Exclusivity clause samples

On the morning of June8, 2017, Mr.Dillahay and a representative of Wells Fargo Securities spoke with Mr.Kelly regarding HIG’s due diligence process and the impending expiration of the exclusivity period on June13, 2017. Mr.Kelly informed Mr.Dillahay that HIG may need an extension of the exclusivity period to complete its due diligence reports that were to be provided to its lenders in connection with the financing of the transaction, as well as to its insurer in connection with the purchase of representations and warranty insurance. Mr. Kelly proposed a two-week extension for exclusivity. Mr.Dillahay expressed concern to Mr.Kelly about HIG’s proposal and the delay it could cause.

On June12, 2017, the NCI Board held a telephonic meeting at which representatives of Paul Hastings, Wells Fargo Securities and Stifel were present. At the request of the NCI Board, a representative of Wells Fargo Securities summarized the status of discussions with HIG, noting that while diligence was in progress HIG was awaiting diligence reports from its third-party advisors, and had asked for an extension on exclusivity. The NCI Board authorized a five-day extension on exclusivity and instructed the representative of Wells Fargo Securities to ask HIG to increase its offer price. The representative of Paul Hastings informed the NCI Board that coming out of discussions with Kirkland on June11th, there were four key issues outstanding under the merger agreement. Specifically, that the reverse termination fee would be NCI’s sole and exclusive remedy (even if Parent willfully breached the merger agreement), a willful and material breach of the no-shop provision (even by third-party advisors and representatives) would trigger termination of the merger agreement by Parent and payment of the Company termination fee, and NCI would be obligated to reimburse Parent for $3,000,000 in expenses in the event the merger agreement was terminated in certain circumstances (including in the event closing did not occur by the outside date, the Parent terminated the merger agreement due to NCI’s breach of its representations, warranties or covenants under the merger agreement in a manner that caused a failure of certain conditions to the offer, or if a Triggering Event (as defined in the merger agreement) had occurred).

1. Exclusivity. During the Exclusivity Period (as defined below), the Company will not, and will ensure that none of its Related Persons (as defined below) will, solicit, negotiate, accept, encourage, consider or otherwise pursue any offer or inquiry from any person or entity, or engage in discussions or other communications or furnish any information regarding, any acquisition or disposition of any interest in any Company capital stock or other equity interest, an equity investment in, or a sale of all or any significant part of the assets of, the Company, or any merger, reorganization, recapitalization, consolidation, share exchange or other business combination or disposition involving the Company, in each case other than with H.I.G.Upon execution of this Agreement, the Company shall, and shall cause each of its Related Persons to, immediately terminate all discussions with any third party regarding a transaction of the type described in this Section. If, during the Exclusivity Period, any party approaches or communicates with the Company, directly or indirectly (i.e., including through any of its Related Persons), regarding any transaction of a type described above (an “Alternative Transaction”), the Company shall promptly notify H.I.G. of such communication (with such notice including any material terms of such proposal) and shall further immediately inform such third party of the existence of an Exclusivity Period (without identifying H.I.G. or any of its respective affiliates or Related Persons).For purposes hereof, “Exclusivity Period” means the period commencing upon the mutual execution of this Agreement and continuing until the earlier of (i)delivery by H.I.G. to the Company of written notice terminating the Exclusivity Period or (ii)11:59 p.m. (New York City time) on June13, 2017. For purposes hereof, “Related Persons” means, with respect to any person, each affiliate of such person and each director, officer, employee, agent, trustee, representative, attorney, accountant and each insurance, environmental, legal, financial and other advisor and other consultants and agents of or to such person or any of its affiliates.

In the branded pharmaceutical industry, the majority of a branded drug’s commercial value is usually realized during the period in which the product has market exclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. The rate of this decline varies by country and by therapeutic category, and the number of generic competitor entrants to the market, among other factors; however, following patent expiration, branded products often continue to have market viability based upon the goodwill of the product name, which typically benefits from trademark protection.

(a) Exclusivity. During the Exclusivity Period, neither Osiris nor any of its Affiliates will (nor will any of them appoint or permit any other Person to) directly or indirectly promote, market, sell or distribute (other than through Stryker in accordance with this Agreement) any Allograft or Allograft Services to any Person in the Territory for use in the Field of Use. Osiris retains the right to present and inform (but not sell or distribute) regarding the Allografts in the Field of Use, through Osiris corporate reports and scientific presentations. With respect to scientific presentations, Osiris agrees to submit the proposed manuscript to Stryker for review and comment reasonably in advance of the proposed presentation and agrees to take into account any reasonable comments provided by Stryker with respect to the presentation.

