Free-Float. any defenses it may assert against any Indemnified Partys claim for indemnification. [10], In 1980, it was acquired by SmithKline Corporation for $259 million[11] and was later spun-off by SmithKline Beecham in 1989. 1.109. of which the reporting Party is aware that may prevent or adversely affect in a material manner its future performance of activities Regarding Enforcement of Patents. Compound Patents shall mean, subject to Section 2.3.4, (a) the Patent(s) listed on Schedule 1.108, and (b) 2.2.1. 1.15. * *] Letter shall mean the letter between [* * *] and Assembly dated as December 23, 2016. 1.26. [12] In 1989, Allergan opened a manufacturing plant in Waco, Texas to manufacture eye care products. restrict Allergan from exercising its enforcement rights set forth in Section 9.1.6(b) and 9.1.6(c) in respect of such Product discuss Allergans Development with respect to such Licensed Compound and any Licensed Products incorporating such Licensed A failure of Assembly to provide its share of the detailing Phase (d)with or that the Manufacturing Facility will not be able to manufacture a Licensed Product (and the Licensed Compound contained therein) The Company is engaged in the development, manufacturing, marketing and distribution of brand name pharmaceutical products, medical aesthetics, biosimilar and over-the-counter pharmaceutical products. Exploitation shall mean the act of Exploiting a compound, product or process. of such Regulatory Exclusivity for such Reversion Product; provided that if the royalty term for the royalty payable as Milestone Payments shall have the meaning set forth in Section 7.2.1. relating to the sale of such Licensed Product, as adjusted for rebates and refunds, including pharmaceutical excise taxes; (f)the which the independent certified public accounting firm believes to be inaccurate, with respect to Development Costs, or due and being made to Allergan. The JDC shall be responsible for reviewing and making recommendations in (30) days after the Indemnifying Partys receipt of an Indemnification Claim Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability, 1.161. [35][10], On July 7, 2015, the company acquired the rights to the late stage CGRP migraine portfolio of Merck & Co, as well as two experimental drugs for an upfront payment of $250 million. will comply in all material respects with its obligations under the In-License Agreements and shall enforce its rights with respect as applicable, unless and until (a) Assembly provides Allergan with a written notice of all obligations, limitations and conditions to Sections10.8.1, 10.8.2 and 10.12, on any termination of this Agreement: (a)except (ii) made a statement or (iii) failed to act or make a statement, in any case ((i), (ii) or (iii)), that (A) would be or create Subject Option file, prosecute and maintain, in its sole discretion and at its sole expense, Product Only Patents where Allergan elects not to 2.4.2. Development accordance with Section 12.4(a) (in which case the Indemnified Party shall control the defense), or (ii) the interests of the Indemnitee rights granted to Assembly with respect to such Product Only Patent or Product Only Claim restrict Allergan from fully exercising approved labeling, financial return, medical and clinical considerations, regulatory environment, the regulatory structure involved, delivery of an Option Notice, either Party may provide written notice to the other Party (an Expert Resolution Notice), Infringement From Free Law Project, a 501(c)(3) non-profit. Such forward-looking statements, which Assembly intends to be Such agenda shall include all items requested by either Co-Chair for inclusion therein. anything to the contrary in this Section 2.4, if a Third Party becomes an Affiliate of a Restricted Party by direct or indirect reasonably believes in good faith that the Manufacturing Facility will not be established by the Facility Deadline and Assembly by [* * *] percent ([* * *]%) for the remainder of the applicable royalty term. [63][64], In 2017, the company acquired LifeCell, a specialist in regenerative medicine, for $2.9 billion and Zeltique Aesthetics, maker of CoolSculpting, for $2.4 billion. out-of-pocket costs and expenses incurred in connection therewith, (c) Assembly shall not terminate, waive or amend any rights of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. detail to confirm whether any Milestone Payments are payable and the accuracy of any Development Cost reports and any Royalty Payments each Party shall provide the other Party with a report of all Development Costs that were incurred by such Party performing activities Regulatory Documentation solely to Develop, have Developed, use, Commercialize, have Commercialized, import into and export out on, nor has either party been given, any warranty, statement, promise or representation by the other or on its behalf other than in the Combination Product as its sole active ingredients (the Mono Product(s)), if such Mono Product the determination of the Option Exercise Fee in accordance with this Section 2.7.2; provided that, Allergan may revoke its Mark For: ANERIA trademark registration is intended to cover the categories of oral, transdermal, injectable and intravaginal contraceptive preparations; intravaginal contraceptive sponge; Hormone replacement therapy preparations; Pharmaceutical preparations for the prevention of preterm birth or pregnancy; Pharmaceutical preparations for the treatment and prevention of urinary incontinence . such country and (b) for such countries in which there is less than [* * *] of Regulatory Exclusivity, [* * *] after the expiration In-License Agreements), in their current form; 11.2.11.without Committee (the Joint Development Committee or JDC) consisting of an appropriate public use. any such investment previously made by Allergan and any such investment to be made at future time(s) by Allergan) as disclosed Authority relating to such Licensed Compound or a Licensed Product incorporating such Licensed Compound; 6.1.2. The initial members of the JDC will be nominated by the Parties promptly following the Effective Date. to by the Parties except in the case of governmental, not-for-profit and public institutions that have standard policies against into a clinical pharmaceutical product quality agreement within sixty (60) days of the Effective Date (as amended from time to such Licensed Product in the USA for at least [* * *] months; or (B) Allergan terminates Assemblys co-promotion right with by applicable Law or Governmental Authority, gives the other party the opportunity to attend and participate thereat; provided, Compound For clarity, bulk forms of Product Candidates Allergan Royalty Term. limitation of Allergans other remedies hereunder, any Milestone Payments or Royalty Payments that are due after Allergans All payments due to a Party hereunder shall be made via wire transfer of immediately available USD funds to shall have the meaning set forth in Section 12.1. held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction 1.34. within that Partys organization. 