10-K

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K

(Mark One)

 þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended September 30, 2013

or

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from     to    .

Commission File Number 001-33451
BIODEL INC.
(Exact Name of Registrant as Specified in Its Charter)

Delaware (State or Other Jurisdiction of Incorporation or Organization)	90-0136863 (I.R.S. Employer Identification No.)
100 Saw Mill Road Danbury, CT (Address of Principal Executive Offices)	06810 (Zip Code)

Registrant's telephone number, including area code
(203) 796-5000
Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Name of Each Exchange on Which Registered
Common Stock, par value $0.01 per share	The NASDAQ Capital Market

Securities registered pursuant to Section 12(g) of the Act:
None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o   No þ

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o   No þ

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days Yes þ   No  o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ   No  o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.:

Large accelerated filer o	Accelerated filer o
Non-accelerated filer o	Smaller reporting company þ

(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b2 of the Exchange Act). Yes o   No þ

The aggregate market value of the common stock of the registrant held by non-affiliates was $40 million based on the last sales price at which the common stock was last sold on the NASDAQ Capital Market on March 31, 2013.

The number of shares outstanding of the registrant's common stock, as of November 29, 2013 was 21,075,870.

Documents Incorporated by Reference

Portions of the registrant's definitive Proxy Statement, or the 2014 Proxy Statement, which will be filed with the Securities and Exchange Commission not later than 120 days after September 30, 2013, for its 2014 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report. With the exception of the portions of the 2014 Proxy Statement expressly incorporated into this Annual Report on Form 10-K by reference, such document shall not be deemed filed as part of this Annual Report on Form 10-K.

BIODEL INC.

INDEX TO REPORT ON FORM 10-K

		Page
	PART I
Item 1:	Business	3
Item 1A:	Risk Factors	18
Item 1B:	Unresolved Staff Comments	38
Item 2:	Properties	38
Item 3:	Legal Proceedings	38
Item 4:	Mine Safety Disclosure	38
	PART II
Item 5:	Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	39
Item 6:	Selected Financial Data	41
Item 7:	Management's Discussion and Analysis of Financial Condition and Results of Operations	42
Item 7A:	Quantitative and Qualitative Disclosures About Market Risk	57
Item 8:	Financial Statements and Supplementary Data	58
Item 9:	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	58
Item 9A:	Controls and Procedures	58
	PART III
Item 10:	Directors, Executive Officers and Corporate Governance	60
Item 11:	Executive Compensation	60
Item 12:	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	60
Item 13:	Certain Relationships and Related Transactions, and Director Independence	60
Item 14:	Principal Accountant Fees and Services	60
	PART IV
Item 15:	Exhibits, Financial Statement Schedules	60

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FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Annual Report on Form 10-K regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Our forward-looking statements in this Annual Report on Form 10-K are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including:

•the progress, timing or success of our research and development and clinical programs for our product candidates;

•the degree to which our ongoing assessment of the data from our recently completed Phase 2 clinical trial of BIOD-123, our lead candidate for an ultra-rapid-acting insulin formulation, and our related chemistry, manufacturing and controls development work, support further clinical development by us or our potential partners;

•our ability to successfully use the data from our Phase 2 clinical trial of BIOD-123 to design and conduct the pivotal clinical trials required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize that candidate;

•the success of our formulation development work to improve the stability of our newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations;

•our ability to conduct the development work necessary to finalize the formulation and design of our dual-chamber glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of a new drug application, or NDA, to the FDA for that product candidate;

•the results of our real-time stability programs for our RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our ultra-rapid-acting RHI- and insulin analog-based product candidates or our glucagon rescue product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;

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•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to produce our products in our final dosage form;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization one or more product candidates;

•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Annual Report, particularly in Item 1A of this Annual Report, and in our other public filings with the Securities and Exchange Commission that could cause actual results or events to differ materially from the forward-looking statements that we make.

You should read this Annual Report and the documents that we have filed as exhibits to the Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. It is routine for internal projections and expectations to change as the year, or each quarter in the year, progresses, and therefore it should be clearly understood that the internal projections and beliefs upon which we base our expectations are made as of the date of this Annual Report on Form 10-K and may change prior to the end of each quarter or the year. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise.

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PART I

ITEM 1: BUSINESS

Overview

We are a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. Our proprietary insulin formulations are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. We refer to these as "ultra-rapid-acting" formulations. Our glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose.

Our most advanced ultra-rapid-acting insulin formulation, BIOD-123, combines recombinant human insulin, or RHI, with our proprietary combination of excipients to increase the rate of absorption following injection when compared to other commercially available insulin formulations, including "rapid-acting" mealtime insulin analogs such as Humalog®, marketed by Eli Lilly, Novolog®, marketed by Novo Nordisk and Apidra®, marketed by Sanofi-Aventis. We are also using our proprietary excipients to develop ultra-rapid-acting insulin analog-based formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog®, or insulin aspart, the active pharmaceutical ingredient in NovoLog®.

An earlier RHI-based formulation known as Linjeta™ (and previously referred to as VIAject®) was the subject of a New Drug Application, or NDA, that we submitted to the FDA in December 2009. In October 2010, the FDA issued a complete response letter stating that the NDA for Linjeta™ could not be approved in its submitted form and that we should conduct two new Phase 3 clinical trials using our preferred commercial formulation of Linjeta™ prior to re-submitting the NDA. Based upon the complete response letter and subsequent feedback that the FDA provided, we decided to develop newer RHI-based formulations with the goal of identifying a formulation with a pharmacokinetic and pharmacodynamic profile similar to Linjeta™, but with improved injection site toleration characteristics. From January 2011 to April 2012, we studied several such newer formulations, including BIOD-123, in Phase 1 clinical trials. In these trials, we used Humalog® as the comparator drug rather than the comparator drug we used in our Phase 3 Linjeta™ clinical trials. In our Phase 3 clinical trials, the comparator drug was Humulin® R, an RHI-based insulin formulation marketed by Eli Lilly that is less rapid-acting than the insulin analog Humalog®.

BIOD-123 achieved our target pharmacokinetic, pharmacodynamic and injection site toleration profiles for a candidate RHI-based formulation in a Phase 1 clinical trial completed in April 2012, and in the third calendar quarter of 2012 we began enrolling patients in a Phase 2 clinical trial of BIOD-123. The Phase 2 clinical trial of BIOD-123 was a randomized, open label, parallel group study conducted at 32 investigative centers in the United States. In the trial, 132 patients with Type 1 diabetes were randomized to receive either BIOD-123 or Humalog® to use as their mealtime insulin during an 18-week treatment period. Both arms of the study used insulin glargine, sold as Lantus®, as the basal insulin. The clinical trial was designed to evaluate the mean change in patients' glycosylated hemoglobin, or HbA1c, levels from baseline as the primary endpoint, and secondary endpoints included postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

The Phase 2 clinical trial of BIOD-123 completed patient dosing in the second calendar quarter of 2013, and in September 2013 we announced preliminary results from the trial. BIOD-123 achieved the primary endpoint of noninferiority for HbA1c relative to Humalog®. The mean HbA1c change from baseline in the BIOD-123 group was -0.08 ± 0.064% and -0.25± 0.063% in the Humalog® group. The 95% confidence interval (-0.01, 0.35) of the between group differences in change from baseline HbA1c did not exceed the FDA-designated threshold of 0.40%, thereby establishing non-inferiority. We expect to provide an update on our further development plans for BIOD-123 after completing our analysis of the data from the Phase 2 clinical trial and following discussions with FDA on clinical trial design, safety and chemistry, manufacturing and controls relating to potential future studies.

In addition to BIOD-123, we have other RHI-based formulations in earlier stages of development. In particular, we are developing ultra-rapid-acting formulations of concentrated insulin that are characterized by a

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rapid onset of action and a prolonged duration of action. We believe these formulations could address an unmet medical need for an insulin with an initial rate of absorption superior to that of existing concentrated insulins and prandial/basal pre-mixed insulins. In November 2013, we announced that we had initiated a Phase 1 clinical trial with BIOD-531, our lead candidate for an ultra-rapid-acting concentrated insulin formulation. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and is formulated with EDTA, citrate and magnesium sulfate. In preclinical studies in diabetic swine, BIOD-531 demonstrated a more rapid rate of absorption and onset of action, along with a similar duration of action, when compared to Humulin® R U-500, a presentation containing 500 units of RHI per millimeter. In other preclinical studies, BIOD-531 also demonstrated a more rapid rate of absorption and onset of action when compared to Humalog® pre-mixed prandial/basal formulations. In the Phase 1 clinical trial of BIOD-531, we will evaluate and compare the onset of action of BIOD-531 to Humulin® R U-500 and to Humalog® prandial/basal pre-mixed insulin. We anticipate reporting top line data from the clinical trial in the first calendar quarter of 2014.

We also continue to develop ultra-rapid-acting insulin analog-based formulations. In January 2013, we announced top-line results from our Phase 1 clinical trial of two insulin analog-based formulations, BIOD-238 and BIOD-250. These formulations, which were manufactured using commercial preparations of Humalog®, generally use the same or similar excipients as BIOD-123 and were intended to be optimized for rapid absorption and injection site toleration. The trial, which was conducted in Australia, was designed to compare the pharmacokinetic and injection site toleration profiles of BIOD-238 and BIOD-250 relative to Humalog®. In the trial, both formulations met our target pharmacokinetic profile for an ultra-rapid-acting insulin analog-based formulation, and BIOD-250 met our target injection site toleration profile. We do not expect to study these formulations in additional clinical trials because they were formulated by adding our proprietary excipients to the marketed formulation of Humalog® and because they do not demonstrate stability characteristics consistent with our target product profile. Accordingly, we are continuing our insulin analog-based formulation work to develop formulations using insulin lispro as the active pharmaceutical ingredient, rather than a marketed presentation of Humalog®.

In addition to our ultra-rapid-acting insulin formulation program, we are developing room temperature stable glucagon presentations for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia. In June 2013, we announced plans to develop a novel glucagon rescue product to treat severe hypoglycemia using a proprietary device from Unilife Corporation. The device, which is being customized for use in emergency situations by patient caregivers with no medical training, is a dual-chamber design that reconstitutes lyophilized glucagon with a liquid diluent immediately prior to injection, and it features automatic needle retraction on full dose delivery. We expect to submit an Investigational New Drug application to the FDA for our dual-chamber glucagon rescue product during the next nine months and anticipate conducting a pivotal clinical trial in the second half of 2014. We are also conducting preclinical testing to develop liquid formulations of glucagon for hypoglycemic rescue and other indications.

Diabetes and Insulin Therapy Overview

Glucose is a simple sugar used by all the cells of the body to produce energy and support life. Humans need a minimum level of glucose in their blood at all times to stay alive. The primary manner in which the body produces blood glucose is through the digestion of food. When a person is not getting this glucose from food digestion, glucose is produced from stores and released by the liver. The body's glucose levels are regulated by insulin. Insulin is a peptide hormone that is naturally secreted by the pancreas. Insulin helps glucose enter the body's cells to provide a vital source of energy.

When a healthy individual begins a meal, the pancreas releases a natural spike of insulin called the first-phase insulin release. In addition to providing sufficient insulin to process the glucose coming into the blood from digestion of the meal, the first-phase insulin release acts as a signal to the liver to stop making glucose while digestion of the meal is taking place. Because the liver is not producing glucose and there is sufficient additional insulin to process the glucose from digestion, the blood glucose levels of healthy individuals remain relatively constant and their blood glucose levels do not become too high.

Diabetes is a disease characterized by abnormally high levels of blood glucose and inadequate levels of, or response to, insulin. There are two major types of diabetes — Type 1 and Type 2. In Type 1 diabetes, the

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body produces no insulin. In the early stages of Type 2 diabetes, although the pancreas does produce insulin, the body loses its early phase insulin response to a meal. In addition, the body's cells do not respond as well as they should to a normal amount of insulin, a condition known as insulin resistance. According to the Centers for Disease Control and Prevention, or CDC, Type 2 diabetes is the more prevalent form of the disease, affecting approximately 90% to 95% of all people diagnosed with diabetes.

Even before any other symptoms are present, one of the first effects of Type 2 diabetes is the loss of the meal-induced first-phase insulin release. In the absence of the first-phase insulin release, the liver will not receive its signal to stop making glucose. As a result, the liver will continue to produce glucose at a time when the body begins to absorb new glucose through the digestion of the meal, and the blood glucose level of patients with diabetes rises too high after eating, a condition known as hyperglycemia. Hyperglycemia causes glucose to attach unnaturally to certain proteins in the blood, interfering with these proteins' ability to perform their normal function of maintaining the integrity of the small blood vessels. With hyperglycemia occurring after each meal, the tiny blood vessels eventually break down and leak. The long-term adverse effects of hyperglycemia include blindness, loss of kidney function, nerve damage and loss of sensation and poor circulation in the periphery, potentially requiring amputation of the extremities.

Patients with diabetes, particularly those with Type 1 diabetes, are also at risk for abnormally low levels of blood glucose, known as hypoglycemia, that can result from excessive insulin between meals. Hypoglycemia can result in loss of mental acuity, confusion, increased heart rate, hunger, sweating and faintness. At very low glucose levels, hypoglycemia can result in loss of consciousness, coma and even death. According to the American Diabetes Association, or ADA, patients with Type 1 diabetes have a serious hypoglycemic event approximately once per year, many of which require hospital emergency room visits.

Insulin Therapy and Its Limitations

Because patients with Type 1 diabetes produce no insulin, the primary treatment for Type 1 diabetes is daily intensive insulin therapy. The treatment of Type 2 diabetes typically starts with management of diet and exercise. Although helpful in the short-term, treatment through diet and exercise alone is not an effective long-term solution for the vast majority of patients with Type 2 diabetes. When diet and exercise are no longer sufficient, treatment commences with various non-insulin medications. These non-insulin medications may be limited in their ability to manage the disease effectively and can have significant side effects. Because of the limitations of non-insulin treatments, many patients with Type 2 diabetes deteriorate over time and eventually require insulin therapy to support their metabolism.

Insulin therapy has been used for more than 80 years to treat diabetes. This therapy usually involves administering several injections of insulin each day. These injections consist of administering a long-acting basal injection one or two times per day and an injection of a rapid-acting insulin at mealtime. Although this treatment regimen is accepted as effective, it has limitations. First, patients generally dislike injecting themselves with insulin due to the inconvenience and pain of needles. As a result, patients tend not to comply adequately with the prescribed treatment regimens and are often inadequately medicated.

More importantly, even when properly administered, insulin injections do not replicate the natural time-action profile of insulin. In particular, the natural spike of the first-phase insulin release in a person without diabetes results in blood insulin levels rising within several minutes of the entry into the blood of glucose from a meal. By contrast, injected insulin enters the blood slowly, with peak insulin levels occurring within 80 to 100 minutes following the injection of recombinant human insulin.

A potential solution is the injection of insulin directly into the vein of diabetic patients immediately before eating a meal. In studies of intravenous injections of insulin, patients exhibited better control of their blood glucose for 3 to 6 hours following the meal. However, for a variety of medical reasons, intravenous injection of insulin before each meal is not a practical therapy.

One of the key improvements in insulin treatments was the introduction in the 1990s and 2000s of rapid-acting insulin analogs, such as Humalog^®, NovoLog^® and Apidra^®. However, even with the rapid-acting insulin analogs, peak insulin levels typically occur within 50 to 70 minutes following the injection. Because the rapid-acting insulin analogs do not adequately mimic the first-phase insulin release, diabetic patients using insulin therapy continue to have inadequate levels of insulin present at the initiation of a meal and too much

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insulin present between meals. This lag in insulin delivery can result in hyperglycemia early after meal onset. Furthermore, the excessive insulin between meals may result in hypoglycemia.

Additional complications of insulin therapy can arise if a patient's response to insulin diminishes with the progression of the disease. Some patients with Type 2 diabetes have severe insulin resistance, resulting in the need to take more than 200 units of insulin per day to control blood glucose elevations. In order to reduce the volume of insulin needed for each injection, many of these patients use Humulin® R U-500, a presentation of Humulin® R containing 500 units of RHI per milliliter (instead of the standard 100 units per milliliter). Humulin® R U-500 has a long duration of action, but its onset of action is very slow and therefore is not ideally suited to cover the elevation of glucose levels associated with meals. Humulin® R U-500 is currently the only concentrated insulin on the U.S. market. Many other patients with Type 2 diabetes and lesser degrees of insulin resistance use mixes of prandial and basal insulins, which offer a combination of shorter- and longer-acting insulins in the convenience of one injection. However, the mealtime component of these "pre-mixed" insulin formulations is typically absorbed more slowly than what is required to optimally cover the elevation of glucose levels associated with meals. Examples of these "pre-mixed" insulins include Humalog^® Mix 75/25, Humalog® Mix 50/50 and NovoLog^® Mix 70/30.

Glucagon Rescue Treatment and Its Limitations

Hypoglycemia is often treated by the oral administration of carbohydrates, such as orange juice or glucose tablets. However, in the case of severe hypoglycemia, the patient often experiences neurologic compromise, such as loss of consciousness or seizure. In these emergency cases, it is typically unsafe for carbohydrates to be administered by mouth and the patient requires the assistance of another person. In such cases, an injection of glucagon can be administered to help quickly raise the patient's blood glucose concentration.

Glucagon, like insulin, is a hormone secreted by the pancreas. Glucagon opposes the action of insulin by promoting the breakdown of glycogen into glucose in the liver, thereby raising the levels of blood glucose. Although glucagon injections are useful in treating severe hypoglycemia, glucagon is inherently unstable in a liquid solution. Therefore, injectable glucagon for the treatment of severe hypoglycemia is currently available only as a rescue kit consisting of a vial containing a dry powder of glucagon and a syringe containing a liquid solution. To administer glucagon with this kit, the liquid solution must first be injected into the vial with the dry powder, the contents need to be adequately mixed and then the solution is drawn back into the syringe. After the glucagon powder is dissolved, it is injected into the patient. In order to properly administer the glucagon, a caregiver must follow this multi-step process in a situation typically made challenging by the patient's condition.

Our Development of Ultra-Rapid-Acting Insulin Formulations

Our proprietary ultra-rapid-acting insulin formulations are designed to be absorbed into the blood faster than the currently marketed rapid-acting insulin analogs. One of the key features of our formulation technology is that it allows the RHI or insulin analog to disassociate, or separate, from the six molecule, or hexameric, form to the single molecule, or monomeric, form and inhibits re-association to the hexameric form. We believe that by favoring the monomeric form, our formulations may allow for more rapid delivery of insulin into the blood because insulin in the form of a single molecule is absorbed more efficiently into the bloodstream. Based upon our preclinical and clinical data, we believe our RHI- and insulin analog-based formulations may produce a profile of insulin levels in the blood that is preferable to the profile typically observed when using the currently marketed "rapid-acting" insulin analogs.

Clinical Trials of Linjeta^TM

We have conducted Phase 1, Phase 2 and Phase 3 clinical trials comparing the performance of our Linjeta^TM formulation of RHI to either Humulin^® R, which is a branded formulation of RHI, or Humalog^®, which is one of the largest selling rapid-acting insulin analogs in the United States. In our Phase 1 and Phase 2 clinical trials, we observed that the Linjeta^TM formulation was more rapidly absorbed than Humulin^® R or Humalog^®. Accordingly, we believe that our ultra-rapid acting formulations better simulate the natural first-phase insulin release in response to a meal that would be typical of healthy individuals.

We completed our two pivotal Phase 3 clinical trials of Linjeta^TM in July 2008. Our pivotal Phase 3 clinical trials were open-label, parallel group, randomized trials conducted at centers in the United States,

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Germany and India. The trials were designed to compare the efficacy and safety of Linjeta^TM to Humulin^® R. One of the trials tested Linjeta^TM in patients with Type 1 diabetes and the other in patients with Type 2 diabetes. We enrolled more than 400 patients in each trial for a six month treatment period. Approximately one-half of the patients in each trial were treated with Linjeta^TM and the remainder with Humulin^® R. The primary objective of the trials was to determine if Linjeta^TM was not inferior to Humulin^® R in the management of blood glucose levels, as measured by the mean change in patients' HbA1c levels from baseline to the end of the trial. HbA1c levels are a measure of patients' average blood glucose levels over a period of approximately 3 months. HbA1c is the FDA's preferred endpoint for diabetes trials. Predefined secondary endpoints in the trials included rates of mild and moderate and severe hypoglycemic events, and changes in body weight. Approximately 400 patients with Type 1 and Type 2 diabetes who completed the pivotal Phase 3 clinical trials elected to participate in a long term safety extension trial in which all patients were treated with Linjeta^TM as their mealtime insulin. The last patient visit in the extension trial was in February 2010.

In December 2009, we submitted an NDA to the FDA under section 505(b)(2) of the FFDCA for clearance to market Linjeta^TM as a treatment for diabetes. In November 2010, the FDA issued a complete response letter requesting additional information regarding our NDA for Linjeta^TM. The complete response letter included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls and tolerability issues relating to localized discomfort upon injection. The FDA requested that we conduct two new Phase 3 clinical trials using our preferred commercial formulation of Linjeta^TM, one in patients with Type 1 diabetes and the other in patients with Type 2 diabetes prior to resubmitting the NDA.

Development of Additional RHI- and Insulin Analog-Based Formulations

Based upon the complete response letter and subsequent feedback that the FDA provided to us, we decided to study newer RHI-based formulations in earlier stage clinical trials. After reviewing the results of a Phase 1 clinical trial of two newer formulations, BIOD-105 and BIOD-107, we determined that the overall pharmacokinetic and pharmacodynamic profiles of these formulations did not demonstrate our target product profile. We subsequently conducted a Phase 1 clinical trial of two additional formulations, BIOD-123 and BIOD-125, and announced top-line results from that trial in April 2012. We determined that both formulations achieved our target pharmacokinetic, pharmacodynamic and toleration profiles.

The Phase 1 clinical trial of BIOD-123 and BIOD-125 evaluated the pharmacokinetic, pharmacodynamic and injection site toleration profiles of these product candidates relative to Humalog^®, a rapid-acting insulin analog. The objective of the clinical trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the Linjeta^TM formulation, but with improved injection site toleration characteristics. The clinical trial was a single-center, randomized, double-blind, three-period crossover trial in 12 patients with Type 1 diabetes. Each study drug was administered subcutaneously on separate days with a washout period between injections. In the Phase 1 clinical trial, absorption rates of BIOD-123 and BIOD-125 were significantly faster than that of Humalog^® as indicated by 64% and 54% reductions, respectively, in mean times to half maximal insulin concentrations (p < 0.001 for both BIOD-123 and BIOD-125 compared to Humalog^®). Both RHI-based formulations and Humalog^® were well tolerated, with injection site toleration generally perceived by patients to be similar to that of their usual mealtime injections used at home. As measured on a 100 mm visual analog scale, or VAS, in which 100 mm is defined as the worst possible injection discomfort, local toleration was not significantly different for BIOD-123 compared to Humalog^® (BIOD-123 mean VAS 3.6 ± 2.1 mm, Humalog^® 1.8 ± 1.1 mm, p=NS). The VAS score for BIOD-125 was slightly higher as compared to Humalog^® (mean VAS 6.8 ± 2.9 mm, p < 0.05).

In the third calendar quarter of 2012 we began enrolling patients in a Phase 2 clinical trial of BIOD-123. The clinical trial was a randomized, open label, parallel group study conducted at 32 investigative centers in the United States. In the clinical trial, 132 patients with Type 1 diabetes were randomized to receive either BIOD-123 or Humalog® to use as their mealtime insulin during an 18-week treatment period. Both arms of the study used insulin glargine, sold as Lantus®, as the basal insulin. The clinical trial was designed to evaluate HbA1c control as the primary endpoint, and secondary endpoints included postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes. Following randomization, subjects entered a six-week dose titration period during which basal insulin and then prandial insulin doses were titrated in order to reach standard ADA recommended preprandial glucose targets. Upon completion of

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the titration period, patients entered a "relative stable dosing period" for an additional 12 weeks. The trial completed patient dosing in the second calendar quarter of 2013.

The Phase 2 clinical trial of BIOD-123 completed patient dosing in the second calendar quarter of 2013, and in September 2013 we announced preliminary results from the trial. BIOD-123 achieved the primary endpoint of noninferiority for HbA1c relative to Humalog®. The mean HbA1c change from baseline in the BIOD-123 group was -0.08 ± 0.064% and -0.25± 0.063% in the Humalog® group. The 95% confidence interval (-0.01, 0.35) of the between group differences in change from baseline HbA1c did not exceed the FDA-designated threshold of 0.40%, thereby establishing non-inferiority. HbA1c change during the stable dosing period was similar in both treatment groups. During this period, the mean change in HbA1c in the BIOD-123 group was -0.01% and in the Humalog® group was +0.02%. Additionally, we observed comparable weight gain, mean hypoglycemia event rates and postprandial glucose excursions between the treatment groups, as well as some trends in favor of BIOD-123 in regard to postprandial glucose excursions to a liquid meal challenge test and weight gain during the stable dosing period. Comparable safety and adverse event profiles were observed in the clinical trial, with the exception of an increased frequency of injection site pain associated with BIOD-123, which appeared to be clinically minor, short-lived and distinctly superior to the toleration profile we observed with Linjeta™ in our earlier Phase 3 clinical trials. We expect to provide an update on our further development plans for BIOD-123 after completing our analysis of the data from the Phase 2 clinical and following discussions with FDA on clinical trial design, safety and chemistry, manufacturing and controls relating to potential future studies.

In addition to BIOD-123, we have other RHI-based formulations in earlier stages of development. In particular, we are developing ultra-rapid-acting formulations of concentrated insulin that are characterized by a rapid onset of action and a prolonged duration of action. We believe these formulations could address an unmet medical need for an insulin with an initial rate of absorption superior to that of Humulin® R U-500 and prandial/basal pre-mixed insulins. In November 2013, we announced that we had initiated a Phase 1 clinical trial with BIOD-531, our lead candidate for an ultra-rapid-acting concentrated insulin formulation. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and is formulated with EDTA, citrate and magnesium sulfate. In preclinical studies in diabetic swine, BIOD-531 demonstrated a more rapid rate of absorption and onset of action, along with a similar duration of action, when compared to Humulin® R U-500, a presentation containing 500 units of RHI per millimeter. In other preclinical studies, BIOD-531 also demonstrated a more rapid rate of absorption and onset of action when compared to Humalog® pre-mixed prandial/basal formulations. In the Phase 1 clinical trial of BIOD-531, we will evaluate and compare the onset and duration of action and injection site tolerability of BIOD-531 to Humulin® R U-500 and to Humalog® prandial/basal pre-mixed insulin. We anticipate reporting top line data from the clinical trial in the first calendar quarter of 2014.

We also continue to develop ultra-rapid-acting insulin analog-based formulations. In January 2013, we announced top-line results from our Phase 1 clinical trial of two insulin analog-based formulations, BIOD-238 and BIOD-250. These formulations, which were manufactured using commercial preparations of Humalog®, use the same combination of or similar excipients as BIOD-123 and were intended to be optimized for rapid absorption and injection site toleration. The trial, which was conducted in Australia, was designed to compare the pharmacokinetic and injection site toleration profiles of BIOD-238 and BIOD-250 relative to Humalog®. In the trial, both formulations met our target pharmacokinetic profile for an ultra-rapid-acting insulin analog-based formulation, and BIOD-250 met our target injection site toleration profile. We do not expect to study these formulations in additional clinical trials because they were formulated by adding our proprietary excipients to the marketed formulation of Humalog® and because they do not demonstrate stability characteristics consistent with our target product profile. Accordingly, we are continuing our insulin analog-based formulation work to develop formulations using insulin lispro as the active pharmaceutical ingredient, rather than a marketed presentation of Humalog®.

Our Development of a Glucagon Rescue Product

We believe that the complexity of the currently available rescue kits and the training required for proper administration of glucagon using those kits has resulted in the underuse of glucagon as a rescue treatment for diabetes patients experiencing severe hypoglycemia. We also believe that the development of room temperature stable presentations or liquid formulations of glucagon can overcome the limitations resulting

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from the rescue kits. In June 2013, we announced plans to develop a novel glucagon rescue product to treat severe hypoglycemia using a proprietary device from Unilife Corporation. The device, which is being customized for use in emergency situations by patient caregivers with no medical training, is a dual-chamber design that automatically reconstitutes lyophilized glucagon with a liquid diluent immediately prior to injection, and it features automatic needle retraction on full dose delivery. We expect to submit an Investigational New Drug application to the FDA for our dual-chamber glucagon rescue product during the next nine months and anticipate conducting a pivotal clinical trial in the second half of 2014. We are also using other proprietary technologies to develop a liquid glucagon formulation that does not require reconstitution and could, therefore, be administered using a pre-filled syringe in an autoinjector or similar device.

Government Regulation

The FDA and other federal, state, local and foreign regulatory agencies impose substantial requirements upon the clinical development, approval, labeling, manufacture, marketing and distribution of drug products. These agencies regulate, among other things, research and development activities and the testing, approval, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, advertising and promotion of our product candidates. The regulatory approval process is generally lengthy and expensive, with no guarantee of a positive result. Moreover, failure to comply with applicable FDA or other requirements may result in civil or criminal penalties, recall or seizure of products, injunctive relief including partial or total suspension of production, or withdrawal of a product from the market.

United States Government Regulation

The FDA regulates, among other things, the research, manufacture, promotion and distribution of drugs in the United States under the FFDCA and other statutes and implementing regulations. We intend to seek FDA approval for our product candidates in an NDA, and not under an application submitted for approval as a biologic under the Public Health Service Act. The process required by the FDA before a drug product candidate may be marketed in the United States under an NDA generally involves the following:

•completion of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA's Good Laboratory Practice, or GLP, regulations;

•submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin;

•for some products, performance of adequate and well-controlled human clinical trials in accordance with the FDA's regulations, including Good Clinical Practices, to establish the safety and efficacy of the product candidate for each proposed indication;

•submission to the FDA of an NDA, and the acceptance for filing of the NDA by the FDA;

•satisfactory completion of an FDA preapproval inspection of the manufacturing facilities at which the product is produced to assess compliance with current Good Manufacturing Practice, or cGMP, regulations; and

•FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.

The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.

Nonclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals and other animal studies. The results of nonclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND to the FDA. Some nonclinical testing may continue even after an IND is submitted. The IND also includes one or more protocols for the initial clinical trial or trials and an investigator's brochure. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions relating to the proposed clinical trials as outlined in the IND and places the clinical trial on a clinical hold. In such cases, the IND sponsor and the FDA must resolve any outstanding concerns or questions before any clinical

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trials can begin. A clinical trial hold also may be imposed at any time before or during studies due to safety concerns or non-compliance with regulatory requirements. An independent institutional review board, or IRB, monitors the clinical centers proposing to conduct the clinical trial and must review and approve the plan for any clinical trial before it commences. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form signed by the trial participants and must monitor the study until completed.

Clinical Trials. Clinical trials involve the administration of the product candidate to human subjects under the supervision of qualified medical investigators according to approved protocols that detail the objectives of the study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor participant safety. Each protocol is submitted to the FDA as part of the IND.

Human clinical trials are typically conducted in three sequential phases, but the phases may overlap, or be combined.

•Phase 1 clinical trials typically involve the initial introduction of the product candidate into human volunteers. In Phase 1 clinical trials, the product candidate is typically tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and pharmacodynamics.

•Phase 2 clinical trials are conducted in a limited patient population to gather evidence about the efficacy of the product candidate for specific, targeted indications, to determine dosage tolerance and optimal dosage, and to identify possible adverse effects and safety risks.

•Phase 3 clinical trials are undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at geographically dispersed clinical trial sites. The size of Phase 3 clinical trials depends upon clinical and statistical considerations for the product candidate and proposed indications, but sometimes can include several thousand patients. Phase 3 clinical trials are intended to establish the overall risk-benefit ratio of the product candidate and provide an adequate basis for product labeling.

Clinical testing must satisfy extensive FDA regulations. Reports detailing the status of the clinical trials must be submitted at least annually to the FDA and safety reports must be submitted for serious and unexpected adverse events. Success in early stage clinical trials does not assure success in later stage clinical trials. The FDA, an IRB or we may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

New Drug Applications. Assuming successful completion of the required clinical trials, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of an NDA. An NDA also must contain extensive manufacturing information, as well as proposed labeling for the finished product. An NDA must contain information about the chemistry and physical characteristics of the drug and a final process for manufacturing the product in accordance with cGMP. The manufacturing process must be capable of consistently producing quality product within specifications approved by the FDA. The manufacturer must develop methods for testing the quality, purity and potency of the final product. In addition, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf life. Prior to approval, the FDA will conduct an inspection of the manufacturing facilities to assess compliance with cGMP.

The FDA reviews all NDAs submitted before it accepts them for filing. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information and is subject to review before the FDA accepts it for filing. After an application is filed, the FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it considers them carefully when making decisions. The FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that must be met in order to secure final approval of the NDA. An applicant receiving a complete response letter may resubmit the application with data and information addressing the FDA's concerns or requirements, withdraw the application without prejudice to a subsequent submission of a related

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application or request a hearing on whether there are grounds for denying approval of the application. If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require us to conduct Phase 4 testing which involves clinical trials designed to further assess a drug's safety and effectiveness after NDA approval, and may require surveillance programs to monitor the safety of approved products which have been commercialized. Once issued, the FDA may withdraw product approval if ongoing regulatory requirements are not met or if safety or efficacy questions are raised after the product reaches the market. The agency may also impose requirements that the NDA holder conduct new studies, make labeling changes, implement Risk Evaluation and Mitigation Strategies, and take other corrective measures.

Section 505(b)(2) NDAs. There are three types of drug registration applications: the full NDA, the abbreviated NDA, which is used for generic drug applications, and the Section 505(b)(2) NDA. We intend to file Section 505(b)(2) NDAs that might, if accepted by the FDA, save time and expense in the development and testing of our product candidates. A full NDA is submitted under Section 505(b)(1) of the FFDCA and must contain full reports of investigations conducted by the applicant to demonstrate the safety and effectiveness of the drug. A Section 505(b)(2) NDA may be submitted for a drug for which one or more of the investigations relied upon by the applicant was not conducted by or for the applicant and for which the applicant has no right of reference from the person by or for whom the investigations were conducted. A Section 505(b)(2) NDA may be submitted based in whole or in part on published literature or on the FDA's finding of safety and efficacy of one or more previously approved drugs, which are known as reference drugs. Thus, the filing of a Section 505(b)(2) NDA may result in approval of a drug based on fewer clinical or nonclinical studies conducted by the applicant than would be required under a full NDA. The number and size of studies that need to be conducted by the sponsor depends on the amount and quality of data pertaining to the reference drug that are publicly available, and on the similarity of and differences between the applicant's drug and the reference drug. In some cases, extensive, time-consuming, and costly clinical and nonclinical studies may still be required for approval of a Section 505(b)(2) NDA.

Because we are developing new formulations of previously approved chemical entities, such as insulin and glucagon, our drug approval strategy is to submit Section 505(b)(2) NDAs to the FDA. We plan to pursue similar routes for submitting applications for our product candidates in foreign jurisdictions if available. The FDA may not agree that our product candidates are approvable pursuant to Section 505(b)(2) NDAs. There is no specific guidance available for Section 505(b)(2) NDAs for insulin or glucagon. In addition, while there is precedent for a glucagon product being approved under a Section 505(b)(2) NDA, we are not aware of any insulin product that has been approved under a Section 505(b)(2) NDA. If the FDA determines that Section 505(b)(2) NDAs are not appropriate and that full NDAs are required for our product candidates, the time and financial resources required to obtain FDA approval for our product candidates could substantially and materially increase, and our product candidates might be less likely to be approved. If the FDA requires full NDAs for our product candidates, or requires more extensive testing and development for some other reason, our ability to compete with alternative products that arrive on the market more quickly than our product candidates would be adversely impacted.

Patent Protections. An applicant submitting a Section 505(b)(2) NDA must certify to the FDA with respect to the patent status of the reference drug upon which the applicant relies in support of approval of its drug. With respect to every patent listed in the FDA's Orange Book, which is the FDA's list of approved drug products, as claiming the reference drug or an approved method of use of the reference drug, the Section 505(b)(2) applicant must certify that: (1) there is no patent information listed by the FDA for the reference drug; (2) the listed patent has expired; (3) the listed patent has not expired, but will expire on a particular date; (4) the listed patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the product in the Section 505(b)(2) NDA; or (5) if the patent is a use patent, that the applicant does not seek approval for a use claimed by the patent. If the applicant files a certification to the effect of clause (1), (2) or (5), FDA approval of the Section 505(b)(2) NDA may be made effective immediately upon successful FDA review of the application, in the absence of marketing exclusivity delays, which are discussed below. If the applicant files a certification to the effect of clause (3), the Section 505(b)(2) NDA approval may not be made effective until the expiration of the relevant patent and the expiration of any marketing exclusivity delays.

If the Section 505(b)(2) NDA applicant provides a certification to the effect of clause (4), referred to as a paragraph IV certification, the applicant also must send notice of the certification to the patent owner and the

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holder of the NDA for the reference drug. The filing of a patent infringement lawsuit within 45 days of the receipt of the notification may prevent the FDA from approving the Section 505(b)(2) NDA for 30 months from the date of the receipt of the notification unless a court determines that a longer or shorter period is appropriate because either party to the action failed to reasonably cooperate in expediting the action. However, the FDA may approve the Section 505(b)(2) NDA before the 30 months have expired if a court decides that the patent is invalid, unenforceable, or not infringed, or if a court enters a settlement order or consent decree stating the patent is invalid or not infringed.

Notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years certain pharmaceutical companies and others have objected to the FDA's interpretation of Section 505(b)(2). If the FDA's interpretation of Section 505(b)(2) is successfully challenged in court, the FDA may be required to change its interpretation of Section 505(b)(2) which could delay or even prevent the FDA from approving any Section 505(b)(2) NDA that we submit. The pharmaceutical industry is highly competitive, and it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of the new product. Moreover, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.

Marketing Exclusivity. Marketing exclusivity provisions under the FFDCA can delay the submission or the approval of Section 505(b)(2) NDAs, thereby delaying a product approved under Section 505(b)(2) from entering the market. The FFDCA provides five-year marketing exclusivity to the first applicant to gain approval of an NDA for a new chemical entity, or NCE, meaning that the FDA has not previously approved any other drug containing the same active moiety. This exclusivity generally prohibits the submission of a Section 505(b)(2) NDA for any drug product containing the active moiety during the five-year exclusivity period. However, submission of a Section 505(b)(2) NDA that certifies that a listed patent is invalid, unenforceable, or will not be infringed, as discussed above, is permitted after four years. In that case, if a patent infringement lawsuit is brought within 45 days after such certification, FDA approval of the Section 505(b)(2) NDA may automatically be stayed until 7.5 years after the NCE approval date. The FFDCA also provides three years of marketing exclusivity for the approval of new and supplemental NDAs for product changes, including, among other things, new indications, dosage forms, routes of administration or strengths of an existing drug, or for a new use, if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application. Five-year and three-year exclusivity will not delay the submission or approval of another full NDA; however, as discussed above, an applicant submitting a full NDA under Section 505(b)(1) would be required to conduct or obtain a right of reference to all of the preclinical and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Other types of exclusivity in the United States include orphan drug exclusivity and pediatric exclusivity. The FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug. Seven-year orphan drug exclusivity is available to a product that has orphan drug designation and that receives the first FDA approval for the indication for which the drug has such designation. Orphan drug exclusivity prevents approval of another application for the same drug for the same orphan indication, for a period of seven years, regardless of whether the application is a full NDA or a Section 505(b)(2) NDA, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Pediatric exclusivity, if granted, provides an additional six months to an existing exclusivity or statutory delay in approval resulting from a patent certification. This six-month exclusivity, which runs from the end of other exclusivity protection or patent delay, may be granted based on the completion of a pediatric study in accordance with an FDA-issued "Written Request" for such a study.

Section 505(b)(2) NDAs are similar to full NDAs filed under Section 505(b)(1) in that they are entitled to any of these forms of exclusivity if they meet the qualifying criteria. They also are entitled to the patent protections described above, based on patents that are listed in the FDA's Orange Book, in the same manner as patents claiming drugs and uses approved for NDAs submitted as full NDAs.

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Other Regulatory Requirements. Maintaining substantial compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial time and financial resources. Drug manufacturers are required to register their establishments with the FDA and certain state agencies, and after approval, the FDA and these state agencies conduct periodic unannounced inspections to ensure continued compliance with ongoing regulatory requirements, including cGMP. In addition, after approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval. The FDA may require post-approval testing and surveillance programs to monitor safety and the effectiveness of approved products that have been commercialized. Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including:

•record-keeping requirements;

•reporting of adverse experiences with the drug;

•providing the FDA with updated safety and efficacy information;

•reporting on advertisements and promotional labeling;

•drug sampling and distribution requirements; and

•complying with electronic record and signature requirements.

In addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market. There are numerous regulations and policies that govern various means for disseminating information to health-care professionals as well as consumers, including to industry sponsored scientific and educational activities, information provided to the media and information provided over the Internet. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label.

The FDA has very broad enforcement authority and the failure to comply with applicable regulatory requirements can result in administrative or judicial sanctions being imposed on us or on the manufacturers and distributors of our approved products, including warning letters, refusals of government contracts, clinical holds, civil penalties, injunctions, restitution, and disgorgement or profits, recall or seizure of products, total or partial suspension of production or distribution, withdrawal of approvals, refusal to approve pending applications, and criminal prosecution resulting in fines and incarceration. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability. In addition, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

Regulations Outside the United States

In addition to regulations in the United States, we will be subject to a variety of laws and regulations in other jurisdictions governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain the necessary approvals by the comparable regulatory authorities of countries outside the United States before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement also vary between jurisdictions.

To obtain regulatory approval of a drug under European Union regulatory systems, we may submit applications for marketing authorizations either under a centralized or decentralized procedure. The centralized procedure is compulsory for medicines produced by certain biotechnological processes, new active substances indicated for the treatment of certain diseases such as AIDS, cancer, neurodegenerative disorders and diabetes, and products designated as orphan medicinal products, and optional for other new active substances and those products which constitute a significant therapeutic, scientific or technical innovation. The procedure provides for the grant of a single marketing authorization that is valid for all European Union member states, as well as for Iceland, Liechtenstein, and Norway. The decentralized procedure provides for approval by one or more other, or concerned, member states of an assessment of an application performed by one member state, known

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as the reference member state. Under this procedure, an applicant submits an application, or dossier, and related materials including a draft summary of product characteristics, and draft labeling and package leaflet, to the reference member state and concerned member states. The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within 90 days of receiving the reference member state's assessment report, each concerned member state must decide whether to approve the assessment report and related materials. If a member state cannot approve the assessment report and related materials on the grounds of potential serious risk to the public health, the disputed points may eventually be referred to the European Commission, whose decision is binding on all member states.

Competition

The pharmaceutical industry is characterized by intense competition and rapidly evolving technology. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs and drug formulations that target endocrine disorders. If approved, our product candidates will compete against many products with similar indications.

If approved, the primary competition for our ultra-rapid-acting insulin formulations will be rapid-acting mealtime injectable insulins. There are several approved injectable rapid-acting mealtime insulin analogs currently on the market including Humalog®, marketed by Eli Lilly and Company, NovoLog®, marketed by Novo Nordisk, and Apidra®, marketed by Sanofi-Aventis. These rapid-acting insulin analogs provide improvement over regular forms of mealtime insulin, including faster subcutaneous absorption, an earlier and greater insulin peak and more rapid post-peak decrease. Both Humalog® and NovoLog® have limited remaining patent protection in the United States and Europe. The possible introduction of lower priced brands or substitutable generic versions of these products could negatively impact the revenue potential of our ultra-rapid-acting product candidates should any be approved.

In addition, other development stage insulin formulations may be approved and compete with ours. Halozyme Therapeutics, Inc. has conducted a Phase 1 and multiple Phase 2 clinical trials of RHI, lispro (the insulin analog in Humalog®) and aspart (the insulin analog in NovoLog®) in combination with a recombinant human hyaluronidase enzyme and has reported that in each case the combination yielded pharmacokinetics and glucodynamics that better mimicked physiologic mealtime insulin release and activity than RHI, Humalog® or NovoLog® alone. Halozyme is currently conducting a clinical trial with approximately 400 patients examining the effects of a preinfusion of hyaluronidase prior to the use of an insulin pump. In 2011, Eli Lilly partnered with a French biotechnology company, Adocia Inc., to develop an insulin analog that would demonstrate a more rapid onset of action. In 2013, Eli Lilly returned all rights to the program to Adocia. Adocia subsequently announced the start of a clinical trial in support of the development of a pre-mixed prandial/basal insulin. Additionally, Novo Nordisk has reported that they have initiated clinical development of an insulin analog intended to provide faster onset of action than the currently available rapid-acting insulin analogs and that a candidate formulation will enter Phase 3 clinical trials in late 2013.

Several companies are also developing alternative insulin systems for diabetes, including MannKind Corporation, which submitted an NDA in early 2009 for an inhalable insulin product candidate. Mannkind's product candidate was not approved by the FDA and MannKind subsequently conducted and completed two additional Phase 3 clinical trials to support a revised NDA. The primary endpoints were met in both trials, and in October 2013 the FDA accepted the resubmission of an NDA for Mannkind's inhaled insulin product candidate. Approval of an inhaled insulin could reduce the overall market for injectable mealtime insulin.

A stable glucagon presentation for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia would also face significant competition if it were to be commercialized. Eli Lilly and Novo Nordisk currently market injectable glucagon rescue kit products. We are aware of several glucagon rescue product candidates in early stage development, such as a potentially competitive auto-injector device being developed by Enject Corporation that integrates glucagon powder and a diluent into a dual-chamber cartridge within that device. Xeris Corporation is developing an auto-injector utilizing a concentrated, non-aqueous glucagon formulation, which currently being studied in a clinical trial. In addition, other companies with expertise in protein stabilization, including Latitude Pharmaceuticals, have announced that they have

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developed a stable glucagon formulation using FDA-approved injectable ingredients. We believe that an intranasal formulation of glucagon is being studied in one or more clinical trials. All of these programs utilize the same active pharmaceutical ingredient as the stable glucagon presentations that we are developing and offer, or may offer, presentations allowing for room temperature storage. In addition, Eli Lilly, Novo Nordisk and Zealand Pharma A/S, a pharmaceutical company based in Denmark, may be developing glucagon analogs, which may also offer advantages over our stable glucagon presentations.

Intellectual Property and Proprietary Technology

The technologies for our ultra-rapid-acting insulin formulations have been developed exclusively by our employees, without input from third parties.

In October 2007 the United States Patent and Trademark Office issued U.S. Patent No. 7,279,457 encompassing our ultra-rapid-acting insulin formulations. If all maintenance fees are paid, the patent will expire no earlier than January 2026. In addition, a related European Patent, EP 1 740 154, was granted in June 2009 and expires in March 2025 in the designated countries if all annuity fees are paid. Two additional European applications on this technology, EP2 319 500 and EP2 106 790, have been allowed. Related applications have been granted in Australia, Canada and Japan. Additional applications with claims directed to formulations containing insulin, insulin derivatives or analogs are currently pending in the U.S. and foreign patent offices.

Our pending patent applications, those we may file in the future, or those we may license from third parties, may not result in patents being issued.

The individual active and inactive ingredients in our ultra-rapid-acting insulin formulations and our liquid glucagon formulations have been known and used for many years and, therefore, are no longer subject to patent protection, except in proprietary combinations. Accordingly, our patent and pending applications are directed to the particular formulations of these ingredients in our products, and to their use. Although we believe our formulations and their uses are or will be patented and provide a competitive advantage, our patents may not prevent others from marketing formulations using the same active and inactive ingredients in similar but different formulations.

We have entered into an agreement with Aegis Therapeutics, LLC, or Aegis, to acquire an exclusive, sublicensable, worldwide license to the protein stabilization technology that we are using in the development of our liquid glucagon formulations. Under the terms of the agreement, Aegis will prepare, file, prosecute and maintain patents and patent applications that are specific to our liquid glucagon formulations in jurisdictions that we may designate from time to time.

We have entered into a customization and commercial supply agreement with Unilife Medical Solutions, Inc., a wholly owned subsidiary of Unilife Corporation, to acquire an exclusive, sublicensable, worldwide license to a proprietary device platform of dual-chamber devices for use with glucagon. Under the terms of the agreement, Unilife Medical Solutions, Inc. will control the patent protection relating to the devices and be the sole owner of improvements thereto.

We require our employees and consultants to execute confidentiality agreements upon the commencement of employment, consulting or collaborative relationships with us. These agreements provide that all confidential information developed or made known during the course of the relationship with us be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees, the agreements provide that all inventions resulting from work performed for us, utilizing our property or relating to our business and conceived or completed by the individual during employment shall be our exclusive property to the extent permitted by applicable law.

Manufacturing

We do not have the facilities required to manufacture our product candidates for use in clinical trials. Therefore, we intend to manufacture our product candidates by contracting with third parties that operate manufacturing facilities in accordance with cGMP.

We have contracted with N.V. Organon, a global producer of insulin, to supply us with all of the insulin that we will need for the testing and manufacturing of our RHI-based formulations. Our agreement with N.V.

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Organon will terminate in June 2018. We believe that our current supplies of insulin, together with the quantities of insulin called for under our existing supply agreement, will be sufficient to allow us to complete our current and anticipated future clinical trials of our proprietary RHI-based formulations.

With regard to our insulin analog-based formulations, we have entered into an agreement with a pharmaceutical company to acquire a limited supply of an insulin analog for use as the active pharmaceutical ingredient in our proprietary formulations. In addition, we have conducted some development work and all of our clinical trials of our insulin analog-based formulations by combining our proprietary excipients with a marketed presentation of an insulin analog.

We have entered into a commercial supply agreement with Bachem AG, a Swiss corporation, for the supply of all of the glucagon we will need for the testing and manufacturing of our dual-chamber glucagon rescue product candidate and our liquid glucagon formulations. The initial term of our agreement with Bachem AG will expire in July 2017. We believe that the quantities of glucagon that we have rights to acquire under this agreement will be sufficient to allow us to complete our current and anticipated future clinical trials of our glucagon rescue product candidates and to support the commercial launch of our dual-chamber glucagon rescue product candidate.