1. Exclusivity. The Exclusivity Period hereby runs from the execution and delivery of this Letter Agreement by the parties hereto through 11:59 pm PACIFIC time on July13, 2017; provided that if, as of the end of such Exclusivity Period, in the Company’s good faith judgment, Sizmek is diligently proceeding with pursuing the Transaction, the Exclusivity Period shall be automatically extended to 11:59 pm PACIFIC time on July16, 2017.

1. Exclusivity. The Exclusivity Period hereby runs from the execution and delivery of this Letter Agreement by the parties hereto through the earlier of (i)11:59 pm PACIFIC time on July17, 2017, and (ii)the signing of a definitive merger agreement between Sizmek and the Company.

b)Exclusivity. The PicoPass License shall be exclusive in the Exclusivity Field for the Exclusivity Period and non-exclusive in all other fields. On expiration of the Exclusivity Period, the PicoPass License will become non-exclusive in the Exclusivity Fields. During the Exclusivity Period, INSIDE agrees that it will not grant a license to the Pico Pass Technology to any other party for use in the Exclusivity Field. For clarity, INSIDE is not precluded by aforementioned exclusivity from selling products or systems that use the PicoPass Technology, provided however that such products or systems are not intended for use in the Exclusivity Field.

Pediatric exclusivity is another type of non-patent exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity, including reference product and orphan exclusivity. This six-month exclusivity may be granted if an application sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity cover the product are extended by six months. Thus, pediatric exclusivity adds six months to existing exclusivity periods applicable to biological products under the BPCIA—namely, the four-year period during which the FDA will not consider an application for a biosimilar product, and the 12-year period during which the FDA will not approve a biosimilar application.

If a product with orphan status receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, meaning that the FDA may not approve any other applications to market the same drug or biologic product for the same indication for seven years, except in limited circumstances, such as if the party holding the exclusivity fails to assure the availability of sufficient quantities of the drug to meet the needs of patients with the disease or condition for which the drug was designated.In addition, the FDA may not approve other applications to market the same drug or biologic product for the same indication for seven years unless the sponsor of the other product demonstrates that its product is clinically superior to the product with orphan drug exclusivity.Under Omnibus legislation signed by President Trump on December 27, 2020, this clinical superiority requirement applies to drugs and biologics that received orphan drug designation before enactment of FDARA in 2017, but have not yet been approved or licensed by FDA.

Orphan exclusivity does not block the approval of a different product for the same rare disease or condition, nor does it block the approval of the same product for different indications.In particular, the concept of what constitutes the "same drug" for purposes of orphan drug exclusivity remains in flux in the context of gene therapies, and the FDA has issued recent draft guidance suggesting that it would not consider two gene therapy products to be different drugs solely based on minor differences in the transgenes or vectors. If a product designated as an orphan drug ultimately receives marketing approval for an indication broader than what was designated in its orphan drug application, it may not be entitled to exclusivity. Orphan medicinal product status in the European Union has similar, but not identical, benefits.

Even if we maintain orphan drug exclusivity for SGT-001 or obtain orphan drug exclusivity for any other product candidate, the exclusivity may not effectively protect the product candidate from competition because regulatory authorities still may authorize different drugs for the same condition or the same drug for the same condition if it is determined by the FDA to be clinically superior to the product with orphan drug exclusivity. Moreover, the concept of what constitutes the “same drug” for purposes of orphan drug exclusivity remains in flux in the context of gene therapies, and the FDA issued draft guidance in January 2020 suggesting that it would not consider two gene therapy products to be different drugs solely based on minor differences in the transgenes or vectors.

Table of Contents Biomet agreed to the following: 1) payment to us of $13.0million within ten days of the effective date (the “Upfront Payment”); 2) annual exclusivity fees (“Annual Exclusivity Fees”) paid annually as long as Biomet maintains exclusivity for the term of the contract to be paid at the beginning of each calendar year; and 3) annual purchase minimums to maintain exclusivity. Upon occurrence of an event that materially and adversely affects Biomet’s ability to distribute the implants, Biomet may be entitled to certain refund rights with respect to the then current Annual Exclusivity Fee, where such refund would be in an amount limited by a formula specified in this agreement that is based substantially on the occurrence’s effect on Biomet’s revenues. The Upfront Payment, the Annual Exclusivity Fees and the fees associated with distributions of processed tissue are considered to be a single performance obligation. Accordingly, the Upfront Payment and the Annual Exclusivity Fees are deferred as received and are being recognized as other revenues over the term of this distribution agreement based on the expected contractual annual purchase minimums relative to the total contractual minimum purchase requirements in this distribution agreement. Additionally, we considered the potential impact of this distribution agreement’s contractual refund provisions and does not expect these provisions to impact future expected revenue related to this distribution agreement.

