documents often require the commercial lending institution to provide written notice (a letter) to the borrower before initiating foreclosure or lien enforcement proceedings. Some of our clients have wondered whether, in In

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

diana, the default letter can come from outside counsel. In my view, an effective notice can come from counsel. But, if the borrower has its own lawyer, the letter probably should come directly from the lender.

Is notice requi

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

Examples of combination products may in

ed? To my knowledge, there is no common law rule or statutory requirement that the borrower receive notice and an opportunity to cure. (The UCC, Article 9.1, has a notice provision in Part 6 “Default,” but the notice requiremen

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

ts apply only to the disposition of collateral after default.) Indeed there are loan documents that do not contain notice provisions, in which case the lender can immediately file suit upon default. On the other hand, if there

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 a notice clause, basic contract law dictates that notice be sent. Usually, notice to the borrower must come from the lender and must be sent to a specific person at a specific address. The best way to ensure effective notice

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

Combination pro

s to do exactly what the parties agreed to do in the written contract(s).

Problem #1 – effective notice. The common question is whether outside counsel can send the letter on the lender’s behalf. Sometimes it makes practical s

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

ense for outside counsel to do so, and I believe this is the routine practice for many Indiana lawyers. Default notice letters sent by outside counsel raise two potential problems, however. The first relates to the effectivenes

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

of the letter. A literal reading of most loan documents state that notice must come from the lender, not from a lawyer on the lender’s behalf. A creative advocate for the defaulting party may argue such notice is invalid. To

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

y knowledge, there is no Indiana case speaking to this specific question. But I think most if not all judges would conclude that notice from outside counsel is effective because the lawyer is a representative of the lender. Mor

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

e importantly, the borrower got the letter. Who sent the letter, it seems to me, is a distinction without a difference.

Problem #2 – ethics. The second and perhaps greater problem, at least for the lender’s attorney, surrounds

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

the ethics of writing to the client of another attorney. The issue is governed by the Indiana Supreme Court’s Rules of Professional Conduct, which regulate the practices of Indiana attorneys. Rule 4.2 “Communication with person

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

Following aspects would a

represented by counsel” states, “In representing a client, a lawyer shall not communicate about the subject of the representation with a person the lawyer knows to be represented by another lawyer in the matter, unless the lawyer

dd to the challenges in developing combination products:

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

has the consent of the other lawyer or is authorized by law or a court order.”

The purpose of Rule 4.2 relates to protections against “overreaching by other lawyers” . . . “interference by those lawyers with the client-lawyer r

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

lationship” . . . and “the uncounseled disclosure of information relating to the representation.” (See, Official Comments). Assuming the default notice letter is a standard, straight forward and to-the-point communication, the

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

pirit of the rule, in my view, is not being violated. This is particularly true if lender’s counsel “carbon copies” the borrower’s attorney on the letter, so that the borrower’s attorney has actual knowledge that the letter has

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

been sent and can counsel his or her client accordingly. Having said that, it’s my understanding that some Indiana lawyers disapprove of this practice and assert it is an ethical violation. I concede there is a decent argument

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

Professional from academic institutions, pharmaceutical industries, health care indust

he practice technically violates Rule 4.2.

Safety first. Despite what I understand to be a relatively common practice, the more prudent approach is for default letters to come from the lender, not lender’s counsel, unless the b

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

rrower is unrepresented. This technique will avoid conflict with the opposing party that could result in ill-will, which in turn could hamper settlement discussions or, more importantly, drive up legal fees associated with a fig

.

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

ht. Keep in mind that the letter still can be drafted by outside counsel. It just needs to be signed in-house and on the lender’s stationery. I therefore recommend that, in Indiana, commercial lending institutions declaring a

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

Companies that provide selfless information through particip

efault should (1) follow the explicit notice instructions in the operative loan documents and (2) have any required default letter come from the lender, not outside counsel, in the event the borrower is represented by an 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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.topadding.org.ua/article/138730/topadding-Notices-Of-Default-Who-Should-Send-The-Letter.html">Notices Of Default: Who Should Send The Letter?</a>

BB link (for phorums):
[url=http://www.topadding.org.ua/article/138730/topadding-Notices-Of-Default-Who-Should-Send-The-Letter.html]Notices Of Default: Who Should Send The Letter?[/url]

Due to issues with renewals of franchise applications for registration to sell franchises in a registration state some Franchisor's are caught between sales and a registration deadlines are delay by regulators. This causes a severe issue and it is happening more and more often. Why is this happening?

Podcasting allows listeners and producers to connect around topics too narrow for traditional broadcasting.

Bad credit car loans are designed especially for the people who are suffering from adverse credit history. These loans enable such people to fulfil their dream of car purchase despite having a bad credit rating.

Tags

Links

Top Adding - Notices Of Default: Who Should Send The Letter?

Related Articles: