Additional Regulatory Matters; Distribution Rights Sample Clauses

Additional Regulatory Matters; Distribution Rights i. As of the Effective Date, Integra (or one of its affiliates) owns the 510(k) clearances for the OS Products (the “OS Product Registrations”). Integra hereby grants authority to SeaSpine to manufacture the OS Products under such OS Product Registrations, until, with respect to each such OS Product Registration, such time as SeaSpine has obtained a “duplicate” OS Product Registration in the applicable jurisdiction. The terms and conditions set forth on Exhibit H shall apply with respect to SeaSpine obtaining such “duplicate” OS Product Registrations. The period between the Effective Date and the date SeaSpine obtains an OS Product Registration in a jurisdiction is referred to herein as the “Phase I Period” for such jurisdiction. ii. SeaSpine owns the 510(k) clearances for the DBM Products (the “DBM Product Registrations”). b. Integra shall have sole responsibility for obtaining all required consents, licenses, authorizations and approvals for the use and sale of the Product worldwide, and such consents, licenses, authorizations and approvals shall be held in the name of Integra or its designee, except as provided in Section 8.11(d) or otherwise in this Agreement or the Mozaik Supply Agreement, of even date herewith, between the Parties. Without limiting Section 1.2, the Products shall be labeled as determined by Integra so long as such labeling complies with applicable Law. c. SeaSpine shall reasonably assist Integra in accordance with Section 8.11(b) by providing information related to the Products when necessary to obtain any consents, licenses, authorizations or approvals, provided that Integra shall reimburse SeaSpine for its costs and expenses associated with SeaSpine’s assistance in providing information related to the Products in obtaining or maintaining consents, licenses, authorizations or approvals for the Product at a per hour charge of $200 (for clarity, such reimbursement obligations will not apply to the costs and expenses associated with activities undertaken by SeaSpine to comply with its obligations under Section 8.11(a)). SeaSpine will provide the FDA or other applicable regulatory authority with access to SeaSpine’s files related to the Products, but shall not be obligated to permit Integra or any foreign governmental regulatory agency to review certain confidential files, including without limitation, the design history files or processing information for the Products. d. SeaSpine hereby grants authority to Integra and its affiliates t...
AutoNDA by SimpleDocs

Related to Additional Regulatory Matters; Distribution Rights

  • Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the Funder has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).

  • Cost Responsibility for Interconnection Facilities and Distribution Upgrades 4.1 Interconnection Facilities 4.2 Distribution Upgrades

