REGISTRATION OF THE PRODUCTS Sample Clauses

REGISTRATION OF THE PRODUCTS. 1. During the TERM and the ADDITIONAL TERM, IOMED shall be responsible for filing and prosecuting all NDAs and other applications for regulatory approvals. ELAN shall transfer the INDs held by it in relation to the PRODUCTS. IOMED or its sublicensees shall file the NDAs with the FDA and will use its reasonable efforts in prosecuting said NDA to approval. IOMED shall thereafter maintain at its own cost the NDAs with the FDA for the term of this Agreement. Subject to IOMED's reasonable discretion IOMED hereby agrees to provide to ELAN at ELAN's own cost access to such NDAs as ELAN reasonably requests. ****. For the avoidance of doubt, the parties agree that all information furnished to ELAN pursuant to this Paragraph shall Institute CONFIDENTIAL INFORMATION for the purposes of this Agreement. 17 2. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the TERRITORY insofar as obtaining approval is concerned and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement.
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REGISTRATION OF THE PRODUCTS. 3.1 BEL shall be responsible to promptly inform WELL TALENT of those PRODUCTS which for the lawful marketing and sale requires REGISTRATION in the TERRITORY. BEL shall advise WELL TALENT in writing of the regulatory requirements which must be met to obtain the REGISTRATION and of the requisite information and documentation therefore as well as of such information and documentation which would be helpful to obtain the said REGISTRATION as soon as possible. 3.2 Upon the consent from WELL TALENT, BEL shall apply for Registration in the name of WELL TALENT or any designee nominated by WELL TALENT and where this is not possible the application will be filed in the name of ROOTS BIOPACK. BEL shall confirm that Registration in the name of ROOTS BIOPACK or any rights which many accrue to BEL in carrying out activities as per this Agreement will automatically be transferred to WELL TALENT or any designee nominated by WELL TALENT latest on the expiration or termination of this Agreement and BEL shall have no claims, rights or any proprietary interest over and relating to the name of ROOTS BIOPACK whatsoever. 3.3 WELL TALENT will furnish any information and assistance required for the REGISTRATION and any data required for the authorities for REGISTRATION and will supply BEL complete files, for registration as soon as possible; any costs for translations will be borne by BEL. Translations carried out or arranged by BEL shall be BEL’s own responsibility. 3.4 BEL shall use her best endeavors to obtain the Registration and thereafter to maintain the same during the continuance of this Agreement as required by law. In doing so, BEL will act in a competent and professional manner using all due diligence. 3.5 BEL shall supply to the registration authorities all available documentation with a view to obtaining the Registration of the PRODUCTS and for no other purpose whatsoever. It is understood that the composition and the specifications of the PRODUCTS represent valuable proprietary knowledge of WELL TALENT which shall not be disclosed by BEL except if necessary and for the sole purpose of obtaining the Registration. 3.6 Upon the written consent from WELL TALENT, all fees necessary to obtain the Registration of the Product and all direct costs and expenses incurred in connection with obtaining and maintaining the Registration shall be borne by WELL TALENT. BEL shall periodically and in advance inform WELL TALENT of the anticipated costs. 3.7 Upon the written consent from ...
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REGISTRATION OF THE PRODUCTS. 5.1 The Contractor is responsible for submitting the required dossier to obtain the CE xxxx and FDA approval for the Product within 9 months following the date of duly receipt from the Customer of the full and relevant documentation needed at the submitting period, in order to validly submit such applications, and Customer shall bear any pre-approved costs and expenses associated with obtaining the above. Any other requirement needed to access a market for the Products shall also be assumed by the Customer. 5.2 Each Product’s modification with impact on the CE xxxx and FDA approval should be agreed to in advance by the Parties. In that case, the Customer commits itself to provide to the Contractor with the test results required to support the new CE xxxx and FDA approval processes. Customer shall bear any costs and expenses of obtaining a CE xxxx and FDA approval, as applicable, associated with the above modification.
