Biosimilar Litigation Sample Clauses

Biosimilar Litigation a) Company shall have the sole right to designate pursuant to Title 42 U.S. Code Section 262(l)(1)(B)(i) or Section 262(l)(7) of the Public Health Services Act (“PHSA”) the outside counsel and in-house counsel who will receive confidential access to any biosimilar product application and manufacturing process information of any biosimilar filer.
Sample 1
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Biosimilar Litigation. (a) Notwithstanding anything to the contrary in this Agreement, AbbVie shall have the first right, but not the obligation, to initiate, control, manage, prosecute and settle any litigation with respect to Biosimilar Products, or any applications seeking Regulatory Approval of Biosimilar Products and any proceedings associated therewith, in connection with any Patents, including any invalidity, unpatentability or unenforceability challenges, oppositions and post-grant proceedings in connection therewith (collectively “Biosimilar Litigation”), in the AbbVie Territory. If I-Mab receives notice or a copy of an application for a Biosimilar Product (a “Biosimilar Application”) submitted to FDA or its foreign counterpart in the AbbVie Territory for which a Licensed Product is a “reference product,” as such term is used in Section 351(i)(4) of the PHSA or the same or like term used in the foreign counterpart, whether or not such notice or copy is provided under any Applicable Laws, or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority in the AbbVie Territory for Drug Approval Application (such as in an instance described in Section 351(1)(9)(C) of the PHSA), I-Mab shall, within five (5) Business Days of receipt of any such notice or communication, notify and provide AbbVie copies of such notice or communication to the extent permitted by Applicable Law. To the extent AbbVie has elected to prosecute any Biosimilar Litigation, AbbVie shall carry out any such rights and responsibilities of the “reference product sponsor,” as defined in Section 351(l)(1)(A) of the PHSA, for purposes of such Biosimilar Application, in consultation with I-Mab to the extent permitted under Applicable Law and at AbbVie’s sole expense. If requested by AbbVie, I-Mab shall seek to obtain access to the Biosimilar Application and related confidential information, including in accordance with Section 351(l)(1)(B)(iii) of the PHSA, if applicable.
Sample 1
Biosimilar Litigation. Notwithstanding anything to the contrary in this Section 10.3 (Enforcement), regardless of the Party that is the “reference product sponsor” for purposes of an application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (“PHSA”) (“Biosimilar Application”), as between the Parties: (a) AstraZeneca shall have the sole right to designate, pursuant to Section 351(l)(1)(B)(ii) of the PHSA, the counsel who shall receive confidential access to the Biosimilar Application; (b) AstraZeneca shall have the sole right to list any Patent Rights, including the Licensed Patent Rights but excluding the Patent Rights granted under the Existing Upstream Licenses, to the extent that such Patent Rights claim or otherwise Cover the applicable Licensed Product as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; (c) [***] or respond to communications under any equivalent or similar listing described in foregoing sub-clauses (a) and (b) in any other jurisdiction in the Territory; and (d) Cellectis shall cooperate in good faith with AstraZeneca with respect to any such certification or notice under Applicable Law, including with respect to proceedings related thereto. If required pursuant to Applicable Law, Cellectis shall prepare such lists and make such responses at AstraZeneca’s direction and cost. At AstraZeneca’s cost, Cellectis shall: (i) provide to AstraZeneca, within [***] of AstraZeneca’s request, all information, including a correct and complete list of Licensed Patent Rights Covering any Licensed Product, that is necessary or reasonably useful to enable AstraZeneca to make such lists and communications with respect to the Licensed Patent Rights solely to the extent not already provided under this Agreement; and (ii) cooperate with AstraZeneca’s reasonable requests in connection therewith, including reasonable requests to meet any submission deadlines, in each case, to the extent required or permitted by Applicable Law. AstraZeneca shall: (A) reasonably consult with Cellectis prior to identifying any Licensed Patent Rights to a Third Party as contemplated by this Section 10.3.5 (Biosimilar ...
Sample 1
Biosimilar Litigation 
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Related to Biosimilar Litigation

  • Third Party Litigation The undersigned agrees to be available to the Company and its affiliates on a reasonable basis in connection with any pending or threatened claims, charges or litigation in which the Company or any of its affiliates is now or may become involved, or any other claims or demands made against or upon the Company or any of its affiliates, regardless of whether or not the undersigned is a named defendant in any particular case.

  • Stockholder Litigation The Company shall give Parent the opportunity to participate in the defense or settlement of any stockholder litigation against the Company and/or its directors relating to the transactions contemplated by this Agreement, and no such settlement shall be agreed to without Parent’s prior written consent.

  • Shareholder Litigation The Company shall give Parent the opportunity to participate in the defense or settlement of any shareholder litigation against the Company and/or its directors relating to the transactions contemplated by this Agreement, and no such settlement shall be agreed to without Parent’s prior written consent.

  • Transaction Litigation In the event that any stockholder litigation related to this Agreement or the transactions contemplated by this Agreement is brought, or, to the Knowledge of the Company, threatened, against the Company or any Indemnified Party from and following the date of this Agreement and prior to the Effective Time (such litigation, other than any Proceeding in connection with, arising out of or otherwise related to a demand for appraisal under Section 262 of the DGCL, which shall be governed by Section 4.2(g), “Transaction Litigation”), the Company shall as promptly as practicable (a) notify Parent thereof and shall keep Parent reasonably informed with respect to the status thereof, (b) give Parent an opportunity to participate in the defense and/or settlement (at Parent’s sole expense and subject to a customary joint defense agreement) of any Transaction Litigation, (c) timely consult with Parent with respect to the defense and/or settlement of any Transaction Litigation and (d) shall consider in good faith Parent’s advice and recommendations with respect to such Transaction Litigation. The Company shall not agree to settle or offer to settle any Transaction Litigation without the prior written consent of Parent (which consent shall not be unreasonably withheld, delayed, or conditioned).

  • No Proceeding or Litigation No suit, action, investigation, inquiry or other proceeding by any Authority or other person or entity will have been instituted or threatened which delays or questions the validity or legality of the transactions contemplated hereby or which, if successfully asserted, would, in the reasonable judgment of Parent, individually or in the aggregate, otherwise have a Material Adverse Effect on the Company's business, financial condition, prospects, assets or operations or prevent or delay the consummation of the transactions contemplated by this Agreement.

  • Infringement and Litigation 11.1 Each party shall promptly notify the other in writing in the event that it obtains knowledge of infringing activity by third parties, or is sued or threatened with an infringement suit, in any country in the LICENSED TERRITORY as a result of activities that concern the LICENSED PATENTS, and shall supply the other party with documentation of the infringing activities that it possesses.

  • Cooperation With Regard to Litigation Executive agrees to cooperate with the Company, during the term and thereafter (including following Executive’s termination of employment for any reason), by making himself available to testify on behalf of the Company or any subsidiary or affiliate of the Company, in any action, suit, or proceeding, whether civil, criminal, administrative, or investigative, and to assist the Company, or any subsidiary or affiliate of the Company, in any such action, suit, or proceeding, by providing information and meeting and consulting with the Board or its representatives or counsel, or representatives or counsel to the Company, or any subsidiary or affiliate of the Company, as may be reasonably requested and after taking into account Executive’s post-termination responsibilities and obligations. The Company agrees to reimburse Executive, on an after-tax basis, for all reasonable expenses actually incurred in connection with his provision of testimony or assistance.

  • No Threatened or Pending Litigation On the Closing Date, no suit, action or other proceeding, or injunction or final judgment relating thereto, shall be threatened or be pending before any court or governmental or regulatory official, body or authority in which it is sought to restrain or prohibit or to obtain damages or other relief in connection with this Agreement or the consummation of the transactions contemplated hereby, and no investigation that might result in any such suit, action or proceeding shall be pending or threatened.

  • Pending Litigation There are no actions, suits, proceedings or written agreements pending, or, to the Company’s knowledge, threatened or proposed, against the Company or any of its Subsidiaries at law or in equity or before or by any federal, state, municipal, or other governmental department, commission, board, or other administrative agency, domestic or foreign, that, either separately or in the aggregate, would reasonably be expected to have a Material Adverse Effect on the Company and any of its Subsidiaries, taken as a whole, or affect issuance or payment of the Subordinated Notes; and neither the Company nor any of its Subsidiaries is a party to or named as subject to the provisions of any order, writ, injunction, or decree of, or any written agreement with, any court, commission, board or agency, domestic or foreign, that either separately or in the aggregate, will have a Material Adverse Effect on the Company and any of its Subsidiaries, taken as a whole.

  • No Governmental Proceeding or Litigation No suit, action, investigation, inquiry or other proceeding by any governmental body or other person or legal or administrative proceeding shall have been instituted or threatened which questions the validity or legality of the transactions contemplated hereby.

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