We have entered into a customization and commercial supply agreement with Unilife Medical Solutions, Inc., a wholly owned subsidiary of Unilife Corporation, to acquire an exclusive, sublicensable, worldwide license to a proprietary device platform of dual-chamber devices for use with glucagon. Under the terms of the agreement, Unilife Medical Solutions, Inc., will develop and be the sole supplier of the device intended for use with our dual-chamber glucagon rescue product candidate. The initial term of our agreement with Unilife Medical Solutions, Inc. will expire in 2028.

Sales and Marketing

We currently have no sales and marketing capabilities and no distribution capabilities. Our current strategy is to selectively enter into collaboration agreements with leading pharmaceutical or biotechnology companies for the commercialization of our product candidates.

Employees

At November 30, 2013 we had 35 full time-employees who perform services for us on a regular basis. We consider our employee relations to be good.

Additional Information

Our website is www.biodel.com. We are not including the information contained on our website as a part of, or incorporating it by reference into, this Annual Report on Form 10-K. We make available free of charge on our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnished it to, the Securities and Exchange Commission. Our reports filed with the Securities and Exchange Commission are also available at the Securities and Exchange Commission's website at www.sec.gov.

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Executive Officers of the Registrant

The following table sets forth our executive officers, their respective ages and positions as of November 30, 2013:

Name	Age	Position
Dr. Errol B. De Souza	60	President and Chief Executive Officer
Gerard Michel	50	Chief Financial Officer
Dr. Alan Krasner	50	Chief Medical Officer
Paul Bavier	41	General Counsel, Chief Compliance Officer and Secretary
Erik Steiner	47	Vice President, Operations

Dr. De Souza joined our management and board of directors in March 2010. Dr. De Souza has over two decades of experience in the biopharmaceutical industry. From March 2009 until March 2010, Dr. De Souza was a pharmaceutical and biotechnology consultant. From April 2003 to January 2009, Dr. De Souza was president and chief executive officer of Archemix Corporation, a privately held biopharmaceutical company focused on aptamer therapeutics. From September 2002 to March 2003, he was president, chief executive officer and a director of Synaptic Pharmaceuticals Corporation, a publicly traded biopharmaceutical company that was acquired by H. Lundbeck A/S in March 2003. Dr. De Souza is a member of the board of directors of each of the following publicly traded companies: Bionomics Ltd. and Targacept, Inc. Dr. De Souza received his B.A. (Honors) in physiology and his Ph.D. in neuroendocrinology from the University of Toronto and he completed his postdoctoral fellowship in neuroscience at The Johns Hopkins University School of Medicine.

Mr. Gerard Michel joined our company in November 2007 as Chief Financial Officer, Vice President of Corporate Development and Treasurer. From October 2003 to November 2007, Mr. Michel served as Chief Financial Officer and from April 2006 to November 2007, Vice President, Corporate Development of NPS Pharmaceuticals, a publicly traded biopharmaceutical company. From June 1995 to July 2002, Mr. Michel served as a Principal of the consulting firm Booz-Allen & Hamilton. From 1988 to 1995, Mr. Michel held various licensing, sales and product management roles at Lederele Labs and Wyeth. Mr. Michel received an MBA and B.S. from The University of Rochester, and an M.S., in Microbiology from The University of Rochester School of Medicine and Dentistry.

Dr. Alan Krasner joined our company in May 2008 as Chief Medical Officer. From 2002 to 2008, Dr. Krasner served as Director in the Department of Clinical Research Metabolic Diseases at Pfizer Global Research and Development where he was responsible for the design, execution, clinical analysis, and reporting of multiple, global clinical trials supporting registration of late stage drug candidates. Dr. Krasner currently serves as a consulting physician at the Joslin Diabetes and Endocrinology Center of the Lawrence and Memorial Hospital in New London, Connecticut. Dr. Krasner holds a B.S. from the Medical Education Honors Program at Northwestern University and an M.D. from Northwestern University Medical School. He completed his residency at Johns Hopkins Hospital in internal medicine and subsequently completed his fellowship at Johns Hopkins Hospital in endocrinology and metabolism.

Mr. Paul Bavier has served as our General Counsel, Chief Compliance Officer and Secretary since December 2013. He served as our General Counsel and Secretary from December 2008 to December 2013. From October 2007 to December 2008, Mr. Bavier served as our Deputy General Counsel. From November 2004 to October 2007, Mr. Bavier served as Assistant General Counsel at Gerber Scientific, Inc. Mr. Bavier began his legal career as an associate in the corporate law department of Ropes & Gray LLP in Boston. He holds a B.A. from Middlebury College and a J. D. from the University of Michigan Law School.

Mr. Erik Steiner co-founded our company and has served as our Vice President, Operations since our inception in December 2003. From February 2003 to December 2003, Mr. Steiner co-founded and served as the Vice President, Operations of Steiner Ventures. From May 1999 to February 2003, Mr. Steiner served as Head of Operations of Cabot McMullen Inc., a film and television production company. Prior thereto, Mr. Steiner served as Administrative Director and Fiscal Administrator of the New Jersey Public Interest Research Group.

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ITEM 1A. RISK FACTORS

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

Since our inception in December 2003, we have incurred significant operating losses. Our net losses were approximately $19.3 million for the fiscal year ended September 30, 2013. As of September 30, 2013, we had a deficit accumulated during the development stage of approximately $215.4 million. We have invested a significant portion of our efforts and financial resources in the development of our ultra-rapid-acting RHI-based insulin product candidates, including our prior Linjeta™ formulation and our current lead formulation, BIOD-123. More recently, we have begun to invest an increasing portion of our efforts and financial resources in the development of our ultra-rapid-acting insulin analog-based formulations, including BIOD-238 and BIOD-250, our concentrated insulin formulations and our stable glucagon presentations.

We expect to continue to incur significant operating losses for at least the next several years as we may:

•conduct clinical trials to study RHI- and insulin analog-based ultra-rapid-acting formulations that may have different pharmacokinetic and pharmacodynamic profiles and be associated with less injection site discomfort than the Linjeta™ formulation;

•conduct additional formulation development work to improve the stability, pharmacokinetic, and pharmacodynamic properties of our ultra-rapid-acting insulin analog-based formulations, our concentrated insulin formulations and our liquid glucagon formulations, or purchase rights related to proprietary technologies that are compatible with our product candidates;

•conduct the development work necessary to finalize the formulation and design of our dual-chamber glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of an NDA to the FDA for that product candidate;

•conduct later stage clinical trials of our ultra-rapid-acting insulin formulations and a stable glucagon presentation, including one or more pivotal clinical trials required for FDA approval of the NDAs;

•produce validation and registration batches of our product candidates to support one or more NDAs;

•conduct the required stability, preclinical and human factors and user acceptability studies to support the approval of one or more insulin pen and glucagon injection devices intended for use with our product candidates;

•purchase active pharmaceutical ingredients and other materials consistent with our existing contractual obligations; and

•conduct clinical development of our other product candidates.

To become and remain profitable, we must succeed in developing and eventually commercializing drugs with significant market potential. This will require us to be successful in a range of challenging activities, including developing proprietary insulin and glucagon product candidates with desirable pharmacokinetic, pharmacodynamic, stability and injection site toleration characteristics and then successfully completing preclinical testing and clinical trials for these formulations, obtaining regulatory approval for these formulations and manufacturing, marketing and selling those products for which we may obtain regulatory approval. We may never succeed in these activities and may never generate revenues that are significant or large enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable could depress the market price of our common stock and could impair our ability to raise capital, expand our business or continue our operations. A decline in the market price of our common stock could also cause you to lose all or a part of your investment.

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We will need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts.

We are a development stage company with no commercial products. All of our product candidates are in early stages of development. Our product candidates will require significant additional clinical development, regulatory approvals and related investment before they can be commercialized. We expect to continue to incur significant research and development expenses as we continue our formulation work and advance these programs through clinical trials. Unless we are successful in consummating a strategic partnership to develop and commercialize an ultra-rapid-acting RHI- or insulin analog-based formulation or a stable glucagon presentation, we may need to raise substantial additional capital to develop and commercialize competitive products. Such financing may not be available on terms acceptable to us, or at all. If we are unable to obtain financing on favorable terms, our business, results of operations and financial condition may be materially adversely affected.

Based upon our current plans, we believe that our existing cash, cash equivalents and restricted cash will be sufficient to fund our anticipated operating expenses and capital expenditures through the second calendar quarter of 2015. However, we cannot assure you that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate. Our future capital requirements will depend on many factors, including:

•the progress, timing or success of our research and development and clinical programs for our product candidates;

•the degree to which our ongoing assessment of the data from our recently completed Phase 2 clinical trial of BIOD-123, our lead candidate for an ultra-rapid-acting insulin formulation, and our related chemistry, manufacturing and controls development work, support further clinical development by us or our potential partners;

•our ability to successfully use the data from our Phase 2 clinical trial of BIOD-123 to design and conduct the pivotal clinical trials required by the FDA to secure approval to commercialize that candidate;

•the success of our formulation development work to improve the stability of our newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations;

•our ability to conduct the development work necessary to finalize the formulation and design of our dual-chamber glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of an NDA to the FDA for that product candidate;

•the results of our real-time stability programs for our RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our ultra-rapid-acting RHI- and insulin analog-based product candidates or our glucagon rescue product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

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•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;

•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to produce our products in our final dosage form;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization one or more product candidates;

•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through public or private equity offerings and debt financings, strategic collaborations and licensing arrangements. If we raise additional funds by issuing additional equity securities, our stockholders will experience dilution. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. If we raise additional funds through collaboration, strategic alliance or licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.

Our short operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We commenced active operations in January 2004. Our operations to date have been limited to organizing and staffing our company, developing and securing our technology and undertaking preclinical studies and clinical trials of our product candidates. We have limited experience completing large-scale, pivotal clinical trials and we have not yet demonstrated our ability to obtain regulatory approval to market a product, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We may need to transition from a company with a research focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

Risks Related to the Development and Commercialization of Our Product Candidates

We have depended heavily on the success of our ultra-rapid-acting mealtime insulin development program.

We have invested a significant portion of our efforts and financial resources in the development of our ultra-rapid-acting insulin product candidates. The FDA concluded that the results from our completed pivotal Phase 3 clinical trials of Linjeta™ were not sufficient to obtain marketing approval for the Linjeta™ formulation, and we chose to advance new formulations into the clinic. Clinical trials of our first two new RHI-based formulations, BIOD-105 and BIOD-107, did not achieve satisfactory results. If we are not able to develop alternative RHI- or insulin-analog based formulations with desirable pharmacokinetic, pharmacodynamic, stability and injection site toleration characteristics, or experience significant delays in doing so, then our business may be materially harmed.

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BIOD-123, our lead candidate for an ultra-rapid-acting RHI-based formulation, achieved the primary endpoint of noninferiority for HbA1c relative to Humalog® in a Phase 2 clinical, and patients in the two treatment groups demonstrated comparable results with regard to secondary endpoints, including weight gain, mean hypoglycemia event rates and postprandial glucose excursions. However, to date, we cannot conclude from our analysis of the data from the Phase 2 clinical trial that BIOD-123 will be shown to be clinically superior to existing rapid-acting insulin analogs in subsequent clinical trials. While evidence of superiority is not required to receive the FDA's approval to market BIOD-123, if we are unable to demonstrate clinical superiority to a rapid-acting analog in one or more secondary end points, such as weight gain, hypoglycemia event rates and postprandial glucose control, the commercial success of BIOD-123, as well as the interest of potential strategic partners, may be limited.

Our development of an RHI- or insulin analog-based formulation may not be successful; some formulations may have different regulatory requirements to obtain marketing approval from the FDA.

While we have significant experience with the technology we use to develop ultra-rapid-acting insulin formulations, our insulin-analog based formulations and concentrated RHI-based formulations are in early stages of development. Furthermore, we have manufactured only a small number of batches of BIOD-123 that we can use to project stability characteristics in a commercial scale manufacturing process, and we have observed that our most recent batches of BIOD-123 have not performed as well as earlier batches in our stability studies. We cannot assure you that our program to advance RHI- or insulin analog-based formulations will demonstrate pharmacokinetic, pharmacodynamic, stability and injection site toleration characteristics that are acceptable to us, a potential strategic partner or the FDA.

The regulatory requirements for any of our newer ultra-rapid-acting insulin formulations may not meet our expectations or may be different from those applicable to Linjeta™. For example, any concentrated insulin formulation we develop may be impacted by concerns about concentrated insulins in general, such as the risk that a patient would administer an incorrect dose of insulin that would induce severe hypoglycemia. Additionally, while BIOD-238 and BIOD 250, which were formulated by adding our proprietary excipients to the marketed presentation of Humalog®, were the subject of a Phase 1 clinical trial in Australia, we expect that we would need to conduct toxicology studies before advancing our insulin analog-based formulations into a Phase 1 clinical trial in the United States.

We have limited experience with developing pharmaceutical preparations of glucagon.

Our experience with the manufacture, testing and analysis of pharmaceutical preparations of glucagon in preclinical studies is limited, and we have not yet conducted any clinical trials using glucagon as an active pharmaceutical ingredient. Because of our limited experience, we may be unable to accurately anticipate the technical challenges that we may face in the development of a glucagon rescue product. For example, due to inconsistent results that we observed in our product candidate screening studies for a liquid glucagon formulation in the fourth calendar quarter of 2012, we decided to focus more of our resources in calendar year 2013 on developing our dual-chamber glucagon rescue product candidate.

The results of preclinical testing and clinical trials do not ensure success in future clinical trials or commercial success.

We have completed and released the results of our two pivotal Phase 3 clinical trials of Linjeta™. We have not completed the development of any products through commercialization. In October 2010, the FDA notified us that it would not approve our NDA for the Linjeta™ formulation, and we subsequently advanced alternate formulations, including BIOD-105, BIOD-107, BIOD-123, BIOD-125, BIOD-238 and BIOD-250 into the clinic and discontinued development of earlier formulations of Linjeta™. The outcomes of preclinical testing and clinical trials of prior formulations of Linjeta™ may not be predictive of the success of clinical trials with current or future formulations of our RHI- or insulin analog-based formulations. For example, despite promising preclinical data, BIOD-105 and BIOD-107 did not meet our preferred target product profile in Phase 1 clinical trials, and we discontinued development of these formulations. In addition, while the tolerability profile of BIOD-123 in a small Phase 1 clinical trial was comparable to that of Humalog®, in the recently completed Phase 2 clinical trial of BIOD-123, patients using BIOD-123 reported more incidences of injection site pain than those using Humalog®. We cannot assure you that the clinical trials of any of our RHI- or insulin analog-based formulations will ultimately be successful. New information regarding the safety, efficacy, toleration and stability of our RHI- or insulin analog-based formulations may arise that may be less favorable than the data observed to date.

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If we are not successful in commercializing any of our product candidates, or are significantly delayed in doing so, our business will be materially harmed. The commercial success of our product candidates will depend on several factors, including the following:

•successful completion of preclinical development and clinical trials;

•our ability to identify and enroll patients who meet clinical trial eligibility criteria;

•receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States;

•establishing that, with regard to an RHI- or insulin analog based-formulation, the formulation is well-tolerated in chronic use;

•establishing that, with regard to a stable glucagon presentation for use as a rescue product, the commercial presentation can be administered effectively by patient caregivers with limited or no training;

•establishing and maintaining commercial manufacturing capabilities and supplies of active pharmaceutical ingredients through arrangements with third-party manufacturers;

•launching commercial sales of the products, whether alone or in collaboration with others;

•competition from other products; and

•continued acceptable safety profiles of the products following approval.

If our clinical trials are delayed or do not produce positive results, we may incur additional costs and ultimately be unable to commercialize our product candidates.

Before obtaining regulatory approval for the sale of our product candidates, we must conduct, at our own expense, extensive preclinical tests to demonstrate the safety of our product candidates in animals and clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials of ultra-rapid-acting insulin formulations or stable glucagon presentations can occur at any stage of testing. We may experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates, including:

•the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we currently anticipate, or participants may drop out of our clinical trials at a higher rate than we anticipate, any of which would result in significant delays;

•our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;

•we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;

•regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;

•the cost of our clinical trials may be greater than we anticipate;

•the supply, stability or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate; and

•the effects of our product candidates may not be the desired effects, may include undesirable side effects or the product candidates may have other unexpected characteristics.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

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•be delayed in obtaining or discontinue our efforts to obtain marketing approval;

•not be able to obtain marketing approval;

•obtain approval for indications that are not as broad as intended; or

•have the product removed from the market after obtaining marketing approval.

Our product development costs will also increase if we experience delays in testing or approvals. We do not know whether any preclinical tests or clinical trials will begin as planned, will need to be redesigned or will be completed on schedule, if at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to commercialize our products or product candidates and may harm our business and results of operations.

If our product candidates are found to cause undesirable side effects we may need to delay or abandon our development and commercialization efforts.

Any undesirable side effects that might be caused by our product candidates could interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications. In addition, if any of our product candidates receive marketing approval and we or others later identify undesirable side effects caused by the product, we could face one or more of the following:

•a change in the labeling statements or withdrawal of FDA or other regulatory approval of the product;

•a change in the way the product is administered; or

•the need to conduct additional clinical trials.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase the costs and expenses of commercializing the product, which in turn could delay or prevent us from generating significant revenues from its sale.

The commercial success of any product candidates that we may develop will depend upon the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community.

Any products that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. Physicians will not recommend our product candidates until clinical data or other factors demonstrate the safety and efficacy of our product candidates as compared to other treatments. Even if the clinical safety and efficacy of our product candidates are established, physicians may elect not to recommend these product candidates for a variety of reasons including the reimbursement policies of government and third-party payors, the effectiveness of our competitors in marketing their products and the possibility that patients may experience more injection site discomfort than they experience with competing products.

The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

•the willingness and ability of patients and the healthcare community to adopt our products;

•the ability to manufacture our product candidates in sufficient quantities with acceptable quality and to offer our product candidates for sale at competitive prices;

•the perception of patients and the healthcare community, including third-party payors, regarding the safety, efficacy and benefits of our product candidates compared to those of competing products or therapies;

•the convenience and ease of administration of our product candidates relative to existing treatment methods;

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•the label and promotional claims allowed by the FDA, such as, in the case of an RHI- or insulin analog-based formulation, claims relating to glycemic control, hypoglycemia, weight gain, injection site discomfort, insulin pump compatibility, expiry dating and required handling conditions;

•the pricing and reimbursement of our product candidates relative to existing treatments; and

•marketing and distribution support for our product candidates.

Our ultra-rapid-acting insulin formulations have not yet been shown to be clinically superior to existing rapid-acting insulin analogs. It may be difficult for us to demonstrate superiority in the future because we anticipate that the primary endpoint of any pivotal clinical trial that we might conduct with an ultra-rapid-acting insulin product candidate would be non-inferiority to the comparator drug product. Furthermore, while BIOD-123 demonstrated a safety profile comparable to Humalog® in our Phase 2 clinical trial, we observed an increased frequency of injection site pain associated with BIOD-123. In all cases, the injection site pain appeared to be clinically minor, short-lived and distinctly superior to the toleration profile we observed with Linjeta™ in our earlier Phase 3 clinical trial. However, uncertainty with regard to the injection site toleration characteristics of BIOD-123 in larger scale clinical trials or upon commercialization, if approved by the FDA, may limit the appeal of this product candidate.

We are aware of other companies with expertise in protein stabilization that are developing stable glucagon presentations. If these formulations are easier to use than any product that we may develop, such as by allowing for room temperature storage in a smaller or more convenient device, our products, even if approved by the FDA, may not achieve commercial success.

The successful development of our product candidates may depend upon our ability to collaborate with or license technology from third parties.

Our ultra-rapid-acting insulin analog-based formulations and our stable glucagon presentations are at early stages of development. In order for us to meet our projected milestones for these programs, we must obtain reliable sources of active pharmaceutical ingredients and other related materials and supplies. Our leading candidates for a stable glucagon presentation are dependent upon licenses we have obtained to proprietary third-party technology, including the license we have obtained from Unilife Medical Solutions, Inc., a wholly owned subsidiary of Unilife Corporation, for a dual-chamber reconstitution device. The termination of these licenses may materially harm our efforts to commercialize a glucagon rescue product. We may also continue to study additional third-party proprietary stabilization technologies for use in these programs. Even if these studies are successful, we cannot assure you that we will be able to license any third-party technologies on terms that would be acceptable to us.

If we fail to enter into strategic collaborations for the commercialization of our product candidates or if our collaborations are unsuccessful, we may be delayed in our commercialization efforts; we may be required to establish our own sales, marketing, manufacturing and distribution capabilities which will be expensive, require additional capital we do not currently have, and could delay the commercialization of our product candidates and have a material and adverse effect on our business; we cannot commercialize our insulin analog-based formulations until all applicable third-party patents have expired.

A broad base of physicians, including primary care physicians, internists and endocrinologists, treat patients with diabetes. A large sales force may be required to educate and support these physicians. In addition, we cannot commercialize on our own any insulin analog-based formulation in the United States until 2014 at the earliest, when the patents covering the currently marketed insulin analogs first begin to expire. Therefore, our current strategy for developing, manufacturing and commercializing our product candidates includes securing collaborations with leading pharmaceutical and biotechnology companies, including those that hold patents covering the currently marketed insulin analogs. To date, we have not entered into any out-licensing collaborations with pharmaceutical or biotechnology companies. We face significant competition in seeking appropriate collaborators. In addition, collaboration agreements are complex and time-consuming to negotiate, document and implement. For all these reasons, it may be difficult for us to find third parties that are willing to enter into collaborations on economic terms that are favorable to us, or at all. Even if we do enter into any such collaboration, the collaboration may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. It is likely that our collaborators will have significant discretion in determining the efforts and resources that they will apply to these collaborations.

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If we fail to enter into collaborations, or if our collaborations are unsuccessful, we may be required to establish our own direct sales, marketing, manufacturing and distribution capabilities. Establishing these capabilities can be time-consuming and expensive and we have little experience in doing so. Because of our size, we would be at a disadvantage to our potential competitors to the extent they collaborate with large pharmaceutical companies that have substantially more resources than we do. As a result, we would not initially be able to field a sales force as large as our competitors or provide the same degree of market research or marketing support. In addition, our competitors would have a greater ability to devote research and development resources toward expansion of the indications for their products. We cannot assure our investors that we will succeed in entering into acceptable collaborations, that any such collaboration will be successful or, if not, that we will successfully develop our own sales, marketing and distribution capabilities.

If we are unable to obtain adequate reimbursement from governments or third-party payors for any products that we may develop or if we are unable to obtain acceptable prices for those products, they may not be purchased or used and our revenues and prospects for profitability will suffer.

Our future revenues and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved product candidates from governmental and other third-party payors, both in the United States and in other markets. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor's determination that use of a product is:

•a covered benefit under its health plan;

•safe, effective and medically necessary;

•appropriate for the specific patient;

•cost-effective; and

•neither experimental nor investigational.

Obtaining reimbursement approval for a product from each government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to each payor. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement. Even when a payor determines that a product is eligible for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable authorities. In addition, eligibility for coverage does not imply that any product will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs.

Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

•decreased demand for any product candidates or products that we may develop;

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•injury to our reputation;

•withdrawal of clinical trial participants;

•costs to defend the related litigation;

•substantial monetary awards to trial participants or patients;

•loss of revenue; and

•the inability to commercialize any products that we may develop.

We currently carry global liability insurance that we believe is sufficient to cover us from potential damages arising from past or future clinical trials of our ultra-rapid-acting insulin formulations and other product candidates that we may advance into the clinic. The amount of insurance that we currently hold may not be adequate to cover all liabilities that we may incur. We intend to expand our insurance coverage to include the sale of commercial products if we obtain marketing approval for any products. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost. If losses from product liability claims exceed our liability insurance coverage, we may ourselves incur substantial liabilities. If we are required to pay a product liability claim, we may not have sufficient financial resources to complete development or commercialization of any of our product candidates and, if so, our business and results of operations would be harmed.

We face substantial competition in the development of our product candidates which may result in others developing or commercializing products before or more successfully than we do.

We are engaged in segments of the pharmaceutical industry that are characterized by intense competition and rapidly evolving technology. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs that target endocrine disorders. We face, and expect to continue to face, intense and increasing competition as new products enter the market and advanced technologies become available. There are several approved injectable rapid-acting mealtime insulin analogs currently on the market including Humalog®, marketed by Eli Lilly and Company, NovoLog®, marketed by Novo Nordisk, and Apidra®, marketed by Sanofi-Aventis. These rapid-acting insulin analogs provide improvement over regular forms of mealtime insulin, including faster subcutaneous absorption, an earlier and greater insulin peak and more rapid post-peak decrease. Both Humalog® and NovoLog® have limited remaining patent protection in the United States and Europe. The possible introduction of lower priced brands or substitutable generic versions of these products could negatively impact the revenue potential of our ultra-rapid-acting product candidates should any be approved.

In addition, other development stage insulin formulations may be approved and compete with ours. Halozyme Therapeutics, Inc. has conducted a Phase 1 and multiple Phase 2 clinical trials of RHI, lispro (the insulin analog in Humalog®) and aspart (the insulin analog in NovoLog®) in combination with a recombinant human hyaluronidase enzyme and has reported that in each case the combination yielded pharmacokinetics and glucodynamics that better mimicked physiologic mealtime insulin release and activity than RHI, Humalog® or NovoLog® alone. Halozyme is currently conducting a clinical trial with approximately 400 patients examining the effects of a preinfusion of hyaluronidase prior to the use of an insulin pump. In 2011, Eli Lilly partnered with a French biotechnology company, Adocia Inc., to develop an insulin analog that would demonstrate a more rapid onset of action. In 2013, Eli Lilly returned all rights to the program to Adocia. Adocia subsequently announced the start of a clinical trial in support of the development of a pre-mixed prandial/basal insulin. Additionally, Novo Nordisk has reported that they have initiated clinical development of an insulin analog intended to provide faster onset of action than the currently available rapid-acting insulin analogs and that a candidate formulation will enter Phase 3 clinical trials in late 2013.

Several companies are also developing alternative insulin systems for diabetes, including MannKind Corporation, which submitted an NDA in early 2009 for an inhalable insulin product candidate. Mannkind's product candidate was not approved by the FDA and MannKind subsequently conducted and completed two additional Phase 3 clinical trials to support a revised NDA. The primary endpoints were met in both trials, and in October 2013 the FDA accepted the resubmission of an NDA for Mannkind's inhaled insulin product candidate. Approval of an inhaled insulin could reduce the overall market for injectable mealtime insulin.

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A stable glucagon presentation for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia would also face significant competition if it were to be commercialized. Eli Lilly and Novo Nordisk currently market injectable glucagon rescue kit products. We are aware of several glucagon rescue product candidates in early stage development, such as a potentially competitive auto-injector device being developed by Enject Corporation that integrates glucagon powder and a diluent into a dual-chamber cartridge within that device. Xeris Corporation is developing an auto-injector utilizing a concentrated, non-aqueous glucagon formulation, which currently being studied in a clinical trial. In addition, other companies with expertise in protein stabilization, including Latitude Pharmaceuticals, have announced that they have developed a stable glucagon formulation using FDA-approved injectable ingredients. We believe that an intranasal formulation of glucagon is being studied in one or more clinical trials. All of these programs utilize the same active pharmaceutical ingredient as the stable glucagon presentations that we are developing and offer, or may offer, presentations allowing for room temperature storage. In addition, Eli Lilly, Novo Nordisk and Zealand Pharma A/S, a pharmaceutical company based in Denmark, may be developing glucagon analogs, which may also offer advantages over our stable glucagon presentations.

Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. Our competitors may develop products that are more effective, safer, more convenient or less costly than any that we are developing or that would render our product candidates obsolete or non-competitive. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours.

Many of our potential competitors have:

•significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize product candidates;

•more extensive experience in preclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products;

•product candidates that have been approved or are in late-stage clinical development; or

•collaborative arrangements in our target markets with leading companies and research institutions.

Our product candidates may be rendered obsolete by technological change.

The rapid rate of scientific discoveries and technological changes could result in one or more of our product candidates becoming obsolete or noncompetitive. For several decades, scientists have attempted to improve the bioavailability of injected formulations and to devise alternative non-invasive delivery systems for the delivery of drugs such as insulin. Our product candidates will compete against many products with similar indications. Our future success will depend not only on our ability to develop our product candidates, but also on our ability to maintain market acceptance against emerging industry developments. We cannot assure current or prospective stockholders that we will be able to do so.

Our business activities involve the storage and use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences.

Our research and development work and manufacturing processes involve the controlled storage and use of hazardous materials, including chemical and biological materials. Our operations also produce hazardous waste products. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials. Although we believe that our safety procedures for handling and disposing of such materials and waste products comply in all material respects with the standards prescribed by federal, state and local laws and regulations, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident or failure to comply with environmental laws, we could be held liable for any damages that may result, and any such liability could fall outside the coverage or exceed the limits of our insurance. In addition, we could be required to incur significant costs to comply with environmental laws and regulations in the future or pay substantial fines or penalties if we violate any of these laws or regulations. Finally, current or future environmental laws and regulations may impair our research, development or production efforts.

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Risks Related to Our Dependence on Third Parties

Use of third parties to manufacture our product candidates may increase the risks that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, or that our contract manufacturers will not be able to manufacture our products in their final dosage form. In any such case, clinical development and commercialization of our product candidates could be delayed, prevented or impaired.

We do not currently own or operate manufacturing facilities for commercial production of our product candidates. We have limited experience in drug manufacturing and we lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale. Our current strategy is to outsource to third parties all of the manufacturing required for our product candidates, including the dual-chamber reconstitution device for use with our glucagon rescue product candidate. We also expect to rely upon third parties to produce materials required for the commercial production of our product candidates if we succeed in obtaining necessary regulatory approvals.

We have recently relied on the University of Iowa to manufacture our ultra-rapid-acting product candidates, but we do not have any commercial manufacturing agreements in place with third parties to support these product candidates. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates or products ourselves, including:

•reliance on the third party for regulatory compliance and quality assurance;

•the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and

•the possible refusal by or inability of the third party to support our manufacturing programs in a time frame that we would otherwise prefer.

Our manufacturers may not be able to comply with current good manufacturing practice, or cGMP, regulations or other regulatory requirements or similar regulatory requirements outside the United States. Our manufacturers are subject to unannounced inspections by the FDA, state regulators and similar regulators outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates.

Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If the third parties that we engage to manufacture product for our clinical trials should cease to continue to do so for any reason, we likely would experience delays in advancing these trials while we identify and qualify replacement suppliers and we may be unable to obtain replacement supplies on terms that are favorable to us. In addition, if we are not able to obtain adequate supplies of our product candidates or the drug substances used to manufacture them, it will be more difficult for us to develop our product candidates and compete effectively.

Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop product candidates and commercialize any products that receive regulatory approval on a timely and competitive basis.

We rely on third parties for design and engineering expertise relating to the development of devices we may use to administer the pharmaceutical preparations of our product candidates.

The success of certain of our product candidates is likely to depend heavily on the design of the devices being used for the administration of our pharmaceutical preparations. For example, while the dual-chamber reconstitution device we intend to use with our leading glucagon rescue product candidate is based on an existing technology platform developed by Unilife Corporation, the device is being customized by Unilife

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Medical Solutions, Inc., a wholly owned subsidiary of Unilife Corporation, for use in an emergency situation. We do not have internal engineering expertise relating to medical devices, and we therefore rely on Unilife Medical Solutions, Inc. to provide such expertise. If our collaboration with Unilife Medical Solutions, Inc. is not successful in this regard, our program to develop a glucagon rescue product will be materially harmed. Additionally, in order to maximize the commercial potential of our ultra-rapid-acting insulin product candidates, we will likely depend on one or more manufacturers of insulin pen injection devices to supply us with a commercially acceptable device. To date, we have not entered into any agreements for the supply of insulin pen injection devices and we cannot assure you that any such devices will be available on terms that will be acceptable to us, if at all.

We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet established timelines for the completion of such trials.

We do not independently conduct clinical trials of our product candidates. We rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions and clinical investigators, to enroll qualified patients and conduct our clinical trials. Our reliance on these third parties for clinical development activities reduces our control over these activities. We are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.

If our suppliers of active pharmaceutical ingredients and other production materials fail to deliver materials and provide services needed for the production of our ultra-rapid-acting insulin formulations or our stable glucagon presentations in a timely and sufficient manner, or if they fail to comply with applicable regulations, clinical development or regulatory approval of our product candidates, commercialization of our products could be delayed, producing additional losses and depriving us of potential product revenue.

We need access to sufficient, reliable and affordable supplies of insulin, glucagon and other materials, such as vials, cartridges, prefilled syringes and, potentially, drug injection devices, for which we rely on various suppliers. We also must rely on those suppliers to comply with relevant regulatory and other legal requirements, including the production of insulin and glucagon in accordance with cGMP. We can make no assurances that our suppliers will comply with cGMP.

We have entered into an agreement with our existing RHI supplier from which we obtain all of the RHI that we use for testing and manufacturing our RHI-based formulations. In July 2011, we amended our agreement with this insulin supplier so that the agreement will terminate in June 2018.

We believe that our current supplies of RHI, together with the quantities of RHI called for under our existing supply agreement, will be sufficient to allow us to complete the full development program required by the FDA in order to receive approval to market an RHI-based formulation if we are successful in developing one. If we are unable to procure sufficient quantities of insulin from our current or any future supplier, if supply of RHI and other materials otherwise becomes limited, or if our suppliers do not meet relevant regulatory requirements, and if we were unable to obtain these materials in sufficient amounts, in a timely manner and at reasonable prices, we could be delayed in the manufacturing and possible commercialization of an ultra-rapid-acting insulin, which may have a material adverse effect on our business. We would incur substantial costs and manufacturing delays if our suppliers are unable to provide us with products or services approved by the FDA or other regulatory agencies.

We have entered into a commercial supply agreement with a third party for the supply of glucagon that we intend to use in the manufacture of our glucagon rescue product candidate. However, we have not

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purchased significant quantities of glucagon from this third-party supplier and we do not anticipate doing so prior to the manufacture of validation batches of a proposed commercial product. Additionally, we have agreed to purchase an excipient used to stabilize one of our glucagon rescue candidate formulations from a third-party that has licensed its proprietary stabilization technologies to us. If this third-party is unable to supply us with sufficient quantities of the stabilizing excipient, our development program for a stable glucagon presentation may be materially harmed.

Apart from our agreement with Unilife Medical Solutions, Inc. for the supply of its dual-chamber reconstitution device, we have not entered into any long-term or exclusive agreements for the supply of one or more insulin analogs or injection devices, some or all of which we would need to procure in significant quantities if we were to commercialize any of our product candidates.

Risks Related to Our Intellectual Property

If we are unable to protect our intellectual property rights, our competitors may develop and market similar or identical products that may reduce demand for our products, and we may be prevented from establishing collaborative relationships on favorable terms.

The following factors are important to our success:

•receiving patent protection for our product candidates;

•maintaining our trade secrets;

•not infringing on the proprietary rights of others; and

•preventing others from infringing on our proprietary rights.

We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. We try to protect our proprietary position by filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development of our business. Because the patent position of pharmaceutical companies involves complex legal and factual questions, the issuance, scope and enforceability of patents cannot be predicted with certainty. Patents, if issued, may be challenged, invalidated or circumvented. Thus, any patents that we own or license from others may not provide any protection against competitors.

In June 2012, we entered into an agreement with Aegis Therapeutics, LLC, or Aegis, to acquire an exclusive, sub-licensable, worldwide license to the protein stabilization technology that we are using in the development of our stable liquid glucagon formulations. Under the terms of the agreement, Aegis will prepare, file, prosecute and maintain patents and patent applications that are specific to our stable glucagon presentations in jurisdictions that we may designate from time to time.

In April 2013, we entered into a customization and commercial supply agreement with Unilife Medical Solutions, Inc., a wholly owned subsidiary of Unilife Corporation, to acquire an exclusive, sub-licensable, worldwide license to a proprietary device platform of dual-chamber devices for use with glucagon. Under the terms of the agreement, Unilife Medical Solutions, Inc. will be the sole owner of improvements to the dual-chamber devices developed under the agreement and any attendant intellectual property rights.

Our pending patent applications, those we may file in the future, or those we may license from third parties, may not result in patents being issued. If patents do not issue with claims encompassing our products, our competitors may develop and market similar or identical products that compete with ours. Even if patents are issued, they may not provide us with proprietary protection or competitive advantages against competitors with similar technology. Failure to obtain effective patent protection for our technology and products may reduce demand for our products and prevent us from establishing collaborative relationships on favorable terms.

The individual active and inactive ingredients in our ultra-rapid-acting insulin formulations and our stable glucagon presentations have been known and used for many years and, therefore, are no longer subject to patent protection, except in proprietary combinations. Accordingly, our patent and pending applications are directed to the particular formulations of these ingredients in our products, and to their use. Although we

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believe our formulations and their uses are or will be patented and provide a competitive advantage, our patents may not prevent others from marketing formulations using the same active and inactive ingredients in different combinations.

The individual active and inactive ingredients in our dual-chamber glucagon rescue product candidate have been known and used for many years and, therefore, are no longer subject to patent protection. As a result, the commercial success of this product candidate, if approved, will depend heavily on the patent protection afforded to the device developed and controlled by Unilife Medical Solutions, Inc.

We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. We try to protect this information by entering into confidentiality agreements with parties that have access to it, such as potential corporate partners, collaborators, employees and consultants. Any of these parties may breach the agreements and disclose our confidential information or our competitors may learn of the information in some other way. Furthermore, others may independently develop similar technologies or duplicate any technology that we have developed. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.

The laws of many foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States. Accordingly, the fact that we have obtained certain patent rights in the United States does not guarantee that we will be able to obtain the same or similar rights elsewhere. Even if we are granted patents in foreign countries, we cannot guarantee that we will be able to enforce our rights effectively.

We may become involved in lawsuits and administrative proceedings to protect, defend or enforce our patents that would be expensive and time-consuming.

In order to protect or enforce our patent rights, we may initiate patent litigation against third parties in the United States or in foreign countries. In addition, we may be subject to certain opposition proceedings conducted in patent and trademark offices challenging the validity of our patents and may become involved in future opposition proceedings challenging the patents of others. For example, in late July 2013, a third party initiated administrative proceedings to oppose two of our more recent patents that have been granted by the European Patent Office in connection with our ultra-rapid-acting insulin formulations. While an earlier issued European patent covers technologies fundamental to our ultra-rapid-acting insulin formulations, the more recent patents may offer additional protections against potential competitors. The defense of intellectual property rights, including patent rights, through lawsuits, interference or opposition proceedings, and other legal and administrative proceedings can be costly and can divert our technical and management personnel from their normal responsibilities. Such costs increase our operating losses and reduce our resources available for development activities. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. For example, during the course of this kind of litigation and despite protective orders entered by the court, confidential information may be inadvertently disclosed in the form of documents or testimony in connection with discovery requests, depositions or trial testimony. This disclosure could materially adversely affect our business and financial results.

Claims by other parties that we infringe or have misappropriated their proprietary technology may result in liability for damages, royalties, or other payments, or stop our development and commercialization efforts.

Competitors and other third parties may initiate patent litigation against us in the United States or in foreign countries based on existing patents or patents that may be granted in the future. Many of our competitors may have obtained patents covering products and processes generally related to our products and processes, and they may assert these patents against us. Moreover, there can be no assurance that these competitors have not sought or will not seek additional patents that may cover aspects of our technology. As a result, there is a greater likelihood of a patent dispute than would be expected if our competitors were pursuing unrelated technologies.

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While we conduct patent searches to determine whether the technologies used in our products infringe patents held by third parties, numerous patent applications are currently pending and may be filed in the future for technologies generally related to our technologies, including many patent applications that remain confidential after filing. Due to these factors and the inherent uncertainty in conducting patent searches, there can be no guarantee that we will not violate third-party patent rights that we have not yet identified.

There may be U.S. and foreign patents issued to third parties that relate to aspects of our product candidates. There may also be patent applications filed by these or other parties in the United States and various foreign jurisdictions that relate to some aspects of our product candidates, which, if issued, could subject us to infringement actions. The owners or licensees of these and other patents may file one or more infringement actions against us. In addition, a competitor may claim misappropriation of a trade secret by an employee hired from that competitor. Any such infringement or misappropriation action could cause us to incur substantial costs defending the lawsuit and could distract our management from our business, even if the allegations of infringement or misappropriation are unwarranted. A need to defend multiple actions or claims could have a disproportionately greater impact. In addition, either in response to or in anticipation of any such infringement or misappropriation claim, we may enter into commercial agreements with the owners or licensees of these rights. The terms of these commercial agreements may include substantial payments, including substantial royalty payments on revenues received by us in connection with the commercialization of our products.

Payments under such agreements could increase our operating losses and reduce our resources available for development activities. Furthermore, a party making this type of claim could secure a judgment that requires us to pay substantial damages, which would increase our operating losses and reduce our resources available for development activities. A judgment could also include an injunction or other court order that could prevent us from making, using, selling, offering for sale or importing our products or prevent our customers from using our products. If a court determined or if we independently concluded that any of our products or manufacturing processes violated third-party proprietary rights, our clinical trials could be delayed and there can be no assurance that we would be able to reengineer the product or processes to avoid those rights, or to obtain a license under those rights on commercially reasonable terms, if at all.

Risks Related to Regulatory Approval of Our Product Candidates

If the FDA does not believe that our product candidates satisfy the requirements for the Section 505(b)(2) approval procedure, or if the requirements for our product candidates under Section 505(b)(2) are not as we expect, the approval pathway will take longer and cost more than anticipated and in either case may not be successful.

We believe our ultra-rapid-acting insulin formulations and our stable glucagon presentation for use as a rescue product qualify for approval under Section 505(b)(2) of the FFDCA. Because we are developing new formulations of previously approved chemical entities, such as insulin and glucagon, our drug approval strategy is to submit Section 505(b)(2) NDAs to the FDA. We plan to pursue similar routes for submitting applications for our product candidates in foreign jurisdictions if available. The FDA may not agree that our product candidates are approvable pursuant to Section 505(b)(2) NDAs. There is no specific guidance available for Section 505(b)(2) NDAs for insulin or glucagon. In addition, while there is precedent for a glucagon product being approved under a Section 505(b)(2) NDA, we are not aware of any insulin product that has been approved under a Section 505(b)(2) NDA. If the FDA determines that Section 505(b)(2) NDAs are not appropriate and that full NDAs are required for our product candidates, the time and financial resources required to obtain FDA approval for our product candidates could substantially and materially increase, and our product candidates might be less likely to be approved. If the FDA requires full NDAs for our product candidates, or requires more extensive testing and development for some other reason, our ability to compete with alternative products that arrive on the market more quickly than our product candidates would be adversely impacted.

Notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years certain pharmaceutical companies and others have objected to the FDA's interpretation of Section 505(b)(2). If the FDA's interpretation of Section 505(b)(2) is successfully challenged in court, the FDA may be required to change its interpretation of Section 505(b)(2) which could delay or even prevent the FDA from

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approving any Section 505(b)(2) NDA that we submit. The pharmaceutical industry is highly competitive, and it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of the new product. Moreover, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition.

Even if one of our product candidates is approved under Section 505(b)(2), the approval may be subject to limitations on the indicated uses for which the product may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product.

Any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other state and federal regulatory authorities. These requirements include, in the case of the FDA, submissions of safety and other post-marketing information and reports, registration requirements, cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. In addition, if any of our product candidates are approved, our product labeling, advertising and promotion would be subject to regulatory requirements and continuing regulatory review. The FDA strictly regulates the promotional claims that may be made about prescription drug products. In particular, a drug may not be promoted in a misleading manner or for uses that are not approved by the FDA as reflected in the product's approved labeling. The FDA and other state and federal entities actively enforce the laws and regulations prohibiting misleading promotion and the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Discovery after approval of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply with state or federal regulatory requirements, may result in actions such as:

•restrictions on such products' manufacturers or manufacturing processes;

•restrictions on the marketing or distribution of a product;

•requirements that we conduct new studies, make labeling changes, and implement Risk Evaluation and Mitigation Strategies;

•warning letters;

•withdrawal of the products from the market;

•refusal to approve pending applications or supplements to approved applications that we submit;

•recall of products;

•fines, restitution or disgorgement of profits or revenue;

•suspension or withdrawal of regulatory approvals;

•refusal to permit the import or export of our products;

•product embargo and/or seizure;

•injunctions; or

•imposition of civil or criminal penalties.

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Changes in law, regulations, and policies may preclude approval of our product under a 505(b)(2) or make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, market and distribute our existing products.

In March 2010, the President signed into law legislation creating an abbreviated pathway for approval under the Public Health Service, or PHS Act, of biological products that are similar to other biological products that are approved under the PHS Act. This legislation also expanded the definition of biological product to include proteins such as insulin. The new law contains transitional provisions governing protein products such as insulin that, under certain circumstances, might permit companies to seek approval for their insulin products as biologics under the PHS Act and might require that Biodel's product be approved under the PHS Act rather than in a 505(b)(2) NDA. We would be unlikely to pursue approval of our RHI- or insulin analog-based product candidates if we were required to seek approval under the PHS Act rather than in a 505(b)(2) NDA.

In addition, the federal and state laws, regulations, policies or guidance may change in a manner that could prevent or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities. It is impossible to predict whether additional legislative changes will be enacted, or FDA regulations, guidance or interpretations implemented or modified, or what the impact of such changes, if any, may be.

Failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our products abroad.

We intend to have our products marketed outside the United States. In order to market our products in the European Union and many other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales and distribution of our products. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ from that required to obtain FDA approval. The regulatory approval processes outside the United States may include all of the risks associated with obtaining FDA approval, as well as additional risks. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any market.

Reports of side effects or safety concerns in related technology fields or in other companies' clinical trials could delay or prevent us from obtaining regulatory approval or negatively impact public perception of our product candidates.

At present, there are a number of clinical trials being conducted by us and by other pharmaceutical companies involving insulin or insulin delivery systems. The major safety concern with patients taking insulin is the occurrence of hypoglycemic events. If we discover that our product is associated with a significantly increased frequency of hypoglycemic or other adverse events, or if other pharmaceutical companies announce that they observed frequent or significant adverse events in their trials involving insulin or insulin delivery systems, we could encounter delays in the commencement or completion of our clinical trials or difficulties in obtaining the approval of our product candidates. In addition, the public perception of our products might be adversely affected, which could harm our business and results of operations, even if the concern relates to another company's product.

Risks Related to Employee Matters and Managing Growth

Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on Errol De Souza, our President and Chief Executive Officer, Gerard Michel, our Chief Financial Officer and Dr. Alan Krasner, our Chief Medical Officer. The loss of the services of any

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of these persons might impede the achievement of our research, development and commercialization objectives. Replacing key employees may be difficult and time-consuming because of the limited number of individuals in our industry with the skills and experiences required to develop, gain regulatory approval of and commercialize our product candidates successfully. We generally do not maintain key person life insurance to cover the loss of any of our employees.

Recruiting and retaining qualified scientific personnel, clinical personnel and sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms, if at all, given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from other companies, universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

We may expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

If our development and commercialization plans for any of our product candidates are successful, we may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of manufacturing, clinical trials management, and regulatory affairs. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Risks Related to Our Common Stock

Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our corporate charter and bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team.

Among others, these provisions:

•establish a classified board of directors such that not all members of the board are elected at one time;

•allow the authorized number of our directors to be changed only by resolution of our board of directors;

•limit the manner in which stockholders can remove directors from the board;

•establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;

•require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;

•limit who may call stockholder meetings;

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•authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a stockholder rights plan or "poison pill" that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and

•require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.

In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

If our stock price is volatile, purchasers of our common stock could incur substantial losses.

Our stock price has been and may continue to be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our common stock may be influenced by many factors, including:

•results of clinical trials of our product candidates or those of our competitors;

•regulatory or legal developments in the United States and other countries;

•variations in our financial results or those of companies that are perceived to be similar to us;

•developments or disputes concerning patents or other proprietary rights;

•the recruitment or departure of key personnel;

•changes in the structure of healthcare payment systems;

•market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts' reports or recommendations;

•general economic, industry and market conditions; and

•the other factors described in this "Risk Factors" section.

Our outstanding warrants may be exercised, and our outstanding shares of preferred stock may be converted, in the future, which would increase the number of shares in the public market and result in dilution to our stockholders.

As a result of our May 2011 registered direct offering and June 2012 private placement, we have outstanding warrants to purchase 2,256,929 shares of our common stock at $9.92 per share and 2,749,469 shares of our common stock at $2.66 per share. The $9.92 per share warrants expire in May 2016 and the $2.66 per share warrants expire in June 2017. We also have outstanding shares of Series B preferred stock that are convertible into 1,950,000 shares of common stock. In June and September 2013 an aggregate of 1,655,607 shares of Series B preferred stock were converted into an equal number of shares of common stock. The exercise of these warrants for, or the conversion of shares of Series B preferred stock into, shares of common stock would be substantially dilutive to the outstanding shares of common stock. Any dilution or potential dilution may cause our stockholders to sell their shares, which would contribute to a downward movement in the stock price of our common stock.

We have never paid any cash dividends on our capital stock and we do not anticipate paying any cash dividends in the foreseeable future.

We have paid no cash dividends on our capital stock to date. We currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of any future debt agreements may preclude us from paying dividends. As a result, we do not expect to pay any cash dividends in the foreseeable future, and payment of cash dividends, if any, will depend on our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors.

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Furthermore, we may in the future become subject to contractual restrictions on, or prohibitions against, the payment of dividends. Capital appreciation, if any, of our common stock will be investors' sole source of gain for the foreseeable future.

We incur substantial costs as a result of operating as a public company, and our management is required to devote substantial time to comply with public company regulations.