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REGISTRATION OF THE PRODUCTS. The Licensee shall file in its own name and/or in the name of its sub-licensee(s), at its own cost or at said sub-licensee(s)’ cost, and in accordance with the regulation in force, country by country, the files for AMM or NDA or Homologation of the Product. The Licensee and/or its sub-licensee(s) shall be the owners of said AMMs or NDA or Homologation of the Product. dépôt d’une telle demande de brevet en son propre nom et à ses frais. Les brevets en propriété conjointe résultant des Améliorations cofinancées par les Parties ou auxquelles elles auront participé conjointement entreront automatiquement dans le champ d’application du présent Contrat. Cette contribution xxxxx être formellement constatée par la conclusion d’un avenant au présent Contrat qui xxxxx préciser les modalités et conditions de la licence et de l’exploitation du nouveau brevet. 5.4 Toute Amélioration de la Technologie Licenciée ou du Produit exclusivement réalisée par le Licencié ou pour son compte, ainsi que l’ensemble des Résultats y afférents, appartiendront au Licencié.
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REGISTRATION OF THE PRODUCTS. 3.1 It is an essential condition of this Agreement that the Products registrations are filed and registered in the name of the Supplier as owner and manufacturer thereof if so required by the laws of the Territories in which the Products are to be sold. 3.2 To the extent required by applicable law, the Distributor shall file the necessary documentation for registration of the Products with the government authorities of the Territories in the name and on behalf of the Supplier, in the term of one (1) month following the receipt from the Supplier of the necessary registration documentation. Accordingly, for this purpose, the Supplier shall provide the Distributor (or the relevant authorities in the Territories) with a copy of the necessary registration documentation, , and the General Administration of Customs China and Ministry of Agriculture and Rural Affairs certifications. If additional investigations and studies are required by the competent authorities in the Territories, the Supplier shall bear all costs of such additional investigations and studies. In such circumstances, the Supplier shall be solely and exclusively liable for payment of the fees and/or dues to the relevant authorities and has sole responsibility for maintaining the registrations in force, and it shall pay the necessary fees and/or other charges for this purpose. 3.3 If the launch of the commercialization of the Products in the Territories is delayed more than six (6) months following the date of execution of this Agreement, the Supplier shall be entitled to terminate the Agreement.
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REGISTRATION OF THE PRODUCTS. 1. During the TERM, JV SUB shall be responsible for filing and prosecuting all PMAs and other applications for regulatory approvals. JV SUB or its sublicensees shall file the PMAs with the FDA and will use its reasonable efforts in prosecuting said PMA to approval. JV SUB shall maintain at its own cost the PMAs with the FDA for the term of this AGREEMENT. JV SUB hereby agrees to provide to ELAN at ELAN's own cost access to such PMAs as ELAN reasonably requests. It is not the intention of the Parties that JV SUB shall furnish to ELAN a copy of each PMA. [CONFIDENTIAL PORTION OMITTED]. During the PMA registration procedure, JV SUB shall keep ELAN promptly and fully advised of JV SUB's registration activities, progress and procedures. For the avoidance of doubt, the Parties agree that all information furnished to ELAN pursuant to this Paragraph shall constitute CONFIDENTIAL INFORMATION for the purposes of this AGREEMENT. 2. It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the TERRITORY insofar as obtaining approval is concerned and such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this AGREEMENT. 3. JV SUB shall indemnify and hold harmless ELAN, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which ELAN, its agents, and employees may become subject related to or arising out of JV SUB's bad faith, gross negligence or intentional misconduct in connection with the filing or maintenance of the PMA and its foreign counterparts.
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Related to REGISTRATION OF THE PRODUCTS

