Clinical Development and License Agreement Sample Contracts

AMENDMENT TO CLINICAL DEVELOPMENT AND LICENSE AGREEMENT
Clinical Development and License Agreement • May 13th, 2011 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

This Amendment (this “Amendment”) to the Clinical Development and License Agreement, dated as of July 14, 2005, as amended on February 15, 2006, May 16, 2006, August 2, 2006, March 12, 2007, September 5, 2007, January 2, 2009, May 26, 2010 and October 4, 2010 (as amended from time to time, the “CDC License”), is dated as of May 12, 2011, by and among CDC V, LLC (“CDC”), NB Athyrium LLC, a Delaware limited liability company (“Athyrium”), BioDelivery Sciences International, Inc. (“BioDelivery”), Arius Pharmaceuticals, Inc., a wholly-owned subsidiary of BioDelivery (“Arius”) and Arius Two, Inc., a wholly-owned subsidiary of BioDelivery (“Arius Two” and together with Arius and BioDelivery, collectively, the “Company”). Capitalized terms used herein and not otherwise defined shall have the meanings given to them in the CDC License.

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BEMA ACQUISITION CONSENT, AMENDMENT, AND WAIVER
Clinical Development and License Agreement • August 9th, 2006 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

This BEMA ACQUISITION CONSENT, AMENDMENT, AND WAIVER (the “Consent”) is entered this August 2, 2006 (the “Consent Date”) by BioDelivery Sciences International, Inc. (“BDSI”), its wholly-owned subsidiary Arius Pharmaceuticals, Inc. (“Arius”), BDSI’s wholly-owned subsidiary Arius Two, Inc. (“Arius Two”), and CDC IV, LLC (“CDC”)

PRINCETON, NEW JERSEY 08542
Clinical Development and License Agreement • September 10th, 2007 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

Reference is hereby made to that certain Clinical Development and License Agreement (as amended, the “CDC License”), dated as of July 14, 2005 among CDC (as successor in interest to Clinical Development Capital LLC), BioDelivery and Arius. Pursuant to the terms of the CDC License, BioDelivery, Arius and Arius Two have requested that CDC consent to, among other things, (i) the acquisition by Arius Two of certain assets related to the BEMA Fentanyl product from QLT USA, Inc., and (ii) the amendment of the CDC License in connection with such acquisition and the subsequent license of certain rights with respect to such assets by Arius to Meda AB; in each case pursuant to the terms of (A) that certain Sublicensing Consent and Amendment, entered into as of the date hereof, by BDSI, Arius and CDC (the “Sublicensing Consent”) and (B) that certain BEMA Acquisition Consent, Amendment and Waiver, entered into as of the date hereof, by BDSI, Arius, Arius Two and CDC (the “Acquisition Consent” and

AMENDMENT TO CLINICAL DEVELOPMENT AND LICENSE AGREEMENT
Clinical Development and License Agreement • September 10th, 2007 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

This Amendment (this “Amendment”) to the Clinical Development and License Agreement, dated as of July 14, 2005 (as amended from time to time, the “CDC License”), is dated as of September 5, 2007, by and among CDC IV, LLC (“CDC”), BioDelivery Sciences International, Inc. (“BioDelivery”), Arius Pharmaceuticals, Inc., a wholly-owned subsidiary of BioDelivery (“Arius”) and Arius Two, Inc., a wholly-owned subsidiary of BioDelivery (“Arius Two” and together with Arius and BioDelivery, collectively, the “Company”). Capitalized terms used herein and not otherwise defined shall have the meanings given to them in the CDC License.

PRINCETON, NEW JERSEY 08542
Clinical Development and License Agreement • August 9th, 2006 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

Reference is hereby made to that certain Clinical Development and License Agreement (as amended, the “CDC License”), dated as of July 14, 2005 among CDC (as successor in interest to Clinical Development Capital LLC), BioDelivery and Arius. Pursuant to the terms of the CDC License, BioDelivery, Arius and Arius Two have requested that CDC consent to, among other things, (i) the acquisition by Arius Two of certain assets related to the BEMA Fentanyl product from QLT USA, Inc., and (ii) the amendment of the CDC License in connection with such acquisition and the subsequent license of certain rights with respect to such assets by Arius to Meda AB; in each case pursuant to the terms of (A) that certain Sublicensing Consent and Amendment, entered into as of the date hereof, by BDSI, Arius and CDC (the “Sublicensing Consent”) and (B) that certain BEMA Acquisition Consent, Amendment and Waiver, entered into as of the date hereof, by BDSI, Arius, Arius Two and CDC (the “Acquisition Consent” and

AMENDMENT TO CLINICAL DEVELOPMENT AND LICENSE AGREEMENT
Clinical Development and License Agreement • March 16th, 2007 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

This Amendment (this “Amendment”) to the Clinical Development and License Agreement, dated as of July 14, 2005 (as amended from time to time, the “CDC License”), is dated as of March 12, 2007, by and among CDC IV, LLC (“CDC”), BioDelivery Sciences International, Inc. (“BioDelivery”), Arius Pharmaceuticals, Inc., a wholly-owned subsidiary of BioDelivery (“Arius”) and Arius Two, Inc., a wholly-owned subsidiary of BioDelivery (“Arius Two” and together with Arius and BioDelivery, collectively, the “Company”). Capitalized terms used herein and not otherwise defined shall have the meanings given to them in the CDC License.

