Biosimilar Litigation Sample Clauses

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. (b) Notwithstanding anything to the contrary in this Agreement, I-Mab shall have the sole right, but not the obligation, to initiate, control, manage, prosecute and settle any Biosimilar Litigation in the I-Mab Territory and any proceedings associated therewith, in connection with any Product Patents, including any invalidity, unpatentability or unenforceability challenges, oppositions and post-grant proceedings in connection therewith. (c) If permitted pursuant to Applicable Law, upon AbbVie’s reques...
AutoNDA by SimpleDocs
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. b) Company shall have the sole right to (1) list any one or more Licensor Patents, insofar as they claim or Cover the Product as required pursuant to Section 262(l)(3)(A) or Section 262(l)(5)(B)(i)(II) of the PHSA, (2) respond to any communications with respect to such lists from the biosimilar filer, and (3) negotiate with the biosimilar filer as to whether to utilize a mechanism for information exchange other than that specified in Section 262(l)(1) of the PHSA and as to such Patent Rights that will be subject to the initial litigation procedure as described in Section 262(l)(4) of the PHSA, to decide which such Patent Rights shall be selected for initial litigation under Section 262(l)(4)(A) or Section 262(l)(5)(B)(i)(II) of the PHSA. Company shall be responsible to comply with the “Biological Product Patent Transparency” provisions under Section 325 of Division BB of the Consolidate Appropriations Act of December 27, 2020. c) Company shall have the sole right to identify one or more Licensor Patents or respond to relevant communications under any equivalent or similar listing to those described in the preceding Section 6.6.b) in any jurisdiction outside the US. d) Company shall consult with Licensor prior to identifying any one or more Licensor Patents to any biosimilar filer as contemplated by this Section 6.6. Company shall consider in good faith advice and suggestions with respect thereto received from Licensor, and notify Licensor of any such lists or communications promptly after they are made, in each case to the extent permitted by Applicable Laws. e) Without limitation to the foregoing Sections 6.6.a) – 6.6.d), if a Party receives a notice of commercial marketing from any biosimilar filer pursuant to Section 262(l)(8) of the PHSA, or any equivalent or similar certification or notice in any other country, such Party shall, within thirty (30) days of receiving such notice, notify the other Party and provide the other Party with copies thereof. Thereafter, Company shall have the first right to seek a preliminary injunction action under Section 262(l)(8)(B) of the PHSA or a declaratory judgment action pursu...
Biosimilar Litigation 

Related to Biosimilar Litigation

  • Third Party Litigation In the event that a Third Party institutes a patent or other infringement suit against any of NovaDel, PAR or HANA or any of its respective Affiliates during the Term, alleging manufacture, use or sale of a Licensed Product in the Territory, infringes one or more patent or other intellectual property rights held by such Third Party (an “Infringement Suit”), the Parties shall cooperate with one another in defending such suit. PAR, as the NDA holder, shall have the first right to direct and control, at its expense, any Infringement Suit (including settlement negotiations, settlement or compromise thereof) to the extent that it relates to the manufacture, use or sale of a Licensed Product but does not implicate the Licensed Technology or Licensed Process. In the event that the Infringement Suit relates to the use of the Licensed Technology or Licensed Process, NovaDel shall have the first right to direct and control, at its expense, any such Infringement Suit (including settlement negotiations, settlement or compromise thereof). To the extent that any amounts become payable to any Third Party as a result of such action, whether through judgment or settlement, then PAR shall, unless HANA is jointly promoting and commercializing the Licensed Product pursuant to Section 2.4 and subject to Section 12.2, bear [***] percent ([***]%) of such amounts with respect to the Exploitation of the Licensed Product; provided, however, that PAR shall have the right to credit [***] percent ([***]%) of any amounts paid by PAR through judgment or settlement with respect to such country against the royalty payments to be paid by PAR to HANA with respect to the sale of the Licensed Product under Section 6.3; provided further, however, that no royalty payment when due, regardless of the amount or number of credits available to PAR shall be reduced by more than [***] percent ([***]%) of the amounts otherwise owed pursuant to Section 6.3 in any calendar quarter. Credits not exhausted in any calendar quarter may be carried into future calendar quarters. Notwithstanding the foregoing, in the event that no payments are due or owing, or contemplated to be due or owing, by PAR to HANA under Article 6 with respect to the sale of the Licensed Product, then NovaDel shall pay to PAR such amount owed to a Third Party up to a cap of [***]% of such amount owed to such Third Party, less any amount already credited to PAR under this Section 10.3. Notwithstanding the foregoing, NovaDel shall have no obligation under this Section 10.3 for any costs, expenses or damages that are paid or payable to a Third Party as a result of an actual or alleged infringement by PAR or HANA to the extent such costs, expenses or damages result from the use of a Product Trademark.

  • 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.

  • Alternative to Litigation 13.2.1 The Parties desire to resolve disputes arising out of this Agreement without litigation. Accordingly, the Parties agree to use the following Dispute Resolution procedures with respect to any controversy or claim arising out of or relating to this Agreement or its breach.