  • How Are Distributions from a Xxxx XXX Taxed for Federal Income Tax Purposes Amounts distributed to you are generally excludable from your gross income if they (i) are paid after you attain age 59½, (ii) are made to your beneficiary after your death, (iii) are attributable to your becoming disabled, (iv) subject to various limits, the distribution is used to purchase a first home or, in limited cases, a second or subsequent home for you, your spouse, or you or your spouse’s grandchild or ancestor, or (v) are rolled over to another Xxxx XXX. Regardless of the foregoing, if you or your beneficiary receives a distribution within the five-taxable-year period starting with the beginning of the year to which your initial contribution to your Xxxx XXX applies, the earnings on your account are includable in taxable income. In addition, if you roll over (convert) funds to your Xxxx XXX from another individual retirement plan (such as a Traditional IRA or another Xxxx XXX into which amounts were rolled from a Traditional IRA), the portion of a distribution attributable to rolled-over amounts which exceeds the amounts taxed in connection with the conversion to a Xxxx XXX is includable in income (and subject to penalty tax) if it is distributed prior to the end of the five-tax-year period beginning with the start of the tax year during which the rollover occurred. An amount taxed in connection with a rollover is subject to a 10% penalty tax if it is distributed before the end of the five-tax-year period. As noted above, the five-year holding period requirement is measured from the beginning of the five-taxable-year period beginning with the first taxable year for which you (or your spouse) made a contribution to a Xxxx XXX on your behalf. Previously, the law required that a separate five-year holding period apply to regular Xxxx XXX contributions and to amounts contributed to a Xxxx XXX as a result of the rollover or conversion of a Traditional IRA. Even though the holding period requirement has been simplified, it may still be advisable to keep regular Xxxx XXX contributions and rollover/ conversion Xxxx XXX contributions in separate accounts. This is because amounts withdrawn from a rollover/conversion Xxxx XXX within five years of the rollover/conversion may be subject to a 10% penalty tax. As noted above, a distribution from a Xxxx XXX that complies with all of the distribution and holding period requirements is excludable from your gross income. If you receive a distribution from a Xxxx XXX that does not comply with these rules, the part of the distribution that constitutes a return of your contributions will not be included in your taxable income, and the portion that represents earnings will be includable in your income. For this purpose, certain ordering rules apply. Amounts distributed to you are treated as coming first from your non-deductible contributions. The next portion of a distribution is treated as coming from amounts which have been rolled over (converted) from any non-Xxxx IRAs in the order such amounts were rolled over. Any remaining amounts (including all earnings) are distributed last. Any portion of your distribution which does not meet the criteria for exclusion from gross income may also be subject to a 10% penalty tax. Note that to the extent a distribution would be taxable to you, neither you nor anyone else can qualify for capital gains treatment for amounts distributed from your account. Similarly, you are not entitled to the special five- or ten- year averaging rule for lump-sum distributions that may be available to persons receiving distributions from certain other types of retirement plans. Rather, the taxable portion of any distribution is taxed to you as ordinary income. Your Xxxx XXX is not subject to taxes on excess distributions or on excess amounts remaining in your account as of your date of death. You must indicate on your distribution request whether federal income taxes should be withheld on a distribution from a Xxxx XXX. If you do not make a withholding election, we will not withhold federal or state income tax. Note that, for federal tax purposes (for example, for purposes of applying the ordering rules described above), Xxxx IRAs are considered separately from Traditional IRAs.

  • Indemnification with Respect to Prohibited Transactions or Loss of REMIC Status Upon the occurrence of an Adverse REMIC Event due to the negligent performance by either the Securities Administrator or the Master Servicer of its duties and obligations set forth herein, the Securities Administrator or the Master Servicer, as applicable, shall indemnify the Certificateholders of the related Residual Certificate against any and all losses, claims, damages, liabilities or expenses (“Losses”) resulting from such negligence; provided, however, that neither the Securities Administrator nor the Master Servicer shall be liable for any such Losses attributable to the action or inaction of the Depositor, the Trustee or the Holder of the Residual Certificate, nor for any such Losses resulting from misinformation provided by any of the foregoing parties on which the Securities Administrator or the Master Servicer, as applicable, has relied. Notwithstanding the foregoing, however, in no event shall the Securities Administrator or the Master Servicer have any liability (1) for any action or omission that is taken in accordance with and in compliance with the express terms of, or which is expressly permitted by the terms of, this Agreement or under any Servicing Agreement, (2) for any Losses other than arising out of malfeasance, willful misconduct or negligent performance by the Securities Administrator or the Master Servicer, as applicable, of its duties and obligations set forth herein, and (3) for any special or consequential damages to Certificateholders of the related Residual Certificate (in addition to payment of principal and interest on the Certificates).

  • Requirement and Characterization of Distributions; Distributions to Record Holders (a) Within 45 days following the end of each Quarter commencing with the Quarter ending on September 30, 2005, an amount equal to 100% of Available Cash with respect to such Quarter shall, subject to Section 17-607 of the Delaware Act, be distributed in accordance with this Article VI by the Partnership to the Partners as of the Record Date selected by the General Partner. All amounts of Available Cash distributed by the Partnership on any date from any source shall be deemed to be Operating Surplus until the sum of all amounts of Available Cash theretofore distributed by the Partnership to the Partners pursuant to Section 6.4 equals the Operating Surplus from the Closing Date through the close of the immediately preceding Quarter. Any remaining amounts of Available Cash distributed by the Partnership on such date shall, except as otherwise provided in Section 6.5, be deemed to be “Capital Surplus.” All distributions required to be made under this Agreement shall be made subject to Section 17-607 of the Delaware Act. (b) Notwithstanding Section 6.3(a), in the event of the dissolution and liquidation of the Partnership, all receipts received during or after the Quarter in which the Liquidation Date occurs, other than from borrowings described in (a)(ii) of the definition of Available Cash, shall be applied and distributed solely in accordance with, and subject to the terms and conditions of, Section 12.4. (c) The General Partner may treat taxes paid by the Partnership on behalf of, or amounts withheld with respect to, all or less than all of the Partners, as a distribution of Available Cash to such Partners. (d) Each distribution in respect of a Partnership Interest shall be paid by the Partnership, directly or through the Transfer Agent or through any other Person or agent, only to the Record Holder of such Partnership Interest as of the Record Date set for such distribution. Such payment shall constitute full payment and satisfaction of the Partnership’s liability in respect of such payment, regardless of any claim of any Person who may have an interest in such payment by reason of an assignment or otherwise.

