Common use of Patent Listing Clause in Contracts

Patent Listing. GSK shall have sole decision-making authority and shall be solely responsible for performing all patent listing acts and requirements for all GSK Products that have become the subject of a Marketing Authorization Approval (“MAA”) or New Drug Application (“NDA”) submitted to any applicable Regulatory Authority, such acts and requirements to include all so-called “Orange Book” listings required under the US Hxxxx-Xxxxxx Act, all acts required of the reference product sponsor under the US Biologicals Price Competition and Innovation Act of 2009 (42 U.S.C. § 262) (“Biologics Act”), or any foreign equivalents thereof. Specifically, GSK will control all of the actions, filings, and communications with any filer for a Follow-On Biologic, (a “Follow-on Biologic Applicant”) under the Biologics Act, including generating the following: (i) the list of Program Technology Patents that GSK believes could be reasonably asserted to be infringed by the launch of the biosimilars product; (ii) the list of Patents included within the Program Technology, if any, which GSK would be willing to license to the Follow-on Biologic Applicant; (iii) the detailed statement describing the factual and legal basis for why each of the listed Patents included within the Program Technology will be infringed by the Follow-on Biologic Applicant; and (iv) the response to the Follow-on Biologic Applicant’s statement regarding validity and enforceability of each of the listed Patents. GSK shall keep KineMed reasonably apprised of the status of such listings through the JPS, and KineMed shall cooperate with GSK at GSK’s expense to list applicable Program Technology Patents, including timely providing to GSK any documentation (such as internal documents, copies of laboratory notebooks, and related materials) and the reasonable assistance of KineMed’s employees, as required, in order to obtain any of such patent term extensions. GSK’s final listing decisions shall not be subject to any further review. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. EXECUTION COPY Confidential

Patent Listing. GSK shall have sole decision-making authority and shall be solely responsible for performing all patent listing acts and requirements for all the Product with respect to which GSK Products has the exclusive rights pursuant to exclusive licenses granted under Article 4 to Develop and commercialize, and that have become the subject of a Marketing Authorization Approval (“MAA”) or New Drug Authorisation Application (“NDA”) submitted to any applicable Regulatory Authority, such . Such acts and requirements to include all so-called “Orange Book” listings required under the US HxxxxXxxxx-Xxxxxx Act, all so-called “Patent Register” listings as required in Canada, all acts required of the reference product sponsor under the US Biologicals Price Competition and Innovation Act of 2009 (42 U.S.C. § 262) (“Biologics Act”), or any foreign equivalents thereof. Specifically, GSK will control all of the actions, filings, and communications with any filer for a Follow-On Biologic, (a “Followfollow-on Biologic Applicant”) biologic applicant under the Biologics Act, including generating the followingfollowing documents: (i) the list of Program Technology Patents patents that GSK believes could be reasonably asserted to be infringed by the launch of the biosimilars product; (ii) the list of Patents included within the Program Technologypatents, if any, which GSK would be willing to license to the Followfollow-on Biologic Applicantbiologic applicant; (iii) the detailed statement describing the *** Confidential Treatment Requested *** factual and legal basis for why each of the listed Patents included within the Program Technology patent will be infringed by the Followfollow-on Biologic Applicantbiologic applicant; and (iv) the response to the Followfollow-on Biologic Applicantbiologic applicant’s statement regarding validity and enforceability of each of the listed Patentspatents. GSK shall keep KineMed reasonably apprised of Prior to such listings, the status of such listings Parties will meet, through the JPS, to evaluate and KineMed shall cooperate with GSK at GSK’s expense to list identify all applicable Program Technology Patents, including timely providing and GSK shall have the right to review, where reasonable, original records relating to any invention for which Patents are being considered by the JPS for any such listing. Notwithstanding the preceding sentence, GSK any documentation (will retain final decision-making authority as to the listing of all applicable Patents for the Product and all other acts pertaining to such patent listings as internal documentsrequired by law, copies statue or regulation, regardless of laboratory notebookswhich Party owns such Patent, and related materials) and any such final decision made in good-faith on the reasonable assistance of KineMed’s employees, as required, in order to obtain any of such patent term extensions. GSK’s final listing decisions matter shall not be subject to any further reviewreview under Section 3.2(d) or otherwise under this Agreement. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933For the avoidance of doubt, AS AMENDED. EXECUTION COPY Confidentialany decision made by GSK under this Section 8.5 shall not be used to determine, as between the Parties, whether a Patent contains any Valid Claim or whether any Product is covered by any Valid Claim.