Back to top

PATENT LICENSE AGREEMENT

IP Intellectual Property License Assignment Agreement

PATENT LICENSE AGREEMENT You are currently viewing:
This IP Intellectual Property License Assignment Agreement involves

MIDDLEBROOK PHARMACEUTICALS, INC. | KEF PHARMACEUTICALS, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: PATENT LICENSE AGREEMENT
Governing Law: New York     Date: 11/13/2007
Industry: BIOTRX     Law Firm: Robinson Bradshaw;Dewey & LeBoeuf LLP     Sector: Healthcare

Search IP Intellectual Property License Assignment Agreement by:

Document Title:

Entire Document: (optional)

50 of the Top 250 law firms use our Products every day
exv10w5
 

EXHIBIT 10.5
PATENT LICENSE AGREEMENT
     This PATENT LICENSE AGREEMENT (this “Agreement”) is made as of                                     , 200___ between MIDDLEBROOK PHARMACEUTICALS, INC., a Delaware corporation (“MiddleBrook”) and KEF PHARMACEUTICALS, INC., a Delaware corporation (“Kef”). MiddleBrook and Kef are each referred to individually as a “Party,” and collectively as the “Parties.”
Background Statement
     MiddleBrook and Kef are Parties to an Asset Purchase Agreement, dated as of November ___, 2007 (the “Purchase Agreement”), and are entering into this Agreement pursuant to Section 3.4(e)(ii) of the Purchase Agreement for the purpose of granting to Kef an exclusive license under the Licensed Patents (as defined in the Purchase Agreement) set forth on Schedule A (the “Licensed Patents”).
Statement of Agreement
     1. Definitions.
     1.1 Terms Defined in Purchase Agreement. Terms defined in the Purchase Agreement and not otherwise defined by this Agreement shall have the meaning given to such terms in the Purchase Agreement.
     1.2 “Adverse Drug Experience” means the definition in the current 21 C.F.R. Section 314.80, as in effect from time to time.
     1.3 “Agreement” has the meaning set forth in the introductory paragraph.
     1.4 “Kef” has the meaning set forth in the introductory paragraph.
     1.5 “Keflex Products” has the meaning given it in the Sublicense.
     1.6 “License” has the meaning set forth in Section 2.
     1.7 “Licensed Patents” has the meaning set forth in the Background Statement.
     1.8 “Licensed Products” means all products that may now or hereafter be sold under the Sublicense.
     1.9 “MiddleBrook” has the meaning set forth in the introductory paragraph.
     1.10 “MiddleBrook’s Knowledge” has the meaning given the “Seller’s Knowledge” in the Purchase Agreement.
     1.11 “Party” means either MiddleBrook or Kef and “Parties” shall mean both MiddleBrook and Kef.
     1.12 “Purchase Agreement” has the meaning set forth in the Background Statement.

 


 

     1.13 “Regulatory Obligations” has the meaning set forth in Section 5.1.
     1.14 “Related Agreements” has the meaning set forth in the Purchase Agreement.
     1.15 “Sublicense” means the Patent Sublicense Agreement, dated as of the date hereof, between MiddleBrook and Kef pursuant to which Kef shall grant a sublicense to MiddleBrook under the Licensed Patents.
     1.16 “Territory” means the United States of America and Puerto Rico.
     2. Grant of License. MiddleBrook hereby grants to Kef, upon and subject to the terms and conditions of this Agreement, a perpetual, irrevocable, royalty-free, exclusive (even as to MiddleBrook) license under the Licensed Patents to develop, make, have made, import, offer for sale and sell Keflex Products in the Territory (the “License”).
     3. Ownership of Licensed Patents. Kef acknowledges that, as between Kef and MiddleBrook, MiddleBrook is the sole and exclusive owner of the Licensed Patents, and Kef shall do nothing inconsistent with such ownership. Kef shall not challenge MiddleBrook’s ownership and rights in or to any of the Licensed Patents or assist others in challenging MiddleBrook’s ownership thereof. Kef agrees that nothing in this Agreement shall give Kef any right, title or interest in the Licensed Patents other than the License granted herein. Upon MiddleBrook’s request, Kef shall provide such information and assistance, and execute and deliver such documents, as MiddleBrook may reasonably request for purposes of registering, maintaining or enforcing any of the Licensed Patents.
     4. Representations and Warranties. MiddleBrook represents and warrants to Kef that: (i) the Licensed Patents constitute all Patents related to or used by MiddleBrook in connection with the manufacture, sale or development of Keflex Products; (ii) each of the Licensed Patents, if issued, is in full force and effect; (iii) all fees necessary to maintain the issued Licensed Patents have been paid in full when due, and there are currently no maintenance fees due for any of the issued Licensed Patents; (iv) there has been no action by the United States Patent and Trademark Office to reexamine, terminate or cancel any Licensed Patent or to decline to issue any Licensed Patent that has not been issued; (v) MiddleBrook has not granted any license under any of the Licensed Patents to develop, make, have made, import, offer for sale or sell Keflex Products other than the license to Kef under this Agreement and; (vi) to MiddleBrook’s Knowledge, no Person (A) has claimed that any Licensed Patent is invalid or unenforceable or (B) is currently infringing any Licensed Patent.
     5. Regulatory Obligations.
     5.1 Performance by MiddleBrook. MiddleBrook shall take all reasonable and appropriate actions, at MiddleBrook’s sole cost and expense, to maintain the Licensed Patents and shall oversee, monitor, coordinate and perform all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to each applicable Regulatory Authority or Governmental Authority with respect to each Patent (the “Regulatory Obligations”). Notwithstanding the foregoing, nothing herein shall operate to prevent Kef from taking such actions as Kef, in its sole discretion, deems appropriate

