ANDA Litigation definition

ANDA Litigation means the Legal Proceedings set forth on Schedule 1.11.
ANDA Litigation means any litigation commenced in connection with the submission by any Third Party of an abbreviated new drug application with respect to any product containing Compound and including a certification pursuant to Section 505(b)(2)(A)(iv) of the FFDCA.
ANDA Litigation means the Legal Proceedings set forth on Schedule 2.04(g).

Examples of ANDA Litigation in a sentence

  • Depomed shall keep Collegium reasonably informed with respect to the status of and any material developments in the ANDA Litigation, including any settlement discussions in connection therewith, and shall consider in good faith any reasonable input provided by Collegium or its counsel with respect thereto.

  • As between Depomed and Collegium, Depomed may settle or otherwise resolve the ANDA Litigation, in its sole and absolute discretion, including by granting ANDA Settlement Distributors the right to Commercialize Generic Versions of Products in the Territory.

  • Any awards for any motions, applications or other filings for recovery of funds (regardless of type or category), including costs, fees and sanctions related to the ANDA Litigation, whether or not they were on file prior to the Closing Date, shall be retained in full by Depomed.

  • As between Depomed and Collegium, from and after the Closing, Depomed shall, at its cost and expense, continue to control, direct and maintain control over the ANDA Litigation.

  • In addition to the foregoing, in respect of any Product ANDA Litigation controlled by Seller, Seller shall (a) keep Buyer reasonably informed regarding Seller’s actions with respect to such action and (b) promptly provide Buyer with copies of all documents and other materials filed by any party to such Product ANDA Litigation with the court before which such Product ANDA Litigation is pending.

  • Section 10.2 Representations and Warranties of Collegium and Newco 79 Section 10.3 Warranty Disclaimer 82 ARTICLE 11 INTELLECTUAL PROPERTY MATTERS 83 Section 11.1 Acuform Patent Prosecution and Maintenance 83 Section 11.2 Acuform Patent Infringement 83 Section 11.3 ANDA Litigation 83 Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

  • Buyer shall review and approve any complaint or other filing made by or on behalf of Seller in any Product ANDA Litigation.

  • Seller will transfer control of any Product ANDA Litigation to Buyer promptly after the Closing.

  • Notwithstanding the foregoing, it is understood and agreed that (x) except for the original notice of a Paragraph IV Claim, Seller’s shall not be obligated to share information pursuant to this Section 4.7 until a common interest agreement has been mutually agreed to and executed by the Parties; and (y) Seller and its Affiliates shall retain the right to initiate Product ANDA Litigation prior to the Closing Date in response to a Paragraph IV Claim.

  • Except for the ANDA Litigation, Depomed and Newco shall cooperate fully with, and as reasonably requested by, Collegium in any action to enforce any Grünenthal Patent in any Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.


More Definitions of ANDA Litigation

ANDA Litigation shall have the meaning ascribed to the term in Section 7.5.2 of this Agreement.

Related to ANDA Litigation

  • Transaction Litigation means any Legal Proceeding commenced or threatened against a Party or any of its Subsidiaries or Affiliates (and/or their respective directors and/or executive officers) or otherwise relating to, involving or affecting such Party or any of its Subsidiaries or Affiliates, in each case in connection with, arising from or otherwise relating to the Transaction or the consummation thereof, other than any Legal Proceedings among the Parties or their Affiliates related to this Agreement.

  • Pending Litigation means a proceeding in a court of law whose activity is in progress but not yet completed.

  • Threatened litigation as used herein shall include governmental investigations and civil investigative demands. “Litigation” as used herein shall include administrative enforcement actions brought by governmental agencies. The Contractor must also disclose any material litigation threatened or pending involving Subcontractors, consultants, and/or lobbyists. For purposes of this section, “material” refers, but is not limited, to any action or pending action that a reasonable person knowledgeable in the applicable industry would consider relevant to the Work under the Contract or any development such a person would want to be aware of in order to stay fully apprised of the total mix of information relevant to the Work, together with any litigation threatened or pending that may result in a substantial change in the Contractor’s financial condition.