We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002 as well as other federal and state laws. These requirements may place a strain on our people, systems and resources. The Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal controls over financial reporting, significant resources and management oversight will be required. This may divert management's attention from other business concerns, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

Risks Related to our June 2012 Private Placement

The number of shares of our common stock outstanding has increased substantially as a result of our June 2012 private placement, and some of the purchasers in the private placement beneficially own significant blocks of our common stock; the securities that we issued in the private placement will be generally available for resale in the public market upon registration under the Securities Act of 1933, as amended, or the Securities Act.

In June 2012, we completed our 2012 private placement of an aggregate of 4,250,020 shares of our common stock, 3,605,607 shares of our Series B preferred stock and warrants to purchase an aggregate of 2,749,469 shares of our common stock. The issuance of these shares and warrants resulted in substantial dilution to stockholders who held our common stock prior to the 2012 private placement. Some of the purchasers in the private placement will have significant influence over the outcome of any stockholder vote, including the election of directors and the approval of mergers or other business combination transactions.

Pursuant to the securities purchase agreement that we entered into with the purchasers in the 2012 private placement, we filed with the Securities and Exchange, or the SEC, a registration statement to register the resale of the shares of common stock and Series B preferred stock issued and sold in the private placement, the shares of common stock issuable upon conversion of the Series B preferred stock issued and sold in the private placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the private placement. Upon the effectiveness of the registration statement, these securities became generally available for resale in the public market. The market price of our common stock could fall as a result of an increase in the number of shares available for sale in the public market.

If we do not maintain effectiveness of the registration statement, we will be required to pay certain liquidated damages, which could be material in amount.

Pursuant to the terms of the securities purchase agreement that we entered into with the purchasers in the 2012 private placement, we have agreed to pay liquidated damages to such purchasers if the registration statement we filed with the SEC, which was declared effective on August 13, 2012, is suspended or ceases to remain continuously effective as to all the securities for which it is required to be effective. We refer to such an event as a registration default. Subject to the specified exceptions, for each 30-day period or portion thereof during which a registration default remains uncured, we are obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1% of the aggregate purchase price paid by each such purchaser in the private placement, up to a maximum of 8% of such aggregate purchase price. These amounts could be material, and any liquidated damages we are required to pay could have a material adverse effect on our financial condition.

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ITEM 1B. UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 2. PROPERTIES

We lease approximately 29,300 square feet of office space and laboratory facilities in Danbury, Connecticut. Our corporate headquarters are located at 100 Saw Mill Road, Danbury, Connecticut, in approximately 19,500 square feet of rentable office space. The lease for our corporate headquarters expires in July, 2019.

ITEM 3. LEGAL PROCEEDINGS

In July 2013, a third party initiated administrative proceedings in Munich, Germany before the European Patent Office to oppose two of our patents that have been granted in connection with our ultra-rapid-acting insulin formulations—EP 2 319 500 and EP2 106 790. The opponent is listed as Dr. Armin K. Bohmann. The opponent requests that the patents be revoked, alleging that the subject matter is not patentable, the inventions are not adequately disclosed and subject matter extends beyond the subject of the applications.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

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PART II-OTHER INFORMATION

ITEM 5 MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

From May 2007 through May 10, 2012, our common stock traded on the NASDAQ Global Market, and, since May 11, 2012, our common stock has traded on the NASDAQ Capital Market, in each case under the symbol "BIOD."

The following table sets forth the high and low sale prices per share for our common stock on the applicable exchange in each of the quarters within our two most recent fiscal years. All prices shown in the table reflect the one-for-four reverse split of our outstanding common stock that we effected on June 11, 2012.

Fiscal Quarter Ended		High		Low
December 31, 2011	$	3.48	$	2.04
March 31, 2012	$	2.96	$	2.24
June 30, 2012	$	4.00	$	2.00
September 30, 2012	$	3.82	$	2.41
December 31, 2012	$	2.98	$	2.13
March 31, 2013	$	2.97	$	2.29
June 30, 2013	$	5.11	$	2.48
September 30, 2013	$	6.08	$	3.05

The closing price of our common stock, as reported on the NASDAQ Capital Market, was $2.16 on December 13, 2013.

Holders

As of November 29, 2013, the number of holders of record of our common stock was 35.

Dividends

We have never paid or declared any cash dividends on our common stock. We currently intend to retain earnings, if any, to finance the growth and development of our business. Payment of future dividends, if any, will be at the discretion of our board of directors.

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Equity Compensation Plan Information

Information relating to compensation plans under which our equity securities are authorized for issuance will be set forth under "Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters" in our definitive proxy statement for our 2014 Annual Meeting of Stockholders.

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ITEM 6. SELECTED FINANCIAL DATA

You should read the following selected financial data together with our financial statements and the related notes which are included elsewhere in this Annual Report and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" section of this Annual Report. We have derived the statement of operations data set forth below for the three-year period ended September 30, 2013 and the balance sheet data as of September 30, 2012 and 2013 set forth below from our audited financial statements which are included in this Annual Report. We have derived the statement of operations data set forth below for the years ended September 30, 2009 and 2010 and the balance sheet data as of September 30, 2009, 2010 and 2011 set forth below from our audited financial statements, which are not included in this Annual Report. Historical results for any prior period are not necessarily indicative of results to be expected in any future period. All share and per share amounts set forth below reflect the one-for-four reverse split of our outstanding common stock that we affected on June 11, 2012.

		Year Ended September 30,
		2009			2010			2011			2012			2013
		(In thousands, except share and per share amounts)
Statement of operations data:
Revenue	$	—		$	—		$	—		$	—		$	—
Operating expenses:
Research and development		32,082			25,778			13,597			12,315			14,296
Government grants		—			—			—			(88	)		(546	)
General and administrative		11,237			11,379			9,625			7,072			6,843
Total operating expenses		43,319			37,157			23,222			19,299			20,593
Other (income) and expense:
Interest and other income		(386	)		(17	)		(60	)		(80	)		(56	)
Adjustment to fair value of common stock warrant liability		—			1,254			(12,611	)		1,510			(1,217	)
Loss before tax provision (benefit)		(42,933	)		(38,394	)		(10,551	)		(20,729	)		(19,320	)
Tax provision (benefit)		337			(104	)		41			18			15
Net loss		(43,270	)		(38,290	)		(10,592	)		(20,747	)		(19,335	)
Net loss applicable to common stockholders	$	(43,270	)	$	(38,290	)	$	(10,592	)	$	(20,747	)	$	(19,335	)
Net loss per share — basic and diluted*	$	(7.28	)	$	(6.34	)	$	(1.36	)	$	(1.91	)	$	(1.24	)
Weighted average shares outstanding — basic and diluted*		5,936,650			6,040,467			7,788,741			10,882,688			15,650,538

		As of September 30,
		2009			2010			2011			2012			2013
		(In thousands)
Balance sheet data:
Cash, cash equivalents, and marketable securities	$	54,640		$	28,923		$	38,701		$	39,050		$	39,781
Working capital		46,787			25,178			35,907			36,756			37,636
Total assets		59,625			32,616			41,505			41,134			41,151
Deficit accumulated during the development stage		(126,464	)		(164,754	)		(175,346	)		(196,093	)		(215,428	)
Total stockholders' equity		50,538			24,060			37,078			31,016			32,563

____________

* Restated for a one for four (1:4) reverse stock split effective on June 11, 2012.

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ITEM 7.  MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read the "Risk Factors" section of this Form 10-K (see Part I-Item 1A above) for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. Our proprietary insulin formulations are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. We refer to these as "ultra-rapid-acting" formulations. Our glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose.

Our most advanced ultra-rapid-acting insulin formulation, BIOD-123, combines recombinant human insulin, or RHI, with our proprietary combination of excipients to increase the rate of absorption following injection when compared to other commercially available insulin formulations, including "rapid-acting" mealtime insulin analogs such as Humalog®, marketed by Eli Lilly, Novolog®, marketed by Novo Nordisk and Apidra®, marketed by Sanofi-Aventis. We are also using our proprietary excipients to develop ultra-rapid-acting insulin analog-based formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog®, or insulin aspart, the active pharmaceutical ingredient in NovoLog®.

An earlier RHI-based formulation known as Linjeta™ (and previously referred to as VIAject®) was the subject of a New Drug Application, or NDA, that we submitted to the FDA in December 2009. In October 2010, the FDA issued a complete response letter stating that the NDA for Linjeta™ could not be approved in its submitted form and that we should conduct two new Phase 3 clinical trials using our preferred commercial formulation of Linjeta™ prior to re-submitting the NDA. Based upon the complete response letter and subsequent feedback that the FDA provided, we decided to develop newer RHI-based formulations with the goal of identifying a formulation with a pharmacokinetic and pharmacodynamic profile similar to Linjeta™, but with improved injection site toleration characteristics. From January 2011 to April 2012, we studied several such newer formulations, including BIOD-123, in Phase 1 clinical trials. In these trials, we used Humalog® as the comparator drug rather than the comparator drug we used in our Phase 3 Linjeta™ clinical trials. In our Phase 3 clinical trials, the comparator drug was Humulin® R, an RHI-based insulin formulation marketed by Eli Lilly that is less rapid-acting than the insulin analog Humalog®.

BIOD-123 achieved our target pharmacokinetic, pharmacodynamic and injection site toleration profiles for a candidate RHI-based formulation in a Phase 1 clinical trial completed in April 2012, and in the third calendar quarter of 2012 we began enrolling patients in a Phase 2 clinical trial of BIOD-123. The Phase 2 clinical trial of BIOD-123 was a randomized, open label, parallel group study conducted at 32 investigative centers in the United States. In the trial, 132 patients with Type 1 diabetes were randomized to receive either BIOD-123 or Humalog® to use as their mealtime insulin during an 18-week treatment period. Both arms of the study used insulin glargine, sold as Lantus®, as the basal insulin. The clinical trial was designed to evaluate HbA1c control as the primary endpoint, and secondary endpoints included postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

The Phase 2 clinical trial of BIOD-123 completed patient dosing in the second calendar quarter of 2013, and in September 2013 we announced preliminary results from the trial. BIOD-123 achieved the primary endpoint of noninferiority for HbA1c relative to Humalog®. The mean HbA1c change from baseline in the BIOD-123 group was -0.08 ± 0.064% and -0.25± 0.063% in the Humalog® group. The 95% confidence

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interval (-0.01, 0.35) of the between group differences in change from baseline HbA1c did not exceed the FDA-designated threshold of 0.40%, thereby establishing non-inferiority. We expect to provide an update on our further development plans for BIOD-123 after completing our analysis of the data from the Phase 2 clinical trial and following discussions with FDA on clinical trial design, safety and chemistry, manufacturing and controls relating to potential future studies.

In addition to BIOD-123, we have other RHI-based formulations in earlier stages of development. In particular, we are developing ultra-rapid-acting formulations of concentrated insulin that are characterized by a rapid onset of action and a prolonged duration of action. We believe these formulations could address an unmet medical need for an insulin with an initial rate of absorption superior to that of existing concentrated insulins and prandial/basal pre-mixed insulins. In November 2013, we announced that we had initiated a Phase 1 clinical trial with BIOD-531, our lead candidate for an ultra-rapid-acting concentrated insulin formulation. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and is formulated with EDTA, citrate and magnesium sulfate. In preclinical studies in diabetic swine, BIOD-531 demonstrated a more rapid rate of absorption and onset of action, along with a similar duration of action, when compared to Humulin® R U-500, a presentation containing 500 units of RHI per millimeter. In other preclinical studies, BIOD-531 also demonstrated a more rapid rate of absorption and onset of action when compared to Humalog® pre-mixed prandial/basal formulations. In the Phase 1 clinical trial of BIOD-531, we will evaluate and compare the onset and duration of action and injection site tolerability of BIOD-531 to Humulin® R U-500 and to Humalog® prandial/basal pre-mixed insulin. We anticipate reporting top line data from the clinical trial in the first calendar quarter of 2014.

We also continue to develop ultra-rapid-acting insulin analog-based formulations. In January 2013, we announced top-line results from our Phase 1 clinical trial of two insulin analog-based formulations, BIOD-238 and BIOD-250. These formulations, which were manufactured using commercial preparations of Humalog®, generally use the same or similar excipients as BIOD-123 and were intended to be optimized for rapid absorption and injection site toleration. The trial, which was conducted in Australia, was designed to compare the pharmacokinetic and injection site toleration profiles of BIOD-238 and BIOD-250 relative to Humalog®. In the trial, both formulations met our target pharmacokinetic profile for an ultra-rapid-acting insulin analog-based formulation, and BIOD-250 met our target injection site toleration profile. We do not expect to study these formulations in additional clinical trials because they were formulated by adding our proprietary excipients to the marketed formulation of Humalog® and because they do not demonstrate stability characteristics consistent with our target product profile. Accordingly, we are continuing our insulin analog-based formulation work to develop formulations using insulin lispro as the active pharmaceutical ingredient, rather than a marketed presentation of Humalog®.

In addition to our ultra-rapid-acting insulin formulation program, we are developing room temperature stable glucagon presentations for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia. In June 2013, we announced plans to develop a novel glucagon rescue product to treat severe hypoglycemia using a proprietary device from Unilife Corporation. The device, which is being customized for use in emergency situations by patient caregivers with no medical training, is a dual-chamber design that automatically reconstitutes lyophilized glucagon with a liquid diluent immediately prior to injection, and it features automatic needle retraction on full dose delivery. We expect to submit an Investigational New Drug application to the FDA for our dual-chamber glucagon rescue product during the next nine months and anticipate conducting a pivotal clinical trial in the second half of 2014. We are also conducting preclinical testing to develop liquid formulations of glucagon for hypoglycemic rescue and other indications.

We are a development stage company. We were incorporated in December 2003 and commenced active operations in January 2004. To date, we have generated no revenues and have incurred significant losses. We expect to continue to incur operating losses as we continue our efforts to develop and commercialize our product candidates. We have financed our operations and internal growth through various financing transactions, including our initial public offering in May 2007 and several subsequent transactions, including, most recently, our June 2013 public offering. We have devoted substantially all of our efforts to research and development activities, including clinical trials. Our net loss was $19.3 million for the year ended September 30, 2013. As of September 30, 2013, we had a deficit accumulated during the development stage of $215.4 million. Research and development and general and administrative expenses, as a percentage of net loss applicable to common stockholders, represent approximately 74% and 35%, respectively, of the expenses that we have incurred since our inception.

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As of September 30, 2013, we had approximately $39.8 million in cash and cash equivalents compared to $39.1 million in cash and cash equivalents as of September 30, 2012. We believe that our existing cash, cash equivalents and restricted cash will be sufficient to fund our anticipated operating expenses and capital expenditures at least until the second calendar quarter of 2015. We believe that future cash expenditures will be partially offset by raising additional capital from research grants, capital markets, proceeds derived from collaborations, including, but not limited to, upfront fees, research and development funding, milestone payments and royalties. We can give no assurances that such funding will, in fact, be realized in the time frames we expect, or at all. We may be required to secure alternative financing arrangements or defer or limit some or all of our research, development or clinical projects.

Financial Operations Overview

Revenues

To date, we have generated no revenues. We do not expect to begin generating any revenues unless any of our product candidates receive marketing approval, or if we receive payments in connection with strategic collaborations that we may enter into for the commercialization of our product candidates.

Research and Development Expenses

Research and development expenses consist of the costs associated with our basic research activities, as well as the costs associated with our drug development efforts, conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings. Our research and development expenses consist of:

•external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites, third-party manufacturing organizations and consultants;

•employee-related expenses, which include salaries and benefits for the personnel involved in our preclinical and clinical drug development and manufacturing activities; and

•facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies.

We intend to focus our research and development efforts on conducting preclinical studies and Phase 1 and Phase 2 clinical trials to determine our preferred development, clinical and regulatory program for our ultra-rapid-acting insulin formulations and our stable glucagon presentations. We also expect to conduct a pivotal clinical trial in support of an NDA for our dual-chamber glucagon rescue product candidate. We anticipate that our research and development expenses for the fiscal year ending September 30, 2014 will increase as compared to the fiscal year ended September 30, 2013, as we continue to:

•conduct the development work necessary to finalize the formulation and design of our dual-chamber glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of an NDA to the FDA for that product candidate;

•conduct additional formulation development work to improve the stability, pharmacokinetic, and pharmacodynamic properties of our ultra-rapid-acting insulin analog-based formulations, our concentrated insulin formulations and our liquid glucagon formulations, or purchase rights related to proprietary technologies that are compatible with our product candidates;

•purchase active pharmaceutical ingredients and other materials to support our research and development activities.

Over the longer term, we anticipate that these expenses will increase further as we:

•conduct later stage clinical trials of our ultra-rapid-acting insulin formulations and our dual-chamber glucagon rescue product, including one or more pivotal clinical trials required for FDA approval of NDAs for these product candidates; and

•Prepare and file an NDA for our dual-chamber glucagon rescue product candidate.

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We have used our employee and infrastructure resources across multiple research projects and our drug development programs for our ultra-rapid-acting insulin formulations, including BIOD-123, BIOD-238 and BIOD-250, our concentrated insulin formulations and our stable glucagon presentations. Substantially all of our research and development expenses incurred to date are attributable to our ultra-rapid-acting insulin program.

In July and September 2012, we were awarded two National Institutes of Health grants for the development of a concentrated ultra-rapid-acting insulin formulation and a stable glucagon formulation, respectively, for use in an artificial pancreas. The July 2012 award is intended to fund research to develop a proprietary ultra-rapid-insulin product candidate at high concentrations suited to provide sufficient quantities of insulin in an external artificial pancreas pump device that has limited volume capacity. The July 2012 award is for two years and totals $582 thousand. The September 2012 award is intended to fund research to develop a proprietary glucagon product candidate optimized to algorithmically deliver glucagon as part of a bi-hormonal closed loop system to mitigate hypoglycemic events. The September 2012 award is for two years and totals $583 thousand.

The following table illustrates, for each period presented, our research and development costs by nature of the cost.

		Year Ended September 30,						December 3, 2003 (Inception) to September 30, 2013
		2011		2012		2013
		(In thousands)
Research and development expenses:
Preclinical expenses	$	3,361	$	3,718	$	4,640	$	25,682
Manufacturing expenses		5,332		2,644		2,428		41,359
Clinical/regulatory expenses		4,904		5,953		7,228		88,359
Total	$	13,597	$	12,315	$	14,296	$	155,400

The following table illustrates, for each period presented, our research and development costs by project. The year ended September 30, 2011 and inception to date are not noted because we did not track expenses by project in prior years, and therefore cannot accurately reflect past expense history by project.

	Year Ended September 30,
		2012		2013
Ultra-rapid-acting insulin formulations:
RHI-based	$	4,013	$	5,390
Insulin analog-based		2,266		1,694
Stable Glucagon		2,154		1,848
Concentrated RHI-based formulations		88		1,181
Other		3,794		4,183
Total	$	12,315	$	14,296

The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, specific timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of, or the period, if any, in which material net cash inflows may commence from our product candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

•the progress, timing or success of our research and development and clinical programs for our product candidates;

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•the degree to which our ongoing assessment of the data from our recently completed Phase 2 clinical trial of BIOD-123, our lead candidate for an ultra-rapid-acting insulin formulation, and our related chemistry, manufacturing and controls development work, support further clinical development by us or our potential partners;

•our ability to successfully use the data from our Phase 2 clinical trial of BIOD-123 to design and conduct the pivotal clinical trials required by the FDA to secure approval to commercialize that candidate;

•the success of our formulation development work to improve the stability of our newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations;

•our ability to conduct the development work necessary to finalize the formulation and design of our dual-chamber glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of an NDA to the FDA for that product candidate;

•the results of our real-time stability programs for our RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our ultra-rapid-acting RHI- and insulin analog-based product candidates or our glucagon rescue product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;

•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to produce our products in our final dosage form;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization one or more product candidates;

•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.

A change in the outcome of any of these variables with respect to the development of ultra-rapid-acting insulin formulations or our liquid glucagon formulation, could mean a significant change in the costs and timing associated with product development.

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General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related expenses for personnel, including stock-based compensation expenses, relating to our internal executive, legal, accounting, finance and information technology departments. Other general and administrative expenses include facility-related costs not otherwise allocated to research and development expense, patent expenses, travel expenses, costs associated with industry conventions and professional fees, such as legal and accounting fees and consulting costs.

We anticipate that our general and administrative expenses in the fiscal year ending September 30, 2014 will remain substantially the same as in the fiscal year ended September 30, 2013 as we continue to focus our efforts on product formulation activities and begin advancing our product candidates into later stage clinical trials, including Phase 3 pivotal trials. Over the longer term, however, these expenses could increase as we prepare to file an NDA in support of our dual chamber glucagon rescue product candidate and, possibly, commence pre-commercialization activities.

Warrant Liability

In June 2012, we issued warrants to purchase 2,749,469 shares of our common stock at an exercise price of $2.66 per share in connection with our June 2012 private placement. These warrants will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. In May 2011, we issued warrants to purchase 2,256,929 shares of our common stock at an exercise price of $9.92 per share in connection with our May 2011 registered direct offering. These warrants will expire on May 17, 2016, five years from the original issuance date of May 18, 2011. Under the terms of both the 2012 warrants and the 2011 warrants, if we enter into a merger or change of control transaction, the holders of the warrants will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require us to purchase the unexercised warrants at the Black-Scholes value (as defined in the applicable warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, we recognize the 2012 and 2011 warrants as liabilities at their fair value on each reporting date.

We use the Black-Scholes valuation model to estimate the fair value of the warrants. The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. Using this model, we recorded an initial warrant liability of $4.8 million for the 2012 warrants and $9.4 million for the 2011 warrants, in each case as of the initial warrant issuance date. The significant assumptions for the model used for the 2012 warrants were remaining terms of the warrants, the common stock price of $3.15 per share, the warrant exercise price of $2.66 per share, a risk-free interest rate of 0.63% and an expected volatility rate of 82%. The significant assumptions for the model used for the 2011 warrants were remaining terms of the warrants, the common stock price of $3.15 per share, the warrant exercise price of $9.92 per share, a risk-free interest rate of 0.63% and an expected volatility rate of 77%. The liability for both the 2012 and 2011 warrants is revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."

In August 2010, we issued warrants to purchase 599,550 shares of our common stock in connection with our August 2010 registered direct offering. On December 1, 2011, the unexercised warrants to purchase 589,000 shares of common stock expired. We revalued the liability from September 30, 2011 through the date of expiration and there was no impact on the statement of operations. The common stock warrant liability associated with these warrants no longer exists.

Interest Income

Interest income consists of interest earned on our cash and cash equivalents and marketable securities. In November 2007, our board of directors approved investment policy guidelines, the primary objectives of which are the preservation of capital, the maintenance of liquidity and maintenance of appropriate fiduciary control, subject to our business objectives and tax situation. We have maintained an investment strategy of investing primarily in a premier commercial money market account, which consists primarily of short-term debt securities issued by the U.S. government, Treasury securities and U.S. government agencies. We intend to maintain this conservative strategy in fiscal year ending September 30, 2014.

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Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our audited financial statements that have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and assumptions. We base our estimates on historical experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 2 to our financial statements appearing at the end of this Annual Report on Form 10-K, we believe that the following accounting policies, which we have discussed with our audit committee, are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations.

Preclinical Study and Clinical Trial Accruals

In preparing our financial statements, we must estimate accrued expenses pursuant to contracts with multiple research institutions, clinical research organizations and contract manufacturers that conduct and manage preclinical studies, clinical trials and manufacture product for these trials on our behalf. This process involves communicating with relevant personnel to identify services that have been performed on our behalf and estimating the level of services performed and the associated costs incurred for services when we have not yet been invoiced for or otherwise notified of the actual cost. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us. The financial terms of these agreements vary and may result in uneven payment flows. To date, we have not adjusted our estimates at any balance sheet date in any material amount. Examples of preclinical study, clinical trial and manufacturing expenses include the following:

•fees paid to contract research organizations in connection with preclinical and toxicology studies and clinical trials;

•fees paid to investigative sites in connection with clinical trials;

•fees paid to contract manufacturers in connection with the production of clinical trial materials; and

•professional service fees.

Government Grants

Grants received are recognized as grant income when the grants become receivable, provided there is reasonable assurance that we will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. We request cash funding under approved grants as expenses are incurred (not in advance) and report these receipts on the statement of operations as a separate line item entitled "Government Grants." The corresponding expenses are included in research and development expenses. In July and September 2012, we were awarded two National Institutes of Health grants for the development of concentrated ultra-rapid-acting insulin formulations and liquid glucagon formulations, respectively, for use in an artificial pancreas. Both awards are for two years and total approximately $580 thousand each. Work on the grant for the development of concentrated ultra-rapid-acting insulin formulation started in August 2012 and expenses incurred were $327 thousand during the twelve months ended September 30, 2013. Work on the grant for the development of novel and stable glucagon formulations for closed loop systems started in January 2013, and expenses incurred were $219 thousand during the twelve months ended September 30, 2013. Corresponding income and receivables were recorded.

Reclassifications

Certain items in the prior year's financial statements have been reclassified to conform with the current year's presentation.

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Share-Based Compensation

Stock Incentive Plan

In March 2013, the shareholders approved the amended and restated 2010 Stock Incentive Plan (the "2010 Plan"). Up to 3,750,000 shares of common stock may be issued pursuant to awards granted under the 2010 Plan, plus 1,540,739 shares of common stock underlying already outstanding awards under the Company's prior plans. As of September 30, 2013, we had 1,951,347 shares of common stock subject to outstanding awards. The contractual life of options granted under the 2010 Plan may not exceed seven years. The 2010 Plan uses a "fungible share" concept under which any awards that are not a full-value award will be counted against the share limit as one (1) share for each share of common stock and any award that is a full-value award will be counted against the share limit as 1.5 shares for each one share of common stock. We have not made any new awards under any prior equity plans after March 2, 2010, the effective date the 2010 Plan was approved by the stockholders. The 2010 Plan replaces the 2004 Stock Incentive Plan and 2005 Non-Employee Directors Stock Option Plan.

We use the Black-Scholes pricing model to calculate the fair value of stock options. The expected life for these grants was calculated in accordance with the simplified method described in the Securities and Exchange Commission Staff Accounting Bulletin (SAB) Topic 14.D.2 in accordance with SAB No. 110.

We recognize compensation costs related to share-based transactions, including employee stock options, in the financial statements based on fair value. The fair value of the stock underlying the options is a significant factor in determining credits or charges to operations appropriate for the share-based payments to both employees and non-employees.

We base our estimate of expected volatility on the historical volatility of our stock. The risk free rate of interest for periods within the contractual life of the stock option is based on the yield of a U.S. Treasury strip on the date the award is granted with a maturity equal to the expected term of the award. We estimate forfeitures based on actual forfeitures during our limited history. Additionally, we have assumed that dividends will not be paid.

For options granted to non-employees and non-directors, primarily consultants who served on our Scientific Advisory Board, we measure fair value of the equity instruments utilizing the Black-Scholes valuation model, if that value is more reliably measurable than the fair value of the consideration or service received. The fair value of these equity investments were periodically revalued as the options were vesting and were recognized as expense over the related period of service or the vesting period, whichever was longer. We have not granted options to non-employees and non-directors since the year ending September 30, 2008. Prior to September 30, 2008, we issued to these non-employees options to purchase an aggregate of 94,278 shares of our common stock. All of these options are currently vested. For the years ended September 30, 2011, 2012 and 2013, the share-based compensation expense (income) related to these options was ($0.04) million, $0, and $0, respectively.

We grant restricted stock units, or RSUs, to executive officers and employees pursuant to the 2010 Plan, from time to time. Each RSU represents one share of common stock. There is no direct cost to the recipients of RSUs, except for any applicable taxes. Except as set forth below with regard to RSUs awarded to employees in place of discretionary cash bonuses, each award vests in installments on each anniversary of the date of grant, and the costs of the awards are determined as the fair market value of the shares on the date of grant. In all cases, costs are expensed per the vesting schedule outlined in the award. For example, RSUs awarded in December 2010 vest annually over three years, with 50% vesting on the first anniversary of the date of grant and the remainder vesting in two equal installments on each anniversary thereafter, and therefore are expensed 50% in the first year and 25% each year in the next two years. Except as set forth below with regard to RSUs awarded to employees in place of discretionary cash bonuses, each year following the annual vesting date, between January 1st and March 15th, we will issue common stock for each vested RSU. During the period when the RSU is vested but not distributed, the RSUs cannot be transferred and the grantee has no voting rights. If we declare a dividend, RSU recipients will receive payment based upon the percentage of RSUs that have vested prior to the date of declaration.

In March 2012, we granted RSUs to our employees in place of the discretionary cash bonuses that were established in connection with the fiscal year ended September 30, 2011. The cost of these awards was

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determined to be the value of the discretionary cash bonuses. These RSUs vested, and the underlying shares were distributed, on September 30, 2012. At that time, the value of the discretionary cash bonuses exceeded the fair market value of the corresponding RSUs.

For the year ended September 30, 2013, the share-based compensation expense, including expenses associated with stock options and RSUs, was $1.5 million, of which $0.7 million is reflected in research and development expenses and $0.8 million is reflected in general and administrative expenses. For the year ended September 30, 2012, the share-based compensation expense, including expenses associated with stock options and RSUs, was $1.8 million, of which $0.7 million is reflected in research and development expenses and $1.1 million is reflected in general and administrative expenses. For the year ended September 30, 2011, the share-based compensation expense was $5.0 million, of which $2.0 million is reflected in research and development expenses and $3.0 million is reflected in general and administrative expenses.

Income Taxes

As part of the process of preparing our financial statements, we are required to estimate our income taxes in each of the jurisdictions in which we operate. This process involves estimating our actual current tax expense together with assessing temporary differences resulting from differing treatments of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities.

At September 30, 2012 and 2013, we recorded a 100% valuation allowance against our net deferred tax asset of approximately $47.9 million and $55.0 million, respectively, as our management believes it is uncertain that it will be fully realized. If we determine in the future that we will be able to realize all or a portion of our net deferred tax asset, an adjustment to the deferred tax valuation allowance would increase net income in the period in which we make such a determination.

As of September 30, 2013, we had net operating loss carry-forwards of approximately $57.6 million for U.S. federal and $112.2 million for state tax purposes. These loss carry-forwards expire between 2024 and 2032. To the extent these net operating loss carry-forwards are available, we intend to use them to reduce the corporate income tax liability associated with our operations. Section 382 of the U.S. Internal Revenue Code generally imposes an annual limitation on the amount of net operating loss carry-forwards that might be used to offset taxable income when a corporation has undergone significant changes in stock ownership. Based on a Section 382 analysis review, we determined that an ownership change under Section 382 occurred on May 12, 2011. We believe that approximately $55.9 million of the $112.2 million federal losses will expire unused as a result of Section 382 limitations. The maximum annual limitation under Section 382 is approximately $2.5 million for 20 years. To the extent our use of net operating loss carry-forwards is limited, future income could be subject to corporate income tax earlier than it would if we were able to use net operating loss carry-forwards, which could result in decreased net income.

We also have state research and development credit carry-forwards of approximately $0.3 million, which expire commencing in fiscal 2022.

Results of Operations

Year Ended September 30, 2013 Compared to Year Ended September 30, 2012

Revenue. We did not recognize any revenue during the years ended September 30, 2013 or 2012.

Research and Development Expenses.

		Year Ended September 30,						Increase
		2012			2013			$	%
		In thousands, except per share amounts
Research and Development	$	12,315		$	14,296		$	1,981	16.1	%
Percentage of net loss		59.4	%		73.9	%

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Research and development expenses were $14.3 million for the year ended September 30, 2013, an increase of $2.0 million, or approximately 16.1%, from $12.3 million for the year ended September 30, 2012. This increase was primarily attributable to increases of $1.2 million in external expenses associated with our clinical trials, $0.4 million in personnel and stock-based compensation expenses, $0.2 million in consulting fees, and $0.1 million in preclinical animal studies.

Research and development expenses for the year ended September 30, 2013 and 2012 include $0.7 million each in stock-based compensation expense related to options granted to employees.

In July and September 2012, we received two National Institutes of Health awards for the development of concentrated ultra-rapid-acting insulin formulation and glucagon formulation for use in an artificial pancreas. The July 2012 award is intended to fund research to develop a proprietary ultra-rapid-insulin product candidate at high concentrations suited to provide sufficient quantities of insulin in an external artificial pancreas pump device that has limited volume capacity. The July award is for two years and totals $582 thousand. The September 2012 award is intended to fund research to develop a proprietary glucagon product candidate optimized to algorithmically deliver glucagon as part of a bi-hormonal closed loop system to mitigate hypoglycemic events. The September 2012 award is for two years and totals $583 thousand. For the year ended September 30, 2013, we reported $327 thousand in government grants for the high concentration ultra-rapid-insulin product candidate and $219 thousand for the glucagon formulation work.

General and Administrative Expenses.

		Year Ended September 30,						Decrease
		2012			2013			$	%
		In thousands, except per share amounts
General and Administrative	$	7,072		$	6,843		$	229	3.2	%
Percentage of net loss		34.1	%		35.4	%

General and administrative expenses were $6.8 million for the year ended September 30, 2013, a decrease of $0.2 million, or 3.2%, from $7.1 million for the year ended September 30, 2012. This decrease is primarily attributable to the adjusted allocation of bonus expense between general and administrative and research and development, which decreased general and administrative expense by $0.3 million when compared to the year ended September 30, 2012.

General and administrative expenses for the year ended September 30, 2013 and 2012 include $0.8 million and $1.1 million, respectively, in stock-based compensation expense related to options granted to employees and non-employee directors.

Interest and Other Income.

		Year Ended September 30,						Decrease
		2012			2013			$	%
		In thousands, except per share amounts
Interest and Other Income	$	80		$	56		$	24	30.0	%
Percentage of net loss		0.39	%		0.29	%

Interest and other income decreased to $0.06 million for the year ended September 30, 2013 from $0.08 million for the year ended September 30, 2012. The decrease is primarily due to lower cash balances during the year.

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Interest Expense. For the years ended September 30, 2013 and 2012, we had no interest expense.

Adjustments to Fair Value of Common Stock Warrant Liability.

		Year Ended September 30,						Decrease
		2012			2013			$		%
		In thousands, except per share amounts
Adjustments to fair value of common stock warrant liability
August 2010 Warrant	$	—		$	—		$	—
May 2011 Warrant		709			(542	)		(1,251	)
June 2012 Warrant		801			(675	)		(1,476	)
Total	$	1,510		$	(1,217	)	$	2,727			180.6	%
Percentage of net loss		128.4	%		59.4	%

The change in fair value of derivative instruments-warrants of $1,510 during the year ended September 30, 2012 was primarily a result of the increase in the price of the common stock from $2.16 per share at September 30, 2011 to $2.97 per share at September 30, 2012. The change in fair value of common stock warrant liability of $(1,217) during the year ended September 30, 2013 was primarily due to shorter terms and reduced volatility.

Net Loss and Net Loss per Share.

		Year Ended September 30,						Decrease
		2012			2013			$	%
		In thousands, except per share amounts
Net loss	$	(20,747	)	$	(19,335	)	$	1,412	6.8	%
Net loss per share	$	(1.91	)	$	(1.24	)

Net loss was $19.3 million, or $(1.24) per share, for the year ended September 30, 2013, compared to $20.7 million, or $(1.91) per share, for the year ended September 30, 2012. The decrease in net loss was primarily due to a decrease in adjustments to fair value of common stock warrant liability and general and administrative expenses, offset by an increase in research and development expenses as noted above.

Year Ended September 30, 2012 Compared to Year Ended September 30, 2011

Revenue. We did not recognize any revenue during the years ended September 30, 2012 or 2011.

Research and Development Expenses.

		Year Ended September 30,						Decrease
		2011			2012			$	%
		In thousands, except per share amounts
Research and Development	$	13,597		$	12,315		$	1,282	9.4	%
Percentage of net loss		128.4	%		59.4	%

Research and development expenses were $12.3 million for the year ended September 30, 2012, a decrease of $1.3 million or 9.4%, from $13.6 million for the year ended September 30, 2011. This decrease was primarily attributable to reductions of $2.6 million in manufacturing expenses and $0.4 million in regulatory expenses. These decreases were offset in part by an increase of $1.4 million in clinical expenses related primarily to our Phase 1 clinical trial of BIOD-123 and BIOD-125 and a net increase of $0.3 million in research and development expenses related to an increase in the number of preclinical animal studies we conducted and a licensing fee paid to Aegis.

The reductions in manufacturing expenses are attributable to savings of $2.2 million as a result of renegotiating the terms of our supply agreement for RHI and $0.4 million in reduced personnel costs. The

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$0.4 million reduction in regulatory expenses resulted from lower professional fees for the year ended September 30, 2012, as compared to 2011, and lower stock-based compensation costs.

Research and development expenses for the twelve months ended September 30, 2011 were reduced by our receipt in January 2011 of approximately $1.2 million in research grants under the Internal Revenue Service's therapeutic tax credit program and were increased by a $1.4 million severance charge resulting from the retirement of our former Chief Scientific Officer.

Research and development expenses for the years ended September 30, 2012 and 2011 include $0.7 million and $1.9 million, respectively, in stock-based compensation expense related to options granted to employees.

In July and September 2012, we received two National Institutes of Health awards for the development of concentrated ultra-rapid-acting insulin formulation and glucagon formulation for use in an artificial pancreas. The July 2012 award is intended to fund research to develop a proprietary ultra-rapid-insulin product candidate at high concentrations suited to provide sufficient quantities of insulin in an external artificial pancreas pump device that has limited volume capacity. The July award is for two years and totals $582 thousand. The September 2012 award is intended to fund research to develop a proprietary glucagon product candidate optimized to algorithmically deliver glucagon as part of a bi-hormonal closed loop system to mitigate hypoglycemic events. The September 2012 award is for two years and totals $583 thousand. For the year ended September 30, 2012, we reported $88 thousand in government grants for the high concentration ultra-rapid-insulin product candidate and did not start the glucagon formulation work.

General and Administrative Expenses.

		Year Ended September 30,						Decrease
		2011			2012			$	%
		In thousands, except per share amounts
General and Administrative	$	9,625		$	7,072		$	2,553	26.5	%
Percentage of net loss		90.9	%		34.1	%

General and administrative expenses were $7.1 million for the year ended September 30, 2012, a decrease of $2.6 million, or 26.5%, from $9.6 million for the year ended September 30, 2011. This decrease is attributable to reductions of $0.2 million in depreciation expense due primarily to fully depreciating our accounting software, $1.9 million in employee and non-employee director stock-based compensation expenses, and other expenses of $0.4 million. General and administrative expenses for the year ended September 30, 2012 and 2011 include $1.1 million and $3.0 million, respectively, in stock-based compensation expense related to options granted to employees and non-employee directors.

Interest and Other Income.

		Year Ended September 30,						Increase
		2011			2012			$	%
		In thousands, except per share amounts
Interest and Other Income	$	60		$	80		$	20	33.3	%
Percentage of net loss		0.57	%		0.39	%

Interest and other income increased to $0.08 million for the year ended September 30, 2012 from $0.06 million for the year ended September 30, 2011. The increase resulted primarily from interest on the higher cash balances generated by our June 2012 private placement.

Interest Expense. For the years ended September 30, 2012 and 2011, we had no interest expense.

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Adjustments to Fair Value of Common Stock Warrant Liability.

		Year Ended September 30,						Decrease
		2011			2012			$	%
		In thousands, except per share amounts
Adjustments to fair value of common stock warrant liability
August 2010 Warrant	$	(4,169	)	$	—		$	4,169
May 2011 Warrant		(8,442	)		709			9,151
June 2012 Warrant		—			801			801
Total	$	(12,611	)	$	1,510		$	14,121	112.0	%
Percentage of net loss		119.1	%		7.3	%

The change in fair value of derivative instruments-warrants of $(12,611) during the year ended September 30, 2011 was primarily a result of the decrease in the price of the common stock from $5.30 per share at September 30, 2010 to $2.16 per share at September 30, 2011. The change in fair value of common stock warrant liability of $1,510 during the year ended September 30, 2012 was a result of the increase in the price of the common stock from $2.16 per share at September 30, 2011 to $2.97 per share at September 30, 2012.

Net Loss and Net Loss per Share.

		Year Ended September 30,						Increase
		2011			2012			$	%
		In thousands, except per share amounts
Net loss	$	(10,592	)	$	(20,747	)	$	10,155	95.9	%
Net loss per share	$	(1.36	)	$	(1.91	)

Net loss was $20.7 million, or $(1.91) per share, for the year ended September 30, 2012, compared to $10.6 million, or $(1.36) per share, for the year ended September 30, 2011. The increase in net loss was primarily due to an increase in adjustments to fair value of common stock warrant liability, as noted above.

Liquidity and Capital Resources

Sources of Liquidity and Cash Flows

As a result of our significant research and development expenditures and the lack of any approved products or other sources of revenue, we have not been profitable and have generated significant operating losses since we were incorporated in 2003. We initially funded our research and development operations through aggregate gross proceeds of $26.6 million from our private financing transactions that we completed prior to our initial public offering. We received an aggregate of approximately $202 million from our initial public offering in May 2007, our follow-on offering in February 2008, our registered direct offerings in August 2010 and May 2011, our private placement in June 2012 and our public offering in June 2013.

At September 30, 2013, we had cash and cash equivalents totaling approximately $39.8 million. We plan to continue to invest our cash and cash equivalents in accordance with our approved investment policy guidelines.

Net cash used in operating activities was $18.6 million for the year ended September 30, 2013, $16.7 million for the year ended September 30, 2012, and $18.3 million for the year ended September 30, 2011. Net cash used in operating activities for the years ended September 30, 2013, 2012 and 2011 primarily reflects the net loss for the period, offset in part by depreciation and amortization, share-based compensation and changes in the fair value of the common stock-warrant liability.

Net cash (used in) provided by investing activities was $(0.1) million for the year ended September 30, 2013, $(0.06) million for the year ended September 30, 2012, and $5.8 million for the year ended September

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30, 2011. Net cash used in investing activities for the years ended September 30, 2013 and 2012 reflects the purchase of property and equipment. Net cash provided by investing activities for the year ended September 30, 2011 primarily reflects the sale of marketable securities offset by the purchase of property and equipment.

Net cash provided by financing activities was $19.4 million for the year ended September 30, 2013, $17.1 million for the year ended September 30, 2012, and $28.2 million for the year ended September 30, 2011. Net cash provided by financing activities for the year ended September 30, 2013 primarily reflects proceeds from the sale of our securities in our underwritten public offering in June 2013 and through our employee stock purchase plan. Net cash provided by financing activities in 2012 primarily reflects proceeds from the sale our securities in our private placement offering in June 2012 and through our employee stock purchase plan. Net cash provided by financing activities in 2011 primarily reflects proceeds from the sale of our securities in our registered direct offering in May 2011 and through our employee purchase plan.

In June 2013, we completed an underwritten public offering of securities in which we issued 4,482,760 shares of our common stock at a price to the public of $4.35 per share. In July 2013 we issued 236,007 additional shares of common stock, at the public offering price of $4.35 per share, in connection with the underwriters' exercise of a portion of their over-allotment. We received net proceeds, after deducting placement agent fees and other offering expenses of approximately $19.2 million from this financing.

In June 2012, we completed a private placement of securities in which we issued 4,250,020 shares of our common stock, 3,605,607 shares of our Series B preferred stock and warrants to purchase 2,749,469 shares of our common stock. We received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $17.1 million from this financing.

In May 2011, we completed a registered direct offering of an aggregate of 3,018,736 shares of our common stock, 1,813,944 shares of our Series A Preferred Stock and warrants to purchase 2,256,929 shares of our common stock at an exercise price of $9.92 per share. The warrants will expire on May 17, 2016. We received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $28.0 million from this financing.

In August 2010, we completed a registered direct offering of an aggregate of 599,550 shares of our common stock and warrants to purchase an additional 559,550 shares of our common stock at an initial exercise price of $18.86 per share. We received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $8.7 million from this financing. In December 2010, the exercise price of the warrants was reset to $6.24 per share and in May 2011, the exercise price of the warrants was reset to $4.70 per share. In August 2011, warrants for a total of 10,550 shares were exercised and we received proceeds of approximately $50 thousand. The remaining warrants for 589,000 shares expired unexercised on December 1, 2011.

Funding Requirements

We believe that our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses and capital expenditures at least until the second calendar quarter of 2015. We have based this estimate upon assumptions that may prove to be wrong and we could use our available capital resources sooner than we currently expect. Our existing capital resources are not sufficient to complete our clinical development program for an ultra-rapid-acting insulin product candidate. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, and to the extent that we may or may not enter into collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current anticipated clinical trials.

Our future capital requirements will depend on many factors, including:

•the progress, timing or success of our research and development and clinical programs for our product candidates;

•the degree to which our ongoing assessment of the data from our recently completed Phase 2 clinical trial of BIOD-123, our lead candidate for an ultra-rapid-acting insulin formulation, and our related chemistry, manufacturing and controls development work, support further clinical development by us or our potential partners;

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•our ability to successfully use the data from our Phase 2 clinical trial of BIOD-123 to design and conduct the pivotal clinical trials required by the or FDA to secure approval to commercialize that candidate;

•the success of our formulation development work to improve the stability of our newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations;

•our ability to conduct the development work necessary to finalize the formulation and design of our dual-chamber glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of an NDA to the FDA for that product candidate;

•the results of our real-time stability programs for our RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and our ability to accurately project long term stability on the basis of accelerated testing;

•our ability to accurately anticipate technical challenges that we may face in the development of our ultra-rapid-acting RHI- and insulin analog-based product candidates or our glucagon rescue product candidates;

•our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;

•our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;

•our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;

•our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

•the degree of clinical utility of our product candidates, particularly with regard to our ultra-rapid-acting insulin formulations, which have not yet been shown to be clinically superior to existing rapid-acting insulin analogs;

•the emergence of competing technologies and products and other adverse market developments, such as advancements in glucagon stabilization technologies that could enable a room-temperature rescue product in a portable, easy to use presentation;

•the ability of our contract manufacturing organizations or collaborators to produce our products in our final dosage form;

•our ability to secure adequate supplies of active pharmaceutical ingredients to support our product development programs and, if successful, the commercialization one or more product candidates;

•our capabilities and strategies for manufacturing, marketing and commercializing a product candidate; and

•our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.

We do not anticipate generating product revenue for the next few years. In the absence of additional funding, we expect our continuing operating losses to result in increases in our cash used in operations over the next several years. To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. We do not currently have any commitments for future external funding.

We may receive additional proceeds from the exercise of the warrants that we issued in connection with our May 2011 registered direct offering and our June 2012 private placement, if any of those warrants are

56

exercised for cash. Whether the warrants are exercised for cash will depend on decisions made by the warrant holders and on whether the market price of our common stock exceeds the $9.92 per share warrant exercise price of the May 2011 warrants or the $2.66 per share warrant exercise price of the June 2012 warrants. The May 2011 warrants and the June 2012 warrants will expire on May 17, 2016 and June 26, 2017, respectively.

While we continue to pursue cost saving initiatives to reduce operating expenses, we will also need to raise additional funds and periodically explore sources of equity or debt financing. We may seek to raise such capital through public or private equity financings, partnerships, joint ventures, debt financings, bank borrowings or other sources. However, additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing shareholders may result. If we fail to obtain additional capital when needed, we may be required to delay, scale back, or eliminate some or all of our research and development programs. The accompanying financial statements do not include any adjustments that may result from the outcome of this uncertainty.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Our exposure to market risk is limited to our cash, cash equivalents and marketable securities. We invest in high-quality financial instruments, as permitted by the terms of our investment policy guidelines. Currently, our excess funds are invested in a premium commercial money market fund with one major financial institution. We do not hedge interest rate exposure. A portion of our investments may be subject to interest rate risk and could fall in value if interest rates were to increase.

Because most of our transactions are denominated in United States dollars, we do not have any material exposure to fluctuations in currency exchange rates.

57

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Refer to page F-1.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Not applicable.

ITEM 9A. CONTROLS AND PROCEDURES

Management's Evaluation of Disclosure Controls and Procedures

We are required to maintain disclosure controls and procedures designed to ensure that material information related to us is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2013 and, based on this evaluation, our chief executive officer and chief financial officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective.

Management's Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting for the company. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or under the supervision of, the company's principal executive and principal financial officers and effected by the company's board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

•pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;

•provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and

•provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company's assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

58

Our management assessed the effectiveness of our internal control over financial reporting as of September 30, 2013. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (1992).

Based on our assessment, management concluded that, as of September 30, 2013, our internal control over financial reporting is effective based on those criteria.

Changes in Internal Control over Financial Reporting

No change in our internal control over financial reporting occurred during the fiscal quarter ended September 30, 2013 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

59

PART III

Certain information required by Part III is omitted from this Annual Report on Form 10-K because we will file a definitive proxy statement within 120 days after the end of our fiscal year for our 2013 annual meeting of stockholders, or proxy statement, and the information included in the proxy statement is incorporated herein by reference.

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Certain information required by this Item is contained under the heading "Executive Officers of the Registrant" in Part I of this Annual Report on Form 10-K. Other information required by this Item will appear in our proxy statement and is incorporated herein by reference.

We have adopted a written code of business conduct and ethics that applies to our principal executive officer, principal financial officer, and principal accounting officer or controller, or persons performing similar functions. Our code of business conduct and ethics, which also applies to our directors and all of our officers and employees, can be found on our website, which is located at www.biodel.com. We intend to disclose any amendments to, or waivers from, our code of business conduct and ethics that are required to be publicly disclosed pursuant to rules of the Securities and Exchange Commission and the NASDAQ Capital Market by filing such amendment or waiver with the Securities and Exchange Commission and by posting it on our website.

ITEM 11. EXECUTIVE COMPENSATION

The information required by this Item will appear in our proxy statement and is incorporated herein by reference.

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by this Item will appear under the headings "Security Ownership of Certain Beneficial Owners and Management" and "Securities Authorized for Issuance under Equity Compensation Plans" in our proxy statement, which sections are incorporated herein by reference.

