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SECOND AMENDMENT TO RESEARCH COLLABORATION AND LICENSE AGREEMENT

Research and Development Agreement

SECOND AMENDMENT TO RESEARCH COLLABORATION AND LICENSE AGREEMENT | Document Parties: ASTRAZENECA AB | PALATIN TECHNOLOGIES, INC You are currently viewing:
This Research and Development Agreement involves

ASTRAZENECA AB | PALATIN TECHNOLOGIES, INC

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Title: SECOND AMENDMENT TO RESEARCH COLLABORATION AND LICENSE AGREEMENT
Governing Law: New York     Date: 2/17/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

SECOND AMENDMENT TO RESEARCH COLLABORATION AND LICENSE AGREEMENT, Parties: astrazeneca ab , palatin technologies  inc
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CONFIDENTIAL TREATMENT REQUEST

SECOND AMENDMENT TO

RESEARCH COLLABORATION AND LICENSE AGREEMENT

This SECOND AMENDMENT (this “ Second Amendment ”) is made effective as of 5 December 2008 (the “ Second Amendment Effective Date ”), by and between PALATIN TECHNOLOGIES, INC., a Delaware corporation having an address of Cedar Brook Corporate Center, 4C Cedar Brook Drive, Cranbury, New Jersey 08512 (“ Palatin ”) and ASTRAZENECA AB, a company incorporated in Sweden under no. 556011-7482 with offices at S-151 85 Södertälje, Sweden (“ AstraZeneca ”).

Recitals

A)     

WHEREAS, AstraZeneca and Palatin are parties to that certain Research Collaboration and License Agreement effective as of January 30, 2007 and amended through a First Amendment effective as of June 27, 2008 (collectively the “ Agreement ”);

 

B)     

WHEREAS, as part of the Agreement, Palatin inter alia granted to AstraZeneca a license to the Licensed Patents and the Parties agreed to collaborate to generate Collaboration Compounds to be owned by AstraZeneca;

 

C)     

WHEREAS, Palatin granted to AstraZeneca Additional Licenses in respect of the Additional Compounds and Additional Licensed Patents specified on Schedule 1 following a JEC Designation on 30 June 2008 and ***;

 

D)     

WHEREAS, Palatin has agreed to grant to AstraZeneca Additional Licenses in respect of further Additional Compounds and Additional Licensed Patents as set forth below in this Second Amendment;

 

INFORMATION MARKED “***” IS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION UNDER RULE 24b-2


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E)     

WHEREAS, in furtherance of the Research Collaboration, Palatin will ***;

 

F)     

WHEREAS, the Parties wish to extend the Collaboration Term and amend the Research Plan to cover further research efforts to be conducted by the Parties;

 

G)     

WHEREAS, the Parties have entered into a Clinical Trial Sponsored Research Agreement of even date herewith, whereby Palatin has agreed to conduct a certain clinical trial ***; and

 

H)     

WHEREAS, the Parties, in view of the above, wish to amend the Agreement on the terms set forth herein.

 

Agreement

NOW, THEREFORE, in consideration of the mutual covenants contained in this Second Amendment, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

1       Definitions and Construction

Capitalized terms used but not defined herein shall have the meanings set forth in the Agreement. Unless the context otherwise requires, reference to “the Agreement” or “this Agreement” shall be construed to mean the Agreement as amended by this Second Amendment.


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2       Amendments to Article 1 (Definitions)

2.1      Sections 1.104 and 1.107 are amended to read in their entirety as follows:

“1.104     “ Additional Compound ” means ***.

1.107     “ Additional Licensed Patents ” means ***

2.2      The following new Sections 1.117-1.125 are added to the Agreement:

“1.117          “ AstraZeneca *** Notice ” has the meaning set forth in Section 3.18.

1.118     “ Clinical Trial Agreement ” means the Clinical Trial Sponsored Research Agreement between Palatin and AstraZeneca of even date herewith.

1.119     “ Lead Compound ” means an Agreement Compound ***.

1.120     “ Lead Optimisation ” means ***.

1.121     “ New Non-Agreement Compound ” has the meaning set forth in Section 3.14.

1.122     “ Non-Agreement Compound ” has the meaning set forth in Section 3.14.

1.123     “ Old Non-Agreement Compound ” has the meaning set forth in Section 3.14.

1.124     “ Research Records ” has the meaning set forth in Section 3.6.

1.125     “ Second Amendment Effective Date ” means 5 December 2008.”

2.3      The Research Plan, Schedule 1.92 to the Agreement, is amended as set forth in Schedule 1.92 to this Second Amendment.

