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Exhibit 10.1

 LICENSE AGREEMENT

This agreement, effective this  18 day of September, 2014 between

PURINE PHARMA LLC, a company incorporated and validly existing under the laws of the State of New Jersey, USA (hereafter referred to as   "Purine").

and

EASTGATE PHARMACEUTICALS, INC., a Company incorporated and validly existing under the laws of the province of Ontario, Canada (hereafter referred to as "Eastgate", and each of Purine and Eastgate individually, a "Party," and collectively, the "Parties").

WHEREAS

		1.	Eastgate is a developer of nutraceutical and/ or pharmaceutical product formulations with novel drug delivery technologies;

		2.	Eastgate has developed certain nutraceutical and/ or pharmaceutical product formulations and intends to commercialize the same worldwide;

		3.	Purine is a cGMP manufacturer of nutraceuticals and/ or pharmaceutical drugs;

		4.	Purine intends to develop the Products (as defined below) into commercial versions and manufacture and distribute the same worldwide under its own label or its customers' private labels; and

		5.	Purine also intends to supply the commercial versions of the Products to Eastgate under Eastgate's label or Eastgate's customers' private labels.

NOW THEREFORE, in consideration of the mutual terms and premises contained herein and for other good and valuable consideration (the sufficiency and receipt of which is hereby acknowledged by the Parties), the Parties agree as follows:

ARTICLE I: CERTAIN DEFINITIONS

		a)	"Affiliate" shall mean:

(i)            an organization of which fifty percent (50%) or more of the voting stock is controlled or owned, directly or indirectly, by either Party to this Agreement; or

(ii)            an organization which directly or indirectly owns or controls fifty percent (50%) or more of the voting stock of either Party to this Agreement; or

		(iii)	an organization, the majority ownership of which is directly or indirectly common to the majority ownership of either Party to this Agreement.

	b)	"Claim" shall have the meaning ascribed thereto in ARTICLE IV(a).

	c)	"Commencement Date" means the date on which Eastgate provide and transferred completed formulations to Purine in full or the date on which this agreement is signed, whichever is earlier.

	d)	"Confidential Information" shall have the meaning ascribed thereto in ARTICLE IX(a) and includes each Party's Intellectual Property and know-how.

	e)	"Customer" shall mean a person or entity which purchases products from either Party.

	f)	"Disclosing Party" shall mean a Party to this Agreement  that discloses, either directly or through its agents, Confidential Information to the Receiving Party;

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	g)	"FDA" means the United States Food and Drug Administration.

	h)	"FD&C Act" means the Federal Food, Drug and Cosmetic Act of 1938, as amended, and the regulations thereunder, including current good manufacturing practice regulations, as the same may be amended or revised.

	i)	"GMP" means current good manufacturing practices for the methods to be used in, and the facilities and controls to be used for, the manufacture, storage, testing and handling of each Product, all as set forth from time-to-time by the FDA pursuant to the FD&C Act and the rules, regulations, guidelines promulgated thereunder (including specifically, Title 21, parts 111, 210 and 211 of the Code of Federal Regulations of the United States.

	j)	"Intellectual Property" means any and all patents (whether existing, pending or applied for), Trademarks (whether existing, pending or applied for), copyright, industrial designs (whether pending existing or applied for), trade secrets, data (including stored versions thereof in any medium), research and development information, business plans, marketing plans, compilations, sketches, sell sheets, information, software, hardware, research, drawings, working papers or other materials or intellectual property in all forms or moral rights in or associated with each of the Parties or any product/s of the parties.

	k)	"Know-How" means, with respect to the Products, all Product-related technical knowledge, manufacturing procedures, expertise, methods, protocols and current and accumulated experiences which any Party hereto acquires in connection with this Agreement and/or has acquired as a result of scientific research, practical experiences and otherwise which have a demonstrated usefulness in manufacturing, obtaining and maintaining Regulatory Approval for such Product, including but not limited to (i) plant validation protocols and specifications; (ii) process validation procedures; (iii) quality control procedures; (iv) analytical methods and procedures; (v) bio-equivalence testing protocols and procedures; (vi) cleaning validation protocols and procedures; (vii) procedures for preparation of applications for Regulatory Approval; (viii) ongoing regulatory compliance procedures; (ix)  formulations and processes (x) new drug applications and (xi) product registration dossiers.

	l)	"Net Sales" means the gross billing price Purine charges its customers for the Products (including any Altered Products), less occupation and excise taxes, and transportation, discounts, returns and allowances in lieu of returns.

	m)	"OTC" means drug products that may be lawfully sold over-the-counter without prescription in the United States of America.

	n)	"Packaging" means all primary containers, including cartons, shipping cases or any other like matter used in packaging or accompanying the Products.

	o)	"Person" means an individual, partnership, joint venture, association, corporation, company and any other form of business organization, government, regulatory or governmental agency, commission or department.

	p)	"Products" shall mean the OTC nutraceutical and pharmaceutical products as specified in Annex I and, unless otherwise specified, shall also include the Altered Products.

	q)	"Label", "Labeled" or "Labeling" means all labels and other written, printed or graphic matter upon (i) each Product or any container or wrapper utilized with such Product, and/or (ii) any written material accompanying each Product, including, without limitation, package inserts.

	r)	"Regulatory Approval" or "Approval" means final FDA approval to market each Product as an OTC product (or, where applicable, such similar regulatory approval as is required in the U.S.A. or other countries).

	s)	"Specifications" means the requirements for each Product necessary to maintain the identity, strength, quality and purity contained in such Product, including references to a DMF or the applicable USP monograph.

	t)	"Technical Information" means, with respect to each Product, all information and expertise each Party acquires in connection with this Agreement and/or has acquired which have a demonstrated usefulness in Manufacturing, Packaging and Labeling and/or obtaining and maintaining Regulatory Approval of such Product pursuant to this Agreement, including, but not limited to, all specifications, manuals and computer programs relating to manufacturing of a Product.

	u)	"Receiving Party" shall mean a Party to this Agreement (including the Receiving Party's directors, officers, agents, and employees) that receives Confidential Information from the Disclosing Party.

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v)                   "Term" shall have the meaning ascribed thereto in ARTICLE XII.

	w)	"Third Party" shall mean any party other than the Parties to this Agreement and their respective Affiliates.

	x)	"Trademarks" means all designs, graphics, logos, symbols and other commercial symbols used by each Party in relation to the Products.

	y)	"Transfer pricing" means the prices at which Purine shall sell the Products to Eastgate as provided in Annex II.

ARTICLE II: RIGHTS AND RESPONSIBILITIES

		a)	Non-exclusive License:  During the Term of this Agreement, Eastgate grants to Purine non-exclusive worldwide rights to develop commercial versions, manufacture under GMP as per FD&C Act, market, distribute, sell and use the Products. The costs of this commercial development, manufacture and distribution shall be completely borne by Purine.  Purine has the exclusive worldwide rights to sell the Products under Purine's own brand label or its customers' private labels and shall be responsible for any and all costs and expenses related to the foregoing.  Eastgate retains the worldwide rights to sell the Products manufactured by Purine under Eastgate's own brand label or Eastgate's customers' private labels.

		b)	Eastgate has provided or will provide the formulations of the Products to Purine and will further provide full Know-How and Technical Information of the Products in a timely fashion. The costs of this formulation, development and transfer of Know-How and Technical Information shall be completely borne by Eastgate.

		c)	Wherever it is required by law or governmental regulations, Eastgate had or may conduct clinical tests for all the Products at its own cost and time, and these test results will be available to support Purine's label claims of the Products.

		d)	Purine cannot distribute the Products under the Eastgate label without the prior written consent of Eastgate.

		e)	Eastgate may change, improve, or modify an existing version of a Product ("Altered Products"). Whenever there is an update on the formulation of any of the Products, Eastgate will provide the technology transfer of such update or improvement to Purine. Purine shall have the same right to develop, manufacture, market, promote, distribute and sell the Altered Products, as it has pursuant to this Agreement in relation to the Products.

		f)	Purine and Eastgate will use their reasonable best efforts to cooperate with each other with respect to obtaining regulatory approval in the countries of distribution of the Products.

		g)	Purine shall promptly inform Eastgate of any significant competitive developments occurring, as and if it becomes aware of same.

ARTICLE III: ROYALTY FEE

		a)	For the first $[*] of  Net Sales sold under Purine's own brand label and/or its customers' private labels Purine shall pay Eastgate a royalty that is equal to [*] % of Net Sales.  Once accumulated Net Sales sold under Purine's own brand label and/or its customers' private labels achieve $[*], Purine shall pay Eastgate a royalty fee equal to [*] % of Net Sales.  This [*]8% Royalty fee will remain in place for the remainder of this agreement after the first $[*] of Net Sales is achieved. The reduced royalty fee of [*]% is a onetime reduction and is not repeated after the first $[*] of net sales are achieved.

		b)	Purine shall provide Eastgate with quarterly sales reports for each Product under this agreement in reasonable written detail no later than forty-five (45) business days after the end of each quarter.  This written report must be certified by the chief financial officer of Purine and set forth in reasonable detail the calculation of the royalties due to Eastgate for such calendar quarter including, without limitation:

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		i)	Number of Purine Licensed Product(s) sold;

		ii)	Net Sales; and

		iii)	Royalty payments owed to Eastgate.

		(c)	Purine shall accompany each report with the payment of amounts due to Eastgate.  Purine shall keep full, true and accurate books of accounts and other records containing all particulars which may be necessary for the purpose of ascertaining and verifying the royalties payable to Eastgate hereunder.  Upon Eastgate's request, Purine, its subsidiaries and sublicensees, if any, shall permit an independent certified accountant selected by Eastgate to periodically have access during ordinary business hours to such records of Purine, its subsidiaries and sublicensees as may be necessary to determine, for any quarter, the correctness of any report and/or payment made under this Agreement.  In the event that any such inspection shows an underreporting and underpayment in excess of [*] % for any quarter, then Purine shall pay the cost of such examination.

		(d)	Failure by Purine to pay any sums due and owing to Eastgate under this Article III when due may lead to suspension of this Agreement.  Eastgate may terminate this Agreement after 60 days notice if  any sum due and owing remains unpaid within five (5) business days of the Due Date and such default occur more than three (3) consecutive times in any calendar year.

  

ARTICLE IV: SALES TO EASTGATE AND TRANSFER PRICING

		a)	Purine may manufacture Products for distribution by Eastgate under Eastgate's own label or under Eastgate's customers' private labels at transfer prices as provided in Appendix II.

		b)	A separate purchase order for each order will be signed by both Parties.  Purine shall deliver the Products to Eastgate on terms FOB, at its Massena location within sixty (60) days after the date of acceptance of Eastgate's firm purchase order, unless Eastgate specifies a later ship date in such order.

		c)	Purine shall supply Eastgate's requirements of each Product in market ready containers. Products shall be placed in corrugated shipper boxes, of suitable strength for shipping or appropriate shipping containers specified and agreed to by both Parties in writing, prior to manufacturing of each product.

		d)	Purine shall purchase all Packaging, unless Eastgate elects to provide certain Packaging components at its own cost.  The language printed on the Packaging shall be English, unless, at Eastgate's option and cost, Purine may include other languages.  The contents of the printed matter in any language must be acceptable to Purine.

		e)	At Eastgate's request, Purine shall provide Eastgate with all required documentation to facilitate Regulatory Approval of the Products.

		f)	Eastgate is responsible for such importing country requirements as clinical testing, advertising certifications and Regulatory Approval under its own label or its customers' private labels. Eastgate shall be responsible for all costs it incurs in connection with such Approval.

ARTICLE V: NEW PRODUCTS

If Eastgate has or develops a product that is not listed on Annex I (each, a "New Product" and collectively, the "New Products") and Purine is not in breach of any provision of this Agreement, Eastgate at its sole discretion shall have the option, but not the obligation, to enter into new agreements with Purine for the license, manufacture or distribution of such New Products.  The terms and conditions of any such new agreements shall be independent of the terms and conditions set forth herein and shall be negotiated by the Parties prior to entry into such agreements.

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ARTICLE VI: TRADEMARKS AND PROMOTIONS

	(a)	Each Party shall take all reasonably necessary steps at its sole discretion to obtain registration of and protect its Trademarks and any applicable patents in its own name. The Parties acknowledge that each Party's Trademarks are their respective exclusive property and shall remain so for the duration of the Term and thereafter.

	(b)	In the event one Party desires to use the other Party's Trademarks, such Party shall submit any and all advertising and promotional materials incorporating the Trademarks to the other for approval prior to utilizing such advertising and promotional materials. The other Party shall have fourteen (14) days from receipt of the proposed promotional materials to advise of its acceptance. Failing notice of the proposed promotional materials being accepted within the said time, the promotional materials submitted shall be deemed to be rejected and the Party shall not be authorized to use the same.

	(c)	Eastgate shall have no obligation to deliver to Purine any promotional and/or advertising material in connection with the Products.

	(d)	Upon each Party's reasonable request, the other Party may, but is not obligated to, assist the requesting Party in training its personnel responsible for the sales and marketing of the Products and provide technical assistance at the sole cost and expense of the requesting Party. Without limiting the generality of the foregoing, each Party shall bear all costs and expenses incurred by its own personnel and employees with respect to the foregoing.

	(e)	Each Party shall promptly inform the other of any violations of the other Party's Intellectual Property rights by Third Parties, as and if it becomes aware of same and shall assist the other Party in defending its rights with respect to the Intellectual Property at the sole cost and expense of the violated Party.

ARTICLE VII: SALES AND TERMS

	(a)	The following terms shall apply for any price changes to Products or Altered Products supplied to EastGate under Eastgate's label or its customers private label:

	(i)	Price changes to the Products and Altered Products (where, for Altered Products, price changes shall include initial pricing of these Altered Products where such pricing is different from that of existing Products at the time) shall only be made after Eastgate receives written notice three (3) months prior to the date on which such price change is to come into effect; and

	(ii)	Such new prices shall be effective on all orders placed by Eastgate for delivery after the end of the said three (3) months.

	(b)	Prices paid by Eastgate to Purine for the Products do not include applicable taxes and shipping charges. Accordingly, Eastgate shall be solely responsible for all shipping charges, duties, levies, taxes, fees, or other charges and including costs associated with importing the Product.

	(c)	Eastgate shall make payment for the purchased Products by way of certified check, bank draft or wire transfer prior to Purine delivering the Products to Eastgate. Products will not be shipped until Purine has received payment in full for the Products. If Purine fails to ship the product within 60 days of order by Eastgate, Eastgate has the right to cancel the entire order and Purine is obligated to refund the full amount of any money advanced/ prepaid by Eastgate within 24 hours of such cancellation of the order/s by Eastgate.

	(d)	Nothing contained in this Agreement shall be construed as  a warranty or representation by Eastgate as to the validity or scope of any of its Intellectual Property, a warranty or representation that any Products manufac­tured, used or sold will be free from infringement of patents, copyrights, or rights of Third Parties, except that Eastgate represents that it has no knowledge of any existing issued patents or copyrights which might be infringed and, except as provided in Article X, an agreement to defend against actions or suits of any nature brought by any Third Parties.  EASTGATE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AS TO THE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE PRODUCTS.

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	(e)	Failure by Eastgate to pay any sums due and owing to Purine in respect of purchased Products when due will automatically lead to suspension of shipment of such Products to Eastgate if any sum due and owing remains unpaid five (5) business days following Eastgate's receipt of notice thereof from Purine. Purine may modify the terms of sale if a) any sum due and owing remains unpaid within five (5) business days following Eastgate's receipt of notice thereof from Purine or b) Eastgate fails to make payments when due more than three consecutive (3) times in any calendar year regardless of whether such default is cured by Eastgate.

	(f)	As between Purine and Eastgate, ownership and title of the Products delivered by Purine to Eastgate shall remain with Purine until Eastgate has paid for the Products in full, whereupon title shall pass to Eastgate. Eastgate shall bear the risk and liability associated with the Products up to the point the Products are delivered to the warehouse or storage area for the Products used by Eastgate. Acting reasonably, Eastgate shall inspect the Products forthwith upon delivery, identify any defective Products and immediately thereafter advise Purine in writing as to the quantity of defective Products with a reasonably detailed description of the alleged defect. Any defective Products identified by Eastgate and accepted by Purine as being defective, whether any such deficiency exists to be determined by Purine in Purine's commercially reasonable discretion, shall be returned to Purine and replaced by Purine at no cost to Eastgate.

	(g)	Purine shall insure and keep the Products insured by responsible insurers, in such amounts as is customarily carried by prudent owners of a similar business, until delivered to Eastgate.

	(h)	Each Party is responsible to carry its own product liability insurance.

ARTICLE VIII: REPRESENTATIONS, WARRANTIES AND COVENANTS

Purine represents and warrants as follows and acknowledges that Eastgate is relying on such representations and warranties:

	(a)	it is a Limited Liability Company duly incorporated and validly existing pursuant to the laws of the New Jersey;

	(b)	Purine has the full power and authority to enter into this Agreement and carry out the transactions contemplated hereby, and that all necessary corporate action has been duly taken in this regard;

	(c)	the entry into this Agreement shall not conflict with any contract, agreement, articles or by-laws of Purine (or similar documentation) order, judgment, ordinance or applicable law;

	(d)	to the best of Purine's knowledge and belief, no person is violating or infringing upon Eastgate's Intellectual Property or Purine's Intellectual Property;

	(e)	it maintains such policies of insurance, issued by responsible insurers, as are appropriate to its business, in such amounts and against such risks as are customarily carried and insured against by owners of comparable businesses, properties and assets; including, but not limited to, adequate product liability insurance; all such policies of insurance are in full force and effect and Purine is not in default, whether as to the payment of premium or otherwise, under the terms of any such policy;

	(f)	it has the requisite experience, facilities, personnel, equipment, and resources to fulfill its obligations in this Agreement;

	(g)	the Products (1) shall be manufactured, packaged, labeled, stored and transported in conformance with all applicable requirements of the FDA (including GMP), and with all applicable laws (including, without limitation, the FD&C Act), as the same may be amended or revised from time to time, (2) shall be manufactured, packaged, labeled in conformance with the Specifications, (3) shall not be adulterated or misbranded within the meaning of the FD&C Act, and (4) shall not be a product which would violate any section of the FD&C Act if introduced into interstate commerce; and

	(h)	during the Term, Purine agrees to use commercially reasonable efforts to effectively manufacture and market the Products including but not limited to development of promotional literature, mailings, and journal advertisements.

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	(i)	Purine covenants to do the following at all times during the Term:  (i) Purine shall not do or attempt to do any act or thing which would in any way interfere with, adversely affect or impair Eastgate's Intellectual Property rights; (ii) Purine shall immediately notify Eastgate of any suspected or attempted infringement or passing off or any pending or threatened litigation or other proceeding concerning the Products or any of Eastgate's Intellectual Property, or any attempt to alter, modify or change the Products, which comes to its attention; (iii) Purine shall not make any oral or written representations to any Third Party or customer which materially vary from the any specifications, operating instructions, labels or representations given or made by Eastgate, with respect to the Products. If any liability is incurred because of such materially varying representations, Purine will and does hereby hold Eastgate harmless with respect to any such representations; and (iv) Purine's representations and warranties contained in ARTICLE VIII (g) shall survive for an indefinite period following execution of this Agreement.

Eastgate represents and warrants as follows and acknowledges that Purine is relying on such representations and warranties:

	(a)	is a corporation duly incorporated and validly existing pursuant to the laws of Ontario, Canada;

	(b)	it has the full power and authority to enter into this Agreement and carry out the transactions contemplated hereby, and that all necessary corporate action has been duly taken in this regard;

	(c)	the entry into this Agreement shall not conflict with any contract, agreement, articles or by-laws of Eastgate (or similar documentation), order, judgment, ordinance or applicable law;

	(d)	Eastgate represents and warrants that it has an unencumbered title and ownership of the nutraceutical and/ or pharmaceutical product formulations that are licensed by Eastgate under this agreement and Eastgate agrees to indemnify and hold Purine harmless in this respect from any claims of any third parties or the current or former employees or directors of Eastgate; and that it has the requisite experience, facilities, personnel, equipment, and resources to fulfill its obligations in this Agreement;

	(e)	it maintains such policies of insurance, issued by responsible insurers, as are appropriate to its business, in such amounts and against such risks as are customarily carried and insured against by owners of comparable businesses, properties and assets, including, but not limited to, adequate product liability insurance; all such policies of insurance are in full force and effect and Eastgate is not in default, whether as to the payment of premium or otherwise, under the terms of any such policy; and

	(f)	the Products (1) shall be distributed, marketed and sold in conformance with all applicable requirements of the FDA (including GMP),  and with all applicable law (including, without limitation, the FD&C Act), as the same may be amended or revised from time to time, (2) shall be  distributed, marketed and sold in conformance with the Specifications, (3) shall not be adulterated or misbranded within the meaning of the FD&C Act, and (4) shall not be a product which would  violate any section of the FD&C Act if introduced into interstate commerce.

