Biosimilars Litigation Sample Clauses

Biosimilars Litigation. In the event that a Product within the scope of this collaboration is a New Biologic Entity in accordance with the definition, applied by the responsible regulatory authority, and in the case of doubt in accordance with the definition specified in the “Biologics Price Competition and Innovation Act of 2009” (the “Biosimilars Act”), and if generic companies might enter the market with a Biosimilar Product equivalent to a Product, the following provisions shall apply: If a Third Party (“Biosimilars Applicant”) has submitted an application (a “BLA”) under 42 U.S.C. §262(k) (approval pathway for biosimilar biological products) of the Biosimilars Act, or under a comparable provision of applicable law outside of the United States, for licensure of a biological product referencing a Product as the reference listed product, 131 shall, no later than five (5) days after receipt of a copy of the BLA, provide Zealand Pharma with notice thereof. If Zealand Pharma wishes to receive a copy of such BLA and other confidential information received by BI from the Biosimilars Applicant with respect to such BLA (the “BLA Materials”) and to receive the other information called for in this Section 14.9.2, and if such provision of materials to Zealand Pharma is subject to the Biosimilars Act, Zealand Pharma shall, within five (5) days of the receipt of such notice from BI, provide written notice to BI and the Biosimilars Applicant of its agreement to be subject to the confidentiality provisions of 42 U.S.C. § 262(1). Within five (5) days after receipt by BI of written confirmation that such notice has been provided to Xxxxx the Biosimilars Applicant, BI shall provide the BLA Materials to a representative of Zealand Pharma authorized to receive such materials under 42 U.S.C. § 262(1)(1)(B)(ii). Promptly after receiving any new BLA Materials from the Biosimilars Applicant, BI shall provide a copy of such information to such Zealand Pharma representative. [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. Except as otherwise set forth herein, BI shall have exclusive control over, and shall bear the expense of, any exchange of information with a Biosimilars Applicant required under the Biosimilars Act or other comparable applicable ex-U.S. laws, the initiation, conduct and settlement of any patent infringement actions ...
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Related to Biosimilars 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.

  • Investigations; Litigation There is no investigation or review pending (or, to the knowledge of Parent, threatened) by any Governmental Entity with respect to Parent or any of its Subsidiaries which would have, individually or in the aggregate, a Parent Material Adverse Effect, and there are no actions, suits, inquiries, investigations or proceedings pending (or, to Parent’s knowledge, threatened) against or affecting Parent or its Subsidiaries, or any of their respective properties at law or in equity before, and there are no orders, judgments or decrees of, or before, any Governmental Entity, in each case which would have, individually or in the aggregate, a Parent Material Adverse Effect.

  • 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.

  • 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.

  • Cost of Litigation In any action at law or in equity or any arbitration to enforce any of the provisions or rights under this Agreement, the unsuccessful party to such litigation, as determined by the court or arbitrator in a final judgment or decree, shall pay the successful party or parties all costs, expenses and reasonable attorneys' fees incurred by the successful party or parties (including without limitation costs, expenses and fees on any appeals), and if the successful party recovers judgment in any such action or proceeding, such costs, expenses and attorneys' fees shall be included as part of the judgment.

  • Liabilities; Litigation (a) The financial statements delivered by Borrower and each Borrower Party are true and correct with no significant change since the date of preparation. Except as disclosed in such financial statements, there are no liabilities (fixed or contingent) affecting the Project, Borrower or any Borrower Party. Except as disclosed in such financial statements, there is no litigation, administrative proceeding, investigation or other legal action (including any proceeding under any state or federal bankruptcy or insolvency law) pending or, to the knowledge of Borrower, threatened, against the Project, Borrower or any Borrower Party which if adversely determined could have a material adverse effect on such party, the Project or the Loan.

  • Dismissal of Litigation Within five (5) days of the Effective Date, Summit, VISX and Pillar Point shall cause all of the Summit/VISX Litigation (as hereinafter defined) to be dismissed with prejudice, with each party to bear its own costs and attorneys' fees. As used herein, "Summit/VISX Litigation" means VISX Partner, Inc. v. Summit Partner, Inc., Santx Xxxxx Xxxxxx Xxxxxxxx Court, Case No. CV 772057; VISX, Incorporated v. Pillar Point Partners, et al., Santx Xxxxx Xxxxxx Xxxxxxxx Court, Case No. 770042; and VISX Partner, Inc., on behalf Pillar Point Partners, United States District Court, District Of Massachusetts, Case No. 96-11739-PBS. The term "Summit/VISX Litigation" includes all counterclaims, cross-claims and the like asserted in the foregoing actions.

  • Settlement of Litigation Hanover shall not, nor shall it permit any of its Subsidiaries to, settle any litigation, investigation, arbitration, proceeding or other claim if Hanover or any of its subsidiaries would be required to pay in excess of $10,000 individually or in the aggregate or if such settlement would obligate Hanover to take any material action or restrict Hanover in any material respect from taking any action at or after the Effective Time.

  • Litigation; Regulatory Action (a) Except as set forth on Schedule 3.10 of the Company Disclosure Schedule, no litigation, claim, suit, investigation or other proceeding before any court, governmental agency or arbitrator is pending against the Company or any of its Subsidiaries, and, to the Knowledge of the Company, (i) no such litigation, claim, suit, investigation or other proceeding has been threatened and (ii) there are no facts which would reasonably be expected to give rise to such litigation, claim, suit, investigation or other proceeding.

  • 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).

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