Notice of Opt-Out Sample Clauses

Notice of Opt-Out. On a Selected Target-by-Selected Target basis, EPIZYME shall have the right, in its sole discretion, to elect to exercise an “EPIZYME Opt-Out”, pursuant to which EPIZYME opts-out of further participation in: (a) Development with respect to the applicable Development Program, such EPIZYME Opt-Out to be exercised only at any time between [**] days prior to and [**] days prior to either the (i) scheduled Initiation of the first Pivotal Clinical Trial (such period, the “Pre-Pivotal Opt-Out Period”), or (ii) estimated date of filing of the first NDA (such period, the “Pre-NDA Opt-Out Period”; and together with the Pre-Pivotal Opt-Out Period, the “Pre-Regulatory Approval Opt-Out Period”); or (b) Commercialization at any time after the first Regulatory Approval by the FDA of a Licensed Compound or Licensed Product from the applicable Development Program (the “Post-Regulatory Approval Opt-Out Period”); in each case by providing written notice to CELGENE of such election. Any such EPIZYME Opt-Out shall, subject to Section 3.8.4, take effect [**] days after the date of such written notice (the “EPIZYME Opt-Out Date”). For purposes of clarity, no rights with respect to the United States shall be transferred by EPIZYME to CELGENE until receipt of all applicable consents and approvals under Antitrust Laws, including the termination or expiration of any applicable waiting periods under the HSR Act pursuant to Section 3.8.5. Subject to Sections 3.8.2(c), 3.8.2(d), 3.8.3(a) and 3.8.3(b), EPIZYME shall not be responsible for Global Development Costs regarding the applicable Development Program incurred after the EPIZYME Opt-Out Date.
Sample 1Sample 2
AutoNDA by SimpleDocs
Notice of Opt-Out. The Opting-Out Party shall provide the other Party with written notice of the Opting-Out Party’s intention to Opt-Out not later than thirty (30) days after the JDC receives pursuant to Section 2.5.1 a written proposal for a new Clinical Study or Post Approval Study or a material modification to a Clinical Study or Post Approval Study being conducted under the Development Plan. In such event, the provisions of Section 2.5.2 shall apply to the conduct of such study as a Unilateral Activity. With respect to a material modification to a Clinical Study or Post Approval Study for which a Party has Opted-Out, any Collaboration Costs that have been incurred prior to the beginning of an Opt-Out Period shall not be reduced or refundable to the Opting-Out Party.
Sample 1Sample 2
Notice of Opt-Out. The Practice is not a participating provider in the Medicare program ("Medicare"), and the physician providing Services on behalf of the Practice ("Practice Physician") does not
Sample 1
Notice of Opt-Out. On a Non-[*] DC-by-Non-[*] DC basis, SUTRO shall have the right, in its sole discretion, to elect to exercise a “SUTRO Opt-Out”, pursuant to which SUTRO opts-out of further participation in: (a) development and commercialization of the Non-[*] DC (and corresponding Licensed Products and Diagnostic Products) in the SUTRO Territory, such SUTRO Opt-Out to be exercised only during the period prior to the filing of the BLA with the FDA for such Non-[*] (the “Pre-Regulatory Approval Opt-Out Period”); or (b) commercialization of the Non-[*] DC (and corresponding Licensed Products and Diagnostic Products) at any time after the first Regulatory Approval by the FDA of the Non-[*] DC (or corresponding Licensed Products) (the “Post-Regulatory Approval Opt-Out Period”); in each case by providing written notice to CELGENE of such election. Any such SUTRO Opt-Out shall, subject to Section 4.6.3, take effect ninety (90) days after the date of such written notice (the “SUTRO Opt-Out Date”). For purposes of clarity, no rights with respect to the SUTRO Territory shall be transferred by SUTRO to CELGENE until receipt of all applicable consents and approvals under Antitrust Laws, including the termination or expiration of any applicable waiting periods under the HSR Act pursuant to Section 4.6.3.
Sample 1
Notice of Opt-Out. With respect to the Co-Co Program, OncoMed shall have the right, in its sole discretion, to elect to exercise its right to opt-out of further participation in both the Development and Commercialization of such Co-Co Program (including the Co-Co Target, all Co-Co Candidates and Co-Co Products, and related Diagnostic Products), which may be exercised by OncoMed at any time during the Co-Co Term by providing [***] written notice to Celgene of such election (such notice, the “OncoMed Opt-Out Notice”); provided that if OncoMed exercises its right to opt-out at any time during the [***], then such notice period shall commence on the date of the OncoMed Opt-Out Notice and continue until [***]. After OncoMed provides such OncoMed Opt-Out Notice, Celgene shall have sole discretion with respect to any matters regarding the sales force, including the designation of sales representatives.
Sample 1

Related to Notice of Opt-Out

  • CAFA Notice Pursuant to 28 U.S.C. § 1715, not later than ten (10) days after the Agreement is filed with the Court, the Settlement Administrator shall cause to be served upon the Attorneys General of each U.S. State in which Settlement Class members reside, the Attorney General of the United States, and other required government officials, notice of the proposed settlement as required by law, subject to Paragraph 5.1 below.

