Provision Language
Definitions
“Research Invention” shall mean any new and useful composition of matter, process, product by process,machine or manufacture, know-how, discovery, improvement, or other intellectual property or any new and useful improvement thereof, whether or not patentable, discovered, conceived, developed or first reduced to practice in the conduct of the Research.
“Research Report” – on a [**] basis, Company shall prepare, and deliver to the Foundation no later than [**] days after the conclusion of [**] during the Research Term, a reasonably detailed written summary report of the results and progress of the Research during [**] (Cl. 2.7).
“Research Tool” shall mean a Research Invention that may contribute to the identification or development of products useful in the Field, and that is none of the following: (a) Drug Candidate(s) identified by Company (or any of its corporate partners, Licensees, or sublicensees); (b) Product(s) based on or containing such Drug Candidate(s); or (c) Company Base IP. For the avoidance of doubt, the parties do not intend the definition of Research Tool to apply, in whole or in part, to any aspect of PTC’s GEMS technology.
RECITALS
WHEREAS, it is the intent of the Foundation and Company to disseminate the results of the Research (as defined below) to other investigators in the spinal muscular atrophy research community and to medical professionals treating spinal muscular atrophy patients, consistent with the overall goal of commercializing therapeutics for SMA; and
5. CONFIDENTIALITY
[…]
5.4 Publication. The parties acknowledge and agree that the SMA research community and medical professionals treating SMA patients will benefit from disclosure of the Data as soon as practicable. Accordingly, should the Foundation wish to publish any Confidential Information contained in a Research Report, it shall provide Company with [**] days’ advance notice of such publication (the “IP Filing Period”) to allow Company to file patent applications covering the Company Technology disclosed in such Research Report; provided, however, that at Company’s reasonable request, the IP Filing Period shall be extended for an additional [**] days if necessary for the filing of appropriate patent applications covering Company Technology disclosed in or apparent from such Research Report. During the IP Filing Period, the Foundation shall maintain as confidential the Data and the Research Report provided to Foundation by Company. Notwithstanding the foregoing, in no event shall Foundation disclose the structures of any chemical compound being researched or developed by Company in any publication or other public forum without the prior written consent of Company. Except as expressly set forth in this Agreement, the Foundation shall not have the right to use the Data to develop, commercialize, market or sublicense any commercial offering of any product or service based on the Data. The Company shall provide in each [**] Research Report a summary section which is suitable for immediate public disclosure and the Foundation may release copies of such portions of each Research Report and supporting Data to any Third Party investigator who requests such material from the Foundation in writing; provided, however, that said Third Party investigator first executes Company’s non-disclosure agreement (it being understood that such non-disclosure agreement will not prohibit said Third Party investigator from applying his or her knowledge of the Data to further SMA research and/or to treatment of SMA patients, but will prohibit him or her from transferring such Data except as incidental and necessary to treating SMA patients). The Foundation will treat all other Data in each Research Report as Company Confidential information. To the extent that any journal or other forum in which the Foundation proposes to publish or disseminate the Data requires the authorship or participation of one or more Company employees or contractors who participated in the Research or in the development of a Drug Candidate or Product, Company shall use commercially reasonable efforts to cause such individuals to cooperate with the Foundation in making such publication and, as necessary or appropriate, to be named as authors (or co-authors) of such publication. Any publication or presentation of Data in any Research Report shall acknowledge each party’s contribution thereto in accordance with customary scientific practice.
6. OWNERSHIP AND USE OF DATA AND INTELLECTUAL PROPERTY
6.1 Ownership; Reversionary License
(d) Research Tools. The parties acknowledge that the SMA research and clinical communities will benefit from the availability of Research Tools. Company agrees to use commercially reasonable efforts to make Research Tools Controlled by it available to members of the spinal muscular atrophy research and clinical communities (excluding for-profit entities engaged in pharmaceutical research and development) for research or educational purposes on commercially reasonable terms as promptly as practicable following request by the Foundation or such person (it being understood that neither Company nor its corporate partners shall charge reach-through royalties with respect to drugs discovered by such persons using Research Tools, so long as such drugs themselves are not covered by Company Technology); provided, however, that Company shall not have any obligation to provide such access before the publication of patent applications containing claims (adequately supported by written description) that cover the relevant Research Tool. Notwithstanding the foregoing, if Company believes in good faith that [**], then Company shall so notify the Foundation in writing, and the parties shall discuss in good faith how to proceed.