  • Multi-year Planning Targets Schedule A may reflect an allocation for the first Funding Year of this Agreement as well as planning targets for up to two additional years, consistent with the term of this Agreement. In such an event, the HSP acknowledges that if it is provided with planning targets, these targets: a. are targets only, b. are provided solely for the purposes of planning, c. are subject to confirmation, and d. may be changed at the discretion of the Funder in consultation with the HSP. The HSP will proactively manage the risks associated with multi-year planning and the potential changes to the planning targets; and the Funder agrees that it will communicate any changes to the planning targets as soon as reasonably possible.

  • Allocation of Registration Opportunities In any circumstance in which all of the Registrable Securities and other shares of the Company with registration rights (the “Other Shares”) requested to be included in a registration contemplated by Section 2(a) cannot be so included as a result of limitations of the aggregate number of shares of Registrable Securities and Other Shares that may be so included, the number of shares of Registrable Securities and Other Shares that may be so included shall be allocated among the Holders and Other Shareholders requesting inclusion of shares pro rata on the basis of the number of shares of Registrable Securities and Other Shares held by such Holders and Other Shareholders; provided, however, that such allocation shall not operate to reduce the aggregate number of Registrable Securities and Other Shares to be included in such registration, if any Holder or Other Shareholder does not request inclusion of the maximum number of shares of Registrable Securities and Other Shares allocated to such Holder or Other Shareholder pursuant to the above-described procedure, then the remaining portion of such allocation shall be reallocated among those requesting Holders and Other Shareholders whose allocations did not satisfy their requests pro rata on the basis of the number of shares of Registrable Securities and Other Shares which would be held by such Holders and Other Shareholders, assuming conversion, and this procedure shall be repeated until all of the shares of Registrable Securities and Other Shares which may be included in the registration on behalf of the Holders and Other Shareholders have been so allocated.

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Conditions & Requirements

  • Ownership, Use and Return of Offering Materials The Offering Materials shall continue to be the property of the Owner and JLL. The Offering Materials will be used by the Potential Investor solely for the purpose of evaluating the possible acquisition of the Property and not for any purpose unrelated to the possible acquisition of the Property. The Offering Materials may not be copied or duplicated without the Owner's and JLL’s prior written consent, and must be returned to JLL (or with JLL’s permission, destroyed by Potential Investor and any Related Party, and in such instance Potential Investor shall certify in writing to JLL and Owner that such information has been so destroyed) immediately upon request or when the Potential Investor declines to make an offer for the Property or terminates any discussions or negotiations with respect to the Property.

  • Notification and Distribution of Materials The Company shall notify the Holders in writing of the effectiveness of the Resale Shelf Registration Statement as soon as practicable, and in any event within one (1) Business Day after the Resale Shelf Registration Statement becomes effective, and shall furnish to them, without charge, such number of copies of the Resale Shelf Registration Statement (including any amendments, supplements and exhibits), the Prospectus contained therein (including each preliminary prospectus and all related amendments and supplements) and any documents incorporated by reference in the Resale Shelf Registration Statement or such other documents as the Holders may reasonably request in order to facilitate the sale of the Registrable Securities in the manner described in the Resale Shelf Registration Statement.

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