September 5, 2007 QLT USA, INC. (“QLT USA”) Fort Collins, CO 80525 Attention: Sean Moriarty Dear Sirs:
Clinical Development and License Agreement • September 10th, 2007 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

Reference is made to the Clinical Development and License Agreement, dated as of July 14, 2005, by and among CDC IV, LLC, as successor in interest of Clinical Development Capital LLC, (“CDC”) BioDelivery Sciences International, Inc. (“Parent”) and Arius Pharmaceuticals, Inc. (“Arius”; together with Parent, “BDSI”), as amended and Security Agreement, dated February 15, 2006, as amended (together, the “CDC Agreement”), under which CDC has certain rights with respect to certain intellectual property rights and assets of Arius related to Arius’ BEMA Fentanyl product. Unless expressly provided otherwise herein, capitalized terms used herein shall have the same meanings provided in that certain Intellectual Property Assignment Agreement, dated as of the date hereof, between Arius Two, Inc. (“Arius Two”) and QLT USA, Inc. (“QLT”) (the “Purchase Agreement”), and the other documents contemplated by the Purchase Agreement, including but not limited to that certain Amended and Restated Security A

NOTICE OF BREACH AND DEMAND FOR DISPUTE RESOLUTION
Clinical Development and License Agreement • August 31st, 2006 • Biodelivery Sciences International Inc • Pharmaceutical preparations

We make reference to the Clinical Development and License Agreement, dated as of July 14, 2005, among BioDelivery Sciences International, Inc., (“BDSI”), Clinical Development Capital LLC (together with its successors and assigns, including, without limitation, CDC IV, LLC, collectively, “CDC”), and Arius Pharmaceuticals, Inc. (such agreement, as amended, the “CDLA”). All capitalized terms used but not defined herein shall have the meanings assigned to such terms in the CDLA.

AMENDED AND RESTATED CLINICAL DEVELOPMENT AND LICENSE AGREEMENT
Clinical Development and License Agreement • March 16th, 2017 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York
NOTICE OF BREACH AND TERMINATION
Clinical Development and License Agreement • August 31st, 2006 • Biodelivery Sciences International Inc • Pharmaceutical preparations

We make reference to the Clinical Development and License Agreement dated as of July 14, 2005 among BioDelivery Sciences International, Inc, (“BDSI”), Clinical Development Capital LLC (together with its successors and assigns, “CDC”), and Arius Pharmaceuticals, Inc. (such agreement, as amended, the “CDLA”).

NOTICE OF BREACH AND TERMINATION
Clinical Development and License Agreement • September 1st, 2006 • CDC Iv LLC • Pharmaceutical preparations

We make reference to the Clinical Development and License Agreement dated as of July 14, 2005 among BioDelivery Sciences International, Inc. (“BDSI”), Clinical Development Capital LLC (together with its successors and assigns, “CDC”), and Arius Pharmaceuticals, Inc. (such agreement, as amended, the “CDLA”).

Contract
Clinical Development and License Agreement • May 22nd, 2006 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

AMENDMENT NO. 2 dated as of May 16, 2006 to that certain Clinical Development and License Agreement dated as of July 14, 2005 between BioDelivery Sciences International, Inc (“BDSI”), Arius Pharmaceuticals, Inc., a wholly-owned subsidiary of BDSI (“Arius”, and together with BDSI, the “Company”) and CDC IV, LLC, a Delaware limited liability company and assignee of Clinical Development Capital LLC (“CDC”) (as the same may be amended, supplemented or otherwise modified, the “Development Agreement”).

CLINICAL DEVELOPMENT AND LICENSE AGREEMENT
Clinical Development and License Agreement • July 21st, 2005 • Biodelivery Sciences International Inc • Pharmaceutical preparations • New York

THIS CLINICAL DEVELOPMENT AND LICENSE AGREEMENT dated as of July 14, 2005 (the “Effective Date”), among Clinical Development Capital LLC (“CDC”), a limited liability company organized under the laws of the State of Delaware, having a business address at 47 Hulfish Street, Suite 310, Princeton, NJ 08542, BioDelivery Sciences International, Inc. (“BioDelivery”), a corporation organized under the laws of the State of Delaware, having a business address at 2501 Aerial Center Parkway, Suite 205, Morrisville, NC 27560, and Arius Pharmaceuticals, Inc., a Delaware corporation and wholly-owned subsidiary of BioDelivery (“Subsidiary”, and together with BioDelivery, the “Company”). CDC and Company are sometimes referred to herein individually as a “Party” and collectively as “Parties”.

AMENDMENT TO CLINICAL DEVELOPMENT AND LICENSE AGREEMENT
Clinical Development and License Agreement • March 16th, 2007 • CDC Iv LLC • Pharmaceutical preparations • New York

This Amendment (this “Amendment”) to the Clinical Development and License Agreement, dated as of July 14, 2005 (as amended from time to time, the “CDC License”), is dated as of March 12, 2007, by and among CDC IV, LLC (“CDC”), BioDelivery Sciences International, Inc. (“BioDelivery”), Arius Pharmaceuticals, Inc., a wholly-owned subsidiary of BioDelivery (“Arius”) and Arius Two, Inc., a wholly-owned subsidiary of BioDelivery (“Arius Two” and together with Arius and BioDelivery, collectively, the “Company”). Capitalized terms used herein and not otherwise defined shall have the meanings given to them in the CDC License.

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