  • Transaction Litigation From and after the date of this Agreement until the earlier of the Acquisition Merger Closing or termination of this Agreement in accordance with its terms, SPAC, on the one hand, and the Company, on the other hand, shall each notify the other in writing promptly after learning of any stockholder demands, other stockholder Actions (including derivative claims) or Actions brought by any third-party relating to this Agreement, any related agreements or any matters relating thereto (collectively, the “Transaction Litigation”) commenced against, in the case of SPAC, any of SPAC or its Subsidiaries or any of their respective Representatives (in their capacity as a Representative of SPAC or any of its Subsidiaries), or, in the case of the Company, any of the Company or its Subsidiaries or any of their respective Representatives (in their capacity as a Representative of the Company or any of its Subsidiaries). SPAC and the Company shall each (i) keep the other reasonably informed regarding any Transaction Litigation, (ii) give the other the opportunity to, at its own cost and expense, participate in the defense, settlement and compromise of any such Transaction Litigation and reasonably cooperate with the other in connection with the defense, settlement and compromise of any such Transaction Litigation, (iii) consider in good faith the other’s advice with respect to any such Transaction Litigation and (iv) reasonably cooperate with each other; provided, however, that in no event shall (x) SPAC or any of its Subsidiaries or any of their respective Representatives settle or compromise any Transaction Litigation without the prior written consent of the Company (not to be unreasonably withheld, conditioned or delayed), or (y) the Company or any of its Subsidiaries any or any of their respective Representatives settle or compromise any Transaction Litigation without the prior written consent of SPAC (not to be unreasonably withheld, conditioned or delayed).

  • 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 the Company, individually or in the aggregate, otherwise have a Material Adverse Effect on Parent'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. 11.2 During the TERM of this Agreement: (a) LICENSEE shall have the first right (but not the obligation) to defend the LICENSED PATENTS against infringement or interference in the FIELD and in the LICENSED TERRITORY by third parties. This right includes bringing any legal action for infringement and defending any counter claim of invalidity or action of a third party for declaratory judgment for non-infringement or non-interference. If, in the reasonable opinion of LICENSEE’s counsel, YALE is required to be a named party to any such suit for standing purposes, LICENSEE may join YALE as a party; provided, however, that (i) YALE shall not be the first named party in any such action, (ii) the pleadings and any public statements about the action shall state that the action is being pursued by LICENSEE and that LICENSEE has joined YALE as a party; and (iii) LICENSEE shall keep YALE reasonably apprised of all developments in any such action. LICENSEE may settle such suits solely in its own name and solely at its own expense and through counsel of its own selection; provided, however, that no settlement shall be entered without YALE’s prior written consent, such consent not to be unreasonably withheld. Without limiting the foregoing, YALE may withhold its consent to any settlement that would in any manner affect the validity, scope or enforceability of any LICENSED PATENT. LICENSEE shall bear the expense of such legal actions. Except for providing reasonable assistance (including joining such actions as described above), at the request and expense of LICENSEE, YALE shall have no obligation regarding the legal actions described in Article 11.2 unless required to participate by law. However, YALE shall have the right to participate in any such action through its own counsel and at its own expense. Any recovery shall first be applied to LICENSEE’s out of pocket expenses and second shall be applied to YALE’s out of pocket expenses, including legal fees. YALE shall recover [***]% of any excess recovery over those expenses. (b) In the event LICENSEE fails to initiate and pursue or participate in the actions described in Article 11.2(a) or in lieu of such actions to initiate negotiations for a sublicense of the infringer, and the infringement has not otherwise abated, within [***] of notification of infringement from YALE, YALE may, in its sole discretion, convert the LICENSE granted in Article 3 to a non-exclusive license. Additionally, YALE shall have the right to initiate legal action such as that described in Article 11.2(a) at its own expense. If, in the reasonable opinion of YALE’s counsel, LICENSEE is required to be a named party to any such suit for standing purposes, YALE may join LICENSEE as party plaintiff to uphold the LICENSED PATENTS, provided, however, that YALE shall keep LICENSEE reasonably apprised of all developments in any such action. In such case, LICENSEE shall provide reasonable assistance to YALE if requested to do so, at YALE’s expense. YALE may settle such actions solely through its own counsel any recovery shall be retained by YALE. YALE may terminate the LICENSE in the country where such legal action is taken. (c) In the event LICENSEE is permanently enjoined from exercising its LICENSE under this Agreement pursuant to an infringement action brought by a third party, or if both LICENSEE and YALE elect not to undertake the defense or settlement of a suit alleging infringement for a period of [***] from notice of such suit, then either party shall have the right to terminate this Agreement in the country where the suit was filed with respect to the LICENSED PATENT following [***] written notice to the other party in accordance with the terms of Article 15.

  • Notice of Legal Matter or Litigation Grantee will send notice to the Substance Use Disorder (SUD) email box, XxxxxxxxxXxxxx.Xxxxxxxxx@xxxx.xxxxx.xx.xx of any litigation or legal matter related to or affecting this Contract within seven (7) calendar days of becoming aware of the litigation or legal matter.

  • 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.

  • Pending Litigation Financial position and prospective long-term profitability of the Single Tenderer, and in the case the Tenderer is a JV, of each member of the JV, shall remain sound according to criteria established with respect to Financial Capability under paragraph I (i) above assuming that all pending litigation will be resolved against the Tenderer. Tenderer shall provide information on pending litigations as per Form CON-2.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!