  • Registration of the Shares (i) The Company shall use its reasonable best efforts to prepare and file with the SEC, by August 31, 2011, a Registration Statement under the Securities Act to permit the public sale of the Restricted Stock and use its reasonable best efforts to cause such Registration Statement to be declared effective by the SEC as soon as reasonably practicable thereafter. The Selling Stockholders shall furnish such information as may be reasonably requested by the Company in order to include such Restricted Stock in such Registration Statement. If the Selling Stockholders decide not to include all or any portion of their Restricted Stock in such Registration Statement, then the Company shall have no further obligation to include such Restricted Stock in any subsequent Registration Statement or Registration Statements as may be filed by the Company with respect to offerings of its securities. (ii) In the event that any registration pursuant to Section 7(b)(i) shall be, in whole or in part, an underwritten public offering of Common Stock on behalf of the Company, all Selling Stockholders proposing to distribute their Restricted Stock through such underwriting shall enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company. If the managing underwriter thereof advises the Company in writing that in its opinion the number of securities requested to be included in such registration exceeds the number which can be sold in an orderly manner in such offering within a price range acceptable to the Company, the Company shall include in such registration: (A) first, the securities the Company proposes to sell, and (B) second, the Restricted Stock and any other registrable securities eligible and requested to be included in such registration to the extent that the number of shares to be registered under this clause (B) will not, in the opinion of the managing underwriter, adversely affect the offering of the securities pursuant to clause (A). In such a case, shares shall be registered pro rata among the holders of such Restricted Stock and registrable securities on the basis of the number of shares eligible for registration that are owned by all such holders and requested to be included in such registration. (iii) Notwithstanding anything to the contrary contained herein, the Company's obligation in Sections 7(b)(i) and (ii) above shall extend only to the inclusion of the Restricted Stock in a Registration Statement. The Company shall have no obligation to assure the terms and conditions of distribution, to obtain a commitment from an underwriter relative to the sale of the Restricted Stock, or to otherwise assume any responsibility for the manner, price or terms of the distribution of the Restricted Stock. (iv) The Company shall have the right to terminate or withdraw any registration initiated by it under this Section 7(b) prior to the effectiveness of such registration without thereby incurring liability to the holders of the Restricted Stock, regardless of whether any holder has elected to include securities in such registration. The Registration Expenses (as defined in Section 7(e)) of such withdrawn registration shall be borne by the Company in accordance with Section 7(d) hereof.