AMENDMENT No. 2 TO SPONSORED RESEARCH AGREEMENT
16. Publications, Presentations and Public Disclosures. Section 5.4 of the Agreement (captioned “Publication”) and Section 5.5 of the Agreement (captioned “Publicity; Regulatory Disclosures”) shall, as of the Second Amendment Effective Date, be amended and restated as follows:
“5.4. Scientific and Medical Publications and Presentations
“(a) Company and Foundation each acknowledge the other party’s interest in publishing or presenting certain results of the Research (including but not limited to the DC Research) to obtain recognition within the scientific community and to advance the state of scientific knowledge and enhance the progress of research in the Field, in all cases in a manner consistent with existing obligations to Third Parties and scientific and industry standards for the research, development and commercialization of small molecules for the treatment, mitigation or prevention of disease. Each party also recognizes their mutual interest in obtaining Patents in support of Products, and the need for such publications or presentations to be strictly monitored to prevent any adverse effect from premature publication or dissemination of results of the activities hereunder. Consequently, the JSC shall establish reasonable policies and procedures with respect to scientific publications and presentations that balance the foregoing interests, and once established both parties shall be bound by such policies and procedures, and may establish a separate publication committee to administer such policies and procedures. In the event no such procedures and policies are established by the JSC, either party, its employees or consultants wishing to make a publication in a scientific or medical journal or a presentation or similar oral disclosure made at a scientific or medical conference without obligation of confidentiality relating to work performed as part of the Research (the “Publishing Party”) shall transmit to the other party (the “Reviewing Party”) a copy of the proposed written publication or a written detailed description of the proposed oral disclosure at least [**] days prior to submission or disclosure (or, in the case of Third Party agreements, such shorter period as required by such Third Party agreement) prior to submission for publication or presentation. The Reviewing Party shall have the right (a) to make modifications to the publication for accuracy or intellectual property reasons, and (b) to obtain a delay in publication or presentation of up to [**] days (or, in the case of Third Party agreements, such shorter period as required by such Third Party agreement) in order to enable patent applications or similar applications protecting rights in such information to be filed, and each party shall have the right to prohibit disclosure of any of its Confidential Information (except as otherwise provided in Section 6.2 of the Agreement) in any such proposed publication or presentation. Notwithstanding the foregoing, in no event shall any publication, presentation, or other public disclosure disclose the chemical structure of any Lead Candidate, Drug Candidate, Development Candidate, or Product absent specific permission from the JSC. In any permitted publication or presentation by a party, the other party’s contribution shall be duly recognized, and authorship shall be determined in accordance with customary practice in the scientific or medical field.
(b) Company shall provide in each Research Report a summary section which is suitable for immediate public disclosure and the Foundation may release copies of such portions of each Research Report and supporting Data other than chemical structures to any Third Party investigator who requests such material from the Foundation in writing; provided, however, that said Third Party investigator first executes Company’s non-disclosure agreement that the Company provides to the Foundation for such purpose (it being understood that such non-disclosure agreement will not prohibit said Third Party investigator from applying his or her knowledge of the Data to further SMA research and/or to treatment of SMA patients, but will prohibit him or her from transferring such Data except as incidental and necessary to treating SMA patients).
(c) The parties acknowledge that during the course of research, development and commercialization of Products, it may be necessary to enter into agreements with Third Parties that require different standards for publication and presentation of research results relating to the Research. Notwithstanding Section 5.4(a) of the Agreement, the party conducting research, development or commercialization of Products may enter into agreements with academic, government, nonprofit or similar entities which allow principal investigators and other external researchers to publish or present the results of their research on terms inconsistent with Section 5.4(a) of the Agreement; provided, that each party entering into such agreements shall use Commercially Reasonable Efforts to include provisions reasonably consistent with and similar to those appearing in Section 5.4(a) of the Agreement in such Third Party agreements.