Proposed Additional Indication is a Related Indication Sample Clauses

Proposed Additional Indication is a Related Indication. Where any such proposed Additional Indication is a Related Indication for the Active Indication in which such Product Candidate/Product is being jointly Developed or Commercialized, the JEC shall consider in good faith any such proposal for Additional Indication Activities. If the Parties mutually agree that such Additional Indication Activities may be carried out for such Product Candidate/Product in a Profit Share Region, and both Parties desire to fund such Additional Indication Activities, then the Parties shall carry out such Additional Indication Activities, and fund such Additional Indication Activities equally, all in accordance with an amendment approved by the JEC to the then-current (or most recently completed) Product Development Plan for such Product Candidate/Product for the applicable Active Indication. If one Party’s representatives on the JEC wish to pursue such Additional Indication Activities and the other Party’s representatives on the JEC do not wish to do so [***].
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Proposed Additional Indication is a Related Indication. Where any such proposed Additional Indication is a Related Indication for the Active Indication in which such Product Candidate/Product is being Developed or Commercialized unilaterally by a Party, then the Participating Party (but not the other Party) shall have the right (but not the obligation) to carry out Additional Indication Activities for such Product Candidate/Product solely for the purpose of obtaining Regulatory Approval for such Product Candidate/Product in such Additional Indication in such Royalty Region, at its sole cost and expense in accordance with an amendment approved by the JEC to the then-current (or most recently completed) Development Plan for such Product Candidate/Product for the applicable Active Indication. In the event the JEC cannot reach agreement on such amendment within a thirty (30)-day period, [***]. 90 Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].
Sample 1
Proposed Additional Indication is a Related Indication. Where any such proposed Additional Indication is a Related Indication for the Active Indication in which such Product Candidate/Product is being jointly Developed or Commercialized, the JEC shall consider in good faith any such proposal for Additional Indication Activities. If the Parties Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. mutually agree that such Additional Indication Activities may be carried out for such Product Candidate/Product in a Profit Share Region, and both Parties desire to fund such Additional Indication Activities, then the Parties shall carry out such Additional Indication Activities, and fund such Additional Indication Activities equally, all in accordance with an amendment approved by the JEC to the then-current (or most recently completed) Product Development Plan for such Product Candidate/Product for the applicable Active Indication. If one Party’s representatives on the JEC wish to pursue such Additional Indication Activities and the other Party’s representatives on the JEC do not wish to do so [***].
Sample 1
Proposed Additional Indication is a Related Indication. Where any such proposed Additional Indication is a Related Indication for the Active Indication in which such Product Candidate/Product is being Developed or Commercialized unilaterally by a Party, then the Participating Party (but not the other Party) shall have the right (but not the obligation) to carry out Additional Indication Activities for such Product Candidate/Product solely for the purpose of obtaining Regulatory Approval for such Product Candidate/Product in such Additional Indication in such Royalty Region, at its sole cost and expense in accordance with an amendment approved by the JEC to the then-current (or most recently completed) Development Plan for such Product Candidate/Product for the applicable Active Indication. In the event the JEC cannot reach agreement on such amendment within a thirty (30)-day period, [***].
Sample 1
Proposed Additional Indication is a Related Indication. Where any such proposed Additional Indication is a Related Indication for the Active Indication in which such Product Candidate/Product is being Developed or Commercialized unilaterally by a Party, then the Participating Party (but not the other Party) shall have the right (but not the obligation) to carry out Additional Indication Activities for such Product Candidate/Product solely for the purpose of obtaining Regulatory Approval for such Product Candidate/Product in such Additional Indication in such Royalty Region, at its sole cost and expense in accordance with an amendment approved by the JEC to the then-current (or most recently completed) Development Plan for such Product Candidate/Product for the applicable Active Indication. In the event the JEC cannot reach agreement on such amendment within a thirty (30)-day period, [***]. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.
Sample 1

Related to Proposed Additional Indication is a Related Indication

  • Notice of Certain Proposed Actions Having Environmental Impact Prompt written notice describing in reasonable detail (A) any proposed acquisition of stock, assets, or property by such Principal Company or any of its Subsidiaries that could reasonably be expected to (1) expose such Principal Company or any of its Subsidiaries to, or result in, Environmental Claims that could reasonably be expected to result in, individually or in the aggregate, a Material Adverse Effect or (2) affect the ability of such Principal Company or any of its Subsidiaries to maintain in full force and effect all material Governmental Authorizations required under any Environmental Laws for their respective operations and (B) any proposed action to be taken by such Principal Company or any of its Subsidiaries to modify current operations in a manner that could reasonably be expected to subject such Principal Company or any of its Subsidiaries to any additional obligations or requirements under any Environmental Laws that could reasonably be expected to result in, individually or in the aggregate, a Material Adverse Effect.