3       Amendments to Article 3 (Research Collaboration)

3.1      Section 3.6 of the Agreement is amended to read in its entirety as follows:


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“3.6      Regulatory Records . Palatin and AstraZeneca each shall maintain, or cause to be maintained, laboratory notebooks and other records (collectively, “ Research Records ”) of its respective activities under the Research Collaboration in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective activities under the Research Collaboration, and which shall be ***; provided always that before destroying any such Research Record upon expiration of such period Palatin shall offer AstraZeneca in writing to transfer such Research Record to AstraZeneca and shall, should AstraZeneca declare in writing that it wishes to have such Research Record transferred, transfer it to AstraZeneca, at AstraZeneca's cost, without unreasonable delay. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such Research Records. Without prejudice to Palatin’s obligations set forth above in this Section 3.6, Palatin shall (i), as from the Second Amendment Effective Date, ***.”

3.2      Palatin confirms that it has provided or will provide to AstraZeneca copies of Additional Know-How pursuant to Section 3.4.1 of the Agreement, promptly after the AstraZeneca Notice on 10 July 2008 and the Second Amendment Effective Date respectively.

3.3      The list of Key Personnel, Schedule 3.2 to the Agreement, is amended as set forth in Schedule 3.2 to this Second Amendment.

3.4      Article 3 of the Agreement is amended by adding the following new Sections 3.13 through 3.20 to the Agreement:

“3.13     All compounds covered or claimed by the patent applications set forth in Schedule 1.107 shall as from the Second Amendment Effective Date constitute Additional Compounds and be included in the Additional License.

3.14     For the purpose hereof, the term “ Non-Agreement Compound ” shall mean any compound – other than an Agreement Compound, AZ Compound or a Collaboration Result – ***.


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3.15     Promptly after the Second Amendment Effective Date, Palatin shall, and shall cause its Affiliates to, without any additional compensation being payable to Palatin, provide to AstraZeneca ***.

3.16     On and after the Second Amendment Effective Date, Palatin shall, and shall cause its Affiliates to, without any additional compensation being payable to Palatin, promptly upon such information becoming available to Palatin, ***.

3.17     Without prejudice to any other rights or licenses granted by Palatin to AstraZeneca under this Agreement, Palatin hereby grants to AstraZeneca and its Affiliates a royalty free, fully paid-up, perpetual, exclusive (including with regard to Palatin and its Affiliates), subject to a retained right thereto for the sole purpose of Palatin carrying out its obligations under the Research Collaboration, right and license in the Territory, with the right to grant sublicenses, under Palatin’s right, title and interest in and to the ***.

3.18     AstraZeneca may, at its sole discretion and at any time during the period starting on the Second Amendment Effective Date and continuing until the earlier to occur of *** select one or more of any Non-Agreement Compound, other than *** for licensing hereunder, by giving Palatin written notice thereof (an “ AstraZeneca Non-Agreement Compound Notice ”).

3.19     Upon AstraZeneca’s provision of an AstraZeneca Non-Agreement Compound Notice to Palatin pursuant to Section 3.18, any Non-Agreement Compound thus selected for licensing hereunder will, without any additional compensation to Palatin, automatically become an Additional Compound and be included in the Additional License, provided , however , that solely in respect of any Old Non-Agreement Compound thus selected for licensing in an AstraZeneca Non-Agreement Compound Notice, the Additional Licence shall be subject to any rights or licenses granted by Palatin to any Third Party prior to the Second Amendment Effective Date ***. AstraZeneca and Palatin shall promptly for identification purposes designate, in writing on a separate document to be attached hereto, the ***. The patents or patent applications thus designated therein shall, for the avoidance of doubt and without prejudice to the generality of Section 1.107, ***.


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3.20     For so long as AstraZeneca has the right to give an AstraZeneca Non-Agreement Compound Notice as to any Non-Agreement Compound, Palatin shall:

(i)     

not grant any Third Party any right as to any Non-Agreement Compounds for any use within the Licensed Field, and

 

(ii)     

not grant any Third Party any right as to any Non-Agreement Compounds as to which AstraZeneca has the right to give an AstraZeneca Non-Agreement Compound Notice for any use outside of the Licensed Field, unless ***.”

 

4       Amendments to Article 4 (Management of the Research Collaboration)

4.1      The following is inserted immediately after the first sentence in Section 4.4.1 of the Agreement:

“In addition to and without limiting Palatin’s obligations set forth above in this Section 4.4.1, Palatin shall at AstraZeneca’s request and expense promptly make available to AstraZenec


 
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