ITEM 13. CERTAIN RELATIONSHIP AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this Item will appear in our proxy statement and is incorporated herein by reference.

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by this Item will appear in our proxy statement and is incorporated herein by reference.

PART IV

ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES

(1) Financial Statements: See Index to Financial Statements and Schedules.

(2) Financial Statement Schedules: Not applicable.

(3) Exhibits: The Exhibit Index annexed to this report is incorporated by reference.

60

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BIODEL INC.
By:	/s/ Errol De Souza
	Dr. Errol De Souza President and Chief Executive Officer Date: December 20, 2013

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Signature	Title	Date
/s/ Errol De Souza	President and Chief Executive Officer (Principal Executive Officer), Director	December 20, 2013
Errol De Souza
/s/ Gerard J. Michel	Chief Financial Officer, Vice President, Corporate Development and Treasurer (Principal Financial and Accounting Officer)	December 20, 2013
Gerard J. Michel
/s/ Julia R. Brown	Director	December 20, 2013
Julia R. Brown
/s/ Barry H. Ginsberg	Director	December 20, 2013
Barry H. Ginsberg
/s/ Ira W. Lieberman	Director	December 20, 2013
Ira W. Lieberman
/s/ Daniel Lorber	Director	December 20, 2013
Daniel Lorber
/s/ Brian J.G. Pereira	Director	December 20, 2013
Brian J.G. Pereira
/s/ Davey S. Scoon	Director	December 20, 2013
Davey S. Scoon

61

Exhibits Index

Exhibit Number	Description of Document
3.1	Registrant's Second Amended and Restated Certificate of Incorporation (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
3.2	Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (Incorporated by reference to exhibit 4.6 to the Registrant's Current Report on Form 8-K filed on May 19, 2011).
3.3	Certificate of Amendment to Registrant's Second Amended and Restated Certificate of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on June 11, 2012).
3.4	Certificate of Designation of Series B Convertible Preferred Stock of the Registrant (Incorporated by reference to Exhibit 4.8 to the Registrant's Current Report on Form 8-K filed on June 27, 2012).
3.5	Certificate of Amendment of Registrant's Second Amended and Restated Certificate of Incorporation, as amended.
3.6	Registrant's Amended and Restated Bylaws (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
4.1	Specimen Common Stock Certificate (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
4.2	Form of Warrant to Purchase Shares of Common Stock issued in the Registrant's May 2011 registered direct offering (Incorporated by reference to exhibit 4.7 to the Registrant's Current Report on Form 8-K filed on May 13, 2011).
4.3	Form of Warrant issued in the Registrant's June 2012 private placement (Incorporated by reference to Exhibit 4.9 to the Registrant's Current Report on Form 8-K filed on June 21, 2012).
10.1	2010 Stock Incentive Plan, as amended March 8, 2012 (Incorporated by reference to Exhibit A of the Registrant's Definitive Proxy Statement on Schedule 14A filed on January 26, 2012).
10.2	2010 Incentive Stock Option Agreement (Incorporated by reference to the exhibits to the Registrant's Quarterly Report on Form 10-Q filed on May 7, 2010).
10.3	2010 Non Statutory Stock Option Agreement (Incorporated by reference to the exhibits to the Registrant's Quarterly Report on Form 10-Q filed on May 7, 2010).
10.4	2010 Restricted Stock Unit Agreement (Incorporated by reference to the exhibits to the Registrant's Quarterly Report on Form 10-Q filed on May 7, 2010).
10.5	Form of Indemnity Agreement entered into between the Registrant and its directors and certain of its executive officers (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.6	Amended and Restated 2004 Stock Incentive Plan (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.7	2005 Employee Stock Purchase Plan (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.8	2005 Non-Employee Directors' Stock Option Plan (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.9	Employment Agreement, dated March 26, 2010, between the Registrant and Errol B. De Souza (Incorporated by reference to the Registrant's Current Report on Form 8-K filed on April 1, 2010).

62

Exhibit Number	Description of Document
10.10	Change of Control Agreement entered into between the Registrant and certain of its executive officers (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.11	Executive Severance Agreement entered into between the Registrant and certain of its executive officers (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.12	Lease Agreement, dated February 2, 2004, between the Registrant and Mulvaney Properties, LLC and amendment thereto dated September 29, 2006 (Incorporated by reference to the exhibits to the Registrant's Registration Statement on Form S-1 (333-140504)).
10.13	Amendment to Lease Agreement, dated February 2, 2004, as amended, by and between the Registrant and Mulvaney Properties LLC. (Incorporated by reference to the Registrant's Current Report on Form 8-K filed on July 27, 2007).
10.14	Amendment to Lease Agreement, dated February 2, 2004, as amended, by and between the Registrant and Mulvaney Properties LLC. (Incorporated by reference to the Registrant's Current Report on Form 8-K filed on October 4, 2007).
10.15*	Amendment to Lease Agreement, dated February 2, 2004, as amended as of November 6, 2013, by and between the Registrant and Mulvaney Properties LLC.
10.16	Offer Letter, dated November 12, 2007, by and between the Registrant and Gerard J. Michel. (Incorporated by reference to the Registrant's Current Report on Form 8-K filed on November 14, 2007).
10.17	Form of Incentive Stock Option Agreement for 2004 Amended and Restated Stock Incentive Plan. (Incorporated by reference to the Registrant's Annual Report on Form 10-K filed on December 21, 2007).
10.18	Form of Option Agreement for 2005 Non-Employee Directors' Stock Option Plan. (Incorporated by reference to the Registrant's Annual Report on Form 10-K filed on December 21, 2007).
10.19	Base salaries of Executive Officers of the Registrant.
10.20	Summary of the Registrant's Non-Employee Director Compensation.
10.21†	Supply Agreement, dated July 7, 2008, between the Registrant and N.V. Organon (Incorporated by reference to exhibit 10.3 the Registrant's Quarterly Report on Form 10-Q filed on August 11, 2008).
10.22†	Letter Agreement, dated November 12, 2009, between the Registrant and N.V. Organon, amending the Supply Agreement, dated July 7, 2008, between the parties. (Incorporated by reference to exhibit 10.22 to Registrant's Annual Report on Form 10-K filed on December 14, 2009).
10.23†	Letter Agreement, dated July 25, 2011, between the Registrant and N.V. Organon amending the Supply Agreement dated July 7, 2008 (Incorporated by reference to Exhibit 10.27 to the Registrant's Annual Report on Form 10-K for the fiscal year ended September 30, 2011 filed on December 15, 2011).
10.24†	License Agreement, effective as of June 8, 2012, between Aegis Therapeutics, LLC and the Registrant (Incorporated by reference to Exhibit 10.01 to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 filed on August 14, 2012).
10.25*††	Commercial Supply Agreement, effective July 17, 2012, between Bachem Americas, Inc. and the Registrant.

63

Exhibit Number	Description of Document
10.26*††	Customization and Commercial Supply Agreement, effective April 8, 2013, between Unilife Medical Solutions, Inc. and the Registrant.
10.27	Securities Purchase Agreement, dated as of June 21, 2012, among the Registrant and the purchasers named therein (Incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed on June 21, 2012).
21.1	Subsidiaries of the Registrant.
23.1	Consent of BDO USA, LLP, Independent Registered Public Accounting Firm.
31.01	Chief Executive Officer — Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.02	Chief Financial Officer — Certification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.01	Chief Executive Officer and Chief Financial Officer — Certification pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS	XBRL Instance Document.*
101.SCH	XBRL Taxonomy Extension Schema Document.*
101.CAL	XBRL Taxonomy Calculation Linkbase Document.*
101.LAB	XBRL Taxonomy Label Linkbase Document.*
101.PRE	XBRL Taxonomy Presentation Linkbase Document.*
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.*

____________

†      Confidential treatment granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

††    Confidential treatment requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

*      Submitted electronically herewith

Attached as Exhibit 101 to this are the following formatted in XBRL (Extensible Business Reporting Language): (i) Balance Sheets; (ii) Statements of Operations, (iii) Statements of Stockholders' Equity; (iv) Statements of Comprehensive Loss; (v) Statements of Cash Flows; and (vi) Notes to Financial Statements.

In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Annual Report on Form 10-K is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act, is deemed not filed for purposes of section 18 of the Exchange Act, and otherwise is not subject to liability under these sections.

64

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BIODEL INC.

INDEX TO FINANCIAL STATEMENTS

	Page
Report of independent registered public accounting firm	F-2
Balance sheets	F-3
Statements of operations	F-4
Statements of stockholders' equity	F-5
Statements of cash flows	F-7
Notes to financial statements	F-9

F-1

Report of Independent Registered Public Accounting Firm

Board of Directors and Stockholders
Biodel Inc.
Danbury, Connecticut

We have audited the accompanying balance sheets of Biodel Inc. (a development stage company) as of September 30, 2013 and 2012 and the related statements of operations, stockholders' equity and cash flows for each of the three years in the period ended September 30, 2013 and the statements of operations, stockholders' equity and cash flows for the period from December 3, 2003 (inception) to September 30, 2013. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Biodel Inc. as of September 30, 2013 and 2012, and the results of its operations and its cash flows for each of the three years in the period ended September 30, 2013, and for the period from December 3, 2003 (inception) to September 30, 2013, in conformity with accounting principles generally accepted in the United States.

/s/ BDO USA, LLP
 
New York, New York
December 20, 2013

F-2

Biodel Inc.
(A Development Stage Company)

Balance Sheets
(In thousands, except share and per share amounts)

		September 30,
		2012			2013
ASSETS
Current:
Cash and cash equivalents	$	39,050			39,781
Restricted cash		60			-
Taxes receivable		34			6
Grant receivable		88			26
Other receivable		9			-
Prepaid and other assets		295			264
Total current assets		39,536			40,077
Property and equipment, net		1,552			1,031
Intellectual property, net		46			43
Total assets	$	41,134		$	41,151
LIABILITIES AND STOCKHOLDERS' EQUITY
Current:
Accounts payable	$	285		$	246
Accrued expenses:
Clinical trial expenses		488			181
Payroll and related		1,248			1,139
Accounting and legal fees		244			226
Severance		141			255
Other		273			319
Income taxes payable		101			75
Total current liabilities		2,780			2,441
Common stock warrant liability		7,338			6,121
Severance payable, long term portion		—			26
Total liabilities		10,118			8,588
Commitments
Stockholders' equity:
Convertible preferred stock, $.01 par value; 50,000,000 shares authorized, 5,419,551 and 1,950,000 issued and outstanding		54			19
Common stock, $.01 par value; 62,500,000 shares authorized; 14,174,545 and 21,070,824 issued and outstanding		142			211
Additional paid-in capital		226,913			247,761
Deficit accumulated during the development stage		(196,093	)		(215,428	)
Total stockholders' equity		31,016			32,563
Total liabilities and stockholders' equity	$	41,134		$	41,151

See accompanying notes to financial statements.

F-3

Biodel Inc.
(A Development Stage Company)

Statements of Operations
(In thousands, except share and per share amounts)

		Year Ended September 30,									December 3, 2003 (Inception) to September 30, 2013
		2011			2012			2013
Revenue	$	—		$	—		$	—		$	—
Operating expenses:
Research and development		13,597			12,315			14,296			155,400
Government grants		—			(88	)		(546	)		(634	)
General and administrative		9,625			7,072			6,843			72,201
Total operating expenses		23,222			19,299			20,593			226,967
Other (income) and expense:
Interest and other income		(60	)		(80	)		(56	)		(5,702	)
Interest expense		—			—			—			78
Adjustments to fair value of common stock warrant liability		(12,611	)		1,510			(1,217	)		(11,064	)
Loss on settlement of debt		—			—			—			627
Loss before tax provision (benefit)		(10,551	)		(20,729	)		(19,320	)		(210,906	)
Tax provision (benefit)		41			18			15			(538	)
Net loss		(10,592	)		(20,747	)		(19,335	)		(210,368	)
Charge for accretion of beneficial conversion rights		—			—			—			(603	)
Deemed dividend — warrants		—			—			—			(4,457	)
Net loss applicable to common stockholders	$	(10,592	)	$	(20,747	)	$	(19,335	)	$	(215,428	)
Net loss per share — basic and diluted*	$	(1.36	)	$	(1.91	)	$	(1.24	)
Weighted average shares outstanding — basic and diluted*		7,788,741			10,882,688			15,650,538

____________

* Restated for a one for four (1:4) reverse stock split effective on June 11, 2012.

See accompanying notes to financial statements.

F-4

Biodel Inc.
(A Development Stage Company)

Statements of Stockholders' Equity
(In thousands, except share and per share amounts)

	Common Stock $01 Par Value			Series A Preferred stock $.01 Par Value					Series B Preferred stock $.01 Par Value						Additional Paid in Capital			Accumulated Other Comprehensive Income (loss)			Deficit Accumulated During the Development Stage			Total Stockholders' Equity
	Shares		Amount	Shares			Amount		Shares			Amount
Balance at Inception (December 3, 2003)	—	$	—	—		$	—		—		$	—		$	—		$	—		$	—		$	—
Shares issued to employees	183,126		2	—			—		—			—			(2	)		—			—			—
January 2004 Proceeds from sale of common stock	1,145,306		11	—			—		—			—			1,343			—			—			1,354
Net loss	—		—	—			—		—			—			—			—			(774	)		(774	)
Balance, September 30, 2004	1,328,432	$	13	—		$	—		—		$	—		$	1,341		$	—		$	(774	)	$	580
Additional stockholder contributions	—		—	—			—		—			—			514			—			—			514
Stock-based compensation	—		—	—			—		—			—			353			—			—			353
Shares issued to employees and directors for services	10,658		—	—			—		—			—			61			—			—			61
July 2005 Private placement — Sale of Series A preferred stock, net of issuance costs of $379	—		—	569,000			6		—			—			2,460			—			—			2,466
Founder's compensation contributed to capital	—		—	—			—		—			—			63			—			—			63
Net loss	—		—	—			—		—			—			—			—			(3,383	)		(3,383	)
Balance, September 30, 2005	1,339,090	$	13	569,000		$	6		—		$	—		$	4,792		$	—		$	(4,157	)	$	654
Stock-based compensation	—		—	—			—		—			—			1,132			—			—			1,132
July 2006 Private placement — Sale of Series B preferred stock, net of issuance costs of $1,795	—		—	—			—		5,380,711			54			19,351			—			—			19,405
July 2006 — Series B preferred stock units issued July 2006 to settle debt	—		—	—			—		817,468			8			3,194			—			—			3,202
Shares issued to employees and directors for services	988		—	—			—		—			—			23			—			—			23
Accretion of fair value of beneficial conversion charge	—		—	—			—		—			—			603			—			(603	)		—
Net loss	—		—	—			—		—			—			—			—			(8,068	)		(8,068	)
Balance, September 30, 2006	1,340,078	$	13	569,000		$	6		6,198,179		$	62		$	29,095		$	—		$	(12,828	)	$	16,348
May 2007 Proceeds from sale of common stock	1,437,500		14	—			—		—			—			78,741			—			—			78,755
Conversion of preferred stock on May 16, 2007	1,601,749		16	(569,000	)		(6	)	(6,198,179	)		(62	)		52			—			—			—
Stock-based compensation	—		—	—			—		—			—			4,224			—			—			4,224
Shares issued to employees, non-employees and directors for services	732		—	—			—		—			—			16			—			—			16
Stock options exercised	885		—	—			—		—			—			5			—			—			5
March 2007 Warrants exercised	659,226		7	—			—		—			—			416			—			—			423
Deemed dividend — warrants	—		—	—			—		—			—			4,457			—			(4,457	)		—
Net loss	—		—	—			—		—			—			—			—			(22,548	)		(22,548	)
Balance, September 30, 2007	5,040,170	$	50	—		$	—		—		$	—		$	117,006		$	—		$	(39,833	)	$	77,223
Proceeds from sale of common stock	815,000		8	—			—		—			—			46,809			—			—			46,817
Issuance of restricted stock	2,428		—	—			—		—			—			172			—			—			172
Stock-based compensation	—		—	—			—		—			—			6,503			—			—			6,503
Stock options exercised	43,600		1	—			—		—			—			901			—			—			902
Warrants exercised	19,802		—	—			—		—			—			112			—			—			112
Net unrealized loss on Marketable Securities	—		—	—			—		—			—			—			(62	)		—			(62	)
Proceeds from sale of stock — ESPP	3,596		—	—			—		—			—			181			—			—			181
Net loss	—		—	—			—		—			—			—			—			(43,361	)		(43,361	)
Balance, September 30, 2008	5,924,596	$	59	—		$	—		—			—		$	171,684		$	(62	)	$	(83,194	)	$	88,487
Stock-based compensation	—		—	—			—		—			—			5,064			—			—			5,064
Stock options exercised	4,413		—	—			—		—			—			25			—			—			25
Net unrealized gain on Marketable Securities	—		—	—			—		—			—			—			62			—			62
Proceeds from the sale of stock — ESPP	21,863		—	—			—		—			—			170			—			—			170
Net loss																					(43,270	)		(43,270	)
Balance, September 30, 2009	5,950,872	$	59	—		$	—		—		$	—		$	176,943		$	—		$	(126,464	)	$	50,538
Registered direct financing	599,550		6	—			—		—			—			8,706			—			—			8,712
Initial value of warrants issued in a registered direct	—		—	—			—		—			—			(2,915	)		—			—			(2,915	)
Stock-based compensation	—		—	—			—		—			—			5,621			—			—			5,621
Stock options exercised	8,076		—	—			—		—			—			68			—			—			68
Net unrealized gain on marketable securities	—		—	—			—		—			—			—			1			—			1
Proceeds from the sale of stock — ESPP	41,393		1	—			—		—			—			324			—			—			325
Net loss	—		—	—			—		—			—			—			—			(38,290	)		(38,290	)

See accompanying notes to financial statements.

F-5

Biodel Inc.
(A Development Stage Company)

Statements of Stockholders' Equity
(In thousands, except share and per share amounts)

	Common Stock $01 Par Value				Series A Preferred stock $.01 Par Value					Series B Preferred stock $.01 Par Value						Additional Paid in Capital			Accumulated Other Comprehensive Income (loss)			Deficit Accumulated During the Development Stage			Total Stockholders' Equity
	Shares			Amount	Shares			Amount		Shares			Amount
Balance, September 30, 2010	6,599,891		$	66	—		$	—		—		$	—		$	188,747		$	1		$	(164,754	)	$	24,060
Registered direct financing	3,018,736			30	1,813,944			18		—			—			27,913			—			—			27,961
Initial value of warrants issued in a registered direct offering	—			—	—			—		—			—			(9,438	)		—			—			(9,438	)
Stock-based compensation	—			—	—			—		—			—			4,920			—			—			4,920
Stock options exercised	104			—	—			—		—			—			—			—			—			—
Warrants exercised	10,549			—	—			—		—			—			50			—			—			50
RSU's granted	15,537			—	—			—		—			—			—			—			—			—
Net unrealized loss on marketable securities	—			—	—			—		—			—			—			(1	)		—			(1	)
Proceeds from the sale of stock — ESPP	17,051			—	—			—		—			—			118			—			—			118
Net loss	—			—	—			—		—			—			—			—			(10,592	)		(10,592	)
Balance, September 30, 2011	9,661,868		$	96	1,813,944		$	18		—		$	—		$	212,310		$	—		$	(175,346	)	$	37,078
Proceeds from the sale of unregistered securities	4,250,020			43	—			—		3,605,607			36			16,999			—			—			17,078
Initial value of warrants issued in private placement financing	—			—	—			—		—			—			(4,832	)		—			—			(4,832	)
Stock-based compensation	—			—	—			—		—			—			1,828			—			—			1,828
Proceeds from the sale of stock — ESPP	10,776			—	—			—		—			—			27			—			—			27
RSUs issued to settle bonus liability	191,719			2	—			—		—			—			582			—			—			584
RSUs granted	60,409			1	—			—		—			—			(1	)		—			—			—
Net loss	—			—	—			—		—			—			—			—			(20,747	)		(20,747	)
Company re-purchase of fractional shares from the reverse stock split	(247	)		—	—			—		—			—			—			—			—			—
Balance, September 30, 2012	14,174,545		$	142	1,813,944		$	18		3,605,607		$	36		$	226,913		$	—		$	(196,093	)	$	31,016
Proceeds from sale of common stock	4,718,767			47	—			—		—			—			19,192			—			—			19,239
Preferred stock conversion	2,109,090			22	(1,813,944	)		(18	)	(1,655,607	)		(17	)		13			—			—			—
Stock-based compensation	—			—	—			—		—			—			1,538			—			—			1,538
Proceeds from the sale of stock — ESPP	13,395			—	—			—		—			—			30			—			—			30
Stock options exercised	30,250			—	—			—		—			—			75			—			—			75
RSUs granted	24,777			—	—			—		—			—			—			—			—			—
Net loss	—			—	—			—		—			—			—			—			(19,335	)		(19,335	)
Balance, September 30, 2013	21,070,824		$	211	—		$	—		1,950,000		$	19		$	247,761		$	—		$	(215,428	)	$	32,563

See accompanying notes to financial statements.

F-6

Biodel Inc.
(A Development Stage Company)

Statements of Cash Flows
(In thousands, except share and per share amounts)

		Year Ended September 30,									December 3, 2003 (Inception) to September 30, 2013
		2011			2012			2013
Cash flows from operating activities:
Net loss	$	(10,592	)	$	(20,747	)	$	(19,335	)	$	(210,368	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		938			725			641			5,444
Founder's compensation contributed to capital		—			—			—			271
Share-based compensation for employees and directors		4,964			1,828			1,538			29,162
Share-based compensation for non-employees		(44	)		—			—			2,274
Loss on settlement of debt		—			—			—			627
Write-off of capitalized patent expense		—			38			—			246
Write-off of loan to related party		—			—			—			41
Adjustment to fair value of common stock warrant liability		(12,611	)		1,510			(1,217	)		(11,064	)
(Increase) decrease in:
Prepaid expenses and other assets		(41	)		111			31			(264	)
Income taxes receivable		81			1			28			(6	)
Grant receivable		—			(88	)		63			(25	)
Other receivable		10			(8	)		8			(1	)
Increase (decrease) in:
Accounts payable		(1,767	)		63			(39	)		246
Income tax payable		58			(2	)		(26	)		75
Accrued expenses and other liabilities		753			(128	)		(247	)		2,950
Total adjustments		(7,659	)		4,050			780			29,976
Net cash used in operating activities		(18,251	)		(16,697	)		(18,555	)		(180,392	)
Cash flows from investing activities:
Purchase of property and equipment		(189	)		(59	)		(118	)		(6,467	)
Purchase of marketable securities		—			—			—			(31,614	)
Sale of marketable securities		6,000			—			—			31,614
Capitalized intellectual properties		—			—			—			(298	)
Loan to related party		—			—			—			(41	)
Net cash (used in) provided by investing activities		5,811			(59	)		(118	)		(6,806	)
Cash flows from financing activities:
Restricted cash		90			—			60			—
Options exercised		—			—			75			1,075
Warrants exercised		50			—			—			585
Net proceeds from employee stock purchase plan		118			27			30			851
Deferred public offering costs		—			—			—			(1,458	)
Stockholder contribution		—			—			—			1,660
Net proceeds from sale of Series A preferred stock 2005		—			—			—			2,466
Net proceeds from sale of Series A preferred stock 2011		2,685			—			—			2,685
Net proceeds from sale of common stock		25,276			—			19,239			180,257
Proceeds from bridge financing		—			—			—			2,575
Net proceeds from sale of Series B preferred stock 2006		—			—			—			19,205
Net proceeds from sale of Series B preferred stock 2012		—			8,491			—			8,491
Net proceeds from sale of unregistered common stock — private placement		—			8,587			—			8,587
Net cash provided by financing activities		28,219			17,105			19,404			226,979
Net increase in cash and cash equivalents		15,779			349			731			39,781
Cash and cash equivalents, beginning of period		22,922			38,701			39,050			—
Cash and cash equivalents, end of period	$	38,701		$	39,050		$	39,781		$	39,781
Cash paid for interest and income taxes was:
Interest	$	—		$	—		$	—		$	9
Income taxes		—			20			12			338

See accompanying notes to financial statements.

F-7

		Year Ended September 30,						December 3, 2003 (Inception) to September 30, 2013
		2011		2012		2013
Non-cash financing and investing activities:
Warrants issued in connection with registered direct offering	$	9,438	$	—	$	—	$	12,353
Warrants issued in connection with unregistered common stock — private placement		—		4,832		—		4,832
Settlement of debt with Series B preferred stock		—		—		—		3,202
Accrued expenses settled with Series B preferred stock		—		—		—		150
Deemed dividend — warrants		—		—		—		4,457
Accretion of fair value of beneficial charge on preferred stock		—		—		—		603
Conversion of convertible preferred stock to common stock		—		—		—		68
Issuance of restricted stock units to settle accrued bonus		—		584		—		584

See accompanying notes to financial statements.

F-8

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements

(In thousands, except share and per share amounts)

1. Business and Basis of Presentation

Business

Biodel Inc. and its wholly owned subsidiary (collectively, "Biodel" or the "Company", and formerly Global Positioning Group Ltd.) is a development stage specialty pharmaceutical company located in Danbury, Connecticut. The Company was incorporated in the State of Delaware on December 3, 2003 and commenced operations in January 2004. The Company formed a wholly owned subsidiary in the United Kingdom in October 2011 ("Biodel UK Limited"). This subsidiary has been inactive since its inception.

The Company focuses on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. The Company's develops its product candidates by applying its proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. The Company's proprietary insulin formulations are designed to be more rapid-acting than the formulations currently available to Type 1 and Type 2 diabetes patients. The Company refers to these as "ultra-rapid-acting" formulations. The Company's glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose.

The Company's most advanced ultra-rapid-acting insulin formulation, BIOD-123, combines recombinant human insulin, or RHI, with the Company's proprietary combination of excipients to increase the rate of absorption following injection when compared to other commercially available insulin formulations, including "rapid-acting" mealtime insulin analogs such as Humalog®, marketed by Eli Lilly, Novolog®, marketed by Novo Nordisk and Apidra®, marketed by Sanofi-Aventis. The Company is also using its proprietary excipients to develop ultra-rapid-acting insulin analog-based formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog®, or insulin aspart, the active pharmaceutical ingredient in NovoLog®.

In addition the Company also has other products in the development stage.

Basis of Presentation

The Company is in the development stage, as defined by Financial Accounting Standards Board ("FASB") ASC 915 (prior authoritative literature: Statement of Financial Accounting Standards No. 7), "Accounting and Reporting by Development Stage Enterprises", as its primary activities since incorporation have been establishing its facilities, recruiting personnel, conducting research and development, business development, business and financial planning and raising capital.

On June 11, 2012, the Company effected a one-for-four reverse split of its outstanding common stock. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the reverse split for all periods reported. (See Note 12.)

2. Summary of Significant Accounting Policies

Research and Development Costs

The Company is in the business of research and development and, therefore, research and development costs include, but are not limited to, salaries and benefits, lab supplies, preclinical fees, clinical trial and related clinical manufacturing costs, allocated overhead costs and professional service providers. Research and development costs are expensed when incurred. Research and development costs aggregated $13,597, $12,315, and $14,296 for the years ended September 30, 2011, 2012 and 2013, respectively.

Government Grants

Grants received are recognized as grant income when the grants become receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is

F-9

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

reasonable assurance the grant will be received. The Company requests cash funding under approved grants as expenses are incurred (not in advance) and report these receipts on the statement of operations as a separate line item entitled "Government Grants" with the corresponding expenses included in research and development. In July and September 2012, the Company was awarded two National Institutes of Health grants for the development of concentrated ultra-rapid-acting insulin formulation and glucagon formulation, respectively, for use in an artificial pancreas. Both awards are for two years and total approximately $580 each. Work on the grant for the development of concentrated ultra-rapid-acting insulin formulation started in August 2012 and expenses incurred were $327 during the year ended September 30, 2013 and $88 for the year ended September 30, 2012. Work on the grant for the development of novel and stable glucagon formulations for closed loop systems started in January 2013, and expenses incurred were $219 during the year ended September 30, 2013. Corresponding income and receivable were recorded.

Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions including, but not limited to, accruals, income taxes payable, forfeiture rate used in the computation of share-based compensation and deferred tax assets. Actual results may differ from those estimates.

Cash and Cash Equivalents

The Company considers currency on hand, demand deposits and all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash and cash equivalents. As of September 30, 2012 and 2013, the Company had cash and cash equivalents of $39,050 and $39,781, respectively, and they are primarily held in a premium commercial money market account.

Restricted Cash

Restricted cash was $60 and $0 as of September 30, 2012 and 2013. This amount was held in a money market account with a bank to secure a credit card purchasing agreement utilized to facilitate employee travel and certain ordinary purchases. As of September 30, 2013 the Company canceled the credit card purchasing agreement and the restriction on the cash was lifted.

In February 2012, the Company brought action against one of its vendors before the American Arbitration Association in New York relating to disputed fees charged to the Company for inventory storage. As part of the arbitration stipulation, the Company established a $1,500 escrow account and recorded an accrual of $741 toward this claim. During the quarter ended June 30, 2012, the Company paid $500 from the escrow account. On July 30, 2012, the Company received a judgment from the arbitrator stating the Company's final amount due was $55. The remaining escrow balance of $945 was removed from the escrow account and transferred to cash. The remaining accrual of $186 was reversed and recorded in research and development expense during the quarter ended September 30, 2012.

Fair Value of Financial Instruments

The carrying amounts of the Company's financial instruments, which include cash and cash equivalents and accounts payable, approximate their fair values due to their short term maturities.

Pre-Launch Inventory

Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If

F-10

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Because all of its product candidates are in early stages of preclinical or clinical development, the Company currently expenses all purchases of pre-launch inventory as research and development, and expects to continue to do so until it can determine the probability of regulatory approval for the applicable product candidate.

For the years ended September 30, 2012 and 2013, the Company expensed $170 and $121, respectively, of costs associated with the purchase of RHI and glucagon as research and development expense after such materials passed quality control inspection by the Company and transfer of title occurred.

Intellectual Property

Intangible assets consist primarily of capitalized costs associated with the Company's ultra-rapid-acting insulin patents and the purchase of two domain addresses. They are amortized using the straight-line method over twenty years. If the Company determines that a patent will not result in future revenues, the cost related to such patent will be expensed in full on the date of that determination. Intellectual property amortization expense for the years ended September 30, 2011, 2012 and 2013 was $4, $3, and $3, respectively.

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation or amortization. Major improvements are capitalized, while maintenance and repairs are expensed in the period the cost is incurred. Property and equipment are depreciated over their estimated useful lives using the straight-line method. Leasehold improvements are amortized using the straight-line method over their estimated useful lives, or the remaining term of the lease, whichever is shorter. When assets are retired or otherwise disposed of, the assets and related accumulated depreciation are removed from the accounts and resulting gains or losses are included in other income (expense) in the statement of operations. Estimated useful lives for each asset category are as follows: Furniture and fixtures — 7 years; Leasehold improvements — estimated useful life or remaining term of lease, whichever is shorter; Laboratory equipment — 7 years; Manufacturing equipment — 5 years; Device development— 5 years; Facility equipment— 3 years and 7 years; Computer equipment — 5 years; and Computer software — 3 years.

Impairment of Long-Lived Assets

Whenever events or changes in circumstances indicate that the carrying amounts of a long-lived asset may not be recoverable, the Company reviews these assets for impairment and determines whether adjustments are needed to carrying values. There were no adjustments to the carrying value of long-lived assets at September 30, 2012 and 2013.

Warrant Liability

The Company applies the provisions of Accounting Standards Codification Topic 480 ("ASC 480") (formerly FASB Staff Position 150-5 (FSP 15-5)), Issuers Accounting under FASB Statement No. 150 for Freestanding Warrants and other Similar Instruments on Shares that are Redeemable or Distinguishing Liabilities from Equities. Pursuant to ASC 480, a freestanding financial instrument (other than outstanding share) that, at inception, embodies an obligation to repurchase the issuer's shares and "requires or may require" the obligation to be settled by transferring assets, qualifies as a liability (if the obligation is conditional, the number of conditions is irrelevant).

The Company issued warrants in June 2012 and recorded a liability determined by the Black-Scholes valuation model. The Black-Scholes valuation model was used because the June 2012 warrants do not contain a repricing provision. The Black-Scholes valuation model takes into account, as of the valuation date, factors

F-11

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. These warrants will be revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."

The Company issued warrants in May 2011 and recorded a liability determined by the Black-Scholes valuation model. The Black-Scholes valuation model was used because the May 2011 warrants do not contain a repricing provision. These warrants will be revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."

The Company issued warrants in August 2010 and recorded a liability determined by the Monte Carlo simulation method, which was used because the August 2010 warrants contain a re-pricing provision. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of future expected stock prices of the Company and its peer group and minimize standard error.

On December 2, 2011, the unexercised warrants to purchase 589,000 shares of common stock expired. The Company revalued the liability associated with these warrants from September 30, 2011 through the date of expiration and there was no material impact on the statement of operations. The common stock warrant liability associated with these warrants no longer exists.

Income Taxes

The Company uses the asset and liability method of accounting for deferred income taxes. The provision for income taxes includes income taxes currently payable and those deferred as a result of temporary differences between the financial statement and tax bases of assets and liabilities. A valuation allowance is provided to reduce deferred tax assets to the amount of future tax benefit when it is more likely than not that some portion of the deferred tax assets will not be realized. Projected future taxable income and ongoing tax planning strategies are considered and evaluated when assessing the need for a valuation allowance. Any increase or decrease in a valuation allowance could have a material adverse or beneficial impact on the Company's income tax provision and net income or loss in the period which the determination is made.

Concentration of Risks and Uncertainties

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company deposits excess cash with major financial institutions in the United States. Balances may exceed the amount of insurance provided on such deposits. The Company believes that its investment policy guideline for its excess cash maintains safety and liquidity through its policies on credit requirements, diversification and investment maturity.

The Company has experienced significant operating losses since inception. At September 30, 2013, the Company had a deficit accumulated during the development stage of $215,428. The Company has generated no revenue to date. The Company has funded its operations to date principally from the sale of securities. The Company expects to incur substantial additional operating losses for the next several years and will need to obtain additional financing in order to complete the clinical development of an ultra-rapid-acting insulin or a glucagon rescue product, launch and commercialize the product if it receives regulatory approval, and continue research and development programs. There can be no assurance that such financing will be available or will be at terms acceptable to the Company.

The Company is currently developing its first product candidates and has no products that have received regulatory approval. Any products developed by the Company will require approval from the FDA or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company's products will

F-12

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

receive the necessary approvals. If the Company is denied such approvals or such approvals are delayed, it would have a material adverse effect on the Company's future operating results.

To achieve profitable operations, the Company must successfully develop, test, manufacture and market products, as well as secure the necessary regulatory approvals. There can be no assurance that any such products can be developed successfully or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed. These factors would have a material adverse effect on the Company's future financial results.

Stock-Based Compensation

In March 2013, the shareholders of the Company approved the amended and restated 2010 Stock Incentive Plan (the "2010 Plan"). Up to 3,750,000 shares of the Company's common stock may be issued pursuant to awards granted under the 2010 Plan, plus 1,540,739 shares of common stock underlying already outstanding awards under the Company's prior plans. As of September 30, 2013, the Company had 1,951,347 shares of common stock subject to outstanding awards. The contractual life of options granted under the 2010 Plan may not exceed seven years. The 2010 Plan uses a "fungible share" concept under which any awards that are not a full-value award will be counted against the share limit as one (1) share for each share of common stock and any award that is a full-value award will be counted against the share limit as 1.5 shares for each one share of common stock. The Company has not made any new awards under any prior equity plans after March 2, 2010, the effective date the 2010 Plan was approved by the Company's stockholders. The 2010 Plan replaces the 2004 Stock Incentive Plan and 2005 Non-Employee Directors Stock Option Plan.

The Company uses the Black-Scholes pricing model to calculate the fair value of stock options. The expected life for grants was calculated in accordance with the simplified method described in the Securities and Exchange Commission Staff Accounting Bulletin (SAB) Topic 14.D.2 in accordance with SAB No. 110.

The risk-free rate of interest for periods within the contractual life of the stock option award is based on the yield of U.S. Treasury strips on the date the award is granted with a maturity equal to the expected term of the award. The Company estimates forfeitures based on actual forfeitures during its limited history. Additionally, the Company has assumed that dividends will not be paid.

For stock options granted to non-employees, the Company measures fair value of the equity instruments utilizing the Black-Scholes valuation model, if that value is more reliably measurable than the fair value of the consideration or service received. The fair value of these instruments is periodically revalued as the options vest, and is recognized as expense over the related period of service or vesting period, whichever is longer. The total cost expensed (credited) for options granted to non-employees for the years ended September 30, 2011, 2012 and 2013 was $(44), $0, and $0, respectively.

The Company expenses ratably over the vesting period the cost of the stock options granted to employees and directors. The total compensation cost for the years ended September 30, 2011, 2012, and 2013 was $4,964, $1,828, and $1,538 respectively. At September 30, 2013, the total compensation cost related to non-vested options not yet recognized was $871, which will be recognized over the next three years assuming the employees complete their service period for vesting of the options. The Black-Scholes valuation model assumptions are as follows and were determined as discussed above:

	Year Ended September 30,
	2011	2012	2013
Expected life (in years)	3.77 - 5.25	3.0 - 4.75	2.39-4.75
Expected volatility	65 - 72%	58 - 76%	80-96%
Expected dividend yield	0%	0%	0%
Risk-free interest rate	0.75 - 1.97%	0.39 - 0.91%	0.25-0.75%
Weighted-average grant date fair value	$6.36	$2.54	$2.43

F-13

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

Participating Securities

In June 2008 the Financial Accounting Standards Board ("FASB") issued ASC 260-10-55 Earnings Per Share — Overall (formerly Financial Statement Position Emerging Issues Task Force 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities) ("ASC 260-10-55"). ASC 260-10-55 provides that securities and unvested share-based payment awards that contain non-forfeitable rights to dividends or dividend equivalents (whether paid or unpaid) are participating securities and shall be included in the computation of earnings per share pursuant to the two-class method.

Warrant Liability — Given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55. These securities were excluded from the per share calculation for all years since their inclusion would be anti-dilutive.

Restricted Stock Units — Given that the holders of Restricted Stock Unit awards ("RSUs") will only receive dividends or dividend equivalents on RSUs that have vested prior to the Company declaring dividends as well as forfeiting their rights to receive dividends or dividend equivalents on any unvested portion, the Company determined that the RSUs are non-participating securities and therefore are not subject to ASC 260-10-55.

Reclassifications:

Certain items in the prior year's financial statements have been reclassified to conform with the current year's presentation.

3. Fair Value Measurement

ASC Topic 820 ("ASC 820"), originally issued as SFAS No. 157, Fair Value Measurements) applies under other accounting pronouncements that require or permit fair value measurements, the FASB having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, ASC 820 does not require any new fair value measurements. The fair value framework requires the categorization of assets and liabilities into three levels based upon the assumptions (inputs) used to price the assets or liabilities. The three levels of inputs used are as follows:

Level 1 — Quoted prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.

As of September 30, 2012 and 2013, the Company had assets and liabilities that fell under the scope of ASC 820. The fair value of the Company's warrant liability was determined by the Monte Carlo simulation method for the warrants issued in connection with the Company's August 2010 financing and by the Black-Scholes valuation model for the warrants issued in connection with the Company's May 2011 and June 2012 financings. The Monte Carlo simulation method is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of future expected stock prices of the Company and its peer group and minimize standard error. The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on

F-14

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

the stock, and the risk-free interest rate for the term of the warrant. Accordingly, the Company's fair value measurements of its warrant liability is classified as a Level 3 input.

The fair value of the Company's financial assets and liabilities carried at fair value and measured on a recurring basis are as follows:

Description		Fair Value at September 30, 2013			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	39,781		$	39,781		—		—
Subtotal		39,781			39,781		—		—
Liabilities:
Common stock warrant liability		(6,121	)		—		—		(6,121	)
Subtotal		(6,121	)		—		—		(6,121	)
Total	$	33,660		$	39,781	$	—	$	(6,121	)

Description		Fair Value at September 30, 2012			Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Market Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Assets:
Cash and cash equivalents	$	39,050		$	39,050	$	—	$	—
Restricted cash		60			60		—		—
Subtotal		39,110			39,110		—		—
Liabilities:	·
Common stock warrant liability		(7,338	)		—		—		(7,338	)
Subtotal		(7,338	)		—		—		(7,338	)
Total	$	31,772		$	39,110	$	—	$	(7,338	)

The Company recognizes transfers into and out of the levels indicated above on the actual date of the event or change in circumstances that caused the transfer of change. All changes within Level 3 can be found in the following Level 3 reconciliation table:

Balance at September 30, 2009	$	—
August 2010 warrant — initial fair value at the date of issuance		(2,915	)
Increase in fair value		(1,254	)
Balance at September 30, 2010		(4,169	)
May 2011 warrant — initial fair value at the date of issuance		(9,438	)
Exercise of warrants		29
Decrease in fair value		12,582
Balance at September 30, 2011		(996	)
June 2012 warrant — initial fair value at the date of issuance		(4,832	)
Increase in fair value		(1,510	)
Balance at September 30, 2012		(7,338	)
Decrease in fair value		1,217
Balance at September 30, 2013	$	(6,121	)

F-15

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The following table presents the Company's liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of September 30, 2012 and September 30, 2013:

Description		Quoted Prices in Active Markets for identical Assets and Liabilities (Level 1)		Significant other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Balance as of September 30, 2012		Quoted Prices in Active Markets for identical Assets and Liabilities (Level 1)		Significant other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Balance as of September 30, 2013
Derivative liabilities related to Warrants	$	—	$	—	$	7,338	$	7,338	$	—	$	—	$	6,121	$	6,121

The following table sets forth a summary of changes in the fair value of the Company's Level 3 liabilities for the twelve months ended September 30, 2013 and September 30, 2012:

Description		Balance at September 30, 2011		Fair Value of warrants upon issuance		Unrealized (gains) or losses		Balance as of September 30, 2012		Fair Value of warrants upon issuance		Unrealized (gains) or losses			Balance as of September 30, 2013
Derivative liabilities related to Warrants	$	996	$	4,832	$	1,510	$	7,338	$	—	$	(1,217	)	$	6,121

The unrealized gains or losses on the derivative liabilities are recorded as a change in fair value of derivative liabilities in the Company's statement of operations. A financial instrument's level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. The fair value of cash and cash equivalents as of September 30, 2013 and 2012 are $39,781 and $39,050, respectively, and the fair value of accounts payable as of September 30, 2013 and 2012 is $246 and $285, respectively, which approximates Net Book Value due to the short term.

4. Net Loss per Share

Net loss per share information is determined using the two-class method, which includes the weighted-average number of common shares outstanding during the period and other securities that participate in dividends ("participating securities"). The Company considers the outstanding warrants participating securities because they include rights to participate in dividends with the common stock on a one-for-one basis. In applying the two-class method, earnings are allocated to both common stock shares and warrants based on their respective weighted-average shares outstanding for the period. Since losses are not allocated to the participating securities, the two-class method results in the same loss per common share calculated using the basic method for the periods presented in these financial statements.

Basic and diluted net loss per share has been calculated by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. All potentially dilutive common shares have been excluded from the calculation of weighted average common shares outstanding since their inclusion would be anti-dilutive.

F-16

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The amount of options, warrants, shares of preferred stock and restricted stock units excluded are as follows:

	Year Ended September 30,
	2011	2012	2013
Common shares issuable upon conversion of Series A Preferred Stock	453,486	453,486	—
Common shares issuable upon conversion of Series B Preferred Stock	—	3,605,607	1,950,000
Common shares underlying warrants issued for common stock	2,875,647	5,006,398	5,006,398
Stock options	1,365,350	1,546,454	1,920,051
Restricted stock units	121,677	68,153	31,296

5. Property and Equipment

Property and equipment consists of the following:

		September 30,
		2012		2013
Furniture and fixtures	$	324	$	324
Leasehold improvements		1,548		1,548
Laboratory equipment		1,945		2,062
Manufacturing equipment		655		655
Facility equipment		65		65
Computer equipment and other		1,308		1,308
Sub-Total		5,845		5,962
Less: Accumulated depreciation and amortization		4,293		4,931
Total	$	1,552	$	1,031

Depreciation expense for the years ended September 30, 2011, 2012, and 2013 was $934, $722, and $638, respectively.

6. Related Party Transactions

The following is a description of material transactions, other than compensation arrangements, since the Company's incorporation on December 3, 2003 to which the Company has been a party and in which any of its directors, executive officers or persons who it knows held more than five percent of any class of capital stock, including their immediate family members who had or will have a direct or indirect material interest. The Company believes that the terms obtained or consideration paid or received, as applicable, in connection with the transactions described below were comparable to terms available or the amounts that would have been paid or received, as applicable, in arm's-length transactions.

Issuance of Series B Convertible Preferred Stock

On July 19, 2006, the Company issued and sold 38,071 shares of Series B convertible preferred stock (see Note 10) and a warrant to purchase 20,496 shares of common stock to its Chief Executive Officer in exchange for a $150 bonus that was earned by him during the calendar year ended December 31, 2005 but voluntarily deferred. At September 30, 2005, the Company accrued $113 of the bonus and the balance of $37 was expensed in fiscal 2006. The full amount of the accrued bonus was exchanged for Series B convertible preferred stock on July 19, 2006.

F-17

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

In connection with the issuance of the Series B convertible preferred stock, the Company retained MSI to serve as placement agent pursuant to an amendment to the Letter Agreement. MSI was paid (a) an aggregate commission of $350 from the sale of the Series B convertible preferred stock, (b) a warrant to purchase 126,903 shares of Series B convertible preferred stock and (c) a warrant to purchase 68,322 shares of common stock. On July 19, 2006, the Company also sold and issued to a director 12,690 shares of Series B convertible preferred stock and a warrant to purchase 6,832 shares of common stock. At the completion of the Series B preferred stock financing, the lead investor remitted the monies for its investment in the Series B Round net of offering-related expenses incurred by the investor group for which the Company was responsible. Total offering expenses were approximately $2,000, of which $1,470 was commissions for the placement of the offering. A director of the Company had arranged to pay for an investment in the Series B preferred stock financing (the "Investment") utilizing a portion of commissions due. Since the monies due for the commission were not received by the Company, the purchase price of the Investment could not be deducted from the monies received. The fair values of the warrants for common stock were $126 and $13 and were computed using the Black-Scholes valuation model using the following assumptions: term of 3.5 years; volatility rate of 50%; risk free rate of 5.05% and a dividend yield of 0.0%. The fair value of the warrants for preferred stock was $167 and was computed using the Black-Scholes valuation model using the following assumptions: term of 3.5 years; volatility rate of 50%; risk free rate of 4.70% and a dividend yield of 0.0%. These amounts were treated as cost of raising capital.

7. Commitments

Chief Executive Officer Employment Agreement

On March 30, 2010, the Company announced the appointment of Errol B. De Souza, Ph.D., as the Company's President, Chief Executive Officer and a Director. In connection with his appointment, Dr. De Souza signed an employment agreement, dated March 26, 2010, setting forth the terms of his employment. The agreement provides for an initial term of employment for the period from March 29, 2010 to March 28, 2014 and it continues for successive one-year terms unless the agreement is terminated by either party on 120 days prior written notice in accordance with the terms of the agreement. The agreement provides for an annual salary of $450 and eligibility for a target bonus of 50% of the annual salary. In addition, Dr. De Souza was granted options to purchase 175,000 Shares of the Company's common stock pursuant to the Company's 2010 Plan. These options vest over a four-year period, with 25% vesting on the first anniversary of the grant date and the rest vesting in equal monthly amounts over the next three years.

The Company may terminate the agreement with or without cause. Dr. De Souza will not be entitled to severance benefits if the Company terminates his employment for cause, or if he terminates his employment without good reason, as defined in the agreement. If the Company terminates Dr. De Souza's employment without cause, or he terminates his employment with the Company for good reason, he is entitled to:

•two times his then current salary, plus two times his target annual bonus for the fiscal year in which he is terminated, plus the pro rata amount of his target annual bonus for the fiscal year in which he is terminated;

•COBRA benefits until the earlier of the end of the 24th month after the date his employment with the Company ends or the date his COBRA coverage expires;

•24 months of acceleration of his outstanding equity compensation awards; and

•full vesting of his outstanding equity compensation awards, if the Company terminates his employment without cause, or he resigns within 12 months following a change in control, as defined in the agreement.

F-18

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

Change in Control and Severance Agreements

Certain employees have agreements which provide for payouts in the event that the Company consummates a change in control. The amount of compensation due as a result of this event is approximately $4,337, as set forth in the agreements. These employees are also entitled to full vesting of their outstanding equity awards. These agreements also provide for routine severance compensation. As of September 30, 2013 and September 30, 2012, no amounts have been accrued.

Former Chief Scientific Officer General Release

Effective December 14, 2010, Dr. Solomon Steiner, the Company's former Chief Scientific Officer, retired from all his management positions with the Company. On the same date, the Company and Dr. Steiner executed a general release agreement. Dr. Steiner is therefore entitled to receive the severance benefits set forth in his employment agreement with the Company that were conditioned upon his signing the release. We recorded a charge of $1,360 for salary, bonus and benefits continuation for twenty-four months and an option acceleration modification charge of $7 in the three months ended December 31, 2010. As of December 31, 2012, the Company has paid the total of $1,360 in salary, bonus and benefits continuation per the terms of the agreement.

Leases

As of September 30, 2013, the Company leased three facilities in Danbury, Connecticut.

The Company renewed its lease for laboratory space for one year on November 6, 2013. This lease provides for annual basic lease payments from February 1, 2014 through January 31, 2015 of $68, plus the annual Consumers Price Index ("CPI") increase for October, not to exceed 6%, plus operating expenses.

The Company renewed its lease agreement for additional office space adjacent to its laboratory space for one year on November 6, 2013. This lease provides for annual basic lease payments from February 1, 2014 through January 31, 2015 of $3, plus the annual CPI increase for October, not to exceed 6%, plus operating expenses.