  • Notice of Sale Each Pledgor acknowledges and agrees that, to the extent notice of sale or other disposition of the Pledged Collateral or any part thereof shall be required by law, ten (10) days’ prior notice to such Pledgor of the time and place of any public sale or of the time after which any private sale or other intended disposition is to take place shall be commercially reasonable notification of such matters. No notification need be given to any Pledgor if it has signed, after the occurrence of an Event of Default, a statement renouncing or modifying any right to notification of sale or other intended disposition.

  • Notice of Delay 12.1. When anything delays or threatens to delay the timely performance of the Purchase Order, Supplier must immediately provide written notice to Buyer in writing of all relevant information, including but not limited to the reasons for the potential delay and Supplier’s short-term and long-term mitigation actions.

  • Notice of Sole Control If at any time the Secured Party delivers to the Financial Institution a Notice of Sole Control in substantially the form set forth in Exhibit A hereto (a “Notice of Sole Control”), the Financial Institution agrees that after receipt of such notice, it will take all instructions with respect to the Collateral Accounts solely from the Secured Party and shall not comply with instructions or entitlement orders of any other person.

  • NOTICE OF DELAYS Except as otherwise provided under this Contract, when either party has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this Contract, that party shall, within one (1) business day, give notice thereof, including all relevant information with respect thereto, to the other party.

  • Notice of Enrollment Notice shall include a list of new employees represented by the Union scheduled to attend the NEO. If practical, the City agrees to provide additional identifying information including, but not limited to, classification and department. Six months from enactment, in the event the City is unable to provide classification and department information in the Notice of Enrollment, the Union can reopen this Agreement for the sole purpose of meeting and conferring over the identifying information provided in this Section II.C.3

  • Notice of Acceptance Notice of each Offeree’s intention to accept, in whole or in part, any Offer made shall be evidenced by a writing signed by such Offeree and delivered to the Company prior to the end of the 20-day period of such offer, setting forth such of the Offeree’s Basic Amount as such Offeree elects to purchase and, if such Offeree shall elect to purchase all of its Basic Amount, such Undersubscription Amount as such Offeree shall elect to purchase (the “Notice of Acceptance”). If the Basic Amounts subscribed for by all Offerees are less than the total Offered Securities, then each Offeree who has set forth Undersubscription Amounts in its Notice of Acceptance shall be entitled to purchase, in addition to the Basic Amounts subscribed for, all Undersubscription Amounts it has subscribed for; provided, however, that should the Undersubscription Amounts subscribed for exceed the difference between the Offered Securities and the Basic Amounts subscribed for (the “Available Undersubscription Amount”), each Offeree who has subscribed for any Undersubscription Amount shall be entitled to purchase only that portion of the Available Undersubscription Amount as the Undersubscription Amount subscribed for by such Offeree bears to the total Undersubscription Amounts subscribed for by all Offerees, subject to rounding by the Board of Directors to the extent it reasonably deems necessary.

  • Notice of Extension (a) If the Property Trustee is the only registered holder of the Debentures at the time the Company selects an Extended Interest Payment Period, the Company shall give written notice to the Administrative Trustees, the Property Trustee and the Trustee of its selection of such Extended Interest Payment Period two Business Days before the earlier of (i) the next succeeding date on which Distributions on the Trust Securities issued by the Trust are payable; or (ii) the date the Trust is required to give notice of the record date, or the date such Distributions are payable, to The Nasdaq National Market or other applicable self-regulatory organization or to holders of the Preferred Securities issued by the Trust, but in any event at least one Business Day before such record date. (b) If the Property Trustee is not the only holder of the Debentures at the time the Company selects an Extended Interest Payment Period, the Company shall give the holders of the Debentures and the Trustee written notice of its selection of such Extended Interest Payment Period at least two Business Days before the earlier of (i) the next succeeding Interest Payment Date; or (ii) the date the Company is required to give notice of the record or payment date of such interest payment to The Nasdaq National Market or other applicable self-regulatory organization or to holders of the Debentures. (c) The quarter in which any notice is given pursuant to paragraphs (a) or (b) of this Section 4.2 shall be counted as one of the 20 quarters permitted in the maximum Extended Interest Payment Period permitted under Section 4.1.

  • Notice of Proposed Transfer The Holder of the Shares shall deliver to the Company a written notice (the “Notice”) stating: (i) the Holder’s bona fide intention to sell or otherwise transfer such Shares; (ii) the name of each proposed purchaser or other transferee (“Proposed Transferee”); (iii) the number of Shares to be transferred to each Proposed Transferee; and (iv) the bona fide cash price or other consideration for which the Holder proposes to transfer the Shares (the “Offered Price”), and the Holder shall offer the Shares at the Offered Price to the Company or its assignee(s).

  • Notice of Events As soon as Guarantor obtains knowledge thereof, Guarantor shall give Guarantied Party written notice of any condition or event which has resulted in (a) a material adverse change in the financial condition of Guarantor or Company or (b) any Event of Default or Potential Event of Default.

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