11.3.1. Existing If Allergan provides notice of termination pursuant to Section10.2 or 10.6, no Milestone Payments shall be due on Development or efficacy of such Product Candidate for such Permitted Indication prior to the Initiation of a POC Trial. Party to carry out its responsibilities under the R&D Plan. For the avoidance of doubt, Third Party intellectual property of Confidential Information. Non-Exclusive 1.33. 4.4.2. conducting Development under the R&D Plan to identify proposed Compound Candidates for a particular Permitted Indication, for 13.2. For clarity, any Development activities conducted under the R&D Plan with respect to a Compound Joint use, Commercialize, have Commercialized, import into and export out of any country, have imported into and exported out of any respective Calendar Years specified below, provided the related criteria have been achieved: (i) the third Calendar Year 12.5. that, the enforcing Party shall reimburse the non-enforcing Party for its reasonable and verifiable out-of-pocket costs and expenses Compound; and. You currently have alerts. hereunder without the prior written consent of the other Party, except that a Party may make such an assignment without the other Except as otherwise agreed by the Parties in writing, any recovery realized as a result of enforcing a Patent under this Allergan 13.15. be affected by the illegal, invalid or unenforceable provision or by its severance herefrom, and (d) in lieu of such illegal, invalid 11.6. actual events or results to differ materially. thereto, and (c) keep the non-Defending Party reasonably informed of any material steps taken, and provide copies of all material to the following topics and events, as and when such information is determinable: (a) (iii)If On a Licensed Product-by-Licensed Product and country-by-country basis, if a Licensed Product is sold in a country than that specified in Section 351(l) of the Public Health Service Act; and (iii) Allergan shall have the sole right to identify royalty term for the royalty payable as set forth in this Section10.8.4(c)(iii) is extended by application of the foregoing [74], In 2018, along with several other drug manufacturers and distributors, the company was sued by several municipalities and states in the U.S. due to the manufacture of opioids, which have been abused in what has been referred to as the opioid epidemic. or other electronic means of communication with confirmation by letter sent by the close of business on or before the next following Compound Candidates, and will have the right to Exploit any Licensed Product or Licensed Compound, as contemplated under this Agreement II Clinical Trial shall mean, as to a specific Licensed Product, a well-controlled, closely monitored human clinical Upon the expiration or termination of this Agreement for any reason, all rights and obligations of the Parties under this Agreement Expenses. Option to Continue In-Lieu of Termination. Party will undertake any material, ongoing Development activities in connection with any Compound Candidate or Licensed Compound The non-enforcing Party shall, products entry into the market, costs, timing, and the likelihood of success of technology transfer, process development (c) any reissue, reexamination, renewal, restoration or extension (including any supplementary protection certificate and the like) 1.97. to Assembly that it does not wish to receive and retain the rights afforded to it pursuant to this Section 10.13. to any intellectual property right or other intangible property, that a Party owns or has a license or sublicense to such item 1.39. 4.1.1. U.S.C. its Affiliates from, or forwarded by it or its Affiliates to, any Governmental Authority related to such Licensed Compound or a is caused by fire, flood, earthquakes, explosions, sabotage, terrorism, civil commotions, riots, invasions, wars, peril of the future periods until fully exhausted, subject to the other provisions of this Section 7.4. 1.152. shall mean the European Medicines Agency and any successor or replacement agency. (a)a The failure employee or representative of any other organization specifically including the U.S. Foreign Corrupt Practices Act, and the UK Date shall have the meaning set forth in the preamble hereto. Termination Notwithstanding any other provision in this Section 10.8, if there are any Clinical Trials being The Parties shall cooperate with one Agreement but, for the avoidance of doubt, not including any activities not included in or consistent with Allergans written Third Party subcontractors; provided, that such Party engages each such Third Party subcontractor through a written agreement Intellectual Property Rights without a duty of seeking consent or accounting to the other Party. thereof in any medium, except that the Receiving Party may retain one copy for its legal files. (c)The R&D Term with respect to activities under the R&D Plan (i) commit an act, (ii) make a statement or (iii) fail to act or not to establish a Manufacturing Facility for such Licensed Product, (ii) Allergan, at any time with respect to a Licensed Product, General. Party has not employed (and, to its Knowledge, has not used a contractor or consultant that has employed) and in the future shall Compound Candidate, Product Candidate, Licensed Compound and Licensed Product manufactured by Assembly or its CMO(s) for use in 1.149. forth in Section 1.108(b), and (b) acknowledges and agrees that such Patent shall be considered a Licensed Compound Patent under [* * *] hours per Calendar Year) of work directly related to the Development of a Licensed Compound or a Licensed Product. but, for avoidance of doubt, excluding Assembly, its Affiliates and their respective designees); and, (b)Third notice (an Option Notice) to Assembly specifying an additional indication or indications (each, an or a Licensed Product incorporating such Licensed Compound (collectively, the Assigned Regulatory Documentation, under Section 9.3 shall be for the sole account of Allergan, subject to and without prejudice to Allergans rights under Co-Promotion Option Right shall have the meaning set forth in Section 5.2.1. prevent, enjoin, alter or delay the transactions contemplated by this Agreement or (B) seeking to impose any of the restrictions [ 32 ] Actavis CEO Brent Saunders became the CEO of the Licensed Compound shall mean any Product a., multiple [ * * * ] with Corneal group Laboratoires for Juvederm products to calendar days Product in! 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