The Company renewed its lease for its corporate office for five years on November 6, 2013. This lease provides for annual basic lease payments from August 1, 2014 through July 31, 2019 of $388, plus the annual CPI increase for May, not to exceed 6%, plus operating expenses. Escalations shall be on an annual basis from August 1, 2015 through July 31, 2019, and will be calculated using the preceding year's basic lease payment, plus the annual CPI increase for May, not to exceed 6%.

Lease expense for the years ended September 2011, 2012, and 2013 was $633, $636, and $646, respectively.

Minimum lease payments under these agreements as of September 30, 2013, as well as equipment leases subsequently entered into, are as follows:

Years Ending September 30,
2014	$	678
2015		588
2016		555
2017		565
2018		580
2019		493
Total	$	3,459

F-19

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

Purchase Commitments

The Company contracted with N.V. Organon, a global producer of RHI, to supply the Company with all of the RHI that the Company will need for testing and manufacturing of the Company's product candidates. In July 2011, the Company executed an amendment with N.V. Organon, which extends the term of the existing supply agreement to June 30, 2018 and releases the Company from any purchase commitments until the third calendar quarter of 2014. These commitments commence in the third calendar quarter of 2014 and extend through the second calendar quarter of 2018 for a total purchase commitment of approximately 160 kilograms of RHI. Both parties have the right to terminate the agreement with six months notice, with the Company having the option to purchase significant additional quantities if the supplier terminates the agreement prior to June 30, 2018. As of September 30, 2013, the Company had purchase commitments of approximately $18,787 associated with the signing of the renewed contract with N.V. Organon.

Commercial Supply Agreement with Bachem Americas

The Company has entered into a commercial supply agreement for the supply of glucagon with Bachem Americas, a supplier of glucagon. The Company is obligated to purchase certain quantities of glucagon pursuant to a rolling forecast submitted by the Company under this agreement.

Customization and Commercial Supply Agreement with Unilife Medical Solutions, Inc.

The Company has entered into a customization and commercial supply agreement with Unilife Medical Solutions, Inc. ("Unilife"), a wholly owned subsidiary of Unilife Corporation, a company which designs, develops and manufactures advanced drug delivery devices. The agreement obligates Unilife to develop and supply dual-chamber reconstitution devices to be used with the Company's glucagon rescue product candidate. The Company is obligated to make payments to Unilife on the achievement of certain development milestones, including a payment of $700 upon the delivery of devices meeting a target profile to be approved by both parties.

Other Commitments

The Company has entered into certain licensing and collaboration agreements for products currently under development. The Company may be obligated in future periods to make additional payments, which would become due and payable only upon the achievement of certain research and development, regulatory, and approval milestones. The specific timing of such milestones cannot be predicted and depend upon future discretionary research and clinical developments, as well as, regulatory agency actions. Further, under the terms of certain agreements the Company may be obligated to pay commercial milestones contingent upon the realization of sales revenues and sublicense revenues. Due to the long range nature of such commercial milestones, they are neither probable at this time nor predictable, and consequently are not considered contingent milestone payment amounts.

Years Ending September 30,
2014	$	1,702
2015		4,929
2016		4,654
2017		4,792
2018		3,677
Total	$	19,754

8. Income Taxes

The Company files its tax returns on a fiscal year basis. For the years ended September 30, 2011, 2012, and 2013, the Company paid only state taxes.

F-20

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The provision for income taxes is as follows:

		Year Ended September 30,
		2011		2012		2013
Current expense
Federal	$	—	$	—	$	—
State		41		18		15
Tax provision	$	41	$	18	$	15

The following reconciles the amount of tax expense at the federal statutory rate to the tax provision (benefit) in operations:

		Year Ended September 30,
		2011			2012			2013
Federal statutory rate		34.00	%		34.00	%		34.00	%
Federal taxes at statutory rate	$	(3,587	)	$	(7,028	)		(6,569	)
Tax expense on permanent differences (a)		(2,631	)		1,137			163
Tax benefit on research and business credits		—			—			—
State taxes, net of federal tax effect		19			12			10
State benefit, net operating loss		(163	)		(312	)		—
Valuation allowance increase (b)		6,382			6,164			6,439
Connecticut research and development refund		—			—			—
Reserve for uncertain tax positions		—			—			—
Other		21			45			(28	)
Actual tax provision	$	41		$	18		$	15

____________

(a) Permanent differences were derived from share based compensation and adjustments to common stock warrant liability.

(b) Net of the Section 382 Adjustment.

The following table summarized the activity related to the Company's liabilities for uncertain tax positions:

		Year Ended September 30,
		2011			2012		2013
Balance, beginning of year	$	86		$	75	$	75
Increase related to current year tax position		—			—		—
Increase related to prior year's tax position		—			—		—
Decrease related to prior year's tax position		(11	)		—		—
Balance, at end of year	$	75		$	75	$	75

The Company files U.S. federal and state tax returns and has determined that its major tax jurisdictions are the United States and Connecticut. The tax years through 2011 remain open due to net operating loss and are subject to examination by the appropriate governmental agencies in the United States and Connecticut carry-forwards.

As of September 30, 2013, the Company had net operating loss ("NOL") carry-forwards of approximately $57,628 (net of Section 382 limitation discussed below) for U.S. federal tax purposes and $112,240 for state tax purposes. These loss carry-forwards expire between 2024 and 2032. To the extent these net operating loss carry-forwards are available, the Company intends to use them to reduce the corporate income tax liability associated with its operations.

F-21

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The ability of the Company to utilize its NOL carry-forwards to reduce future taxable income is subject to various limitations under the Internal Revenue Code Section 382 ("Section 382"). The utilization of such carry-forwards may be limited upon the occurrence of certain ownership changes, including the purchase or sale of stock by 5% shareholders and the offering of stock by the Company during any three-year period resulting in an aggregate change of more than 50% in the beneficial ownership of the Company. In the event of an ownership change, Section 382 imposes an annual limitation on the amount of a Company's taxable income that can be offset by these carry-forwards. As of September 30, 2011, the Company completed a study of the impact of Section 382 limitation on future payments and determined that the statutory provisions limited the Company's ability to realize future tax benefits. Accordingly, the Company decreased federal net operating loss carry-forwards by approximately $55,929 and federal research and development credit carry-forwards by $1,817.

The Company also has state research and development credit carry-forwards of approximately $339, which expire commencing in fiscal 2022.

The major components of deferred tax assets and valuation allowances and deferred tax liabilities at September 30, 2012 and 2013 are as follows:

		September 30,
		2012			2013
Deferred Tax Assets
Net operating losses	$	24,969		$	25,149
Capitalized expense		21,907			28,913
Research and development credits		477			224
Depreciation of fixed assets		51			445
Other		453			283
Total deferred tax asset		47,857			55,014
Valuation Allowance		(47,857	)		(55,014	)
Net Deferred Tax Assets	$	—		$	—

As the Company has not yet achieved profitable operation, management does not believe that it is more likely than not that the tax benefits as of September 30, 2013 will be realized and therefore has recorded a valuation allowance against its deferred tax assets.

9. Financings

June 2013 Public Offering

On June 24, 2013, the Company completed an underwritten public offering of 4,482,760 shares of its common stock at a price to the public of $4.35 per share. On July 22, 2013, the Company issued 236,007 additional shares of common stock, at the public offering price of $4.35 per share, in connection with the underwriters' exercise of a portion of their over-allotment option. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses, of $19.2 million.

June 2012 Private Placement

In June 2012, the Company completed a private placement (the "2012 Private Placement") of an aggregate of 4,250,020 shares of the Company's common stock, 3,605,607 shares of the Company's Series B preferred stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. For each unit, consisting of either a share of common stock or Series B preferred stock and a warrant to purchase 0.35 of a share of common stock, the purchasers in the June 2012 Private Placement paid a negotiated price of $2.355. The warrants are immediately exercisable and will expire on

F-22

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

June 26, 2017, five years from the original issuance date of June 27, 2012. The Company received net proceeds, after deducting placement agents' fees and other transaction expenses, of approximately $17,100 from the 2012 Private Placement.

Each share of Series B preferred stock is convertible into one share of the Company's common stock at any time at the option of the holder, except that the securities purchase agreement that the Company entered into in connection with the 2012 Private Placement (the "Securities Purchase Agreement") provides that a holder will be prohibited from converting shares of Series B preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series B preferred stock will receive a payment equal to $0.01 per share of Series B preferred stock before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series B preferred stock, holders of Series B preferred stock and holders of the Company's Series A preferred stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series B preferred stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series B preferred stock will be required to amend the terms of the Series B preferred stock. Holders of Series B preferred stock are entitled to receive, and the Company is required to pay, dividends on shares of the Series B preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.

As required by the Securities Purchase Agreement, the Company filed a Registration Statement on Form S-3 (the "Registration Statement") with the Securities and Exchange Commission (the "SEC") on July 27, 2012, which was within 30 days after the closing of the 2012 Private Placement. The Registration Statement, which was declared effective on August 13, 2012, registers the resale of the shares of common stock and Series B preferred stock issued and sold in the 2012 Private Placement, the shares of common stock issuable upon conversion of the Series B preferred stock issued and sold in the 2012 Private Placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the 2012 Private Placement. Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to pay liquidated damages to the purchasers in the 2012 Private Placement if, after effectiveness of the Registration Statement and subject to certain specified exceptions, the Company suspends the use of the Registration Statement or the Registration Statement ceases to remain continuously effective as to all the securities for which it is required to be effective (each such event, a "Registration Default"). Subject to specified exceptions, for each 30-day period or portion thereof during which a Registration Default remains uncured, the Company is obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1.0% of the aggregate purchase price paid by each such purchaser in the 2012 Private Placement, up to a maximum of 8.0% of such aggregate purchase price. As of the date of these financial statements, the Company does not believe that it is probable that it will be obligated to pay any such liquidated damages. Accordingly, the Company has not established an accrual for liquidated damages.

In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the 2012 Private Placement will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.

During the year ended September 30, 2013, the Company recorded an adjustment to fair value of common stock warrant liability of $675, within Other (income) expense, to reflect the decrease in the

F-23

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

valuation of the warrants from September 30, 2012 to September 30, 2013. At September 30, 2013, the fair value of the warrant liability utilizing the Black-Scholes valuation model was approximately $4,958.

The following summarizes the changes in value of the warrant liability from the date of issuance through September 30, 2013:

Balance at September 30, 2011	$	—
Initial fair value, at the date of issuance		4,832
Increase in fair value		801
Balance at September 30, 2012		5,633
Decrease in fair value		(675	)
Balance at September 30, 2013	$	4,958

May 2011 Registered Direct Offering

In May 2011, the Company completed a registered direct offering of an aggregate of 3,018,736 shares of the Company's common stock, 453,486 shares of the Company's Series A preferred stock and warrants to purchase 2,256,929 shares of the Company's common stock. The shares and warrants were sold in units consisting of (i) one share of common stock and (ii) one warrant to purchase 0.1625 of a share of common stock, at an exercise price of $9.92 per share of the Company's common stock. However, one investor also purchased units consisting of one share of Series A preferred stock and a warrant to purchase 0.1625 of a share of common stock. No fractional warrants were issued. Each unit was sold at a price of $8.64 per unit. These units were not issued or certificated. The shares and warrants were immediately separated. The warrants will expire on May 17, 2016, five years from the issuance date of May 18, 2011. The Company received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $28.0 million from this financing.

Each share of Series A preferred stock is convertible into one quarter of a share of the Company's common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the shares of Series A preferred stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of the Company's common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series A preferred stock will receive a payment equal to $0.01 per share of Series A preferred stock before any proceeds are distributed to the holders of the Company's common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series A preferred stock, holders of Series A preferred stock will participate ratably in the distribution of any remaining assets with the Company's common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series A preferred stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series A preferred stock will be required to amend the terms of the Series A preferred stock. The Series A preferred stock will not be entitled to receive any dividends, unless and until specifically declared by the Company's board of directors.

In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the May 2011 financing will be entitled to receive consideration as if they had exercised the warrant immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. As per the terms of the warrants, the holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.

F-24

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The Company's warrant liability is marked-to-market each reporting period with the change in fair value recorded as a gain or loss within Other Expense ("Adjustment to fair value of common stock warrant liability"), until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified as an equity instrument. Because the warrants issued in the May 2011 financing do not contain a re-pricing provision, the Company is using the Black-Scholes valuation model to estimate the fair value of the warrants. Using this model, the Company recorded an initial warrant liability of $9,438 as of May 18, 2011 (the warrant issuance date). The significant assumptions of the model were warrants and common stock outstanding, remaining terms of the warrants, the per stock price of $2.06, a risk-free rate of 1.89% and expected volatility rate of 75%.

During the year ended September 30, 2013, the Company recorded an adjustment to fair value of common stock warrant liability of $542, within Other (income) expense, to reflect the decrease in the valuation of the warrants from September 30, 2012 to September 30, 2013. At September 30, 2013, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $1,163.The following summarizes the changes in value of the warrant liability from the date of issuance through September 30, 2013:

Balance at September 30, 2010	$	—
Initial fair value, at the date of issuance		9,438
Decrease in fair value		(8,442	)
Balance at September 30, 2011		996
Increase in fair value		709
Balance at September 30, 2012		1,705
Decrease in fair value		(542	)
Balance at September 30, 2013	$	1,163

August 2010 Registered Direct Offering

In August 2010, the Company sold to two institutional investors an aggregate of 599,550 units, with each unit consisting of (i) one share of common stock and (ii) one warrant to purchase one share of common stock, for a purchase price of $15.72 per unit. These units were not issued or certificated. The shares and warrants were immediately separated and the Company issued 599,550 shares of its common stock and warrants to purchase an additional 599,550 shares of the Company's common stock. This financing resulted in net proceeds of $8,700.

In August 2011, one investor exercised 10,550 warrants, at $4.70 per share, and the Company received proceeds totaling approximately $50. Subsequently, on December 1, 2011 the remaining 589,000 warrants expired unexercised.

Fair Value Assumptions Used in Accounting for Warrant Liability

The Company has determined its warrant liability to be a Level 3 fair value measurement and used the Black Scholes valuation model to calculate the fair value for the fiscal year ended September 30, 2012 and 2013.

F-25

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

At the measurement date, the Company estimated the fair value for the June 2012 warrants using the Black-Scholes valuation model using the following assumptions:

		September 30, 2012		September 30, 2013
June 2012 Financing
Stock price	$	2.97		$3.15
Exercise price	$	2.66		$2.66
Risk-free interest rate		0.62	%	0.63%
Expected remaining term		4.74 years		3.74 years
Expected volatility		98	%	82%
Dividend yield		0	%	0%
Warrants outstanding June 2012 registered direct		2,749,469		2,749,469

The Company estimated the fair value for the May 2011 warrants using the Black-Scholes valuation model at the measurement dates of September 30, 2013 and 2012, respectively using the following assumptions:

	September 30, 2012	September 30, 2013
May 2011 Financing
Stock price	$2.97	$3.15
Exercise price	$9.92	$9.92
Risk-free interest rate	0.31%	0.63%
Expected remaining term	3.63 years	2.63 years
Expected volatility	82%	77%
Dividend yield	0%	0%
Warrants outstanding May 2011 registered direct	2,256,929	2,256,929

Risk-Free Interest Rate. This is the United States Treasury rate for the measurement date having a term equal to the expected remaining term of the warrant. An increase in the risk-free interest rate will increase the fair value and the associated derivative liability.

Expected Remaining Term. This is the period of time over which the warrant is expected to remain outstanding and is based on management's estimate, taking into consideration the remaining contractual life.

Expected Volatility. This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. Since the Company's stock has been traded for the expected remaining term of the warrants, the Company uses its own historic volatility over the retrospective period corresponding to the expected remaining term of the warrants on the measurement date. Extra weighting is attached to those companies most similar in terms of size and business activity. An increase in the expected volatility will increase the fair value and the associated derivative liability.

Dividend Yield. The Company has not made any dividend payments nor does it have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease the fair value and the associated derivative liability.

Participating Securities

If at any time the Company grants, issues or sells securities or other property to holders of any class of common stock the holders of the warrants are entitled to also acquire those same securities as if they held the number of shares of common stock acquirable upon complete exercise of the warrants.

F-26

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

As such, given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55 earnings per share. These securities were excluded for the years ended September 30, 2013, 2012 and 2011 earnings per share calculation since their inclusion would be anti-dilutive.

10. Stockholders' Equity

Common Stock

The Company's authorized common stock consists of 62,500,000 shares of a single class of common stock, having a par value of $0.01 per share. The holders of the common stock are entitled to one vote for each share and have no cumulative voting rights or preemptive rights.

On June 24, 2013, the Company completed an underwritten public offering of 4,482,760 shares of its common stock at a price to the public of $4.35 per share. On July 22, 2013, the Company issued 236,007 additional shares of common stock, at the public offering price of $4.35 per share, in connection with the underwriters' exercise of a portion of their over-allotment option. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses, of $19.2 million.

On June 27, 2012 the Company completed a private placement of an aggregate of 4,250,020 shares of common stock, 3,605,607 shares of Series B preferred stock and warrants to purchase 2,256,929 shares of common stock at an exercise price of $2.66 per share. The Company received net proceeds, after deducting placement agent fees and other offering expenses of approximately $17,100 from this financing. In June 2013, 176,964 shares of the Company's Series B Convertible Preferred Stock were converted into an equal number of shares of common stock. In September 2013, 1,478,643 shares of the Company's Series B Convertible Preferred Stock were converted into an equal number of shares of common stock.

On May 12, 2011, the Company completed a registered direct offering of an aggregate of 3,018,736 shares of common stock, 1,813,944 shares of Series A preferred stock and warrants to purchase 2,256,929 shares of common stock at an exercise price of $9.92 per share. The Company received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $28,000 from this financing. In August 2013, 1,813,944 shares of the Company's Series A Convertible Preferred Stock, convertible at a 4:1 ratio, were converted into 453,483 shares of common stock.

On August 24, 2010, the Company completed a registered direct offering of an aggregate of 599,550 shares of common stock and warrants to purchase an additional 599,550 shares of common stock at an exercise price of $18.864. The Company received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $8,700 from this financing.

On February 12, 2008, the Company completed a follow-on public offering of 815,000 shares of its common stock at a price to the public of $62.00 per share. The Company received net proceeds from this offering, after deducting underwriting discounts and commissions and expenses, of $46,817. Certain of the Company's stockholders sold 137,500 shares in the offering. The Company did not receive any proceeds from the sale of shares from the selling stockholders.

On May 16, 2007, the Company completed an initial public offering of 1,437,500 shares of its common stock at a price to the public of $60.00 per share. The offering resulted in gross proceeds of $86,300. The Company received net proceeds from the offering of approximately $78,800 after deducting underwriting discounts and commissions and additional offering expenses. The completion of the initial public offering resulted in the conversion of the Company's Series A and B convertible preferred stock. A total of 1,601,749 shares of common stock were issued upon the conversion of the preferred stock.

F-27

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

As of September 30, 2013, the Company had the following warrants outstanding:

(i) May 2011 financing —

 (a) warrants to purchase 2,256,929 shares of the Company's common stock with an exercise price of $9.92 per share

(ii) June 2012 financing —

(a) warrants to purchase 2,066,969 shares of the Company's common stock with an exercise price of $2.66 per share and

(b) Series B convertible preferred stock — warrants to purchase 682,500 shares of the Company's common stock with an exercise price of $2.66 per share.

Preferred Stock

The Company is authorized to issue up to 50,000,000 shares of preferred stock, having a par value of $0.01 per share. The Company's preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by the Company's Board of Directors, without further action by stockholders, and may include voting rights (including the right to vote as a series on particular matters), preferences as to dividends and liquidation and conversion, redemption rights and sinking fund provisions. The issuance of preferred stock could reduce the rights, including voting rights, of the holders of common stock and, therefore, could reduce the value of the common stock. In particular, specific rights granted to holders of preferred stock could be used to restrict the Company's ability to merge with or sell the Company's assets to a third party, thereby preserving control of the Company by existing management.

Series A Preferred Stock May 2011 Financing

As part of the May 2011 registered direct offering, the Company issued 1,813,944 shares of the Company's Series A preferred stock to one investor. The investor purchased units consisting of one share of Series A preferred stock and a warrant to purchase 0.1625 of a share of common stock. No fractional warrants were issued. Each unit was at a price of $8.84 per unit.

Each share of Series A preferred stock is convertible into 0.25 of a share of the Company's common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the shares of series A preferred stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of the Company's common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series A preferred stock will receive a payment equal to $0.01 per share of Series A preferred stock before any proceeds are distributed to the holders of the Company's common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series A preferred stock, holders of Series A preferred stock and holders of the Company's Series B stock will participate ratably in the distribution of any remaining assets with the Company's common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series A preferred stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series A preferred stock will be required to amend the terms of the Series A preferred stock. The Series A preferred stock will not be entitled to receive any dividends, unless and until specifically declared by the Company's board of directors.

In August 2013, 1,813,944 shares of the Company's Series A Convertible Preferred Stock were converted into 453,483 shares of common stock.

Series A Preferred Stock July 2005 Private Placement

In July 2005, the company authorized 1,050,000 shares of its Series A preferred stock and completed a private placement of 569,000 shares of these shares, of which 0 shares were issued and outstanding as of

F-28

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

September 30, 2007. In addition, in connection with the July 2006 private placement, the Company issued warrants to purchase shares of the Company's series A preferred stock. All such warrants were expired as of September 30, 2012.

In connection with the Series A preferred stock issuance, the Company entered into a registration rights agreement with the purchasers of its stock, which provided, among other things, for liquidated damages if the Company were initially unable to register and obtain an effective registration of the securities within the allotted time. The stockholders could not demand registration until one hundred and eighty (180) days after the Company had effected a qualified initial public offering. The penalties were (i) one and three quarters (1¾%) percent of the aggregate number of shares of underlying common stock for each month, or part thereof, after a ninety (90) day period that a registration statement was not filed with the SEC or (ii) one (1%) percent of the aggregate number of shares of underlying common stock for each month if the forgoing filed registration statement was not declared effective by the SEC within one hundred and twenty (120) days.

Each share of Series A preferred stock was automatically converted into a number of shares of common stock equal to the quotient of $3.54 divided by $1.00 immediately subsequent to the date of the initial public offering.

As part of the compensation agreement, the placement agent received 69,875 Series A warrants. Each warrant consists of the right to purchase one share of fully paid and non-assessable common stock for a period of seven years which expired on July 12, 2012.

Series B Preferred Stock June 2012 Private Placement

In June 2012, the Company completed a private placement of an aggregate of 4,250,020 shares of the Company's common stock, 3,605,607 shares of the Company's Series B Convertible Preferred Stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. For each unit consisting of either a share of common stock or Series B preferred stock and a warrant to purchase 0.35 of a share of common stock, the purchasers in the June 2012 Private Placement paid a negotiated price of $2.355.

Each share of Series B preferred stock is convertible into one share of the Company's common stock at any time at the option of the holder, except that the securities purchase agreement that the Company entered into in connection with the 2012 Private Placement (the "Securities Purchase Agreement") provides that a holder will be prohibited from converting shares of Series B preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series B preferred stock will receive a payment equal to $0.01 per share of Series B preferred stock before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series B preferred stock, holders of Series B preferred stock and holders of the Company's Series A preferred stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series B preferred stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series B preferred stock will be required to amend the terms of the Series B preferred stock. Holders of Series B preferred stock are entitled to receive, and the Company is required to pay, dividends on shares of the Series B preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.

As required by the Securities Purchase Agreement, the Company filed a Registration Statement on Form S-3 (the "Registration Statement") with the Securities and Exchange Commission (the "SEC") on July 27,

F-29

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

2012, which was within 30 days after the closing of the 2012 Private Placement. The Registration Statement, which was declared effective on August 13, 2012, registers the resale of the shares of common stock and Series B preferred stock issued and sold in the 2012 Private Placement, the shares of common stock issuable upon conversion of the Series B preferred stock issued and sold in the 2012 Private Placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the 2012 Private Placement. Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to pay liquidated damages to the purchasers in the 2012 Private Placement if, after effectiveness of the Registration Statement and subject to certain specified exceptions, the Company suspends the use of the Registration Statement or the Registration Statement ceases to remain continuously effective as to all the securities for which it is required to be effective (each such event, a "Registration Default"). Subject to specified exceptions, for each 30-day period or portion thereof during which a Registration Default remains uncured, the Company is obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1.0% of the aggregate purchase price paid by each such purchaser in the 2012 Private Placement, up to a maximum of 8.0% of such aggregate purchase price. As of the date of these financial statements, the Company does not believe that it is probable that it will be obligated to pay any such liquidated damages. Accordingly, the Company has not established an accrual for liquidated damages.

In June 2013, 176,964 shares of the Company's Series B Convertible Preferred Stock were converted into an equal number of shares of common stock. In September 2013, an additional 1,478,643 shares of the Company's Series B Convertible Preferred Stock were converted into an equal number of shares of common stock.

Series B Preferred Stock July 2006 Private Placement

In July 2006, the Company authorized 6,500,000 shares of its Series B preferred stock and completed a private placement of 5,380,711 of these shares, of which 0 shares were issued and outstanding as of September 30, 2007. In addition, in connection with the July 2006 private placement the Company issued warrants to purchase shares of the Company's Series B preferred stock. All such warrants were expired as of September 30, 2012.

As a result of the conversion option, the Company considered the features contained in the Series B preferred stock to ascertain whether the shares contained a beneficial conversion feature and determined that the issuance of the Series B preferred stock resulted in a beneficial conversion feature in the amount of $603.

Shares Reserved for Future Issuance

As of September 30, 2013, the Company reserved shares of common stock for future issuance as follows:

2010 stock incentive plan	5,290,739
2005 employee stock purchase plan	475,000
Common shares issuable upon conversion of Series B Preferred Stock	1,950,000
Warrants issued in connection with May 2011 registered direct offering	2,256,929
Warrants issued in connection with June 2012 private placement	2,749,469
Total	12,722,137

2004 Stock Incentive Plan

The Company established the 2004 Stock Incentive Plan on October 1, 2004 (the "Plan"), as amended in March 2007, and subsequently replaced by the 2010 Stock Incentive Plan. The Plan provides for the granting of shares of common stock or securities convertible into or exercisable for shares of common stock, including stock options ("Incentive Stock Options") to directors, employees, consultants and advisors of or to the

F-30

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

Company. Incentive Stock Options can be awarded only to persons who are employees of the Company at the time of the grant. Stock options are exercisable at the conclusion of the vesting period. Employees can exercise their vested shares up to 90 days after termination of services. No awards may be granted under the Plan after the effective date of the 2010 Plan.

The Plan is be administered by either the Board of Directors of the Company or a Committee thereof, which determines the terms and conditions of the awards granted under the Plan, including the recipient of the award, the nature of the award, the exercise price of the award, the number of shares subject to the award and the exercisability thereof.

Non-employee directors are not entitled to receive awards other than the non-qualified stock options the plan directs be issued to non-employee directors.

2010 Stock Incentive Plan

In March 2013, the stockholders of the Company approved the amended and restated 2010 Stock Incentive Plan (the "2010 Plan"). Up to 3,750,000 shares of the Company's common stock may be issued pursuant to awards granted under the 2010 Plan, plus 1,540,739 shares of common stock underlying already outstanding awards under the Company's prior plans. As of September 30, 2013, the Company had 1,951,347 shares of common stock subject to outstanding awards. The contractual life of options granted under the 2010 Plan may not exceed seven years. The 2010 Plan uses a "fungible share" concept under which any awards that are not a full-value award will be counted against the share limit as one (1) share for each share of common stock and any award that is a full-value award will be counted against the share limit as 1.5 shares for each one share of common stock. The Company has not made any new awards under any prior equity plans after March 2, 2010 — the effective date the 2010 Plan was approved by the Company's stockholders. The 2010 Plan replaces the 2004 Stock Incentive Plan and 2005 Non-Employee Directors Stock Option Plan.

2005 Employee Stock Purchase Plan

The Company's 2005 Employee Stock Purchase Plan, or the Purchase Plan, was adopted by its Board of Directors and approved by its stockholders on March 20, 2007. The Purchase Plan became effective upon the closing of the Company's initial public offering. The Purchase Plan is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Code.

Under the Purchase Plan, eligible employees may contribute up to 15% of their eligible earnings for the period of that offering withheld for the purchase of common stock under the Purchase Plan. The employee's purchase price is equal to the lower of: 85% of the fair market value per share on the start date of the offering period in which the employee is enrolled or 85% of the fair market value per share on the semi-annual purchase date. The Purchase Plan imposes a limitation upon a participant's right to acquire common stock if immediately after the purchase, the employee would own 5% or more of the total combined voting power or value of the Company's common stock or of any of its affiliates not eligible to participate in the Purchase Plan. The Purchase Plan provides for an automatic rollover when the purchase price for a new offering period is lower than previously established purchase price(s). The Purchase Plan also provides for a one-time election that allows an employee the opportunity to enroll into a new offering period when the new offering is higher than their current offering price. This election must be made within 30 days from the start of a new offering period. Offering periods are twenty-seven months in length. The compensation cost in connection with the plan for the years ended September 30, 2011, 2012 and 2013 was $53, $16, and $5 respectively.

An aggregate of 475,000 shares of common stock are reserved for issuance pursuant to purchase rights to be granted to the Company's eligible employees under the Purchase Plan. The Purchase Plan shares are replenished annually on the first day of each fiscal year by virtue of an evergreen provision. The provision allows for share replenishment equal to the lesser of 1% of the total number of shares outstanding on that date or 25,000 shares. As of September 30, 2011, 2012 and 2013, a total of 341,097, 355,321 and 366,926 shares,

F-31

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

respectively, were reserved and available for issuance under this plan. For the years ended September 30, 2011, 2012 and 2013, the Company issued a total of, 83,903, 94,679 and 108,074 shares, respectively, under the Purchase Plan.

2005 Non-Employee Directors' Stock Option Plan

The Company's 2005 Non-Employee Directors' Stock Option Plan (the "Directors' Plan") was adopted by its Board of Directors and approved by its stockholders on March 20, 2007 and subsequently replaced with the 2010 Stock Incentive Plan. The Directors' Plan became effective upon the closing of the Company's initial public offering. An aggregate of 125,000 shares of common stock were reserved for issuance under the Directors' Plan. Upon the effective date of the registration statement in connection with the Company's initial public offering, each of its non-employee directors automatically received an initial option to purchase 6,250 shares of common stock. Upon appointment, non-employee directors receive a one-time grant of an option to purchase 6,250 shares of common stock. Annually, non-employee directors receive an option to purchase 5,000 shares of common stock. Effective March 3, 2009, these shares vest pro rata over one year. However, in the event a non-employee director has not served since the date of the preceding annual meeting of stockholders, that director will receive an annual grant that has been reduced pro rata for each full quarter prior to the date of grant during which such person did not serve as a non-employee director.

The fair value per share is being recognized as compensation expense over the applicable vesting period. The fair value per share for awards granted as of December 31, 2008 through September 30, 2012 was calculated using the Black-Scholes valuation model.

The fair value of the common stock for the grants from December 23, 2004 through November 1, 2006 was determined using a retrospective valuation. The fair value of the common stock for the grants during December 2006 and subsequently was determined contemporaneously with the grants.

F-32

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The following table summarizes the stock option activity through September 30, 2013:

Options	Number		Weighted Average Exercise Price	Weighted Average Remaining Contractual Life in Years		Aggregate Intrinsic Value
Balance, September 30, 2004	—	$	—		$	—
Granted	96,358		5.64			—
Outstanding balance, September 30, 2005	96,358		5.64			—
Granted	115,401		22.60			—
Forfeited, expired	15,054		13.60			—
Outstanding balance, September 30, 2006	196,705		12.92			—
Granted	238,961		55.84			—
Exercised	886		5.64			—
Forfeited, expired	13,283		22.60			—
Outstanding balance, September 30, 2007	421,497		27.20			—
Granted	431,849		67.52			—
Exercised	43,604		20.72			—
Forfeited, expired	25,892		44.16			—
Outstanding balance, September 30, 2008	783,850		55.68			—
Granted	152,875		10.76			—
Exercised	4,416		5.64			—
Forfeited, expired	80,398		55.52			—
Outstanding balance, September 30, 2009	851,911		47.24			—
Granted	328,530		16.37			—
Exercised	8,081		8.43			—
Forfeited, expired	13,469		52.16			—
Outstanding balance, September 30, 2010	1,158,891		38.72			—
Granted	290,834		6.36			—
Exercised	104		5.64			—
Forfeited, expired	84,271		38.48			—
Outstanding balance, September 30, 2011	1,365,350		32.68			—
Granted	215,877		2.54			—
Forfeited, expired	34,773		32.09			—
Outstanding balance September 30, 2012	1,546,454	$	27.80			—
Granted	486,000		2.43			—
Exercised	30,250		2.48			—
Forfeited, expired	82,153		15.37			—
Outstanding balance September 30, 2013	1,920,051	$	22.31	4	$	445
Exercisable shares, September 30, 2013	1,258,612	$	32.14	3	$	51

F-33

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

Restricted Stock Units

The Company grants restricted stock units ("RSUs") to executive officers and employees pursuant to the 2010 Plan from time to time. There is no direct cost to the recipients of RSUs, except for any applicable taxes.

On March 8, 2012, the Company's stockholders approved an amendment to the 2010 Plan to increase the number of shares of common stock authorized for issuance thereunder solely for the purpose of allowing the Company to issue an 191,719 restricted stock units to certain of the Company's employees in place of an aggregate of $823 in discretionary cash bonuses in connection with the fiscal year ended September 30, 2011 (the "2011 Bonus RSUs"). The 2011 Bonus RSUs vested and were distributed on September 30, 2012. The Company had previously accrued and expensed the $823 in the fiscal year ended September 30, 2011. The 2011 Bonus RSUs vested in full and was distributed on September 30, 2012. Since the total fair value of the 2011 Bonus RSUs did not exceed the discretionary aggregate cash bonus value of $823, the Company did not record any additional stock-based compensation expense in the year ended September 30, 2012. The accrued bonus liability was settled in March 2012 and, accordingly, the liability, net of taxes, in the amount of $582 was reversed into additional paid-in-capital. Each RSU award that was granted in December 2010 to our executive officers and employees represents one share of common stock and each award vests annually over three years, with fifty percent vesting on the first anniversary of the date of grant and the remainder vesting in two equal installments on each anniversary thereafter. Each year following the annual vesting date, between January 1st and March 15th, the Company will issue common stock for each vested RSU. During the period when the RSU is vested but not distributed, the RSUs cannot be transferred and the grantee has no voting rights. If the Company declares a dividend, RSU recipients will receive payment based upon the percentage of RSUs that have vested prior to the date of declaration. The costs of the awards, determined as the fair market value of the shares on the grant date, are expensed per the vesting schedule outlined in the award. For example, the December 2010 RSU awards vest over three years and are expensed 50% the first year and 25% the next two years; whereas, the December 2009 RSU awards are expensed ratably over the four year vesting period.

Based on historical experience of option cancellations, the Company has estimated an annualized forfeiture rate of 7.5% for employee RSUs. Forfeiture rates will be adjusted over the requisite service period when actual forfeitures differ, or are expected to differ, from the estimate. As of September 30, 2013, the executives, the board of directors and employees had 374,925 vested and distributed RSUs.

The stock-based compensation expense associated with the RSUs has been recorded in the statement of operations and in additional paid-in-capital on the balance sheets is as follows:

		September 30,
		2011		2012		2013
Stock compensation expense — RSUs	$	585	$	1,202	$	363

At September 30, 2013, there was $50 of total unrecognized stock-based compensation expense related to RSU awards granted under the 2004 Stock Incentive Plan and the 2010 Plan. This expense is expected to be recognized over the remaining vesting periods up to four years.

F-34

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

The following table summarizes RSU activity from October 1, 2010 through September 30, 2013:

	Shares		Weighted Average Grant-Date Fair Value
Non-vested and outstanding balance at September 30, 2009	—	$	—
Shares granted	62,510		15.80
Shares forfeited or expired	246		15.80
Non-vested and outstanding balance at September 30, 2010	62,264		15.80
Changes during the period:
Shares granted	90,639		7.56
Shares vested and issued	22,435		17.20
Shares forfeited or expired	8,791		9.40
Non-vested and outstanding balance at September 30, 2011	121,677		9.40
Changes during the period:
Shares granted	274,189		2.36
Shares vested and issued	327,713		3.45
Non-vested and outstanding balance at September 30, 2012	68,153	$	10.51
Changes during the period:
Shares granted	—		—
Shares vested and issued	36,851		10.26
Shares forfeited or expired	6		15.80
Non-vested and outstanding balance at September 30, 2013	31,296		10.48

11. Employee Benefit Plan

Effective January 1, 2006, the Company established a 401(k) plan covering substantially all employees. Employees may contribute up to 100% of their salary per year (subject to maximum limit prescribed by federal tax law). The Company may elect to make a discretionary contribution or match a discretionary percentage of employee contributions. For the years ended September 30, 2011, 2012 and 2013, the Company had not elected to make any contributions to the plan.

12. Reverse Stock Splits

On June 11, 2012, the Company amended its certificate of incorporation in order to effect a one-for-four reverse split of its outstanding common stock and to fix on a post-split basis the number of authorized shares of its common stock at 25,000,000 (reduced from 100,000,000 authorized shares). As a result of the 2012 reverse stock split, each share of Company common stock outstanding at the effective time was automatically changed into one-quarter of a share of common stock. No fractional shares were issued in connection with the 2012 reverse stock split, and cash of $0.3 was paid in lieu of fractional shares. Also as a result of the 2012 reverse stock split, the number of shares of common stock subject to outstanding options, RSUs and warrants issued by the Company and the number of shares reserved for future issuance under the Company's stock plans have been reduced by a factor of four. There was no alteration to the par value of the common stock or any modification of the voting rights or other terms thereof. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the 2012 reverse stock split for all periods reported. Additionally, on November 1, 2012 as a result of a special stockholders meeting, authorized shares was increased from 25,000,000 to 62,500,000.

On April 12, 2007, the Company completed a 0.7085 for one (0.7085:1) reverse stock split rounding all fractional shares down to the next full share. Stockholders received cash in lieu of fractional shares. After the 2007 reverse split, there were 2,000,957 shares of common stock outstanding. The 2007 reverse split did not

F-35

Biodel Inc.

(A Development Stage Company)

Notes to Financial Statements — (Continued)

(In thousands, except share and per share amounts)

reduce the number of authorized shares of common stock, alter the par value or modify the voting rights or other terms thereof. As a result of the 2007 reverse split, the conversion prices and/or the numbers of shares issuable upon the exercise of any outstanding options and warrants to purchase common stock were proportionally adjusted pursuant to the respective anti-dilution terms of the 2004 Stock Incentive Plan and the respective warrant agreements. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the 2007 reverse split for all periods reported.

13. Summary Selected Quarterly Financial Data (Unaudited)

The following table sets forth certain unaudited quarterly statement of operations data for the eight quarters ended September 30, 2013. This information is unaudited, but in the opinion of management, it has been prepared substantially on the same basis as the audited financial statements and all necessary adjustments, consisting only of normal recurring adjustments, have been included in the amounts stated below to state fairly the unaudited quarterly results of operations. The results of operations for any quarter are not necessarily indicative of the results of operations for any future period.

Quarter Ended
(in thousands, except share and per share amounts)

		December 31, 2012			March 31, 2013			June 30, 2013			September 30, 2013
Revenue	$	—		$	—		$	—		$	—
Net loss	$	(3,669	)	$	(5,220	)	$	(9,631	)	$	(815	)
Basic and diluted net loss per common share(1)	$	(0.26	)	$	(0.37	)	$	(0.66	)	$	(0.04	)
Weighted average common shares basic and diluted		14,176,057			14,182,451			14,573,110			19,622,878

Quarter Ended
(in thousands, except share and per share amounts)

		December 31, 2011			March 31, 2012			June 30, 2012			September 30, 2012
Revenue	$	—		$	—		$	—		$	—
Net loss	$	(4,501	)	$	(4,316	)	$	(6,051	)	$	(5,879	)
Basic and diluted net loss per common share(1)	$	(0.47	)	$	(0.45	)	$	(0.60	)	$	(0.42	)
Weighted average common shares basic and diluted		9,673,529			9,688,384			10,152,194			13,982,826

____________

(1) Basic earnings (loss) per share calculation for the third and fourth quarter include the weighted average effect of stock issuances; therefore, the sum of the quarterly earnings per share will not equal full-year earnings per share amounts which reflect the weighted average effect on an annual basis.

F-36

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EX-10.15

OPTION TO RENEW DATED AS OF NOVEMBER 6, 2013

TO LEASE AGREEMENT DATED AS OF JULY 23, 2007

Exhibit 10.15

THIS OPTION TO RENEW dated as of November 6, 2013, to COMMERCIAL LEASE dated as of July 23, 2007 and LEASE AMENDMENT dated as of October 1, 2007, by and between MULVANEY PROPERTIES, LLC, a Connecticut limited liability company with offices at 4 Christopher Columbus Avenue, Danbury, CT  06810 (“Landlord”), and BIODEL, INC., a Delaware corporation, with offices at 100 Saw Mill Road, Danbury, Connecticut  06810 (“Tenant”);

WITNESSETH:

WHEREAS, Landlord and Tenant executed a Lease Agreement dated as of July 23, 2007, pursuant to the terms of which Tenant leased approximately 19,525 square feet for its offices, or other such use as is permitted in the zoning regulations relevant to the demised premises.

WHEREAS, Landlord and Tenant executed a Lease Amendment dated as of October 1, 2007, pursuant to the terms of which Landlord and Tenant amended the Lease so that the term and the renewal option was changed to seven (7) years instead of five (5) years.

NOW, THEREFORE, in consideration of the mutual covenants and obligations contained herein, Landlord and Tenant hereby exercise this Option to Renew as follows:

1.

PREMISES

The premises is situated in the City of Danbury, County of Fairfield, State of Connecticut, described as 100 Saw Mill Road.

2.

TERM

As requested by the Tenant, this Option to Renew will revert to the original term of Five (5) years, instead of the Seven (7) years per the Lease Amendment and will commence on August 1, 2014 and terminating on July 31, 2019.

3.

BASE RENT

Effective as of August 1, 2014, the schedule of Base Rent shall be as outlined below:

Period	Annual Base Rent	Monthly Base Rent
August 1, 2014 -	$388,288.80 plus annual	$32,357.40 plus annual
July 31, 2019	CPI for May	CPI for May

4.

ESCALATION

Escalations shall be on an annual basis.  For the years August 1, 2015 through July 31, 2019, the escalation shall be the Base Rent of Option Year 2, (including CPI increase for May) plus annual CPI Increases for May.  The CPI shall be set at a maximum of 6%.

5.

ENTIRE AGREEMENT

Except as modified herein, all terms and conditions of the Lease shall remain in full force and effect.

IN WITNESS WHEREOF, the parties hereto have caused this Option to Renew to be executed by their duly authorized representatives as of the date first written above.

LANDLORD:
MULVANEY PROPERTIES, LLC
By:	/s/ George Mulvaney	Witness:	/s/ Paul Salce
	George Mulvaney		Paul Salce
	Member
TENANT:
BIODEL, INC.
By:	/s/ Erik Steiner	Witness:	/s/ Janette Blackstock
	Erik Steiner		Janette Blackstock
	Vice President, Operations

EX-10.23

Exhibit 10.23

BASE SALARIES OF NAMED EXECUTIVE OFFICERS OF THE REGISTRANT

The following are the base salaries (on an annual basis) of the named executive officers of the Company:

Name and Title		Base Salary(1)
Errol De Souza President and Chief Executive Officer	$	491,730
Gerard J. Michel Chief Financial Officer, Vice President Corporate Development and Treasurer	$	344,000
Alan Krasner Chief Medical Officer	$	340,000
Paul Bavier General Counsel, Chief Compliance Officer and Secretary	$	260,000
Erik Steiner Vice President, Operations	$	222,000

____________

(1) Base salaries effective October 1, 2013.

EX-10.24

Exhibit 10.24

SUMMARY OF THE REGISTRANT'S NON-EMPLOYEE DIRECTOR COMPENSATION

The Company pays each of its non-employee directors $30,000 annually or $60,000 annually to its Chairman. In addition, non-employee directors receive the following committee-related fees annually: (1) $7,500 for participating on the Audit Committee or $15,000 for chairing the committee; (2) $5,000 for participating on the Compensation Committee or $15,000 for chairing the committee; (3) $2,500 for participating on the Nominating and Governance Committee or $5,000 for chairing the committee; and (4) $2,500 for participating on the Science and Technology Committee or $5,000 for chairing the committee.

Upon appointment, non-employee directors receive a one-time grant of an option to purchase 6,250 shares of common stock. These options vest pro rata over one year. Annually, non-employee directors receive an option to purchase 5,000 shares of common stock, which also vest pro rata over one year. The exercise price of these options is the fair market value on the date of grant. Each such option expires seven years after the date of grant under the Company's 2010 Stock Incentive Plan.

The Company reimburses its non-employee directors for reasonable expenses incurred in connection with attending board and committee meetings.

EX-10.25

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

Exhibit 10.25

COMMERCIAL SUPPLY AGREEMENT FOR GLUCAGON

This Commercial Supply Agreement for Glucagon (the “Agreement”), dated July 17, 2012 (the “Effective Date”), is entered between Biodel Inc. (“Biodel”), a Delaware corporation having its principal place of business at 100 Saw Mill Road, Danbury, CT  06810-5106, and Bachem Americas, Inc., a California corporation having its principal place of business at 3132 Kashiwa Street, Torrance, CA 90505 and Bachem AG, a Swiss corporation having its principal place of business at Hauptstrasse 144, 4416 Bubendorf, Switzerland, (collectively, “Bachem”).

BACKGROUND

A.

Biodel desires to have Bachem supply to it from time to time clinical trial, regulatory registration and commercial supplies of the active pharmaceutical ingredient glucagon (the “Product”) as further described in the Specifications (as defined below) and all on the terms and conditions set forth in this Agreement for the purposes of formulating Biodel’s own pharmaceutical formulations using the Product (the “End Products”).

B.

Bachem desires to manufacture for Biodel clinical trial, regulatory registration and commercial supplies of the Product.

NOW, THEREFORE, in consideration of the premises and the mutual agreement set forth herein, the parties agree as follows:

1.

Supply of the Product; Safety Stock.

1.1

Bachem shall manufacture and supply Product that meets the specifications set forth in Annex 1 to the Quality Assurance Agreement attached hereto as Exhibit B (the “Specifications”) in the quantities and at the times requested by Biodel from time to time pursuant to the terms of this Agreement.

1.2

Upon Biodel’s written request, and notwithstanding anything to the contrary in Section 3, Bachem shall manufacture and maintain, on a continuous basis for purchase by Biodel, a safety stock of the Product in an amount that is the greater of (i) [**], or (ii) [**]. In the event the Agreement terminates for any reason, Bachem shall promptly deliver the safety stock (or a portion thereof) to Biodel, and Biodel shall pay Bachem for the same, upon the terms and conditions in effect immediately prior to such termination.

1.3

Bachem shall provide such facilities, equipment, labor and raw materials as may be necessary to perform the manufacturing, processing, storing testing and packaging of the Product as may be required herein.

2.

Term. The initial term of this Agreement shall be for a period of five (5) years from the Effective Date, and shall renew automatically for additional one (1) year terms unless either party notifies the other in writing of its intention not to renew this Agreement at least twelve months prior to the end of the then-current term.

3.

Forecasts and Purchase Orders.

3.1

Upon the completion of each calendar quarter, Biodel will provide to Bachem a rolling forecast of its anticipated required quantity of the Product over a period of [**] months from the date of the forecast. The first [**] of each forecast shall be binding on Bachem to supply and on Biodel to purchase the listed quantities. Any quantities specified in each forecast beyond the first [**] of such forecast shall be for the purpose of assisting Bachem in its planning and will not

Page 1 of 34

constitute an obligation of Biodel to purchase such quantities of Product. Bachem shall make commercially reasonable efforts to supply the Product in quantities that exceed [**] percent ([**]%) of the most recent forecasted amounts for any periods subject to a binding purchase order. For clarity, if Bachem is unable to supply such excess quantites despite its commercially reasonable efforts to do so, such failure will not constitute a breach of this Agreement.

3.2

Upon the Effective Date, and thereafter upon the completion of each [**], Biodel shall issue a binding purchase order for the then-current binding portion of the forecast. Once issued, purchase orders may not be cancelled or modified by Biodel unless authorized in writing by Bachem.

3.3

Biodel shall place all orders for the Product by delivering to Bachem a written purchase order specifying the product, quantity, delivery date and any specific instructions. The delivery date so specified shall not be less than [**] days from the date of the order for Product amounts that were reflected in the applicable forecast. For Product amounts exceeding the forecasted amounts, longer delivery times, but in no event later than [**] days from the date of the purchase order, may apply. Bachem will confirm each purchase order within [**] days of receipt of a written purchase order.

3.4

Bachem shall deliver Product ordered pursuant to each purchase order by the delivery date specified in such purchase order. Bachem shall notify Biodel of anticipated delays of greater than [**] business days in completing any order, which notice shall be sent to Biodel immediately after Bachem becomes aware of such delay. Bachem shall keep Biodel advised of all relevant information concerning the extent of any such delay in delivery and shall use all reasonable efforts to minimize such delay. In the event of [**] delivery delays of greater than [**] business days within any [**] month period, Biodel shall receive a reduction of [**] percent ([**]%) of the Purchase Price of any subsequent late order, so long as the cause of the delay is reasonably within the control of Bachem and not excused pursuant Section 10.

3.5

Product shall be manufactured only at the Bachem manufacturing site located in Bubendorf, Switzerland.

4.

Delivery and Payment Terms; Purchase Price.

4.1

All Product sold hereunder shall be shipped FCA (Bachem facility, Torrance, CA) according to Incoterms^® 2010 to Biodel’s facility or other designated location in the United States of America. Bachem shall arrange for shipment of Product to the address, and with the carrier specified by Biodel, and Bachem shall invoice Biodel for all shipping and handling costs reasonably incurred. Title of the Product shall pass to Biodel upon delivery of the Product to a common carrier for shipment.