	(g)	Eastgate covenants to do the following at all times during the Term:  (i) Eastgate shall not do or attempt to do any act or thing which would in any way interfere with, adversely affect or impair Purine's Intellectual Property rights;  (ii) Eastgate shall immediately notify Purine of any suspected or attempted infringement or passing off or any pending or threatened litigation or other proceeding concerning the Products or any of Purine's Intellectual Property, or any attempt to alter, modify or change the Products, which comes to its attention; (iii) Eastgate shall not make any oral or written representations to any Third Party or Customer which materially vary from the specifications, operating instructions, labels or representations given or made by Purine if any, with respect to the Products. If any liability is incurred because of such materially varying representations, Eastgate will and does hereby hold Purine harmless with respect to any such representations; and (iv) Eastgate's representations and warranties contained in this ARTICLE VIII (g) shall survive for an indefinite period following execution of this Agreement.

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ARTICLE IX: CONFIDENTIALITY

	(a)	Purine and Eastgate each acknowledge that in performing this Agreement there will be information exchanged that is of a confidential or of a secret nature, including, but not limited to, each other's Intellectual Property, information which is or may be either applicable to or related in any way to the Products, technical data, business opportunities, services and other products developed or being developed, pricing information, financial information, research and development information, plans, processes, formulae, ingredients, chemicals, systems and business systems, copyrights, patents (whether issued, pending or applied for), trademarks, trade names, prototypes, and any other intellectual property, marketing strategies, sales and distribution information, inventions, designs (including industrial designs), drawings, sketches, test results, discoveries and methods of production, trade secrets, suppliers and distributors, licenses, software and hardware, manuals, margins, other information and any other information that each Party may regard as confidential ("Confidential Information"). Each Party covenants and agrees with the other Party to keep all Confidential Information strictly confidential unless or until:

		(i)	said information shall become known to Third Parties not under any obligation of confidentiality to the Disclosing Party, or shall become publicly known through no fault of the Receiving Party, or

		(ii)	said information was already in the Receiving Party's possession prior to the disclosure of said information to the Receiving Party, except in cases when the information has been covered by a preexisting confidentiality agreement, or

(iii) said information shall be subsequently disclosed to the Receiving Party by a Third Party not under any   obligation of confidentiality to the Disclosing Party (provided however, that in such event, the Receiving Party shall notify the Disclosing Party of such disclosure by a Third Party), or said information is approved for disclosure by prior written consent of the Disclosing Party,

(iv) said information is required to be disclosed by court order or govern­mental law or regulation, provided that the Receiving Party gives the Disclosing Party prompt notice of any such requirement and cooperates with the Disclosing Party in attempting to limit such disclosure  or

(v) said information is required, in the opinion of counsel to the Disclosing Party, to be disclosed pursuant to United States securities laws.

	(b)	  Each Party therefore agrees that during the Term and for a period of two (2) years following the termination of the Agreement for any reason, it will not either individually or in conjunction with any other person, business, corporation or any other entity, directly or indirectly solicit, induce or cause, or attempt to solicit, induce or cause, any of the present or future employees of the other to terminate or adversely alter his or her  relationship with Purine or Eastgate as the case may be.

	(c)	Upon termination of this Agreement, each Party shall forthwith return or destroy the other Party's Confidential Information and all copies in its possession and/or control, to the other Party.

	(d)	Further, the Parties acknowledge and agree that the obligations under this ARTICLE IX, except for the obligations set forth in ARTICLE IX(b), shall remain in effect in perpetuity, notwithstanding this Agreement being terminated or ending.

	(e)	Each Party hereby acknowledges and agrees that:

	(i)	the restrictions set forth in this section are reasonable in the circumstances and all defenses to the strict enforcement thereof by the Receiving Party are hereby waived;

	(ii)	a violation of any of the provisions in this section will result in immediate and irreparable harm and damages to the Disclosing Party; and,

	(iii)	in the event of any violation of any provisions of this section, the Disclosing Party shall, in addition to any other right/remedy to relief available to it at law or equity, be entitled to obtain relief by way of temporary or permanent injunction and all such other relief as any court of competent jurisdiction may deem just and proper.

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ARTICLE X: INDEMNIFICATION

Purine shall defend and indemnify and hold Eastgate and its trustees, officers, agents and employees (the "Indemnitees") harmless from any judgments and other liabilities based upon claims or causes of action against Eastgate or its officers, directors, employees or agents which arise out of alleged negligence in the development, manufacture or sale of the Products by Purine, its subsidiaries, and any sublicensees, or from the use by the end users of the Products, except to the extent that such judgments or liabilities arise in whole or in part from the gross negligence or willful misconduct or unsubstantiated claims on formulations by  Eastgate or its directors, employees or agents, provided that Eastgate promptly notifies Purine of any such claim coming to its attention and that it cooperates with Purine in the defense of such claim.  If any such claims or causes of action are made, Eastgate shall be defended by counsel to Purine, subject to Eastgate's approval, which shall not be unreasonably withheld.  Eastgate reserves the right to be represented by its own counsel at its own expense.

ARTICLE XI: COVENANTS REASONABLE

Each Party hereby acknowledges and agrees that all restrictions contained in this Agreement are reasonable, valid and binding, and necessary in the circumstances in order to adequately protect the economic interests of each other. Without the covenants set forth in this Agreement, each Party would not have agreed to enter into the Agreement and, accordingly, all defenses to the strict enforcement thereof by each other are hereby waived by each other to the fullest extent permitted by law.

ARTICLE XII: TERMS, TERMINATION AND REMEDIES

	(a)	This Agreement shall become effective upon the date stated above and shall, unless otherwise provided hereunder, remain in force for a period of five (5) years from the date of execution of this Agreement by both Parties and shall be automatically renewed for successive five (5) year periods thereafter unless either party provides the other party with written notice of its intention not to renew this Agreement at least eighteen (18) months prior to the expiration of the initial term or any renewal term of this Agreement, as applicable.  "Term" shall mean the initial five (5) year term plus renewal periods, if any.  For the avoidance of doubt, the rights granted to Purine under Article II and Article IV shall remain non-exclusive throughout the Term.  Purine has the right to terminate this Agreement with eighteen (18) months prior notice if Eastgate's current chief executive officer ceases to serve as an officer or director and if, in the reasonable discretion of Purine, such change would prevent the terms of this Agreement being complied with and/ or fulfilled.   Eastgate has the right to terminate this Agreement with eighteen (18) months prior notice if Purine's current chief executive officer ceases to serve as an officer and if, in the reasonable discretion of Eastgate, such change would prevent the terms of this Agreement being complied with and/ or fulfilled.

	(b)	In any case during the term of this Agreement the Parties may terminate this Agreement at any time by mutual consent in writing.

	(i)	Eastgate may terminate this Agreement, at any time during the Term and with immediate effect by giving thirty (30) business day prior written notice to Purine after the occurrence of any of the following:

	1.	Purine becoming insolvent and/or bankrupt, making a proposal in bankruptcy or being petitioned into bankruptcy under the bankruptcy or insolvency laws of any jurisdiction in which Purine conducts its business, or if Purine makes an assignment to any Third Party for the benefit of creditors of all of the property and assets of such party, if a trustee or liquidator of a party is appointed;

	2.	A breach of this Agreement by Purine (other than the material breaches of this Agreement specified in ARTICLE III (d)) that remains uncured for more than 30  days after receipt of written notice thereof  to Purine; or

	3.	Purine ceases business operations in any way, including, but not limited to, the voluntary or involuntary winding up.

	(ii)	Without prejudice to any right or remedy available to Eastgate, Eastgate will have just cause to terminate this Agreement, immediately if:

9

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	1.	Purine is in breach of the confidentiality provisions contained in ARTICLE IX of this Agreement; or

	2.	Purine breaches any material representation, warranty, or covenant contained in this Agreement.

	(iii)	Purine may terminate this Agreement, at any time during the Term and with immediate effect by giving thirty (30) business day prior written notice to Eastgate after the occurrence of any of the following:

	1.	Eastgate becoming insolvent and/or bankrupt, making a proposal in bankruptcy or being petitioned into bankruptcy under the bankruptcy or insolvency laws of any jurisdiction in which Eastgate conducts its business, or if Eastgate makes an assignment to any Third Party for the benefit of creditors of all of the property and assets of such party, if a trustee or liquidator of a party is appointed;

	2.	A breach of this Agreement by Eastgate (other than the material breaches of this Agreement specified in ARTICLE VII (e)) that remains uncured for more than 30  days after receipt of written notice thereof from Purine; or

	3.	Eastgate ceases business operations in any way, including, but not limited to, the voluntary or involuntary winding up.

	(iv)	Without prejudice to any right or remedy available to Purine, Purine will have  just cause to terminate this Agreement, immediately if:

	1.	Eastgate is in breach of the confidentiality provisions contained in ARTICLE IX of this Agreement; or

	2.	Eastgate breaches any material representation, warranty, or covenant contained in this Agreement.

	(c)	Any debt of each to the other existing under this Agreement at the time of termination hereof, shall become immediately due and payable, without need of demand, upon the effective date of such termination.

	(d)	Notwithstanding the termination of this Agreement, each Party shall have access to any and all rights and remedies as against each other, and such remedies shall be cumulative in nature.

ARTICLE XIII: MODIFICATIONS, ADDITIONS

This Agreement may not be amended, changed, augmented, in whole or in part, except in writing executed by both Parties, and no waiver of any of the provisions or conditions of this Agreement or any of the rights of a Party hereto shall be effective or binding unless such waiver shall be in writing and signed by the Party claimed to have given or consented thereto. No consent, approval, agreement or waiver by any Party hereto to or of any breach of any of the obligations or representations hereunder shall be deemed to be a waiver of any other condition or subsequent breach of the same or any other obligation or representation by the other Party or Parties, nor shall any forbearance by the first Party or Parties to seek a remedy for any non-compliance or breach by another Party be deemed a waiver by the first Party or Parties of its rights and remedies with respect to such non-compliance or breach. In particular, the Parties agree that they will each act reasonably and in good faith in executing any amendments to this Agreement which further sets forth and defines the relationship between the Parties contemplated herein.

ARTICLE XIV: NOTICES

Any notice or other writing required or permitted to be given hereunder or for the purpose hereof (hereinafter in this ARTICLE XIV called a "Notice") to any Party shall be sufficiently given if delivered personally or if sent by prepaid registered mail:

(a) In case of a notice to Eastgate at:

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Eastgate Pharmaceuticals, Inc.

488 Champagne Drive,

Toronto, Ontario M3J 2T, Canada

Attention: Anna Gluskin

with a copy to

Sichenzia Ross Friedman Ference LLP

61 Broadway, 32nd Floor

New York, NY 10006

Attention: Gregory Sichenzia, Esquire

(b) In the case of notice to Purine at:

Purine Pharma LLC

5 County Route 42

Massena, NY 13662, USA

Attention: Venkat Kakani

Email: vkakani@purinepharma.com

With a copy to

Charles J. Casale Jr, P.A.

1540 Kuser Road, Suite A-7

Mercerville, NJ 08619

or at such other address as the Party to whom such writing is to be given shall have last notified to the Party giving the same in the manner provided in this section.

	(i)	Any Notice delivered personally to the Party to whom it is addressed shall be deemed to have been given and received on the day it is so delivered at such address.

	(ii)	Any Notice mailed as aforesaid shall be deemed to have been given and received on the seventh business day following the date of its mailing.

	(iii)	Any Notice transmitted by facsimile or other form of recorded communication shall be deemed given and received on the business day of transmission, unless transmitted after 5:00 p.m. in which instance shall be deemed to be given and received on the first business day after its transmission.

PUBLIC ANNOUNCEMENTS: Neither Party is permitted to make public announcement of this Agreement or any contemplated agreements/ arrangements between Purine and Eastgate without the express written permission of the other.  Further, the text/ matter of any public announcement/s of this or any agreements between Purine and Eastgate must be approved prior by both parties.  Notwithstanding the foregoing, Eastgate shall, upon the advice of its legal counsel, be allowed to disclose such information as & to the extent required by the United States securities laws without Purine's prior review or approval, as long as such disclosure is notified to Purine within 48 hours following such disclosure

ARTICLE XV: CIRCUMSTANCES BEYOND CONTROL (FORCE MAJEURE)

Neither Party to this Agreement shall be held responsible for the non-compliance of its obligations relative to the provisions of the present agreement if it is due to reasons beyond its direct control, such as earthquakes, war, terrorist acts, civil war, revolution, insurrection, embargo or imperative legal measures.

ARTICLE XVI: GOVERNING LAW – DISPUTES

	(a)	This Agreement shall be construed and governed by the laws of the State of New York.

11

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	(b)	In the event of any dispute arising between the Parties in relation to this Agreement, the Parties shall make their reasonable efforts to settle the dispute amicably. The Parties agree that any unresolved dispute by amicable means shall be finally settled by binding arbitration in accordance with the Rules of International Arbitration, conducted in the State of New York. In particular, the arbitration shall be conducted by a single arbitrator mutually agreed to by the Parties.  The Arbitrator shall render his or her decision within ninety (90) days of the date of the Arbitration Notice. The decision of the Arbitrator shall be final and binding, including any decision as to costs, and no appeal shall lie therefrom.

	(c)	The cost of arbitration shall be equally borne by the Parties.

ARTICLE XVII: SUCCESSORS

This Agreement shall inure to the benefit of and be binding upon the Parties, their respective subsidiaries, holding companies, parent companies, affiliates, directors, officers, employees, agents, successors, and assigns.   For the avoidance of doubt, the terms and provisions of this Agreement shall be binding on purchasers or assignees of Eastgate's rights to the Product to extent permitted by applicable law.

ARTICLE XVIII: INDEPENDENT CONTRACTORS

	(a)	The Parties are independent contractors. Nothing in this Agreement shall be construed to constitute the Parties as principal and agent, employer and employee, franchiser and franchisee, partners, joint venturers, co-owners or otherwise as participants in a joint undertaking.

	(b)	Neither Party has any right or authority whatsoever to assume or to create any liability, obligation or responsibility, expressed or implied, on behalf of or in the name of the other or to bind the other in any manner whatsoever.

ARTICLE XIX: RECITALS, APPENDICES AND HEADINGS

	(a)	The recitals to this Agreement and the appendices annexed hereto constitute an integral part hereof.

	(b)	The headings in this Agreement are intended for convenience purposes only and shall not be used for the purpose of the interpretation hereof.

ARTICLE XX: ENTIRE AGREEMENT

This Agreement reflects the entire understanding between the Parties with respect to the subject matter contained herein, and supersedes all prior oral or written statements and representations of the Parties with respect to the subject matter hereof.

ARTICLE XXI: COUNTERPARTS

This Agreement may be executed in counterparts and delivered by facsimile/other electronic transmission, each of which when so delivered shall be deemed to be an original and all of which shall constitute one and the same document.

ARTICLE XXII: EXPENSES

Unless, otherwise stated in this agreement, all costs and expenses (including, without limitation, the fees and disbursement of legal counsel) incurred in connection with this Agreement and the transactions contemplated herein shall be paid by the Party incurring such expenses.

ARTICLE XXIII: FURTHER ASSURANCES

The Parties shall, with reasonable diligence, do all such things and provide all such reasonable assurances, such further documents or instruments as may be reasonably required by the other Party or that may be reasonably necessary or desirable to effect the purpose of this Agreement and carry out its provisions.

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ARTICLE XXIV: CURRENCY

Unless otherwise stated, any references to currency amounts are in United States Dollars.

ARTICLE XXV: ASSIGNMENT

This Agreement may not be assigned by either Party without the express prior written consent of the other Party, which consent may not be unreasonably withheld and/or delayed by either Party.

[Signature page follows immediately]

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IN WITNESS WHEREOF, on the date first above written, the parties have executed this Agreement in two originals, of which each party has taken one.

	PURINE PHARMA LLC.	EASTGATE PHARMACEUTICALS INC.

 

	
Per:

	
Per:

	
Name: Venkat Kakani

	
Name: Anna E. Gluskin

	
Title: CEO

	
CEO

  

  

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Annex I

The initial Products transferred by Eastgate are:

E-drops

Puralene

Nano D-3

WartX

VCleanZZ

Cleanezze

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[*] INDICATES CONFIDENTIAL PORTION HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION

Annex II

Transfer Pricing

 

	
 Product

	
 

	
Price per bottle

	
 

	
 

	
Batch Size

	
 

	
V-CLEAN-60ml

	
$

	
 

	
[*]

	
 

	
 

	
 

	
[*]

	
 

	
Cleanezze-60ml

	
$

	
 

	
[*]

	
 

	
 

	
 

	
[*]

	
 

	
WartsX-7ml

	
$

	
 

	
[*]

	
 

	
 

	
 

	
[*]

	
 

	
Puralene-30ml

	
$

	
 

	
[*]

	
 

	
 

	
 

	
[*]

	
 

	
E-Drops-30ml

	
$

	
 

	
[*]

	
 

	
 

	
 

	
[*]

	
 

	
Nano D3-50ml

	
$

	
 

	
[*]

	
 

	
 

	
 

	
[*]

	
 

  

16Exhibit 10.3

 

Execution Version

Confidential

 

Confidential Materials omitted and
filed separately with the Securities and Exchange Commission.

Triple asterisks denote omissions.

 

LICENSE AGREEMENT

 

This LICENSE AGREEMENT (the “Agreement”)
is effective as of September 17, 2014 (the “Effective Date”) by and between Spectrum Pharmaceuticals, Inc. a
Delaware corporation (“Spectrum”) and CASI Pharmaceuticals, Inc., a Delaware corporation (“Licensee”).
Licensee and Spectrum are each referred to herein by name or, individually, as a “Party” or, collectively, as
“Parties.”

 

BACKGROUND

 

A.         Spectrum
owns and/or controls rights in and to a pharmaceutical product comprising Captisol® and a compound known as melphalan, including
all of its optical isomers, and salt, ester and polymorphic forms (the “Product”).

 

B.         Licensee
desires to obtain a license to develop and commercialize the Product for use in the Field in the Licensee Territory (each capitalized
term as defined below), and Spectrum desires to grant Licensee such a license.

 

NOW, THEREFORE, in consideration of the
mutual covenants and agreements provided herein below and other consideration, the receipt and sufficiency of which is hereby acknowledged,
Licensee and Spectrum hereby agree as follows:

 

ARTICLE 1

DEFINITIONS

 

The following capitalized terms shall have
the meanings given in this Article 1 when used in this Agreement:

 

1.1         “AAA”
has the meaning set forth in Section 10.2.

 

1.2         “AAA
Rules” has the meaning set forth in Section 10.2.

 

1.3         “Additional
Products” has the meaning set forth in Section 3.4.1.

 

1.4         “Affiliate”
shall mean with respect to either Party, any Person controlling, controlled by or under common control with such Party, for so
long as such control exists. For purposes of this Section 1.4 only, “control” shall mean (i) direct or indirect
ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such
corporate entity or (ii) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management
or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

 

1.5         “Agreement”
has the meaning set forth in the Preamble including any schedules, exhibits, annexures, attached hereto or any amendments and modifications.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	 

    	 

    

 

1.6         “Agreement
Year” shall mean a twelve (12) month period from the Effective Date and each anniversary thereof.

 

1.7         “Applicable
Laws” shall mean, with respect to a Party’s activities under this Agreement, any and all laws, ordinances, orders,
rules, rulings, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable
jurisdiction applicable to such Party’s activities.

 

1.8         “Auditing
Party” has the meaning set forth in Section 5.5.

 

1.9         “Business
Day” shall mean any day other than a Saturday, Sunday or any other day on which commercial banks in the United States,
the People’s Republic of China or Hong Kong are authorized or required by law to remain closed.

 

1.10       “Captisol”
means Captisol®, also known scientifically as sulfobutylether β(beta) cyclodextrin, sodium salt, including all of its
optical isomers, and salt, ester, and polymorphic forms.

