Conduct of the Research Program. (a) 4DMT and uniQure shall each use Commercially Reasonable Efforts to conduct the Research Program in accordance with the Research Plan. In addition, uniQure shall use Commercially Reasonable Efforts to assess reasonably promptly whether each Designated Capsid Variant provided to uniQure in connection with assessing the Delivery Success Criteria can be manufactured in insect cells. (b) Either Party shall have the right to utilize the services of any Third Party to perform its obligations under the Research Plan to the extent that such Third Party is specifically approved in the Research Plan or otherwise approved by the JRSC, provided that any permitted Third Party must have entered into a written agreement with such Party that includes terms and conditions (i) protecting and limiting use and disclosure of Confidential Information at least to the same extent as under ARTICLE VIII, and (ii) requiring the Third Party and its personnel to assign to such Party all right, title and interest in and to any intellectual property (and intellectual property rights) created or conceived in connection with performance of subcontracted activities. Each Party shall remain at all times fully liable for its responsibilities under this Agreement. (c) 4DMT and uniQure shall conduct the Research Program in accordance with all applicable Laws, including, if and as applicable, Good Laboratory Practices. Each Party hereby certifies that it will not employ or otherwise use in any capacity in performing any activity hereunder the services of any person or entity known to it to be debarred under 21 USC §335a. (d) If the JRSC determines that it is desirable to transfer the AAV Capsid Variant Libraries into baculovirus, then prior to such transfer, the Parties will negotiate in good faith an amendment to this Agreement specifying the allocation of ownership of Materials, Know-How, and Patent Rights. Except as otherwise agreed by the Parties in writing, in no event shall 4DMT transfer the 4DMT AAV Capsid Variant Libraries to uniQure, and in no event shall uniQure transfer its baculovirus insect cell manufacturing Know-How to 4DMT.
Appears in 3 contracts
Samples: Collaboration and License Agreement (4D Molecular Therapeutics Inc.), Collaboration and License Agreement (uniQure N.V.), Collaboration and License Agreement (uniQure B.V.)
Conduct of the Research Program. (a) 4DMT shall initiate work on the Research Plan for Liver and uniQure the Research Plan for CNS within [***] ([***]) weeks after the New CLA Effective Date. Any amendments to the Research Plan for CNS or the Research Plan for Liver will be only as agreed by the JRSC.
(b) 4DMT shall each use Commercially Reasonable Efforts to conduct the Research Program in accordance with the Research PlanPlan for CNS and the Research Plan for Liver. In addition4DMT shall have an affirmative obligation during the term the Research Program and thereafter during the term of this Agreement to disclose all data and other information related to the Research Plan on a timely basis, uniQure shall use Commercially Reasonable Efforts including, without limitation, all Vector Characterization Data created pursuant to assess reasonably promptly the Research Program, the Research Plan for Liver, and the Research Plan for CNS, as well as the existence and status of all New Capsid Variants generated outside the Research Program during the applicable CNS Term or Liver Term (as applicable based on whether each Designated the variant at issue is a New CNS Variant or a New Liver Variant), and all Vector Characterization Data associated with such New Capsid Variant provided to uniQure in connection Variants. For clarity, New CNS Variants only arise during the CNS Term, and New Liver Variants only arise during the Liver Term, even though they, or the Vector Characterization Data with assessing respect thereto, may be later reported between the Delivery Success Criteria can be manufactured in insect cellsParties.
(bc) Either Party shall have the right to utilize the services of any Third Party to perform its obligations under the Research Plan to the extent that such Third Party is specifically approved in the Research Plan or otherwise approved by the JRSC, provided that any permitted Third Party must have entered into a written agreement with such Party that includes terms and conditions (i) protecting and limiting use and disclosure of Confidential Information at least to the same extent as under ARTICLE VIII, and (ii) requiring the Third Party and its personnel to assign to such Party all right, title and interest in and to any intellectual property (and intellectual property rights) created or conceived in connection with performance of subcontracted activities. Each Party shall remain at all times fully liable for its responsibilities under this Agreement.
(cd) 4DMT and uniQure shall conduct the Research Program in accordance with all applicable Laws, including, if and as applicable, Good Laboratory Practices. Each Party hereby certifies that it will not employ or otherwise use in any capacity in performing any activity hereunder the services of any person or entity known to it to be debarred under 21 USC §335a.
(d) If . For clarity, each of the JRSC determines that it is desirable New CNS Variants and each of the New Liver Variants to transfer be entered into validation studies under the AAV Capsid Variant Libraries into baculovirus, then prior to such transfer, Research Program shall meet the Parties will negotiate applicable Delivery Success Criteria as defined in good faith an amendment to this Agreement specifying the allocation of ownership of Materials, Know-How, and Patent Rights. Except as otherwise agreed by Research Plans unless the Parties in their discretions agree otherwise in writing, in no event shall 4DMT transfer the 4DMT AAV Capsid Variant Libraries to uniQure, and in no event shall uniQure transfer its baculovirus insect cell manufacturing Know-How to 4DMT.
Appears in 2 contracts
Samples: Collaboration and License Agreement (4D Molecular Therapeutics Inc.), Collaboration and License Agreement (uniQure N.V.)