4.2

Payment for Product accepted by Biodel shall be made in U.S. dollars within [**] days of Biodel’s receipt of the invoice, such invoice to be sent to Biodel, Attention Accounts Payable, upon shipment of the Product.

The purchase price in effect for the Product ordered hereunder (the “Purchase Price”) shall be as shown in Exhibit A until the [**] anniversary of the Effective Date. Following the [**] anniversary of the Effective Date, [**] days prior written notice to Biodel must be provided in order to increase the Purchase Price

Page 2 of 34

applicable to each [**] month period thereafter. In any event the Purchase Price may only be increased for such [**]-month period by the greater of (a) any increase in the United States of America Producer Price Index for Industry, Pharmaceutical preparation manufacturing, Primary products  (BLS Series ID pcu 325412325412P) (“PPI index”) over the period intervening since the last increase or (b) a percentage increase that is reasonably calculated to address extraordinary market conditions that have increased the component costs of the Product in a manner that this not adequately captured by the PPI index. In connection with a price adjustment made pursuant to subsection (b), Bachem will provide to Biodel budgetary and price documentation reasonably requested by Biodel, and such adjustment shall be reasonably satisfactory to Biodel.

4.3

If during the term of this Agreement any Competent Authority (defined below) requires a change to the Specifications, manufacturing process or analytical methods of the Product, the parties shall discuss in good faith the consequences thereof and consider whether amending any of the terms of this Agreement would be warranted in order to effect the change. If such change, required by any Competent Authority is uniquely related to the use of the Product in the End Products, then Bachem shall in no event be required to implement such change to the extent that this would (i) adversely affect Bachem’s ability to manufacture Product for its other customers or (ii) necessitate a material change to Bachem’s manufacturing processes. If a change to the Specifications, manufacturing process or analytical methods of the Product is voluntarily requested by Bachem, then Bachem shall be responsible for all costs incurred by Bachem in effecting the change, however Biodel shall not be required to accept such change if it is (i) not required for use of the Product in the End Products and (ii) would affect the safety, efficacy or quality of the End Products or would require significant regulatory filings or additional development work or would result in cost increases for Biodel. In the event that Biodel requests a change to the Specifications, manufacturing process or analytical methods of the Product, Bachem agrees to consider the and discuss the desired change in good faith with Biodel with the prior understanding that Biodel shall be responsible for Bachem costs associated with effecting the change if accepted by Bachem.

For the purposes of this agreement, "Competent Authority" means the FDA in the United States or any other applicable national, supranational, federal, state or local regulatory agency or entity having the responsibility, jurisdiction, and authority to approve the manufacture, use, importation, packaging, labeling, marketing, and sale of Product in any country.

4.4

Any federal, state, county or municipal sales or use tax, excise or similar charge, VAT or other tax assessment (other than that assessed against income), fee or other charge lawfully assessed or charged by a Competent Authority on the sale or transportation of Product sold to Biodel pursuant to this Agreement shall be paid by Biodel.

4.5

If Bachem contracts to sell Product as a bulk active pharmaceutical ingredient to any third party that purchases Product as a bulk active pharmaceutical ingredient of a quality and in a quantity that is substantially similar to that purchased or forecasted by Biodel, and if such contract imposes an effective price (taking into account all discounts and rebates in whatever form given) lower than the then-current effective price paid by Biodel for the Product, then Bachem shall promptly notify Biodel thereof and shall also make such lower effective price available to Biodel going forward with respect to any payments made by Biodel for Product following such notice.

Page 3 of 34

4.6

Bachem shall promptly notify Biodel of any problems, supply shortages of raw materials, or other situations that are likely to adversely affect the production of any Product, or its timely delivery to Biodel in accordance with a purchase order therefor. For the avoidance of doubt, Bachem’s notification to Biodel regarding such problem or production situation shall not relieve either party of any responsibility, if any, in connection therewith under this Agreement.

5.

Regulatory Requirements.

5.1

Bachem shall be responsible for complying with all applicable requirements of Competent Authorities relating directly to the manufacture of the Product for sale to Biodel, including without limitation Current Good Manufacturing practice obligations as required under the section 501(a)(2.)(b) “Adulterated Drugs and Devices:” of the Food and Drug Cosmetic Act and as described in the US Code of Federal Regulations, parts 210 and  211 and as detailed in applicable guidance documents such as ICH Q7 “ Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Additional FDA guidance documents in use or produced in the future associated with active ingredient production and control shall be applicable.

In addition, Bachem shall be responsible for complying with European Commission’s   Directives associated with good manufacturing practices, specifically Article 46 (f) of Directive 2001/83/EC and Article 50 (f) of Directive 2001/82/EC; as amended by Directives 2004/27/EC and 2004/28/EC respectively and as detailed in EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II: Basic Requirements for Active Substances used as Starting Materials as well as applicable guidance documents in use or produced in the future associated with active ingredient production and control. cGMP rules for active pharmaceutical ingredients (API) for use in Clinical Trials, Eudralex Vol. IV, Part II, §19.

Both parties shall comply with all other regulatory authority requirements relating to their respective obligations hereunder, including without limitation, registration as drug producers. The parties shall provide each other with reasonable assistance in communicating information to the appropriate regulatory authorities concerning the Product.

5.2

Bachem agrees to use its commercially reasonable efforts to assist Biodel in obtaining FDA approval of Biodel’s new drug application with respect to the Product and End Products, as well as marketing authorization approvals and other related approvals from Competent Authorities in Europe and Japan and such other countries with respect to which Biodel may seek Bachem’s assistance from time to time. Bachem shall compile and maintain a drug master file (“ DMF ”) with respect to the Product with the FDA and the EMEA, and such other Competent Authorities subject to potential additional compensation to Bachem as may be agreed upon by the parties in good faith and subject to consideration of readily available suitable submissions, and Bachem shall grant Biodel rights of reference to the DMF and, at Biodel’s request, shall provide Biodel and such Competent Authorities appropriate letters of access. In the event that Biodel pays for submission in any particular jurisdiction, Bachem shall not grant rights of reference to the DMF unless the charges paid by Biodel are refunded in full. Bachem shall maintain and update such DMF’s during the term of this Agreement as required by such Competent Authorities and shall give Biodel prompt written notice of any changes in the same.

Page 4 of 34

5.3

Bachem shall maintain and enforce safety procedures for the handling and manufacture of the Product that comply in all respects with all applicable national, supranational, federal, state and local occupational safety and health requirements and Bachem’s approvals and permits. Bachem shall provide Biodel with a material safety data sheet for the Product.

Bachem shall give to Biodel [**] days prior written notice (in accordance with the provisions of Section 15) of any proposed major changes to the manufacture of the Product, including any changes that may adversely impact the quality of the Product, the Drug Master File or the related manufacturing processes and testing methods.

5.4

Each party shall promptly advise the other of any safety or toxicity problem of which such party becomes aware regarding the Product.

6.

Bachem Representations and Warranties. Bachem represents and warrants to Biodel that:

6.1

Upon delivery to Biodel in accordance with Section 4.1 hereof, all Product batches will be free from defects in material and workmanship, will have been manufactured and packaged to meet and be in accordance with the Specifications and with the applicable regulatory requirements described in Section 5 above, as well as all applicable Swiss and U.S. laws and regulations and the Quality Agreement, and will not be adulterated or misbranded.

6.2

All facilities, equipment, manufacturing operations and processes used in the manufacture, testing and packaging of the Product by Bachem will remain during the term of this Agreement in material compliance with all applicable laws and regulations, including without limitation, health, safety and environmental laws, statutes, ordinances, regulations, rules and orders.

7.

Product Release and Acceptance.

7.1

Upon shipment by Bachem of a given Product production batch, Bachem shall send Biodel a finished product certificate of analysis stating the results of the analyses conducted with respect to each Product batch, and certifying that the Product batch has been manufactured in accordance with cGMP, the Specifications and the Quality Agreement (the “Release Documents”). If Biodel has not notified Bachem to the contrary within [**] days of receipt of the Release Documents for each batch of Product, then the batch is deemed accepted. Bachem shall invoice Biodel with each shipment and such invoice shall be due on a net [**]-day basis. Batch records and quality control records for each batch may be examined by Biodel on-site at the Bachem facility in Bubendorf, Switzerland.

7.2

Biodel shall have the right not to accept any Product that complies with Specifications, but which has not been manufactured by Bachem in accordance with the procedures and processes agreed to pursuant to this Agreement and the Quality Agreement.

7.3

Biodel may inspect any shipment of Product to determine whether any portion of it fails to conform to the applicable purchase order or the Specifications or the Quality Agreement. In the event of any such failure, Biodel may reject the shipment or any nonconforming portion thereof, by written notice to Bachem delivered within [**] days of Biodel’s receipt of such shipment; however, any such rejection after receipt of an invoice properly sent above shall not extinguish Biodel’s liability to pay timely such invoice, subject to Section 7.5. Such notice

Page 5 of 34

shall specify the manner in which the shipment fails to conform. In the absence of any such notice, Biodel shall be deemed to have accepted the Product. If there is a disagreement between the parties as to whether the Product meets the Specifications, then samples from the batch which is in dispute will be submitted to an independent testing laboratory acceptable to both parties for testing. The determination of such independent laboratory will be binding. The cost of the testing by the independent laboratory shall be borne by the party whose results differ from those of the independent laboratory as to whether the Product in question meets the Specifications.

7.4

The parties recognize that because statistical samples will be used by both parties to perform acceptance testing, there is a possibility that a defect could go unnoticed until actual use by Biodel or ultimate users. If noncompliance with the Specifications is shown through use of Product by Biodel or ultimate users, Biodel shall notify Bachem by facsimile within [**] business days of becoming aware of such nonconformance, provide relevant documentation to Bachem and resolve any such disputes regarding the nonconformance according to the provisions of Section 7.3.

7.5

In the event any Product batch is shown not to conform to the Specifications in any certificate of analysis provided by Bachem, in any testing performed by or for Biodel or through use of the Product, and any disagreement has been resolved in Biodel’s favor pursuant to subsection 7.3 above, then Bachem shall, at Biodel’s option, either (i) replace the nonconforming batch with a conforming batch within [**] days of receipt of such request from Biodel for such batch, or (ii) provide a credit (or refund, if a credit is not practical due to termination or expiration of the Agreement) in the amount of  the Purchase Price paid by Biodel for the nonconforming batch. The parties shall discuss appropriate steps to be taken to dispose of nonconforming batches and costs associated with return shipment or destruction will be the responsibility of Bachem. Nothing in this Section 7.5 shall be deemed to limit Bachem’s liability as otherwise expressly set forth in this Agreement (including under Section 14.2) with respect to such nonconforming batches.

7.6

In the event that the approved batch record contains an authorized reprocessing step, Bachem shall be allowed to conduct that authorized step without prior consent of Biodel in accordance with Section 5.9 of the Quality Assurance Agreement. Bachem will notify Biodel of all such instances of reprocessing that are not authorized by the batch record for the Product.

7.7

Bachem shall:

a)

Retain samples of Product from each lot manufactured (and related records) pursuant to this Agreement for a period of [**] years after Biodel’s acceptance of such lot (or for such longer period as may be required by applicable laws or Competent Authorities). The sample size shall be at least [**] the size necessary to conduct quality control testing. Retained samples shall be stored in the same packaging as the distributed Product.

b)

Properly store the retain sample of each lot. For clarity, retain samples are maintained solely by and on behalf of Bachem and shall be not be made available to Biodel except at the sole discretion of Bachem.

c)

Maintain full and adequate records to ensure Bachem’s ability to perform a complete lot history via lot tracing of the Product. It is acknowledged by the Parties, that the language of such documentation may be English or

Page 6 of 34

German. Upon request, Bachem shall make available to Biodel any copies of records for on-site review.

8.

Inspections and Auditing.

8.1

Upon reasonable notice to Bachem, Bachem shall make available to Biodel for review during normal business hours at the offices of Bachem in Bubendorf, Switzerland, all records and reports relating to the manufacture, processing, testing and packaging of the Product. During the Term of this Agreement, Biodel shall have the right [**] each calendar year, and on such other occasions as Biodel can reasonably show cause, during normal business hours and upon at least [**] prior notice (or upon [**] prior notice in the case of for cause audits), to audit and inspect the areas of the Bachem facility(ies) where manufacture, processing, testing, packaging, storage and transportation of materials related to or used in the manufacture of the Product take place for the purposes of conducting quality control audits required for its internal control or confirming compliance with legal or other requirements as imposed pursuant to this Agreement. A representative of Bachem may be present during such inspections. Such representatives of Biodel must observe all Bachem procedures and shall have no responsibility for or right to supervise Bachem’s employees performing the manufacture, processing, testing, packaging, storage or transportation operations or for the operations themselves. Biodel shall be responsible for all its expenses related to such audits.

8.2

Bachem shall promptly notify Biodel of the results, observations and outcome of all inspections and/or audits of Bachem’s facilities and/or operations conducted by Competent Authorities, including without limitation the FDA, that relate directly to the Product or that may impact Bachem’s ability to manufacture the Product for Biodel or either party’s governmental authorizations in connection with such manufacture. At Biodel’s request, Bachem shall provide Biodel with copies, redacted as necessary to preserve the confidentiality of third parties, of all correspondence and other communications with Competent Authorities in connection with such inspections or audits.

8.3

Should any inspections or audits referred to in Sections 8.1 or 8.2 require any major process changes, Bachem shall notify Biodel immediately and the parties shall discuss the means for implementing such changes pursuant to Section 4.4 and the Quality Assurance Agreement.

8.4

The parties agree that in the case of an emergency affecting the quality of the Product, Bachem shall immediately notify Biodel of such emergency and allow a Biodel representative access to those areas of Bachem’s premises concerned with or affecting the Product.

8.5

For the avoidance of doubt, the rights and obligations of the parties set forth in Sections 6.16-6.19 of the Quality Assurance Agreement shall be in addition to, and shall not be construed to limit, the rights and obligations of the parties set forth in this Article 8 of this Agreement.

9.

Recall.

9.1

Biodel shall have the right to initiate any recall of Product manufactured pursuant to this Agreement, required by applicable laws or regulations or deemed necessary by Biodel, and Bachem shall provide all reasonable assistance requested by Biodel in connection therewith.

Page 7 of 34

9.2

In the event that Product manufactured pursuant to this Agreement is recalled as a result of Bachem's proven negligence, willful misconduct or breach of this Agreement, and, to the extent that such recall does not result from Biodel's negligence, willful misconduct or breach of this Agreement, then Bachem shall reimburse Biodel for Biodel's direct reasonable costs and expenses actually incurred by Biodel in connection with the recall up to [**] percent ([**]%) the amount paid by Biodel for Product purchased from Bachem over the preceding [**] months. Biodel’s direct costs may include, but are not limited to, costs of retrieving Product already delivered to customers, costs of replacement Product and End Product, costs and expenses Biodel is required to pay for notification, shipping and handling charges, fines payable by Biodel in connection with such recall and all other costs reasonably related to the recall. To the extent that a recall is due to any reason other than one that is attributable to Bachem's negligence, willful misconduct or breach of this Agreement, Biodel shall pay all costs and expenses of the recall.

10.

Force Majeure. The obligations of each party under this Agreement, with the exception of the payment of monies owed for deliverables provided in accordance with the terms of this Agreement, shall be suspended during the period and to the extent that such party is prevented or hindered from complying with such obligations by any cause beyond its reasonable control, including lock-outs, acts of God, war, riot, civil commotion, malicious damage, compliance with any new law or governmental order, rule, regulation or direction not required due to a party’s breach of its obligations hereunder, accident, fire, flood, storm, and mandatory recalls in connection with the performance of this Agreement (other than due to such party’s breach of its obligations hereunder). In such event, the party concerned shall give notice to the other party as soon as reasonably practicable stating the date and extent of the suspension of its activities, and the cause of such suspension. Any party whose obligations have been so suspended shall resume the performance of such obligations as soon as reasonably practicable after the removal of the cause and shall so notify the other party. In the event that the cause continues for more than three (3) months, the party not invoking the force majeure excuse under this Section 10 may terminate this Agreement on thirty (30) days’ written notice.

11.

Insurance.

11.1

For the term of this Agreement and [**] years thereafter, each party shall purchase and maintain in effect, at its sole cost, a policy of comprehensive general liability insurance in amounts not less than $[**] per occurrence and $[**] in annual aggregate liability. Such comprehensive general liability insurance shall provide broad form contractual liability coverage for each party’s indemnification obligations under this Agreement. The minimum amounts of coverage required herein shall not be construed to limit liability with respect to each party’s indemnification or other obligations under this Agreement.

11.2

The parties shall provide each other with written evidence of such insurance upon the other party’s request. Each party shall provide the other party with written notice at least [**] days prior to the cancellation, non-renewal or adverse material change in such insurance.

12.

Adverse Event Reports: Product Complaints.

12.1

Biodel shall be solely responsible for receiving, recording and responding to all customer inquiries and complaints and all reports of alleged adverse events relating to finished pharmaceutical medications or formulas incorporating the Product. Biodel shall be solely responsible for reporting all such matters to government authorities in accordance with the applicable law; provided, that

Page 8 of 34

Bachem shall cooperate with Biodel and provide any technical information relating to investigations, quality attributes, formulation, manufacture or stability of the Product reasonably necessary or useful to enable Biodel to perform all such activities.

12.2

Bachem shall promptly investigate any adverse events or product complaints potentially associated with the active ingredient and/or production of the active ingredient. Biodel shall provide all available information related to such adverse event or product complaint to Bachem in advance of the initiation of such investigation. Any such investigation shall identify the cause of events or complaints, if identifiable, and Bachem shall provide Biodel with a written report documenting the investigation and resolution of the same.

13.

Confidentiality. The parties hereby affirm and incorporate by reference into this Agreement the Confidentiality Agreement between the parties dated July 11, 2011. Regardless of any termination provision set forth therein, the terms of the Confidentiality Agreement shall control the parties rights and obligations with regard to the treatment of the other party’s confidential information (including any such information disclosed under this Agreement) for as long as this Agreement remains in effect, unless otherwise agreed by the parties in writing.

14.

Indemnification

14.1

Subject to the provisions of Section 14.3 below, Biodel shall indemnify, defend and hold Bachem and its affiliates, directors, officers, employees and agents (collectively, the “Bachem Indemnitees”) harmless from and against any and all damages, losses, liabilities, claims, demands, judgments, settlements, costs and expenses (including without limitation, reasonable attorneys' fees and other costs of defense) (collectively “Damages”) to the extent attributable to, or arising out of (i) any breach of any representation or warranty or covenant of Biodel hereunder, (ii) the negligence or willful misconduct of Biodel, or (iii) the formulation, development, application or commercialization of End Products comprised of Product supplied by Bachem to Biodel in accordance with the Specifications and the Quality Agreement and other terms of this Agreement (unless such Damages are the subject of a claim for indemnification that Biodel may assert pursuant to Section 14.2).

14.2

Subject to the provisions of Section 14.3 below, Bachem shall indemnify, defend and hold Biodel and its affiliates, directors, officers, employees, licensees and agents (collectively, the “ Biodel Indemnitees ”) from and against any and all Damages to the extent attributable to, or arising out of (i) any breach of representation or warranty or covenant of Bachem hereunder or pursuant to the Quality Agreement or (ii) the negligence or willful misconduct of Bachem or (iii) any infringement or claim of infringement of any patent, trademark or other intellectual property rights based on the manufacture and release of the Product furnished under the provisions of this Agreement and/or other use of Bachem know-how or (iv) the failure of the Product to meet the Specifications.

14.3

No indemnity under this Article 14 shall be applicable unless the indemnified party (the “Indemnitee”) (i) gives the indemnifying party (the “Indemnitor”) prompt notice of any third party claim, suit or action brought against the Indemnitee in accordance with this Section 14.3, (ii) allows the Indemnitor to defend the same, without prejudice to the right of the Indemnitee to participate at its expense through counsel of its own choosing, (iii) renders the Indemnitor all assistance reasonably necessary in defending against such claim, suit or action at the Indemnitor’s expense, and (iv) does not compromise or settle such claim,

Page 9 of 34

suit or action without the Indemnitor’s prior written consent. The Indemnitor shall not settle such claim, suit or action without the Indemnitee’s consent if such settlement results in any obligation or liability on the part of the Indemnitee. If there is a failure to deliver notice under (i) above within [**] days after the commencement of any action with respect to any Damages, and such failure is prejudicial to the Indemnitor’s ability to defend such action, then the Indemnitor shall be relieved of any liability to the Indemnitee pursuant to this Article 14; provided, that Indemnitee’s failure to so deliver written notice to the Indemnitor shall not relieve Indemnitor of any liability it may otherwise have to the Indemnitee. An Idemnitee will be entitled at its own expense to be represented by its own counsel in any third party litigation or similar proceeding.

15.

Notices. Any notice or request required or permitted to be given under or in connection with this Agreement shall be in writing in the English language and shall be deemed to have been duly given on the date of delivery if delivered personally or by email, by confirmed facsimile or by courier on the party to whom such notice or request is to be given, or, if sent by certified or registered mail, or the equivalent, postage prepaid, on the fifth day after the date mailed, to the address set forth for such party below or such other address as directed in writing from time to time:

In the case of Biodel:

Biodel Inc.

100 Saw Mill Road

Danbury, CT  06810-5106,

Attn:  Gerard Michel, Chief Financial Officer

Tel : 203-796-4884

Fax: 203-796-5002

E-mail : gmichel@biodel.com

With a copy to:  

Biodel Inc.

100 Saw Mill Road

Danbury, CT  06810-5106,

Attn:  Paul Bavier, General Counsel

Page 10 of 34

In the case of Bachem:

Bachem Americas, Inc.

3132 Kashiwa Street

Torrance CA  90505

Attn:  President & COO

Tel: 310-539-4171

Fax: 310-539-9428

E-mail:  [**]

With a copy to:

Bachem AG

Hauptstrasse 144

4416 Bubendorf, Switzerland

Attn:  Vice President & COO

Tel: +41 61 935 2333

Fax: +41 61 935 2325

E-mail:  [**]

16.

Governing Law. The enforceability of the provisions of this Agreement shall be governed, construed and enforced solely in accordance with the laws of the State of New York.

17.

Entirety of Agreement:  Amendment and Waiver. This Agreement and the appendices attached hereto (including the Quality Agreement) set forth the entire agreement between the parties as to the subject matter hereof and merges all prior discussions and negotiations between them and neither of the parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein. Neither this Agreement, nor any of the terms or provisions hereof or appendices hereto, may be amended, modified, supplemented or waived, except by a written instrument signed by the parties hereto (or, in the case of a waiver, by the party granting such waiver). No waiver of any of the provisions of this Agreement shall be deemed to be or shall constitute a waiver of any other provisions hereof (whether or not similar), nor shall such waiver constitute a continuing waiver. No failure of a party hereto to insist upon strict compliance by the other party hereto with any obligation, covenant, agreement or condition contained in this Agreement shall operate as a waiver of any subsequent or other failure. This Agreement may not be modified by any custom or course of dealing between the parties.

18.

Termination.

18.1

This Agreement may be terminated prior to its expiration:

(i)

by the mutual written agreement of Biodel and Bachem with respect to the termination of this entire Agreement or any portion hereof;

(ii)

by either party, upon written notice, if there shall have been a material breach by the other party (the “Breaching Party”) of any of the terms or provisions of this Agreement and such breach shall not have been cured within [**] days after such Breaching Party shall have received notice of such breach from the non-breaching party setting forth the particularities of the breach and the non-breaching party’s intent to terminate the Agreement; or

Page 11 of 34

(iii)

by either party upon written notice, if the other party is adjudged bankrupt or becomes the subject of dissolution, liquidation or bankruptcy proceedings, whether voluntary or involuntary, that are not dismissed within sixty (60) days or applies for judicial or extrajudicial settlement with creditors, or makes an assignment for the benefit of creditors.

18.2

Termination or expiration of this Agreement for any reason shall not relieve the parties of any obligation accruing prior to termination and shall not extinguish any antecedent breach of any of the provisions of this Agreement (including without limitation the right to indemnification pursuant to Section 14). For clarity, any purchase orders issued and confirmed prior to the termination of this Agreement shall be completed according to the terms of this Agreement except in the case of termination by Biodel pursuant to Section 18.1(ii) due to an uncured breach by Bachem.

18.3

Upon termination or expiration of the Agreement, each party shall cease using the other party’s confidential information as defined in the Confidentiality Agreement as further set forth in Section 13 and shall promptly return all originals, copies, reproductions and summaries of the other party’s confidential information, or at the disclosing party’s option, certify destruction of the same in writing.

19.

Assignment. Neither of the parties shall assign or transfer this Agreement or any of their respective rights or obligations hereunder without the prior written consent of the other party, which shall not be unreasonably withheld or delayed, except that either party may assign this Agreement and the rights and obligations hereunder without the consent of the other party (i) to any affiliate, or (ii) to a third party in connection with the sale of all or substantially all of the business of the party to which this Agreement relates. However, Bachem may not assign this Agreement or any of its respective rights or obligations without Biodel’s consent if such assignment would cause a change in the Product not approved by Biodel or Bachem’s ability to timely produce the Product; provided, that if such change occurs following such assignment, Biodel shall have the right to terminate this Agreement upon 30 days written notice. This Agreement is binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns.

20.

Technology. No license of technology of any kind whatsoever (including without limitation any formulations, operating procedures, or proprietary know-how, whether patented or unpatented), copyright, trademark or other intellectual property, or right therein, is granted by Bachem to Biodel or by Biodel to Bachem under this Agreement.

21.

Independent Contractor. This Agreement shall not create an agency, partnership, joint venture or employer/employee relationship between the parties hereto. Biodel and Bachem each hereby agree not to represent itself in any such capacity in any manner whatsoever in reliance on the terms of this Agreement. The sole relationship established by this Agreement is that of independent contractors, and nothing hereunder shall be construed to give either party the power or authority to act for, represent, bind or commit the other party.

22.

Survivorship. The representations, warranties and covenants of the parties contained within Sections 3.3–3.4 (with respect to outstanding purchase orders), 4.1-4.3 (with respect to outstanding purchase orders and invoices), 5, 7 (with respect to outstanding purchase orders), 8, 9, 11 (as provided in the Section) 12-16, 18.2-18.3 and 20-25 shall survive any expiration or termination of this Agreement.

23.

Publicity. No advertising, sales, publicity, press release or promotional material or public

Page 12 of 34

statements concerning the Product, this Agreement or the business relationship between Biodel and Bachem, or in which either party’s name is mentioned, shall be issued, released or made use of by the other party or anyone acting on its behalf without the prior written approval of such party; provided, that nothing in this Agreement shall be deemed to prohibit either party from:  (i) releasing materials or public statements, subject to Section 13, which do not refer to the other party or this Agreement or disclose the terms of this Agreement, or from issuing press releases or other public statements notifying appropriate governmental agencies in accordance with, or otherwise complying with the requirements of, any applicable law or regulation or relevant stock exchange without the consent of the other party (except that the party releasing such information shall, to the extent practical, provide reasonable advance notice to the other party of the intended release and the content of such release, and will limit the release of such information to the minimum required by such applicable laws, regulations or stock exchange rules); or (ii) disclosing the contents of this Agreement to its existing shareholders, existing or prospective investors or acquirers or its affiliates or, in the case of Biodel, its licensees, in each case who have each signed an undertaking to keep the contents hereof confidential.

24.

Remedies Cumulative. The remedies for nonperformance provided herein are cumulative and are not exclusive of any remedy provided by law.

25.

Arbitration. Any dispute, controversy or claim arising out of or in connection with this Agreement or the breach, termination or invalidity hereof, that the parties are unable to resolve between themselves, shall be settled by arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association. The proceedings shall take place in New York, New York. The arbitration shall be conducted by a single arbitrator.

26.

Severability. In the event that any provision of this Agreement shall be found in any jurisdiction to be illegal or unenforceable in law or equity, such finding shall in no event invalidate any other provision of this Agreement in that jurisdiction, and this Agreement shall be deemed amended to the minimum extent required to comply with the law of such jurisdiction.

27.

Singular and Plural Forms. The use herein of the singular form shall also denote the plural form, and the use herein of the plural form shall denote the singular form, as in each case the context may require.

28.

Headings. The headings contained in this Agreement are for convenience of reference only and shall not constitute a part hereof or define, limit or otherwise affect the meaning of any of the terms or provisions hereof.

29.

Counterparts.

This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which, when taken together, shall constitute one and the same instrument.

30.

Quality Assurance Agreement. Bachem and Biodel entered into the Quality Assurance Agreement as of even date herewith. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Assurance Agreement will govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Assurance Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement will govern.

Page 13 of 34

IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed by their authorized representatives on the Effective Date.

Torrance,   July 18, 2012                                 

Bachem Americas, Inc.

By:	/s/ Alex Fässler
	Alex Fässler
	President & COO

Acknowledged by

Bubendorf,      July 18^th, 2012                 

Bachem AG

By:	/s/ Dr. Fritz Dick	By:	/s/ Dr. Anne-Kathrin Stoller
	Dr. Fritz Dick		Dr. Anne-Kathrin Stoller
	Chief Operating Officer		Vice President Marketing and Sales

Danbury, Connecticut, USA

Biodel Inc.

By:	/s/ Gerard Michel
	Gerard Michel
	Chief Financial Officer

List of Exhibits:

Exhibit A:

Prices

Exhibit B:

Quality Assurance Agreement

Page 14 of 34

Biodel/Bachem
Exhibit A
Prices

Glucagon

A. Prices for the Product

Product: Glucagon

Bachem No: 4074733 A

Pricing is applicable for quantities ordered from Bachem on a single date, whether on one purchase order which may stipulate multiple deliveries or on multiple purchase orders.

Quantity (grams)	Price/Gram ($)
[**] grams:	$[**]
[**] grams	$[**]
[**] grams	$[**]
[**] grams	$[**]
[**] grams	$[**]
[**] grams	$[**]
[**] grams	$[**]
[**] grams	$[**]

Pricing provided above shall remain in effect through the [**] anniversary of the Effective Date as set forth in Section 4.3 of the Agreement.

Page 15 of 34

CONFIDENTIAL

Biodel/Bachem
Exhibit B
Quality Assurance Agreement

Glucagon

Bachem / Biodel QA Agreement

Page  1/15

CONFIDENTIAL

Biodel / Bachem
Quality Assurance Agreement
Generic API

This Quality Assurance Agreement (the “Quality Assurance Agreement”) is made as of July 17, 2012 ("Effective Date") between Bachem AG, an entity organized under the laws of Switzerland, with its principal place of business at Hauptstrasse 144, CH-4416 Bubendorf, Switzerland (“Bachem”), and Biodel Inc., an entity organized under the laws of Connecticut with its principal place of business at 100 Saw Mill Road, Danbury, CT 06810-5106, USA (“Biodel”).

PREAMBLE

WHEREAS,  Bachem is engaged in the business of manufacturing of active pharmaceutical ingredients (API) and has a broad proprietary know-how in the development of the manufacturing process for peptides including related analytical methods as well as in the manufacturing of peptides;

WHEREAS,  Biodel is a company engaged in research, development and sale of medicinal products;

WHEREAS,   Biodel and Bachem entered into that certain Commercial Supply Agreement for Glucagon (the “Commercial Agreement”) of even date herewith for the supply by Bachem to Biodel of commercial supplies of Product (as defined below);

WHEREAS, the Parties now desire to set forth in this Quality Assurance Agreement a plan, prepared by Biodel and Bachem, for determining the conformity of Product supplied by Bachem to Biodel under the Commercial Supply Agreement to the Specifications (as defined below).

NOW THEREFORE, in consideration of premises and mutual promises herein made, and in consideration of representations, warranties, and covenants herein contained, Bachem and Biodel agree as follows:

ARTICLE  1

PREAMBLE AND DEFINITIONS

Section 1.1 Preamble. The preamble to this Quality Assurance Agreement forms an integral part hereof.

Section 1.2 Definitions. Unless the context otherwise requires, the following terms as used in this Quality Assurance Agreement shall have the following meaning:  

“Annex” means an exhibit annexed to and forming part of this Quality Assurance Agreement.

"Competent Authorities" mean the FDA in the United States or any other applicable national, supranational, federal, state or local regulatory agency or entity having the responsibility, jurisdiction, and authority to approve the manufacture, use, importation, packaging, labeling, marketing, and sale of Product or Biodel’s Pharmaceutical Products in any country where Bachem has authorized Biodel to access Bachem’s DMF.

"Biodel’s Pharmaceutical Products" means Biodel's pharmaceutical medications or formulations, including those in any manner arising or resulting from the use of the Product in connection with the above medications.

Bachem / Biodel QA Agreement

Page  2/15

CONFIDENTIAL

Certificate of Analysis" means a certificate in writing for each batch of Product, signed by a Qualified Person or its deputy, that provide full analytical results of the batch of Product, a TSE-Safety-Certificate and certifies (a) the conformity of the batch of Product to the Specifications and (b) that manufacturing and release records of the respective batch of Product were reviewed by Bachem and manufacturing and release of the respective batch of Product is in accordance with all applicable GMP requirements and the provisions of this Quality Assurance Agreement and the Commercial Agreement.

“Commercial Agreement” has the meaning set forth in the preamble above.

“Confidential Information” means, with respect to a Party, all information of a confidential nature which may be disclosed by or on behalf of that Party to the other Party including, but not limited to, the Product Information and information relating to the disclosing Party’s business or scientific strategies, research, product development, marketing, customers, opportunities, finances, sales and pricing of products, processes, and all other written information clearly identified as "Confidential" when submitted by the disclosing Party to the receiving Party.

“DMF” means Drug Master File maintained with the FDA or its equivalent maintained with a Competent Authority in any other country.

“GMP” means the (a) current regulations for Good Manufacturing Practice as outlined in the US Code of Federal Regulations and applicable FDA guidance documents as amended and (b) the ICH Q7 guideline for the production and release of active substances and in EC Directive 2003/94/EC as amended from time to time and transposed into the respective national laws of the member states of the European Union and the equivalent US (FDA) laws and regulations.

“Latent Defect” means, with respect to Product, a hidden or latent defect not detected by the analytical test methods in operation at the date of shipment to Biodel of the relevant Product by Bachem and which was not detected by Biodel during the initial Testing Period.

“Major Deviation” means a deviation which is likely to have an adverse impact on Product quality, safety, efficacy or stability.

“Minor Deviation” means any deviation that will not have any adverse impact on Product quality, safety, efficacy or stability.

“Major Change” means a change that may adversely impact on quality, safety, efficacy, stability, or regulatory compliance of the Product. Any change that will require authority approval is also defined as Major Change.

“Minor Change” means a change that will not have any adverse impact on Product quality, safety, efficacy, stability, or regulatory compliance, and will not require authority approval.

"OOS" means out of specification and, with respect to a Product or testing of a Product, means that the Product does not conform to the Specifications or the results of testing of the Product indicate non-conformance of the Product to the Specifications.

"Party" or "Parties" shall mean Bachem or Biodel, individually or collectively as the context requires.

"Product" means synthetically manufactured human glucagon as described in more detail in the Specifications in Annex 1 of this Quality Assurance Agreement, as non-sterile active pharmaceutical ingredient(s) in bulk form, manufactured under GMP requirements.

“Qualified Person” has the meaning ascribed to it in EC Directive 2003/94/EEC as amended or as in any other applicable GMP regulation.

"Specifications" means the specifications for the Product, as more specifically described in Annex 1 of this Quality Assurance Agreement. Annex 1 may be modified from time to time by written amendment to this Quality Assurance Agreement in accordance with Section 12.4.

Bachem / Biodel QA Agreement

Page  3/15

CONFIDENTIAL

“Testing Period” means the time after Biodel’s receipt of any shipment of Product to subject such shipment, on a sample basis, to quality control testing to determine conformity with the relevant Specifications, and whether or not a Product is free from defects in workmanship or materials, and manufactured according to GMP.

“TSE-Safety-Certificate” means a certificate certifying that a batch of the Product(s) complies with or is outside the scope of monograph 5.2.8 of the EP.

“USP” means current United States Pharmacopeia official compendia of standards.

“EP” means current European Pharmacopoeia official compendia of standards.

Section 1.3 Interpretation. Words denoting the singular include the plural and vice versa, words denoting a gender include all genders, and words denoting persons include corporations and all other legal entities.

ARTICLE  2
SUBJECT OF THIS QUALITY ASSURANCE AGREEMENT

Section 2.1 The purpose of this Quality Assurance Agreement is to define and to establish the obligations and responsibilities of Bachem and Biodel relating to the quality assurance requirements of the manufacture, release and supply of the Product pursuant to the Commercial Agreement by Bachem in accordance with GMP guidelines for active pharmaceutical ingredients (APIs), namely the US Code of Federal Regulations, FDA guidance documents and ICH Q7 GMP Guide for APIs as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member states of the PIC scheme.

ARTICLE  3
QUALITY ASSURANCE AGREEMENT CONTACT INFORMATION

Section 3.1 Notices. Any notice, request, delivery, approval or consent required or permitted to be given under this Quality Assurance Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted by telecopy with a confirming copy, by e-mail with a confirming copy, sent by overnight courier or registered mail to the Party to whom it is directed at its address shown in Section 3.02 and Section 3.03 or such other address as such Party shall have last given by notice to the other Party.

Section 3.2 Notices to Bachem. Any notice to Bachem under this Quality Assurance Agreement shall be addressed to:

Bachem AG, Hauptstrasse 144

4410 Bubendorf, Switzerland

[**]

Telephone: + 41 61 935 2333

Fax: + 41 61 935 2480

e.mail: [**]

Section 3.3 Notices to Biodel. Any notice to Biodel shall be addressed to:

Biodel Inc., 100 Saw Mill Road

Danbury, CT 06810-5106, USA

Paul Bavier

Telephone: 203.796.5000

Fax: +  203.796.5001

e.mail: pbavier@biodel.com

Bachem / Biodel QA Agreement

Page  4/15

CONFIDENTIAL

ARTICLE  4

THE PRODUCT

Section 4.1 Product. The Product covered by this Quality Assurance Agreement, together with the related Specifications, is listed in Annex 1.

ARTICLE  5

SUPPLY AND MANUFACTURE

Section 5.1 Premises and Subcontracting. Bachem will manufacture and release the Product at its site in Bubendorf, Switzerland. Bachem may subcontract quality control work provided that the respective contract laboratories have been qualified by Bachem. In case Bachem subcontracts any work, Bachem is solely responsible for the fulfillment of the obligations of this Quality Assurance Agreement by its subcontractors.

Section 5.2 GMP Guidelines. The premises, equipment and systems used to manufacture and release the Product must be in compliance with all GMP requirements, including the principles detailed in the US Code of Federal Regulations, and ICH Q7 GMP Guide for APIs, as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member states of the PIC scheme.

Section 5.3 Materials. Bachem shall be responsible for procuring all materials for manufacturing, release and supply of the Product. Bachem shall also be responsible for the specifications and the release of such materials. Upon Biodel’s request, Bachem shall provide access to such specifications and release documents for such materials to Biodel on site at Bachem’s facility.

Section 5.4 Manufacturing Batch Records. Bachem shall maintain the manufacturing process and method information in its own format in manufacturing batch records.

Section 5.5 Manufacturing Process. Product must be manufactured, tested, released and packed in compliance with the requirements of the provisions of this Quality Assurance Agreement and the Commercial Agreement. Any changes made to the established manufacturing process are subject to Bachem’s change control process as described in Article 7 of this Quality Assurance Agreement hereunder. Biodel shall be notified in advance of any changes associated with the manufacture and quality control of Product.

Section 5.6 Facilities. Bachem shall manufacture the Product in facilities which are regularly monitored by Bachem to demonstrate compliance with applicable GMP guidelines and codes of practice for the type of production.

Section 5.7 Batch Numbering. Bachem shall implement and use a unique batch numbering system for numbering each batch of Product. This number shall appear on all documents relating to the particular batch of Product.

Section 5.8 Date of Manufacture. Bachem shall allocate the date of manufacture as the date when all manufacturing work has been completed and the batch is ready for release testing.

Section 5.9 Re-Test Date. The re-test date for Product shall be allocated based on the date of manufacture together with the retest period established by stability data generated using Product produced by the validated manufacturing process.

Section 5.10 Rework and Reprocessing. Reprocessing and rework of Product is permitted with rework steps that have been validated as part of the manufacturing process and in accordance with the provisions of the ICH Q7 guideline. In the case where the manufacturing process is soon to be registered

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CONFIDENTIAL

with any Competent Authority program or has been registered with any Competent Authority, Bachem will notify Biodel prior to reworking.

Section 5.11 Manufacturing and Equipment Data. Bachem shall be responsible for keeping records of equipment usage, cleaning, raw material batch numbers and certification as well as in process results and parameters. Such documentation shall be retained by Bachem as described in Section 6.9 hereunder.

Section 5.12 Training and Personnel. Bachem shall maintain a GMP compliant training program. Bachem will ensure and document that employees have and maintain education, training, and experience appropriate to their job duties. Bachem will not employ any person or cGMP service provider listed in the DMF that has been debarred by any Competent Authorities or, to Bachem’s knowledge, is currently under any investigation which could lead to such debarment. Bachem will provide the required statement supporting the claim that none of the employees or cGMP service providers listed in the DMF have been debarred or, to Bachem’s knowledge, are under investigation by any Competent Authorities.

Section 5.13 Drug Master File: In mutually agreed countries Bachem will maintain the Product DMF according to requirements defined by each local Competent Authority. Bachem will provide a letter to the specified Competent Authority at Biodel’s request in accordance with Section 5.2 of the Commercial Agreement allowing such Competent Authority to review Bachem’s Product DMF relative to any Biodel submission.

QUALITY ASSURANCE AND QUALITY CONTROL

Section 6.1 Sampling and Samples. Bachem shall ensure that representative samples of Product are taken in accordance with GMP guidelines.

Section 6.2 Testing of Raw Materials. Bachem shall ensure that materials and packaging components used to manufacture the Product(s) are in compliance with the specifications as defined by Bachem and, if applicable, disclosed to Biodel. Reduced testing shall be permitted for vendors that have been formally qualified by Bachem. In this case raw materials for use in the manufacture of the Product shall be tested at a minimum for identity on each shipment delivered.

Section 6.3 In-Process Testing. Bachem shall be responsible for ensuring that all required in-process testing is completed using suitable methods, when applicable, and documented. This will include environmental controls where required. Bachem shall also be responsible for defining appropriate tests and criteria.

Section 6.4 Specifications. Bachem shall implement Specifications for the Product as mutually agreed in this Quality Assurance Agreement. It will remain the responsibility of Biodel to ensure that the Specifications are appropriate for the intended use of Product.

Section 6.5   Approval to ship the Product. Bachem shall be responsible for ensuring that Product conforms to the Specifications and has been made and tested in accordance with the manufacturing procedure and with all provisions of this Quality Assurance Agreement. This will be carried out by Bachem’s Qualified Person or deputy before any shipment of Product to Biodel.

Section 6.6 Certificate of Analysis. Bachem shall issue a Certificate of Analysis serving as a confirmation that the Product has been manufactured and tested in accordance with the GMP requirements and with all provisions of this Quality Assurance Agreement. The Certificate of Analysis will be signed by Bachem’s Qualified Person or deputy and provide full analytical results for each batch. It will be supplied with each delivery of each batch of Product.

Section 6.7 Release of Product for use by Biodel. Biodel shall also be responsible that all further medicinal use of Product is in accordance with the relevant laws and regulations.

Section 6.8 Documentation. Bachem shall create and maintain complete manufacturing and control documentation that is at minimum comprised of (i) a completed batch production record including in-process controls; and (ii) a completed analytical batch record; and (iii) equipment charts and print-outs; and (iv) any documentation on investigations, deviations, OOS or failures as applicable.

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Section 6.9 Document Retention. Bachem shall retain all documentation relevant to the manufacture and release of the Product securely and for a minimum of [**] years. The documentation will be available to Biodel and Competent Authorities for on-site review at Bachem in Bubendorf.

Section 6.10 Retained Samples. Bachem shall retain sufficient samples of Product for [**] years after batch release. A quantity sufficient to perform at least [**] of Product shall be retained. Biodel shall retain sufficient samples of Product for the longest shelf life of Biodel’s Pharmaceutical Product batches plus [**]. A quantity sufficient to perform at least [**] of Product shall be retained.

Section 6.11 Stability Studies. Bachem will run stability testing under ICH conditions according to the relevant Bachem’s SOP.

Section 6.12 Rejection of Product by Biodel. Any problem likely to cause rejection (excluding Latent Defects as defined above) of Product shall promptly be notified to Bachem after it is identified and in any event within [**] business days of receipt of Product by Biodel.

Section 6.13 Reference Standards: Bachem will use a fully qualified internal reference standard which is qualified according to expectations of Competent Authorities and as detailed in current guidance documents which may be amended from time to time. Bachem and Biodel will collaborate to consider implementation of USP methods and reference standard when appropriate and practical.

Section 6.14 Conflict Resolution of Analytical Issues. In the event that a dispute arises between Bachem and Biodel in the analysis of the Product, the resolution shall conform with GMP rules on OOS results and shall proceed in stages. The first stage requires direct communication between analytical experts from the Parties to determine that the methods of analysis are the same and are being executed in the same manner at both sites. In a second stage, carefully controlled and split samples shall be exchanged to attempt to reach agreement. Should there be a failure to achieve a common set of results, analytical experts from the Parties shall be required to meet to work through the analysis of a mutually agreed sample. If these actions fail to achieve a common set of results, a qualified, independent, third party referee laboratory shall be used to achieve resolution. This laboratory shall be selected mutually by the Parties. The results from this referee laboratory shall be binding on both Parties. Whatever the outcome, Biodel retains the right to decide whether the Product will be used to manufacture Biodel’s Pharmaceutical Product. Nothing in this Section 6.14 shall be construed to limit Biodel’s rights under Article 7 of the Commercial Agreement.

Section 6.15 Conflict Resolution in Quality Assurance Issues. In the event that a dispute arises between Bachem and Biodel concerning the acceptability of a batch of Product, the resolution shall proceed in stages. The first stage requires direct communication between the responsible quality assurance personnel from the Parties to determine the facts of the matter and to produce an investigation report. This report shall contain complete details of the problem together with any discussion on the validity and weight to be applied to any results. The investigation report shall be reviewed by the senior quality personnel from the Parties and the Parties shall determine together the action to take. If these actions fail to achieve resolution, a qualified, independent external quality consultant shall be used to decide the appropriate action. This consultant shall be selected mutually by the Parties. The results from this consultant shall be binding on both Parties. Whatever the outcome, Biodel retains the right to decide whether the Product will be used to manufacture Biodel’s Pharmaceutical Product. Nothing in this Section 6.15 shall be construed to limit Biodel’s rights under Article 7 of the Commercial Agreement.

Section 6.16 Right to Audit. Bachem shall allow representatives of Biodel to have access to its manufacturing, warehousing and laboratory premises and to the associated records including inspection reports, Bachem responses and corrective actions generated from the inspection by any Competent Authority, related to Product or Quality Systems and redacted as necessary to preserve the confidential information of third parties, with prior written, reasonable notice for audit purposes. Biodel shall follow Bachem systems and procedures to ensure the safety, confidentiality and security of Bachem processes, facilities and personnel during any audit. Responses to audit findings will be provided by Bachem within [**] business days of Bachem’s receipt of an audit findings report from Biodel.

Section 6.17 Audit Schedule:

Without limiting Biodel’s rights under Article 8 of the Commercial Agreement, Bachem agrees to support Biodel audits according the following schedule:

[**]

Bachem / Biodel QA Agreement

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Section 6.18 Audit of Competent Authorities. Bachem shall permit inspection by applicable Competent Authorities. Bachem shall notify Biodel, in advance to the extent practical, of any inspections by a Competent Authority specifically related to the Product. If results of an unrelated inspection by a Competent Authority may impact Product, Bachem shall notify Biodel promptly.

Section 6.19 Interactions with Competent Authorities. In the cases of responses to findings by inspectors representing Competent Authorities, Bachem will meet mandatory response timelines and in the case where time is needed to provide a complete response, Bachem will notify the Competent Authority and work aggressively to ensure the complete responses meet timelines specified by the Competent Authorities.

In the case of queries directed to Bachem from Competent Authorities reviewing the drug master file relative to Biodel submissions (including IND, CTA, NDA, MAA filings), Bachem will provide to Biodel copies of all queries and responses thereto, redacted as necessary to preserve Bachem proprietary information, and work with Biodel to ensure a timely response to each query such that review cycles will not be extended by the Competent Authorities. Biodel acknowledges that such responses may also need to be coordinated with third parties and that this may lead to longer response times and to limited flexibility for the response.

In the case when DMF queries received by Bachem from Competent Authorities are associated with third parties’ applications, Bachem will notify Biodel if the regulatory queries may impact Biodel’s Pharmaceutical Products and program timelines. In the case when queries or requested changes from regulators may produce a conflict between Biodel’s Pharmaceutical Products and program(s) and Bachem’s’ changes relative to a third party’s application, Bachem will cooperate with Biodel in order to ensure that Biodel’s Pharmaceutical Products and programs are not impacted. Biodel will also cooperate in good faith to support the intended change.

Section 6.20 Latent Defects. Upon discovery that any batch, previously approved by Bachem and delivered to Biodel, fails to conform to its Specifications or the regulatory dossier or has in any way been adulterated, Bachem shall promptly notify Biodel of such failure and of the nature thereof in detail, including supplying Biodel with all relevant investigation reports and data. Bachem shall investigate all such failures promptly, at its expense,  and co-operate with Biodel in determining the cause for the failure and the corrective action required.

Section 6.21 Product Complaints. Biodel shall be responsible for coordinating the investigation of any complaints about the Biodel’s Pharmaceutical Product made from Product(s) and shall notify Bachem of any complaint which may be related to the quality of Product. Bachem shall investigate and provide a rapid initial response and a report as soon as possible.