 

1.11       “Captisol
Patents” means all patents and patent applications in the Licensee Territory which pertain to Captisol, other than the
Spectrum Patents, and which now or at any time during the Term are owned by or licensed to *** or any *** Affiliate with the right
to sublicense, including any and all extensions, renewals, continuations, substitutions, continuations-in-part, divisions, patents-of-addition,
reissues, reexaminations and/or supplementary protection certificates to any such patents. Set forth in Exhibit 1.11
attached hereto include, without limitation, a list of the Captisol Patents as of the Effective Date. Such Exhibit 1.11
may be updated by *** from time to time during the Term.

 

1.12       “Chairperson”
has the meaning set forth in Section 2.1.3.

 

1.13       “Change
of Control” means, with respect to either Party, (i) the sale of all or substantially all of such Party’s assets
or business relating to this Agreement; (ii) a merger, consolidation, share exchange or other similar transaction involving such
Party and any Third Party which results in the holders of the outstanding voting securities of such Party immediately prior to
such merger, consolidation, share exchange or other similar transaction ceasing to hold more than fifty percent (50%) of the combined
voting power of the surviving, purchasing or continuing entity immediately after such merger, consolidation, share exchange or
other similar transaction, or (iii) the acquisition by a person or entity, or group of persons or entities acting in concert, of
more than fifty percent (50%) of the outstanding voting equity securities of such Party; in all cases of clauses (i)-(iii),
where such transaction is to be entered into with any person or group of persons other than the other Party or its Affiliates.

 

1.14       “Commercialization”
shall mean, with respect to the Product, any and all processes and activities conducted to establish and maintain sales for the
Product (including with respect to reimbursement and patient access), including offering for sale, detailing, selling (including
launch), marketing (including education and advertising activities), promoting, storing, transporting, distributing, and importing
the Product, but shall exclude Development of the Product. For clarity, Commercialization shall include the manufacture of the
Product in support of the foregoing processes and activities, including, to the extent applicable, packaging, labeling and other
finishing activities, quality control and assurance testing, in each case, with respect to such product. “Commercialize”
and “Commercializing” shall have their correlative meanings.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-2-

    	 

    

 

1.15       “Commercially
Reasonable Efforts” shall mean the carrying out of obligations or tasks using efforts not less than the efforts a reasonably
prudent company engaged in the development and commercialization of a pharmaceutical product having similar market potential, profit
potential, or strategic value at a similar stage of its development or product life as the Product, would use based on conditions
then prevailing and taking into account relevant commercial and economic factors.

 

1.16       “Common
Stock” has the meaning set forth in Section 5.1.

 

1.17       “Confidential
Information” has the meaning set forth in Section 7.1.

 

1.18       “Control”
shall mean, with respect to any Intellectual Property right, possession by a party (including its Affiliates) of the right (whether
by ownership, license or otherwise) to grant to another party a license or a sublicense under such Intellectual Property right
without violating the terms of any agreement or other arrangement with any third party. “Controlled” and “Controlling”
shall have their correlative meanings. Notwithstanding anything to the contrary in this Agreement, in the event that a Third Party
acquires (including by merger or consolidation) a Party or an Affiliate of a Party, or a Party or an Affiliate of a Party transfers
to a Third Party all or substantially all of its assets to which this Agreement relates (such Third Party and its Affiliates immediately
prior to such acquisition or transfer (the “Subject Transaction”), collectively, the “Acquiring Entities”),
the following shall not be deemed to be Controlled by such Party or its Affiliates for purposes of this Agreement: (i) any subject
matter owned or controlled by any Acquiring Entity immediately prior to the effective date of such Subject Transaction, and (ii)
any subject matter developed or acquired by or on behalf of any Acquiring Entity after a Subject Transaction independently, without
accessing or practicing subject matter within the Licensed Technology or any other technology or information made available to
such Party under this Agreement.

 

1.19       “***”
shall mean ***.

 

1.20       “Development”
shall mean, with respect to the Product, any and all processes and activities conducted to obtain and maintain Regulatory Approval
for the Product, including preclinical testing, test method development and stability testing, toxicology, formulation, process
development, quality assurance/control development, statistical analysis, clinical studies (including trials for additional indications
for the Product for which a Regulatory Approval has been obtained), quality of life assessments, pharmacoeconomics, post-marketing
studies, label expansion studies, regulatory affairs, and further activities relating to the clinical development or preparation
of such product for filing MAAs with Regulatory Authorities and Commercialization. “Develop” and “Developing”
shall have their correlative meanings.

 

1.21       “Dispute”
has the meaning set forth in Section 10.1.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-3-

    	 

    

 

1.22       “DMF”
means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the
Term, by *** with the FDA, and equivalent filings in other jurisdictions.

 

1.23       “Effective
Date” has the meaning set forth in the Preamble.

 

1.24       “Enforcing
Party” has the meaning set forth in Section 6.5.5.

 

1.25       “Field”
shall mean the use of the Product for the diagnosis, prevention and therapy of all diseases, conditions and disorders in humans.

 

1.26       “First
Commercial Launch” shall mean the first shipment of the Product in commercial quantities for commercial sale to a Third
Party in Licensee Territory after receipt of all applicable Regulatory Approvals therefor from the applicable Regulatory Authority
in Licensee Territory.

 

1.27       “Foreign
Marketing Approval” has the meaning set forth in Section 4.1.6.

 

1.28       “Imported
Product Regulatory Approval” has the meaning set forth in Section 4.1.6.

 

1.29       “Indemnify”
has the meaning set forth in Section 8.5.1.

 

1.30       “Initial
Transfer” has the meaning set forth in Section 4.2.3.

 

1.31       “Intellectual
Property” shall mean intellectual property rights of every kind and nature throughout the world, however denominated,
including all rights and interests pertaining to or deriving from:

 

(a)          Patent
and Know-How;

 

(b)          trademarks,
trade names, service marks, service names, brands, trade dress and logos, domain names, and the goodwill and activities associated
therewith;

 

(c)          copyrights,
works of authorship, rights of privacy and publicity, moral rights, and similar proprietary rights of any kind or nature, in all
media now known or hereafter created; and

 

(d)          any
and all registrations, applications, recordings, licenses, statutory rights, common-law rights and rights relating to any of the
foregoing.

 

1.32       “International
Accounting Standards” shall mean the International Financial Reporting Standards or U.S. Generally Accepted Accounting
Principles.

 

1.33       “Invention”
has the meaning set forth in Section 6.1.2.

 

1.34       “Investment
Agreement” has the meaning set forth in Section 5.1.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-4-

    	 

    

 

1.35       “JPC”
has the meaning set forth in Section 2.1.1.

 

1.36       “Joint
Patents” has the meaning set forth in Section 6.1.1(c).

 

1.37       “Joint
Inventions” has the meaning set forth in Section 6.1.1(c).

 

1.38       “Know-How”
shall mean inventions, business, marketing, technical and manufacturing information, know-how and materials, including technology,
software, instrumentation, specifications, devices, data, compositions, formulas, biological materials, assays, reagents, constructs,
compounds, discoveries, procedures, processes, practices, protocols, methods, techniques, results of experimentation or testing,
knowledge, trade secrets, skill and experience, in each case whether or not patentable or copyrightable.

 

1.39       “Licensee”
has the meaning set forth in the Preamble.

 

1.40       “Licensee
Indemnitees” has the meaning set forth in Section 8.5.1.

 

1.41       “Licensee
Inventions” has the meaning set forth in Section 6.1.1(b).

 

1.42       “Licensee
Know-How” shall mean any and all Know-How Controlled by Licensee or its Affiliates during the Term that is reasonably
necessary or useful for the Development or Commercialization of the Product for use in the Field. Licensee Know-How shall also
include Licensee Inventions.

 

1.43       “Licensee
Territory” shall mean People’s Republic of China including, Hong Kong, Macau and Taiwan.

 

1.44       “Licensee
Trademarks” has the meaning set forth in Section 4.3.4(a).

 

1.45       “Losses”
has the meaning set forth in Section 8.5.1.

 

1.46       “MAA”
shall mean a new drug application or similar application or submission filed with or submitted to any Regulatory Authority to obtain
permission to commence marketing and sales of the Product in any particular jurisdiction.

 

1.47       “Made”
has the meaning set forth in Section 6.1.2.

 

1.48       “Manufacturing
Cost” shall mean Spectrum’s, or Non-Spectrum Foreign Regulatory Approval Holder’s, bona fide and actual manufacturing
cost or bona fide invoiced cost from a Third Party manufacturer.

 

1.49       “Material
Impact” shall mean a material adverse effect on the regulatory status or commercial sales of the Product.

 

1.50       “Material
Impact Matters” has the meaning set forth in Section 2.3.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-5-

    	 

    

 

1.51       “Net
Sales” has the meaning set forth in the Upstream Stream Licenses.

 

1.52       “Non-Spectrum
Foreign Marketing Approval Holder” has the meaning set forth in Section 4.1.6.

 

1.53       “Party”
or “Parties” has the meaning set forth in the Preamble.

 

1.54       “Patent”
shall mean any of the following, whether existing now or in the future anywhere in the world: (i) any issued patent, including
inventor's certificates, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant
for protection of inventions; and (ii) any pending application for any of the foregoing, including any continuation, divisional,
substitution, continuations-in-part, provisional and converted provisional applications.

 

1.55       “Payment
Period” has the meaning set forth in Section 5.2.2.

 

1.56       “Person”
shall mean any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government
or political subdivision thereof.

 

1.57       “Prior
CDA” has the meaning set forth in Section 7.3.

 

1.58       “Product”
has the meaning set forth in the Preamble.

 

1.59       “Prosecution
and Maintenance” shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent,
as well as re-examinations, reissues, requests for Patent term extensions and the like with respect to such Patent, together with
the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent.

 

1.60       “Regulatory
Approval” shall mean, with respect to the Product in a particular jurisdiction, approval or other permission by the applicable
Regulatory Authorities sufficient to initiate manufacturing, importing, marketing and sales of such product, including pricing
and reimbursement approvals.

 

1.61       “Regulatory
Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department,
bureau or other governmental entity with authority over the Development, Commercialization or other use or exploitation (including
the granting of Regulatory Approvals) of the Product in any jurisdiction, including the FDA.

 

1.62       “Regulatory
Filing” shall mean any filing, application, or submission with any Regulatory Authority, including MAAs and authorization,
approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with
or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions
with the relevant Regulatory Authority, in each case with respect to the Product.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-6-

    	 

    

 

1.63       “Senior
Executives” has the meaning set forth in Section 2.3.

 

1.64       “Spectrum”
has the meaning set forth in the Preamble.

 

1.65       “Spectrum
Copyrights” shall mean all works of authorship (including advertising, marketing and promotional materials, artwork,
labeling, and other works of authorship), and all copyrights, moral rights and other rights and interests thereto throughout the
Licensee Territory, whether or not registered, that are (i) Controlled by Spectrum or its Affiliates, and (ii) are delivered
to Licensee by Spectrum for use in connection with the Product.

 

1.66       “Spectrum
Indemnitees” has the meaning set forth in Section 8.5.2.

 

1.67       “Spectrum
Inventions” has the meaning set forth in Section 6.1.1(a).

 

1.68       “Spectrum
Know-How” shall mean any and all Know-How Controlled by Spectrum or its Affiliates during the Term that is reasonably
necessary or useful for the Development or Commercialization of the Product for use in the Field. Spectrum Know-How shall also
include Spectrum Inventions.

 

1.69       “Spectrum
Patents” shall mean any and all Patents Controlled by Spectrum or its Affiliates (other than the Captisol Patents) during
the Term claiming (i) the composition of or formulation for, (ii) any method, composition or apparatus for the manufacture
of, or (iii) any method of using in the Field, in each case of clause (i), (ii), and (iii), the Product. Spectrum Patents shall
also include Patents that claim Spectrum Inventions. A list of Spectrum Patents is appended hereto as Exhibit 1.69
and will be updated periodically to reflect changes thereto during the Term.

 

1.70       “Spectrum
Product Marks” has the meaning set forth in Section 4.3.4(c).

 

1.71       “Spectrum
Technology” shall mean the Spectrum Know-How, Spectrum Patents and Spectrum Copyrights.

 

1.72       “Spectrum
Trademarks” shall mean the trademarks and service marks, the goodwill associated therewith, and all registrations and
applications relating thereto, that are (i) Controlled by Spectrum or its Affiliates, during the Term, and (ii) used
by Spectrum in connection with the Product. A list of Spectrum Trademarks is appended hereto as Exhibit 1.72 and will
be updated periodically to reflect changes thereto during the Term.

 

1.73       “Spectrum
Territory” shall mean all countries and territories throughout the world other than the Licensee Territory.

 

1.74       “Supply
Agreement” has the meaning set forth in Section 4.5.2.

 

1.75       “Term”
has the meaning set forth in Section 9.1.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-7-

    	 

    

 

1.76       “Territory”
shall mean all of the countries and territories in the world. A Party’s respective “Territory” shall mean, in
the case of Spectrum, the Spectrum Territory, and in the case of Licensee, the Licensee Territory.

 

1.77       “Third
Party” shall mean any Person other than Licensee, Spectrum or their respective Affiliates.

 

1.78       “Third-Party
Claim” has the meaning set forth in Section 8.5.1.

 

1.79       “Upstream
Licenses” shall mean ***.

 

1.80       “Upstream
Payments” has the meaning set forth in Section 5.2.1.

 

1.81       “Wind-Down
Period” has the meaning set forth in Section 9.8.2.

 

ARTICLE 2

GOVERNANCE

 

2.1         Joint
Product Committee.

 

2.1.1           Establishment.
Promptly after the Effective Date, Licensee and Spectrum shall establish a joint product committee (the “JPC”)
to oversee, review and coordinate the activities of Licensee under this Agreement, including the Development and Commercialization
of the Product for use in the Field in the Licensee Territory.

 

2.1.2           Responsibilities.
The JPC shall be responsible for: (i) overseeing, reviewing and monitoring Licensee’s activities under this Agreement
including, without limitation, any clinical trials proposed to be conducted by Licensee; (ii) facilitating access to and the
exchange of information between the Parties related to the Development and/or Commercialization of the Product for use in the Field
in the Licensee Territory; and (iii) undertaking and/or approving such other matters as are specifically provided for the
JPC under this Agreement.

 

2.1.3           Membership.
The JPC shall be comprised of an equal number of representatives from each of Spectrum and Licensee and unless otherwise agreed
such number shall be two (2) senior representatives from each Spectrum and Licensee. Either Party may replace its respective JPC
representatives at any time with prior notice to the other Party, provided, that such replacement is of comparable authority
and scope of functional responsibility within that Party’s organization as the person he or she is replacing. Unless otherwise
agreed by the Parties, the JPC shall have at least one representative with relevant decision-making authority from each Party such
that the JPC is able to effectuate all of its decisions within the scope of its responsibilities. Licensee shall select one of
its representatives as the chairperson for the JPC (the “Chairperson”) and the Licensee may replace the Chairperson
upon written notice to Spectrum. The Chairperson shall be responsible for calling meetings, preparing and circulating an agenda
in advance of each meeting (which agenda will include every matter requested by either Party), and preparing and issuing minutes
of each meeting within thirty (30) days thereafter.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-8-

    	 

    

 

2.2        Meetings.
The JPC shall hold meetings (either in person, by teleconference or videoconference) at such times and places as the Parties may
mutually agree, provided, that, unless the Parties agree otherwise, the JPC shall meet at least semi-annually during the
Development of the Product for use in the Field in the Licensee Territory, and at least annually thereafter. Each Party shall bear
its own costs associated with attending such meetings. As appropriate, other employees of the Parties may attend the JPC’s
meetings as nonvoting observers, but no Third Party personnel may attend unless otherwise agreed by the Parties. At the request
of Spectrum and with prior written approval of Licensee, which shall not be unreasonably withheld, Third Party licensees of Spectrum
for the development and commercialization of the Product for use in the Field in the Spectrum Territory may attend the JPC’s
meetings as nonvoting participants if they have agreed to confidentiality terms at least as restrictive as those set forth in this
Agreement. Each Party may also call for special meetings to resolve particular matters requested by such Party.

 

2.3        Decision
Making. Decisions of the JPC shall be made by consensus of the members present in person or by other means (e.g., teleconference)
at any meeting, with at least one representative from each Party participating in such vote. The members of the JPC shall at all
times use good faith efforts to reach consensus on matters properly referred to the JPC. In the event that the JPC is unable to
reach consensus with respect to a particular matter within its purpose, then either Party may, by written notice to the other,
refer the matter to the respective business head of each Party or their respective designee who is senior in rank and authority
to such Party’s JPC representatives (the “Senior Executives”) for resolution by good faith discussions
for a period of at least fifteen (15) Business Days. In the event that the Senior Executives are unable to reach agreement with
respect to such matter within such fifteen (15) Business Days, then Licensee shall have the final decision-making authority with
respect to such matter, except in the event that such matter is reasonably possible to create a Material Impact in the Spectrum
Territory (the “Material Impact Matters”) and Spectrum notifies Licensee during or before any referral
of the matter to Senior Executives of each Party for resolution of Spectrum’s belief that such matter is a Material Impact
Matter, in which case, Spectrum shall have the final decision-making authority.

 

2.4        Authority.
The JPC shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development and
Commercialization of the Product for use in the Field in the Licensee Territory, consistent with good pharmaceutical practices
and commercially reasonable consideration of the optimal balance of maximizing long-term sale of the Product in the Licensee Territory.

 

2.5        Day-to-Day
Responsibilities. Each Party shall: (i) be responsible for day-to-day implementation and operation of the activities hereunder
for which it has or is otherwise assigned responsibility under this Agreement, provided, that such implementation is not
inconsistent with the express terms of this Agreement or the decisions of the JPC within the scope of their authority specified
herein; and (ii) keep the other Party informed as to the progress of such activities as reasonably requested by the other
Party and as otherwise determined by the JPC.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-9-

    	 

    

 

2.6        JPC
Participation; Discontinuation. It is understood that Spectrum’s participation on the JPC shall be as a matter of right,
but not an obligation. Accordingly, Spectrum may, at its discretion, elect to discontinue its participation in the JPC at any time
during the Term upon written notice to Licensee. If Spectrum provides such written notice, then JPC shall have no further authority
under this Agreement and shall cease to function, and thereafter decisions which were previously to be made by the JPC as set forth
and contemplated in this Agreement shall be made solely by the Licensee in its reasonable discretion except that all decisions
with respect to Material Impact Matters shall be made solely by Spectrum, and all of the rights and obligations of the Parties
under this Agreement shall continue in full force and effect as rights and obligations directly between the Parties, including,
without limitation, each Party’s obligations to provide and rights to receive results, data and other information generated
from the other Party’s activities with respect to the Development of the Product for use in the Field.

 

ARTICLE 3

LICENSES AND EXCLUSIVITY

 

3.1         Grant
to Licensee.

 

3.1.1           License.
Subject to and in accordance with the terms and conditions of this Agreement, Spectrum hereby grants to Licensee, during the Term,
(i) an exclusive (even as to Spectrum and its Affiliates, except to the extent necessary to perform their obligations under
this Agreement), irrevocable (except as set forth in Article 9), fully paid-up, royalty-free (except as set forth in Section
5.2.1), sublicenseable at any tier (in accordance with Section 3.1.2) license to use the Spectrum Know-How, and under the Spectrum
Patents and Captisol Patents, to Commercialize (including to use, sale, offer for sale and import) the Product solely in the Licensee
Territory and solely for use in the Field, subject to and in accordance with Section 4.3, and (ii) a non-exclusive, irrevocable
(except as set forth in Article 9), fully paid-up, royalty-free, sublicenseable at any tier (in accordance with Section 3.1.2)
license to use the Spectrum Know-How, and under the Spectrum Patents and Captisol Patents, to Develop the Product solely in the
Licensee Territory and solely for use in the Field, subject to and in accordance with Sections 4.1 and 4.2.

 

3.1.2           Sublicenses.
Neither Licensee nor any of its Affiliates may grant or authorize sublicenses under the license under Section 3.1.1 without
the prior written consent of Spectrum, which approval shall not be unreasonably withheld, delayed, or conditioned, except that
Licensee shall have the right to sublicense at any tier the license under Section 3.1.1 to its Affiliates without the consent of
Spectrum; provided, that Licensee shall promptly notify Spectrum of any such license grant to its Affiliates. Licensee shall be
responsible for the failure by its Affiliates to comply with, and Licensee shall ensure the compliance by each of its Affiliates
with, the terms of this Agreement including all relevant restrictions, limitations and obligations.

