Other Major Territories In the Sample Clauses

Other Major Territories In the. Major Territories outside of the United States, the Parties will utilize a recognized independent third party such as IMS Midas or another equivalent recognized vendor to determine the proportion of Net Sales of Collaboration Products in a given calendar quarter that is prescribed for the RA Indication, IBD Indication and Other Indications in accordance with the Extended Units Total Prescription. In the event that the Parties determine that IMS Midas’ or another equivalent vendor’s Extended Units Total Prescription are not sufficient to provide the Parties with accurate information to determine the proportion of Net Sales of Collaboration Products in a given calendar quarter that is prescribed for the RA Indication, IBD Indication and Other Indications in one or more Major Territories, the Parties may contract with IMS Midas or other recognized provider of similar services to establish a method to more accurately capture the required information, or take such other measures as shall be necessary to establish such sales levels with reasonable certainty. In the event that such service providers are unable to provide the Parties with accurate information, the Parties may mutually agree to consider other methods for allocating Net Sales between RA Indication, IBD Indication and Other Indications, which may include, but need not be limited to, type of doctor writing a script, dispensing location, and other relevant facts.
Sample 1
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Related to Other Major Territories In the

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Priority on Piggyback Registrations If the Piggy-Back Registration relates to an Underwritten Offering and the managing underwriter or underwriters of such Underwritten Offering, selected by the Company pursuant to Section 8, to which such Piggy-Back Registration relates advise the Participating Piggy-Back Holders in writing that the total amount of Registrable Securities that such Participating Piggy-Back Holders intend to include in the Piggy-Back Registration in addition to any other securities the Company intends to register would be greater than the total number of securities which can be sold in such Underwritten Offering without having a material adverse affect on the success of such Underwritten Offering, the Company shall include in such Piggy-Back Registration (i) first, 100% of the Class A Common Stock, Class D Common Stock or other securities that would be convertible into, or exchangeable or exercisable for, shares of Class A Common Stock or Class D Common Stock the Company proposes to sell, and (ii) second, to the extent of the number of Registrable Securities requested to be included in such registration which, with the advice of such managing underwriter or underwriters, can be sold without having the adverse effect referred to above, the number of Registrable Securities which the Participating Piggy-Back Holders have requested to be included in such registration, such amount to be allocated pro rata among all Participating Piggy-Back Holders on the basis of the relative amount of Registrable Securities requested to be included therein by each Participating Piggy-Back Holder.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Priority on Primary Registrations If a Piggyback Registration is an underwritten primary registration on behalf of the Company, and the managing underwriters advise the Company in writing that in their opinion the number of securities requested to be included in such registration exceeds the number which can be sold in such offering without adversely affecting the marketability of the offering, the Company shall include in such registration (i) first, the securities the Company proposes to sell, (ii) second, the Registrable Securities requested to be included in such registration, pro rata among the holders of such Registrable Securities on the basis of the number of shares owned by each such holder, and (iii) third, other securities requested to be included in such registration.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Priority on Registrations (i) Notwithstanding the provisions of Section 2(a) hereof, in the case of an Underwritten Offering by the Company of Common Shares or securities convertible into or exchangeable or exercisable for Common Shares, the managing underwriter or underwriters of the Underwritten Offering may limit the number of Registrable Common Shares included in the Underwritten Offering pursuant to any Registration Statement or qualification if, in its or their reasonable opinion, the number of Registrable Common Shares proposed to be sold in such Underwritten Offering exceeds the number that can be sold without materially adversely interfering with the orderly sale and distribution of the securities being offered pursuant to such Registration Statement or qualification. In the event the number is to be so limited in the Underwritten Offering, qualification or registration, a sufficient number of securities shall be eliminated to reduce the total amount of securities to be included in such Underwritten Offering, qualification or registration to the amount recommended by such underwriter. In reducing the amount of securities to be included in such Underwritten Offering, qualification or registration, the Company will include in such Underwritten Offering, qualification or registration (A) first, all securities the Company proposes to sell, and (B) second, to the extent not inconsistent with the Stock Purchase Agreement or the Securities Purchase Agreement dated as of November 13, 1995 by and among the Company, Partners I and Parallel I, as amended, and all documents related thereto, all Registrable Common Shares Beneficially Owned by Holders requested to be included in the Underwritten Offering, qualification or registration and Common Shares requested to be included by other holders of Common Shares who have registration rights in respect thereof pari passu with the registration rights granted hereby, reduced pro rata according to the number of Registrable Common Shares or Common Shares which are Beneficially Owned by Holders and each such other holder, as the case may be, and requested to be included in such registration or qualification in good faith with the bona fide intention of selling the same.

  • Priority on Primary Piggyback Registrations If a Piggyback Registration is initiated as a primary underwritten offering on behalf of the Company and the managing underwriters advise the Company and the Holders (if any Holders have elected to include Registrable Securities in such Piggyback Registration) that in their good faith opinion the number of securities proposed to be included in such offering exceeds the number of securities which can be sold in such offering without materially delaying or jeopardizing the success of the offering (including the price per security proposed to be sold in such offering), the Company shall include in such registration and offering (i) first, the number of Shares that the Company proposes to sell, and (ii) second, the number of securities requested to be included therein by holders of securities, including the Holders (if any Holders have elected to include Registrable Securities in such Piggyback Registration), pro rata (as nearly as practicable) among all participating holders on the basis of the number of securities requested to be included therein by all such holders or as such holders and the Company may otherwise agree.

  • Priority of Piggyback Registration If the managing underwriter or underwriters of any proposed offering of Registrable Securities included in a Piggyback Registration informs the Company and the participating Holders in writing that, in its or their opinion, the number of securities that such Holders and any other Persons intend to include in such offering exceeds the number that can be sold in such offering without being likely to have a significant adverse effect on the price, timing or distribution of the securities offered or the market for the securities offered, then the securities to be included in such Registration shall be (i) first, one hundred percent (100%) of the securities that the Company proposes to sell, and (ii) second, and only if all the securities referred to in clause (i) have been included, the number of Registrable Securities that, in the opinion of such managing underwriter or underwriters, can be sold without having such adverse effect, with such number to be allocated among the Holders that have requested to participate in such Registration based on an amount equal to the lesser of (i) the number of such Registrable Securities requested to be sold by such Holder, and (ii) a number of such shares equal to such Holder’s Pro Rata Portion and (iii) third, and only if all of the Registrable Securities referred to in clause (ii) have been included in such Registration, any other securities eligible for inclusion in such Registration.

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