Section 6.22 Product Recall. Biodel shall be responsible for instituting a medical product recall scheme for Biodel’s Pharmaceutical Product. Bachem will inform Biodel as soon as possible, but no later than [**] after Bachem becomes aware of such information, if Bachem with reasonable cause considers a batch of Biodel’s Pharmaceutical Product should be recalled. In case Biodel does not agree, then Biodel releases Bachem from all consequent financial and liability obligations. Biodel shall notify Bachem of any recall of Biodel’s Pharmaceutical Product, which may be due to manufacture, components or tests performed on Product(s) by Bachem. Bachem shall provide a rapid initial response and then a full report as soon as possible. The Parties shall cooperate on the response to the authorities.

ARTICLE  6

DEVIATIONS AND INVESTIGATIONS

Section 7.1 Deviations. (Major) Bachem shall ensure that any deviation is carefully investigated, evaluated and documented by quality assurance of Bachem. In case of Major Deviations Bachem quality assurance and/or regulatory affairs will notify Biodel and include Biodel in the evaluation and determination of acceptability of the materials for use by Biodel as well as compliance to GMP, the impact on conformity with regulatory submissions and regulatory reporting requirements. Each investigation must give rise to an explanation and/or corrective action, which must be reviewed and approved by Bachem's

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quality assurance personnel and approved by Biodel. Bachem will ensure investigation closeout and corrective actions are completed prior to release of Product, if applicable.

Section 7.2 Deviations. (Minor) Bachem shall ensure that any Minor Deviation is carefully evaluated and documented by quality assurance of Bachem. In the case of Minor Deviations Bachem quality assurance and regulatory affairs will evaluate the acceptability regarding GMP, and the impact on conformity with regulatory submissions. Each investigation must give rise to an explanation and/or corrective action, which must be reviewed and approved by Bachem's quality assurance personnel. Bachem will ensure investigation closeout and corrective actions are completed prior to release of Product, if applicable. Bachem will ensure investigation closeout and corrective actions are completed prior to release of Product. Bachem will provide access to all documentation with respect to minor deviations to Biodel on-site at Bachem’s facility.

Section 7.3 OOS Results, and Failure Investigations. Bachem shall be responsible for investigating any OOS results that occur with testing of the Product. According to Bachem’s OOS procedure, an initial lab error investigation will clarify whether the OOS result was caused by a lab error or by a batch failure. In case of a batch failure the investigation will be expanded at minimum to cover earlier and later production lots. Each investigation must give rise to an explanation and/or corrective action which must be reviewed and approved by Bachem's quality assurance. OOS and failure investigations must be completed prior to Product release. Bachem will notify Biodel of all confirmed OOS results and failure investigations for any production lots of GMP human glucagon produced with the same manufacturing process, test procedure and specification as used to produce Product for Biodel.

ARTICLE  7

CHANGE CONTROL

Change Control. Bachem shall maintain a local change control system that ensures compliance with GMP, regulatory submissions and with all provisions of this Quality Assurance Agreement. All changes will be evaluated by competent management personnel regarding the technical implications. In case of established manufacturing procedures Bachem’s quality assurance and regulatory affairs will evaluate the acceptability of changes regarding GMPs, the impact on Product quality and stability as well as on conformity with regulatory submissions. Bachem will notify Biodel of any/all proposed Major Changes to the manufacturing process, quality controls, specifications, methods of control, prior to initiation and refrain from making major process changes without Biodel’s prior approval and such approval is not to be unreasonably withheld.

ARTICLE  8

VALIDATION AND QUALIFICATION

Section 9.1 Process Validation. Bachem shall be responsible that the manufacturing process used is fully validated, approved by Bachem’s Quality assurance and Regulatory Affairs groups and meets Competent Authorities requirements. Bachem will document the process validation, and at Biodel’s request, disclose such documentation to Biodel for on-site review at Bachem.

Section 9.2 Equipment Calibration Bachem shall be responsible for ensuring that manufacturing is carried out according to Competent Authorities requirements and ICH Q7A rules using calibrated equipment.

Section 9.3 Cleaning Validation. Bachem shall be responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent cross contamination. Bachem shall also be responsible for conducting cleaning verification or validation as appropriate to ensure the integrity of all products.

Section 9.4 Facility and Utility Qualification (IQ, OQ, PQ). Bachem shall be responsible for the qualification as appropriate of all relevant utility, equipment, computer systems and facilities associated with the manufacture, storage or testing of Product according to Competent Authorities requirements.

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ARTICLE  9

SPECIFIC RESPONSIBILITIES

Without limiting each Party’s rights and obligations as otherwise set forth in this Quality Assurance Agreement and the Commercial Agreement, the following chart sets forth each Party’s specific responsibilities in connection with quality assurance matters relating to the manufacture of Product:

RESPONSIBILITY	Bachem	Biodel
Manufacture
Manufacture of the API	Yes	No
Development of manufacturing process for the API	Yes	No
Manufacturing documentation for the API	Yes	No
Ownership of manufacturing process and documentation for the API	Yes	No
Procurement of the API raw and starting materials	Yes	No
Analytical, Laboratory, Sampling and Control
Retain and store samples of all materials and the API	Yes	No
Sampling, analysis and release of materials for API	Yes	No
In-process analyses for manufacture of the API	Yes	No
Reference standards for laboratory analysis performed by Bachem	Yes	No
Incoming material testing of the API upon receipt and keeping retained samples as legally required	No	Yes
Quality Assurance Activities for API
Batch numbering	Yes	No
Approval of master batch documents	Yes	No
Preparation and review of the batch production, analytical and packaging records as well as of associated documents	Yes	No
Assurance of correct storage conditions for the API prior to shipment to Biodel	Yes	No
Release of API to Biodel.	Yes	No
Shipping documentation	Yes	No
Material safety data sheet provision	Yes	No
Maintain a change control system	Yes	No
Approve API Specifications*)	Yes	Yes
Ensure that Specifications are appropriate for further use	No	Yes
Change Control for Specifications*)	Yes	Yes
Change Control review and approvals for Major Changes*)	Yes	Yes
Failure investigation in case of batch failure	Yes	No
Regulatory Documentation for API
Scheduling and ordering the regulatory work, documentation and submissions for API as needed	No	Yes
Submission and maintenance of DMF for API	Yes	No
Stability studies for the API	Yes	No
NDA or MAA submission and maintenance for Biodel’s  Drug Products	No	Yes
Hosting GMP Inspections for the API by the Competent Authorities	Yes	No
Maintain site registration licenses	Yes	No

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Validation for API
Qualification of equipment for manufacturing and analysis	Yes	No
Cleaning validation and cleaning verification	Yes	No
Validation of test methods	Yes	No
Validation of manufacturing process	Yes	No
Validation of computerized systems	Yes	No
Complaint Handling, Drug Safety
Review and resolution of Biodel’s Pharmaceutical Product quality complaints when applicable to API	Support where relevant	Yes
Decisions regarding the notification of critical API quality issues to Swissmedic and Biodel.	Yes	No
Decisions regarding recalls and field alerts of Biodel’s Pharmaceutical Product	No	Yes

* require mutual approval

ARTICLE  10

CONFIDENTIALITY

Section 11.1 Confidentiality Restriction of Use. The Confidential Information communicated by one Party to the other Party under this Quality Assurance Agreement through written documents or by any other means or any part thereof shall be kept in confidence by the receiving Party which agrees to use the Confidential Information solely for the purpose of implementing this Quality Assurance Agreement. This confidentiality shall survive the termination of this Quality Assurance Agreement for [**] years.

ARTICLE  11

MISCELLANEOUS

Section 12.1 Review terms of QAA. Bachem and Biodel shall evaluate in good faith the validity of the provisions defined in this Quality Assurance Agreement every [**] years (or sooner, to the extent required by applicable laws) starting at the Effective Date.

Section 12.2 Governing Law, Dispute Resolution. The interpretation and construction of this Quality Assurance Agreement shall be governed by the laws as set out in the Commercial Agreement and any dispute arising in connection with this Quality Assurance Agreement shall be solved as set out in the same Commercial Agreement except as otherwise specifically set forth in this Quality Assurance Agreement.

Section 12.3  Annexes. The Annexes referenced in this Quality Assurance Agreement are specifically made a part hereof.

Section 12.4 Amendment. Any amendment or modification of this Quality Assurance Agreement must be in writing and signed by authorized representatives of both Parties.

Section 12.5 Prevailing Agreement. To the extent that there is a conflict between, or ambiguity relating to, this Quality Assurance Agreement and the Commercial Agreement, the wording of this Quality Assurance Agreement shall govern any and all quality matters and the Commercial Agreement shall govern all other matters.

Section 12.6 Language. This Quality Assurance Agreement is made in the English language.

Section 12.7 Number of Copies. Two master copies exist, one with each of the Parties.

Bachem / Biodel QA Agreement

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Section 12.8 Term. This Quality Assurance Agreement shall commence as of the Effective Date and shall terminate upon the later of (a) the expiration or termination of the Commercial Agreement or (b) the delivery of the last shipment of Product to Biodel pursuant to the Commercial Agreement. Termination of this Quality Assurance Agreement shall not relieve the Parties of any obligation accruing prior to termination and shall not extinguish any antecedent breach of any provisions thereof, and such provisions of this Quality Assurance Agreement which, by their terms, survive shall continue in full force and effect after such termination.

Section 12.9 Assignment. Neither of the Parties shall assign or transfer this Quality Assurance Agreement or any of their respective rights or obligations hereunder without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed, except that either Party may assign this Agreement and the rights and obligations hereunder without the consent of the other Party in the event such assigning Party concurrently assigns the Commercial Agreement; provided, that the assignee and the scope of such assignment of this Quality Assurance Agreement shall be the same as for such assignment of the Commercial Agreement.

IN WITNESS WHEREOF, the Parties have caused this Quality Assurance Agreement to be duly executed by their authorized representatives on the Effective Date.

Bubendorf, 18 July 2012

Bachem AG

By:	/s/ Gerhard Haas	By:	/s/ S. Dunkel
	Dr. Gerhard Haas		Dr. Silke Dunkel,
	VP QA/RA		Team Leader Release Management

Danbury, Connecticut, USA

Biodel Inc.

By:	/s/ Gerard Michel	By:	/s/ Robert E. Hauser
	Gerard Michel		Dr. Robert Hauser
	Chief Financial Officer		Vice President, Manufacturing

Bachem / Biodel QA Agreement

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Biodel / Bachem
Quality Assurance
Agreement
ANNEX 1 SPECIFICATIONS
Glucagon

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. [**]

Bachem / Biodel QA Agreement

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Product: Glucagon, Pharma Grade Material

Bachem No.: 4074733A

Peptide Sequence:

[**]

Bachem / Biodel QA Agreement

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Biodel / Bachem
Quality Assurance
Agreement
ANNEX 2 APPROVED CONTRACT LABORATORIES
Glucagon

Certain analytical services are provided for Bachem AG by contract laboratories. Following please find the list of these institutes / companies including their potential service(s). All listed subcontractors are appropriately qualified by Bachem. Alternatively to using a contract laboratory these tests may be performed in house at Bachem provided that the specific technique is available.

Contract laboratory	Description of typical service(s)
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]

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FIRST AMENDMENT
TO THE
COMMERCIAL SUPPLY AGREEMENT FOR GLUCAGON

THIS FIRST AMENDMENT TO THE COMMERCIAL SUPPLY AGREEMENT FOR GLUCAGON (this “Amendment”) is dated as of June 14, 2013 (the “Amendment Effective Date”) by and between Biodel, Inc., a Delaware corporation, and Bachem Americas, Inc., a California corporation. Capitalized terms not otherwise defined in this Amendment will have the same meaning as set forth in the Agreement, (defined below).

RECITALS

WHEREAS, Biodel and Bachem entered into a Commercial Supply Agreement for Glucagon on July 17, 2012, (the “Agreement”); and

WHEREAS, Bachem and Biodel have agreed to agree on new pricing under Exhibit A of the Agreement;

WHEREAS, the parties wish to amend the Agreement to reflect their discussions regarding the obligations of payment and forecasts, consistent with Sections 3, 5 and 6 of the Agreement.

NOW, THEREFORE, in consideration of the foregoing promises and the representations, warranties, covenants and agreements herein contained, the parties hereto, intending to be legally bound, agree as follows:

1. Amendments.

The parties agree to delete and replace Exhibit A of the Agreement, with the attached Exhibit A.

The parties agree the following will be added to the end of Section 3.1 of the Agreement:

“In consideration of the above, the parties agree that the initial forecast for the Product, effective I April 2013, for the forthcoming quarter(s), and years are as follows:

Row	Purpose	Projected Qty (grams)	Date Required
1	[**]	[**]	[**]
2	[**]	[**]	[**]
3	[**]	[**]	[**]
4	[**]	[**]	[**]
5	[**]	[**]	[**]
6	[**]	[**]	[**]
7	[**]	[**]	[**]
8	[**]	[**]	[**]
9	[**]	[**]	[**]
10	[**]	[**]	[**]

The parties agree any pricing changes referenced on Exhibit A of the Agreement will continue to be dictated by Section 4.2 of the Agreement. Any cost savings indicated in the pricing listed on Exhibit A of the Agreement, is based upon a binding forecast by Biodel, as indicated above.”

2. No Other Amendments. Except as expressly amended hereby, all of the terms and conditions of the Agreement shall remain in full force and effect.

3. Execution in Counterparts. This Amendment may be executed in two (2) counterparts, each of which shall be deemed an original but which together shall constitute one (1) and the same instrument. This

Page 32 of 34

Amendment may be executed by facsimile or “PDF” signatures, which signatures shall have the same force and effect as original signatures.

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed and delivered by their respective duly authorized officers as of the day and year first above written, each copy of which shall for all purposes be deemed to be an original.

BIODEL INC.

By:  /s/ Gerald Michel

Name:  Gerald Michel
Title:  CFO/VP Business Development

BACHEM AMERICAS, INC.

By:  /s/ Dr. Alex Fassler

Name:  Dr. Alex Fassler
Title:  President & Chief Operating Officer

BACHEM AG

By:  /s/ Dr. Fritz Dick

Name:  Dr. Fritz Dick
Title:  Chief Operating Officer

By:  /s/ Dr. Anne-Kathrin Stoller

Name:  Dr. Anne-Kathrin Stoller
Title:  Vice President Marketing and Sales

Page 33 of 34

Exhibit A
Prices – Glucagon
Biodel/Bachem

Quantity quoted: less than or equal to [**] g
Price Per Unit: (USD) [**]/ g
GMP Grade Material.
Forecasted API requirements for [**].
Forecasted API requirements for [**].

Quantity quoted: greater than [**] g
Price Per Unit: (USD) [**]/ g
GMP Grade Material.
Forecasted API requirements for [**].

Projected costs outside of the [**] years quoted above may change based upon Section 4.2 of the Agreement.

Page 34 of 34

EX-10.26

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

Exhibit 10.26

CUSTOMIZATION AND COMMERCIAL SUPPLY AGREEMENT

THIS CUSTOMIZATION AND COMMERCIAL SUPPLY AGREEMENT is entered into this 8th day of April 2013 (“Effective Date”) by and between UNILIFE MEDICAL SOLUTIONS, INC., a corporation organized under the laws of Delaware (collectively, “Unilife ”), and BIODEL INC., a company organized under the laws of Delaware (“Biodel”). Unilife and Biodel may hereinafter be referred to individually as a “Party” or collectively as the “Parties.”

RECITALS

WHEREAS, Unilife designs, develops and manufactures advanced drug delivery devices;

WHEREAS, Biodel is in the business of developing and commercializing products and treatments for diabetes and other diseases; and

WHEREAS, Biodel desires to purchase advanced drug delivery devices from Unilife and Unilife desires to sell advanced drug delivery devices to Biodel, on the terms and conditions contained in this Agreement.

NOW, THEREFORE , Unilife and Biodel agree as follows:

1.

Certain Definitions

In this Agreement, capitalized terms shall have the meaning set forth herein, including the following:

1.1

“Affiliate” shall mean an entity that directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with a specified person. “Control” (including the terms “controlled by” and “under common control with”) means the ownership or control of securities possessing at least 50% of the voting power of all outstanding voting securities of an entity or the power otherwise to direct or cause the direction of the management and policies of such entity, whether through the ownership of voting stock or otherwise. For the purposes of this definition, partnerships, joint ventures or similar entities also shall be deemed to be Affiliates of such Party if a Party and/or its Affiliates are a majority in interest of the partners, venturers or other members of such entities.

1.2

 “Accounting Period” means, during the Exclusivity Term, (a) a period of time beginning on the first day of the calendar quarter in which the Combination Product is Launched in the United States and ending the following year on last day of prior calendar quarter, and (b) each [**] month period thereafter.

1.3

“Applicable Laws” means any law, statute, rule, regulation, guideline, order, judgment and/or ordinance of any kind whatsoever of any Regulatory Authority, including the regulations and guidelines of the FDA and, to the extent applicable, all current good manufacturing practices.

1.4

“Agreement” means this Customization and Commercial Supply Agreement, together with all exhibits and schedules, attached hereto, as the same may be supplemented, modified or amended from time to time in writing by the mutual agreement of the Parties.

1.5

“Approval Date” means the date of first approval of the Combination Product and its corresponding label by the FDA and/or similar foreign Regulatory Authority.

_____		_____
(Initial)	1	(Initial)

1.6

 “CDA” has the meaning set forth in Section .

1.7

“Combination Product” means the product to be marketed and sold by Biodel that combines the Unilife Device with the Drug.

1.8

“Confidential Information” has the meaning set forth in the CDA.

1.9

“Customization Committee” has the meaning set forth in Section .

1.10

“Default Event” has the meaning set forth in Section (a).

1.11

“Drug Master File” means a drug master file or equivalent submitted to the FDA and the technical dossier or equivalent submitted to the European Medicines Authority (or other European Regulatory Authority), in each case, with respect to the Unilife Device (and equivalent submissions with Regulatory Authorities in other countries in a Region) in support of Biodel’s Regulatory Filings for the Combination Product.

1.12

“Development Phase” means the period commencing on the Effective Date and ending upon the delivery of the customized Unilife Device which satisfies Milestone #3 as may be defined and mutually accepted by the Parties through the Customization Committee (and payment of any fees associated therewith), as set forth in the Development Plan.

1.13

“Development Plan” means the development plan to customize the Unilife Device such that it meets the Target Device Profile, which plan is attached as Exhibit A to this Agreement, as such plan may be amended from time to time by the mutual agreement of the Parties.

1.14

“Drug” means Biodel's lyophilized glucagon and diluent.

1.15

“Exclusivity Maintenance Fee” means a fee payable to Unilife in consideration of maintaining, during the applicable Accounting Period, the exclusive rights granted by Unilife in Section , which fee shall become due (subject to the standard payment terms set forth in this Agreement), as follows:

(a)

$[**] upon first day of the first three Accounting Periods (which amount shall be in addition to any royalty payments payable to Unilife for the same Accounting Period pursuant to Section ); except that payment in the first Accounting Period shall not be triggered until the Combination Product is Launched; and

(b)

$[**] upon the last day of every other Accounting Period, reduced on a dollar-for-dollar basis by any royalty payments payable to Unilife for the same Accounting Period pursuant to Section .

1.16

 “Exclusivity Term” means for the geographical areas set forth below, the period of time commencing on the Effective Date and ending the earliest of the following dates if no Default Event has occurred:

(a)

for all Regions, [**] days following occurrence of any of the following (provided that Unilife notifies Biodel in writing of its intent to terminate the Exclusivity Term pursuant to this provision and Biodel does not cure such failure within [**] days):

(i)

The failure of Biodel (or an Affiliate, licensee, distributor or other Third Party partner) to pay the Exclusivity Maintenance Fee when and if due;

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(Initial)	2	(Initial)

(ii)

The failure of Biodel (or an Affiliate, licensee, distributor or other Third Party partner) to Launch the Combination Product within any country in the Region of the United States and Canada by the Launch Deadline;  

(iii)

The failure of Biodel (or an Affiliate, licensee, distributor or other Third Party partner) to submit one or more  Purchase Orders calling for the delivery of at least [**] Unilife Devices in any Accounting Period other than the first Accounting Period; or

(iv)

The failure of Biodel (or an Affiliate, licensee, distributor or other Third Party partner) to use commercially reasonable efforts to develop and commercialize the Combination Product in light of the relevant product labeling requirements, market potential, competitive and regulatory environment, and medical and clinical considerations.

(b)

For each Region other than [**], and ROW, the failure of Biodel (or an Affiliate, licensee, distributor or other Third Party partner) to Launch the Combination Product within any country in such Region by the Launch Deadline (provided that Unilife notifies Biodel in writing of its intent to terminate the Exclusivity Term pursuant to this provision and Biodel does not cure such failure within [**] days);

(c)

For each Region other than [**], on the date occurring [**] years after Biodel has Launched the Combination Product in at least one country in such Region, if the Combination Product accounts for less than [**] percent ([**]%) of the then-existing market (“Market Share”) in such Region for glucagon kits or devices labeled for use in the Therapeutic Area, as determined by publicly available sales data from a reputable Third Party source (provided that Unilife notifies Biodel in writing of its intent to terminate the Exclusivity Term pursuant to this provision and Biodel does not cure such failure within [**] days); and

(d)

For all Regions the expiration or termination of this Agreement.

If Biodel fails to meet any of the payment, Launch, or Market Share requirements for the maintenance of the exclusivity rights, such exclusive rights shall be revoked and become non-exclusive rights for the applicable Regions or sub-Region(s). Upon the occurrence of a Default Event, the Exclusivity Term shall mean the period of time beginning on the date of such occurrence and ending on the fifteenth (15^th) anniversary of the Effective Date and shall be an extension of only those rights which are maintained or otherwise remain granted, and in those Regions as identified above, without prior revocation, to Biodel at the time of such Default Event.

1.17

 “FDA” means the United States Food and Drug Administration or any successor agency thereto.

1.18

“Forecast” has the meaning set forth in Section .

1.19

“Improvements” means any invention or discovery that is conceived or first reduced in the course of either Party performing services, duties, and responsibilities under this Agreement, and includes any improvement, modification, derivative, reproduction or product of the Unilife Device, the Drug or the Combination Product, whether invented or discovered solely by Biodel, solely by Unilife or jointly by Biodel and Unilife, or their respective Affiliates.

1.20

“Intellectual Property Rights” means patent rights, trademarks, service marks, trade names, registered designs, design rights, copyright (including rights in computer software), rights in and to databases, rights in and to Know-How, and any rights in or to property similar to any of the foregoing in any part of the world whether or not registered or capable of registration, the right to apply

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(Initial)	3	(Initial)

for the registration of any such rights, and all rights or forms of protection having equivalent or similar effect, in any part of the world.

1.21

“Know-How” means technical and other information which is not in the public domain, including information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), processes (including manufacturing processes, specifications and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports, manufacturing data or summaries. The fact that an item is known to the public will not be taken to exclude the possibility that a compilation including the item, and/or a development relating to the item, is not known to the public. Know-How includes any rights including trade secrets, copyright, database, or design rights protecting such Know-How.

1.22

“Launch” or “Launched” means sale or distribution of the Combination Product in a Region or country for use within the subject Region or country, whether sold directly by Biodel, an Affiliate or a Third Party having sub-licensed the rights in, or purchased, such Combination Product from Biodel.

1.23

“Launch Deadline” means, for a given Region as applicable, the date that is calculated as follows:  

(a)

For the United States and Canada Region, [**] months following Effective Date, plus an additional number of days equal to:  [**]; and

(b)

For each Region other than the United States and Canada, [**] months following the Effective Date, plus an additional number of days equal to:  [**].

1.24

“Manufacture” means the storage, handling, production, materials procurement, processing, manufacture, assembly, filling, finishing, testing and packaging of the Unilife Device or its components in accordance with the terms of this Agreement.

1.25

“Manufacturing Standards” means a complete compilation of manufacturing and control instructions and procedures, sampling and testing procedures, other appropriate quality standards and Specifications used to produce the Unilife Device under established conditions set forth in the Quality Agreement.

1.26

 “Net Sales” means, with respect to any Combination Product, the gross amount billed by Biodel, its sub-licensees and their respective Affiliates for the Combination Product less the following: (i) normal and customary trade, quantity and/or cash discounts, returns or credits (including due to rejections, defects or recalls of the Combination Product or because of rebates or retroactive price adjustments), allowances, rebates and charge-backs, to the extent actually accrued; (ii) sales taxes, value-added taxes, excise or use taxes, tariffs, duties and customs fees and other taxes (excluding income taxes), duties or other governmental charges imposed with respect to sales of the Combination Product that are actually paid; (iii) credits or allowances given or made for rejection or return of, and for uncollectible amounts on, previously sold Combination Product or for rebates or retroactive price reductions (including Medicare, Medicaid and similar types of rebates and chargebacks); and (iv) freight, postage, shipping, insurance and other transportation expenses associated with the Combination Product that are itemized in the gross amount billed and are actually paid by Biodel or its Affiliates or sub-licensees. All calculations shall be made in accordance with U.S. generally accepted accounting principles.

1.27

“Purchase Order” has the meaning set forth in Section .

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(Initial)	4	(Initial)

1.28

“Quality Agreement” means a quality agreement to be negotiated in good faith by the Parties and entered into by them as soon as is reasonably practical following the Effective Date.

1.29

 “Region(s)” means:  (a) the United States and Canada; (b) the European Economic Area and Switzerland, (c) Japan, and (d) the Rest of the World (“the ROW”) (i.e., all other countries in the world except those located in the Regions described in clauses (a), (b), and (c) of this definition); each of which shall be considered separable “sub-Regions” herein.

1.30

“Regulatory Approvals” means any approval of an applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical product, medical device or combination thereof in any Region.

1.31

“Regulatory Authority” means the FDA and any other federal, national, multi-national, state, provincial or local regulatory agency, department, bureau or other governmental entity, including any such entity with authority over the manufacture, marketing or sale of pharmaceutical or biotechnology products, medical devices or combinations thereof.

1.32

“Regulatory Materials” means regulatory applications, submissions, notifications, registrations, Regulatory Approvals and/or other filings made to or with a Regulatory Authority, including the Drug Master File, that are necessary or reasonably desirable in order to Manufacture, or market, distribute, sell and import a pharmaceutical or biotechnology product, medical device or combination thereof in a particular country or regulatory jurisdiction.

1.33

“Royalty Report” has the meaning set forth in Section .

1.34

“Royalty Term” means, on a country-by-country basis, with respect to the Combination Product, a period that is the longer of: (a) if the manufacture, use or sale of such Combination Product in such country is covered by a Valid Claim, the term for which such Valid Claim remains in effect, or (b) ten (10) years after the date of the Launch of the Combination Product in such country.

1.35

“Services” means all activities to be performed by Unilife pursuant to this Agreement, including those services specifically provided in the Development Plan.

1.36

“Similar Unilife Device” means a dual chamber mixing system intended for the injection of a pharmaceutical product, including the EZMix™ dual chamber mixing platform.

1.37

“Specifications” collectively means the drawings and product descriptions, to be attached as Exhibit B to this Agreement, as the same may be modified or supplemented from time to time by the mutual agreement of the Parties through the Customization Committee.

1.38

“Target Device Profile” means a Unilife Device having the characteristics and meeting the criteria established by mutual agreement of the Customization Committee, which characteristics and criteria shall automatically become Exhibit C to this Agreement when established.

1.39

“Territory” means the world.

1.40

“Term” has the meaning set forth in Section .

1.41

“Termination for Insolvency” has the meaning set forth in Section

1.42

“Therapeutic Area” means the use of Drug for the treatment of hypoglycemia.

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(Initial)	5	(Initial)

1.43

“Third Party” means any person or entity not a Party to this Agreement, excluding an Affiliate of either Party.

1.44

“Unilife Device” means a device customized for Biodel based on Unilife’s proprietary EZMix™ dual chamber mixing platform.

1.45

“Unilife Improvements” has the meaning set forth in Section (b).

1.46

“Unilife Intellectual Property Rights” means all Intellectual Property Rights that are controlled by Unilife or its Affiliates as of the Effective Date or are filed by or granted to Unilife or its Affiliates during the Term and that claim the composition, design, manufacture, or use of the Unilife Device or a Similar Unilife Device, including but not limited to the patents and patent applications listed in Exhibit D to this Agreement, and as may be amended by Unilife from time-to-time.

1.47

“Unilife Know-How” means all Know-How that is controlled by Unilife or its Affiliates as of the Effective Date or (b) made by or on behalf of Unilife or its Affiliates during the Term, and, in the case of both (a) and (b), is reasonably necessary or useful for the research, development, manufacture, use, importation or sale of the Unilife Device or Combination Product in the Therapeutic Area.

1.48

“Unilife Technology” means the Unilife Intellectual Property Rights, the Unilife Know-How and Unilife Improvements.

1.49

“Unit Price” has the meaning set forth in Section .

1.50

“Valid Claim” shall means, on a country-by-country basis, a claim of an issued and unexpired patent in any Unilife Technology, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

2.

Development

2.1

Development Plan. The Development Plan sets forth the responsibilities of the Parties during the Development Phase with respect to, and timelines for delivering, the deliverables and milestones that the Parties have agreed to for customizing the EZMix™ dual chamber mixing platform to produce the Unilife Device for use with the Drug and Biodel's clinical development program for the Combination Product. The Development Plan also sets forth (i) the amounts due to Unilife by Biodel for the development work; and (ii) the supply obligations of Unilife with respect to the Unilife Device, and of Biodel with respect to the Drug, for use in any Development Plan activities. Without limiting the foregoing, Parties shall be responsible for the following during the Development Phase:

(a)

The Parties shall form a customization committee comprising of two (2) or more representatives from Biodel and two or more (2) representatives from Unilife (the “Customization Committee”). The representatives for either Party may be changed, from time-to-time, upon written notice to the other Party. The Customization Committee shall meet, by teleconference or in person at least twice per month, unless a particular meeting is waived by mutual consent, on such dates and at such times as agreed to by the Parties through the Customization Committee, and if applicable, mutually agreeable locations. Each Party shall be responsible for its own expenses for participating in the Customization Committee. The Customization Committee shall define and mutually approve the Target Device Profile, oversee the performance of the Services and suggest modifications to the Development Plan, as appropriate, for the Parties’ consideration and mutual agreement.

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(Initial)	6	(Initial)

(b)

Unilife shall provide to Biodel certain deliverables within the disclosed time intervals in consideration of the associated fixed milestone payments set forth in the Development Plan, the first of which (following the execution of the Agreement) shall be the delivery of a mutually-approved Unilife Device that meet the Target Device Profile.

(c)

Unilife [**] Unilife [**] Biodel [**] Biodel [**] Biodel’s [**] Unilife’s [**].

(d)

Unilife shall plan, with Biodel's input, and execute a formative user study to assess the human factors-informed final design of the Unilife Device.

(e)

Biodel shall use commercially reasonable efforts to develop and commercialize the Combination Product in light of the relevant product labeling requirements, market potential, competitive and regulatory environment, and medical and clinical considerations.

2.2

Additional Services. In addition to the foregoing Services to be provided by Unilife during the Development Phase, Unilife shall, at the option of Biodel, provide Biodel with the following additional Services:

(a)

Unilife will provide, free of charge, a report on the characterization of the device performance that will include both functional testing data and a detailed potential extractables list. Unilife will assist in the design of the analytical testing and stability studies necessary to obtain data for Regulatory Approval of the Drug and Combination Product. If requested by Biodel, Unilife will work with Biodel and conduct the stability studies at an industry-leading, cGMP-compliant, Third Party laboratory mutually-agreed upon by the Parties through the Customization Committee to aid in the rapid adoption of the Unilife Device.

(b)

Unilife is experienced with FDA requirements for the design and conduct of formative and summative human factors studies. Unilife has established relationships with opinion leaders and study sites to conduct human factors studies for the Unilife Device. Unilife’s experience and human factors data can also be easily leveraged by Biodel to collaboratively conduct summative human factor studies.

2.3

Development Standards of Conduct. Each Party shall perform, and shall ensure that its Affiliates, and permitted Third Party contractors perform, the activities for which it is responsible under the Development Plan in a diligent, workmanlike and good scientific manner and in strict compliance with this Agreement, including Manufacturing Standards and Applicable Laws.

2.4

Equipment. Capital equipment associated with the manufacture of the Unilife Device will be purchased and owned by Unilife. Unilife’s obligations to manage the activities of a Third Party fill-finish contract manufacturer, including the transfer of the lyophilization protocol of the Combination Device, as defined under Section 2.1(c) shall cease no later than upon delivery of Milestone #3 to Biodel, whereupon such obligations and responsibilities shall pass to Biodel.

2.5

Regulatory Filings.

(a)

Except as specifically set forth in Section  below, Biodel shall be responsible for preparing and filing all Regulatory Materials with respect to the Combination Product, and

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(Initial)	7	(Initial)

seeking all Regulatory Approvals in the Territory for the Combination Product. Unilife shall assist Biodel in obtaining Regulatory Approvals and preparing Regulatory Materials at Biodel’s reasonable request from time to time. Except as specifically set forth in Section  below, (i) all Regulatory Materials for the Combination Product in the Territory shall be filed in the name of Biodel, and Biodel alone shall be responsible for all communications and other dealings with the Regulatory Authorities relating to the Combination Product in the Territory, except as required by a Regulatory Authority; and (ii) to the maximum extent permitted by law, Biodel shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for the Combination Product in the Territory or, in the event such Regulatory Approvals and/or Regulatory Materials may not be owned by Biodel, they shall be held for the benefit of Biodel and shall be transferable as directed by Biodel. In the event that any such Regulatory Approvals and/or Regulatory Materials are not transferable to Biodel, then upon expiration or termination of this Agreement or earlier upon request of Biodel, Unilife shall use its best efforts to assist Biodel in obtaining Regulatory Approvals and/or Regulatory Materials for the Combination Product substantially similar to the non-transferable Regulatory Approvals and/or Regulatory Materials.

(b)

Notwithstanding Section  above, Unilife shall prepare and submit a Drug Master File with the FDA (and equivalent submissions with Regulatory Authorities in other Regions) with respect to the Unilife Device in support of Biodel’s Regulatory Filings. Unilife shall maintain and update such Drug Master Files during the Term hereof as required by Applicable Law and shall give Biodel prompt written notice of any changes in the same. Unilife shall provide Biodel with letters of authorization, rights of reference and other appropriate letters of consent or instruments with respect to such Drug Master Files in such forms as reasonably requested by Biodel.

3.

License Grants

3.1

License to Biodel. During the Exclusivity Term, Unilife hereby grants to Biodel an exclusive (even as to Unilife), revocable, worldwide, sub-licensable license, under the Unilife Technology, to the extent necessary or useful to develop, use, import, sell, offer for sale, and market the Combination Product in the Therapeutic Area in the Territory; provided that such exclusive rights are subject to the provisions of Section  herein. Unilife shall not develop, manufacture, use, import, sell, offer for sale, or market a Similar Unilife Device for any Third Party to use with a lyophilized glucagon and diluent in the Therapeutic Area within the Territory during the Exclusivity Term. The foregoing license and right shall survive termination of this Agreement only if a Default Event occurs; provided that only those rights accrued and/or maintained by Biodel at the time of such Default Event shall survive. Upon actuation of any of the provisions of Section , such license grants to Biodel in such Regions shall be on a non-exclusive, revocable, worldwide, sub-licensable license basis, under the Unilife Technology, to the extent necessary or useful to develop, use, import, sell, offer for sale, and market the Combination Product in the Therapeutic Area, while remaining on an exclusive basis in all other Regions of the Territory where the conditions of Section  are met or maintained.

3.2

Continuity of Supply. Upon the occurrence of a Default Event, Unilife hereby further grants to Biodel, for the duration of the Exclusivity Term, a worldwide, sub-licensable license, under the Unilife Technology, in the form (exclusive or non-exclusive) accrued and/or maintained by Biodel at the time of such Default Event and [**].

3.3

License to Unilife. Biodel hereby grants to Unilife the right to access and use the data generated by Biodel under the Development Plan relating to the Unilife Device solely for Unilife's internal product development purposes.

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(Initial)	8	(Initial)

4.

Purchase and Supply Obligations

4.1

Manufacture and Supply. During the Term, Unilife shall Manufacture and supply Biodel, and Biodel shall purchase, the Unilife Device in the quantities and at the times requested by Biodel from time to time, in accordance with and pursuant to the terms of this Agreement. Unilife shall Manufacture the Unilife Device in accordance with the Manufacturing Standards, Specifications, all Applicable Laws and the other provisions hereof. Unilife agrees not to make any modifications or changes to (a) the Specifications, (b) the Manufacturing Standards, or (c) the location of the designated final manufacturing facility from York, Pennsylvania, without the prior written consent of Biodel, and to promptly provide written notice to Biodel in the event Unilife believes that any such modifications or changes may be necessary. The Specifications shall be amended only upon mutual agreement of Biodel and Unilife.

4.2

Purchase Price and Payments.

(a)

Biodel shall pay Unilife $[**] for each Unilife Device (the “Unit Price”), in addition to the royalty payments, if any, required by Section  below. Upon payment by Biodel of the Exclusivity Maintenance Fee for the 3rd Accounting Period, Biodel shall pay Unilife a Unit Price of $[**] for each Unilife Device, henceforth referred to as the new “Unit Price”, in addition to the royalty payments, if any, required by Section  below.

(b)

During the Royalty Term, on a country by country basis, Biodel shall pay to Unilife a royalty payment equal to [**] percent ([**]%) of Net Sales by Biodel, its sub-licensees and their respective Affiliates. The obligation to pay royalties under this Section 4.2 shall expire on a country-by-country basis. For clarity, the Royalty Term shall be determined separately for each country in the Territory and Biodel shall have no obligation to pay royalties for Net Sales in a particular country after expiration of the Royalty Term in such country, notwithstanding the fact that the Royalty Term may not have expired in other countries.

(c)

Beginning [**], Unilife may increase the Unit Price once per calendar year by providing Biodel at least [**] days’ prior written notice; in which case the Unit Price shall be adjusted for such [**] month period by the percentage change, if any, in accordance with the US Bureau of Labor Statistics Producers Price Index (PPI) for “All Other Plastics Product Manufacturing” PCU326199326199, but the Unit Price shall not be more than [**] percent ([**]%) of the immediately preceding [**] period.

4.3

Forecasts. In order to assist Unilife in its production planning, on the date of execution of this Agreement and on the first day of each calendar month thereafter, Biodel shall advise Unilife in writing (such advice, a “Forecast”), of its estimated requirements of Unilife Devices to be shipped for each month commencing with the first month after delivery of such Forecast and ending on the month occurring [**] months thereafter. Such Forecasts shall not bind either Party to any commitments to purchase or supply Unilife Devices, with firm quantity orders and commitments being provided instead on a [**] months rolling basis via Purchase Order as detailed in Section . Subject to the limitations provided in this Agreement, Biodel may, in its sole discretion, update its estimated requirements of Unilife Device in the next Forecast delivered. It is understood and agreed that, subject to the restrictions contained Section  below, estimates contained in the Forecasts shall not constitute commitments to purchase Unilife Devices or Purchase Orders.

4.4

Orders. Purchase orders for the Unilife Device shall be delivered monthly by Biodel at least [**] months prior to the requested shipment thereof (each, a “Purchase Order”); provided that for each Purchase Order requesting shipment thereafter, no such Purchase Order shall specify a quantity for any given month covered by the Purchase Order that is greater than [**]% of the amount that was originally designated for such month when it was the [**] month in the [**] month Forecast, and  no such

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(Initial)	9	(Initial)

Purchase Order shall specify a quantity for any given month covered by the Purchase Order that is less than [**]% of the amount originally designated for such month when it was the [**] month in the [**] month Forecast. Unilife shall notify Biodel of the specific shipment date for such ordered Unilife Devices.

4.5

Reasonable Accommodations. Unilife shall use reasonable business efforts to comply with unplanned changes in the Forecasts but shall not be required to accept orders for Unilife Devices that are not within the guidelines set forth above.

4.6

Sample Testing and Records. Unilife shall test samples of each lot of Unilife Device supplied hereunder for compliance with the Specifications and the Manufacturing Standards and to record the results and keep said results on file for a period of five (5) years (or longer if required by any Applicable Law) after the expiration of the shelf-life of the tested lot of Unilife Devices. Unilife shall keep retention samples of the Unilife Devices for a period of two (2) years after the expiration of the shelf-life of the tested lot of the Unilife Devices (or such longer period if required by any Applicable Law). Unilife shall undertake to maintain sufficient records to permit (a) confirmation of the cause of any Unilife Device defect; (b) confirmation of the Unilife Device's conformance with the Specifications, and its Manufacture in accordance with the Manufacturing Standards; and (c) compliance with any other Applicable Law.

5.

Financial Terms; Delivery and Acceptance

5.1

Payment Terms.

(a)

All payments for milestone deliverables and of the Unit Price shall be due within net [**] days of the date of Biodel's receipt of Unilife’s invoice therefor. Unilife shall send invoices to Biodel upon shipment of Unilife Devices to Biodel.

(b)

Not later than [**] days after each December, March, June, and September in each calendar year during the Royalty Term, Biodel shall submit to Unilife a report of royalties due to Unilife for the preceding quarter year (each a “Royalty Report”) setting forth the: (i) the quantity of Combination Products sold in countries in which royalties are due; (ii) the gross amount billed for such Combination Products; (iii) the deductions permitted under Section  to arrive at Net Sales; and (iv) the royalty computations and subject of payment. Each Royalty Report may be an estimate of such actual royalties due to Unilife under GAAP revenue recognition, with any shortfalls subject to the interest terms in Section . If no royalties are due, a statement shall be sent to Unilife stating such fact. Payment of the full amount of any royalties to Unilife for the preceding quarter year shall accompany each Royalty Report. Biodel shall keep for a period of at least six (6) years after the date of entry, full, accurate and complete books and records consistent with sound business and accounting practices and in such detail as to enable the determination of the amounts due to Unilife from Biodel pursuant to the terms of this Agreement.

(c)

On reasonable notice and during regular business hours, Unilife or the authorized representative of Unilife reasonably acceptable to Biodel shall have the right to inspect the books of accounts, records and other relevant documentation of Biodel in order to ascertain or verify the amount of royalties and other payments due to Unilife hereunder, and the accuracy of the information provided to Unilife in the Royalty Reports. The cost of such inspection shall be borne by Unilife, unless it is determined in such inspection that Unilife has been underpaid in any period by more than [**] percent ([**]%) of the amount that Unilife should have been paid, in which case the cost of such inspection shall be reimbursed to Unilife by Biodel. If such inspection reveals a surplus in royalties actually paid to Unilife by Biodel, Unilife shall refund to Biodel the surplus amount within [**] days after such inspection.

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(Initial)	10	(Initial)

5.2

Interest. Payments not received by Unilife within such net [**] day period shall accrue interest at the rate of the lesser of [**] percent ([**]%) per month or the maximum rate allowed by Applicable Law. All payments due hereunder to Unilife shall be made in United States Dollars, and are exclusive of all sales, use, value added, withholding and other taxes and duties.

5.3

Shipment. Unilife agrees to deliver the Unilife Device DAP Biodel’s Third Party fill and finish manufacturer (Incoterms 2010) using a carrier selected by Biodel for shipment to Biodel pursuant to the instructions and conditions provided by Biodel in writing. Title to the Unilife Devices shall pass to Biodel upon delivery thereof to the Third Party fill and finish manufacturer. Unless otherwise agreed, delivery of the Unilife Devices to the carrier shall take place at Unilife’s Manufacturing facility, and Unilife shall be responsible for shipping costs.

5.4

Timing of Shipment. Unilife shall ship the Unilife Devices for each Purchase Order upon completion and testing required pursuant to the Quality Agreement, unless Biodel instructs Unilife to hold such Unilife Device (or part thereof) and delay shipment of such Unilife Devices for up to [**] days.

5.5

Testing and Acceptance. With each shipment of Unilife Devices, Unilife shall provide Biodel with such certificates and documentation as set forth in the Quality Agreement.

6.

Regulatory; Audits

6.1

Regulatory Requirements.

(a)

Unilife shall be responsible for complying with all Applicable Laws relating to the manufacture of the Unilife Devices for sale to Biodel. Both Parties shall comply with all other Regulatory Authority requirements relating to their respective obligations hereunder. The Parties shall provide each other with reasonable assistance in communicating information to the appropriate Regulatory Authorities concerning the Unilife Device.

(b)

As provided in Section , Unilife shall submit and maintain Drug Master Files for the Unilife Device and assist Biodel in obtaining Regulatory Approvals for the Combination Product in the Regions and such other countries with respect to which Biodel may seek Unilife’s assistance from time to time.

(c)

Unilife shall maintain and enforce safety procedures for the handling and manufacture of the Unilife Device that comply in all respects with all applicable national, supranational, federal, state and local occupational safety and health requirements and Unilife’s approvals and permits. Unilife shall provide Biodel with a material safety data sheet for any hazardous chemical substance in the Unilife Device.

(d)

Without limiting a Party’s rights and obligations under the Quality Agreement, each Party shall promptly advise the other of any safety problem of which such Party becomes aware regarding the Unilife Device.

6.2

Audits.

(a)

During the Term, Biodel or its agents may, during normal working hours, perform a quality audit of Unilife facilities, including its physical plant and documentation, or its permitted subcontractor’s facilities, involved in manufacturing of the Unilife Device to verify compliance with Specifications, Manufacturing Standards and this Agreement. Biodel will advise Unilife a minimum of [**] before the audit, specifying the subject of the audit. Biodel may conduct an audit under this Section  not more than [**] during each calendar year during the Term.

(b)

In addition to the rights under Section , Biodel has the right to perform a

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(Initial)	11	(Initial)

“for cause” quality audit of Unilife’s facilities, including its physical plant and documentation, or its permitted subcontractor’s facilities, involved in the manufacturing of the Unilife Device. Such “for cause” audit and document review shall be conducted by Biodel or its agents at a time, date and duration mutually agreeable to Biodel and Unilife, but no later than [**] business days after Biodel’s request. Without limiting the foregoing, Biodel’s right to conduct a “for cause” may be triggered by (i) customer complaint regarding the Unilife Device, (ii) Third Party litigation or the threat of litigation relating to the Unilife Device, (iii) correspondence from a Regulatory Authority regarding or relating to the Unilife Device, or (iv) any other event or circumstance that relates to the quality of the Unilife Device.

(c)

In case of a negative audit outcome under Section 6.2(a) or Section 6.2(b), Unilife or its subcontractors shall respond to the audit in writing with corrective actions and timelines and shall perform at Unilife’s expense, or at the subcontractor’s expense, the requested or appropriate modifications. Unilife shall evidence these modifications and Biodel shall be entitled to perform an additional audit with prior notice to verify such modifications.

(d)

Unilife shall make itself immediately available for any Regulatory Authority or other governmental inspection directly or indirectly  involving the Unilife Device and the manufacture thereof, and Unilife shall notify Biodel in writing within twenty-four (24) hours of any substantive inspection related to the Unilife Device by such Regulatory Authority or other governmental entity and promptly provide Biodel with a copy of any notices, communications or written report of the results of such inspection that Unilife receives from the applicable Regulatory Authority or other government entity in so far as the report relates to the Unilife Device or the manufacture thereof, and any responses or other communications it sends to any Regulatory Authority or other governmental authority concerning the Unilife Device. For clarity, such obligations of Unilife to notify Biodel regarding substantive actions of Regulatory Authorities or other governmental entities related to the actual Unilife Device.

(e)

Upon reasonable notice and during normal business hours, Unilife will provide Biodel and/or its Third Party representatives with reasonable escorted access to the Manufacturing site(s) and allow Biodel to observe Manufacturing runs of the Unilife Device to the extent that Biodel’s right to observe shall not interfere with Unilife’s manufacturing operations.

6.3

Unilife Device Recalls. In the event that one or more Unilife Devices manufactured pursuant to this Agreement are recalled as a result of Unilife's negligence, willful misconduct or breach of this Agreement, and, to the extent that such recall does not result from Biodel's negligence, willful misconduct or breach of this Agreement, then Unilife shall reimburse Biodel for (i) the Unit Price paid by Biodel to Unilife for such recalled Unilife Devices, and (ii) all of Biodel's other direct reasonable costs and expenses actually incurred in connection with the recall including costs of retrieving Unilife Devices or the Combination Product already delivered, costs of replacement Unilife Device, costs and expenses Biodel is required to pay for notification, shipping and handling charges, fines payable in connection with such recall, and all other costs reasonably related to the recall. In the event of any such recall, and without limiting any other rights Biodel may have, Biodel shall have the right to modify its Purchase Orders and any forecasted orders included in any Forecast preceding such recall. To the extent that a recall of the Combination Product is due to any reason other than one that is attributable to Unilife's negligence, willful misconduct or breach of this Agreement, Biodel shall pay all costs and expenses of the recall.

7.

Continuity of Supply

7.1

Reasonable Assistance to [**].

(a)

In the event that (i) Unilife discontinues production of or fails to supply the Unilife Device, except if such halt in production or supply is under a Termination by Unilife under Section 10, or (ii) Biodel terminates this Agreement for cause in accordance with Section , Section  or Section  (each a “Default Event”), Unilife, upon Biodel’s request, shall provide Biodel, [**]

_____		_____
(Initial)	12	(Initial)

provided that only those rights (exclusive or non-exclusive) accrued and/or maintained by Biodel at the time of such Default Event shall survive.

(b)

Such assistance may include, without limitation, allowing Biodel, [**] to (i) consult with employees or agents of Unilife with expertise in the Manufacture of the Product, (ii) observe Manufacturing runs of the Product at the Manufacturing site(s) during normal business hours and (iii) process transfer assistance. [**]

7.2

Product Import and Export. Unilife shall cooperate with Biodel in executing any other documents or licenses necessary for Biodel to comply with any export or import or other similar applicable laws of the Territory with respect to the Unilife Device or Combination Product.

8.

Representations and Warranties

8.2.

Mutual Representations and Warranties. Each Party hereby represents, warrants, and covenants (as applicable) to the other Party as follows, as of the Effective Date:

(a)

It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement.