 

3.2         Activities
Outside the Field and Outside the Licensee Territory.

 

3.2.1           Licensee
Rights Limited to the Field and the Licensee Territory. Licensee agrees that neither it, nor any of its Affiliates, will Develop
(including file for Regulatory Approval with respect to) or Commercialize (including use, sale, offer for sale or import) the Product
anywhere in the world, or for any use anywhere in the world, except in the Licensee Territory, and for use in the Field in the
Licensee Territory, only in accordance with and under this Agreement. Licensee agrees that neither it, nor any of its Affiliates,
will use or otherwise exploit, except as expressly licensed under this Agreement, any Spectrum Patents, Spectrum Know-How and/or
Spectrum Trademark, or their counterparts in a country outside the Licensee Territory.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-10-

    	 

    

 

3.2.2           Territorial
Integrity. Each Party shall use Commercially Reasonable Efforts to prevent any Product sold or otherwise distributed by such
Party, directly or indirectly, from being sold, distributed or otherwise transported for use outside its respective Territory.

 

3.3         Upstream
Licenses. In addition to the payment obligations under Section 5.2, Licensee shall, and shall cause its Affiliates and sublicensees
to, comply with all the terms and conditions of the Upstream Licenses applicable to Licensee or its Affiliates or sublicensees,
or to Spectrum due to Licensee’s or its Affiliates’ or sublicensees’ activities, under this Agreement in the
Licensee Territory. To the extent that any provisions are more restrictive, or broader, under the Upstream Licenses than may be
explicitly set out in the Agreement, such more restrictive or broader provisions shall govern Licensee’s rights. During the
Term, Spectrum shall promptly furnish Licensee with copies of (a) complete and unredacted copies of the Upstream Licenses and any
relevant ancillary agreements, exhibits, schedules, or other documents which set forth and are sufficient to fully describe all
the terms and conditions with which Licensee must comply in relation to the Upstream Licenses, (b) all amendments of the Upstream
Licenses, and (c) all correspondence (or in the case of oral discussions, a summary of such discussions) with or from and reports
received from or provided to licensors under the Upstream Licenses to the extent material to Licensee or the rights granted or
to be granted to Licensee under this Agreement. In addition, during the Term, Spectrum shall provide copies of all notices received
by Spectrum relating to any alleged breach or default by Spectrum under the Upstream Licenses within five (5) Business Days after
Spectrum’s receipt thereof.

 

3.4         Assistance
to Obtain Rights to Additional Products.

 

3.4.1           Introduction
to Third Parties with Rights to Additional Products. With regard to any current and/or future proprietary, licensed or acquired
pharmaceutical or biologic assets or products, and any and all other derivatives, and/or improvements thereof, that Spectrum Controls
or that come under the Control of Spectrum, other than the Product (the “Additional Products”), to the extent
Development and Commercialization rights in the Licensee Territory are Controlled by Third Parties, at Licensee’s reasonable
request, Spectrum shall use good faith efforts, solely from the perspective of Spectrum’s best interests, to introduce Licensee
to such Third Parties to facilitate Licensee to license or acquire such rights in the Licensee Territory from such Third Parties,
with the understanding that Licensee shall be solely responsible for all costs or consideration related to a license or acquisition
of such rights in the Licensee Territory from such Third Parties.

 

3.4.2           Efforts
to Obtain Rights in the Licensee Territory. Spectrum shall use good faith efforts, solely from the perspective of Spectrum’s
best interests, when engaging in negotiations with Third Parties to license or acquire any Development and Commercialization rights
for any pharmaceutical or biologic assets or products, and any and all other derivatives, and/or improvements thereof owned by
such third parties, to license or acquire Development and Commercialization rights thereto in the Licensee Territory.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-11-

    	 

    

 

3.4.3           Termination
Upon Change of Control. Licensee acknowledges and agrees that Spectrum’s obligations under Sections 3.4.1 and 3.4.2 above
shall terminate and be of no further effect upon the consummation of Change of Control by Spectrum.

 

3.5         No
Other Rights. Each Party acknowledges that the rights and licenses granted under this Article 3 and elsewhere in this
Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement,
no right, title, or interest of any nature whatsoever is granted, whether by implication, estoppel, reliance, or otherwise, by
either Party to the other Party. All rights with respect to Know-How, Patents or other Intellectual Property rights that are not
specifically granted herein are reserved to the owner thereof. Without limiting the foregoing and unless otherwise provided in
the Supply Agreement, Spectrum grants no rights to Licensee to manufacture, import, sell or offer for sale bulk Captisol.

 

ARTICLE 4

REGULATORY MATTERS, DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT

 

4.1         Regulatory
Matters.

 

4.1.1           General.
Licensee shall be responsible for all correspondence, meetings and other interactions, with the relevant Regulatory Authorities
concerning regulatory activities related to the Product in the Field in the Licensee Territory, and for preparing and filing any
and all Regulatory Filings for Regulatory Approval for the Product in the Field in the Licensee Territory at its sole expense and
shall use Commercially Reasonable Efforts in doing so. Spectrum shall assist and cooperate with Licensee in connection with the
preparation, filing and maintenance of such Regulatory Filings, as reasonably requested by Licensee. All Regulatory Approvals in
the Licensee Territory shall be owned by Licensee and filed and obtained in Licensee’s and/or Spectrum’s name in accordance
with Applicable Laws.

 

4.1.2           Reporting.
Licensee shall keep Spectrum fully informed of regulatory developments relating to the Product in the Field in the Licensee Territory
and shall promptly notify Spectrum in writing of any action or decision by any Regulatory Authority in the Licensee Territory regarding
the Product in the Field. Licensee shall provide Spectrum for review and comment all draft Regulatory Filings in its original language
(with a summary in English) and in electronic form (other than routine correspondence) at least twenty (20) Business Days (or in
the event of a shorter filing deadline, as soon as practicable) in advance of their intended date of submission to a Regulatory
Authority in the Licensee Territory. Spectrum shall use good faith efforts to provide Licensee with comments to such draft Regulatory
Filings prior to the intended date of submission, and Licensee shall consider in good faith any comments thereto provided by Spectrum.
Notwithstanding the foregoing, Licensee shall provide Spectrum with copies of the portions of all regulatory submissions containing
Captisol data alone (and not in conjunction with any product formulation) thirty-five (35) days prior to submission and shall use
commercially reasonable efforts to incorporate Spectrum’s comments on the same. Licensee shall promptly notify Spectrum of
any Regulatory Filings (other than routine correspondence) submitted to or received from any Regulatory Authority in the Licensee
Territory regarding the Product in the Field, and shall provide copies thereof at least five (5) Business Days after submission
or receipt, which copy may be provided in its original language and in electronic form. Licensee shall keep Spectrum informed of
all meetings, conferences and discussions with any Regulatory Authority in the Licensee Territory concerning the Product, and shall
provide Spectrum with a summary of the substantive content discussed in any such meeting, conferences or discussions within five
(5) Business Days after such meetings, conferences or discussions. In addition, upon Spectrum’s request, Licensee shall promptly
meet and confer with Spectrum to discuss any regulatory matters related to the Product in the Licensee Territory, either in person
at Licensee’s facility or by audio or video teleconference as Spectrum may elect.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-12-

    	 

    

 

4.1.3      Regulatory
Costs. Licensee shall be solely responsible for all of its costs and expenses related to the preparation, filing and maintenance
of all Regulatory Approvals for the Product in the Field in the Licensee Territory. Spectrum shall support Licensee, as reasonably
requested by Licensee, in obtaining Regulatory Approvals in Licensee Territory, including providing necessary documents or other
materials in Spectrum’s possession required by Applicable Laws to obtain Regulatory Approvals in such territory, all in accordance
with the terms and conditions of this Agreement, provided, that Spectrum shall be under no obligation to generate any additional
data unless specifically agreed by Spectrum and Licensee.

 

4.1.4      Access
and Rights of Reference.

 

(a)          Spectrum
hereby grants to Licensee a right of reference to all Regulatory Filings filed by or on behalf of Spectrum, which right of reference
Licensee may use for the sole purpose of seeking, obtaining and maintaining Regulatory Approvals and Developing and Commercializing
the Product in the Field in the Licensee Territory. At Licensee’s reasonable request, Spectrum shall submit to the Regulatory
Authorities a copy of the Regulatory Filings related to the Product, which are reasonably determined by Spectrum to be necessary
to support Licensee’s application for Regulatory Approvals in the Licensee Territory. Notwithstanding the foregoing, Licensee
shall have the right to reference the DMF solely in connection with Licensee’s Regulatory Filings submitted in connection
with obtaining Regulatory Approval for the Product in Licensee Territory.

 

(b)          Spectrum
and *** shall have the right to reference and utilize all toxicology/safety and other scientific data developed on the Product
by Licensee, its sublicensees or Affiliates, at no cost to Spectrum or ***. Upon written request by Spectrum or ***, Licensee shall
either provide Spectrum or ***, as applicable, with a copy of all such data or shall make such data accessible to Spectrum or ***,
as applicable, at such times and locations mutually agreed upon by the parties.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-13-

    	 

    

 

4.1.5      Reporting;
Adverse Drug Reactions.

 

(a)          Pharmacovigilance
Agreement. Promptly after the Effective Date, the Parties shall enter into a pharmacovigilance agreement on reasonable and
customary terms, including: (a) providing detailed procedures regarding the maintenance of core safety information and the
exchange of safety data relating to the Product within appropriate timeframes and in an appropriate format to enable each Party
to meet both expedited and periodic regulatory reporting requirements; and (b) ensuring compliance with the reporting requirements
of all applicable Regulatory Authorities on a worldwide basis for the reporting of safety data in accordance with all applicable
regulatory and legal requirements regarding the management of safety data. Each Party hereby agrees to comply with its respective
obligations under such pharmacovigilance agreement and to cause its Affiliates to comply with such obligations.

 

(b)          Adverse
Event Reporting. As between the Parties: (a) Licensee or its designee shall be responsible for the timely reporting of
all adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to the Product to the appropriate
Regulatory Authorities in the Licensee Territory; and (b) Spectrum or its designee shall be responsible for reporting all
adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to the Product to the appropriate
Regulatory Authorities in the Spectrum Territory; all in accordance with Applicable Laws.

 

4.1.6      Spectrum
Assistance for Imported Products. In the event that (a) to apply for Regulatory Approval for the Product as an imported
drug or product (an “Imported Product Regulatory Approval”) in a country or regulatory jurisdiction within the
Licensee Territory, a Regulatory Authority or Applicable Laws of such country or regulatory jurisdiction requires the applicant
to hold a marketing authorization, certificate of pharmaceutical product, or an equivalent certification for such Product outside
of such country or regulatory jurisdiction within the Licensee Territory (a “Foreign Marketing Approval”), (b) Licensee
decides to seek Imported Product Regulatory Approval for such Product in such country or regulatory jurisdiction, and (c) Licensee
requests Spectrum, if Spectrum is the Foreign Marketing Approval holder for such Product, to authorize Licensee to file, in Spectrum’s
name, or if, Spectrum’s Affiliate or a Third Party is the Foreign Marketing Approval holder for such Product (the “Non-Spectrum
Foreign Marketing Approval Holder”), to procure such Non-Spectrum Foreign Marketing Approval Holder to authorize Licensee
to file in such Non-Spectrum Foreign Marketing Approval Holder’s name, for such Imported Product Regulatory Approval for
such Product, then, Spectrum shall, and shall use commercially reasonable efforts to cause any Non-Spectrum Marketing Approval
Holder to, provide all reasonable assistance, facilitation and support including providing all documents and data reasonably requested
by Licensee in a timely manner and at Licensee’s cost to effectuate such Imported Product Regulatory Approval including:

 

(a)          Licensee
shall have sole responsibility for, and sole decision-making authority with respect to, preparing, filing, obtaining and maintaining
the Imported Product Regulatory Approvals and related Regulatory Filings, provided, that Spectrum shall, and shall cause
its Affiliates and any Non-Spectrum Foreign Marketing Approval Holder to, at the request of Licensee, cooperate with Licensee to
prepare, file, obtain and maintain such Imported Product Regulatory Approvals and related Regulatory Submissions.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-14-

    	 

    

 

(b)          Spectrum
shall:

 

(i)          if
Spectrum holds the Foreign Marketing Approval, authorize Licensee, and provide all reasonable assistance, facilitation and support
including providing all documentations and data reasonably requested by Licensee to Licensee, to file, in Spectrum’s name,
for Imported Product Regulatory Approval in such country or regulatory jurisdiction, at the direction of Licensee and for Licensee’s
sole benefit; or

 

(ii)         if
a Non-Spectrum Foreign Marketing Approval Holder holds the Foreign Marketing Approval for such Product, use commercially reasonable
efforts to cause such Non-Spectrum Foreign Marketing Approval Holder to authorize and provide all reasonable assistance, facilitation
and support including providing all documentations and data reasonably requested by Licensee to Licensee, to file, in such Non-Spectrum
Foreign Marketing Approval Holder’s name, for Imported Product Regulatory Approval in such country or regulatory jurisdiction,
at the direction of Licensee and for Licensee’s sole benefit.

 

(c)          If
the Regulatory Authority or Applicable Laws in such country or regulatory jurisdiction allows the Spectrum to appoint a local agent
(or registration agent) to assist in the filing, maintenance or amendment of the Imported Product Regulatory Approval, then Spectrum
shall appoint, or use commercially reasonable efforts to procure any Non-Spectrum Foreign Marketing Approval Holder to appoint,
including providing a power of attorney which effectuates such appointment and registering such appointment with the relevant Regulatory
Authority, Licensee or its designated Affiliate as its designated local agent for the Imported Product Regulatory Approval process
inclusive of, to the fullest extent possible, the receipt of communications from the Regulatory Authority and submission of all
relevant Regulatory Submissions.

 

(d)          Spectrum
shall use commercially reasonable efforts to cause any Non-Spectrum Foreign Marketing Approval Holder to grant to Licensee, during
the Term, an exclusive (even as to Spectrum, its Affiliates, and any Non-Spectrum Foreign Marketing Approval Holder), irrevocable
(except as set forth in Article 9), fully-paid, royalty-free (except as set forth in Section 5.2.1), sublicenseable (in accordance
with Section 3.1.2) license under such Imported Product Regulatory Approvals to Develop and Commercialize the Product solely in
the Licensee Territory and solely for use in the Field in accordance with this Agreement. In addition, Spectrum shall cause any
Non-Spectrum Foreign Marketing Approval Holder to, provide to Licensee, all benefits of any Imported Product Regulatory Approvals
and enforce, at Licensee’s cost and expense, at the request of and for the account of Licensee, any rights of Spectrum or
its Affiliates arising under any Imported Product Regulatory Approvals against any Person.

 

(e)          Spectrum
shall use commercially reasonable efforts to cause any Non-Spectrum Foreign Regulatory Approval Holder to Manufacture and supply
via the named manufacturer or supplier on the relevant Imported Product Regulatory Approval all Products for Commercialization
under the Imported Product Regulatory Approvals in the Territory to Licensee and its designated Affiliates and sublicensees at
a price per Product equal to the Non-Spectrum Foreign Regulatory Approval Holder’s Manufacturing Cost (as may change from
time to time) for such Product plus ***.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-15-

    	 

    

 

(f)          Spectrum
shall, and hereby appoints, and shall use commercially reasonable efforts to cause its Affiliates and any Non-Spectrum Foreign
Marketing Approval Holder to appoint, Licensee as its attorney-in-fact to Develop and Commercialize the Product under the Imported
Product Regulatory Approval on Spectrum’s or the Non-Spectrum Foreign Marketing Approval Holder’s behalf, and shall
execute a power of attorney in favor of Licensee to this effect during the Term.

 

(g)          Spectrum
shall, and shall use commercially reasonable efforts to cause its Affiliates and any Non-Spectrum Foreign Marketing Approval Holder
to, (x) notify Licensee of all communications received from the applicable Regulatory Authority with respect to any Imported Product
Regulatory Approvals, (y) provide all official original copies of all Imported Product Regulatory Approvals received from the applicable
Regulatory Authority to Licensee, and (z) provide copies of any written correspondence received from the applicable Regulatory
Authorities with respect to any Imported Product Regulatory Approvals to Licensee, in each case, promptly after receipt thereof.

 

(h)          Spectrum
shall not, and shall use commercially reasonable efforts to cause its Affiliates and any Non-Spectrum Foreign Marketing Approval
Holder to not, interact or communicate with the CFDA regarding the Imported Product Regulatory Approvals without the prior approval
or participation of Licensee.

 

(i)          If
at any time Spectrum, its Affiliates or any Non-Spectrum Foreign Marketing Approval Holder are permitted by the applicable Regulatory
Authority to transfer the Imported Product Regulatory Approval to Licensee, Spectrum shall, and hereby does, and shall cause its
Affiliates and any Non-Spectrum Foreign Marketing Approval Holder to, assign to Licensee or its designated Affiliate, all rights,
title and interests in and to such Imported Product Regulatory Approvals and related Regulatory Submissions for the Product in
the Field in the Territory. Spectrum agrees and covenants that it shall, and shall cause it Affiliates and any Non-Spectrum Foreign
Marketing Approval Holder to, promptly take any and all actions necessary to effectuate the prompt assignment of such Imported
Product Regulatory Approvals and related Regulatory Submissions, or to enable Licensee or its designated Affiliate to obtain new
Imported Product Regulatory Approvals or related Regulatory Submissions, including executing and delivering all documents or instruments,
and providing all copies of documents or information, that may be necessary, required or which Licensee or its designated Affiliate
may request.

 

4.2        Development.

 

4.2.1      General.
Licensee shall take the lead in, and be responsible for, conducting the Development activities, including clinical trials, as may
be reasonably necessary to expeditiously obtain Regulatory Approvals for the Product for use in the Field in the Licensee Territory.
Except as otherwise provided herein, it is understood and agreed that, as between the Parties, all Development efforts for the
Product for use in the Field in the Licensee Territory shall be at the sole expense of Licensee.

 

4.2.2      Clinical
Trials. If additional clinical trials are required in the Licensee Territory, Licensee shall promptly inform JPC and shall
not conduct any clinical trial without the prior approval of the JPC in accordance with Section 2.3.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-16-

    	 

    

 

4.2.3      Development
Assistance. Promptly after the Effective Date, but not to exceed thirty (30) days following the Effective Date, Spectrum shall,
at its own cost and expense, make available to Licensee the Spectrum Know-How that exists on the Effective Date and was not previously
provided to Licensee (but without an obligation for Spectrum personnel to travel) including all Spectrum Know-How developed, collected,
or submitted as part of an investigational new drug application or similar application or submission filed with or submitted to
any Regulatory Authority to obtain permission to commence clinical trials in relation to the Product in any particular jurisdiction
(the “Initial Transfer”). For clarity, the Initial Transfer shall not require Spectrum to conduct any new Development
work or prepare or complete any reports not already completed. After the Initial Transfer, Spectrum shall provide Licensee with
reasonable assistance regarding scientific, clinical and/or manufacturing matters (including the chemistry, manufacture and controls
of the Product) in the Development of the Product in the Field in the Licensee Territory. Such assistance shall include the transfer
of additional Spectrum Know How to Licensee and reasonable access to Spectrum personnel involved in the research and Development
of the Product, either in-person or by teleconference. Notwithstanding the foregoing or anything in this Agreement to the contrary,
Licensee is solely responsible for (i) use of all documentation provided by Spectrum, including without limitation, use in
any regulatory submission to the regulatory agencies in the Licensee Territory, (ii) document control and retention, and (iii) determining
the suitability of any documentation provided by Spectrum hereunder for use in any regulatory submission.

 

4.2.4      Diligence.
Licensee shall use Commercially Reasonable Efforts to Develop and obtain and maintain Regulatory Approval for the Product for at
least one indication in the Field in the Licensee Territory and shall not take actions that would be reasonably likely to create
a Material Impact. As applicable, Licensee is also obligated to conduct the diligence requirements applicable to Licensee in the
Licensee Territory listed on Exhibit D of the ***. Licensee will have no other diligence obligations with respect to the Development
of the Product under this Agreement.

 

4.3        Commercialization.

 

4.3.1      General.
Except as otherwise provided herein, it is understood and agreed that, as between the Parties, all Commercialization efforts for
the Product for use in the Field in the Licensee Territory shall be at the sole expense of Licensee.