  • Combination Product The term “

  • Development Plan As defined in Section 3.2(a).

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Selection Criteria Each Contract is secured by a new or used Motorcycle. No Contract has a Contract Rate less than 1.00%. Each Contract amortizes the amount financed over an original term no greater than 84 months (excluding periods of deferral of first payment). Each Contract has a Principal Balance of at least $500.00 as of the Cutoff Date.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Notice of Third Party Claims; Assumption of Defense The Indemnified Person shall give notice as promptly as is reasonably practicable to Barberry of the assertion of any claim, or the commencement of any suit, action or proceeding, by any Person not a party hereto (a “Third Party Claim”) in respect of which indemnity may be sought under this Agreement; provided that the failure of the Indemnified Person to promptly give notice shall not relieve Barberry of its obligations except to the extent (if any) that Barberry shall have been prejudiced thereby. Barberry may, at its own expense, participate in the defense of any Third Party Claim, suit, action or proceeding (a) upon notice to the Indemnified Person and (b) upon delivery by Barberry to the Indemnified Person a written agreement that the Indemnified Person is entitled to indemnification for all Losses arising out of such Third Party Claim, suit, action or proceeding and that Barberry shall be liable for the entire amount of any Loss, at any time during the course of any such Third Party Claim, suit, action or proceeding, assume the defense thereof; provided, however, that (i) Barberry’s counsel is reasonably satisfactory to the Indemnified Person, and (ii) Barberry shall thereafter consult with the Indemnified Person upon the Indemnified Person’s reasonable request for such consultation from time to time with respect to such Third Party Claim, suit, action or proceeding. If Barberry assumes such defense, the Indemnified Person shall have the right (but not the duty) to participate in the defense thereof and to employ counsel, at its own expense, separate from the counsel employed by Barberry. If, however, the Indemnified Person reasonably determines in its judgment that representation by Barberry’s counsel of both Barberry and the Indemnified Person would present such counsel with a conflict of interest, then such Indemnified Person may employ separate counsel to represent or defend it in any such Third Party Claim, action, suit or proceeding and Barberry shall pay all of the fees and disbursements in connection with the retention of such separate counsel. If Barberry fails to promptly notify the Indemnified Party that Barberry desires to defend the Third Party Claim pursuant, or if Barberry gives such notice but fails to prosecute vigorously and diligently or settle the Third Party Claim, then the Indemnified Party will have the right to defend, at the sole cost and expense of Barberry, the Third Party Claim by all appropriate proceedings, which proceedings will be prosecuted by the Indemnified Person in good faith or will be settled at the discretion of the Indemnified Person (with the consent of Barberry, which consent will not be unreasonably withheld). The Indemnified Person will have full control of such defense and proceedings, including any compromise or settlement thereof. Whether or not Barberry chooses to defend or prosecute any such Third Party Claim, suit, action or proceeding, all of the parties hereto shall cooperate in the defense or prosecution thereof.

  • Competitive Bid Option In addition to Ratable Loans pursuant to Section 2.2, but subject to the terms and conditions of this Agreement (including, without limitation, the limitation set forth in Section 2.1.1 as to the maximum aggregate principal amount of all outstanding Loans hereunder), the Borrower may, as set forth in this Section 2.3, request the Lenders, prior to the Facility Termination Date, to make offers to make Competitive Bid Loans to the Borrower. Each Lender may, but shall have no obligation to, make such offers, and the Borrower may, but shall have no obligation to, accept any such offers in the manner set forth in this Section 2.3. Each Competitive Bid Loan shall be repaid by the Borrower on the last day of the Interest Period applicable thereto. Each Competitive Bid Loan shall be in the minimum amount of $5,000,000 (and in multiples of $1,000,000 if in excess thereof).

  • Regulatory Approval Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.

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