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NON-DISCLOSURE AGREEMENT

THIS NON-DISCLOSURE AGREEMENT (this “Agreement”) is made and entered into as of [date] between [Your Company name] having its place of business at [ address] (“Company”) and [company 2], having its place of business at [Address]

Purpose:Company and [company 2] wish to

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

explore a business opportunity of mutual interest and in connection with this opportunity wishes to execute this Non Disclosure Agreement (“Agreement”).

1. Confidential Information: Confidential information means any information disclosed to by one party to the other, either directly or indirectly in

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

Examples of combination products may in

riting, orally or by inspection of tangible or intangible objects, including without limitation documents, business plans, source code, software, documentation, financial analysis, marketing plans, customer names, customer list, customer data. Confidential Information may also include information discl

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

osed to a party by third parties at the direction of a Disclosing Party. Confidential Information shall not, however, include any information which the Receiving party can establish (i) was publicly known and made generally available in the public domain prior to the time of disclosure; (ii) becomes pu

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

licly known and made generally available after disclosure through no action or inaction of Receiving Party; or (iii) is in the possession of Receiving Party, without confidentiality restrictions, at the time of disclosure by the Disclosing Party as shown by Receiving Party’s files and records immediate

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

Combination pro

y prior to the time of disclosure. The party disclosing the Confidential Information shall be referred to as “Disclosing Party” in the Agreement and the party receiving the Confidential Information shall be referred to as “Receiving Party” in the Agreement.

2. Non-use and Non-disclosure: The Receiving

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

Party agrees not to use any Confidential Information for any purpose except to evaluate and engage in discussions concerning a potential business relationship between the parties hereto. Receiving Party agrees not to disclose any Confidential Information to third parties or to its employees, except to

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

those employees who are required to have the information in order to evaluate or engage in discussions concerning the contemplated business relationship. The Receiving Party shall not reverse engineer, disassemble or decompile any prototypes, software or other tangible objects which embody the Disclosi

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

g Party's Confidential Information and which are provided to the Receiving Party hereunder.

3. Maintenance of Confidentiality Information: The Receiving Party agrees that it shall take all reasonable measures to protect the secrecy of and avoid disclosure and unauthorized use of the Confidential Info

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

rmation. Without limiting the foregoing, Receiving Party shall take at least those measures that Receiving Party takes to protect its own most highly confidential information and shall have its employees, if any, who have access to Confidential Information sign a non-use and non-disclosure agreement in

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

content substantially similar to the provisions hereof, prior to any disclosure of Confidential Information to such employees. The Receiving Party shall not make any copies of Confidential Information unless the same are previously approved in writing by the Disclosing Party. The Receiving Party shall

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

Following aspects would a

eproduce the Disclosing Party’s proprietary rights notices on any such approved copies, in the same manner in which such notices were set forth in or on the original. The Receiving Party shall immediately notify the Disclosing Party in the event of any unauthorized use or disclosure of the Confidential

dd to the challenges in developing combination products:

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

Information.

4. No Obligation: Nothing herein shall obligate either party to proceed with any transaction between them, and each party reserves the right, in its sole discretion, to terminate the discussions contemplated by this Agreement concerning the business opportunity.

5. No Warranty: ALL CONF

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

DENTIAL INFORMATION IS PROVIDED “AS IS”. NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS, IMPLIED OR OTHERWISE, REGARDING ITS ACCURACY, COMPLETENESS OR PERFORMANCE.

6. Return of Materials: All documents and other tangible objects containing or representing Confidential Information and all copies thereof w

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

ich are in the possession of Receiving Party shall be and remain the property of the Disclosing Party and shall be promptly returned to the Disclosing Party upon the Disclosing Party’s request.

7. No License: Nothing in this Agreement is intended to grant any rights to either party under any patent, m

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

ask work right or copyright of Company, nor shall this Agreement grant Receiving Party any rights in or to Confidential Information except as expressly set forth herein.

8. Term: This Agreement shall survive for a period of 3 years from the date of disclosure of the Confidential Information.

9. Remed

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

Professional from academic institutions, pharmaceutical industries, health care indust

es: The Receiving Party agrees that any violation or threatened violation of this Agreement will cause irreparable injury to the Disclosing Party, entitling the Disclosing Party to obtain injunctive relief in addition to all legal remedies.

10. Miscellaneous:This Agreement shall bind and inure to the

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

enefit of the parties hereto and their successors and assigns. This Agreement shall be governed by the laws of [name of your state, country], without reference to conflict of laws principles. This document contains the entire agreement between the parties with respect to the subject matter hereof. Any

.

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

failure to enforce any provision of this Agreement shall not constitute a waiver thereof or of any other provision hereof. This Agreement may not be amended, nor any obligation waived, except by a writing signed by both parties hereto. Any and all disputes arising under or related to this Agreement sha

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

Companies that provide selfless information through particip

l be adjudicated exclusively in [name of your state, country]. The parties have executed this Nondisclosure Agreement as of the date first above written.

Your Company Name. [Compnay 2] By: ___________________ By: Name: ________________ Name: Title: _________________ Title: Date: _________________ Date

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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