Table of Contents product is sufficiently profitable not to justify maintenance of market exclusivity. Market exclusivity would not prevent the approval of a similar drug that is shown to be safer, more effective or otherwise clinically superior.

2.4Exclusivity. The continuation of exclusivity in the Exclusive License shall be subject to Section2.6. In the event additional exclusive fields are added in accordance with Section2.7, the License shall be exclusive as agreed by the Parties for such Additional Field (defined below), and the definitions of Exclusive Areas and Field of Use shall be deemed to include such, additional exclusive fields.

(b)In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to [***]. Sensile shall respond to such exclusivity request within [***] with acceptance or denial of the request for exclusivity. In the event Sensile accepts such request by written notice to scPharma (the “Exclusivity Acceptance Notice”), scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth in Section3 below. For each Additional Field granted to scPharma exclusively, the Incremental Disposable Units volume established in Exhibit2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: [***].

2.Exclusivity. During the term of the Sub-Advisory Agreement commencing on the effective date of the Sub-Advisory Agreement, RREEF will provide exclusively to Bluerock its services with respect to serving as an investment adviser or sub-adviser to an interval fund or non-traded Real Estate Investment Trust (“REIT”) that principally invests in private commercial real estate debt and which is distributed primarily through broker-dealers and/or registered investment advisers (“RREEF Exclusivity”). Following the termination of the Sub-Advisory Agreement, RREEF Exclusivity shall continue for two months in the event the Sub-Advisory Agreement is terminated for cause or otherwise as a result of RREEF’s breach of the Sub-Advisory Agreement or RREEF voluntarily terminates the Sub-Advisory Agreement; provided however, such exclusivity provision shall not apply if Bluerock or the Board has retained any additional sub-adviser(s) with respect to the Fund (excluding as a permitted consultant or sub-adviser, Mercer Investment Management, Inc.); and, provided further, all of RREEF’s existing investment funds, REITs and investment mandates to invest in private commercial real estate debt are excluded from this exclusivity provision. For the avoidance of doubt, such RREEF Exclusivity shall apply to any RREEF subsidiaries formed by RREEF that provide such similar services as those described in the Sub-Advisory Agreement; provided however, that such RREEF Exclusivity shall not apply to affiliates of the corporate parent of RREEF.

20.Non-exclusivity. This Agreement is not exclusive and the Fund recognizes that Vigilant may provide similar services to other persons or entities.

1. Exclusivity. The Company agrees that it shall not, and shall not permit any of its subsidiaries to, and will cause its and their respective officers, directors, employees, advisors (including attorneys, accountants, financial advisors, consultants and investment bankers), agents and representatives not to, at any time from the date hereof through the date that is fifteen (15) days after the date hereof (the “Exclusivity Period”), directly or indirectly, (a)solicit, initiate or actively encourage submission of proposals or offers from any person or entity, other than Z Capital and its affiliates, relating to any acquisition of the Company or any of its subsidiaries or a material portion of their respective assets or voting securities, or any business combination involving the Company or any of its subsidiaries, or (b)participate in any negotiations regarding, or furnish to any other person or entity any non-public information with respect to, or otherwise further cooperate in any way with, or assist or actively participate in, actively facilitate or encourage, any effort or attempt by any other person or entity other than Z Capital and its affiliates to do or seek any of the foregoing. During the Exclusivity Period, the Company shall promptly advise Z Capital if any such proposal or offer, or any inquiry by any person or entity with respect thereto, is made, shall promptly inform Z Capital of all the terms and conditions thereof, and shall furnish to Z Capital copies of any such written proposal or offer and the contents of any communications in response thereto. In addition, the Company agrees that it will immediately cease, from the date hereof through the end of the Exclusivity Period, any existing discussions or negotiations with any person or entity other than Z Capital and its affiliates that relate to, or may reasonably be expected to lead to, any transaction of the type described in Section1(a).

On August10, 2018, the Strategic Committee met with Company management and representatives of Needham& Company and Pillsbury to discuss the revised Indication of Interest submitted by Parent on August9, 2018. The representatives of Needham& Company provided an overview of the revised Indication of Interest, including that it would be an all-cash transaction at $1.39 per share and that it involved a 90-day exclusivity period. The Strategic Committee discussed shortening the exclusivity period and including certain transaction document delivery milestones to ensure that progress on a potential transaction was being made during exclusivity. The Strategic Committee instructed the representatives of Needham& Company to approach Parent and provide it with an opportunity to improve its proposal with a deadline for submission of August14, 2018.

We believe that any of our product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

Table of Contents which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee.

If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity. Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval of the same drug or biological product as defined by the FDA or if our drug candidate is determined to be contained within the competitor’s product for the same indication or disease. If a drug or biological product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan product exclusivity. Orphan drug status has similar but not identical benefits in the European Union.