 

4.3.2      Diligence.
Licensee will use Commercially Reasonable Efforts to Commercialize the Product in the Field in each country in the Licensee Territory
in which Regulatory Approval is received and shall not take actions that would be reasonably likely to create a Material Impact.
Without limiting the foregoing, Licensee agrees to, directly or through one or more of its Affiliates, use Commercially Reasonable
Efforts (i) to launch the Product for use in the Field as soon as practicable in the Licensee Territory, and thereafter (ii) to
market, promote and sell the Product in the Field throughout the Licensee Territory to maximize Net Sales with respect thereto.
As applicable, Licensee is also obligated to conduct the diligence requirements listed on Exhibit D of the ***. Licensee will have
no other diligence obligations with respect to the Commercialization of the Product under this Agreement.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-17-

    	 

    

 

4.3.3      Pricing.
Licensee shall have the sole right to determine pricing of the Product in the Field in the Licensee Territory, provided,
that Licensee and Spectrum shall discuss the pricing strategy for the Licensee Territory.

 

4.3.4      Trademarks.

 

(a)          Licensee
Trademarks. Licensee shall have the right to select the Product names and all trademarks, including any Spectrum Trademarks
(subject to Section 4.3.4(b) and only to the extent Spectrum has the right to grant a license to such Spectrum Trademarks to Licensee),
used in connection with the Commercialization of the Product for use in the Field, including special promotional or advertising
taglines, in each case in the Licensee Territory (all such trademarks, other than the Spectrum Trademarks, specific to the Product
and including all goodwill associated therewith, and all applications, registrations, extensions and renewals relating thereto,
shall be referred to as the “Licensee Trademarks”). Licensee shall be the exclusive owner of the Licensee Trademarks,
and shall use Commercially Reasonable Efforts to register and maintain, at its expense, such Licensee Trademarks as shall be used
for Commercialization of the Product for use in the Field in the Licensee Territory.

 

(b)          Reference
to Spectrum as Licensor.

 

(i)          Spectrum
Trademarks. To the extent permitted by Applicable Laws, at Spectrum’s election, the labels and packaging of the Product
and all promotional materials for the Product shall include text identifying Spectrum as the licensor of the Product and a Spectrum
Trademark to be placed in a size and location reasonably agreed to by the Parties, provided, that such mark: (i) is
used in a consistent and noticeable manner sufficient to constitute trademark usage under Applicable Laws, (ii) is clearly
identified as a trademark (i.e., through the use of a “®”, “TM” or other appropriate identifier),
(iii) is not used as combination marks with other marks or trademarks, and (iv) is reasonably less prominent in size and location
as the Licensee Trademarks. Licensee shall obtain Spectrum’s review and approval prior to the first use of the Spectrum Trademarks
in such labeling, packaging or promotional materials, such approval not to be unreasonably withheld if the Spectrum Trademarks
are used in a manner that is consistent with Spectrum’s reasonable usage guidelines for such Spectrum Trademarks.

 

(ii)         Trademark
License. In connection with Section 4.3.4(b)(i) above, Spectrum hereby grants to Licensee an exclusive license to use
the Spectrum Trademarks (except with respect to the Spectrum’s trade name under which such license to use is non-exclusive)
for the packaging, labeling, marketing, promotion, distribution and sale of the Product for use in the Field in the Licensee Territory
in accordance with this Agreement, and Licensee shall have the right to exercise such license through its Affiliates, provided,
that Licensee shall be responsible for the failure by its Affiliates to comply with, and Licensee guarantees the compliance by
each of its Affiliates with, the terms of this Agreement including all relevant restrictions, limitations and obligations. Spectrum
shall own all right, title and interest in and to the Spectrum Trademarks and the registrations thereof and all goodwill from the
use of the Spectrum Trademarks shall vest in and inure to the benefit of Spectrum. Spectrum shall use Commercially Reasonable
Efforts to register and maintain, at Licensee’s expense, such Spectrum Trademarks as shall be used for Commercialization
of the Product for use in the Field in the Licensee Territory.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-18-

    	 

    

 

(c)          Spectrum
Product Marks. Spectrum shall have the right, but not the obligation, to brand the Product for use in the Field in the Spectrum
Territory using the Licensee Trademarks (“Spectrum Product Marks”). Accordingly, Licensee shall provide to Spectrum
copy proofs of each Licensee Trademark and reasonable usage guidelines therefor as such mark is registered with the applicable
Regulatory Authorities in the Licensee Territory for Spectrum’s review and consideration. Spectrum shall obtain Licensee’s
review and approval prior to the first use of the Spectrum Product Marks in such labeling, packaging or promotional materials,
such approval not to be unreasonably withheld if the Spectrum Product Marks are used in a manner that is consistent with Licensee’s
reasonable usage guidelines for such Spectrum Product Marks. Subject to this Section 4.3.4(c), Licensee further hereby grants to
Spectrum an exclusive license to use the Spectrum Product Marks (except with respect to the Licensee’s trade name under which
such license to use is non-exclusive), to the extent Spectrum Product Marks exist in the Spectrum Territory, consistent with the
usage guidelines applicable to Licensee and its Affiliates’ use of such Licensee Trademarks in the Licensee Territory solely
in connection with the Development and Commercialization of the Product solely for use in the Field and solely in the Spectrum
Territory for the packaging, labeling, marketing, promotion, distribution and sale of the Product for use in the Field in the Spectrum
Territory in accordance with this Agreement, and Spectrum shall have the right to exercise such license through its Affiliates
or sublicense a Third Party, provided, that Spectrum shall be responsible for the failure by its Affiliates or Third Party
sub-licensees to comply with, and Spectrum guarantees the compliance by each of its Affiliates with, the terms of this Agreement
including all relevant restrictions, limitations and obligations. Licensee shall own all right, title and interest in and to any
Spectrum Product Marks and the registrations thereof and all goodwill from the
use of the Spectrum Product Marks shall vest in and inure to the benefit of Licensee. The above notwithstanding, Licensee
shall have the right, but not the obligation, to register or maintain any Spectrum Product Marks in the Spectrum Territory.

 

4.4         Reporting.
Without limiting any other provisions of this Agreement, Licensee shall keep Spectrum reasonably informed through the JPC as to
the progress of its activities with respect to the Development and Commercialization of the Product or otherwise under this Article 4
and provide such reports and information with respect thereto as designated by the JPC or as may be reasonably requested by Spectrum.
In addition, Licensee shall promptly notify Spectrum if it anticipates or there are material deviations from the Commercialization
Plan(s) or any development diligence requirement, and shall discuss in good faith and keep Spectrum informed as to any corrective
actions that it intends or is taking to address such deviations.

 

4.5         Manufacturing
and Supply.

 

4.5.1      No
Manufacturing Rights. Spectrum retains all rights with respect to manufacturing of the Product.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-19-

    	 

    

 

4.5.2      Supply.
Subject to the terms and conditions of this Agreement, Spectrum shall use Commercially Reasonable Efforts to supply or have supplied
to Licensee or its designee all quantities of the Product ordered by Licensee for use in the Field in the Licensee Territory in
accordance with a separate written agreement to be negotiated between the Parties pursuant to Section 4.5.3 below (a “Supply
Agreement”). Licensee shall solely purchase from Spectrum its entire requirement of the Product and Spectrum shall have
the right to manufacture and have manufactured such quantities of the Product for Licensee.

 

4.5.3      Supply
Agreement. Within ninety (90) days of the Effective Date, the Parties shall negotiate and execute a Supply Agreement for the
supply by Spectrum to Licensee of the requirements of the Product ordered by Licensee for Development and Commercialization in
the Licensee Territory.

 

4.5.4      Supply
Price and Adjustment. The price per unit of each Product supplied by Spectrum under the Supply Agreement shall be equal to
Spectrum’s Manufacturing Cost (as may change from time to time) for such Product plus ***.

 

4.5.5      Quality
Agreement. Within ninety (90) days of executing the Supply Agreement, Spectrum and Licensee shall execute a mutually acceptable
quality agreement that allocates roles and responsibilities to each Party with respect to quality control and regulatory compliance
with respect to supply of the Product to Licensee.

 

ARTICLE 5

PAYMENTS

 

5.1         Upfront
Equity Consideration. As consideration for the licenses granted under Section 3.1 and Licensee’s other rights under
this Agreement, Licensee shall issue 3,228,627 shares of Licensee’s common stock, par value $0.01 per share (the “Common
Stock”) in accordance with the terms and conditions of that certain investment agreement between the Parties as of the
even date hereof (the “Investment Agreement”).

 

5.2        Payments
to Upstream Licensors.

 

5.2.1      Payments.
Licensee shall pay to Spectrum any and all payments due from Spectrum to *** under the Upstream Licenses on account
of the Development and/or Commercialization of the Product in the Field in the Licensee Territory by Licensee and its Affiliates
and sublicensees (the “Upstream Payments”) including running royalty payments; provided that if Licensee
is obligated to make any Upstream Payments due to the achievement of a milestone, Licensee shall only pay: (a) a prorated portion
of any Upstream Payments triggered by the occurrence of a sales milestones reached in part due to sales by Licensee in the Licensee
Territory; and (b) any Upstream Payments triggered by the occurrence of a development milestone wherein the trigger is explicitly
defined as the achievement of a milestone in the Licensee Territory or achieved as a direct result of Licensee’s Development
of the Product in the Licensee Territory. As an example of Licensee’s obligation to only pay a prorated portion of an Upstream
Payment triggered by the occurrence of a sales milestone, if (x) a sales milestone payment of $10,000,000 is triggered due to the
occurrence of aggregate annual sales of the Product within a territory covering the Licensed Territory reaching a certain threshold
and (y) at the triggering of the sales milestone payment, Licensee’s annual sales of the Product in the Licensee Territory
for the year the payment is triggered account for 10% of total sales of the Product in a territory which covers the Licensee Territory,
then (z) Licensee shall pay $1,000,000 of that $10,000,000 sales milestone payment. Except for (i) the upfront equity consideration
under Section 5.1, and (ii) the Upstream Payments under this Section 5.2.1, no payment shall be due from Licensee to
Spectrum for the Development and/or Commercialization of the Product in the Field in the Licensee Territory.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-20-

    	 

    

 

5.2.2      Payment
Reports and Payments. For as long as Licensee is obligated to make the Upstream Payments in accordance with Section 5.2.1,
within thirty (30) days after the last day of each calendar quarter, Licensee will deliver to Spectrum a report of Net Sales of
the Product by Licensee, its Affiliates and sublicensees during the preceding quarterly period (any such period, a “Payment
Period”), with all the Upstream Payments in accordance with Section 5.2.1, if any, for the Payment Period covered
by such report being due no later than forty (40) days after the last day of such Payment Period. For any Upstream Payments triggered
due to the occurrence of a sales milestone, Spectrum shall provide Licensee with an invoice no later than twenty (20) days before
such Upstream Payment is due if feasible or such other documentation and such invoice or documentation will set forth: (a) the
Licensee’s prorated portion of such Upstream Payment, (b) how the Licensee’s prorated portion of the Upstream Payment
was calculated and reasonable support for the calculation, and (c) the date when such Upstream Payment is due. In relation to any
Upstream Payment, which Spectrum claims is triggered due to the occurrence of a development milestone achieved as a direct result
of Licensee’s Development of the Product in the Licensee Territory (other than wherein the trigger is explicitly defined
as the achievement of a milestone in the Licensee Territory), Spectrum shall provide Licensee with information, reasonably requested
by Licensee, regarding the Development of the Product in the Spectrum Territory sufficient for Licensee to determine whether Licensee’s
Development has triggered such an Upstream Payment.

 

5.3        Payment
Method. All payments due under this Agreement to Spectrum shall be made by bank wire transfer in immediately available funds
to an account designated by Spectrum. All payments hereunder shall be made in the legal currency of the United States of America,
and all references to “$” or “Dollars” shall refer to United States dollars. To the extent that Applicable
Law imposes withholding taxes on any payments from Licensee to Spectrum pursuant to this Agreement, Licensee may withhold such
taxes and pay such amounts to the relevant government authority. For any Upstream Payments where Spectrum cannot reduce any amounts
owed to the Upstream Licensor under the applicable Upstream License with respect to withholding taxes paid by the Licensee under
this Agreement, all amounts payable to Spectrum pursuant to this Agreement shall be made without reduction for any withholding
or similar taxes paid by Licensee. For any Upstream Payments where Spectrum can reduce any amounts owed to the Upstream Licensor
under the applicable Upstream License with respect to withholding taxes paid by the Licensee under this Agreement, the Licensee
may deduct from the amounts payable to Spectrum pursuant to this Agreement any withholding or similar taxes paid by Licensee. Licensee
shall furnish to Spectrum appropriate evidence of payment of such taxes or other amount required by Applicable Laws to be deducted
from any payment due under this Agreement to Spectrum, including any tax or withholding levied by a foreign taxing authority in
respect of such payment.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-21-

    	 

    

 

5.4        Support
Fees. Spectrum will provide to Licensee at its own expense: (a) *** (***) hours of regulatory and development support
during the first Agreement Year, and (b) *** (***) hours of regulatory and development support for each Agreement year after
the first anniversary of the Effective Date. Regulatory and development support provided by Spectrum to Licensee, in excess of
the number of free hours, set forth above, in any Agreement Year, shall be charged at a rate of $*** per hour. For clarity, the
costs incurred by Spectrum to provide the Initial Transfer under Section 4.2.3 shall also be borne by Spectrum and shall not be
charged to Licensee or counted toward the hours set out in the this Section that Spectrum will provide to Licensee at its own expense.

 

5.5        Records;
Audit. The Parties will, and will cause its Affiliates to, keep and maintain for three (3) years after the relevant calendar
quarter complete and accurate books and records in sufficient detail so that Net Sales and payments made hereunder can be properly
calculated. No more frequently than once during each calendar year during the Term and once during the three (3) year period thereafter,
the Parties will permit independent third party auditors appointed by Spectrum, *** or Licensee (the party requesting an audit,
the “Auditing Party”) and with at least forty-five (45) days advance notice at any time during normal business
hours, accompanied at all times, to inspect, audit and copy reasonable amounts of relevant accounts and records of the non-Auditing
Party and its Affiliates and reports submitted to the non-Auditing Party and its Affiliates by its sublicensees pertaining to a
payment period that is not earlier than thirty-six (36) months from the date of conclusion of the audit, for the sole purpose of
verifying the accuracy of the calculation of Upstream Payments to Spectrum pursuant to this Article 5. The accounts, records
and reports related to any particular period of time may only be audited one time under this Section 5.5. The Auditing Party
will cause their independent third party auditors not to provide the Auditing Party with any copies of such accounts, records or
reports and not to disclose to the Auditing Party any information other than information relating solely to the accuracy of the
accounting and payments made by Licensee pursuant to this Article 5. The Auditing Party will cause its independent third party
auditors to promptly provide a copy of their report to non-Auditing Party. If such audit determines that payments are due to Spectrum,
Licensee will pay to Spectrum any such additional amounts within ten (10) Business Days after the date on which such auditor’s
written report is delivered to Licensee and the Auditing Party, unless such audit report is disputed by Licensee, in which case
the dispute will be resolved in accordance with Article 10. If such audit determines that Licensee has overpaid any amounts
to Spectrum, Spectrum will refund any such overpaid amounts to Licensee within ten (10) Business Days after the date on which such
auditor’s written report is delivered to Licensee and the Auditing Party. Any such inspection of records will be at the Auditing
Party’s expense unless such audit discloses a deficiency or overpayment in the payments made by Licensee (whether for itself
or on behalf of its Affiliates) of more than *** percent (***%) of the aggregate amount payable for the relevant period, in the
case of such a deficiency, Licensee will bear the cost of such audit, or in the case of such overpayment caused by Spectrum, Spectrum
shall bear the cost of such audit. Each of the parties agree that all information subject to review under this Section 5.5 is non-Auditing
Party’s Confidential Information that is subject to confidentiality and non-use obligations under Section 7.2, and Auditing
Party agrees that it shall cause its independent third party auditors to also retain all such information subject to the non-disclosure
and non-use restrictions of Section 7.2 or similar (but no less stringent) obligations of confidentiality and non-use customary
in the accounting industry. 

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-22-

    	 

    

 

5.6        Late
Payment. Any payments or portions thereof due hereunder which are not paid when due shall bear interest equal to the lesser
of (i) the rate equal to the thirty (30) day U.S. dollar LIBOR rate effective for the date that payment was due, as published by
The Wall Street Journal, Internet Edition at www.wsj.com in the “Money Rates” column, on the date such payment was
due, plus an additional *** percent (***%), or (ii) the maximum rate permitted by Applicable Laws, calculated on the number of
days such payment is delinquent. This Section 5.6 shall in no way limit any other remedies available to Spectrum.

 

ARTICLE 6

INTELLECTUAL PROPERTY

 

6.1        Ownership
of Inventions.

 

6.1.1      Ownership.

 

(a)          Spectrum
shall own all right, title and interest to (i) any and all Inventions solely Made by or on behalf of Spectrum or its Affiliates
in connection with their activities under this Agreement and (ii) any and all Patents claiming any such Inventions described
in the foregoing clause (ii) (collectively, “Spectrum Inventions”).

 

(b)          Licensee
shall own all right, title and interest to (i) any and all Inventions solely Made by or on behalf of Licensee or its Affiliates
or sublicensees in connection with their activities under this Agreement, and (ii) any and all Patents claiming any such Inventions
described in the foregoing clause (i) (collectively, “Licensee Inventions”).

 

(c)          The
Parties shall jointly own all right, title and interest to (i) any and all Inventions jointly Made by at least one employee,
agent, consultant, contractor, Affiliate, or sublicensee of Spectrum and at least one employee, agent, consultant, contractor,
Affiliate, or sublicensee of Licensee (each having the obligation to assign such Inventions to either Spectrum or Licensee), and
(ii) any and all Patents claiming such Inventions described in the foregoing clause (i) (“Joint Patents”
and collectively with Inventions described in clause (i), “Joint Inventions”).

 

(d)          During
the Term, Spectrum Inventions and Joint Inventions shall be included in the definition of Spectrum Technology, Spectrum Patents,
Spectrum Know-How, and Spectrum Copyrights, as applicable, and subject to the licenses granted under Section 3.1. For the
avoidance of doubt, Spectrum reserves the right to use, practice or otherwise exploit any and all Spectrum Inventions and Joint
Inventions subject to the licenses granted under Section 3.1.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-23-

    	 

    

 

6.1.2      Interpretation.
For purposes of this Section 6.1, “Invention” shall mean any invention
(whether or not patentable), data, results, ideas, discovery, development, method, process, know-how, works of authorship or other
information that is Made by or on behalf of a Party or the Parties; and “Made” shall mean developed,
conceived, authored, acquired or created by or on behalf of a Party or the Parties. It
is understood that except as expressly set forth under this Section 6.1, inventorship, authorship and other indicia of which
Party Made an Invention will be determined in accordance with United States or the relevant foreign Intellectual Property laws
under which the relevant foreign Intellectual Property right exists in effect at the time such Invention was Made.

 

6.2        License
Grant to Spectrum. Licensee hereby grants to Spectrum a perpetual, irrevocable, fully paid-up, royalty free, exclusive license,
with the right to grant sublicenses at any tier, under Licensee Know-How (including, without limitation, Licensee Inventions) and
Licensee’s rights in the Joint Inventions, to research, Develop, make, have made, use, sell, offer for sale, have sold, import
and otherwise Commercialize the Product in the Spectrum Territory.

 

6.3        Patent
Prosecution. Spectrum shall control the Prosecution and Maintenance of Spectrum Patents and Joint Patents. Licensee will bear
the costs of Prosecution and Maintenance of all Spectrum Patents and Joint Patents in the Licensee Territory. Costs billed to or
incurred by Spectrum for the Prosecution and Maintenance of all Spectrum Patents and Joint Patents in the Licensee Territory will
be rebilled to Licensee and are due within thirty (30) days of rebilling by Spectrum.

 

6.4        Defense
of Third Party Infringement Claims. If the Product becomes the subject of a Third Party’s claim or assertion of infringement
of a Patent relating to the manufacture, use, sale, offer for sale or importation of the Product for use in the Field in the Licensee
Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall
agree on and enter into a “common interest agreement” wherein such Parties agree to their shared, mutual interest in
the outcome of such potential dispute, and thereafter, the Parties shall promptly confer to consider the claim or assertion and
the appropriate course of action.

