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So, your band just finished recording their first album and are now looking to get 1000 retail-ready CD’s inside shiny jewel cases, with killer graphics and all the prerequisite bells & whistles for a CD replication project. Good f

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

or you and your band - this is by no means a trivial undertaking!

But WAIT, there are potential land-mines around the corner if you’re not careful. Have you covered someone else’s song? Do you have samples of another artist’s music on

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

Examples of combination products may in

your CD? What about copyright issues - both on your material, and anyone else’s? Unless you pay careful attention to the finer details, you could get burned – legally or otherwise… Ouch!

The following tips, recommendations, considera

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

tions and answers to common questions that will help prevent you from falling into any land-mines or legal licensing pot holes and enable you to move forward on a successful CD replication project:

Covering Someone Else’s Song:

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

While many artists think it’s OK to cover someone else’s original performance without the necessary mechanical license - especially if there are no samples of that performance on their disc - you are in a legal grey-area and run the

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

Combination pro

risk of having problems later on. It is therefore recommended that you obtain the mechanical license to comply with copyright laws and to properly pay royalties to the original songwriter.

Tips and Recommendations:

- Contact

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

the Harry Fox Agency in New York. Here you can obtain the license and prepay royalty fees. If you are replicating less than 2500 CD units, you can complete your application online by visiting the Song File website.

- Perhaps a better

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

choice, though more time consuming is to contact the copyright holder directly and negotiate a royalty rate. This could be a much better choice for you if your CD sells well. In order to find out who owns the song’s copyright you will

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

have to contact American Society of Composers, Authors & Publishers (ASCAP)

Sampling Other Artist’s Songs:

This is not a grey-area, but a hard and fast rule:

- If you are sampling another artist’s material (regardl

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

ess of how small that sample), you must obtain the proper license – period!

Tips and Recommendations:

- This license is called a Master Use License. You cannot replicate copies of your CD without this licensing paperwork.

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

Any replicator or CD replication company who makes you copies is potentially liable without this license - and will be very firm on this point and will not proceed with your order until you can produce it.

- Again, you can find out

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

Following aspects would a

who owns the rights to songs by contacting ASCAP. There are no exceptions to this rule, so be prepared ahead of time and don’t get your project rejected by your CD replication partner.

Q: What is a IP Replication Rights Form

dd to the challenges in developing combination products:

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

?

A: Most reputable CD replication companies have joined the Anti-Piracy Compliance Program run by the International Recording Media Association (IRMA). The IRMA protects copyright holders (owners) from unauthorized duplication of

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

their materials (intellectual property). The IRMA also goes after pirates and replicators who duplicate unauthorized product. What this means to you is that if you try to duplicate discs with someone else’s content, without the suppor

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

rights paperwork you could loose your masters and money as your CD replication company gets closed down by the IRMA.

- Obviously this would be an extreme example, but the threat remains and no reputable replication company would tak

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

e the risk. They would simply reject your masters and refuse to duplicate - and many change a cancellation fee. It’s your responsibility to gather the required licenses/releases ahead of time.

Q: How do I copyright my own materials

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

Professional from academic institutions, pharmaceutical industries, health care indust

?

A: You would get in touch with the US Library of Congress (www.copyright.gov) to request the forms needed to copyright your music.

- Once complete, send them the form, a copy of your recorded materials (on CD), a lyric sheet a

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

nd the registration fee. Within a few weeks you would receive confirmation that your material was copyrighted.

- Once copyrighted you should seek a licensing agency who can track all radio plays of your songs and pay you for any roya

.

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

lties due.

In Conclusion:

Cutting your master disc is only the beginning on your road to a successful CD release. Before anything else, you need to make sure you have the licensing paperwork in place. If you send a master to a

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

Companies that provide selfless information through particip

CD replication company who doesn’t ask you for IPR paperwork - RUN! Piracy is a big problem in the industry and agencies like the IRMA are actively pursuing those individuals and companies not following the rules. You have been warned

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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Having one's own registered office adds to ones credibility, product reliability and enhances goodwill. Now getting this facility has become very easy as this can be done online.

If you have good team members then you can afford to rely on them to do their part, micromanagement will only bring grief.

Many industrial machines using compressed air as an energy source, use air cylinders or other pneumatic actuators to do the actual work....

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