Exclusivity. During the Research Term and two (2) years thereafter, Arcturus shall not engage in any research or development activities for which LUNAR™ and UNA Oligomer are used and whose target is the same as or substantially similar to the targets of the Research Program (i.e., […***…]). If Takeda requests to add additional targets in the Research Program, the parties hereto will negotiate in good faith an amendment to this Agreement, including the scope of exclusivity set forth in this Section 2.7 and Appendix B. Any amendments to the Research Program and Budget must be approved in writing by both parties.

(a)mRNA and UNA Oligomer Exclusivity. With respect to a particular Development Target, during the corresponding Development Target Exclusivity Period, Arcturus shall not conduct or participate in, or advise, assist or intentionally enable any Third Party to conduct or participate in the preclinical or clinical development, manufacture or commercialization of any product containing mRNA (including Modified mRNA) or UNA Oligomer with respect to such Development Target. The “Development Target Exclusivity Period” means the period beginning on the date that a Target becomes a Development Target and ending on the earlier of (i) the date that such Development Target becomes a Discontinued Target or (ii) termination of the Agreement with respect to such Development Target.

(c)LUNAR Exclusivity. Within the first […***…] years after the Effective Date, Arcturus shall not conduct or participate in, or advise, assist or intentionally enable any Third Party to conduct or participate in the preclinical or clinical development, manufacture or commercialization of any product utilizing LUNAR Nanoparticle Delivery Technology with respect to a Development Target.

3.3.3Reserved Target Exclusivity. With respect to each Reserved Target, during the Reserved Target Exclusivity Period, Arcturus shall not conduct or participate in, or advise, assist or intentionally enable any Third Party to conduct or participate in the preclinical or clinical development, manufacture or commercialization of (a) any product containing mRNA, including Modified mRNA, or UNA Oligomer with respect to such Reserved Target, or (b) without offering Ultragenyx the right of first negotiation comparable to that described in Section 3.3.1(b), any other RNA Product or a product utilizing the LUNAR Delivery Technology with respect to such Reserved Target. The foregoing restriction shall expire on the […***…] anniversary of the Effective Date (such period for each Reserved Target, the “Reserved Target Exclusivity Period”), provided, that the Reserved Target Exclusivity Period may be extended, upon written notice to Arcturus, on a Reserved Target-by-Reserved Target basis for up to […***…] additional […***…] year period(s) by paying the Exclusivity Extension Fee pursuant to Section 7.3. For clarity, Section 3.3.1 and not this Section 3.3.3 shall apply to any Reserved Target that becomes a Development Target pursuant to Section 3.1.2 or Section 3.1.3.

(c)Royalty Reduction upon Loss of Exclusivity.In any country in which there is no Valid Claim claiming the composition of, or the method of making or using, a particular Opt-Out Product, and no Regulatory Exclusivity granted with respect to such Opt-Out Product, during the Royalty Term for such Opt-Out Product and country, the applicable Party shall owe royalties under this Section 8.5 on Net Sales of such Opt-Out Product in such country at a rate that is […***…] ([…***…]%) of the applicable Royalty Rate.

2. Exclusivity. ShoreTel agrees that, from the time of the execution of this Agreement until 11:59 pm Pacific Time on August6, 2017 (the “Exclusivity Period”), it will not, and will not permit any of its Representatives to: (i)solicit, initiate, encourage or seek the submission of any Acquisition Proposal; (ii)enter into any agreement, arrangement or understanding with respect to any Acquisition Proposal, including any letter of intent, term sheet or other similar document relating to any such proposal; or (iii)enter into or participate in any discussions or negotiations regarding, or furnish to any Person any information for the purpose of facilitating the making of, or take any other action to facilitate any inquiries or the making of, any proposal that constitutes, or would reasonably be expected to lead to, any Acquisition Proposal. ShoreTel further agrees that, during the Exclusivity Period, it will, and it will direct its Representatives to, immediately cease and cause to be terminated any existing activities, discussions or negotiations with any Person conducted heretofore with respect to the matters described in clauses (i), (ii) and (iii)of the preceding sentence.

11.17Non-Exclusivity. Supplier acknowledges and agrees that Supplier may not be Owlet's exclusive supplier of the Products, and that Owlet is free to purchase the same Products or similar products from other suppliers as Owlet may determine in its sole discretion and to manufacture the Product or similar products internally.

2.1 Exclusivity. Subject to Section2.2 below, Biose agrees that during the Term it will manufacture and supply exclusively to Evelo (and to no third party) non-genetically modified, single Strain Product(s) intended for oral delivery. Biose shall not conduct any such activities (manufacture and supply of non genetically modified single Strain Product(s) intented for oral delivery) for any third party, or enable any third party to conduct any such activities.