 

6.5        Enforcement.

 

6.5.1      Notice.
Licensee will promptly report in writing to Spectrum any (a) known or suspected third party infringement of any Spectrum Patents,
Spectrum Trademarks, or Spectrum Copyrights, or (b) unauthorized use or misappropriation of any Spectrum Know-How or other
Confidential Information by a Third Party of which it becomes aware, and will provide Spectrum with all available evidence supporting
such infringement or unauthorized use or misappropriation. Spectrum will promptly report in writing to Licensee any (a) known
or suspected third party infringement of any Licensee Inventions, Licensee Trademarks, or Spectrum Product Marks, or (b) unauthorized
use or misappropriation of any Licensee Know-How or other Confidential Information by a Third Party of which it becomes aware,
and will provide Licensee with all available evidence supporting such infringement or unauthorized use or misappropriation.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-24-

    	 

    

 

6.5.2      Right
to Enforce Spectrum Patents, Spectrum Trademarks or Spectrum Copyrights. Spectrum will have the first right, but not the obligation,
to take any reasonable measures it deems appropriate to stop activities in the Licensee Territory infringing the Spectrum Patents,
Spectrum Trademarks or Spectrum Copyrights or the use without proper authorization of any Spectrum Know-How, in each case in connection
with a Third Party’s manufacture, use, sale, offering for sale, or importation of Product for use in the Field in the Licensee
Territory, including initiating or prosecuting an infringement or other appropriate action against. If Spectrum does not initiate
any such measures within one hundred twenty (120) days of receiving written notice from Licensee of such activities (or within
a reasonable shorter time period if a shorter period to take action is required by Applicable Laws to avoid the loss of legal rights),
then Licensee will have the second right, but not the obligation, to take any reasonable measures it deems appropriate to stop
such activities, provided, that, Licensee must coordinate and consult with Spectrum regarding such measures and will not
take any measures, without the written permission of Spectrum, which permission will not be unreasonably withheld. It shall be
reasonable for Spectrum to withhold such permission if Spectrum reasonably believes such measures will affect the protection that
any Spectrum-Controlled Intellectual Property affords Spectrum. Licensee will have no right to settle any infringement or misappropriation
Action under this Section 6.5.2 in a manner that diminishes the rights or interests of Spectrum without the express written
consent of Spectrum. In addition, Licensee will not settle any such action in a manner that admits the invalidity or unenforceability
of any Spectrum-Controlled Intellectual Property without obtaining the prior written consent of Spectrum.

 

6.5.3      Right
to Enforce Licensee Inventions, Licensee Trademarks or Spectrum Product Marks. Licensee will have the first right, but not
the obligation, to take any reasonable measures it deems appropriate to stop activities in the Spectrum Territory infringing the
Licensee Inventions, Licensee Trademarks or Spectrum Product Marks or the use without proper authorization of any Licensee Know-How,
in each case in connection with a Third Party’s manufacture, use, sale, offering for sale, or importation of Product for
use in the Field in the Spectrum Territory, including initiating or prosecuting an infringement or other appropriate action against.
If Licensee does not initiate any such measures within one hundred twenty (120) days of receiving written notice from Spectrum
of such activities (or within a reasonable shorter time period if a shorter period to take action is required by Applicable Laws
to avoid the loss of legal rights), then Spectrum will have the second right, but not the obligation, to take any reasonable measures
it deems appropriate to stop such activities, provided, that, Spectrum must coordinate and consult with Licensee regarding
such measures and will not take any measures, without the written permission of Licensee, which permission will not be unreasonably
withheld. It shall be reasonable for Licensee to withhold such permission if Licensee reasonably believes such measures will affect
the protection that any Licensee -Controlled Intellectual Property affords Licensee. Spectrum will have no right to settle any
infringement or misappropriation Action under this Section 6.5.3 in a manner that diminishes the rights or interests of Licensee
without the express written consent of Licensee. In addition, Spectrum will not settle any such action in a manner that admits
the invalidity or unenforceability of any Licensee-Controlled Intellectual Property without obtaining the prior written consent
of Licensee.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-25-

    	 

    

 

6.5.4      Right
to Enforce Joint Patents or Joint Inventions. Spectrum will have the first right, but not the obligation, to take any reasonable
measures it deems appropriate to stop activities in the Licensee Territory infringing the Joint Patents or Joint Inventions or
the use without proper authorization of any Joint Invention, in each case in connection with a Third Party’s manufacture,
use, sale, offering for sale, or importation of Product for use in the Field in the Territory, including initiating or prosecuting
an infringement or other appropriate action against. If Spectrum does not initiate any such measures within one hundred twenty
(120) days of becoming aware of such activities (or within a reasonable shorter time period if a shorter period to take action
is required by Applicable Laws to avoid the loss of legal rights), then Licensee will have the second right, but not the obligation,
to take any reasonable measures it deems appropriate to stop such activities in the Licensee Territory, provided, that,
Licensee must coordinate and consult with Spectrum regarding such measures and will not take any measures, without the written
permission of Spectrum, which permission will not be unreasonably withheld. Licensee will have no right to settle any infringement
or misappropriation Action under this Section 6.5.4 in a manner that diminishes the rights or interests of Spectrum without
the express written consent of Spectrum. In addition, Licensee will not settle any such action in a manner that admits the invalidity
or unenforceability of any Joint Patent or Joint Inventions without obtaining the prior written consent of Spectrum.

 

6.5.5      Cooperation.
The Party commencing, controlling or defending any enforcement action under this Section 6.5 (the “Enforcing Party”)
shall keep the other Party reasonably informed of the progress of such action, and such other Party shall have the right to participate
with counsel of its own choice at its own expense. In any event, the other Party shall reasonably cooperate with the Enforcing
Party, including providing information and materials, at the Enforcing Party’s request and expense.

 

6.5.6      Recoveries.
Any recovery received as a result of any enforcement action to enforce any Intellectual Property pursuant to this Section 6.5
shall be used first to reimburse the Enforcing Party for the costs and expenses (including court, attorneys’ and professional
fees) incurred in connection with such action, and the remainder of the recovery shall be shared as following: (i) if the
enforcement action is filed in the Enforcing Party’s territory, one hundred percent (100%) of such recovery shall be paid
to the Enforcing Party, and (ii) if the enforcement action is not filed in the Enforcing Party’s territory, *** percent
(***%) of such recovery shall be paid to the Enforcing Party and *** percent (***%) of such recovery shall be paid to the other
Party. All recovery by Licensee in excess of its costs and expenses shall be treated as Net Sales and subject to royalty obligations
under the Upstream Licenses.

 

6.5.7      Patents
Claiming Spectrum Inventions. During the Term, Patents claiming Spectrum Inventions that are necessary or useful for the Development
and Commercialization of the Product shall be deemed Spectrum Patents and the enforcement thereof shall be subject to Sections 6.5.1-
6.5.6 above.

 

6.5.8      Infringement
of Captisol Patents by Third Parties. If Licensee becomes aware that a Third Party may be infringing a Captisol Patent, it
will promptly notify Spectrum in writing, providing all information available to Licensee regarding the potential infringement.
Licensee acknowledges that *** shall take whatever, if any, action it deems appropriate, in its sole discretion, against the alleged
infringer. If *** elects to take action, Licensee shall, at ***’s request and expense, cooperate and shall cause its employees
to cooperate with *** in taking any such action, including but not limited to, cooperating with the prosecution of any infringement
suit by *** related to a Captisol Patent. Licensee shall not take any such action against the alleged infringer related to a Captisol
Patent without the written consent of ***.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-26-

    	 

    

 

 

6.6        Patent
Marking. At Spectrum’s request, Licensee shall mark (or cause to be marked) the Product marketed and sold hereunder with
appropriate Spectrum Patent numbers or indicia in accordance with Applicable Laws.

 

ARTICLE 7

CONFIDENTIALITY

 

7.1        Confidentiality;
Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed by the Parties in writing, the
Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose
other than as provided for in this Agreement any confidential or proprietary information or materials furnished to it by the other
Party pursuant to this Agreement (collectively, “Confidential Information”). Notwithstanding the foregoing,
Confidential Information shall not be deemed to include information or materials to the extent that it can be established by written
documentation by the receiving Party that such information or material:

 

7.1.1      was
already known to or possessed by the receiving Party without any obligation of confidentiality, at the time of its disclosure to
the receiving Party hereunder;

 

7.1.2      was
generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party hereunder;

 

7.1.3      became
generally available to the public or otherwise part of the public domain after its disclosure hereunder other than through any
act or omission of the receiving Party in breach of this Agreement;

 

7.1.4      was
independently developed by the receiving Party without use of or reference to the other Party’s Confidential Information
as demonstrated by documented evidence prepared by the receiving Party contemporaneously with such independent development; or

 

7.1.5      was
disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to
the disclosing Party not to disclose such information to others.

 

7.2         Authorized
Use and Disclosure. Each Party may use and disclose Confidential Information of the other Party as follows: (i) under
appropriate confidentiality provisions substantially equivalent to those in this Agreement in connection with the performance of
its obligations or exercise of rights granted to such Party in this Agreement; (ii) to the extent such disclosure is reasonably
necessary for the Prosecution and Maintenance of Patents (including applications therefor) in accordance with this Agreement, prosecuting
or defending litigation, complying with applicable governmental regulations, filing for, conducting preclinical or clinical trials,
obtaining and maintaining regulatory approvals (including Regulatory Approvals), or otherwise required by Applicable Laws or the
rules of a recognized stock exchange, provided, that if a Party is required by Applicable Laws or stock exchange to make
any such disclosure of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures
(for example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement
and, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential
treatment of such Confidential Information required to be disclosed; (iii) to its Affiliates and sublicensees, in each case
under appropriate confidentiality provisions substantially equivalent to those of this Agreement; (iv) in communication with
existing and potential investors, acquirers, consultants, advisors (including financial advisors, lawyers and accountants) and
others on a need to know basis, in each case under appropriate confidentiality provisions substantially equivalent to those of
this Agreement; or (v) to the extent mutually agreed to by the Parties.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-27-

    	 

    

 

7.3         Prior
Agreements. This Agreement supersedes the Confidentiality Agreement between Spectrum and Licensee dated January 28, 2014 (the
“Prior CDA”) with respect to information disclosed thereunder. All information or materials disclosed or provided
by Spectrum to Licensee under the Prior CDA shall be deemed Confidential Information of Spectrum (subject to the exceptions set
forth herein) and shall be subject to Licensee’s confidentiality obligations under this Article 7. All information disclosed
by Licensee under the Prior CDA shall be deemed Confidential Information of Licensee (subject to the exceptions set forth herein)
and shall be subject to Spectrum’s confidentiality obligations under this Article 7.

 

7.4         Scientific
Publications. Licensee shall submit to Spectrum any proposed publication or public disclosure containing clinical or scientific
results relating to the Product for use in the Field at least sixty (60) days in advance to allow Spectrum to review such
proposed publication or disclosure. Spectrum shall notify Licensee in writing during such sixty (60)-day reviewing period if Spectrum
wishes to (a) remove its Confidential Information from such proposed publication or presentation, in which event Licensee
shall remove such Confidential Information from its proposed publication or presentation; or (b) request a reasonable delay
in publication or presentation in order to protect patentable information, in which event Licensee shall delay the publication
or presentation for a period of no more than one hundred twenty (120) days to enable patent applications to be filed in accordance
with Section 6.3 protecting inventions disclosed in such publication or presentation. For clarity, if Spectrum fails to notify
Licensee during the sixty (60)-day reviewing period as provided under this Section 7.4, Licensee shall be free to proceed
with the proposed publication or presentation.

 

7.5        Publicity.

 

7.5.1      Confidential
Terms. Each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without the
prior approval of the other Party, except to advisors (including consultants, financial advisors, attorneys and accountants), potential
and existing investors and acquirers on a need to know basis, in each case under circumstances that reasonably protect the confidentiality
thereof, or to the extent necessary to comply with the terms of agreements with Third Parties, or to the extent required by Applicable
Laws, including securities laws. Notwithstanding the foregoing, the Parties agree upon the initial press release(s) to announce
the execution of this Agreement, which is attached hereto as Exhibit 7.5.1; thereafter, Spectrum and Licensee may each disclose
to Third Parties the information contained in such press release(s) without the need for further approval by the other.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-28-

    	 

    

 

7.5.2      Publicity
Review. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant
developments regarding the Product for use in the Field in the Licensee Territory and other activities in connection with this
Agreement, beyond what may be strictly required by Applicable Laws and the rules of a recognized stock exchange, and each Party
may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld,
conditioned or delayed. Such disclosures may include achievement of significant events in the Development (including regulatory
process) or Commercialization of the Product for use in the Field in the Licensee Territory. Unless otherwise requested by Spectrum,
Licensee shall indicate that Spectrum is the owner and licensor of the Product and Spectrum Technology in each public disclosure
issued by Licensee regarding the Product. When Spectrum elects to make any such public disclosure under this Section 7.5.2,
it will give Licensee reasonable notice to review and comment on such statement, it being understood that if Licensee does not
notify Spectrum in writing within a three (3) Business Day period or such shorter period if required by Applicable Laws of any
reasonable objections, as contemplated in this Section 7.5.2, such disclosure shall be deemed approved, and in any event Licensee
shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to
be observed in such disclosures shall be accuracy, compliance with Applicable
Laws and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory
Authorities and the need to keep investors and others informed regarding the requesting Party’s business, including as required
by the rules of a recognized stock exchange.

 

ARTICLE 8

REPRESENTATIONS, WARRANTIES AND COVENANTS; INDEMNIFICATION

 

8.1        Licensee
Representations and Warranties. Licensee represents and warrants to Spectrum that:

 

8.1.1      it
is duly organized and validly existing under the Applicable Laws of the jurisdiction of its incorporation, and has full corporate
power and authority to enter into this Agreement and to carry out the provisions hereof;

 

8.1.2      it
is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this
Agreement on its behalf has been duly authorized to do so by all requisite corporate action;

 

8.1.3      this
Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery and performance of
this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material Applicable Laws;

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-29-

    	 

    

 

8.1.4      Licensee,
its Affiliates and their employees and contractors have not and shall not, in connection with the performance of their respective
obligations under this Agreement directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment
of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity
or other person for purpose of obtaining or retaining business for or with, or directing business to, any person, including Licensee
(it being understood that, without any limitation to the foregoing, Licensee, and to its knowledge, its and its Affiliates’
employees and contractors, has not directly or indirectly promised, offered or provided any corrupt payment, gratuity, emolument,
bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other
person in connection with the performance of Licensee’s obligations under this Agreement, and shall not, directly or indirectly,
engage in any of the foregoing). Notwithstanding the foregoing, the intent of this warranty is to ensure compliance with the US
Foreign Corrupt Practices Act of 1977, as amended, UK Bribery Act, and any rules or regulations thereunder or any similar anti-corruption
or anti-bribery laws applicable to company or any of its affiliates or subsidiaries (in each case, as in effect at the time of
such action).  Licensee will certify annually to conducting an effective compliance program and Spectrum will have rights
to audit the Company’s compliance program periodically; and

 

8.1.5      it
is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or threatens the validity
of this Agreement.

 

8.2        Spectrum’s
Warranties. Spectrum represents and warrants to Licensee, as of the Effective Date, that:

 

8.2.1      it
is duly organized and validly existing under the Applicable Laws of the jurisdiction of its incorporation, and has full corporate
power and authority to enter into this Agreement and to carry out the provisions hereof;

 

8.2.2      it
is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this
Agreement on its behalf has been duly authorized to do so by all requisite corporate action;

 

8.2.3      this
Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery and performance of
this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material Applicable Laws;

 

8.2.4      it
has the full right, power and authority under the Spectrum Technology, Spectrum Trademarks, Captisol Patents, and the Upstream
Licenses to grant the licenses to Licensee as purported to be granted pursuant to this Agreement;

 

8.2.5      as
of the Effective Date, it has provided complete and unredacted copies of the Upstream Licenses and any relevant ancillary agreements,
exhibits, schedules, or other documents including any and all amendments thereto) which set forth and are sufficient to fully describe
all the terms and conditions with which Licensee must comply in relation to the Upstream Licenses.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-30-

    	 

    

 

8.2.6      the
Upstream Licenses represent all the material agreements Spectrum or its Affiliates have entered into that may affect Licensee’s
exercise of the rights granted under this Agreement;

 

8.2.7      it
is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or threatens the validity
of this Agreement;

 

8.2.8      as
of the Effective Date, Spectrum has not granted, and will not grant during the Term, rights to any Third Party under the Spectrum
Technology that conflict with the rights granted to Licensee hereunder;

 

8.2.9      as
of the Effective Date, Spectrum has not received any written notice of any threatened claims or litigation seeking to invalidate
or otherwise challenge the Spectrum Patents, Spectrum’s rights therein, or the Captisol Patents;

 

8.2.10    to
its actual knowledge, as of the Effective Date, none of the Spectrum Patents or Captisol Patents are subject to any pending re-examination,
opposition, interference or litigation proceedings; and

 

8.2.11    to
its actual knowledge, as of the Effective Date, the performance of Development and Commercialization activities in accordance with
this Agreement will not infringe any Intellectual Property rights of any Third Party in the Licensee Territory, including any issued
patent of any Third Party in the Licensee Territory or, if and when issued, any claim within any published patent application of
any Third Party in the Licensee Territory.

 

8.3        Disclaimer
of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 8, SPECTRUM AND LICENSEE EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS,
EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING THE LICENSED TECHNOLOGY),
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.

 

8.4        Spectrum’s
Representations, Warranties, and Covenants. Spectrum represents, warrants and covenants to Licensee and agrees that:

 

8.4.1      it
and its Affiliates are in compliance, and it shall comply, and shall cause its Affiliates to comply, in all material respects,
with all Upstream Licenses;

 

8.4.2      it
shall not, during the Term, amend any Upstream License in any manner that adversely affects the rights granted to Licensee hereunder
or Spectrum’s ability to materially perform its obligations hereunder; and

 

8.4.3      it
and its Affiliates shall not, during the Term, do or fail to do any acts, which cause to be terminated or result in the termination
of any Upstream Licenses or result in the loss of any rights under any Upstream Licenses, which would adversely affect the rights
granted to Licensee hereunder or Spectrum’s ability to materially perform its obligations hereunder.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-31-

    	 

    

 

8.5        Indemnification.

 

8.5.1      Indemnification
by Spectrum. Spectrum hereby agrees to defend, hold harmless and indemnify (collectively, “Indemnify”) Licensee
and its Affiliates, and its and their agents, directors, officers and employees (the “Licensee Indemnitees”)
from and against any liability or expense (including reasonable legal expenses and attorneys’ fees) (collectively, “Losses”)
resulting from suits, claims, actions and demands, in each case brought by a Third Party (each, a “Third-Party Claim”)
against any Licensee Indemnitee arising out of: (i) a breach of any of Spectrum’s representations and warranties under Section 8.2
or representations, warranties and covenants under Section 8.4; (ii) the Development, Commercialization or other exploitation
of the Product by Spectrum, its Affiliates, or sub-licensees in the Spectrum Territory; or (iii) the gross negligence or intentional
misconduct of any Spectrum Indemnities. Spectrum’s obligation to Indemnify the Licensee Indemnitees pursuant to this Section 8.5.1
shall not apply to the extent that any such Losses (A) arise from the gross negligence or intentional misconduct of any Licensee
Indemnitee; (B) arise from any breach by Licensee of this Agreement; or (C) are Losses for which Licensee is obligated
to Indemnify the Spectrum Indemnitees pursuant to Section 8.5.2.

 

8.5.2      Indemnification
by Licensee. Licensee hereby agrees to Indemnify Spectrum and its Affiliates, and its and their agents, directors, officers
and employees (the “Spectrum Indemnitees”) from and against any and all Losses resulting from Third-Party Claims
arising out of: (i) a breach of any of Licensee’s representations and warranties under Section 8.1; (ii) the
Development, Commercialization or other exploitation of the Product by the Licensee, its Affiliates, or sub-licensees in the Licensee
Territories; or (iii) the gross negligence or intentional misconduct of any Licensee Indemnities. Licensee’s obligation
to Indemnify the Spectrum Indemnitees pursuant to this Section 8.5.1 shall not apply to the extent that any such Losses (A) arise
from the gross negligence or intentional misconduct of any Spectrum Indemnitee; (B) arise from any breach by Spectrum of this
Agreement; or (C) are Losses for which Spectrum is obligated to Indemnify the Licensee Indemnitees pursuant to Section 8.5.1.