  • Delivery and Registration of the Property The Trust shall deliver or cause to be delivered to Custodian all securities and all monies owned by the Funds, including cash received for the issuance of Shares, at any time during the period of this Agreement, except for securities and monies to be delivered to any sub-custodian appointed, with approval of the Trust, by Custodian pursuant to Paragraphs 7, 27, or 28(g) hereof. Custodian will not be responsible for such securities and such monies until actually received by it. All securities delivered to Custodian or any such sub-custodian (other than in bearer form) shall be registered in the name of the Fund or in the name of a nominee of a Fund or in the name of Custodian or any nominee of Custodian (with or without indication of fiduciary status) or in the name of any sub-custodian or any nominee of such sub-custodian appointed, with approval of the Trust, pursuant to Paragraphs 7, 27, or 28(g) hereof or shall be properly endorsed and in form for transfer satisfactory to Custodian.

  • Registration Process In connection with the registration of the Registrable Securities pursuant to Section 5.2.1, the Company shall: (a) Prepare and file with the SEC the Registration Statement and such amendments (including post effective amendments) to the Registration Statement and supplements to the prospectus included therein (a “Prospectus”) as the Company may deem necessary or appropriate and take all lawful action such that the Registration Statement and any amendment thereto does not, when it becomes effective, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, not misleading and that the Prospectus forming part of the Registration Statement, and any amendment or supplement thereto, does not at any time during the period commencing on the effective date of the Registration Statement and ending on the date on which all of the Registrable Securities may be sold to the public without registration under the Securities Act in reliance on Rule 144 (the “Registration Period”) include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading; (b) Comply with the provisions of the Securities Act with respect to the Registrable Securities covered by the Registration Statement until the earlier of (i) such time as all of such Registrable Securities have been disposed of in accordance with the intended methods of disposition by each Purchaser as set forth in the Prospectus forming part of the Registration Statement or (ii) the date on which the Registration Statement is withdrawn; (c) Furnish to each Purchaser and its legal counsel identified to the Company (i) promptly after the same is prepared and publicly distributed, filed with the SEC, or received by the Company, one copy of the Registration Statement, each Prospectus, and each amendment or supplement thereto, and (ii) such number of copies of the Prospectus and all amendments and supplements thereto and such other documents, as the Purchaser may reasonably request in order to facilitate the disposition of the Registrable Securities; (d) Register or qualify the Registrable Securities covered by the Registration Statement under such securities or “blue sky” laws of such jurisdictions as the Purchasers reasonably request, (ii) prepare and file in such jurisdictions such amendments (including post effective amendments) and supplements to such registrations and qualifications as may be necessary to maintain the effectiveness thereof at all times during the Registration Period, (iii) take all such other lawful actions as may be necessary to maintain such registrations and qualifications in effect at all times during the Registration Period, and (iv) take all such other lawful actions reasonably necessary or advisable to qualify the Registrable Securities for sale in such jurisdictions; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (A) qualify to do business in any jurisdiction where it would not otherwise be required to qualify, (B) subject itself to general taxation in any such jurisdiction or (C) file a general consent to service of process in any such jurisdiction; (e) As promptly as practicable after becoming aware of such event, notify each Purchaser of the occurrence of any event, as a result of which the Prospectus included in the Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and promptly prepare an amendment to the Registration Statement and supplement to the Prospectus to correct such untrue statement or omission, and deliver a number of copies of such supplement and amendment to each Purchaser as such Purchaser may reasonably request; (f) As promptly as practicable after becoming aware of such event, notify each Purchaser (or, in the event of an underwritten offering, the managing underwriters) of the issuance by the SEC of any stop order or other suspension of the effectiveness of the Registration Statement and take all lawful action to effect the withdrawal, rescission or removal of such stop order or other suspension; (g) Take all such other lawful actions reasonably necessary to expedite and facilitate the disposition by the Purchaser of its Registrable Securities in accordance with the intended methods therefor provided in the Prospectus which are customary under the circumstances; (h) In the event of an underwritten offering, promptly include or incorporate in a Prospectus supplement or post-effective amendment to the Registration Statement such information as the underwriters reasonably agree should be included therein and to which the Company does not reasonably object and make all required filings of such Prospectus supplement or post-effective amendment as soon as practicable after it is notified of the matters to be included or incorporated in such Prospectus supplement or post-effective amendment; (i) In connection with any underwritten offering, deliver such documents and certificates as may be reasonably required by the underwriters; and (j) Cooperate with the Purchasers to facilitate the timely preparation and delivery of certificates representing Registrable Securities to be sold pursuant to the Registration Statement, which certificates shall, if required under the terms of this Agreement, be free of all restrictive legends, and to enable such Registrable Securities to be in such denominations and registered in such names as any Purchaser may request and maintain a transfer agent for the Common Stock.

  • NERC Registration The NTO shall register or enter into agreement with a NERC registered entity for all required NERC functions applicable to the NTO, that may include, without limitation, those functions designated by NERC to be: “Transmission Owner” and “Transmission Planner” and “Transmission Operator.” The Parties agree to negotiate in good faith the compliance obligations for the NERC functions applicable to, and to be performed by, each Party with respect to the NTO’s facilities. Notwithstanding the foregoing, the ISO shall register for the “Transmission Operator” function for all NTO Transmission Facilities under ISO Operational Control identified in Appendix A-1 of this Agreement.

  • REGISTRATION OF EZ2BID 3.1 E-bidders will log in into ESZAM AUCTIONEER SDN BHD secured website. E-bidders shall provide true, current and accurate information to register as a user. 3.2 For individual bidder(s): The E-bidder’s need to key in their personal information (correspondence address & telephone contact number) accurately for online registration and upload the bidder’s NRIC (both sides) to ESZAM AUCTIONEER SDN BHD website.