(b)

It has the corporate or organizational power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; it has taken all necessary corporate or organizational action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and this Agreement has been duly executed and delivered on its behalf, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms and this Agreement will not violate (i) such Party’s certificate of incorporation or bylaws, (ii) any agreement, instrument or contractual obligation to which such Party is bound in any material respect, (iii) any requirement of any applicable laws or regulation, or (iv) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party.

(c)

It is not a party to and will not enter into any agreement that would materially prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement.

(d)

It shall possess during the Term all licenses, registrations, permits and other authorizations required by any Regulatory Authority or other governmental body, law, rule or regulation within the Territory to fulfill its other obligations in accordance with the terms of this Agreement.

_____		_____
(Initial)	13	(Initial)

8.3.

Unilife Representations and Warranties. In addition to the representations, warranties and covenants in Section , Unilife hereby represents, warrants, and covenants (as applicable) to Biodel as follows, as of the Effective Date:

(a)

Unilife has not used prior to the Effective Date and shall not use, during the Term, any employee, consultant, agent or contractor who has been debarred by any Regulatory Authority, or is the subject of debarment proceedings by a Regulatory Authority.

(b)

All Unilife Devices supplied hereunder (i) shall be Manufactured in conformance with all Applicable Laws; (ii) shall not be adulterated or misbranded within the meaning of the U.S. Federal Food, Drug and Cosmetic Act of 1938, as amended, and shall not be a product which would violate any Applicable Laws if introduced into interstate commerce; and (iii) shall conform to the Specifications, the Manufacturing Standards and any additional standards agreed to in writing by the Parties through the Customization Committee.

(c)

Unilife maintains and shall, during the Term of this Agreement, maintain applicable ISO certifications in good standing and notify Biodel immediately in the event of any change in certification status.

(d)

The development, Manufacture, use, import, sale or offer for sale in the Territory of the Unilife Device does not infringe any Third Party intellectual property rights. Unilife has not received any written notice from any Third Party asserting or alleging that the Unilife Device or a Similar Unilife Device infringed or misappropriated the intellectual property rights of such Third Party and no Third Party has initiated, or threatened in writing to initiate, any litigation against Unilife, or by sending a cease-and-desist letter, with respect to the Unilife Device or a Similar Unilife Device.

(e)

Unilife Devices delivered by Unilife to Biodel pursuant to this Agreement shall be free from defects in material, workmanship and design, and shall conform to any technical conditions or standards provided by the certificate of analysis.

8.4.

UNILIFE DISCLAIMER OF WARRANTIES. UNILIFE HEREBY DISCLAIMS ALL WARRANTIES WITH RESPECT TO ANY UNILIFE DEVICE EXCEPT FOR THOSE EXPRESS WARRANTIES SPECIFICALLY SET FORTH IN THIS AGREEMENT, INCLUDING ALL IMPLIED WARRANTIES WITH RESPECT TO DEVICES SUCH AS IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

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(Initial)	14	(Initial)

9.

Indemnification; Insurance; Limitation of Liability

9.1

Indemnification by Unilife. Unilife shall defend, indemnify, and hold harmless Biodel, its Affiliates and their respective officers, directors, employees, and agents (“Representatives”) from and against any and all claims, losses, demands, causes of action, and all related costs and expenses of every kind (including reasonable attorneys’ fees, costs, and expenses) occurring, growing out of, incident to, or resulting directly or indirectly from: (a) a breach by Unilife of any of its representations, warranties, or obligations under the Agreement; (b) the negligence or willful misconduct of Unilife, its agents, representatives, employees and/or subcontractors in performing its obligations under the Agreement; or (c) an infringement of an intellectual property right of a Third Party pertaining to the Unilife Technology used by or on behalf of Unilife in connection with the intended manufacture, use or sale of the Unilife Device.

9.2

Indemnification by Biodel. Except as otherwise provided in Section 9.1 above, Biodel shall defend, indemnify, and hold harmless Unilife, its Affiliates and their respective Representatives from and against any and all claims, losses, demands, causes of action, and all related costs and expenses of every kind (including reasonable attorneys’ fees, costs, and expenses) occurring, growing out of, incident to, or resulting directly or indirectly from: (a) a breach by Biodel of any of its representations, warranties, or obligations under the Agreement; (b) the negligence or willful misconduct of Biodel, its agents, representatives, employees and/or subcontractors in the performance of any of its obligations under the Agreement, (c) an infringement of an intellectual property right of a Third Party as a result of Biodel’s Drug except to the extent that it arises from Unilife Technology, or (d) the marketing, distribution, sale or use of the Combination Product, except to the extent that such claim arises out of (i) a breach by Unilife of any of its representations, warranties, or obligations under the Agreement, or (ii) the negligence or willful misconduct of Unilife, its agents, representatives, employees and/or subcontractors in performing its obligations under the Agreement.

9.3

Conditions of Indemnity.

(a)

The Party claiming a right of indemnification or defense under this Agreement shall provide the indemnifying Party prompt written notice (in all events within [**] days) of any such claim, including a copy thereof, served upon it, and shall cooperate fully with the indemnifying Party and its legal representatives in the investigation of any such claim, at the indemnifying Party’s expense.

(b)

The indemnifying Party shall have the right to exercise sole control over the defense and settlement of any such claim, including the sole right to select defense counsel and to direct the defense or settlement of any such claim; provided that the indemnifying Party shall not enter into any non-monetary settlement or admit fault or liability on the indemnified Party’s behalf without the prior written consent of the indemnified Party, which consent shall not be unreasonably withheld, delayed or conditioned. Notwithstanding the foregoing, if the indemnified Party is advised by counsel that there may be a conflict between the positions of the indemnifying Party and the indemnified Party in conducting the defense of such action, then the indemnified Party may elect to conduct the defense to the extent reasonably determined by such counsel to be necessary to protect the interests of the indemnified Party, at the expense of the Indemnifying Party, if it is determined by agreement of the indemnifying Party and the indemnified Party, or by a court of competent jurisdiction, that the indemnified Party is entitled to indemnification hereunder for the indemnified amounts giving rise to such action. If the indemnifying Party elects not to assume the defense of such claim or action, the indemnifying Party shall reimburse the indemnified Party for the reasonable legal fees and expenses incurred and shall be bound by the results obtained by the indemnified Party in respect of such claim or action if it is determined by agreement of the indemnifying Party and the indemnified Party or by a court of competent jurisdiction that the indemnified Party is entitled to indemnification hereunder for the indemnified amounts giving rise to such action; provided, however, that no such claim or action shall be settled without the written consent of the

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(Initial)	15	(Initial)

indemnifying Party. Without limiting the foregoing, the indemnified Party shall have the right to select and to obtain representation by separate legal counsel, and except as provided for above, all costs and expenses incurred by the indemnified Party for such separate legal counsel shall be borne by the indemnified Party.

(c)

Either Party shall be relieved of any indemnification obligation hereunder if the indemnified Party either (i) fails to materially follow the procedures set forth herein, and such failure materially impairs the ability of the indemnifying Party to carry out its obligations hereunder; (ii) compromises or settles any claim without the indemnifying Party’s prior written approval; or (iii) makes any admission or takes any other action with respect to any such claim that, in the indemnifying Party’s reasonable judgment, is prejudicial to the defense of such claim, without the indemnifying Party’s prior written approval.

9.4

Insurance. Each Party shall secure and maintain in full force and effect throughout the Term policies of insurance, including general commercial liability and product liability, with limits, deductibles and other terms appropriate to the conduct of their business. Each Party shall furnish certificates evidencing such insurance upon the other Party’s request.

9.5

LIMITATION OF LIABILITY. EXCEPT TO THE EXTENT EACH PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER UNDER SECTION  FOR THIRD PARTY CLAIMS, OR TO THE EXTENT RELATED TO A PARTY'S BREACH OF ITS OBLIGATIONS OF CONFIDENTIALITY UNDER SECTION , NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES OR AGENTS SHALL BE LIABLE FOR ANY PUNITIVE, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES , WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY. EXCEPT TO THE EXTENT EACH PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER UNDER SECTION  FOR THIRD PARTY CLAIMS, OR TO THE EXTENT RELATED TO A PARTY'S BREACH OF ITS OBLIGATIONS OF CONFIDENTIALITY UNDER SECTION , EACH PARTY’S TOTAL AGGREGATE LIABILITY TO THE OTHER PARTY FOR ANY AND ALL CLAIMS RELATED TO, OR IN CONNECTION WITH THIS AGREEMENT OR THE PRODUCT (WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, BY STATUTE OR OTHERWISE) IN ANY TWELVE (12) MONTH PERIOD SHALL BE LIMITED TO AN AMOUNT EQUAL TO 20% OF THE TOTAL REVENUE UNILIFE RECEIVED FROM BIODEL FOR THE TWELVE (12) MONTHS PRIOR TO SUCH CLAIMS.

10.

Term and Termination

10.1

Term. Unless otherwise agreed to by the Parties, this Agreement shall be effective as of the Effective Date of this Agreement and shall expire upon the fifteenth (15^th) anniversary thereof, unless terminated earlier in accordance with the terms of this Agreement, provided that the term of this Agreement shall automatically renew for successive one (1) year periods thereafter, unless a Party provides written notice to the other of its desire to terminate this Agreement at the end of the then current term at least ninety (90) days prior to the expiration of such term (the “Term ”).

10.2

Termination for Material Breach. Either Party will have the right to terminate the Agreement upon written notice to the other Party if, after receiving written notice of a material breach of the Agreement, the other Party fails to cure such breach within [**] days from the date of such notice. Biodel shall be obligated to pay Unilife all payments due for milestones achieved under the Development Plan, including all noncancellable obligations, upon termination by either Party under this Section . Biodel shall also be obligated to pay Unilife all amounts payable to a contract manufacturer during the Development Phase under Section 2.1(c) at the time of such termination and any costs associated for equipment purchased for Biodel under Section 2.4.

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(Initial)	16	(Initial)

10.3

Termination for Non-Agreement on Customization. Either Party will have the right to terminate this Agreement upon written notice to the other Party in the event that the Parties (through the Customization Committee) do not reach an agreement on the achievement of certain milestones listed in the Development Plan. If Unilife fails to deliver an initial functional concept of the customized Unilife Device, either Party may terminate this Agreement and Unilife shall refund to Biodel the payment associated with Milestone #1 in exchange for return of all deliverables and confidential information transferred to Biodel by Unilife. If the Parties do not reach agreement through the Customization Committee on the successful achievement of Milestones #2 or #3 in the Development Plan, either Party may terminate this Agreement and Biodel shall be obligated to pay Unilife all payments due for milestones achieved prior to termination. Biodel shall have the right to terminate this Agreement in the event that Unilife fails to meet the customization  milestone actions detailed in the Development Plan, subject to a [**] days period to cure such non-delivery at the discretion of Biodel, and Biodel shall be obligated to pay Unilife all payments due for milestones achieved prior to termination. Biodel shall also be obligated to pay Unilife all amounts payable to a contract manufacturer during the Development Phase under Section 2.1(c) at the time of such termination.

10.4

Termination for Insolvency. A Party may terminate the Agreement upon bankruptcy, insolvency, dissolution or winding up of the other Party (“Termination for Insolvency”). Upon termination of the Agreement, Unilife and Biodel will cooperate to provide for an orderly conclusion of the milestones or deliverables undertaken by Unilife hereunder. In the event of Termination for Insolvency of either Party, either Party will, upon request by the other Party, transfer all works in progress and Unilife Devices manufactured under this Agreement to the other Party.

10.5

Residual Obligations. The obligations of the Parties that would reasonably be expected to survive termination of the Agreement will survive termination of the Agreement. Specifically, Sections -, , and - shall survive any termination of this Agreement.

11.

Confidentiality

11.1

Confidential Information of the Parties. The Parties have previously executed a Confidential Disclosure Agreement (“CDA”) on January 29, 2013, and agree that the provisions of the CDA and any amendments thereto, whenever they are executed, are incorporated herein and shall govern the Parties’ relationship hereunder. The CDA and any amendments thereto shall remain in full force and effect during the Term. The restrictions on use and non-disclosure of Confidential Information shall not apply in respect of announcements or disclosures made pursuant to Section 14.3 herein.

11.2

Relationship Between Parties. The relationship between Biodel and Unilife under this Agreement is intended to be that of independent contractors. Nothing in this Agreement is intended to be construed so as to constitute Biodel and Unilife as partners or joint venturers, or either Party as the employee, agent or legal representative of the other Party.

12.

Intellectual Property

12.1

Improvements. Except as set forth below, the rights of ownership in Improvements and any Intellectual Property Rights disclosing and/or claiming such Improvements are retained by the Party that employs or otherwise engages the inventor. Notwithstanding the foregoing:  

(a)

Biodel shall be the sole and exclusive owner of any Improvements (and related Intellectual Property Rights) to the extent such Improvement relates to the Drug, including compositions, formulations, and uses, whether the same is made jointly by or on behalf of Biodel and Unilife or solely by or on behalf of Biodel or Unilife (the “Biodel Improvements”).

_____		_____
(Initial)	17	(Initial)

(b)

Unilife shall be the sole and exclusive owner of any Improvements (and related Intellectual Property Rights) to the extent such Improvements relate to the Unilife Device, including its components and uses, whether the same is made jointly by or on behalf of Biodel and Unilife and/or Affiliates or solely by or on behalf of Biodel or Unilife and/or Affiliates (the “Unilife Improvements”).

12.2

Patents and Patent Applications.

(a)

Unilife agrees not to file any patent application related to, or claiming, that portion of the Combination Product that is not based on Unilife Technology. Biodel agrees not to file any patent application related to, or claiming, a device based on Unilife Technology, including Unilife Improvements, or other aspects of the Unilife Device. For clarity, Biodel owns all Intellectual Property Rights in any and all Biodel Improvements.

(b)

In the event that either Biodel or Unilife, or any of their respective Affiliates, solely or jointly, develops any supplementary, complementary, or ancillary innovations protectable by patent (whether by utility and/or design patent), which are related to the Unilife Device, such as product packaging innovations (collectively, “Complementary Innovations”), ownership and assignment of such patent applications or patents issued therefrom shall be assigned to Unilife and/or its designated Affiliate, whether prepared and filed by or on behalf of Unilife or Biodel. Unilife and/or its designated Affiliate shall provide, and hereby grants, Biodel and/or its designated Affiliate an irrevocable, worldwide, royalty-free license, to patents or patent applications directed to such Complementary Innovations to the extent necessary or useful to develop, use, import, sell, offer for sale, and market the Complementary Innovations.

12.3

Disclosure and Assignment. Each Party shall promptly disclose, in writing, to the other Party all Improvements to which the other Party has ownership or license rights (either solely or jointly) as set forth herein. The Parties hereby transfer and assign (and will ensure the transfer and assignment of, by itself or any Third Party or Affiliate engaged by the Party) to the other Party all right, title and interest to those Improvements (and related Intellectual Property Rights) to which the other Party is entitled, as set forth above. The Party transferring Improvements hereunder shall execute and do all things necessary to vest the entire right and title to and interest in the Improvements (and related Intellectual Property Rights) to the receiving Party or its designee in any Region. The provisions of this Section  shall also apply to Biodel’s assignment obligations regarding Complementary Innovations under Section .

12.4

Nothing in the Agreement is intended or will operate to transfer ownership of the Intellectual Property Rights of a Party existing as of the Effective Date (or any part of it, including rights in Confidential Information) to the other Party and no licenses or grants of any interest in such Intellectual Property Rights are intended or provided other than as expressly set out in Section 3, even if such rights are necessary for the practice of any Improvement.

13.

Dispute Resolution

13.1

Disputes. Any contractual dispute arising under this Agreement (the “Dispute”) shall be discussed first by the respective chief executive officers of each Party or his/her designee for attempted resolution by good faith discussions within [**] days. In the event that the chief executive officers or his/her designee are not able to resolve such Dispute within such [**] day period, and do not agree to extend the time period for resolving the Dispute, unless the Parties otherwise agree to extend the time period for resolving the Dispute, then such Dispute shall be resolved pursuant to the provisions of Section .

13.2

Arbitration. If the Dispute is not resolved pursuant to Section , such Dispute must be referred to and finally resolved by arbitration, to which the Parties hereto expressly agree and submit. The

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(Initial)	18	(Initial)

arbitration will be submitted to the International Centre for Dispute Resolution of the American Arbitration Association (“AAA”) and conducted in accordance with the Commercial Arbitration Rules of the AAA (“Rules”). Pre-hearing information exchange shall be limited to the reasonable production of relevant, nonprivileged documents and carried out expeditiously. There will be one arbitrator selected by mutual agreement of the Parties. It is the intent of the Parties that, barring extraordinary circumstances, arbitration proceedings will be concluded within [**] days from the date the arbitrator is appointed. The arbitral tribunal may extend this time limit in the interests of justice. Failure to adhere to this time limit shall not constitute a basis for challenging the award. The arbitration will be conducted in English and the place of arbitration will be in New Castle County, Delaware, USA. Either Party may, without waiving any remedy under this Agreement, apply to the arbitral tribunal and/or any court having jurisdiction any interim, provisional, injunctive or conservatory relief that is necessary to protect the rights or property of that Party until the arbitration award is rendered or the Dispute is otherwise resolved. Any decision rendered by the arbitral tribunal will be final and binding on the Parties, and judgment thereon may be entered by any court of competent jurisdiction, including any court that has jurisdiction over either of the Parties or any of their assets. The Parties expressly agree that the arbitral tribunal will be empowered to award and order equitable or injunctive relief with respect to matters brought before it, provided however, that such remedy or relief is consistent with the remedies and limitations set forth in this Agreement. The Parties agree that all arbitral proceedings conducted pursuant to this Section, including the existence of any arbitral proceedings, information disclosed in the course of such arbitral proceedings, and any settlements, negotiations, discussions, proposals, and awards related thereto shall be considered Confidential Information. The Parties may, however, disclose such information to an appropriate court, as is necessary to seek enforcement of any award rendered by the arbitral tribunal.

1.3

Governing law; Venue. This Agreement shall be governed by the laws of the State of Delaware, without regard to conflicts of law rules. The Parties agree that the Uniform Commercial Code and the 1980 United Nations Convention on Contracts for the International Sale of Goods shall not apply to or affect any term of this Agreement.

14.

Miscellaneous

14.1

Notices. All notices and other communications required or permitted hereunder, must, in order to be effective, be in writing and delivered personally (with personal delivery including delivery by courier or reputable international delivery service) or sent by certified or registered mail, postage prepaid, return receipt requested or sent by facsimile transmission. Items delivered personally or by facsimile transmission shall be deemed delivered on the date of delivery and items sent by certified or registered mail shall be deemed delivered three (3) days after mailing. The address of the Parties for purposes of this provision are as follows (as the same may be changed by a Party giving notice thereof to the other which is delivered in like manner): (i) with respect to Unilife Corporation, 250 Cross Farm Lane, York, Pennsylvania 17406, Attention: General Counsel and (ii) with respect to Biodel, 100 Saw Mill Road, Danbury, Connecticut 06810, Attention: General Counsel.

14.2

Assignment; Amendment and Waiver. Neither this Agreement, nor any rights or obligations hereunder, may be assigned or otherwise transferred by either Party, without the prior consent of the other Party (which consent shall not be unreasonably withheld or delayed); provided, however, that either Party may assign this Agreement, and its rights and obligations hereunder, without the other Party's consent, if such assignment is made with prior notice to the other Party and then only to the extent made in connection with the transfer or sale of all, or substantially all, of the business of that Party of the type to which this Agreement relates. In any event, no assignment shall relieve the assigning Party of its obligations to the other Party hereunder. The rights and obligations of the Parties shall be binding upon, and inure to the benefit of, successors and permitted assigns. No modification, amendment, termination, supplement or waiver under this Agreement shall be binding unless made in a writing which is clearly identified as such a modification,

_____		_____
(Initial)	19	(Initial)

amendment, termination, supplement or waiver and signed by both Parties. No waiver shall be implied from conduct, or a failure to enforce, rights or a delay in enforcing rights.

14.3

Announcements. The Parties agree that either Party may issue a press release announcing the execution of this Agreement, provided that the same is shared in advance. Neither Party shall make any other public disclosure relating to this Agreement without the prior consent of the other Party, except to the extent that such disclosure is required by applicable law, rule or regulation.

14.4

Counterparts. This Agreement may be executed in one or more counterparts and in paper or electronic format, each of which shall be deemed an original, and which together constitute one and the same instrument to which both Parties shall be bound.

14.5

Scope of Agreement; Further Assurances. This Agreement, including any Addendum(s), represents the entire agreement between the Parties relating to the subject matter hereof and supersedes all prior and contemporaneous representations, understandings, discussions, negotiations, correspondence, commitments and agreements, whether written or oral and whether by either Party's employees or representatives. Each of the Parties shall execute and deliver all additional documents and shall do any and all things reasonably required in connection with the performance of obligations undertaken by it in this Agreement and to effectuate in good faith the intent of the Parties.

14.6

Headings; Section References; Construction. The article headings of this Agreement are for convenience only and should not be interpreted to limit or affect, in any way, the meaning of the language contained in this Agreement. References to “Section” mean Sections of this Agreement. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have drafted the Agreement or authorized the ambiguous provision. All references to “hereof,” “hereto” and “hereunder” shall refer to this Agreement. All words used in this Agreement will be construed to be of such gender or number as the circumstances require. Unless otherwise expressly provided, the words “include,” “includes” and “including” do not limit the preceding words or terms and shall be deemed to be followed by the words “without limitation.”  All references to the word “will” are interchangeable with the word “shall” and shall be understood to be imperative or mandatory in nature.

14.7

Severability. In the event that any provision of this Agreement is determined to be illegal or otherwise enforceable, such provision shall be construed as if it were written so as to be legal and enforceable to the maximum extent possible, the entire Agreement shall not fail on account thereof, and the balance of the Agreement shall be continued in full force and effect, all so as to effectuate, to the greatest extent possible, the intent of the Parties.

14.8

Force Majeure. Neither Party shall be liable for any delay for failure in performance, including interruption in the manufacture, supply or distribution of any Unilife Device due to any reason or unforeseen circumstances beyond the affected Party's reasonable control, including acts of God or public authorities, war and war measures, civil unrest, fire, epidemics, inevitable accidents, delays in transportation, delivery or supply, labor disputes. The obligations and rights of the excused Party shall be extended on a day-to-day basis for a period equal to the period of the excusable delay. In the event that a Party’s non-performance extends for a period greater than sixty (60) days as permitted by this Section 14.8, the other Party may terminate the Agreement upon written notice to the non-performing Party subject to the provisions for curing by the non-performing Party in Section 10.

14.9

Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. If any signature is delivered by facsimile transmission or by email delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the Party executing (or on whose behalf such

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(Initial)	20	(Initial)

signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

{SIGNATURE PAGE FOLLOWS}

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.

UNILIFE MEDICAL SOLUTIONS, INC.		BIODEL INC.
By:	/s/ Molly Miller	By:	/s/ Gerard Michel
Name:	Molly Miller	Name:	Gerard Michel
Title:	Director and GM	Title:	CFO

_____		_____
(Initial)	21	(Initial)

EXHIBIT A

DEVELOPMENT PLAN

DEVELOPMENT PLAN: CUSTOMIZATION AND SUPPLY MILESTONES
Milestone	Deliverable	Quantity	Delivery Date	Payment
1	Executed Initial Agreement	[**]	[**]	[**]
2	[**]	[**]	[**]	[**]
3	[**]	[**]	[**]	[**]
4	[**]	[**]	[**]	[**]

All payments for milestone deliverables and of the Unit Price shall be due within net [**] days of the date of Biodel's receipt of Unilife’s invoice therefor.

_____		_____
(Initial)	22	(Initial)

EXHIBIT B

SPECIFICATIONS

Packaging Specification

Sub Assembly	Sterility Method	Packaging Configuration
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]
[**]	[**]	[**]

Product Characteristic Specification

Product Characteristic	Specification
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]

Material Specification

Fluid-Path Material	Specification
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]

Drug Specification

Characteristic	Specification
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]

_____		_____
(Initial)	23	(Initial)

EXHIBIT C

TARGET DEVICE PROFILE

_____		_____
(Initial)	24	(Initial)

EXHIBIT D

UNILIFE INTELLECTUAL PROPERTY RIGHTS

“Unilife Intellectual Property Rights” means all Intellectual Property Rights that are controlled by Unilife or its Affiliates as of the Effective Date or are filed by or granted to Unilife or its Affiliates during the Term and that claim the composition, design, manufacture, or use of the Unilife Device or a Similar Unilife Device, including but not limited to the following, and as may be amended by Unilife from time-to-time:

Country/Jurisdiction	Patent/Appln. No.
International PCT Application	[**]
USA	[**]
Taiwan	[**]

_____		_____
(Initial)	25	(Initial)

EX-23.1

Exhibit 23.1

Consent of Independent Registered Public Accounting Firm

Board of Directors and Stockholders
Biodel Inc.
Danbury, Connecticut

We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-182877and 333-188576) and the Registration Statements on Form S-8 (Nos. 333-144407, 333-168903 and 333-180409) of Biodel, Inc. of our report dated December 20, 2013, relating to the financial statements, which appears in this Form 10-K for the year ended September 30, 2013.

/s/BDO USA, LLP

New York, New York

December 20, 2013

EX-31.1

Exhibit 31.01

CERTIFICATION

I, Errol De Souza, certify that:

1. I have reviewed this Annual Report on Form 10-K of Biodel Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the Registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

5. The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's Board of Directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

/s/ Errol De Souza

Errol De Souza
President and Chief
Executive Officer
Date: December 20, 2013

EX-31.2

Exhibit 31.02

CERTIFICATION

I, Gerard Michel, certify that:

1) I have reviewed this Annual Report on Form 10-K of Biodel Inc.;

2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

4) The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the Registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

5) The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's Board of Directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

/s/ Gerard Michel

Gerard Michel
Chief Financial Officer, Vice President,
Corporate Development and Treasurer
Date: December 20, 2013

EX-32.1

Exhibit 32.01

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report on Form 10-K of Biodel Inc. (the "Company") for the year ended September 30, 2013 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned Errol De Souza, President and Chief Executive Officer of the Company and Gerard Michel, Chief Financial Officer, Vice President Corporate Development and Treasurer of the Company, each hereby certifies that: (1) the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/ Errol De Souza

Errol De Souza,
President and
Chief Executive Officer
Dated: December 20, 2013

/s/ Gerard Michel

Gerard Michel
Chief Financial Officer,
Vice President, Corporate
Development and Treasurer
Date: December 20, 2013

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Financings

12 Months Ended

Sep. 30, 2013

Financing Transactions [Abstract]

Financings

9. Financings

June 2013 Public Offering

On June 24, 2013, the Company completed an underwritten public offering of 4,482,760 shares of its common stock at a price to the public of $4.35 per share. On July 22, 2013, the Company issued 236,007 additional shares of common stock, at the public offering price of $4.35 per share, in connection with the underwriters' exercise of a portion of their over-allotment option. The Company received net proceeds from this offering, after deducting underwriting discounts, commissions and expenses, of $19.2 million.

June 2012 Private Placement

In June 2012, the Company completed a private placement (the "2012 Private Placement") of an aggregate of 4,250,020 shares of the Company's common stock, 3,605,607 shares of the Company's Series B preferred stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. For each unit, consisting of either a share of common stock or Series B preferred stock and a warrant to purchase 0.35 of a share of common stock, the purchasers in the June 2012 Private Placement paid a negotiated price of $2.355. The warrants are immediately exercisable and will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. The Company received net proceeds, after deducting placement agents' fees and other transaction expenses, of approximately $17,100 from the 2012 Private Placement.

Each share of Series B preferred stock is convertible into one share of the Company's common stock at any time at the option of the holder, except that the securities purchase agreement that the Company entered into in connection with the 2012 Private Placement (the "Securities Purchase Agreement") provides that a holder will be prohibited from converting shares of Series B preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series B preferred stock will receive a payment equal to $0.01 per share of Series B preferred stock before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series B preferred stock, holders of Series B preferred stock and holders of the Company's Series A preferred stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series B preferred stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series B preferred stock will be required to amend the terms of the Series B preferred stock. Holders of Series B preferred stock are entitled to receive, and the Company is required to pay, dividends on shares of the Series B preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.

As required by the Securities Purchase Agreement, the Company filed a Registration Statement on Form S-3 (the "Registration Statement") with the Securities and Exchange Commission (the "SEC") on July 27, 2012, which was within 30 days after the closing of the 2012 Private Placement. The Registration Statement, which was declared effective on August 13, 2012, registers the resale of the shares of common stock and Series B preferred stock issued and sold in the 2012 Private Placement, the shares of common stock issuable upon conversion of the Series B preferred stock issued and sold in the 2012 Private Placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the 2012 Private Placement. Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to pay liquidated damages to the purchasers in the 2012 Private Placement if, after effectiveness of the Registration Statement and subject to certain specified exceptions, the Company suspends the use of the Registration Statement or the Registration Statement ceases to remain continuously effective as to all the securities for which it is required to be effective (each such event, a "Registration Default"). Subject to specified exceptions, for each 30-day period or portion thereof during which a Registration Default remains uncured, the Company is obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1.0% of the aggregate purchase price paid by each such purchaser in the 2012 Private Placement, up to a maximum of 8.0% of such aggregate purchase price. As of the date of these financial statements, the Company does not believe that it is probable that it will be obligated to pay any such liquidated damages. Accordingly, the Company has not established an accrual for liquidated damages.

In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the 2012 Private Placement will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.

During the year ended September 30, 2013, the Company recorded an adjustment to fair value of common stock warrant liability of $675, within Other (income) expense, to reflect the decrease in the valuation of the warrants from September 30, 2012 to September 30, 2013. At September 30, 2013, the fair value of the warrant liability utilizing the Black-Scholes valuation model was approximately $4,958.

The following summarizes the changes in value of the warrant liability from the date of issuance through September 30, 2013:

$

Balance at September 30, 2011	$	—
Initial fair value, at the date of issuance		4,832
Increase in fair value		801
Balance at September 30, 2012	5,633
Decrease in fair value		(675	)
Balance at September 30, 2013	$	4,958

May 2011 Registered Direct Offering

In May 2011, the Company completed a registered direct offering of an aggregate of 3,018,736 shares of the Company's common stock, 453,486 shares of the Company's Series A preferred stock and warrants to purchase 2,256,929 shares of the Company's common stock. The shares and warrants were sold in units consisting of (i) one share of common stock and (ii) one warrant to purchase 0.1625 of a share of common stock, at an exercise price of $9.92 per share of the Company's common stock. However, one investor also purchased units consisting of one share of Series A preferred stock and a warrant to purchase 0.1625 of a share of common stock. No fractional warrants were issued. Each unit was sold at a price of $8.64 per unit. These units were not issued or certificated. The shares and warrants were immediately separated. The warrants will expire on May 17, 2016, five years from the issuance date of May 18, 2011. The Company received net proceeds, after deducting placement agent fees and other offering expenses, of approximately $28.0 million from this financing.

Each share of Series A preferred stock is convertible into one quarter of a share of the Company's common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the shares of Series A preferred stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of the Company's common stock then issued and outstanding. In the event of the Company's liquidation, dissolution or winding up, holders of the Series A preferred stock will receive a payment equal to $0.01 per share of Series A preferred stock before any proceeds are distributed to the holders of the Company's common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series A preferred stock, holders of Series A preferred stock will participate ratably in the distribution of any remaining assets with the Company's common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series A preferred stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series A preferred stock will be required to amend the terms of the Series A preferred stock. The Series A preferred stock will not be entitled to receive any dividends, unless and until specifically declared by the Company's board of directors.

In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the May 2011 financing will be entitled to receive consideration as if they had exercised the warrant immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. As per the terms of the warrants, the holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.

The Company's warrant liability is marked-to-market each reporting period with the change in fair value recorded as a gain or loss within Other Expense ("Adjustment to fair value of common stock warrant liability"), until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified as an equity instrument. Because the warrants issued in the May 2011 financing do not contain a re-pricing provision, the Company is using the Black-Scholes valuation model to estimate the fair value of the warrants. Using this model, the Company recorded an initial warrant liability of $9,438 as of May 18, 2011 (the warrant issuance date). The significant assumptions of the model were warrants and common stock outstanding, remaining terms of the warrants, the per stock price of $2.06, a risk-free rate of 1.89% and expected volatility rate of 75%.

During the year ended September 30, 2013, the Company recorded an adjustment to fair value of common stock warrant liability of $542, within Other (income) expense, to reflect the decrease in the valuation of the warrants from September 30, 2012 to September 30, 2013. At September 30, 2013, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $1,163.The following summarizes the changes in value of the warrant liability from the date of issuance through September 30, 2013:

Balance at September 30, 2010	$	—
Initial fair value, at the date of issuance		9,438
Decrease in fair value		(8,442	)
Balance at September 30, 2011		996
Increase in fair value		709
Balance at September 30, 2012	$	1,705
Decrease in fair value		(542	)
Balance at September 30, 2013	$	1,163

August 2010 Registered Direct Offering

In August 2010, the Company sold to two institutional investors an aggregate of 599,550 units, with each unit consisting of (i) one share of common stock and (ii) one warrant to purchase one share of common stock, for a purchase price of $15.72 per unit. These units were not issued or certificated. The shares and warrants were immediately separated and the Company issued 599,550 shares of its common stock and warrants to purchase an additional 599,550 shares of the Company's common stock. This financing resulted in net proceeds of $8,700.

In August 2011, one investor exercised 10,550 warrants, at $4.70 per share, and the Company received proceeds totaling approximately $50. Subsequently, on December 1, 2011 the remaining 589,000 warrants expired unexercised.

Fair Value Assumptions Used in Accounting for Warrant Liability

The Company has determined its warrant liability to be a Level 3 fair value measurement and used the Black Scholes valuation model to calculate the fair value for the fiscal year ended September 30, 2012 and 2013.

At the measurement date, the Company estimated the fair value for the June 2012 warrants using the Black-Scholes valuation model using the following assumptions:

 

	September 30, 2012			September 30, 2013
June 2012 Financing
Stock price	$	2.97		$	3.15
Exercise price	$	2.66		$	2.66
Risk-free interest rate		0.62	%		0.63	%
Expected remaining term	4.74 years			3.74 years
Expected volatility		98	%		82	%
Dividend yield		0	%		0	%
Warrants outstanding June 2012 registered direct		2,749,469			2,749,469

The Company estimated the fair value for the May 2011 warrants using the Black-Scholes valuation model at the measurement dates of September 30, 2013 and 2012, respectively using the following assumptions:

	September 30, 2012			September 30, 2013
May 2011 Financing
Stock price	$	2.97		$	3.15
Exercise price	$	9.92		$	9.92
Risk-free interest rate		0.31	%		0.63	%
Expected remaining term	3.63 years			2.63 years
Expected volatility		82	%		77	%
Dividend yield		0	%		0	%
Warrants outstanding May 2011 registered direct		2,256,929			2,256,929

Risk-Free Interest Rate. This is the United States Treasury rate for the measurement date having a term equal to the expected remaining term of the warrant. An increase in the risk-free interest rate will increase the fair value and the associated derivative liability.

Expected Remaining Term. This is the period of time over which the warrant is expected to remain outstanding and is based on management's estimate, taking into consideration the remaining contractual life.

Expected Volatility. This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. Since the Company's stock has been traded for the expected remaining term of the warrants, the Company uses its own historic volatility over the retrospective period corresponding to the expected remaining term of the warrants on the measurement date. Extra weighting is attached to those companies most similar in terms of size and business activity. An increase in the expected volatility will increase the fair value and the associated derivative liability.

Dividend Yield. The Company has not made any dividend payments nor does it have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease the fair value and the associated derivative liability.

Participating Securities

If at any time the Company grants, issues or sells securities or other property to holders of any class of common stock the holders of the warrants are entitled to also acquire those same securities as if they held the number of shares of common stock acquirable upon complete exercise of the warrants.

As such, given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55 earnings per share. These securities were excluded for the years ended September 30, 2013, 2012 and 2011 earnings per share calculation since their inclusion would be anti-dilutive.

XML

Financings (Details) (USD $) In Thousands, unless otherwise specified	12 Months Ended
	Sep. 30, 2013	Sep. 30, 2012	Sep. 30, 2011
Private Placement [Member]
Summary of changes in fair value of warrant liability
Beginning Balance	$ 5,633
Initial fair value at date of issuance		4,832
Increase in fair value		801
Decrease in fair value	(675)
Ending Balance	4,958	5,633
May 2011 registered direct offering [Member]
Summary of changes in fair value of warrant liability
Beginning Balance	1,705	996
Initial fair value at date of issuance			9,438
Increase in fair value		709
Decrease in fair value	(542)		(8,442)
Ending Balance	$ 1,163	$ 1,705	$ 996

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Statements of Operations (USD $) In Thousands, except Share data, unless otherwise specified	12 Months Ended						118 Months Ended
	Sep. 30, 2013		Sep. 30, 2012		Sep. 30, 2011		Sep. 30, 2013
Income Statement [Abstract]
Revenue
Operating expenses:
Research and development	14,296		12,315		13,597		155,400
Government grants	(546)		(88)				(634)
General and administrative	6,843		7,072		9,625		72,201
Total operating expenses	20,593		19,299		23,222		226,967
Other (income) and expense:
Interest and other income	(56)		(80)		(60)		(5,702)
Interest expense							78
Adjustments to fair value of common stock warrant liability	(1,217)		1,510		(12,611)		(11,064)
Loss on settlement of debt							627
Loss before tax provision (benefit)	(19,320)		(20,729)		(10,551)		(210,906)
Tax provision (benefit)	15		18		41		(538)
Net loss	(19,335)		(20,747)		(10,592)		(210,368)
Charge for accretion of beneficial conversion rights							(603)
Deemed dividend - warrants							(4,457)
Net loss applicable to common stockholders	$ (19,335)		$ (20,747)		$ (10,592)		$ (215,428)
Net loss per share - basic and diluted	$ (1.24)	[1]	$ (1.91)	[1]	$ (1.36)	[1]
Weighted average shares outstanding - basicand diluted	15,650,538	[1]	10,882,688	[1]	7,788,741	[1]

[1] Restated for a one for four (1:4) reverse stock split effective on June 11, 2012.

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Summary of Significant Accounting Policies

12 Months Ended

Sep. 30, 2013

Summary of Significant Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Research and Development Costs

The Company is in the business of research and development and, therefore, research and development costs include, but are not limited to, salaries and benefits, lab supplies, preclinical fees, clinical trial and related clinical manufacturing costs, allocated overhead costs and professional service providers. Research and development costs are expensed when incurred. Research and development costs aggregated $13,597, $12,315, and $14,296 for the years ended September 30, 2011, 2012 and 2013, respectively.

Government Grants

Grants received are recognized as grant income when the grants become receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The Company requests cash funding under approved grants as expenses are incurred (not in advance) and report these receipts on the statement of operations as a separate line item entitled "Government Grants" with the corresponding expenses included in research and development. In July and September 2012, the Company was awarded two National Institutes of Health grants for the development of concentrated ultra-rapid-acting insulin formulation and glucagon formulation, respectively, for use in an artificial pancreas. Both awards are for two years and total approximately $580 each. Work on the grant for the development of concentrated ultra-rapid-acting insulin formulation started in August 2012 and expenses incurred were $327 during the year ended September 30, 2013 and $88 for the year ended September 30, 2012. Work on the grant for the development of novel and stable glucagon formulations for closed loop systems started in January 2013, and expenses incurred were $219 during the year ended September 30, 2013. Corresponding income and receivable were recorded.

Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions including, but not limited to, accruals, income taxes payable, forfeiture rate used in the computation of share-based compensation and deferred tax assets. Actual results may differ from those estimates.

Cash and Cash Equivalents

The Company considers currency on hand, demand deposits and all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash and cash equivalents. As of September 30, 2012 and 2013, the Company had cash and cash equivalents of $39,050 and $39,781, respectively, and they are primarily held in a premium commercial money market account.

Restricted Cash

Restricted cash was $60 and $0 as of September 30, 2012 and 2013. This amount was held in a money market account with a bank to secure a credit card purchasing agreement utilized to facilitate employee travel and certain ordinary purchases. As of September 30, 2013 the Company canceled the credit card purchasing agreement and the restriction on the cash was lifted.

In February 2012, the Company brought action against one of its vendors before the American Arbitration Association in New York relating to disputed fees charged to the Company for inventory storage. As part of the arbitration stipulation, the Company established a $1,500 escrow account and recorded an accrual of $741 toward this claim. During the quarter ended June 30, 2012, the Company paid $500 from the escrow account. On July 30, 2012, the Company received a judgment from the arbitrator stating the Company's final amount due was $55. The remaining escrow balance of $945 was removed from the escrow account and transferred to cash. The remaining accrual of $186 was reversed and recorded in research and development expense during the quarter ended September 30, 2012.

Fair Value of Financial Instruments

The carrying amounts of the Company's financial instruments, which include cash and cash equivalents and accounts payable, approximate their fair values due to their short term maturities.

Pre-Launch Inventory

Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Because all of its product candidates are in early stages of preclinical or clinical development, the Company currently expenses all purchases of pre-launch inventory as research and development, and expects to continue to do so until it can determine the probability of regulatory approval for the applicable product candidate.

For the years ended September 30, 2012 and 2013, the Company expensed $170 and $121, respectively, of costs associated with the purchase of RHI and glucagon as research and development expense after such materials passed quality control inspection by the Company and transfer of title occurred.

Intellectual Property

Intangible assets consist primarily of capitalized costs associated with the Company's ultra-rapid-acting insulin patents and the purchase of two domain addresses. They are amortized using the straight-line method over twenty years. If the Company determines that a patent will not result in future revenues, the cost related to such patent will be expensed in full on the date of that determination. Intellectual property amortization expense for the years ended September 30, 2011, 2012 and 2013 was $4, $3, and $3, respectively.

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation or amortization. Major improvements are capitalized, while maintenance and repairs are expensed in the period the cost is incurred. Property and equipment are depreciated over their estimated useful lives using the straight-line method. Leasehold improvements are amortized using the straight-line method over their estimated useful lives, or the remaining term of the lease, whichever is shorter. When assets are retired or otherwise disposed of, the assets and related accumulated depreciation are removed from the accounts and resulting gains or losses are included in other income (expense) in the statement of operations. Estimated useful lives for each asset category are as follows: Furniture and fixtures — 7 years; Leasehold improvements — estimated useful life or remaining term of lease, whichever is shorter; Laboratory equipment — 7 years; Manufacturing equipment — 5 years; Device development— 5 years; Facility equipment— 3 years and 7 years; Computer equipment — 5 years; and Computer software — 3 years.

Impairment of Long-Lived Assets

Whenever events or changes in circumstances indicate that the carrying amounts of a long-lived asset may not be recoverable, the Company reviews these assets for impairment and determines whether adjustments are needed to carrying values. There were no adjustments to the carrying value of long-lived assets at September 30, 2012 and 2013.

Warrant Liability

The Company applies the provisions of Accounting Standards Codification Topic 480 ("ASC 480") (formerly FASB Staff Position 150-5 (FSP 15-5)), Issuers Accounting under FASB Statement No. 150 for Freestanding Warrants and other Similar Instruments on Shares that are Redeemable or Distinguishing Liabilities from Equities. Pursuant to ASC 480, a freestanding financial instrument (other than outstanding share) that, at inception, embodies an obligation to repurchase the issuer's shares and "requires or may require" the obligation to be settled by transferring assets, qualifies as a liability (if the obligation is conditional, the number of conditions is irrelevant).

The Company issued warrants in June 2012 and recorded a liability determined by the Black-Scholes valuation model. The Black-Scholes valuation model was used because the June 2012 warrants do not contain a repricing provision. The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. These warrants will be revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."

The Company issued warrants in May 2011 and recorded a liability determined by the Black-Scholes valuation model. The Black-Scholes valuation model was used because the May 2011 warrants do not contain a repricing provision. These warrants will be revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption "Adjustment to fair value of common stock warrant liability."

The Company issued warrants in August 2010 and recorded a liability determined by the Monte Carlo simulation method, which was used because the August 2010 warrants contain a re-pricing provision. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of future expected stock prices of the Company and its peer group and minimize standard error.

On December 2, 2011, the unexercised warrants to purchase 589,000 shares of common stock expired. The Company revalued the liability associated with these warrants from September 30, 2011 through the date of expiration and there was no material impact on the statement of operations. The common stock warrant liability associated with these warrants no longer exists.

Income Taxes

The Company uses the asset and liability method of accounting for deferred income taxes. The provision for income taxes includes income taxes currently payable and those deferred as a result of temporary differences between the financial statement and tax bases of assets and liabilities. A valuation allowance is provided to reduce deferred tax assets to the amount of future tax benefit when it is more likely than not that some portion of the deferred tax assets will not be realized. Projected future taxable income and ongoing tax planning strategies are considered and evaluated when assessing the need for a valuation allowance. Any increase or decrease in a valuation allowance could have a material adverse or beneficial impact on the Company's income tax provision and net income or loss in the period which the determination is made.

Concentration of Risks and Uncertainties

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company deposits excess cash with major financial institutions in the United States. Balances may exceed the amount of insurance provided on such deposits. The Company believes that its investment policy guideline for its excess cash maintains safety and liquidity through its policies on credit requirements, diversification and investment maturity.

The Company has experienced significant operating losses since inception. At September 30, 2013, the Company had a deficit accumulated during the development stage of $215,428. The Company has generated no revenue to date. The Company has funded its operations to date principally from the sale of securities. The Company expects to incur substantial additional operating losses for the next several years and will need to obtain additional financing in order to complete the clinical development of an ultra-rapid-acting insulin or a glucagon rescue product, launch and commercialize the product if it receives regulatory approval, and continue research and development programs. There can be no assurance that such financing will be available or will be at terms acceptable to the Company.

The Company is currently developing its first product candidates and has no products that have received regulatory approval. Any products developed by the Company will require approval from the FDA or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company's products will receive the necessary approvals. If the Company is denied such approvals or such approvals are delayed, it would have a material adverse effect on the Company's future operating results.

To achieve profitable operations, the Company must successfully develop, test, manufacture and market products, as well as secure the necessary regulatory approvals. There can be no assurance that any such products can be developed successfully or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed. These factors would have a material adverse effect on the Company's future financial results.

Stock-Based Compensation

In March 2013, the shareholders of the Company approved the amended and restated 2010 Stock Incentive Plan (the "2010 Plan"). Up to 3,750,000 shares of the Company's common stock may be issued pursuant to awards granted under the 2010 Plan, plus 1,540,739 shares of common stock underlying already outstanding awards under the Company's prior plans. As of September 30, 2013, the Company had 1,951,347 shares of common stock subject to outstanding awards. The contractual life of options granted under the 2010 Plan may not exceed seven years. The 2010 Plan uses a "fungible share" concept under which any awards that are not a full-value award will be counted against the share limit as one (1) share for each share of common stock and any award that is a full-value award will be counted against the share limit as 1.5 shares for each one share of common stock. The Company has not made any new awards under any prior equity plans after March 2, 2010, the effective date the 2010 Plan was approved by the Company's stockholders. The 2010 Plan replaces the 2004 Stock Incentive Plan and 2005 Non-Employee Directors Stock Option Plan.

The Company uses the Black-Scholes pricing model to calculate the fair value of stock options. The expected life for grants was calculated in accordance with the simplified method described in the Securities and Exchange Commission Staff Accounting Bulletin (SAB) Topic 14.D.2 in accordance with SAB No. 110.

The risk-free rate of interest for periods within the contractual life of the stock option award is based on the yield of U.S. Treasury strips on the date the award is granted with a maturity equal to the expected term of the award. The Company estimates forfeitures based on actual forfeitures during its limited history. Additionally, the Company has assumed that dividends will not be paid.

For stock options granted to non-employees, the Company measures fair value of the equity instruments utilizing the Black-Scholes valuation model, if that value is more reliably measurable than the fair value of the consideration or service received. The fair value of these instruments is periodically revalued as the options vest, and is recognized as expense over the related period of service or vesting period, whichever is longer. The total cost expensed (credited) for options granted to non-employees for the years ended September 30, 2011, 2012 and 2013 was $(44), $0, and $0, respectively.

The Company expenses ratably over the vesting period the cost of the stock options granted to employees and directors. The total compensation cost for the years ended September 30, 2011, 2012, and 2013 was $4,964, $1,828, and $1,538 respectively. At September 30, 2013, the total compensation cost related to non-vested options not yet recognized was $871, which will be recognized over the next three years assuming the employees complete their service period for vesting of the options. The Black-Scholes valuation model assumptions are as follows and were determined as discussed above:

		Year Ended September 30,
		2011		2012		2013
Expected life (in years)		3.77 - 5.25		3.0 - 4.75		2.39-4.75
Expected volatility		65 - 72%		58 - 76%		80-96%
Expected dividend yield		0%		0%		0%
Risk-free interest rate		0.75 - 1.97%		0.39 - 0.91%		0.25-0.75%
Weighted-average grant date fair value	$	6.36	$	2.54	$	2.43

Participating Securities

In June 2008 the Financial Accounting Standards Board ("FASB") issued ASC 260-10-55 Earnings Per Share — Overall (formerly Financial Statement Position Emerging Issues Task Force 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities) ("ASC 260-10-55"). ASC 260-10-55 provides that securities and unvested share-based payment awards that contain non-forfeitable rights to dividends or dividend equivalents (whether paid or unpaid) are participating securities and shall be included in the computation of earnings per share pursuant to the two-class method.

Warrant Liability — Given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55. These securities were excluded from the per share calculation for all years since their inclusion would be anti-dilutive.

Restricted Stock Units — Given that the holders of Restricted Stock Unit awards ("RSUs") will only receive dividends or dividend equivalents on RSUs that have vested prior to the Company declaring dividends as well as forfeiting their rights to receive dividends or dividend equivalents on any unvested portion, the Company determined that the RSUs are non-participating securities and therefore are not subject to ASC 260-10-55.

Reclassifications:

Certain items in the prior year's financial statements have been reclassified to conform with the current year's presentation.