 

8.5.3      Additional
Indemnities.

 

(a)          In
addition to the indemnities set forth in Section 8.5.1, Spectrum hereby agrees to Indemnify the Licensee Indemnitees from and against
any and all Losses resulting from any breach by Spectrum of Section 3.1 (Grant to Licensee), Section 4.1.4 (Rights of Reference),
Section 4.2.3 (Development Assistance), or Section 8.4.3 (Spectrum’s Representations, Warranties, and Covenants), as single
event or in combination with one or more breaches, that: (i) has a material adverse effect on Licensee’s Development or Commercialization
of the Product in the Licensee Territory, and (ii) if curable, shall have continued uncured for ninety (90) days after written
notice thereof was provided to Spectrum by Licensee.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-32-

    	 

    

 

 

(b)          In
addition to the indemnities set forth in Section 8.5.2, Licensee hereby agrees to Indemnify the Spectrum Indemnitees from and against
any and all Losses resulting from any breach by Licensee of Section 3.1 (Grant to Licensee), Section 3.2.1 (Licensee Rights Limited
to the Field and the Licensee Territory), Section 3.3 (Upstream Licenses), or Sections 4.2.4 and 4.3.2 (Diligence), as single event
or in combination with one or more breaches, that: (i) has a material adverse effect on Spectrum’s rights under the Upstream
Licenses, and (ii) if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided to Licensee
by Spectrum.

 

8.5.4      Procedure.
To be eligible to be Indemnified hereunder, the indemnified Party shall provide the indemnifying Party with prompt notice of the
Third-Party Claim giving rise to the indemnification obligation pursuant to this Section 8.5 and the exclusive ability to
defend (with the reasonable cooperation of the indemnified Party) or settle any such claim, provided, that the indemnifying
Party shall not enter into any settlement that admits fault, wrongdoing or damages without the indemnified Party’s written
consent, such consent not to be unreasonably withheld or delayed. The indemnified Party shall have the right to participate, at
its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party,
provided, that the indemnifying Party shall have no obligations with respect to any Losses resulting from the indemnified
Party’s admission, settlement or other communication without the prior written consent of the indemnifying Party.

 

8.6        NO
CONSEQUENTIAL DAMAGES. NOTWITHSTANDING THE FOREGOING, IN NO EVENT WILL EITHER PARTY BE LIABLE TO OTHER PARTY FOR ANY CONSEQUENTIAL,
INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM
A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, OR ARISE FROM EITHER PARTY’S
INDEMNIFICATION OBLIGATIONS UNDER THIS ARTICLE 8 OR EITHER PARTY’S MATERIAL BREACH UNDER SECTION 9.10.

 

8.7        MAXIMUM
LIABILITY. EXCEPT FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS HEREUNDER, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT,
IN NO EVENT SHALL THE MAXIMUM AGGREGATE LIABILITY OF EITHER PARTY IN RESPECT OF ALL CLAIMS UNDER THIS AGREEMENT EXCEED THE ***.

 

ARTICLE 9

TERM AND TERMINATION AND MATERIAL BREACH

 

9.1        Term.
This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to the other provisions
of this Article 9, shall be perpetual (the “Term”).

 

9.2        Termination
for Breach. Each Party may terminate this Agreement in the event the other Party materially breaches this Agreement, and such
breach, if curable, shall have continued uncured for ninety (90) days after written notice thereof was provided to the breaching
Party by the terminating Party. Any such termination shall become effective at the end of such ninety (90) day period unless, if
applicable, the breaching Party has cured any such breach prior to the expiration of such ninety (90) day period.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-33-

    	 

    

 

9.3        Termination
for Patent Challenge. If Licensee or any of its Affiliates challenges under any court action or proceeding, or before any patent
office, the validity, patentability, enforceability, scope or non-infringement of any Spectrum Patent, or initiates a reexamination
of any Spectrum Patent, or assists any Third Party to conduct any of the foregoing activities (each, a “Challenge”),
Spectrum will have the right to immediately terminate this Agreement. In any event, Licensee shall notify Spectrum at least thirty
(30) days prior to initiating any such Challenge.

 

9.4        Termination
of Upstream Licenses. To the extent any Upstream License is terminated, the rights granted hereunder with respect to such Upstream
License shall also hereby terminate.

 

9.5        Termination
for Insolvency. Each Party shall have the right to terminate this Agreement upon delivery of written notice to the other Party
in the event that (i) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a
petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment
of a receiver or trustee of such other Party or its assets, (ii) such other Party is served with an involuntary petition against
it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within ninety (90) days of its filing,
or (iii) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.

 

9.6        Provision
for Insolvency. All rights and licenses granted under or pursuant to any Section of this Agreement are rights to “intellectual
property” (as defined in Section 101(35A) of Bankruptcy Code). Each Party hereby acknowledges that (i) copies of research
data, (ii) laboratory samples, (iii) product samples, (iv) formulas, (v) laboratory notes and notebooks, (vi) data and results
related to clinical trials, (vii) Regulatory Filings and Regulatory Approvals, (viii) rights of reference in respect of Regulatory
Filings and Regulatory Approvals, (ix) pre-clinical research data and results, and (x) marketing, advertising and promotional materials,
in each case, that relate to such intellectual property, constitute “embodiments” of such intellectual property pursuant
to Section 365(n) of the Bankruptcy Code. Each Party agrees not to interfere with the other Party’s exercise, pursuant
to Section 365(n) of the Bankruptcy Code, of rights and licenses to intellectual property licensed hereunder and embodiments
thereof and agrees to use Commercially Reasonable Efforts to assist such other Party to obtain such intellectual property and embodiments
thereof in the possession or control of Third Parties as reasonably necessary for such other Party to exercise, pursuant to Section
365(n) of the Bankruptcy Code, such rights and licenses. Each Party shall take any and all action requested by the other Party
to ensure that the foregoing provisions of this Section 9.6 may be fully effectuated under Applicable Laws, and, if requested
by the other Party, each Party shall procure that any past, existing or future creditor of the other Party irrevocably waives in
writing any and all rights that such creditor may have to the intellectual property licensed hereunder and embodiments thereof.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-34-

    	 

    

 

9.7        General
Effects of Termination.

 

9.7.1      Termination
of Rights. In the event of termination of this Agreement for any reason, all rights and licenses granted to Licensee herein
shall immediately terminate.

 

9.7.2      Accrued
Obligations. Termination of this Agreement for any reason shall not release either Party of any obligation or liability which,
at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination.

 

9.7.3      Non-Exclusive
Remedy. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without prejudice
to other remedies such Party may have at law or equity.

 

9.7.4      General
Survival. Article 1 (Definitions), Article 6 (Intellectual Property), Article 7 (Confidentiality), Article 10
(Dispute Resolution), Article 11 (Miscellaneous) and Sections 5.5 (Records; Audit)(for a period of three (3) years after
the effectiveness of the termination of this Agreement), 8.5 (Indemnification), 8.6 (No Consequential Damages), 8.7 (Maximum Liability),
9.7 (General Effects of Termination), 9.8 (Additional Effects of Termination), 9.9 (Termination Press Releases), and 9.10 (Material
Breach) shall survive termination of this Agreement for any reason. Except as otherwise provided in this Article 9, all rights
and obligations of the Parties under this Agreement shall terminate upon termination of this Agreement for any reason.

 

9.8        Additional
Effects of Certain Terminations. If this Agreement is terminated by Spectrum, then:

 

9.8.1      Ongoing
Trials. If there are any ongoing clinical trials with respect to the Product being conducted by or on behalf of Licensee (or
its Affiliate) at the time of notice of termination, Licensee agrees to (i) promptly transition to Spectrum or its designee
some or all of such clinical trials and the activities related to or supporting such trials, or (ii) terminate such clinical
trials in each case, as requested by Spectrum. The Parties recognize that early termination of this Agreement requires both discussion
and coordination between the Parties to ensure patient safety, continuity of treatment, if appropriate, and compliance with Applicable
Laws. Upon early termination of this Agreement, the Parties shall cooperate to provide for an orderly transition or cessation of
any clinical trials, as requested by Spectrum. Each Party further agrees to take no action or forego taking action if such action
or forbearance would in any manner jeopardize patient safety or cause the other Party to violate any Applicable Laws.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-35-

    	 

    

 

9.8.2      Commercialization.
To avoid a disruption in the supply of the Product, if this Agreement is terminated after the First Commercial Launch of the Product
for use in the Field in the Licensee Territory, Licensee and its Affiliates shall continue to distribute and sell such Product
for use in the Field in the Licensee Territory, in accordance with the terms and conditions of this Agreement, for a period reasonably
sufficient for them to sell off all amounts of Product in Licensee’s inventory not to exceed *** (***) months from the effective
date of such termination (the “Wind-Down Period”). Notwithstanding any other provision of this Agreement, during
this Wind-Down Period, Licensee’s and its Affiliates’ rights with respect to the Product (including the licenses granted
under Section 3.1) shall be non-exclusive and Spectrum shall have the right to engage one or more partners(s) or distributor(s)
of the Product in all or part of the Licensee Territory. During the Wind-Down Period, Licensee shall continue to make any and all
Upstream Payments to Spectrum for the Product sold or disposed by Licensee, its Affiliates, or its sublicensees. After the Wind-Down
Period, Licensee and its Affiliates shall not sell the Product or make any representation regarding their status as a licensee
of or distributor for Spectrum for the Product. Within thirty (30) days of expiration of the Wind-Down Period, Licensee shall notify
Spectrum of any quantity of the Product remaining in Licensee’s inventory and Spectrum shall have the option, upon notice
to Licensee, to purchase any such quantities of the Product, as applicable, from Licensee at a price equal to the amounts paid
by Licensee for such Product.

 

9.8.3      Regulatory
Filings. Licensee shall promptly assign and transfer to Spectrum all Regulatory Filings for the Product that are held or controlled
by or under authority of Licensee, and shall take such actions and execute such other instruments, assignments and documents as
may be necessary to effect the transfer of rights under the Regulatory Filings to Spectrum. Licensee shall cause each of its Affiliates
or sublicensees to transfer any such Regulatory Filings to Spectrum if this Agreement terminates. If Applicable Laws prevents or
delays the transfer of ownership of a Regulatory Filing to Spectrum, Licensee shall grant, and does hereby grant, to Spectrum an
exclusive and irrevocable right of access and reference to such Regulatory Filing for the Product, and shall cooperate fully to
make the benefits of such Regulatory Filings available to Spectrum and/or its designee(s). Within sixty (60) days after notice
of such termination, Licensee shall provide to Spectrum copies of all such Regulatory Filings, and of all preclinical and clinical
data (including raw data, original records, investigator reports, both preliminary and final, statistical analyses, expert opinions
and reports, safety and other electronic databases) and other Know-How pertaining to the Product, or the manufacture thereof. Spectrum
shall be free to use and disclose such Regulatory Filings and other items in connection with the exercise of its rights and licenses
under this Section 9.8.

 

9.8.4      License
to Spectrum. Licensee hereby grants Spectrum, effective upon the effective date of termination of this Agreement, a perpetual,
irrevocable, fully paid-up, royalty free, non-exclusive license, with the right to grant sublicenses at any tier, under Licensee
Know-How (including, without limitation, Licensee Inventions) and Licensee’s rights in the Joint Inventions, to research,
Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Product in the Licensee
Territory.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-36-

    	 

    

 

9.8.5      Transition
Assistance. Licensee agrees to fully cooperate with Spectrum and its designee(s) to facilitate a smooth, orderly and prompt
transition of the Development and Commercialization of the Product to Spectrum and/or its designee(s) during this Wind-Down Period.
Without limiting the foregoing, Licensee shall promptly provide Spectrum (i) all commercial data generated by Licensee under
this Agreement including copies of customer lists, customer data and other customer information relating to the Product, and (ii) manufacturing
information (including protocols for the production, packaging, testing and other manufacturing activities) relating to the Product
in Licensee’s Control, which in each case Spectrum shall have the right to use and disclose for any purpose during this Wind-Down
Period and thereafter. Upon request by Spectrum, Licensee shall transfer to Spectrum some or all quantities of the Product in its
or its Affiliates’ Control (as requested by Spectrum), within thirty (30) days after the end of this Wind-Down Period, provided,
that Spectrum shall reimburse Licensee for the out-of-pocket costs that Licensee actually incurred to manufacture or otherwise
acquire the quantities so provided to Spectrum. If any Product was manufactured by any Third Party for Licensee, or Licensee had
contracts with vendors which contracts are necessary or useful for Spectrum to take over responsibility for the Product in the
Licensee Territory, then Licensee shall to the extent possible and requested in writing by Spectrum, assign all of the relevant
Third-Party contracts to Spectrum, and in any case, Licensee agrees to cooperate with Spectrum to ensure uninterrupted supply of
the Product. If Licensee or its Affiliate manufactured any Product at the time of termination, then Licensee (or its Affiliate)
shall continue to provide for manufacturing of such Product for Spectrum, at its fully-burdened manufacturing cost therefor, from
the date of notice of such termination until such time as Spectrum is able, using Commercially Reasonable Efforts to do so but
no longer than the expiration of the Wind-Down Period, to secure an acceptable alternative commercial manufacturing source from
which sufficient quantities of the Product may be procured and legally sold in the Licensee Territory.

 

9.8.6      Costs
and Expenses. Except as expressly provided herein, Licensee shall perform its obligations under this Section 9.8 at its
own costs without consideration from Spectrum. Spectrum shall be responsible for its own costs of performing its activities under
this Section 9.8.

 

9.9        Termination
Press Releases. In the event of termination of this Agreement for any reason, the Parties shall cooperate in good faith to
coordinate public disclosure of such termination and the reasons therefor, and shall not, except to the extent required by Applicable
Laws or the rules of a recognized stock exchange, disclose such information without the prior approval of the other Party, such
approval not to be unreasonably withheld, conditioned or delayed. When Spectrum elects to make a public disclosure under this Section 9.9,
Spectrum shall provide Licensee with a draft of any such public disclosure it intends to issue three (3) Business Days in advance
and with the opportunity to review and comment on such statement, it being understood that if Licensee does not notify Spectrum
in writing within such three (3) Business Day period (or such shorter period if required by Applicable Laws or the rules of a recognized
stock exchange) of any reasonable objections, such disclosure shall be deemed approved, and in any event the Parties shall work
diligently and reasonably to agree on the text of any such proposed disclosure in an expeditious manner. The principles to be observed
in such disclosures shall be accuracy, compliance with Applicable Laws and regulatory guidance documents, reasonable sensitivity
to potential negative reactions to such news and the need to keep investors and others informed regarding the Parties’ business
and other activities.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-37-

    	 

    

 

9.10      Material
Breach.

 

9.10.1    Spectrum
agrees that any breach by Spectrum of Section 3.1 (Grant to Licensee), Section 4.1.4 (Rights of Reference), Section 4.2.3 (Development
Assistance), or Section 8.4.3 (Spectrum’s Representations, Warranties, and Covenants) as single event or in combination with
one or more breaches, that has a material adverse effect on Licensee’s Development or Commercialization of the Product in
the Licensee Territory shall be deemed a material breach by Spectrum of this Agreement, and, if such breach, if curable, shall
have continued uncured for ninety (90) days after written notice thereof was provided to Spectrum by Licensee,  then:
(a) subject to Section 8.7, Licensee shall be entitled to recovery of damages for such material breach without any limitation on
the amount or type of damages (including special, consequential (including loss of profits and loss of revenue), incidental, punitive
or indirect damages); and (b) Licensee, in addition to being entitled to exercise all rights provided herein (unless Licensee has
also terminated this Agreement under Section 9.2) or granted by law, including, without limitation, recovery of damages, will be
entitled to specific performance of its rights and Spectrum’s obligations under the above Sections 3.1 (Grant to Licensee),
Section 4.1.4 (Rights of Reference), Section 4.2.3 (Development Assistance), or Section 8.4.3 (Spectrum’s Representations,
Warranties, and Covenants) of the Agreement, without the necessity of posting any bond and without the necessity of establishing
that monetary relief would not provide an adequate remedy. Spectrum agrees that Licensee may seek, and AAA (or any court having
competent jurisdiction in relation to any injunctive or provisional relief necessary) may grant, specific performance in the event
of such Spectrum’s material breach, and that monetary damages would not be adequate compensation for any loss incurred by
reason of a material breach by Spectrum as recited in this Section of this Agreement, and hereby agrees to waive any defense in
any action for specific performance, including that a remedy at law would be adequate.

 

9.10.2    Licensee
agrees that any breach by Licensee of Section 3.1 (Grant to Licensee), Section 3.2.1 (Licensee Rights Limited to the Field and
the Licensee Territory), Section 3.3 (Upstream Licenses), or Sections 4.2.4 and 4.3.2 (Diligence) as single event or in combination
with one or more breaches, that has a material adverse effect on Spectrum’s rights under the Upstream Licenses shall be deemed
a material breach by Licensee of this Agreement, and, if such breach, if curable, shall have continued uncured for ninety (90)
days after written notice thereof was provided by Spectrum to Licensee, then: (a) subject to Section 8.7, Spectrum shall be entitled
to recovery of damages for such material breach without any limitation on the amount or type of damages (including special, consequential
(including loss of profits and loss of revenue), incidental, punitive or indirect damages); and (b) Spectrum, in addition to being
entitled to exercise all rights provided herein or granted by law, including, without limitation, recovery of damages, will be
entitled to specific performance of its rights and Licensee’s obligations under the above Sections 3.1 (Grant to Licensee),
Section 3.2.1 (Licensee Rights Limited to the Field and the Licensee Territory), Section 3.3 (Upstream Licenses), or Sections 4.2.4
and 4.3.2 (Diligence) of the Agreement, without the necessity of posting any bond and without the necessity of establishing that
monetary relief would not provide an adequate remedy. Licensee agrees that Spectrum may seek, and AAA (or any court having competent
jurisdiction in relation to any injunctive or provisional relief necessary) may grant, specific performance in the event of such
Licensee’s material breach, and that monetary damages would not be adequate compensation for any loss incurred by reason
of a material breach by Licensee as recited in this Section of this Agreement, and hereby agrees to waive any defense in any action
for specific performance, including that a remedy at law would be adequate.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-38-

    	 

    

 

ARTICLE 10

DISPUTE RESOLUTION

 

10.1      Disputes.
If the Parties are unable to resolve any dispute or other matter arising out of or in connection with this Agreement (“Dispute”),
either Party may, by written notice to the other, have such Dispute referred to the respective business heads of the Parties for
attempted resolution by good faith negotiations within fifteen (15) Business Days after such notice is received. In such event,
each Party shall cause its respective business head to meet (face-to-face or by teleconference) and be available to attempt to
resolve such Dispute. If the Parties should resolve such Dispute under this Section 10.1, a memorandum setting forth their
agreement will be prepared and signed by both Parties if requested by either Party. The Parties shall cooperate in an effort to
limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the Dispute. If the
Parties are unable to resolve such Dispute under this Section 10.1, then either Party may submit such Dispute to arbitration
pursuant to Section 10.2 below or initiate proceedings pursuant to Section 10.3 below,
as applicable. No Dispute shall be submitted to arbitration under Section 10.2 below and no proceedings shall be initiated
pursuant to Section 10.3 below, as applicable, until the following procedures in this Section 10.1 have been satisfied, unless
the Senior Executives have already attempted to resolve such Dispute pursuant to Section 2.3, in which case, either Party
may refer such Dispute to arbitration pursuant to Section 10.2 below or initiate proceedings pursuant to Section 10.3 below,
as applicable, provided, that any applicable statute of limitations with respect to such Dispute shall be tolled
while the Parties attempt to resolve such Dispute in accordance with Section 2.3 or this Section 10.1.