  • Material Litigation is defined in Section 6.7.

  • Litigation means any action, suit or proceeding before any court, mediator, arbitrator or Governmental Authority.

  • Disclosed Litigation has the meaning specified in Section 3.01(b).

  • Litigation Claims means the claims, rights of action, suits or proceedings, whether in law or in equity, whether known or unknown, that any Debtor or any Estate may hold against any Person or Entity, including, without limitation, the Causes of Action of the Debtors or their Estates, in each case solely to the extent of the Debtors’ or their Estates’ interest therein. A non-exclusive list of the Litigation Claims held by the Debtors as of the Effective Date will be Filed with the Plan Supplement, which will be deemed to include any derivative actions filed against any Debtor as of the Effective Date.

  • Lawsuit means any lawsuit, arbitration or other dispute resolution filed by either party herein pertaining to any of this Warrant, the Facility Agreement and the Registration Rights Agreement.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • dispute resolution proceeding ’ means any process in which an alternative means of dispute resolution is used to resolve an issue in controversy in which a neutral is appointed and specified parties participate;

  • Civil action means all suits or claims of a civil nature in a state or federal court, whether cognizable as cases at law or in equity or admiralty. "Civil action" does not include any of the following:

  • Third Party Infringement Claim has the meaning set forth in Section 9.4.

  • Patent Prosecution means the responsibility and authority for (a) preparing, filing and prosecuting applications (of all types) for any Patent, (b) paying, filing and maintenance fees relating to any Patent, (c) managing any interference, opposition, re-issue, reexamination, revocation, nullification, or cancellation proceeding relating to the foregoing, (d) deciding to abandon Patent(s) and (e) settling any interference, opposition, revocation, nullification or cancellation proceeding.

  • Infringement Claim means a third party claim alleging that the Equipment manufactured by Motorola or the Motorola Software directly infringes a United States patent or copyright.

  • Plaintiffs’ Releasees means Plaintiffs, and any and all of their related parties, including, without limitation, any and all members of their immediate families, agents or other persons acting on their behalf, attorneys, advisors, financial advisors, accountants, assigns, creditors, heirs, estates and legal representatives.

  • Infringement Action has the meaning set forth in Section 9.6(b).

  • Regulatory Action means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

  • Unresolved Claim means a Claim, which at the relevant time, in whole or in part: (a) has not been Finally Determined to be a Proven Claim in accordance with the Amended Claims Procedure Order and this Plan; (b) is validly disputed in accordance with the Amended Claims Procedure Order; and/or (c) remains subject to review and for which a Notice of Allowance or Notice of Revision or Disallowance (each as defined in the Amended Claims Procedure Order) has not been issued to the Creditor in accordance with the Amended Claims Procedure Order as at the date of this Plan, in each of the foregoing clauses, including both as to proof and/or quantum;

  • Unresolved Claims has the meaning set forth in Section 7.6(c).

  • Legal Action means and includes any claim, counterclaim, demand, action, suit, counterclaim, arbitration, inquiry, proceeding or investigation before any

  • Defendants’ Releasees means Defendants and their current and former parents, affiliates, subsidiaries, officers, directors, agents, successors, predecessors, assigns, assignees, partnerships, partners, trustees, trusts, employees, Immediate Family Members, insurers, reinsurers, and attorneys.

  • Third Party Infringement has the meaning set forth in Section 5.1.

  • Intellectual Property Claim means the assertion by any Person of a claim (whether asserted in writing, by action, suit or proceeding or otherwise) that any Borrower’s ownership, use, marketing, sale or distribution of any Inventory, Equipment, Intellectual Property or other property or asset is violative of any ownership of or right to use any Intellectual Property of such Person.

  • Tax Contest means an audit, review, examination, or any other administrative or judicial proceeding with the purpose or effect of redetermining Taxes (including any administrative or judicial review of any claim for refund).

  • Defendants means all of the Individual Defendants and the Corporate Defendants, individually, collectively, or in any combination.