Novartis Responsibility. Grant Recipient agrees that Novartis’ responsibility is solely to provide the Grant Amount. Novartis will not be liable to Grant Recipient or to any other person for the Grant Activity or the use of the Grant Amount (including any claims or losses related thereto). Novartis may terminate this Agreement and require Grant Recipient to return the Grant Amount and take other corrective action if Grant Recipient breaches this Agreement.
Novartis Responsibility. Sponsorship Recipient agrees that Novartis’ responsibility is solely to provide the Sponsorship Amount and to receive the tangible benefit. Novartis will not be liable to Sponsorship Recipient or to any other person for the Sponsorship Activity or the use of the Sponsorship Amount (including any claims or losses related thereto). Novartis may terminate this Agreement and require Sponsorship Recipient to return the Sponsorship Amount and take other corrective action if Sponsorship Recipient breaches this Agreement.
Novartis Responsibility. Recipient agrees that Novartis’ responsibility is solely to provide the Amount stated in Exhibit A. Novartis will not be liable to Recipient or to any other person for the Activity or the use of the Amount (including any claims or losses related thereto). Novartis may terminate this Agreement and require Recipient to return the Amount and take other corrective action if Recipient breaches this Agreement.
Novartis Responsibility. As between the Parties, Novartis shall be solely responsible in its sole discretion for regulatory activities under this Agreement, including: (a) determining the regulatory plans and strategies for the Product; (b) making all Regulatory Filings with respect to the Product, except for those that are required to be made by CBMG or its Affiliates under Applicable Law, in which case Novartis shall have the right to review and provide its written approval prior to the submission of such Regulatory Filings to the SAMR or other relevant Regulatory Authority; (c) obtaining and maintaining all Regulatory Approvals for the Product, except for those which are required to be obtained by CBMG or its Affiliates under Applicable Law, in which case Novartis shall have the right to review and give its written approval prior to the submission of any application for such Regulatory Approvals to the SAMR or other relevant Regulatory Authority; and (d) conducting all meetings with Regulatory Authorities in connection with the Development and Regulatory Approval of the Product, in each case ((a) through (d)), in the Territory. Any such activities may be performed by Novartis, its Affiliates, or its designees.
Novartis Responsibility. Recipient agrees that Novartis’ responsibility is to provide the Amount and to provide input, competences and network to the project. Novartis will not be liable to Recipient or to any other person for the Activity or the use of the Amount (including any claims or losses related thereto). Novartis may terminate this Agreement and require Recipient to return the Amount and take other corrective action if Recipient breaches this Agreement.
Novartis Responsibility.
(a) shall through the JPC, keep BicycleTx reasonably informed in relation to the preparation, filing, prosecution and maintenance of the [***], including by:
(i) providing BicycleTx with a copy of material communications to and from any patent authority in the Territory regarding the [***] and claims therein; and
(ii) providing drafts of any communications to any patent authority covered by (i) above and any material filings to be made to such patent authorities in the Territory sufficiently in advance of submitting such communications or filings so as to allow for a reasonable opportunity for BicycleTx to review and comment on such communications and filings;
(b) shall through the JPC, consider and take into account BicycleTx’s comments in relation to the preparation, filing, prosecution and maintenance of [***]; and
(c) shall, in accordance with Clause 3.8.2, make all decisions relating thereto including, for the avoidance of doubt, all decisions relating to the filing, prosecuting, maintenance and management, including strategies relating to the Unified Patent Court and Unitary Patent in Europe, such as, but not limited to, the filing or withdrawing of an opt- out and validating as a Unitary Patent or as a classical European Patent. BicycleTx will reasonably cooperate with Novartis in connection with the prosecution and maintenance, including with US 173051874v18 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. respect to the Unified Patent Court and Unitary Patent in Europe, and including by providing reasonable access to relevant persons and executing all documentation reasonably requested by Novartis within the timeframe reasonably requested by Novartis. If during the Term, Novartis intends to allow any [***] to lapse or become abandoned without having first filed a substitute, Novartis shall notify BicycleTx through the JPC of such intention at least [***] prior to the date upon which such [***] shall lapse or become abandoned, and BicycleTx shall have the right, but not the obligation, to assume responsibility for the prosecution and maintenance thereof at its sole cost and expense with counsel of its choice, except if Novartis notifies the JPC in writing that it considers, acting in good faith, that [***].