 

10.2      Arbitration.
Except with respect to Disputes related to Intellectual Property rights as provided under Section 10.3 below, if the Parties are
unable to resolve a Dispute under Section 10.1 above, either Party may,
upon written notice to the other Party, submit such Dispute for resolution by final, binding arbitration in the manner described
in this Section 10.2 below, as applicable. Any arbitration under this Section 10.2
below, as applicable, shall be conducted by the American Arbitration Association (“AAA”) in New York,
New York in accordance with the then-current Commercial Rules of Arbitration of AAA (“AAA Rules”), except as
modified by this Section 10.2 below, as applicable. The arbitration
shall be conducted by a single arbitrator. The costs of such arbitration shall be shared equally by the Parties, and each Party
shall bear its own expenses in connection with the arbitration. The Parties shall use good faith efforts to complete arbitration
under this Section 10.2 within ninety (90) days following the initiation of such arbitration. The arbitrator shall establish
reasonable additional procedures to facilitate and complete such arbitration within such ninety (90) day period. Nothing in this
Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim
relief or provisional remedy, including injunctive relief. Notwithstanding the foregoing, if the dispute involves *** as a party,
then the arbitration shall be conducted in accordance with the ***.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-39-

    	 

    

 

10.3      Other
Disputes. If the Parties are unable to resolve a Dispute related to Intellectual Property rights under Section 10.1 above,
either Party may initiate legal proceedings with respect thereto. Each of the Parties irrevocably agrees that the federal or state
courts in New York, New York shall have the exclusive jurisdiction to hear and decide any suit, action, proceedings, and/or settle
any such Disputes, and for these purposes, each Party irrevocably submits to the jurisdiction of the courts of New York. EACH OF
THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY
LEGAL PROCEEDING (WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATED TO THIS AGREEMENT.

 

ARTICLE 11

MISCELLANEOUS

 

11.1      Affiliates;
Licensees. For clarity and without limitation, each Party shall have the right to exercise any of its rights and licenses or
perform or delegate all or any portion of any of its obligations under this Agreement through any of its Affiliates, provided,
that each Party shall remain responsible to the other Party under this Agreement for all activities of its Affiliates to the same
extent as if such activities had been undertaken by such Party itself. In addition, Spectrum shall have the right to exercise any
of its rights and licenses or perform or delegate all or any portion of any of its obligations under this Agreement through any
of its Third Party licensees, provided, that Spectrum shall require each such licensee to be bound by a written agreement
containing terms and conditions consistent with the terms and conditions of this Agreement.

 

11.2      Governing
Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced
in accordance with the laws of the State of New York, without reference to conflicts of laws principles. Notwithstanding the foregoing,
a breach of any of the Upstream Licenses shall be governed by and construed in accordance with the laws of the State of California
(without giving effect to any conflicts of law principles that require the application of the law of a different state).

 

11.3      Assignment.
This Agreement shall not be assignable by either Party to any Third Party without the written consent of the other Party and any
such attempted assignment shall be void. Notwithstanding the foregoing, either Party may assign this Agreement, without the written
consent of the other Party, to an Affiliate of such Party or an entity that acquires all or substantially all of the business or
assets of such Party to which this Agreement pertains (whether by merger, reorganization, acquisition, sale, operation of law or
otherwise), and agrees in writing to be bound by the terms and conditions of this Agreement. No assignment or transfer of this
Agreement shall be valid and effective unless and until the assignee/transferee agrees in writing to be bound by the provisions
of this Agreement. The terms and conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors
and assigns of the Parties. Except as expressly provided in this Section 11.3, any attempted assignment or transfer of this
Agreement shall be null and void.

 

11.4      Notices.
Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and
shall be deemed to have been sufficiently given if delivered in person, transmitted by facsimile (receipt verified) or by express
courier service (signature required) or five (5) days after it was sent by registered letter, return receipt requested (or its
equivalent), provided, that no postal strike or other disruption is then in effect or comes into effect within two (2) days
after such mailing, to the Party to which it is directed at its address or facsimile number shown below or such other address or
facsimile number as such Party will have last given by notice to the other Party.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-40-

    	 

    

 

	 	If to Spectrum, addressed to:	 
	 	 	 
	 	 	Spectrum Pharmaceuticals, Inc.
	 	 	11500 South Eastern Ave. Suite 240
	 	 	Henderson, NV 89052
	 	 	Attn:  Legal Department
	 	 	Telephone number: 	(702) 835-6300
	 	 	Facsimile number: 	 (702) 260-7405
	 	 	 
	 	With a copy to:	 
	 	 	Stradling Yocca Carlson & Rauth
	 	 	660, Newport Center Dr, Suite 1600
	 	 	Newport Beach, CA 92660
	 	 	Attn:  Shivbir S. Grewal, Esq.
	 	 	Telephone number:  	(949) 725-4000
	 	 	Facsimile number:  	(949) 725-4100
	 	 	 
	 	If to Licensee, addressed to:	 
	 	 	 
	 	 	CASI Pharmaceuticals, Inc.
	 	 	9620 Medical Center Drive, Suite 300
	 	 	Rockville, MD 20850
	 	 	Attn: General Counsel
	 	 	 
	 	 	Telephone number:  	(240) 864-2781
	 	 	Facsimile number: 	 (240) 864-2782
	 	 	 
	 	With a copy to:	 
	 	 	 
	 	 	Ropes & Gray LLP
	 	 	36F, Park Place 1601 Nanjing Road West
	 	 	Shanghai 200040, China
	 	 	Attention: Geoffrey Lin and Arthur Mok
	 	 	Telephone:  +86 21 6157 5200
	 	 	Facsimile: + 86 21 6157 5299

 

11.5      Waiver.
Neither Party may waive or release any of its rights or interests in this Agreement except in writing. The failure of either Party
to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver
of that right or excuse a similar subsequent failure to perform any such term or condition. No waiver by either Party of any condition
or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition
or term.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-41-

    	 

    

 

11.6      Severability.
If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good
faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all
other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to
carry out the intentions of the Parties as nearly as may be possible. Such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other jurisdiction. If a Party seeks to avoid a provision
of this Agreement by asserting that such provision is invalid, illegal or otherwise unenforceable, the other Party shall have the
right to terminate this Agreement pursuant to Section 9.2 upon sixty (60) days prior written notice to the asserting Party,
unless such assertion is eliminated and cured within such sixty (60) day period.

 

11.7      Entire
Agreement/Modification. This Agreement, including its Exhibits, sets forth all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties and supersedes and terminates all prior agreements and understandings
between the Parties including the Prior CDA. No subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties.

 

11.8      Relationship
of the Parties. The Parties agree that the relationship of Spectrum and Licensee established by this Agreement is that of independent
contractors. Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish
an employment, agency or any other relationship. Except as may be specifically provided herein, neither Party shall have any right,
power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability
or obligation, express or implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any purpose.

 

11.9      Force
Majeure. Except with respect to payment of money, neither Party shall be liable to the other for failure or delay in the performance
of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by earthquake, riot,
civil commotion, war, terrorist acts, strike, flood, change of law, political unrest, or governmental acts or restriction, or other
cause that is beyond the reasonable control of the respective Party. The Party affected by such force majeure will provide the
other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent
and duration of the interference with its activities), and will use Commercially Reasonable Efforts to overcome the difficulties
created thereby and to resume performance of its obligations as soon as practicable. If the performance of any such obligation
under this Agreement is delayed owing to such a force majeure for any continuous period of more than one hundred eighty (180) days,
the Parties will consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-42-

    	 

    

 

11.10    Compliance
with Applicable Laws/Other.  Notwithstanding anything to the contrary contained herein, all rights and obligations of
Spectrum and Licensee are subject to prior compliance with, and each Party shall comply with, all Applicable Laws, including obtaining
all necessary approvals required by the applicable agencies of the governments of the relevant jurisdictions. In addition, each
Party shall conduct its activities under this Agreement in accordance with good scientific and business practices.

 

11.11    Interpretation.
The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting
any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the
particular Articles, Sections or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto. Unless
context otherwise clearly requires, whenever used in this Agreement: (i) the words “include” or “including”
shall be construed as incorporating, also, “but not limited to” or “without limitation;” (ii) the
word “day” or “year” means a calendar day or year unless otherwise specified; (iii) the word “notice”
shall mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written
communications contemplated under this Agreement; (iv) the words “hereof,” “herein,” “hereby”
and derivative or similar words refer to this Agreement (including any Exhibits); (v) the word “or” shall be construed
as the inclusive meaning identified with the phrase “and/or;”(vi) provisions that require that a Party, the Parties
or a committee hereunder “agree,” “consent” or “approve” or the like shall require that such
agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise;
(vii) words of any gender include the other gender; (viii) words using the singular or plural number also include the
plural or singular number, respectively; (ix) references to any specific law, rule or regulation, or article, section or other
division thereof, shall be deemed to include the then-current amendments thereto or any replacement law, rule or regulation thereof;
and (x) neither Party or its Affiliates shall be deemed to be acting “on behalf of” the other Party hereunder.

 

11.12    Counterparts.
This Agreement may be executed in two counterparts, each of which shall be deemed an original, and all of which together, shall
constitute one and the same instrument.

 

[The remainder of this page intentionally
left blank; the signature page follows.]

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	-43-

    	 

    

 

IN WITNESS WHEREOF, the Parties
have executed this Agreement in duplicate originals by their duly authorized representatives as of the Effective Date.

 

	SPECTRUM PHARMACEUTICALS, INC.	 	CASI PHARMACEUTICALS, INC.
	 	 	 
	By:	/s/ Rajesh C. Shrotriya	 	By:	/s/ Ken K. Ren
	Name:  Rajesh C. Shrotriya, MD	 	Name:  Ken K. Ren
	Title:  Chairman and CEO	 	Title:  Chief Executive Officer

 

List
of Exhibits:

 

Exhibit
1.11: Captisol Patents

Exhibit 1.69:
Spectrum Patents

Exhibit 1.72:
Spectrum Trademarks

Exhibit 7.5.1:
Press Release(s)

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	 

    	 

    

 

Exhibit 1.11

 

Captisol Patents

 

	Title	 	Country	 	Application

 No.	 	Effective

 filing date	 	Patent No.	 	Grant Date
	***	 	***	 	***	 	***	 	***	 	***
	 	***	 	***	 	***	 	***	 	***
	***	 	***	 	***	 	***	 	***	 	***
	 	***	 	***	 	***	 	***	 	***
	***	 	***	 	***	 	***	 	***	 	***
	 	***	 	***	 	***	 	***	 	***

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	 

    	 

    

 

Exhibit 1.69

 

Spectrum Patents

 

	Title	 	Country	 	Application

 No.	 	Effective

 filing date	 	Patent No.	 	Grant Date
	***	 	***	 	***	 	***	 	***	 	***

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	 

    	 

    

 

Exhibit 1.72

 

Spectrum Trademarks

 

None.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	 

    	 

    

 

Exhibit 7.5.1

 

Press Release(s)

 

See attached.

 

*** = Portions of this exhibit have been omitted pursuant to
a request for confidential treatment.  An unredacted version of this exhibit has been filed separately with the Commission.

    	 

    	 

    

 

Spectrum Pharmaceuticals Out-Licenses

Rights for Greater China to CASI Pharmaceuticals
for Three of Its Drugs

 

		·	Spectrum receives a 19.99% stake (pre-transaction) in CASI, a NASDAQ-listed, oncology-focused Company
with expertise and focus on markets in China and a $1.5 million promissory note

 

HENDERSON, Nev. and ROCKVILLE, Md. (September
18, 2014) – Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial
and drug development operations with a primary focus in hematology and oncology, and CASI Pharmaceuticals, Inc. (Nasdaq: CASI),
a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing
cancer and other unmet medical needs for the global market with a primary focus on China, announce the signing of license agreements
whereby CASI has been granted exclusive rights to two of Spectrum Pharmaceuticals’ commercial oncology drugs, Zevalin®
(ibritumomab tiuxetan) Injection for intravenous use and Marqibo® (vinCRIStine sulfate LIPOSOME injection) for intravenous
infusion, and a Phase 3 drug candidate, Captisol-EnabledTM Melphalan (CE melphalan), for development and commercialization
in China, including Taiwan, Hong Kong and Macau.

 

ZEVALIN is used in the treatment of non-Hodgkin’s
lymphoma (NHL) and MARQIBO is used in the treatment of acute lymphoblastic leukemia (ALL). CE melphalan has met the endpoints in
a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.
Spectrum plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for CE melphalan in the second half
of 2014.

 

CASI will be responsible for the development
and commercialization of the three drugs, including the submission of import drug registration applications to regulatory authorities
and conducting any confirmatory clinical studies in greater China, if and as required.

 

“We are delighted to see our anticancer
drugs to be developed and marketed in greater China through CASI, a NASDAQ-listed Company focused on China,” said Rajesh
C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “The management of CASI has a track record
of successfully developing anticancer drugs in China. We are pleased to be a shareholder of CASI at this early stage of their development
and look forward to CASI creating value for our shareholders as they grow. China’s pharmaceutical market is growing at a
rapid pace and is already approaching second place to only the United States in the world. The greater China drug market for anticancer
drugs is projected to become the world’s largest in the next decade and CASI has the opportunity to take a leading position
to address these significant unmet medical needs. We are impressed with the management team at CASI and their expertise in China,
and look forward to sharing in the success of our drugs in this important market.”

 

Spectrum Pharmaceuticals, Inc., 11500 S.
Eastern Ave., Ste. 240  •  Henderson, Nevada 89052   •   Tel: 702-835-6300

•   Fax: 702-260-7405   •   www.sppirx.com   •   NASDAQ:
SPPI

 

CASI Pharmaceuticals, Inc., 9620 Medical
Center Drive, Ste. 300 • Rockville, Maryland 20852   •   Tel: 240-864-2643

•   Fax: 301-325-2437   •   www.casipharmaceuticals.com   •   NASDAQ:
CASI

 

    	 

    	 

    

 

Commenting on the transaction, Ken K. Ren,
Ph.D., CASI’s Chief Executive Officer, said, “We are very excited to have entered into this transaction with Spectrum,
a Company with a successful track record of developing and commercializing drugs expeditiously in the U.S. The addition of these
three drugs transforms our pipeline and significantly expands our market share potential in China. Our transaction is structured
rather uniquely in that the shares and note represent the purchase price to Spectrum and is in lieu of royalties and milestones
normally associated with traditional licenses, thereby aligning Spectrum’s interest with our shareholders. We look forward
to a productive relationship with Spectrum.”

 

Dr. Ren added, “These drug products
come with strong intellectual property protection and significant technology barriers. We are currently preparing the import drug
registration applications in greater China, initially for ZEVALIN and MARQIBO, and since both drugs are approved for sale in the
U.S., we anticipate that confirmatory clinical trials will be required for marketing approval in our territory. The submission
of the import drug registration for CE melphalan will follow immediately after its approval by the U.S. FDA. The annual incidence
in China for NHL, ALL and multiple myeloma is increasing each year with high mortality rates, it is our goal to have these innovative
products available to patients in greater China as soon as possible to address these unmet medical needs, and as Spectrum expands
these drugs into additional indications in the U.S., we too will apply for expanded labels in our territory.”

 

In addition to its initial stake in CASI,
Spectrum Pharmaceuticals will have certain rights to maintain its post-transaction ownership position. Spectrum Pharmaceuticals
also will have the opportunity to designate a member to CASI’s board of directors. Detailed information on the transaction
can be found in CASI’s Report on Form 8-K, which will be filed with the Securities and Exchange Commission.

 

H.C. Wainwright & Co., LLC acted as
Spectrum's advisor.

 

About Spectrum Pharmaceuticals, Inc.

 

Spectrum Pharmaceuticals is a leading biotechnology
company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum
and its affiliates market five oncology drugs: FUSILEV® (levoleucovorin) for Injection; FOLOTYN® (pralatrexate injection);
ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use; MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous
infusion; and BELEODAQTM (belinostat) for Injection. Spectrum's strong track record in in-licensing and acquiring differentiated
drugs, and expertise in clinical development have generated a robust, diversified and growing pipeline of product candidates in
advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

 

    	 

    	 

    

 

About CASI Pharmaceuticals, Inc.

 

CASI is a biopharmaceutical company dedicated
to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs
for the global market with a primary focus on China.. CASI’s product pipeline includes exclusive regional rights to ZEVALIN
(ibritumomab tiuxetan), MARQIBO (vinCRIStine sulfate LIPOSOME injection) and Captisol-Enabled (propylene glycol-free) melphalan
(CE melphalan) in greater China (including Taiwan, Hong Kong and Macau). CASI’s development pipeline also includes its proprietary
drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial)
currently under reformulation development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D
operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.comand in the Company’s filings
with the U.S. Securities and Exchange Commission.

 

About ZEVALIN
and the ZEVALIN Therapeutic Regimen

 

ZEVALIN (ibritumomab
tiuxetan) injection for intravenous use, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular
B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular
non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.

 

ZEVALIN is a CD20-directed
radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled
ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic
effects of a beta-emitting radioisotope.

 

Important
ZEVALIN Safety Information

 

Deaths
have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities
were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation,
or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe
and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN
therapeutic regimen.

 

Please
see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN
can be found at www.ZEVALIN.com.

 

About MARQIBO

 

MARQIBO is a novel,
sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA-approved
for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or
greater relapse or whose disease has progressed following two or more anti-leukemia therapies. (The encapsulation technology, utilized
in this formulation, has been shown to provide prolonged circulation of vincristine in the blood).

 

    	 

    	 

    

 

Please see
important safety information below and the full prescribing information for MARQIBO at www.marqibo.com.

 

Indication
and usage

 

MARQIBO
is a liposomal vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic
leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This
indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.

 

Important safety
information

 

CONTRAINDICATIONS

 

		·	MARQIBO is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth
syndrome

 

		·	MARQIBO is contraindicated in patients with hypersensitivity to vincristine sulfate or any of the
other components of MARQIBO (vinCRIStine sulfate LIPOSOME injection

 

		·	MARQIBO is contraindicated for intrathecal administration

 

About Captisol-Enabled Melphalan

 

Captisol-enabled, PG-free melphalan is
a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been
granted an Orphan Drug Designation by the FDA. This formulation eliminates the use of propylene glycol, which has been reported
to cause renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds. The use of the
Captisol technology to reformulate melphalan also improves its stability and is anticipated to allow for slower infusion rates
and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity for pre-transplant
chemotherapy.

 

About Captisol

 

Captisol is a patent-protected,
chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented
and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences
Center for specific use in drug development and formulation. This unique technology has enabled seven FDA-approved products, including
Onyx Pharmaceuticals’ Kyprolis®, Baxter International’s Nexterone® and Merck’s
NOXAFIL IV. There are also more than 30 Captisol-enabled products currently in clinical development.

 

    	 

    	 

    

 

Forward-Looking Statements – Spectrum
Pharmaceuticals, Inc.

 

This press release may contain forward-looking
statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties
that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations.
These statements include, but are not limited to, statements that relate to our business and its future, including sales of Spectrum’s
drug products, certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to
assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum
or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the
possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new
applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that
our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs,
the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained
revenue history, our limited marketing experience, our customer concentration, the possibility for fluctuations in customer orders,
evolving market dynamics, our dependence on third parties for clinical trials, manufacturing, distribution, information and quality
control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained
in this press release except as required by law.

 

SPECTRUM PHARMACEUTICALS, INC. ®,
FUSILEV®, FOLOTYN®, ZEVALIN®, and MARQIBO® are
registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. BELEODAQTM, REDEFINING
CANCER CARETM and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks
are the property of their respective owners.

 

© 2014 Spectrum Pharmaceuticals,
Inc. All Rights Reserved.

 

Forward-Looking Statements – CASI
Pharmaceuticals, Inc.

 

This news release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for
future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous
assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made,
and no duty to update forward-looking statements is assumed.

 

    	 

    	 

    

 

Actual results could differ materially
from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern
as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from
trading on the Nasdaq Capital Market; the volatility in the market price of our common stock; the difficulty of executing our business
strategy in China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and
distribution of our proposed product candidate or future candidates; risks relating to the need for additional capital and the
uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with
any early-stage products under development; the risk that results in preclinical models are not necessarily indicative of clinical
results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack
of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization,
if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other
risks). Such factors, among others, could have a material adverse effect upon our business, results of operations and financial
condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made.
Additional information about the factors and risks that could affect our business, financial condition and results
of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

 

	SPECTRUM INVESTOR CONTACT:

    

    Spectrum Pharmaceuticals, Inc.

    Shiv Kapoor

    Vice President, Strategic Planning & Investor 

    Relations

    702-835-6300

    InvestorRelations@sppirx.com	CASI INVESTOR CONTACTS:

    

    CASI Pharmaceuticals, Inc.

    240.864.2643

    ir@casipharmaceuticals.com

    

    LHA

    Kim Sutton Golodetz

    212.838.3777

    kgolodetz@lhai.com

 

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