2


 

to ensure that all Regulatory Obligations are properly and timely performed, subject to prior notice to and consultation with MiddleBrook.
     5.2 Regulatory Meetings and Correspondence. MiddleBrook shall be responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to each Patent. Kef shall execute such notices, powers of attorney, acknowledgments, consents and other instruments as MiddleBrook may reasonably request to authorize MiddleBrook to act on Kef’s behalf for all actions before and communications with Regulatory Authorities and other Governmental Authorities, including the United States Patent and Trademark Office, as shall be necessary and appropriate to enable MiddleBrook to perform the Regulatory Obligations.
     5.3 Exchange of Information. The Parties shall establish procedures to ensure that the Parties exchange on a timely basis all necessary information to enable MiddleBrook to comply with all Regulatory Obligations, including, without limitation, filing updates, pharmacovigilance filings and investigator notifications. To the extent either Party receives any information regarding Adverse Drug Experiences related to the use of any Keflex Products, such Party shall, (i) within five (5) days of its receipt of such information, provide the other Party with such information, (ii) promptly provide all follow-up information that may reasonably be requested and (iii) otherwise act in accordance with such Adverse Event Reporting Procedures to be agreed upon in writing by the Parties from time to time. Without limiting the foregoing requirement, MiddleBrook shall provide Kef with copies of all communications between MiddleBrook and any Governmental Authorities relating to any of the Licensed Patents, Approved Registrations, IND and Keflex Products, in every case within five (5) Business Days of the sending or receipt of such communication by MiddleBrook.
     5.4 Costs and Expenses. MiddleBrook shall bear all costs and expenses of performing the Regulatory Obligations.
     6. Infringement of Licensed Patents.
     6.1 Conduct of Actions. If either Party shall receive notice of any infringement or threatened infringement of any of the Licensed Patents, such Party shall immediately notify the other Party of such infringement or threatened infringement, providing all information relating thereto possessed by the notifying Party. Except as provided below, MiddleBrook may initiate and control any legal action relating to infringement of any of the Licensed Patents; provided, however, that (i) MiddleBrook shall keep Kef fully apprised of all activity in such action, (ii) Kef shall have the right to participate in such action at its own expense, (iii) MiddleBrook shall not take any position in such action inconsistent with Kef’s exclusive license under the Licensed Patents and (iv) no settlement of any such action shall be made without the consent of Kef, which shall not be unreasonably withheld or delayed. Upon notice of infringement, if MiddleBrook fails within a reasonable time thereafter to initiate legal action relating to any such infringement of any of the Licensed Patents, or if the Sublicense shall have terminated, Kef may initiate and control any legal action relating to infringement of the Licensed Patents relating to the Keflex Products. The Parties hereby agree that either Party may include the other as a party plaintiff in any such action and that each Party shall cooperate, at the expense of the Party controlling the relevant legal action, in the prosecution of such action as reasonably requested by the Party controlling such action. Any monetary recovery in connection with such action shall

3


 

first be applied to reimburse MiddleBrook and Kef for out-of-pocket expenses (including attorneys’ fees) incurred in prosecuting such action. Any remaining monetary recovery in such action shall be equitably divided between the Parties on the basis of their respective damages resulting from the claimed infringement. The Party controlling any legal action pursuant to this Section 6.1 shall bear all expenses of such action, other than the fees of any counsel the other Party may engage if it chooses to participate separately in such action.
     6.2 Action Initiated Against Kef. In the event that a declaratory judgment action alleging invalidity or infringement of any of the Licensed Patents shall be brought against Kef, MiddleBrook, at its option, shall have the right, within thirty (30) days after commencement of such action, to intervene and take over the sole defense of the action at its own expense.
     6.3 Cooperation. In any infringement action, either Party may institute to enforce the Licensed Patents pursuant to this Agreement, the other Party shall, at the expense of the Party initiating such action, reasonably cooperate and, to the extent possible, have its applicable employees testify when requested and make available relevant records, papers, information, samples, specimens and the like.
     7. Indemnification; Insurance.
     7.1 Indemnification by MiddleBrook. MiddleBrook shall defend, indemnify and hold harmless Kef from and against all liabilities, losses, obligations, claims, judgments, awards, relief, settlements, costs and expenses (including costs of any product recall and reasonable attorneys’ fees, experts’ fees, investigation costs and other expenses of litigation) which Kef, its shareholders, directors, officers, employees and representatives may suffer or incur arising out of (i) the development, manufacture, marketing, advertising, sale or use by MiddleBrook or its successors, directly or indirectly, of the Licensed Products (excluding any such activities conducted by Kef or its successors, in connection with the Keflex Products, if the Sublicense should terminate), (ii) the performance or failure of performance by MiddleBrook of the Regulatory Obligat
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more