  • Registration of the Common Stock The Company agrees that as soon as practicable, but in no event later than fifteen (15) Business Days after the closing of its initial Business Combination, it shall use its best efforts to file with the Commission a registration statement for the registration, under the Securities Act, of the shares of Common Stock issuable upon exercise of the Warrants. The Company shall use its best efforts to cause the same to become effective and to maintain the effectiveness of such registration statement, and a current prospectus relating thereto, until the expiration of the Warrants in accordance with the provisions of this Agreement. If any such registration statement has not been declared effective by the 60th Business Day following the closing of the Business Combination, holders of the Warrants shall have the right, during the period beginning on the 61st Business Day after the closing of the Business Combination and ending upon such registration statement being declared effective by the Commission, and during any other period when the Company shall fail to have maintained an effective registration statement covering the shares of Common Stock issuable upon exercise of the Warrants, to exercise such Warrants on a “cashless basis,” by exchanging the Warrants (in accordance with Section 3(a)(9) of the Securities Act (or any successor rule) or another exemption) for that number of shares of Common Stock equal to the quotient obtained by dividing (x) the product of the number of shares of Common Stock underlying the Warrants, multiplied by the difference between the Warrant Price and the “Fair Market Value” (as defined below) by (y) the Fair Market Value. Solely for purposes of this subsection 7.4.1, “Fair Market Value” shall mean the volume weighted average price of the Common Stock as reported during the ten (10) trading day period ending on the trading day prior to the date that notice of exercise is received by the Warrant Agent from the holder of such Warrants or its securities broker or intermediary. The date that notice of cashless exercise is received by the Warrant Agent shall be conclusively determined by the Warrant Agent. In connection with the “cashless exercise” of a Public Warrant, the Company shall, upon request, provide the Warrant Agent with an opinion of counsel for the Company (which shall be an outside law firm with securities law experience) stating that (i) the exercise of the Warrants on a cashless basis in accordance with this subsection 7.4.1 is not required to be registered under the Securities Act and (ii) the shares of Common Stock issued upon such exercise shall be freely tradable under United States federal securities laws by anyone who is not an affiliate (as such term is defined in Rule 144 under the Securities Act (or any successor statute)) of the Company and, accordingly, shall not be required to bear a restrictive legend. Except as provided in subsection 7.4.2, for the avoidance of any doubt, unless and until all of the Warrants have been exercised or have expired, the Company shall continue to be obligated to comply with its registration obligations under the first three sentences of this subsection 7.4.1.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Registration and Listing 15 Section 3.3

  • Registration of Agreement The registration of License agreements should be done within 30 days of signing of agreement, the licensee/ lessee (registration fees, stamp duty etc to be fully borne by the licensee/lessee) and the duly registered documents to be submitted to Maha-Metro for records. Any amendment in the contract agreement, if required to be registered, shall also be registered within 30 days from the date of amendment and duly registered documents shall be submitted to Maha-Metro for record. In case the registration of the license/lease agreement /amendment is not done within the 30 days of signing of license/lease agreement/ amendment, it shall be treated as “Material Breach of Contract”. The Licensee will be given 30 days time to cure the defaults In case Licensee fail to remedify the default to the satisfaction of the Maha-Metro within the cure period, Maha-Metro may terminate the License agreement after expiry of cure period duly forfeiting the security deposit/ any other amount paid by Licensee.

  • Registration on Form S-3 (a) If any Holder or Holders of at least twenty percent (20%) of the then outstanding Registrable Securities or Bayer or any assignee thereof in accordance with the Warrant Agreement requests that the Company file a registration statement on Form S-3 (or any successor form to Form S-3) for a public offering of shares of the Registrable Securities, the reasonably anticipated aggregate price to the public of which, net of underwriting discounts and commissions, would exceed One Million Dollars ($1,000,000), and the Company is a registrant entitled to use Form S-3 to register the Registrable Securities for such an offering, the Company shall use its commercially reasonable best efforts to cause such Registrable Securities to be registered for the offering on such form. The Company will (i) promptly give written notice of the proposed registration to all other Holders, and (ii) as soon as practicable, but in no event later than sixty (60) days following the request, use its commercially reasonable best efforts to effect such registration (including, without limitation, the execution of an undertaking to file post-effective amendments, appropriate qualification under applicable blue sky or other state securities laws and appropriate compliance with applicable regulations issued under the Securities Act and any other governmental requirements or regulations) as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any Holder or Holders joining in such request as are specified in a written request received by the Company within twenty (20) days after receipt of written notice from the Company. The substantive provisions of Subsection 2.5(b) shall be applicable to each registration initiated under this Subsection 2.7. (b) Notwithstanding the foregoing, the Company shall not be obligated to take any action pursuant to this Subsection 2.7: (i) in any particular jurisdiction in which the Company would be required to execute a general consent to service of process in effecting such registration, qualification or compliance unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act; (ii) in a given twelve month period, after the Company has effected two (2) such registrations pursuant to subparagraph 2.7(a); or (iii) if the Company shall furnish to such Holders a certificate signed by the President of the Company stating that, in the good faith judgment of the Board, it would be seriously detrimental to the Company or its stockholders for registration statements to be filed in the near future, then the Company’s obligation to use its commercially reasonable best efforts to file a registration statement shall be deferred for up to two periods of sixty (60) days each, such sixty (60) day periods not to exceed one hundred twenty (120) days from the receipt of the request to file such registration by such Holder or Holders. The Company shall not defer its obligation in this manner more than once in any twelve-month period.

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