When a drug candidate is licensed to different licensees in different territories, the ability of each licensee to obtain marketing approval for the product may depend on access to data generated by the other. While license agreements do not always address this issue, there are some terms that can be useful in this type of situation.
Last year, a U.S. biotech company received a complete response letter from FDA for its experimental therapy. The results of two Phase III studies were submitted with the company’s New Drug Application (NDA). Unfortunately, the primary endpoint was not met in one of the studies. The FDA advisory committee recommended approval, but in the end, FDA required additional clinical testing to approve the drug.
The twist here is that data from a Phase III study in Japan had showed that the drug was safe and effective, but patient-level data was not included in the U.S. NDA because that data was not available to the U.S. company. You see, the U.S. biotech company is a licensee of the experimental drug product, but Japan is not part of its territory. Another licensee has Japanese rights and owns the results from the Phase III study conducted in Japan.
Would the patient-level data have been enough for FDA to approve the therapy? Maybe not.
Can provisions be included in license agreements to provide a licensee with access to data generated by another licensee? Yes.
Following are sample provisions from two publicly-filed agreements, where a non-worldwide licensee negotiated for access to data generated by other licensees.
In the 2007 Collaboration Agreement between Amgen and Daiichi Sankyo for rights to commercialize denosumab in Japan, the parties agreed to the following terms with respect to sharing of regulatory filings and clinical data in each other’s territory:
4.8 Sharing of Regulatory Filings. Each of the Parties will disclose to the other a draft copy of any Regulatory Filing in the Territory in the original language no less than thirty (30) days prior to filing it with a Governmental Authority. Each Party will consider in good faith any comments made by the other Party with respect to such filings. Each Party shall, no less frequently than quarterly, and more often as reasonably requested by the other Party, provide to the other Party (in such format as reasonably requested) all material preclinical and clinical data arising out of or relating to Dmab in trials thereof in the Territory (and outside the Territory, for Amgen) (or such subset of such data as the Parties may agree). Each of the Parties shall maintain a database which contains all clinical trial data accumulated from all clinical trials of Dmab in the Territory (in a computer readable format reasonably requested by Amgen). Upon the request of either Party, the other Party shall provide a right of reference to any requested Regulatory Filings or Regulatory Approvals in the Territory, and Amgen shall provide the same such right of reference to Collaborator with respect to such Regulatory Filings and Regulatory Approvals outside the Territory, in each case as reasonably necessary for the requesting Party’s development or commercialization of Dmab as permitted hereunder (or, with respect to Amgen, manufacture of Dmab). Notwithstanding the foregoing, Amgen shall not be required to provide to Collaborator nor to allow Collaborator to access (but shall provide a right of reference as set forth in Section 4.15.3 (Amgen Cooperation) to the extent necessary) Amgen’s manufacturing information with respect to Dmab or any sections of any such Regulatory Filing related thereto and neither Party shall have an obligation to provide information relating to any product other than Dmab.
In another Daiichi Sankyo agreement, this one the 2008 License, Co-Development and Co-Commercialization Agreement with ArQule for rights to ArQule’s oncology candidate, ARQ 197, outside of Japan and certain other Asian countries, the parties included the following provision for sharing data among licensees:
3.10.3 Right of Access. Each Party shall provide the other Party with access to all clinical project plans and clinical data, results and information derived from or relating to all Clinical Trials conducted, and all Regulatory Filings prepared, with respect to Collaboration Compounds and/or Licensed Products (collectively, “Product-Related Data”) in English and at no additional cost or expense. Notwithstanding anything to the contrary in this Agreement, ARQULE (a) may use, and provide to its Third Party licensees and collaborators, such Product-Related Data; provided, that, (i) ARQULE shall only have the right to share such Product-Related Data to its Third Party collaborators and licensees that have granted ARQULE the reciprocal right to share with DS clinical data, results and information, and information derived from or related to Regulatory Filings controlled by such Third Party collaborators and licensees for use with Licensed Products under this Agreement and (ii) ARQULE shall, upon DS’s request, use Commercially Reasonable Efforts to coordinate a global clinical trial targeting both within the Territory and the Asian Territory involving its Third Party collaborators and DS; (b) may use such Product-Related Data for the performance of its obligations and exercise of its rights under this Agreement; and (c) shall have a right of access, a right of reference and a right to use and incorporate all such Product-Related Data in any Regulatory Filings and Drug Approval Applications it makes with respect to Licensed Products. The Parties shall cooperate so that such Product-Related Data is transferred to ARQULE as expeditiously as possible.
These may or may not be model provisions, but they are two real-world examples of terms that have been used to provide a licensee with rights to data generated by the licensor or other licensees.